“(F) Participation in the paycheck protection program.—In an agreement to participate in a loan on a deferred basis under paragraph (36), the participation by the Administration shall be 100 percent.”
; and
“(36) Paycheck protection program.—
“(A) Definitions.—In this paragraph—
“(i) the terms ‘appropriate Federal banking agency’ and ‘insured depository institution’ have the meanings given those terms in section 3 of the Federal Deposit Insurance Act (12 U.S.C. 1813);
“(ii) the term ‘covered loan’ means a loan made under this paragraph during the covered period;
“(iii) the term ‘covered period’ means the period beginning on February 15, 2020 and ending on June 30, 2020;
“(iv) the term ‘eligible recipient’ means an individual or entity that is eligible to receive a covered loan;
“(v) the term ‘eligible self-employed individual’ has the meaning given the term in section 7002(b) of the Families First Coronavirus Response Act (Public Law 116–127);
“(vi) the term ‘insured credit union’ has the meaning given the term in section 101 of the Federal Credit Union Act (12 U.S.C. 1752);
“(vii) the term ‘nonprofit organization’ means an organization that is described in section 501(c)(3) of the Internal Revenue Code of 1986 and that is exempt from taxation under section 501(a) of such Code;
“(viii) the term ‘payroll costs’—
“(I) means—
“(aa) the sum of payments of any compensation with respect to employees that is a—
“(AA) salary, wage, commission, or similar compensation;
“(BB) payment of cash tip or equivalent;
“(CC) payment for vacation, parental, family, medical, or sick leave;
“(DD) allowance for dismissal or separation;
“(EE) payment required for the provisions of group health care benefits, including insurance premiums;
“(FF) payment of any retirement benefit; or
“(GG) payment of State or local tax assessed on the compensation of employees; and
“(bb) the sum of payments of any compensation to or income of a sole proprietor or independent contractor that is a wage, commission, income, net earnings from self-employment, or similar compensation and that is in an amount that is not more than $100,000 in 1 year, as prorated for the covered period; and
“(II) shall not include—
“(aa) the compensation of an individual employee in excess of an annual salary of $100,000, as prorated for the covered period;
“(bb) taxes imposed or withheld under chapters 21, 22, or 24 of the Internal Revenue Code of 1986 during the covered period;
“(cc) any compensation of an employee whose principal place of residence is outside of the United States;
“(dd) qualified sick leave wages for which a credit is allowed under section 7001 of the Families First Coronavirus Response Act (Public Law 116–127); or
“(ee) qualified family leave wages for which a credit is allowed under section 7003 of the Families First Coronavirus Response Act (Public Law 116–127); and
“(ix) the term ‘veterans organization’ means an organization that is described in section 501(c)(19) of the Internal Revenue Code that is exempt from taxation under section 501(a) of such Code.
“(B) Paycheck protection loans.—Except as otherwise provided in this paragraph, the Administrator may guarantee covered loans under the same terms, conditions, and processes as a loan made under this subsection.
“(C) Registration of loans.—Not later than 15 days after the date on which a loan is made under this paragraph, the Administration shall register the loan using the TIN (as defined in section 7701 of the Internal Revenue Code of 1986) assigned to the borrower.
“(D) Increased eligibility for certain small businesses and organizations.—
“(i) In general.—During the covered period, in addition to small business concerns, any business concern, nonprofit organization, veterans organization, or Tribal business concern described in section 31(b)(2)(C) shall be eligible to receive a covered loan if the business concern, nonprofit organization, veterans organization, or Tribal business concern employs not more than the greater of—
“(I) 500 employees; or
“(II) if applicable, the size standard in number of employees established by the Administration for the industry in which the business concern, nonprofit organization, veterans organization, or Tribal business concern operates.
“(ii) Inclusion of sole proprietors, independent contractors, and eligible self-employed individuals.—
“(I) In general.—During the covered period, individuals who operate under a sole proprietorship or as an independent contractor and eligible self-employed individuals shall be eligible to receive a covered loan.
“(II) Documentation.—An eligible self-employed individual, independent contractor, or sole proprietorship seeking a covered loan shall submit such documentation as is necessary to establish such individual as eligible, including payroll tax filings reported to the Internal Revenue Service, Forms 1099–MISC, and income and expenses from the sole proprietorship, as determined by the Administrator and the Secretary.
“(iii) Business concerns with more than 1 physical location.—During the covered period, any business concern that employs not more than 500 employees per physical location of the business concern and that is assigned a North American Industry Classification System code beginning with 72 at the time of disbursal shall be eligible to receive a covered loan.
“(iv) Waiver of affiliation rules.—During the covered period, the provisions applicable to affiliations under section 121.103 of title 13, Code of Federal Regulations, or any successor regulation, are waived with respect to eligibility for a covered loan for—
“(I) any business concern with not more than 500 employees that, as of the date on which the covered loan is disbursed, is assigned a North American Industry Classification System code beginning with 72;
“(II) any business concern operating as a franchise that is assigned a franchise identifier code by the Administration; and
“(III) any business concern that receives financial assistance from a company licensed under section 301 of the Small Business Investment Act of 1958 (15 U.S.C. 681).
“(v) Employee.—For purposes of determining whether a business concern, nonprofit organization, veterans organization, or Tribal business concern described in section 31(b)(2)(C) employs not more than 500 employees under clause (i)(I), the term ‘employee’ includes individuals employed on a full-time, part-time, or other basis.
“(vi) Affiliation.—The provisions applicable to affiliations under section 121.103 of title 13, Code of Federal Regulations, or any successor thereto, shall apply with respect to a nonprofit organization and a veterans organization in the same manner as with respect to a small business concern.
“(E) Maximum loan amount.—During the covered period, with respect to a covered loan, the maximum loan amount shall be the lesser of—
“(i)
(I) the sum of—
“(aa) the product obtained by multiplying—
“(AA) the average total monthly payments by the applicant for payroll costs incurred during the 1-year period before the date on which the loan is made, except that, in the case of an applicant that is seasonal employer, as determined by the Administrator, the average total monthly payments for payroll shall be for the 12-week period beginning February 15, 2019, or at the election of the eligible recipient, March 1, 2019, and ending June 30, 2019; by
“(BB) 2.5; and
“(bb) the outstanding amount of a loan under subsection (b)(2) that was made during the period beginning on January 31, 2020 and ending on the date on which covered loans are made available to be refinanced under the covered loan; or
“(II) if requested by an otherwise eligible recipient that was not in business during the period beginning on February 15, 2019 and ending on June 30, 2019, the sum of—
“(aa) the product obtained by multiplying—
“(AA) the average total monthly payments by the applicant for payroll costs incurred during the period beginning on January 1, 2020 and ending on February 29, 2020; by
“(BB) 2.5; and
“(bb) the outstanding amount of a loan under subsection (b)(2) that was made during the period beginning on January 31, 2020 and ending on the date on which covered loans are made available to be refinanced under the covered loan; or
“(ii) $10,000,000.
“(F) Allowable uses of covered loans.—
“(i) In general.—During the covered period, an eligible recipient may, in addition to the allowable uses of a loan made under this subsection, use the proceeds of the covered loan for—
“(I) payroll costs;
“(II) costs related to the continuation of group health care benefits during periods of paid sick, medical, or family leave, and insurance premiums;
“(III) employee salaries, commissions, or similar compensations;
“(IV) payments of interest on any mortgage obligation (which shall not include any prepayment of or payment of principal on a mortgage obligation);
“(V) rent (including rent under a lease agreement);
“(VI) utilities; and
“(VII) interest on any other debt obligations that were incurred before the covered period.
“(ii) Delegated authority.—
“(I) In general.—For purposes of making covered loans for the purposes described in clause (i), a lender approved to make loans under this subsection shall be deemed to have been delegated authority by the Administrator to make and approve covered loans, subject to the provisions of this paragraph.
“(II) Considerations.—In evaluating the eligibility of a borrower for a covered loan with the terms described in this paragraph, a lender shall consider whether the borrower—
“(aa) was in operation on February 15, 2020; and
“(bb)
(AA) had employees for whom the borrower paid salaries and payroll taxes; or
“(BB) paid independent contractors, as reported on a Form 1099–MISC.
“(iii) Additional lenders.—The authority to make loans under this paragraph shall be extended to additional lenders determined by the Administrator and the Secretary of the Treasury to have the necessary qualifications to process, close, disburse and service loans made with the guarantee of the Administration.
“(iv) Refinance.—A loan made under subsection (b)(2) during the period beginning on January 31, 2020 and ending on the date on which covered loans are made available may be refinanced as part of a covered loan.
“(v) Nonrecourse.—Notwithstanding the waiver of the personal guarantee requirement or collateral under subparagraph (J), the Administrator shall have no recourse against any individual shareholder, member, or partner of an eligible recipient of a covered loan for nonpayment of any covered loan, except to the extent that such shareholder, member, or partner uses the covered loan proceeds for a purpose not authorized under clause (i).
“(G) Borrower requirements.—
“(i) Certification.—An eligible recipient applying for a covered loan shall make a good faith certification—
“(I) that the uncertainty of current economic conditions makes necessary the loan request to support the ongoing operations of the eligible recipient;
“(II) acknowledging that funds will be used to retain workers and maintain payroll or make mortgage payments, lease payments, and utility payments;
“(III) that the eligible recipient does not have an application pending for a loan under this subsection for the same purpose and duplicative of amounts applied for or received under a covered loan; and
“(IV) during the period beginning on February 15, 2020 and ending on December 31, 2020, that the eligible recipient has not received amounts under this subsection for the same purpose and duplicative of amounts applied for or received under a covered loan.
“(H) Fee waiver.—During the covered period, with respect to a covered loan—
“(i) in lieu of the fee otherwise applicable under paragraph (23)(A), the Administrator shall collect no fee; and
“(ii) in lieu of the fee otherwise applicable under paragraph (18)(A), the Administrator shall collect no fee.
“(I) Credit elsewhere.—During the covered period, the requirement that a small business concern is unable to obtain credit elsewhere, as defined in section 3(h), shall not apply to a covered loan.
“(J) Waiver of personal guarantee requirement.—During the covered period, with respect to a covered loan—
“(i) no personal guarantee shall be required for the covered loan; and
“(ii) no collateral shall be required for the covered loan.
“(K) Maturity for loans with remaining balance after application of forgiveness.—With respect to a covered loan that has a remaining balance after reduction based on the loan forgiveness amount under section 1106 of the CARES Act—
“(i) the remaining balance shall continue to be guaranteed by the Administration under this subsection; and
“(ii) the covered loan shall have a maximum maturity of 10 years from the date on which the borrower applies for loan forgiveness under that section.
“(L) Interest rate requirements.—A covered loan shall bear an interest rate not to exceed 4 percent.
“(M) Loan deferment.—
“(i) Definition of impacted borrower.—
“(I) In general.—In this subparagraph, the term ‘impacted borrower’ means an eligible recipient that—
“(aa) is in operation on February 15, 2020; and
“(bb) has an application for a covered loan that is approved or pending approval on or after the date of enactment of this paragraph.
“(II) Presumption.—For purposes of this subparagraph, an impacted borrower is presumed to have been adversely impacted by COVID–19.
“(ii) Deferral.—During the covered period, the Administrator shall—
“(I) consider each eligible recipient that applies for a covered loan to be an impacted borrower; and
“(II) require lenders under this subsection to provide complete payment deferment relief for impacted borrowers with covered loans for a period of not less than 6 months, including payment of principal, interest, and fees, and not more than 1 year.
“(iii) Secondary market.—During the covered period, with respect to a covered loan that is sold on the secondary market, if an investor declines to approve a deferral requested by a lender under clause (ii), the Administrator shall exercise the authority to purchase the loan so that the impacted borrower may receive a deferral for a period of not less than 6 months, including payment of principal, interest, and fees, and not more than 1 year.
“(iv) Guidance.—Not later than 30 days after the date of enactment of this paragraph, the Administrator shall provide guidance to lenders under this paragraph on the deferment process described in this subparagraph.
“(N) Secondary market sales.—A covered loan shall be eligible to be sold in the secondary market consistent with this subsection. The Administrator may not collect any fee for any guarantee sold into the secondary market under this subparagraph.
“(O) Regulatory capital requirements.—
“(i) Risk weight.—With respect to the appropriate Federal banking agencies or the National Credit Union Administration Board applying capital requirements under their respective risk-based capital requirements, a covered loan shall receive a risk weight of zero percent.
“(ii) Temporary relief from tdr disclosures.—Notwithstanding any other provision of law, an insured depository institution or an insured credit union that modifies a covered loan in relation to COVID–19-related difficulties in a troubled debt restructuring on or after March 13, 2020, shall not be required to comply with the Financial Accounting Standards Board Accounting Standards Codification Subtopic 310–40 (‘Receivables – Troubled Debt Restructurings by Creditors’) for purposes of compliance with the requirements of the Federal Deposit Insurance Act (12 U.S.C. 1811 et seq.), until such time and under such circumstances as the appropriate Federal banking agency or the National Credit Union Administration Board, as applicable, determines appropriate.
“(P) Reimbursement for processing.—
“(i) In general.—The Administrator shall reimburse a lender authorized to make a covered loan at a rate, based on the balance of the financing outstanding at the time of disbursement of the covered loan, of—
“(I) 5 percent for loans of not more than $350,000;
“(II) 3 percent for loans of more than $350,000 and less than $2,000,000; and
“(III) 1 percent for loans of not less than $2,000,000.
“(ii) Fee limits.—An agent that assists an eligible recipient to prepare an application for a covered loan may not collect a fee in excess of the limits established by the Administrator.
“(iii) Timing.—A reimbursement described in clause (i) shall be made not later than 5 days after the disbursement of the covered loan.
“(iv) Sense of the senate.—It is the sense of the Senate that the Administrator should issue guidance to lenders and agents to ensure that the processing and disbursement of covered loans prioritizes small business concerns and entities in underserved and rural markets, including veterans and members of the military community, small business concerns owned and controlled by socially and economically disadvantaged individuals (as defined in section 8(d)(3)(C)), women, and businesses in operation for less than 2 years.
“(Q) Duplication.—Nothing in this paragraph shall prohibit a recipient of an economic injury disaster loan made under subsection (b)(2) during the period beginning on January 31, 2020 and ending on the date on which covered loans are made available that is for a purpose other than paying payroll costs and other obligations described in subparagraph (F) from receiving assistance under this paragraph.
“(R) Waiver of prepayment penalty.—Notwithstanding any other provision of law, there shall be no prepayment penalty for any payment made on a covered loan.”
“(D) an emergency involving Federal primary responsibility determined to exist by the President under the section 501(b) of the Robert T. Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C. 5191(b)); or”
; and
“(1) Debtor.—The term ‘debtor’—
“(A) subject to subparagraph (B), means a person engaged in commercial or business activities (including any affiliate of such person that is also a debtor under this title and excluding a person whose primary activity is the business of owning single asset real estate) that has aggregate noncontingent liquidated secured and unsecured debts as of the date of the filing of the petition or the date of the order for relief in an amount not more than $7,500,000 (excluding debts owed to 1 or more affiliates or insiders) not less than 50 percent of which arose from the commercial or business activities of the debtor; and
“(B) does not include—
“(i) any member of a group of affiliated debtors that has aggregate noncontingent liquidated secured and unsecured debts in an amount greater than $7,500,000 (excluding debt owed to 1 or more affiliates or insiders);
“(ii) any debtor that is a corporation subject to the reporting requirements under section 13 or 15(d) of the Securities Exchange Act of 1934 (15 U.S.C. 78m, 78o(d)); or
“(iii) any debtor that is an affiliate of an issuer, as defined in section 3 of the Securities Exchange Act of 1934 (15 U.S.C. 78c).”
“(iii) any debtor that is an affiliate of an issuer (as defined in section 3 of the Securities Exchange Act of 1934 (15 U.S.C. 78c)).”
“(1) Debtor.—The term ‘debtor’ means a small business debtor.”
“(V) Payments made under Federal law relating to the national emergency declared by the President under the National Emergencies Act (50 U.S.C. 1601 et seq.) with respect to the coronavirus disease 2019 (COVID–19).”
“(d)
(1) Subject to paragraph (3), for a plan confirmed prior to the date of enactment of this subsection, the plan may be modified upon the request of the debtor if—
“(A) the debtor is experiencing or has experienced a material financial hardship due, directly or indirectly, to the coronavirus disease 2019 (COVID–19) pandemic; and
“(B) the modification is approved after notice and a hearing.
“(2) A plan modified under paragraph (1) may not provide for payments over a period that expires more than 7 years after the time that the first payment under the original confirmed plan was due.
“(3) Sections 1322(a), 1322(b), 1323(c), and the requirements of section 1325(a) shall apply to any modification under paragraph (1).”
“(i)
(1)
(A) In addition to any other amounts, the Secretary of Labor shall provide for the transfer of funds during the applicable period to the accounts of the States in the Unemployment Trust Fund, by transfer from amounts reserved for that purpose in the Federal unemployment account, in accordance with the succeeding provisions of this subsection.
“(B) The amount of funds transferred to the account of a State under subparagraph (A) during the applicable period shall, as determined by the Secretary of Labor, be equal to one-half of the amounts of compensation (as defined in section 3306(h) of the Internal Revenue Code of 1986) attributable under the State law to service to which section 3309(a)(1) of such Code applies that were paid by the State for weeks of unemployment beginning and ending during such period. Such transfers shall be made at such times as the Secretary of Labor considers appropriate.
“(C) Notwithstanding any other law, funds transferred to the account of a State under subparagraph (A) shall be used exclusively to reimburse governmental entities and other organizations described in section 3309(a)(2) of such Code for amounts paid (in lieu of contributions) into the State unemployment fund pursuant to such section.
“(D) For purposes of this paragraph, the term ‘applicable period’ means the period beginning on March 13, 2020, and ending on December 31, 2020.
“(2)
(A) Notwithstanding any other provision of law, the Secretary of the Treasury shall transfer from the general fund of the Treasury (from funds not otherwise appropriated) to the Federal unemployment account such sums as the Secretary of Labor estimates to be necessary for purposes of making the transfers described in paragraph (1).
“(B) There are appropriated from the general fund of the Treasury, without fiscal year limitation, the sums referred to in subparagraph (A) and such sums shall not be required to be repaid.”
“(5)
(A) Notwithstanding paragraph (3), subsection (c)(1)(B), and any other limitation on total benefits in this Act, for registration periods beginning on or after April 1, 2020, but on or before July 31, 2020, a recovery benefit in the amount of $1,200 shall be payable to a qualified employee with respect to any registration period in which the employee received unemployment benefits under paragraph (1)(A), and in any registration period in which the employee did not receive unemployment benefits due to the limitation in subsection (c)(1)(B) or due to reaching the maximum number of days of benefits in the benefit year beginning July 1, 2019, under subsection (c)(1)(A). No recovery benefits shall be payable under this section upon the exhaustion of the funds appropriated under subparagraph (B) for payment of benefits under this subparagraph.
“(B) Out of any funds in the Treasury not otherwise appropriated, there are appropriated $425,000,000 to cover the cost of recovery benefits provided under subparagraph (A), to remain available until expended.”
“SEC. 6428. 2020 RECOVERY REBATES FOR INDIVIDUALS.
“(a) In General.—In the case of an eligible individual, there shall be allowed as a credit against the tax imposed by subtitle A for the first taxable year beginning in 2020 an amount equal to the sum of—
“(1) $1,200 ($2,400 in the case of eligible individuals filing a joint return), plus
“(2) an amount equal to the product of $500 multiplied by the number of qualifying children (within the meaning of section 24(c)) of the taxpayer.
“(b) Treatment of Credit.—The credit allowed by subsection (a) shall be treated as allowed by subpart C of part IV of subchapter A of chapter 1.
“(c) Limitation Based on Adjusted Gross Income.—The amount of the credit allowed by subsection (a) (determined without regard to this subsection and subsection (e)) shall be reduced (but not below zero) by 5 percent of so much of the taxpayer’s adjusted gross income as exceeds—
“(1) $150,000 in the case of a joint return,
“(2) $112,500 in the case of a head of household, and
“(3) $75,000 in the case of a taxpayer not described in paragraph (1) or (2).
“(d) Eligible Individual.—For purposes of this section, the term ‘eligible individual’ means any individual other than—
“(1) any nonresident alien individual,
“(2) any individual with respect to whom a deduction under section 151 is allowable to another taxpayer for a taxable year beginning in the calendar year in which the individual’s taxable year begins, and
“(3) an estate or trust.
“(e) Coordination With Advance Refunds of Credit.—
“(1) In general.—The amount of credit which would (but for this paragraph) be allowable under this section shall be reduced (but not below zero) by the aggregate refunds and credits made or allowed to the taxpayer under subsection (f). Any failure to so reduce the credit shall be treated as arising out of a mathematical or clerical error and assessed according to section 6213(b)(1).
“(2) Joint returns.—In the case of a refund or credit made or allowed under subsection (f) with respect to a joint return, half of such refund or credit shall be treated as having been made or allowed to each individual filing such return.
“(f) Advance Refunds and Credits.—
“(1) In general.—Subject to paragraph (5), each individual who was an eligible individual for such individual’s first taxable year beginning in 2019 shall be treated as having made a payment against the tax imposed by chapter 1 for such taxable year in an amount equal to the advance refund amount for such taxable year.
“(2) Advance refund amount.—For purposes of paragraph (1), the advance refund amount is the amount that would have been allowed as a credit under this section for such taxable year if this section (other than subsection (e) and this subsection) had applied to such taxable year.
“(3) Timing and manner of payments.—
“(A) Timing.—The Secretary shall, subject to the provisions of this title, refund or credit any overpayment attributable to this section as rapidly as possible. No refund or credit shall be made or allowed under this subsection after December 31, 2020.
“(B) Delivery of payments.—Notwithstanding any other provision of law, the Secretary may certify and disburse refunds payable under this subsection electronically to any account to which the payee authorized, on or after January 1, 2018, the delivery of a refund of taxes under this title or of a Federal payment (as defined in section 3332 of title 31, United States Code).
“(C) Waiver of certain rules.—Notwithstanding section 3325 of title 31, United States Code, or any other provision of law, with respect to any payment of a refund under this subsection, a disbursing official in the executive branch of the United States Government may modify payment information received from an officer or employee described in section 3325(a)(1)(B) of such title for the purpose of facilitating the accurate and efficient delivery of such payment. Except in cases of fraud or reckless neglect, no liability under sections 3325, 3527, 3528, or 3529 of title 31, United States Code, shall be imposed with respect to payments made under this subparagraph.
“(4) No interest.—No interest shall be allowed on any overpayment attributable to this section.
“(5) Alternate taxable year.—In the case of an individual who, at the time of any determination made pursuant to paragraph (3), has not filed a tax return for the year described in paragraph (1), the Secretary may—
“(A) apply such paragraph by substituting ‘2018’ for ‘2019’, and
“(B) if the individual has not filed a tax return for such individual’s first taxable year beginning in 2018, use information with respect to such individual for calendar year 2019 provided in—
“(i) Form SSA–1099, Social Security Benefit Statement, or
“(ii) Form RRB–1099, Social Security Equivalent Benefit Statement.
“(6) Notice to taxpayer.—Not later than 15 days after the date on which the Secretary distributed any payment to an eligible taxpayer pursuant to this subsection, notice shall be sent by mail to such taxpayer’s last known address. Such notice shall indicate the method by which such payment was made, the amount of such payment, and a phone number for the appropriate point of contact at the Internal Revenue Service to report any failure to receive such payment.
“(g) Identification Number Requirement.—
“(1) In general.—No credit shall be allowed under subsection (a) to an eligible individual who does not include on the return of tax for the taxable year—
“(A) such individual’s valid identification number,
“(B) in the case of a joint return, the valid identification number of such individual’s spouse, and
“(C) in the case of any qualifying child taken into account under subsection (a)(2), the valid identification number of such qualifying child.
“(2) Valid identification number.—
“(A) In general.—For purposes of paragraph (1), the term ‘valid identification number’ means a social security number (as such term is defined in section 24(h)(7)).
“(B) Adoption taxpayer identification number.—For purposes of paragraph (1)(C), in the case of a qualifying child who is adopted or placed for adoption, the term ‘valid identification number’ shall include the adoption taxpayer identification number of such child.
“(3) Special rule for members of the armed forces.—Paragraph (1)(B) shall not apply in the case where at least 1 spouse was a member of the Armed Forces of the United States at any time during the taxable year and at least 1 spouse satisfies paragraph (1)(A).
“(4) Mathematical or clerical error authority.—Any omission of a correct valid identification number required under this subsection shall be treated as a mathematical or clerical error for purposes of applying section 6213(g)(2) to such omission.
“(h) Regulations.—The Secretary shall prescribe such regulations or other guidance as may be necessary to carry out the purposes of this section, including any such measures as are deemed appropriate to avoid allowing multiple credits or rebates to a taxpayer.”
Amounts made available in appropriations under clauses (ii), (iii), and (iv) of this subparagraph may be transferred between such appropriations upon the advance notification of the Committees on Appropriations of the House of Representatives and the Senate. Such transfer authority is in addition to any other transfer authority provided by law.
“Sec. 6428. 2020 Recovery Rebates for individuals.”.
In the case of a governmental plan (as defined in section 414(d) of the Internal Revenue Code of 1986), clause (ii) shall be applied by substituting the date which is 2 years after the date otherwise applied under clause (ii).
the plan or contract is operated as if such plan or contract amendment were in effect, and
“(I) Temporary waiver of minimum required distribution.—
“(i) In general.—The requirements of this paragraph shall not apply for calendar year 2020 to—
“(I) a defined contribution plan which is described in this subsection or in section 403(a) or 403(b),
“(II) a defined contribution plan which is an eligible deferred compensation plan described in section 457(b) but only if such plan is maintained by an employer described in section 457(e)(1)(A), or
“(III) an individual retirement plan.
“(ii) Special rule for required beginning dates in 2020.—Clause (i) shall apply to any distribution which is required to be made in calendar year 2020 by reason of—
“(I) a required beginning date occurring in such calendar year, and
“(II) such distribution not having been made before January 1, 2020.
“(iii) Special rules regarding waiver period.—For purposes of this paragraph—
“(I) the required beginning date with respect to any individual shall be determined without regard to this subparagraph for purposes of applying this paragraph for calendar years after 2020, and
“(II) if clause (ii) of subparagraph (B) applies, the 5-year period described in such clause shall be determined without regard to calendar year 2020.”
In the case of a governmental plan, subclause (II) shall be applied by substituting “2024” for “2022”.
“(22) Charitable contributions.—In the case of taxable years beginning in 2020, the amount (not to exceed $300) of qualified charitable contributions made by an eligible individual during the taxable year.”
“(f) Definitions Relating to Qualified Charitable Contributions.—For purposes of subsection (a)(22)—
“(1) Eligible individual.—The term ‘eligible individual’ means any individual who does not elect to itemize deductions.
“(2) Qualified charitable contributions.—The term ‘qualified charitable contribution’ means a charitable contribution (as defined in section 170(c))—
“(A) which is made in cash,
“(B) for which a deduction is allowable under section 170 (determined without regard to subsection (b) thereof), and
“(C) which is—
“(i) made to an organization described in section 170(b)(1)(A), and
“(ii) not—
“(I) to an organization described in section 509(a)(3), or
“(II) for the establishment of a new, or maintenance of an existing, donor advised fund (as defined in section 4966(d)(2)).
“(B) in the case of payments made before January 1, 2021, the payment by an employer, whether paid to the employee or to a lender, of principal or interest on any qualified education loan (as defined in section 221(d)(1)) incurred by the employee for education of the employee, and”
Such term shall not include any wages taken into account under section 7001 or section 7003 of the Families First Coronavirus Response Act.
“(1) in the case of a taxable year beginning before January 1, 2021, the aggregate of the net operating loss carryovers to such year, plus the net operating loss carrybacks to such year, and
“(2) in the case of a taxable year beginning after December 31, 2020, the sum of—
“(A) the aggregate amount of net operating losses arising in taxable years beginning before January 1, 2018, carried to such taxable year, plus
“(B) the lesser of—
“(i) the aggregate amount of net operating losses arising in taxable years beginning after December 31, 2017, carried to such taxable year, or
“(ii) 80 percent of the excess (if any) of—
“(I) taxable income computed without regard to the deductions under this section and sections 199A and 250, over
“(II) the amount determined under subparagraph (A).”
“(C) for taxable years beginning after December 31, 2020, be reduced by 20 percent of the excess (if any) described in subsection (a)(2)(B)(ii) for such taxable year.”
“(D) Special rule for losses arising in 2018, 2019, and 2020.—
“(i) In general.—In the case of any net operating loss arising in a taxable year beginning after December 31, 2017, and before January 1, 2021—
“(I) such loss shall be a net operating loss carryback to each of the 5 taxable years preceding the taxable year of such loss, and
“(II) subparagraphs (B) and (C)(i) shall not apply.
“(ii) Special rules for reits.—For purposes of this subparagraph—
“(I) In general.—A net operating loss for a REIT year shall not be a net operating loss carryback to any taxable year preceding the taxable year of such loss.
“(II) Special rule.—In the case of any net operating loss for a taxable year which is not a REIT year, such loss shall not be carried to any preceding taxable year which is a REIT year.
“(III) REIT year.—For purposes of this subparagraph, the term ‘REIT year’ means any taxable year for which the provisions of part II of subchapter M (relating to real estate investment trusts) apply to the taxpayer.
“(iii) Special rule for life insurance companies.—In the case of a life insurance company, if a net operating loss is carried pursuant to clause (i)(I) to a life insurance company taxable year beginning before January 1, 2018, such net operating loss carryback shall be treated in the same manner as an operations loss carryback (within the meaning of section 810 as in effect before its repeal) of such company to such taxable year.
“(iv) Rule relating to carrybacks to years to which section 965 applies.—If a net operating loss of a taxpayer is carried pursuant to clause (i)(I) to any taxable year in which an amount is includible in gross income by reason of section 965(a), the taxpayer shall be treated as having made the election under section 965(n) with respect to each such taxable year.
“(v) Special rules for elections under paragraph (3).—
“(I) Special election to exclude section 965 years.—If the 5-year carryback period under clause (i)(I) with respect to any net operating loss of a taxpayer includes 1 or more taxable years in which an amount is includible in gross income by reason of section 965(a), the taxpayer may, in lieu of the election otherwise available under paragraph (3), elect under such paragraph to exclude all such taxable years from such carryback period.
“(II) Time of elections.—An election under paragraph (3) (including an election described in subclause (I)) with respect to a net operating loss arising in a taxable year beginning in 2018 or 2019 shall be made by the due date (including extensions of time) for filing the taxpayer’s return for the first taxable year ending after the date of the enactment of this subparagraph.”
“(e) Effective Dates.—
“(1) Net operating loss limitation.—The amendments made by subsections (a) and (d)(2) shall apply to—
“(A) taxable years beginning after December 31, 2017, and
“(B) taxable years beginning on or before such date to which net operating losses arising in taxable years beginning after such date are carried.
“(2) Carryovers and carrybacks.—The amendments made by subsections (b), (c), and (d)(1) shall apply to net operating losses arising in taxable years beginning after December 31, 2017.”
“(A) General rule.—A net operating loss for any taxable year—
“(i) shall be a net operating loss carryback to the extent provided in subparagraphs (B) and (C)(i), and
“(ii) except as provided in subparagraph (C)(ii), shall be a net operating loss carryover—
“(I) in the case of a net operating loss arising in a taxable year beginning before January 1, 2018, to each of the 20 taxable years following the taxable year of the loss, and
“(II) in the case of a net operating loss arising in a taxable year beginning after December 31, 2017, to each taxable year following the taxable year of the loss.”
shall not fail to be treated as timely made if made not later than the date which is 120 days after the date of the enactment of this Act.
“(1) Limitation.—In the case of a taxpayer other than a corporation—
“(A) for any taxable year beginning after December 31, 2017, and before January 1, 2026, subsection (j) (relating to limitation on excess farm losses of certain taxpayers) shall not apply, and
“(B) for any taxable year beginning after December 31, 2020, and before January 1, 2026, any excess business loss of the taxpayer for the taxable year shall not be allowed.”
“(B) Treatment of capital gains and losses.—
“(i) Losses.—Deductions for losses from sales or exchanges of capital assets shall not be taken into account under subparagraph (A)(i).
“(ii) Gains.—The amount of gains from sales or exchanges of capital assets taken into account under subparagraph (A)(ii) shall not exceed the lesser of—
“(I) the capital gain net income determined by taking into account only gains and losses attributable to a trade or business, or
“(II) the capital gain net income.”
“(5) Special rule.—In the case of a corporation making an election under this paragraph—
“(A) paragraph (1) shall not apply, and
“(B) subsection (c) shall not apply to the first taxable year of such corporation beginning in 2018.”
in a manner similar to the manner provided in section 6411(b) of the Internal Revenue Code of 1986.
“(10) Special rule for taxable years beginning in 2019 and 2020.—
“(A) In general.—
“(i) In general.—Except as provided in clause (ii) or (iii), in the case of any taxable year beginning in 2019 or 2020, paragraph (1)(B) shall be applied by substituting ‘50 percent’ for ‘30 percent’.
“(ii) Special rule for partnerships.—In the case of a partnership—
“(I) clause (i) shall not apply to any taxable year beginning in 2019, but
“(II) unless a partner elects not to have this subclause apply, in the case of any excess business interest of the partnership for any taxable year beginning in 2019 which is allocated to the partner under paragraph (4)(B)(i)(II)—
“(aa) 50 percent of such excess business interest shall be treated as business interest which, notwithstanding paragraph (4)(B)(ii), is paid or accrued by the partner in the partner’s first taxable year beginning in 2020 and which is not subject to the limits of paragraph (1), and
“(bb) 50 percent of such excess business interest shall be subject to the limitations of paragraph (4)(B)(ii) in the same manner as any other excess business interest so allocated.
“(iii) Election out.—A taxpayer may elect, at such time and in such manner as the Secretary may prescribe, not to have clause (i) apply to any taxable year. Such an election, once made, may be revoked only with the consent of the Secretary. In the case of a partnership, any such election shall be made by the partnership and may be made only for taxable years beginning in 2020.
“(B) Election to use 2019 adjusted taxable income for taxable years beginning in 2020.—
“(i) In general.—Subject to clause (ii), in the case of any taxable year beginning in 2020, the taxpayer may elect to apply this subsection by substituting the adjusted taxable income of the taxpayer for the last taxable year beginning in 2019 for the adjusted taxable income for such taxable year. In the case of a partnership, any such election shall be made by the partnership.
“(ii) Special rule for short taxable years.—If an election is made under clause (i) for a taxable year which is a short taxable year, the adjusted taxable income for the taxpayer’s last taxable year beginning in 2019 which is substituted under clause (i) shall be equal to the amount which bears the same ratio to such adjusted taxable income determined without regard to this clause as the number of months in the short taxable year bears to 12”
“(vii) any qualified improvement property.”
, and
“(E)(vii) 20”.
“(14) with respect to distilled spirits removed after December 31, 2019, and before January 1, 2021, free of tax for use in or contained in hand sanitizer produced and distributed in a manner consistent with any guidance issued by the Food and Drug Administration that is related to the outbreak of virus SARS–CoV–2 or coronavirus disease 2019 (COVID–19).”
“(D) a respiratory protective device that is approved by the National Institute for Occupational Safety and Health under part 84 of title 42, Code of Federal Regulations (or any successor regulations), and that the Secretary determines to be a priority for use during a public health emergency declared under section 319.”
“(j) Risk Management Plans.—Each manufacturer of a drug described in subsection (a) or of any active pharmaceutical ingredient or any associated medical device used for preparation or administration included in the drug, shall develop, maintain, and implement, as appropriate, a redundancy risk management plan that identifies and evaluates risks to the supply of the drug, as applicable, for each establishment in which such drug or active pharmaceutical ingredient of such drug is manufactured. A risk management plan under this section shall be subject to inspection and copying by the Secretary pursuant to an inspection or a request under section 704(a)(4).”
“(d) Interagency Notification.—Not later than 180 days after the date of enactment of this subsection, and every 90 days thereafter, the Secretary shall transmit a report regarding the drugs of the current drug shortage list under this section to the Administrator of the Centers for Medicare & Medicaid Services.”
“(2) In carrying out this subsection with respect to any establishment manufacturing a drug approved under subsection (c) or (j) of section 505 for which a notification has been submitted in accordance with section 506C is, or has been in the last 5 years, listed on the drug shortage list under section 506E, or that is described in section 505(j)(11)(A), a copy of the report shall be sent promptly to the appropriate offices of the Food and Drug Administration with expertise regarding drug shortages.”
“(3)
(A) Each person who registers with the Secretary under this section with regard to a drug shall report annually to the Secretary on the amount of each drug listed under paragraph (1) that was manufactured, prepared, propagated, compounded, or processed by such person for commercial distribution. Such information may be required to be submitted in an electronic format as determined by the Secretary. The Secretary may require that information required to be reported under this paragraph be submitted at the time a public health emergency is declared by the Secretary under section 319 of the Public Health Service Act.
“(B) By order of the Secretary, certain biological products or categories of biological products regulated under section 351 of the Public Health Service Act may be exempt from some or all of the reporting requirements under subparagraph (A), if the Secretary determines that applying such reporting requirements to such biological products or categories of biological products is not necessary to protect the public health.”
“SEC. 506J. DISCONTINUANCE OR INTERRUPTION IN THE PRODUCTION OF MEDICAL DEVICES.
“(a) In General.—A manufacturer of a device that—
“(1) is critical to public health during a public health emergency, including devices that are life-supporting, life-sustaining, or intended for use in emergency medical care or during surgery; or
“(2) for which the Secretary determines that information on potential meaningful supply disruptions of such device is needed during, or in advance of, a public health emergency;
“(b) Timing.—A notice required under subsection (a) shall be submitted to the Secretary—
“(1) at least 6 months prior to the date of the discontinuance or interruption; or
“(2) if compliance with paragraph (1) is not possible, as soon as practicable.
“(c) Distribution.—
“(1) Public availability.—To the maximum extent practicable, subject to paragraph (2), the Secretary shall distribute, through such means as the Secretary determines appropriate, information on the discontinuance or interruption of the manufacture of devices reported under subsection (a) to appropriate organizations, including physician, health provider, patient organizations, and supply chain partners, as appropriate and applicable, as described in subsection (g).
“(2) Public health exception.—The Secretary may choose not to make information collected under this section publicly available pursuant to this section if the Secretary determines that disclosure of such information would adversely affect the public health, such as by increasing the possibility of unnecessary over purchase of product, component parts, or other disruption of the availability of medical products to patients.
“(d) Confidentiality.—Nothing in this section shall be construed as authorizing the Secretary to disclose any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code.
“(e) Failure To Meet Requirements.—If a person fails to submit information required under subsection (a) in accordance with subsection (b)—
“(1) the Secretary shall issue a letter to such person informing such person of such failure;
“(2) not later than 30 calendar days after the issuance of a letter under paragraph (1), the person who receives such letter shall submit to the Secretary a written response to such letter setting forth the basis for noncompliance and providing information required under subsection (a); and
“(3) not later than 45 calendar days after the issuance of a letter under paragraph (1), the Secretary shall make such letter and any response to such letter under paragraph (2) available to the public on the internet website of the Food and Drug Administration, with appropriate redactions made to protect information described in subsection (d), except that, if the Secretary determines that the letter under paragraph (1) was issued in error or, after review of such response, the person had a reasonable basis for not notifying as required under subsection (a), the requirements of this paragraph shall not apply.
“(f) Expedited Inspections and Reviews.—If, based on notifications described in subsection (a) or any other relevant information, the Secretary concludes that there is, or is likely to be, a shortage of an device, the Secretary shall, as appropriate—
“(1) prioritize and expedite the review of a submission under section 513(f)(2), 515, review of a notification under section 510(k), or 520(m) for a device that could help mitigate or prevent such shortage; or
“(2) prioritize and expedite an inspection or reinspection of an establishment that could help mitigate or prevent such shortage.
“(g) Device Shortage List.—
“(1) Establishment.—The Secretary shall establish and maintain an up-to-date list of devices that are determined by the Secretary to be in shortage in the United States.
“(2) Contents.—For each device included on the list under paragraph (1), the Secretary shall include the following information:
“(A) The category or name of the device in shortage.
“(B) The name of each manufacturer of such device.
“(C) The reason for the shortage, as determined by the Secretary, selecting from the following categories:
“(i) Requirements related to complying with good manufacturing practices.
“(ii) Regulatory delay.
“(iii) Shortage or discontinuance of a component or part.
“(iv) Discontinuance of the manufacture of the device.
“(v) Delay in shipping of the device.
“(vi) Delay in sterilization of the device.
“(vii) Demand increase for the device.
“(viii) Facility closure.
“(D) The estimated duration of the shortage as determined by the Secretary.
“(3) Public availability.—
“(A) In general.—Subject to subparagraphs (B) and (C), the Secretary shall make the information in the list under paragraph (1) publicly available.
“(B) Trade secrets and confidential information.—Nothing in this subsection shall be construed to alter or amend section 1905 of title 18, United States Code, or section 552(b)(4) of title 5 of such Code.
“(C) Public health exception.—The Secretary may elect not to make information collected under this subsection publicly available if the Secretary determines that disclosure of such information would adversely affect the public health (such as by increasing the possibility of hoarding or other disruption of the availability of the device to patients).
“(h) Rule of Construction.—Nothing in this section shall be construed to affect the authority of the Secretary on the date of enactment of this section to expedite the review of devices under section 515 of the Federal Food, Drug, and Cosmetic Act, section 515B of such Act relating to the priority review program for devices, and section 564 of such Act relating to the emergency use authorization authorities.
“(i) Definitions.—In this section:
“(1) Meaningful disruption.—The term ‘meaningful disruption’—
“(A) means a change in production that is reasonably likely to lead to a reduction in the supply of a device by a manufacturer that is more than negligible and affects the ability of the manufacturer to fill orders or meet expected demand for its product;
“(B) does not include interruptions in manufacturing due to matters such as routine maintenance or insignificant changes in manufacturing so long as the manufacturer expects to resume operations in a short period of time, not to exceed 6 months;
“(C) does not include interruptions in manufacturing of components or raw materials so long as such interruptions do not result in a shortage of the device and the manufacturer expects to resume operations in a reasonable period of time; and
“(D) does not include interruptions in manufacturing that do not lead to a reduction in procedures or diagnostic tests associated with a medical device designed to perform more than one procedure or diagnostic test.
“(2) Shortage.—The term ‘shortage’, with respect to a device, means a period of time when the demand or projected demand for the device within the United States exceeds the supply of the device.”
“(1) An in vitro diagnostic test defined in section 809.3 of title 21, Code of Federal Regulations (or successor regulations) for the detection of SARS–CoV–2 or the diagnosis of the virus that causes COVID–19, and the administration of such a test, that—
“(A) is approved, cleared, or authorized under section 510(k), 513, 515, or 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k), 360c, 360e, 360bbb–3);
“(B) the developer has requested, or intends to request, emergency use authorization under section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3), unless and until the emergency use authorization request under such section 564 has been denied or the developer of such test does not submit a request under such section within a reasonable timeframe;
“(C) is developed in and authorized by a State that has notified the Secretary of Health and Human Services of its intention to review tests intended to diagnose COVID–19; or
“(D) other test that the Secretary determines appropriate in guidance.”
“(6) Additional amounts for supplemental awards.—In addition to any amounts made available pursuant to this subsection, section 402A of this Act, or section 10503 of the Patient Protection and Affordable Care Act, there is authorized to be appropriated, and there is appropriated, out of any monies in the Treasury not otherwise appropriated, $1,320,000,000 for fiscal year 2020 for supplemental awards under subsection (d) for the detection of SARS–CoV–2 or the prevention, diagnosis, and treatment of COVID–19.”
“(p) Report.—Not later than 4 years after the date of enactment of the Coronavirus Aid, Relief, and Economic Security Act, and every 5 years thereafter, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on the activities and outcomes of the grant programs under subsection (b).”
“(B) Grant periods.—The Director may award grants under this subsection for periods of not more than 5 years.”
“(iii) how the rural underserved populations in the local community or region to be served will benefit from and be involved in the development and ongoing operations of the network;”
; and
“(i) Report.—Not later than 4 years after the date of enactment of the Coronavirus Aid, Relief, and Economic Security Act, and every 5 years thereafter, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on the activities and outcomes of the grant programs under subsections (e), (f), and (g), including the impact of projects funded under such programs on the health status of rural residents with chronic conditions.”
; and
“(3) Statutory references to reserve.—A reference in any Federal statute, except in the case of subsection (b), to the ‘Reserve Corps’ of the Public Health Service or to the ‘reserve’ of the Public Health Service shall be deemed to be a reference to the Ready Reserve Corps.”
“(19) Chapter 1223, Retired Pay for Non-Regular Service.
“(20) Section 12601, Compensation: Reserve on active duty accepting from any person.
“(21) Section 12684, Reserves: separation for absence without authority or sentence to imprisonment.”
; and
“(b)
(1) The authority vested”
“(2) For purposes of”
; and
“(3) For purposes of paragraph (19) of subsection (a), the terms ‘Military department’, ‘Secretary concerned’, and ‘Armed forces’ in such title 10 shall be deemed to include, respectively, the Department of Health and Human Services, the Secretary of Health and Human Services, and the Commissioned Corps.”
“(1) Consent.—The following shall apply with respect to the contents of any record referred to in subsection (a):
“(A) Such contents may be used or disclosed in accordance with the prior written consent of the patient with respect to whom such record is maintained.
“(B) Once prior written consent of the patient has been obtained, such contents may be used or disclosed by a covered entity, business associate, or a program subject to this section for purposes of treatment, payment, and health care operations as permitted by the HIPAA regulations. Any information so disclosed may then be redisclosed in accordance with the HIPAA regulations. Section 13405(c) of the Health Information Technology and Clinical Health Act (42 U.S.C. 17935(c)) shall apply to all disclosures pursuant to subsection (b)(1) of this section.
“(C) It shall be permissible for a patient’s prior written consent to be given once for all such future uses or disclosures for purposes of treatment, payment, and health care operations, until such time as the patient revokes such consent in writing.
“(D) Section 13405(a) of the Health Information Technology and Clinical Health Act (42 U.S.C. 17935(a)) shall apply to all disclosures pursuant to subsection (b)(1) of this section.”
“(D) To a public health authority, so long as such content meets the standards established in section 164.514(b) of title 45, Code of Federal Regulations (or successor regulations) for creating de-identified information.”
“(k) Definitions.—For purposes of this section:
“(1) Breach.—The term ‘breach’ has the meaning given such term for purposes of the HIPAA regulations.
“(2) Business associate.—The term ‘business associate’ has the meaning given such term for purposes of the HIPAA regulations.
“(3) Covered entity.—The term ‘covered entity’ has the meaning given such term for purposes of the HIPAA regulations.
“(4) Health care operations.—The term ‘health care operations’ has the meaning given such term for purposes of the HIPAA regulations.
“(5) HIPAA regulations.—The term ‘HIPAA regulations’ has the meaning given such term for purposes of parts 160 and 164 of title 45, Code of Federal Regulations.
“(6) Payment.—The term ‘payment’ has the meaning given such term for purposes of the HIPAA regulations.
“(7) Public health authority.—The term ‘public health authority’ has the meaning given such term for purposes of the HIPAA regulations.
“(8) Treatment.—The term ‘treatment’ has the meaning given such term for purposes of the HIPAA regulations.
“(9) Unsecured protected health information.—The term ‘unprotected health information’ has the meaning given such term for purposes of the HIPAA regulations.”
“(c) Use of Records in Criminal, Civil, or Administrative Contexts.—Except as otherwise authorized by a court order under subsection (b)(2)(C) or by the consent of the patient, a record referred to in subsection (a), or testimony relaying the information contained therein, may not be disclosed or used in any civil, criminal, administrative, or legislative proceedings conducted by any Federal, State, or local authority, against a patient, including with respect to the following activities:
“(1) Such record or testimony shall not be entered into evidence in any criminal prosecution or civil action before a Federal or State court.
“(2) Such record or testimony shall not form part of the record for decision or otherwise be taken into account in any proceeding before a Federal, State, or local agency.
“(3) Such record or testimony shall not be used by any Federal, State, or local agency for a law enforcement purpose or to conduct any law enforcement investigation.
“(4) Such record or testimony shall not be used in any application for a warrant.”
“(f) Penalties.—The provisions of sections 1176 and 1177 of the Social Security Act shall apply to a violation of this section to the extent and in the same manner as such provisions apply to a violation of part C of title XI of such Act. In applying the previous sentence—
“(1) the reference to ‘this subsection’ in subsection (a)(2) of such section 1176 shall be treated as a reference to ‘this subsection (including as applied pursuant to section 543(f) of the Public Health Service Act)’; and
“(2) in subsection (b) of such section 1176—
“(A) each reference to ‘a penalty imposed under subsection (a)’ shall be treated as a reference to ‘a penalty imposed under subsection (a) (including as applied pursuant to section 543(f) of the Public Health Service Act)’; and
“(B) each reference to ‘no damages obtained under subsection (d)’ shall be treated as a reference to ‘no damages obtained under subsection (d) (including as applied pursuant to section 543(f) of the Public Health Service Act)’.”
“(i) Antidiscrimination.—
“(1) In general.—No entity shall discriminate against an individual on the basis of information received by such entity pursuant to an inadvertent or intentional disclosure of records, or information contained in records, described in subsection (a) in—
“(A) admission, access to, or treatment for health care;
“(B) hiring, firing, or terms of employment, or receipt of worker’s compensation;
“(C) the sale, rental, or continued rental of housing;
“(D) access to Federal, State, or local courts; or
“(E) access to, approval of, or maintenance of social services and benefits provided or funded by Federal, State, or local governments.
“(2) Recipients of federal funds.—No recipient of Federal funds shall discriminate against an individual on the basis of information received by such recipient pursuant to an intentional or inadvertent disclosure of such records or information contained in records described in subsection (a) in affording access to the services provided with such funds.”
“(j) Notification in Case of Breach.—The provisions of section 13402 of the HITECH Act (42 U.S.C. 17932) shall apply to a program or activity described in subsection (a), in case of a breach of records described in subsection (a), to the same extent and in the same manner as such provisions apply to a covered entity in the case of a breach of unsecured protected health information.”
“(B) Communities with—
“(i) high rates of infant mortality or poor perinatal outcomes; or
“(ii) high rates of infant mortality or poor perinatal outcomes in specific subpopulations within the community.”
; and
“(i) collaboration with the local community in the development of the project;”
“(iv) the use and collection of data demonstrating the effectiveness of such program in decreasing infant mortality rates and improving perinatal outcomes, as applicable, or the process by which new applicants plan to collect this data.”
“(1) In general.—Recipients of grants”
; and
“(2) Other programs.—The Secretary shall ensure coordination of the program carried out pursuant to this section with other programs and activities related to the reduction of the rate of infant mortality and improved perinatal and infant health outcomes supported by the Department.”
“(i) progress toward achieving any grant metrics or outcomes related to reducing infant mortality rates, improving perinatal outcomes, or reducing the disparity in health status;
“(ii) recommendations on potential improvements that may assist with addressing gaps, as applicable and appropriate; and
“(iii) the extent to which the grantee coordinated with the community in which the grantee is located in the development of the project and delivery of services, including with respect to technical assistance and mentorship programs.”
; and
“(f) GAO Report.—
“(1) In general.—Not later than 4 years after the date of the enactment of this subsection, the Comptroller General of the United States shall conduct an independent evaluation, and submit to the appropriate Committees of Congress a report, concerning the Healthy Start program under this section.
“(2) Evaluation.—In conducting the evaluation under paragraph (1), the Comptroller General shall consider, as applicable and appropriate, information from the evaluations under subsection (e)(2)(B).
“(3) Report.—The report described in paragraph (1) shall review, assess, and provide recommendations, as appropriate, on the following:
“(A) The allocation of Healthy Start program grants by the Health Resources and Services Administration, including considerations made by such Administration regarding disparities in infant mortality or perinatal outcomes among urban and rural areas in making such awards.
“(B) Trends in the progress made toward meeting the evaluation criteria pursuant to subsection (e)(2)(B), including programs which decrease infant mortality rates and improve perinatal outcomes, programs that have not decreased infant mortality rates or improved perinatal outcomes, and programs that have made an impact on disparities in infant mortality or perinatal outcomes.
“(C) The ability of grantees to improve health outcomes for project participants, promote the awareness of the Healthy Start program services, incorporate and promote family participation, facilitate coordination with the community in which the grantee is located, and increase grantee accountability through quality improvement, performance monitoring, evaluation, and the effect such metrics may have toward decreasing the rate of infant mortality and improving perinatal outcomes.
“(D) The extent to which such Federal programs are coordinated across agencies and the identification of opportunities for improved coordination in such Federal programs and activities.”
“(iii) Authority during a public health emergency.—
“(I) In general.—Notwithstanding clause (ii), the Secretary, shall, to the maximum extent practicable, use competitive procedures when entering into transactions to carry out projects under this subsection for purposes of a public health emergency declared by the Secretary under section 319. Any such transactions entered into during such public health emergency shall not be terminated solely due to the expiration of such public health emergency, if such public health emergency ends before the completion of the terms of such agreement.
“(II) Report.—After the expiration of the public health emergency declared by the Secretary under section 319, the Secretary shall provide a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives regarding the use of any funds pursuant to the authority under subclause (I), including any outcomes, benefits, and risks associated with the use of such funds, and a description of the reasons for the use of such authority for the project or projects.”
“SEC. 512A. PRIORITY ZOONOTIC ANIMAL DRUGS.
“(a) In General.—The Secretary shall, at the request of the sponsor intending to submit an application for approval of a new animal drug under section 512(b)(1) or an application for conditional approval of a new animal drug under section 571, expedite the development and review of such new animal drug if preliminary clinical evidence indicates that the new animal drug, alone or in combination with 1 or more other animal drugs, has the potential to prevent or treat a zoonotic disease in animals, including a vector borne-disease, that has the potential to cause serious adverse health consequences for, or serious or life-threatening diseases in, humans.
“(b) Request for Designation.—The sponsor of a new animal drug may request the Secretary to designate a new animal drug described in subsection (a) as a priority zoonotic animal drug. A request for the designation may be made concurrently with, or at any time after, the opening of an investigational new animal drug file under section 512(j) or the filing of an application under section 512(b)(1) or 571.
“(c) Designation.—
“(1) In general.—Not later than 60 calendar days after the receipt of a request under subsection (b), the Secretary shall determine whether the new animal drug that is the subject of the request meets the criteria described in subsection (a). If the Secretary determines that the new animal drug meets the criteria, the Secretary shall designate the new animal drug as a priority zoonotic animal drug and shall take such actions as are appropriate to expedite the development and review of the application for approval or conditional approval of such new animal drug.
“(2) Actions.—The actions to expedite the development and review of an application under paragraph (1) may include, as appropriate—
“(A) taking steps to ensure that the design of clinical trials is as efficient as practicable, when scientifically appropriate, such as by utilizing novel trial designs or drug development tools (including biomarkers) that may reduce the number of animals needed for studies;
“(B) providing timely advice to, and interactive communication with, the sponsor (which may include meetings with the sponsor and review team) regarding the development of the new animal drug to ensure that the development program to gather the nonclinical and clinical data necessary for approval is as efficient as practicable;
“(C) involving senior managers and review staff with experience in zoonotic or vector-borne disease to facilitate collaborative, cross-disciplinary review, including, as appropriate, across agency centers; and
“(D) implementing additional administrative or process enhancements, as necessary, to facilitate an efficient review and development program.”
“(i) Authorization of Appropriations.—To carry out this section, there is authorized to be appropriated $23,711,000 for each of fiscal years 2021 through 2025.”
“(3) Priorities in making awards.—In awarding grants or contracts under paragraph (1), the Secretary may give priority to qualified applicants that train residents in rural areas, including for Tribes or Tribal Organizations in such areas.”
“(4) the Administrator of the Health Resources and Services Administration;”
“(i) Reports.—Not later than September 30, 2023, and not less than every 5 years thereafter, the Council shall submit to the Secretary, and to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report on the recommendations described in subsection (a).”
; and
“SEC. 753. EDUCATION AND TRAINING RELATING TO GERIATRICS.
“(a) Geriatrics Workforce Enhancement Program.—
“(1) In general.—The Secretary shall award grants, contracts, or cooperative agreements under this subsection to entities described in paragraph (1), (3), or (4) of section 799B, section 801(2), or section 865(d), or other health professions schools or programs approved by the Secretary, for the establishment or operation of Geriatrics Workforce Enhancement Programs that meet the requirements of paragraph (2).
“(2) Requirements.—
“(A) In general.—A Geriatrics Workforce Enhancement Program receiving an award under this section shall support the training of health professionals in geriatrics, including traineeships or fellowships. Such programs shall emphasize, as appropriate, patient and family engagement, integration of geriatrics with primary care and other appropriate specialties, and collaboration with community partners to address gaps in health care for older adults.
“(B) Activities.—Activities conducted by a program under this section may include the following:
“(i) Clinical training on providing integrated geriatrics and primary care delivery services.
“(ii) Interprofessional training to practitioners from multiple disciplines and specialties, including training on the provision of care to older adults.
“(iii) Establishing or maintaining training-related community-based programs for older adults and caregivers to improve health outcomes for older adults.
“(iv) Providing education on Alzheimer’s disease and related dementias to families and caregivers of older adults, direct care workers, and health professions students, faculty, and providers.
“(3) Duration.—Each grant, contract, or cooperative agreement or contract awarded under paragraph (1) shall be for a period not to exceed 5 years.
“(4) Applications.—To be eligible to receive a grant, contract, or cooperative agreement under paragraph (1), an entity described in such paragraph shall submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require.
“(5) Program requirements.—
“(A) In general.—In awarding grants, contracts, and cooperative agreements under paragraph (1), the Secretary—
“(i) shall give priority to programs that demonstrate coordination with another Federal or State program or another public or private entity;
“(ii) shall give priority to applicants with programs or activities that are expected to substantially benefit rural or medically underserved populations of older adults, or serve older adults in Indian Tribes or Tribal organizations; and
“(iii) may give priority to any program that—
“(I) integrates geriatrics into primary care practice;
“(II) provides training to integrate geriatric care into other specialties across care settings, including practicing clinical specialists, health care administrators, faculty without backgrounds in geriatrics, and students from all health professions;
“(III) emphasizes integration of geriatric care into existing service delivery locations and care across settings, including primary care clinics, medical homes, Federally qualified health centers, ambulatory care clinics, critical access hospitals, emergency care, assisted living and nursing facilities, and home- and community-based services, which may include adult daycare;
“(IV) supports the training and retraining of faculty, primary care providers, other direct care providers, and other appropriate professionals on geriatrics;
“(V) emphasizes education and engagement of family caregivers on disease management and strategies to meet the needs of caregivers of older adults; or
“(VI) proposes to conduct outreach to communities that have a shortage of geriatric workforce professionals.
“(B) Special consideration.—In awarding grants, contracts, and cooperative agreements under this section, the Secretary shall give special consideration to entities that provide services in areas with a shortage of geriatric workforce professionals.
“(6) Priority.—The Secretary may provide awardees with additional support for activities in areas of demonstrated need, which may include education and training for home health workers, family caregivers, and direct care workers on care for older adults.
“(7) Reporting.—
“(A) Reports from entities.—Each entity awarded a grant, contract, or cooperative agreement under this section shall submit an annual report to the Secretary on the activities conducted under such grant, contract, or cooperative agreement, which may include information on the number of trainees, the number of professions and disciplines, the number of partnerships with health care delivery sites, the number of faculty and practicing professionals who participated in such programs, and other information, as the Secretary may require.
“(B) Report to congress.—Not later than 4 years after the date of enactment of the Title VII Health Care Workforce Reauthorization Act of 2019 and every 5 years thereafter, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that provides a summary of the activities and outcomes associated with grants, contracts, and cooperative agreements made under this section. Such reports shall include—
“(i) information on the number of trainees, faculty, and professionals who participated in programs under this section;
“(ii) information on the impact of the program conducted under this section on the health status of older adults, including in areas with a shortage of health professionals; and
“(iii) information on outreach and education provided under this section to families and caregivers of older adults.
“(C) Public availability.—The Secretary shall make reports submitted under paragraph (B) publically available on the internet website of the Department of Health and Human Services.
“(b) Geriatric Academic Career Awards.—
“(1) Establishment of program.—The Secretary shall, as appropriate, establish or maintain a program to provide geriatric academic career awards to eligible entities applying on behalf of eligible individuals to promote the career development of such individuals as academic geriatricians or other academic geriatrics health professionals.
“(2) Eligibility.—
“(A) Eligible entity.—For purposes of this subsection, the term ‘eligible entity’ means—
“(i) an entity described in paragraph (1), (3), or (4) of section 799B or section 801(2); or
“(ii) another accredited health professions school or graduate program approved by the Secretary.
“(B) Eligible individual.—For purposes of this subsection, the term ‘eligible individual’ means an individual who—
“(i)
(I) is board certified or board eligible in internal medicine, family practice, psychiatry, or licensed dentistry, or has completed required training in a discipline and is employed in an accredited health professions school or graduate program that is approved by the Secretary; or
“(II) has completed an approved fellowship program in geriatrics, or has completed specialty training in geriatrics as required by the discipline and any additional geriatrics training as required by the Secretary; and
“(ii) has a junior, nontenured, faculty appointment at an accredited health professions school or graduate program in geriatrics or a geriatrics health profession.
“(C) Clarification.—If an eligible individual is promoted during the period of an award under this subsection and thereby no longer meets the criteria of subparagraph (B)(ii), the individual shall continue to be treated as an eligible individual through the term of the award.
“(3) Application requirements.—In order to receive an award under paragraph (1), an eligible entity, on behalf of an eligible individual, shall—
“(A) submit to the Secretary an application, at such time, in such manner, and containing such information as the Secretary may require;
“(B) provide, in such form and manner as the Secretary may require, assurances that the eligible individual will meet the service requirement described in paragraph (6); and
“(C) provide, in such form and manner as the Secretary may require, assurances that the individual has a full-time faculty appointment in a health professions institution and documented commitment from such eligible entity that the individual will spend 75 percent of the individual’s time that is supported by the award on teaching and developing skills in interdisciplinary education in geriatrics.
“(4) Equitable distribution.—In making awards under this subsection, the Secretary shall seek to ensure geographical distribution among award recipients, including among rural or medically underserved areas of the United States.
“(5) Amount and duration.—
“(A) Amount.—The amount of an award under this subsection shall be at least $75,000 for fiscal year 2021, adjusted for subsequent years in accordance with the consumer price index. The Secretary shall determine the amount of an award under this subsection for individuals who are not physicians.
“(B) Duration.—The Secretary shall make awards under paragraph (1) for a period not to exceed 5 years.
“(6) Service requirement.—An individual who receives an award under this subsection shall provide training in clinical geriatrics, including the training of interprofessional teams of health care professionals. The provision of such training shall constitute at least 75 percent of the obligations of such individual under the award.
“(c) Nonapplicability of Provision.—Notwithstanding any other provision of this title, section 791(a) shall not apply to awards made under this section.
“(d) Authorization of Appropriations.—There is authorized to be appropriated $40,737,000 for each of fiscal years 2021 through 2025 for purposes of carrying out this section.”
“(18) Nurse managed health clinic.—The term ‘nurse managed health clinic’ means a nurse-practice arrangement, managed by advanced practice nurses, that provides primary care or wellness services to underserved or vulnerable populations and that is associated with a school, college, university or department of nursing, federally qualified health center, or independent nonprofit health or social services agency.”
“(1) addressing challenges, including through supporting training and education of nursing students, related to the distribution of the nursing workforce and existing or projected nursing workforce shortages in geographic areas that have been identified as having, or that are projected to have, a nursing shortage;
“(2) increasing access to and the quality of health care services, including by supporting the training of professional registered nurses, advanced practice registered nurses, and advanced education nurses within community based settings and in a variety of health delivery system settings; or
“(3) addressing the strategic goals and priorities identified by the Secretary and that are in accordance with this title.
“(i) Biennial Report on Nursing Workforce Program Improvements.—Not later than September 30, 2020, and biennially thereafter, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report that contains an assessment of the programs and activities of the Department of Health and Human Services related to enhancing the nursing workforce, including the extent to which programs and activities under this title meet the identified goals and performance measures developed for the respective programs and activities, and the extent to which the Department coordinates with other Federal departments regarding programs designed to improve the nursing workforce.”
“(f) Authorized Clinical Nurse Specialist Programs.—Clinical nurse specialist programs eligible for support under this section are education programs that—
“(1) provide registered nurses with full-time clinical nurse specialist education; and
“(2) have as their objective the education of clinical nurse specialists who will, upon completion of such a program, be qualified to effectively provide care through the wellness and illness continuum to inpatients and outpatients experiencing acute and chronic illness.”
; and
“(i) nursing”
“(ii) individuals including licensed practical nurses, licensed vocational nurses, certified nurse assistants, home health aides, diploma degree or associate degree nurses, and other health professionals, such as health aides or community health practitioners certified under the Community Health Aide Program of the Indian Health Service, to become registered nurses with baccalaureate degrees or nurses with graduate nursing education;”
“(C) developing and implementing internships, accredited fellowships, and accredited residency programs in collaboration with one or more accredited schools of nursing, to encourage the mentoring and development of specialties.”
“(a) In General.—For the purpose of”
“(b) Part E.—For the purpose of carrying out part E, there are authorized to be appropriated $117,135,000 for each of the fiscal years 2021 through 2025.”
“(ii) Limitation.—An employer shall not be required to pay more than $200 per day and $10,000 in the aggregate for each employee for paid leave under this section.”
“(f) Limitations.—An employer shall not be required to pay more than either—
“(1) $511 per day and $5,110 in the aggregate for each employee, when the employee is taking leave for a reason described in paragraph (1), (2), or (3) of section 5102(a); or
“(2) $200 per day and $2,000 in the aggregate for each employee, when the employee is taking leave for a reason described in paragraph (4), (5), or (6) of section 5102(a).”
“(B) The State ensures that applications for unemployment compensation, and assistance with the application process, are accessible, to the extent practicable in at least two of the following: in person, by phone, or online.”
“(4) The Director of the Office of Management and Budget shall have the authority to exclude for good cause from the requirements under subsection (b) certain employers of the United States Government with respect to certain categories of Executive Branch employees.”
“SEC. 5112. AUTHORITY TO EXCLUDE CERTAIN EMPLOYEES.
“The Director of the Office of Management and Budget shall have the authority to exclude for good cause from the definition of employee under section 5110(1) certain employees described in subparagraphs (E) and (F) of such section, including by exempting certain United States Government employers covered by section 5110(2)(A)(i)(V) from the requirements of this title with respect to certain categories of Executive Branch employees.”
“(A) Eligible employee.—
“(i) In general.—In lieu of the definition in sections 101(2)(A) and 101(2)(B)(ii), the term ‘eligible employee’ means an employee who has been employed for at least 30 calendar days by the employer with respect to whom leave is requested under section 102(a)(1)(F).
“(ii) Rule regarding rehired employees.—For purposes of clause (i), the term ‘employed for at least 30 calendar days’, used with respect to an employee and an employer described in clause (i), includes an employee who was laid off by that employer not earlier than March 1, 2020, had worked for the employer for not less than 30 of the last 60 calendar days prior to the employee’s layoff, and was rehired by the employer.”
“(ii) Advancing credit.—In anticipation of the credit, including the refundable portion under clause (i), the credit may be advanced, according to forms and instructions provided by the Secretary, up to an amount calculated under subsection (a), subject to the limits under subsection (b), both calculated through the end of the most recent payroll period in the quarter.”
“(6) regulations or other guidance to permit the advancement of the credit determined under subsection (a).”
; and
“(i) Treatment of Deposits.—The Secretary of the Treasury (or the Secretary’s delegate) shall waive any penalty under section 6656 of the Internal Revenue Code of 1986 for any failure to make a deposit of the tax imposed by section 3111(a) or 3221(a) of such Code if the Secretary determines that such failure was due to the anticipation of the credit allowed under this section.”
“(B) Advancing credit.—In anticipation of the credit, including the refundable portion under subparagraph (A), the credit may be advanced, according to forms and instructions provided by the Secretary, up to an amount calculated under subsection (a), subject to the limits under subsection (b), both calculated through the end of the most recent payroll period in the quarter.”
“(6) regulations or other guidance to permit the advancement of the credit determined under subsection (a).”
; and
“(i) Treatment of Deposits.—The Secretary of the Treasury (or the Secretary’s delegate) shall waive any penalty under section 6656 of the Internal Revenue Code of 1986 for any failure to make a deposit of the tax imposed by section 3111(a) or 3221(a) of such Code if the Secretary determines that such failure was due to the anticipation of the credit allowed under this section.”
“(D) that, as of January 1, 2000, was maintained by an employer—
“(i) described in section 501(c)(3) of the Internal Revenue Code of 1986,
“(ii) who has been in existence since at least 1938,
“(iii) who conducts medical research directly or indirectly through grant making, and
“(iv) whose primary exempt purpose is to provide services with respect to mothers and children.”
“(D) that, as of January 1, 2000, was maintained by an employer—
“(i) described in section 501(c)(3),
“(ii) who has been in existence since at least 1938,
“(iii) who conducts medical research directly or indirectly through grant making, and
“(iv) whose primary exempt purpose is to provide services with respect to mothers and children.”
“(C) as necessary to carry out the purposes of this Act, including to ensure consistency between this Act and Division E and Division G of the Families First Coronavirus Response Act.”
“(c) Investigations and Collection of Data.—The Secretary of Labor or his designee may investigate and gather data to ensure compliance with this Act in the same manner as authorized by sections 9 and 11 of the Fair Labor Standards Act of 1938 (29 U.S.C. 209; 211).”
“(E) Safe harbor for absence of deductible for telehealth.—In the case of plan years beginning on or before December 31, 2021, a plan shall not fail to be treated as a high deductible health plan by reason of failing to have a deductible for telehealth and other remote care services.”
“(D) Menstrual care product.—For purposes of this paragraph, the term ‘menstrual care product’ means a tampon, pad, liner, cup, sponge, or similar product used by individuals with respect to menstruation or other genital-tract secretions.”
“(f) Reimbursements for Menstrual Care Products.—For purposes of this section and section 105, expenses incurred for menstrual care products (as defined in section 223(d)(2)(D)) shall be treated as incurred for medical care.”
“(8) Enhancing telehealth services for federally qualified health centers and rural health clinics during emergency period.—
“(A) In general.—During the emergency period described in section 1135(g)(1)(B)—
“(i) the Secretary shall pay for telehealth services that are furnished via a telecommunications system by a Federally qualified health center or a rural health clinic to an eligible telehealth individual enrolled under this part notwithstanding that the Federally qualified health center or rural clinic providing the telehealth service is not at the same location as the beneficiary;
“(ii) the amount of payment to a Federally qualified health center or rural health clinic that serves as a distant site for such a telehealth service shall be determined under subparagraph (B); and
“(iii) for purposes of this subsection—
“(I) the term ‘distant site’ includes a Federally qualified health center or rural health clinic that furnishes a telehealth service to an eligible telehealth individual; and
“(II) the term ‘telehealth services’ includes a rural health clinic service or Federally qualified health center service that is furnished using telehealth to the extent that payment codes corresponding to services identified by the Secretary under clause (i) or (ii) of paragraph (4)(F) are listed on the corresponding claim for such rural health clinic service or Federally qualified health center service.
“(B) Special payment rule.—
“(i) In general.—The Secretary shall develop and implement payment methods that apply under this subsection to a Federally qualified health center or rural health clinic that serves as a distant site that furnishes a telehealth service to an eligible telehealth individual during such emergency period. Such payment methods shall be based on payment rates that are similar to the national average payment rates for comparable telehealth services under the physician fee schedule under section 1848. Notwithstanding any other provision of law, the Secretary may implement such payment methods through program instruction or otherwise.
“(ii) Exclusion from fqhc pps calculation and rhc air calculation.—Costs associated with telehealth services shall not be used to determine the amount of payment for Federally qualified health center services under the prospective payment system under section 1834(o) or for rural health clinic services under the methodology for all-inclusive rates (established by the Secretary) under section 1833(a)(3).”
“(iii) The Secretary may waive the provisions of clause (ii) during the emergency period described in section 1135(g)(1)(B).”
“(II) during the emergency period described in section 1135(g)(1)(B), a hospice physician or nurse practitioner may conduct a face-to-face encounter required under this clause via telehealth, as determined appropriate by the Secretary; and”
“(iv)
(I) For discharges occurring during the emergency period described in section 1135(g)(1)(B), in the case of a discharge of an individual diagnosed with COVID–19, the Secretary shall increase the weighting factor that would otherwise apply to the diagnosis-related group to which the discharge is assigned by 20 percent. The Secretary shall identify a discharge of such an individual through the use of diagnosis codes, condition codes, or other such means as may be necessary.
“(II) Any adjustment under subclause (I) shall not be taken into account in applying budget neutrality under clause (iii)
“(III) In the case of a State for which the Secretary has waived all or part of this section under the authority of section 1115A, nothing in this section shall preclude such State from implementing an adjustment similar to the adjustment under subclause (I).”
“(VI) A COVID–19 vaccine and its administration described in section 1861(s)(10)(A).”
; and
“(4) Ensuring access during covid–19 public health emergency period.—
“(A) In general.—During the emergency period described in section 1135(g)(1)(B), subject to subparagraph (B), a prescription drug plan or MA–PD plan shall, notwithstanding any cost and utilization management, medication therapy management, or other such programs under this part, permit a part D eligible individual enrolled in such plan to obtain in a single fill or refill, at the option of such individual, the total day supply (not to exceed a 90-day supply) prescribed for such individual for a covered part D drug.
“(B) Safety edit exception.—A prescription drug plan or MA–PD plan may not permit a part D eligible individual to obtain a single fill or refill inconsistent with an applicable safety edit.”
“(2) Nothing in this title, title XVIII, or title XI shall be construed as prohibiting receipt of any care or services specified in paragraph (1) in an acute care hospital that are—
“(A) identified in an individual’s person-centered service plan (or comparable plan of care);
“(B) provided to meet needs of the individual that are not met through the provision of hospital services;
“(C) not a substitute for services that the hospital is obligated to provide through its conditions of participation or under Federal or State law, or under another applicable requirement; and
“(D) designed to ensure smooth transitions between acute care settings and home and community-based settings, and to preserve the individual’s functional abilities.”
“(ii) for 2021, 0 percent; and”
; and
“(f)
(1) During the emergency period described in section 1135(g)(1)(B), the Secretary shall expand the program under subsection (e)(3) pursuant to paragraph (2).
“(2) In expanding the program under subsection (e)(3), the following shall apply:
“(A)
(i) In addition to the hospitals described in subsection (e)(3), the following hospitals shall be eligible to participate in the program:
“(I) Hospitals described in clause (iii) of section 1886(d)(1)(B).
“(II) Hospitals described in clause (v) of such section.
“(III) Critical access hospitals (as defined in section 1861(mm)(1)).
“(ii) Subject to appropriate safeguards against fraud, waste, and abuse, upon a request of a hospital described in clause (i), the Secretary shall provide accelerated payments under the program to such hospital.
“(B) Upon the request of the hospital, the Secretary may do any of the following:
“(i) Make accelerated payments on a periodic or lump sum basis.
“(ii) Increase the amount of payment that would otherwise be made to hospitals under the program up to 100 percent (or, in the case of critical access hospitals, up to 125 percent).
“(iii) Extend the period that accelerated payments cover so that it covers up to a 6-month period.
“(C) Upon the request of the hospital, the Secretary shall do the following:
“(i) Provide up to 120 days before claims are offset to recoup the accelerated payment.
“(ii) Allow not less than 12 months from the date of the first accelerated payment before requiring that the outstanding balance be paid in full.
“(3) Nothing in this subsection shall preclude the Secretary from carrying out the provisions described in clauses (i), (ii), and (iii) of paragraph (2)(B) and clauses (i) and (ii) of paragraph (2)(C) under the program under subsection (e)(3) after the period for which this subsection applies.
“(4) Notwithstanding any other provision of law, the Secretary may implement the provisions of this subsection by program instruction or otherwise.”
“(d) Delay in Application of Premium Requirement.—During the 30 day period beginning on the date of enactment of this Act, a State shall not be ineligible for the increase to the Federal medical assistance percentage of the State described in subsection (a) on the basis that the State imposes a premium that violates the requirement of subsection (b)(2) if such premium was in effect on the date of enactment of this Act.”
“(x) for fiscal year 2020, of $13,000,000; and
“(xi) for the period beginning on October 1, 2020, and ending on November 30, 2020, the amount equal to the pro rata portion of the amount appropriated for such period for fiscal year 2020.”
“(x) for fiscal year 2020, of $7,500,000; and
“(xi) for the period beginning on October 1, 2020, and ending on November 30, 2020, the amount equal to the pro rata portion of the amount appropriated for such period for fiscal year 2020.”
“(x) for fiscal year 2020, of $5,000,000; and
“(xi) for the period beginning on October 1, 2020, and ending on November 30, 2020, the amount equal to the pro rata portion of the amount appropriated for such period for fiscal year 2020.”
“(x) for fiscal year 2020, of $12,000,000; and
“(xi) for the period beginning on October 1, 2020, and ending on November 30, 2020, the amount equal to the pro rata portion of the amount appropriated for such period for fiscal year 2020.”
“(G) subject to paragraph (3), $337,500,000 for the period beginning on January 1, 2020, and ending on September 30, 2020; and
“(H) subject to paragraph (3), for the period beginning on October 1, 2020, and ending on November 30, 2020, the amount equal to the pro rata portion of the amount appropriated for such period for fiscal year 2020.”
; and
“(8) Additional programs.—
“(A) In general.—Not later than 6 months after the date of enactment of this paragraph, in addition to the 8 States selected under paragraph (1), the Secretary shall select 2 States to participate in 2-year demonstration programs that meet the requirements of this subsection.
“(B) Selection of states.—
“(i) In general.—Subject to clause (ii), in selecting States under this paragraph, the Secretary—
“(I) shall select States that—
“(aa) were awarded planning grants under subsection (c); and
“(bb) applied to participate in the demonstration programs under this subsection under paragraph (1) but, as of the date of enactment of this paragraph, were not selected to participate under paragraph (1); and
“(II) shall use the results of the Secretary’s evaluation of each State’s application under paragraph (1) to determine which States to select, and shall not require the submission of any additional application.
“(C) Requirements for selected states.—Prior to services being delivered under the demonstration authority in a State selected under this paragraph, the State shall—
“(i) submit a plan to monitor certified community behavioral health clinics under the demonstration program to ensure compliance with certified community behavioral health criteria during the demonstration period; and
“(ii) commit to collecting data, notifying the Secretary of any planned changes that would deviate from the prospective payment system methodology outlined in the State’s demonstration application, and obtaining approval from the Secretary for any such change before implementing the change.”
“(iii) Payments for amounts expended after 2019.—The Federal matching percentage applicable under subparagraph (B) to amounts expended by a State participating in the demonstration program under this subsection shall—
“(I) in the case of a State participating in the demonstration program as of January 1, 2020, apply to amounts expended by the State during the 8 fiscal quarter period (or any portion of such period) that begins on January 1, 2020; and
“(II) in the case of a State selected to participate in the demonstration program under paragraph (8), during first 8 fiscal quarter period (or any portion of such period) that the State participates in a demonstration program.”
“(G) $310,000,000 for fiscal year 2020; and
“(H) $51,808,219 for the period beginning on October 1, 2020, and ending on November 30, 2020.”
“SEC. 505G. REGULATION OF CERTAIN NONPRESCRIPTION DRUGS THAT ARE MARKETED WITHOUT AN APPROVED DRUG APPLICATION.
“(a) Nonprescription Drugs Marketed Without an Approved Application.—Nonprescription drugs marketed without an approved drug application under section 505, as of the date of the enactment of this section, shall be treated in accordance with this subsection.
“(1) Drugs subject to a final monograph; category i drugs subject to a tentative final monograph.—A drug is deemed to be generally recognized as safe and effective under section 201(p)(1), not a new drug under section 201(p), and not subject to section 503(b)(1), if—
“(A) the drug is—
“(i) in conformity with the requirements for nonprescription use of a final monograph issued under part 330 of title 21, Code of Federal Regulations (except as provided in paragraph (2)), the general requirements for nonprescription drugs, and conditions or requirements under subsections (b), (c), and (k); and
“(ii) except as permitted by an order issued under subsection (b) or, in the case of a minor change in the drug, in conformity with an order issued under subsection (c), in a dosage form that, immediately prior to the date of the enactment of this section, has been used to a material extent and for a material time under section 201(p)(2); or
“(B) the drug is—
“(i) classified in category I for safety and effectiveness under a tentative final monograph that is the most recently applicable proposal or determination issued under part 330 of title 21, Code of Federal Regulations;
“(ii) in conformity with the proposed requirements for nonprescription use of such tentative final monograph, any applicable subsequent determination by the Secretary, the general requirements for nonprescription drugs, and conditions or requirements under subsections (b), (c), and (k); and
“(iii) except as permitted by an order issued under subsection (b) or, in the case of a minor change in the drug, in conformity with an order issued under subsection (c), in a dosage form that, immediately prior to the date of the enactment of this section, has been used to a material extent and for a material time under section 201(p)(2).
“(2) Treatment of sunscreen drugs.—With respect to sunscreen drugs subject to this section, the applicable requirements in terms of conformity with a final monograph, for purposes of paragraph (1)(A)(i), shall be the requirements specified in part 352 of title 21, Code of Federal Regulations, as published on May 21, 1999, beginning on page 27687 of volume 64 of the Federal Register, except that the applicable requirements governing effectiveness and labeling shall be those specified in section 201.327 of title 21, Code of Federal Regulations.
“(3) Category iii drugs subject to a tentative final monograph; category i drugs subject to proposed monograph or advance notice of proposed rulemaking.—A drug that is not described in paragraph (1), (2), or (4) is not required to be the subject of an application approved under section 505, and is not subject to section 503(b)(1), if—
“(A) the drug is—
“(i) classified in category III for safety or effectiveness in the preamble of a proposed rule establishing a tentative final monograph that is the most recently applicable proposal or determination for such drug issued under part 330 of title 21, Code of Federal Regulations;
“(ii) in conformity with—
“(I) the conditions of use, including indication and dosage strength, if any, described for such category III drug in such preamble or in an applicable subsequent proposed rule;
“(II) the proposed requirements for drugs classified in such tentative final monograph in category I in the most recently proposed rule establishing requirements related to such tentative final monograph and in any final rule establishing requirements that are applicable to the drug; and
“(III) the general requirements for nonprescription drugs and conditions or requirements under subsection (b) or (k); and
“(iii) in a dosage form that, immediately prior to the date of the enactment of this section, had been used to a material extent and for a material time under section 201(p)(2); or
“(B) the drug is—
“(i) classified in category I for safety and effectiveness under a proposed monograph or advance notice of proposed rulemaking that is the most recently applicable proposal or determination for such drug issued under part 330 of title 21, Code of Federal Regulations;
“(ii) in conformity with the requirements for nonprescription use of such proposed monograph or advance notice of proposed rulemaking, any applicable subsequent determination by the Secretary, the general requirements for nonprescription drugs, and conditions or requirements under subsection (b) or (k); and
“(iii) in a dosage form that, immediately prior to the date of the enactment of this section, has been used to a material extent and for a material time under section 201(p)(2).
“(4) Category ii drugs deemed new drugs.—A drug that is classified in category II for safety or effectiveness under a tentative final monograph or that is subject to a determination to be not generally recognized as safe and effective in a proposed rule that is the most recently applicable proposal issued under part 330 of title 21, Code of Federal Regulations, shall be deemed to be a new drug under section 201(p), misbranded under section 502(ee), and subject to the requirement for an approved new drug application under section 505 beginning on the day that is 180 calendar days after the date of the enactment of this section, unless, before such day, the Secretary determines that it is in the interest of public health to extend the period during which the drug may be marketed without such an approved new drug application.
“(5) Drugs not grase deemed new drugs.—A drug that the Secretary has determined not to be generally recognized as safe and effective under section 201(p)(1) under a final determination issued under part 330 of title 21, Code of Federal Regulations, shall be deemed to be a new drug under section 201(p), misbranded under section 502(ee), and subject to the requirement for an approved new drug application under section 505.
“(6) Other drugs deemed new drugs.—Except as provided in subsection (m), a drug is deemed to be a new drug under section 201(p) and misbranded under section 502(ee) if the drug—
“(A) is not subject to section 503(b)(1); and
“(B) is not described in paragraph (1), (2), (3), (4), or (5), or subsection (b)(1)(B).
“(b) Administrative Orders.—
“(1) In general.—
“(A) Determination.—The Secretary may, on the initiative of the Secretary or at the request of one or more requestors, issue an administrative order determining whether there are conditions under which a specific drug, a class of drugs, or a combination of drugs, is determined to be—
“(i) not subject to section 503(b)(1); and
“(ii) generally recognized as safe and effective under section 201(p)(1).
“(B) Effect.—A drug or combination of drugs shall be deemed to not require approval under section 505 if such drug or combination of drugs—
“(i) is determined by the Secretary to meet the conditions specified in clauses (i) and (ii) of subparagraph (A);
“(ii) is marketed in conformity with an administrative order under this subsection;
“(iii) meets the general requirements for nonprescription drugs; and
“(iv) meets the requirements under subsections (c) and (k).
“(C) Standard.—The Secretary shall find that a drug is not generally recognized as safe and effective under section 201(p)(1) if—
“(i) the evidence shows that the drug is not generally recognized as safe and effective under section 201(p)(1); or
“(ii) the evidence is inadequate to show that the drug is generally recognized as safe and effective under section 201(p)(1).
“(2) Administrative orders initiated by the secretary.—
“(A) In general.—In issuing an administrative order under paragraph (1) upon the Secretary’s initiative, the Secretary shall—
“(i) make reasonable efforts to notify informally, not later than 2 business days before the issuance of the proposed order, the sponsors of drugs who have a listing in effect under section 510(j) for the drugs or combination of drugs that will be subject to the administrative order;
“(ii) after any such reasonable efforts of notification—
“(I) issue a proposed administrative order by publishing it on the website of the Food and Drug Administration and include in such order the reasons for the issuance of such order; and
“(II) publish a notice of availability of such proposed order in the Federal Register;
“(iii) except as provided in subparagraph (B), provide for a public comment period with respect to such proposed order of not less than 45 calendar days; and
“(iv) if, after completion of the proceedings specified in clauses (i) through (iii), the Secretary determines that it is appropriate to issue a final administrative order—
“(I) issue the final administrative order, together with a detailed statement of reasons, which order shall not take effect until the time for requesting judicial review under paragraph (3)(D)(ii) has expired;
“(II) publish a notice of such final administrative order in the Federal Register;
“(III) afford requestors of drugs that will be subject to such order the opportunity for formal dispute resolution up to the level of the Director of the Center for Drug Evaluation and Research, which initially must be requested within 45 calendar days of the issuance of the order, and, for subsequent levels of appeal, within 30 calendar days of the prior decision; and
“(IV) except with respect to drugs described in paragraph (3)(B), upon completion of the formal dispute resolution procedure, inform the persons which sought such dispute resolution of their right to request a hearing.
“(B) Exceptions.—When issuing an administrative order under paragraph (1) on the Secretary’s initiative proposing to determine that a drug described in subsection (a)(3) is not generally recognized as safe and effective under section 201(p)(1), the Secretary shall follow the procedures in subparagraph (A), except that—
“(i) the proposed order shall include notice of—
“(I) the general categories of data the Secretary has determined necessary to establish that the drug is generally recognized as safe and effective under section 201(p)(1); and
“(II) the format for submissions by interested persons;
“(ii) the Secretary shall provide for a public comment period of no less than 180 calendar days with respect to such proposed order, except when the Secretary determines, for good cause, that a shorter period is in the interest of public health; and
“(iii) any person who submits data in such comment period shall include a certification that the person has submitted all evidence created, obtained, or received by that person that is both within the categories of data identified in the proposed order and relevant to a determination as to whether the drug is generally recognized as safe and effective under section 201(p)(1).
“(3) Hearings; judicial review.—
“(A) In general.—Only a person who participated in each stage of formal dispute resolution under subclause (III) of paragraph (2)(A)(iv) of an administrative order with respect to a drug may request a hearing concerning a final administrative order issued under such paragraph with respect to such drug. If a hearing is sought, such person must submit a request for a hearing, which shall be based solely on information in the administrative record, to the Secretary not later than 30 calendar days after receiving notice of the final decision of the formal dispute resolution procedure.
“(B) No hearing required with respect to orders relating to certain drugs.—
“(i) In general.—The Secretary shall not be required to provide notice and an opportunity for a hearing pursuant to paragraph (2)(A)(iv) if the final administrative order involved relates to a drug—
“(I) that is described in subsection (a)(3)(A); and
“(II) with respect to which no human or non-human data studies relevant to the safety or effectiveness of such drug have been submitted to the administrative record since the issuance of the most recent tentative final monograph relating to such drug.
“(ii) Human data studies and non-human data defined.—In this subparagraph:
“(I) The term ‘human data studies’ means clinical trials of safety or effectiveness (including actual use studies), pharmacokinetics studies, or bioavailability studies.
“(II) The term ‘non-human data’ means data from testing other than with human subjects which provides information concerning safety or effectiveness.
“(C) Hearing procedures.—
“(i) Denial of request for hearing.—If the Secretary determines that information submitted in a request for a hearing under subparagraph (A) with respect to a final administrative order issued under paragraph (2)(A)(iv) does not identify the existence of a genuine and substantial question of material fact, the Secretary may deny such request. In making such a determination, the Secretary may consider only information and data that are based on relevant and reliable scientific principles and methodologies.
“(ii) Single hearing for multiple related requests.—If more than one request for a hearing is submitted with respect to the same administrative order under subparagraph (A), the Secretary may direct that a single hearing be conducted in which all persons whose hearing requests were granted may participate.
“(iii) Presiding officer.—The presiding officer of a hearing requested under subparagraph (A) shall—
“(I) be designated by the Secretary;
“(II) not be an employee of the Center for Drug Evaluation and Research; and
“(III) not have been previously involved in the development of the administrative order involved or proceedings relating to that administrative order.
“(iv) Rights of parties to hearing.—The parties to a hearing requested under subparagraph (A) shall have the right to present testimony, including testimony of expert witnesses, and to cross-examine witnesses presented by other parties. Where appropriate, the presiding officer may require that cross-examination by parties representing substantially the same interests be consolidated to promote efficiency and avoid duplication.
“(v) Final decision.—
“(I) At the conclusion of a hearing requested under subparagraph (A), the presiding officer of the hearing shall issue a decision containing findings of fact and conclusions of law. The decision of the presiding officer shall be final.
“(II) The final decision may not take effect until the period under subparagraph (D)(ii) for submitting a request for judicial review of such decision expires.
“(D) Judicial review of final administrative order.—
“(i) In general.—The procedures described in section 505(h) shall apply with respect to judicial review of final administrative orders issued under this subsection in the same manner and to the same extent as such section applies to an order described in such section except that the judicial review shall be taken by filing in an appropriate district court of the United States in lieu of the appellate courts specified in such section.
“(ii) Period to submit a request for judicial review.—A person eligible to request a hearing under this paragraph and seeking judicial review of a final administrative order issued under this subsection shall file such request for judicial review not later than 60 calendar days after the latest of—
“(I) the date on which notice of such order is published;
“(II) the date on which a hearing with respect to such order is denied under subparagraph (B) or (C)(i);
“(III) the date on which a final decision is made following a hearing under subparagraph (C)(v); or
“(IV) if no hearing is requested, the date on which the time for requesting a hearing expires.
“(4) Expedited procedure with respect to administrative orders initiated by the secretary.—
“(A) Imminent hazard to the public health.—
“(i) In general.—In the case of a determination by the Secretary that a drug, class of drugs, or combination of drugs subject to this section poses an imminent hazard to the public health, the Secretary, after first making reasonable efforts to notify, not later than 48 hours before issuance of such order under this subparagraph, sponsors who have a listing in effect under section 510(j) for such drug or combination of drugs—
“(I) may issue an interim final administrative order for such drug, class of drugs, or combination of drugs under paragraph (1), together with a detailed statement of the reasons for such order;
“(II) shall publish in the Federal Register a notice of availability of any such order; and
“(III) shall provide for a public comment period of at least 45 calendar days with respect to such interim final order.
“(ii) Nondelegation.—The Secretary may not delegate the authority to issue an interim final administrative order under this subparagraph.
“(B) Safety labeling changes.—
“(i) In general.—In the case of a determination by the Secretary that a change in the labeling of a drug, class of drugs, or combination of drugs subject to this section is reasonably expected to mitigate a significant or unreasonable risk of a serious adverse event associated with use of the drug, the Secretary may—
“(I) make reasonable efforts to notify informally, not later than 48 hours before the issuance of the interim final order, the sponsors of drugs who have a listing in effect under section 510(j) for such drug or combination of drugs;
“(II) after reasonable efforts of notification, issue an interim final administrative order in accordance with paragraph (1) to require such change, together with a detailed statement of the reasons for such order;
“(III) publish in the Federal Register a notice of availability of such order; and
“(IV) provide for a public comment period of at least 45 calendar days with respect to such interim final order.
“(ii) Content of order.—An interim final order issued under this subparagraph with respect to the labeling of a drug may provide for new warnings and other information required for safe use of the drug.
“(C) Effective date.—An order under subparagraph (A) or (B) shall take effect on a date specified by the Secretary.
“(D) Final order.—After the completion of the proceedings in subparagraph (A) or (B), the Secretary shall—
“(i) issue a final order in accordance with paragraph (1);
“(ii) publish a notice of availability of such final administrative order in the Federal Register; and
“(iii) afford sponsors of such drugs that will be subject to such an order the opportunity for formal dispute resolution up to the level of the Director of the Center for Drug Evaluation and Research, which must initially be within 45 calendar days of the issuance of the order, and for subsequent levels of appeal, within 30 calendar days of the prior decision.
“(E) Hearings.—A sponsor of a drug subject to a final order issued under subparagraph (D) and that participated in each stage of formal dispute resolution under clause (iii) of such subparagraph may request a hearing on such order. The provisions of subparagraphs (A), (B), and (C) of paragraph (3), other than paragraph (3)(C)(v)(II), shall apply with respect to a hearing on such order in the same manner and to the same extent as such provisions apply with respect to a hearing on an administrative order issued under paragraph (2)(A)(iv).
“(F) Timing.—
“(i) Final order and hearing.—The Secretary shall—
“(I) not later than 6 months after the date on which the comment period closes under subparagraph (A) or (B), issue a final order in accordance with paragraph (1); and
“(II) not later than 12 months after the date on which such final order is issued, complete any hearing under subparagraph (E).
“(ii) Dispute resolution request.—The Secretary shall specify in an interim final order issued under subparagraph (A) or (B) such shorter periods for requesting dispute resolution under subparagraph (D)(iii) as are necessary to meet the requirements of this subparagraph.
“(G) Judicial review.—A final order issued pursuant to subparagraph (F) shall be subject to judicial review in accordance with paragraph (3)(D).
“(5) Administrative order initiated at the request of a requestor.—
“(A) In general.—In issuing an administrative order under paragraph (1) at the request of a requestor with respect to certain drugs, classes of drugs, or combinations of drugs—
“(i) the Secretary shall, after receiving a request under this subparagraph, determine whether the request is sufficiently complete and formatted to permit a substantive review;
“(ii) if the Secretary determines that the request is sufficiently complete and formatted to permit a substantive review, the Secretary shall—
“(I) file the request; and
“(II) initiate proceedings with respect to issuing an administrative order in accordance with paragraphs (2) and (3); and
“(iii) except as provided in paragraph (6), if the Secretary determines that a request does not meet the requirements for filing or is not sufficiently complete and formatted to permit a substantive review, the requestor may demand that the request be filed over protest, and the Secretary shall initiate proceedings to review the request in accordance with paragraph (2)(A).
“(B) Request to initiate proceedings.—
“(i) In general.—A requestor seeking an administrative order under paragraph (1) with respect to certain drugs, classes of drugs, or combinations of drugs, shall submit to the Secretary a request to initiate proceedings for such order in the form and manner as specified by the Secretary. Such requestor may submit a request under this subparagraph for the issuance of an administrative order—
“(I) determining whether a drug is generally recognized as safe and effective under section 201(p)(1), exempt from section 503(b)(1), and not required to be the subject of an approved application under section 505; or
“(II) determining whether a change to a condition of use of a drug is generally recognized as safe and effective under section 201(p)(1), exempt from section 503(b)(1), and not required to be the subject of an approved application under section 505, if, absent such a changed condition of use, such drug is—
“(aa) generally recognized as safe and effective under section 201(p)(1) in accordance with subsection (a)(1), (a)(2), or an order under this subsection; or
“(bb) subject to subsection (a)(3), but only if such requestor initiates such request in conjunction with a request for the Secretary to determine whether such drug is generally recognized as safe and effective under section 201(p)(1), which is filed by the Secretary under subparagraph (A)(ii).
“(ii) Exception.—The Secretary is not required to complete review of a request for a change described in clause (i)(II) if the Secretary determines that there is an inadequate basis to find the drug is generally recognized as safe and effective under section 201(p)(1) under paragraph (1) and issues a final order announcing that determination.
“(iii) Withdrawal.—The requestor may withdraw a request under this paragraph, according to the procedures set forth pursuant to subsection (d)(2)(B). Notwithstanding any other provision of this section, if such request is withdrawn, the Secretary may cease proceedings under this subparagraph.
“(C) Exclusivity.—
“(i) In general.—A final administrative order issued in response to a request under this section shall have the effect of authorizing solely the order requestor (or the licensees, assignees, or successors in interest of such requestor with respect to the subject of such order), for a period of 18 months following the effective date of such final order and beginning on the date the requestor may lawfully market such drugs pursuant to the order, to market drugs—
“(I) incorporating changes described in clause (ii); and
“(II) subject to the limitations under clause (iv).
“(ii) Changes described.—A change described in this clause is a change subject to an order specified in clause (i), which—
“(I) provides for a drug to contain an active ingredient (including any ester or salt of the active ingredient) not previously incorporated in a drug described in clause (iii); or
“(II) provides for a change in the conditions of use of a drug, for which new human data studies conducted or sponsored by the requestor (or for which the requestor has an exclusive right of reference) were essential to the issuance of such order.
“(iii) Drugs described.—The drugs described in this clause are drugs—
“(I) specified in subsection (a)(1), (a)(2), or (a)(3);
“(II) subject to a final order issued under this section;
“(III) subject to a final sunscreen order (as defined in section 586(2)(A)); or
“(IV) described in subsection (m)(1), other than drugs subject to an active enforcement action under chapter III of this Act.
“(iv) Limitations on exclusivity.—
“(I) In general.—Only one 18-month period under this subparagraph shall be granted, under each order described in clause (i), with respect to changes (to the drug subject to such order) which are either—
“(aa) changes described in clause (ii)(I), relating to active ingredients; or
“(bb) changes described in clause (ii)(II), relating to conditions of use.
“(II) No exclusivity allowed.—No exclusivity shall apply to changes to a drug which are—
“(aa) the subject of a Tier 2 OTC monograph order request (as defined in section 744L);
“(bb) safety-related changes, as defined by the Secretary, or any other changes the Secretary considers necessary to assure safe use; or
“(cc) changes related to methods of testing safety or efficacy.
“(v) New human data studies defined.—In this subparagraph, the term ‘new human data studies’ means clinical trials of safety or effectiveness (including actual use studies), pharmacokinetics studies, or bioavailability studies, the results of which—
“(I) have not been relied on by the Secretary to support—
“(aa) a proposed or final determination that a drug described in subclause (I), (II), or (III) of clause (iii) is generally recognized as safe and effective under section 201(p)(1); or
“(bb) approval of a drug that was approved under section 505; and
“(II) do not duplicate the results of another study that was relied on by the Secretary to support—
“(aa) a proposed or final determination that a drug described in subclause (I), (II), or (III) of clause (iii) is generally recognized as safe and effective under section 201(p)(1); or
“(bb) approval of a drug that was approved under section 505.
“(vi) Notification of drug not available for sale.—A requestor that is granted exclusivity with respect to a drug under this subparagraph shall notify the Secretary in writing within 1 year of the issuance of the final administrative order if the drug that is the subject of such order will not be available for sale within 1 year of the date of issuance of such order. The requestor shall include with such notice the—
“(I) identity of the drug by established name and by proprietary name, if any;
“(II) strength of the drug;
“(III) date on which the drug will be available for sale, if known; and
“(IV) reason for not marketing the drug after issuance of the order.
“(6) Information regarding safe nonprescription marketing and use as condition for filing a generally recognized as safe and effective request.—
“(A) In general.—In response to a request under this section that a drug described in subparagraph (B) be generally recognized as safe and effective, the Secretary—
“(i) may file such request, if the request includes information specified under subparagraph (C) with respect to safe nonprescription marketing and use of such drug; or
“(ii) if the request fails to include information specified under subparagraph (C), shall refuse to file such request and require that nonprescription marketing of the drug be pursuant to a new drug application as described in subparagraph (D).
“(B) Drug described.—A drug described in this subparagraph is a nonprescription drug which contains an active ingredient not previously incorporated in a drug—
“(i) specified in subsection (a)(1), (a)(2), or (a)(3);
“(ii) subject to a final order under this section; or
“(iii) subject to a final sunscreen order (as defined in section 586(2)(A)).
“(C) Information demonstrating prima facie safe nonprescription marketing and use.—Information specified in this subparagraph, with respect to a request described in subparagraph (A)(i), is—
“(i) information sufficient for a prima facie demonstration that the drug subject to such request has a verifiable history of being marketed and safely used by consumers in the United States as a nonprescription drug under comparable conditions of use;
“(ii) if the drug has not been previously marketed in the United States as a nonprescription drug, information sufficient for a prima facie demonstration that the drug was marketed and safely used under comparable conditions of marketing and use in a country listed in section 802(b)(1)(A) or designated by the Secretary in accordance with section 802(b)(1)(B)—
“(I) for such period as needed to provide reasonable assurances concerning the safe nonprescription use of the drug; and
“(II) during such time was subject to sufficient monitoring by a regulatory body considered acceptable by the Secretary for such monitoring purposes, including for adverse events associated with nonprescription use of the drug; or
“(iii) if the Secretary determines that information described in clause (i) or (ii) is not needed to provide a prima facie demonstration that the drug can be safely marketed and used as a nonprescription drug, such other information the Secretary determines is sufficient for such purposes.
“(D) Marketing pursuant to new drug application.—In the case of a request described in subparagraph (A)(ii), the drug subject to such request may be resubmitted for filing only if—
“(i) the drug is marketed as a nonprescription drug, under conditions of use comparable to the conditions specified in the request, for such period as the Secretary determines appropriate (not to exceed 5 consecutive years) pursuant to an application approved under section 505; and
“(ii) during such period, 1,000,000 retail packages of the drug, or an equivalent quantity as determined by the Secretary, were distributed for retail sale, as determined in such manner as the Secretary finds appropriate.
“(E) Rule of application.—Except in the case of a request involving a drug described in section 586(9), as in effect on January 1, 2017, if the Secretary refuses to file a request under this paragraph, the requestor may not file such request over protest under paragraph (5)(A)(iii).
“(7) Packaging.—An administrative order issued under paragraph (2), (4)(A), or (5) may include requirements for the packaging of a drug to encourage use in accordance with labeling. Such requirements may include unit dose packaging, requirements for products intended for use by pediatric populations, requirements to reduce risk of harm from unsupervised ingestion, and other appropriate requirements. This paragraph does not authorize the Food and Drug Administration to require standards or testing procedures as described in part 1700 of title 16, Code of Federal Regulations.
“(8) Final and tentative final monographs for category i drugs deemed final administrative orders.—
“(A) In general.—A final monograph or tentative final monograph described in subparagraph (B) shall be deemed to be a final administrative order under this subsection and may be amended, revoked, or otherwise modified in accordance with the procedures of this subsection.
“(B) Monographs described.—For purposes of subparagraph (A), a final monograph or tentative final monograph is described in this subparagraph if it—
“(i) establishes conditions of use for a drug described in paragraph (1) or (2) of subsection (a); and
“(ii) represents the most recently promulgated version of such conditions, including as modified, in whole or in part, by any proposed or final rule.
“(C) Deemed orders include harmonizing technical amendments.—The deemed establishment of a final administrative order under subparagraph (A) shall be construed to include any technical amendments to such order as the Secretary determines necessary to ensure that such order is appropriately harmonized, in terms of terminology or cross-references, with the applicable provisions of this Act (and regulations thereunder) and any other orders issued under this section.
“(c) Procedure for Minor Changes.—
“(1) In general.—Minor changes in the dosage form of a drug that is described in paragraph (1) or (2) of subsection (a) or the subject of an order issued under subsection (b) may be made by a requestor without the issuance of an order under subsection (b) if—
“(A) the requestor maintains such information as is necessary to demonstrate that the change—
“(i) will not affect the safety or effectiveness of the drug; and
“(ii) will not materially affect the extent of absorption or other exposure to the active ingredient in comparison to a suitable reference product; and
“(B) the change is in conformity with the requirements of an applicable administrative order issued by the Secretary under paragraph (3).
“(2) Additional information.—
“(A) Access to records.—A sponsor shall submit records requested by the Secretary relating to such a minor change under section 704(a)(4), within 15 business days of receiving such a request, or such longer period as the Secretary may provide.
“(B) Insufficient information.—If the Secretary determines that the information contained in such records is not sufficient to demonstrate that the change does not affect the safety or effectiveness of the drug or materially affect the extent of absorption or other exposure to the active ingredient, the Secretary—
“(i) may so inform the sponsor of the drug in writing; and
“(ii) if the Secretary so informs the sponsor, shall provide the sponsor of the drug with a reasonable opportunity to provide additional information.
“(C) Failure to submit sufficient information.—If the sponsor fails to provide such additional information within a time prescribed by the Secretary, or if the Secretary determines that such additional information does not demonstrate that the change does not—
“(i) affect the safety or effectiveness of the drug; or
“(ii) materially affect the extent of absorption or other exposure to the active ingredient in comparison to a suitable reference product,
“(3) Determining whether a change will affect safety or effectiveness.—
“(A) In general.—The Secretary shall issue one or more administrative orders specifying requirements for determining whether a minor change made by a sponsor pursuant to this subsection will affect the safety or effectiveness of a drug or materially affect the extent of absorption or other exposure to an active ingredient in the drug in comparison to a suitable reference product, together with guidance for applying those orders to specific dosage forms.
“(B) Standard practices.—The orders and guidance issued by the Secretary under subparagraph (A) shall take into account relevant public standards and standard practices for evaluating the quality of drugs, and may take into account the special needs of populations, including children.
“(d) Confidentiality of Information Submitted to the Secretary.—
“(1) In general.—Subject to paragraph (2), any information, including reports of testing conducted on the drug or drugs involved, that is submitted by a requestor in connection with proceedings on an order under this section (including any minor change under subsection (c)) and is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code, shall not be disclosed to the public unless the requestor consents to that disclosure.
“(2) Public availability.—
“(A) In general.—Except as provided in subparagraph (B), the Secretary shall—
“(i) make any information submitted by a requestor in support of a request under subsection (b)(5)(A) available to the public not later than the date on which the proposed order is issued; and
“(ii) make any information submitted by any other person with respect to an order requested (or initiated by the Secretary) under subsection (b), available to the public upon such submission.
“(B) Limitations on public availability.—Information described in subparagraph (A) shall not be made public if—
“(i) the information pertains to pharmaceutical quality information, unless such information is necessary to establish standards under which a drug is generally recognized as safe and effective under section 201(p)(1);
“(ii) the information is submitted in a requestor-initiated request, but the requestor withdraws such request, in accordance with withdrawal procedures established by the Secretary, before the Secretary issues the proposed order;
“(iii) the Secretary requests and obtains the information under subsection (c) and such information is not submitted in relation to an order under subsection (b); or
“(iv) the information is of the type contained in raw datasets.
“(e) Updates to Drug Listing Information.—A sponsor who makes a change to a drug subject to this section shall submit updated drug listing information for the drug in accordance with section 510(j) within 30 calendar days of the date when the drug is first commercially marketed, except that a sponsor who was the order requestor with respect to an order subject to subsection (b)(5)(C) (or a licensee, assignee, or successor in interest of such requestor) shall submit updated drug listing information on or before the date when the drug is first commercially marketed.
“(f) Approvals Under Section 505.—The provisions of this section shall not be construed to preclude a person from seeking or maintaining the approval of an application for a drug under sections 505(b)(1), 505(b)(2), and 505(j). A determination under this section that a drug is not subject to section 503(b)(1), is generally recognized as safe and effective under section 201(p)(1), and is not a new drug under section 201(p) shall constitute a finding that the drug is safe and effective that may be relied upon for purposes of an application under section 505(b)(2), so that the applicant shall be required to submit for purposes of such application only information needed to support any modification of the drug that is not covered by such determination under this section.
“(g) Public Availability of Administrative Orders.—The Secretary shall establish, maintain, update (as determined necessary by the Secretary but no less frequently than annually), and make publicly available, with respect to orders issued under this section—
“(1) a repository of each final order and interim final order in effect, including the complete text of the order; and
“(2) a listing of all orders proposed and under development under subsection (b)(2), including—
“(A) a brief description of each such order; and
“(B) the Secretary’s expectations, if resources permit, for issuance of proposed orders over a 3-year period.
“(h) Development Advice to Sponsors or Requestors.—The Secretary shall establish procedures under which sponsors or requestors may meet with appropriate officials of the Food and Drug Administration to obtain advice on the studies and other information necessary to support submissions under this section and other matters relevant to the regulation of nonprescription drugs and the development of new nonprescription drugs under this section.
“(i) Participation of Multiple Sponsors or Requestors.—The Secretary shall establish procedures to facilitate efficient participation by multiple sponsors or requestors in proceedings under this section, including provision for joint meetings with multiple sponsors or requestors or with organizations nominated by sponsors or requestors to represent their interests in a proceeding.
“(j) Electronic Format.—All submissions under this section shall be in electronic format.
“(k) Effect on Existing Regulations Governing Nonprescription Drugs.—
“(1) Regulations of general applicability to nonprescription drugs.—Except as provided in this subsection, nothing in this section supersedes regulations establishing general requirements for nonprescription drugs, including regulations of general applicability contained in parts 201, 250, and 330 of title 21, Code of Federal Regulations, or any successor regulations. The Secretary shall establish or modify such regulations by means of rulemaking in accordance with section 553 of title 5, United States Code.
“(2) Regulations establishing requirements for specific nonprescription drugs.—
“(A) The provisions of section 310.545 of title 21, Code of Federal Regulations, as in effect on the day before the date of the enactment of this section, shall be deemed to be a final order under subsection (b).
“(B) Regulations in effect on the day before the date of the enactment of this section, establishing requirements for specific nonprescription drugs marketed pursuant to this section (including such requirements in parts 201 and 250 of title 21, Code of Federal Regulations), shall be deemed to be final orders under subsection (b), only as they apply to drugs—
“(i) subject to paragraph (1), (2), (3), or (4) of subsection (a); or
“(ii) otherwise subject to an order under this section.
“(3) Withdrawal of regulations.—The Secretary shall withdraw regulations establishing final monographs and the procedures governing the over-the-counter drug review under part 330 and other relevant parts of title 21, Code of Federal Regulations (as in effect on the day before the date of the enactment of this section), or make technical changes to such regulations to ensure conformity with appropriate terminology and cross references. Notwithstanding subchapter II of chapter 5 of title 5, United States Code, any such withdrawal or technical changes shall be made without public notice and comment and shall be effective upon publication through notice in the Federal Register (or upon such date as specified in such notice).
“(l) Guidance.—The Secretary shall issue guidance that specifies—
“(1) the procedures and principles for formal meetings between the Secretary and sponsors or requestors for drugs subject to this section;
“(2) the format and content of data submissions to the Secretary under this section;
“(3) the format of electronic submissions to the Secretary under this section;
“(4) consolidated proceedings for appeal and the procedures for such proceedings where appropriate; and
“(5) for minor changes in drugs, recommendations on how to comply with the requirements in orders issued under subsection (c)(3).
“(m) Rule of Construction.—
“(1) In general.—This section shall not affect the treatment or status of a nonprescription drug—
“(A) that is marketed without an application approved under section 505 as of the date of the enactment of this section;
“(B) that is not subject to an order issued under this section; and
“(C) to which paragraph (1), (2), (3), (4), or (5) of subsection (a) do not apply.
“(2) Treatment of products previously found to be subject to time and extent requirements.—
“(A) Notwithstanding subsection (a), a drug described in subparagraph (B) may only be lawfully marketed, without an application approved under section 505, pursuant to an order issued under this section.
“(B) A drug described in this subparagraph is a drug which, prior to the date of the enactment of this section, the Secretary determined in a proposed or final rule to be ineligible for review under the OTC drug review (as such phrase ‘OTC drug review’ was used in section 330.14 of title 21, Code of Federal Regulations, as in effect on the day before the date of the enactment of this section).
“(3) Preservation of authority.—
“(A) Nothing in paragraph (1) shall be construed to preclude or limit the applicability of any provision of this Act other than this section.
“(B) Nothing in subsection (a) shall be construed to prohibit the Secretary from issuing an order under this section finding a drug to be not generally recognized as safe and effective under section 201(p)(1), as the Secretary determines appropriate.
“(n) Investigational New Drugs.—A drug is not subject to this section if an exemption for investigational use under section 505(i) is in effect for such drug.
“(o) Inapplicability of Paperwork Reduction Act.—Chapter 35 of title 44, United States Code, shall not apply to collections of information made under this section.
“(p) Inapplicability of Notice and Comment Rulemaking and Other Requirements.—The requirements of subsection (b) shall apply with respect to orders issued under this section instead of the requirements of subchapter II of chapter 5 of title 5, United States Code.
“(q) Definitions.—In this section:
“(1) The term ‘nonprescription drug’ refers to a drug not subject to the requirements of section 503(b)(1).
“(2) The term ‘sponsor’ refers to any person marketing, manufacturing, or processing a drug that—
“(A) is listed pursuant to section 510(j); and
“(B) is or will be subject to an administrative order under this section of the Food and Drug Administration.
“(3) The term ‘requestor’ refers to any person or group of persons marketing, manufacturing, processing, or developing a drug.”
“(ee) If it is a nonprescription drug that is subject to section 505G, is not the subject of an application approved under section 505, and does not comply with the requirements under section 505G.
“(ff) If it is a drug and it was manufactured, prepared, propagated, compounded, or processed in a facility for which fees have not been paid as required by section 744M.”
“(3) Relationship to orders under section 505g.—A final sunscreen order shall be deemed to be a final order under section 505G.”
“(A) In general.—A sponsor may request”
; and
“(B) Confidential meetings.—A sponsor may request one or more confidential meetings with respect to a proposed sunscreen order, including a letter deemed to be a proposed sunscreen order under paragraph (3), to discuss matters relating to data requirements to support a general recognition of safety and effectiveness involving confidential information and public information related to such proposed sunscreen order, as appropriate. The Secretary shall convene a confidential meeting with such sponsor in a reasonable time period. If a sponsor requests more than one confidential meeting for the same proposed sunscreen order, the Secretary may refuse to grant an additional confidential meeting request if the Secretary determines that such additional confidential meeting is not reasonably necessary for the sponsor to advance its proposed sunscreen order, or if the request for a confidential meeting fails to include sufficient information upon which to base a substantive discussion. The Secretary shall publish a post-meeting summary of each confidential meeting under this subparagraph that does not disclose confidential commercial information or trade secrets. This subparagraph does not authorize the disclosure of confidential commercial information or trade secrets subject to 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code.”
“(f) Exclusivity.—
“(1) In general.—A final sunscreen order shall have the effect of authorizing solely the order requestor (or the licensees, assignees, or successors in interest of such requestor with respect to the subject of such request and listed under paragraph (5)) for a period of 18 months, to market a sunscreen ingredient under this section incorporating changes described in paragraph (2) subject to the limitations under paragraph (4), beginning on the date the requestor (or any licensees, assignees, or successors in interest of such requestor with respect to the subject of such request and listed under paragraph (5)) may lawfully market such sunscreen ingredient pursuant to the order.
“(2) Changes described.—A change described in this paragraph is a change subject to an order specified in paragraph (1) that permits a sunscreen to contain an active sunscreen ingredient not previously incorporated in a marketed sunscreen listed in paragraph (3).
“(3) Marketed sunscreen.—The marketed sunscreen ingredients described in this paragraph are sunscreen ingredients—
“(A) marketed in accordance with a final monograph for sunscreen drug products set forth at part 352 of title 21, Code of Federal Regulations (as published at 64 Fed. Reg. 27687); or
“(B) marketed in accordance with a final order issued under this section.
“(4) Limitations on exclusivity.—Only one 18-month period may be granted per ingredient under paragraph (1).
“(5) Listing of licensees, assignees, or successors in interest.—Requestors shall submit to the Secretary at the time when a drug subject to such request is introduced or delivered for introduction into interstate commerce, a list of licensees, assignees, or successors in interest under paragraph (1).”
“SEC. 586H. SUNSET.
“This subchapter shall cease to be effective at the end of fiscal year 2022.”
“PART 10— FEES RELATING TO OVER-THE-COUNTER DRUGS
“SEC. 744L. DEFINITIONS.
“In this part:
“(1) The term ‘affiliate’ means a business entity that has a relationship with a second business entity if, directly or indirectly—
“(A) one business entity controls, or has the power to control, the other business entity; or
“(B) a third party controls, or has power to control, both of the business entities.
“(2) The term ‘contract manufacturing organization facility’ means an OTC monograph drug facility where neither the owner of such manufacturing facility nor any affiliate of such owner or facility sells the OTC monograph drug produced at such facility directly to wholesalers, retailers, or consumers in the United States.
“(3) The term ‘costs of resources allocated for OTC monograph drug activities’ means the expenses in connection with OTC monograph drug activities for—
“(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers, employees, and committees and costs related to contracts with such contractors;
“(B) management of information, and the acquisition, maintenance, and repair of computer resources;
“(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and
“(D) collecting fees under section 744M and accounting for resources allocated for OTC monograph drug activities.
“(4) The term ‘FDA establishment identifier’ is the unique number automatically generated by Food and Drug Administration’s Field Accomplishments and Compliance Tracking System (FACTS) (or any successor system).
“(5) The term ‘OTC monograph drug’ means a nonprescription drug without an approved new drug application which is governed by the provisions of section 505G.
“(6) The term ‘OTC monograph drug activities’ means activities of the Secretary associated with OTC monograph drugs and inspection of facilities associated with such products, including the following activities:
“(A) The activities necessary for review and evaluation of OTC monographs and OTC monograph order requests, including—
“(i) orders proposing or finalizing applicable conditions of use for OTC monograph drugs;
“(ii) orders affecting status regarding general recognition of safety and effectiveness of an OTC monograph ingredient or combination of ingredients under specified conditions of use;
“(iii) all OTC monograph drug development and review activities, including intra-agency collaboration;
“(iv) regulation and policy development activities related to OTC monograph drugs;
“(v) development of product standards for products subject to review and evaluation;
“(vi) meetings referred to in section 505G(i);
“(vii) review of labeling prior to issuance of orders related to OTC monograph drugs or conditions of use; and
“(viii) regulatory science activities related to OTC monograph drugs.
“(B) Inspections related to OTC monograph drugs.
“(C) Monitoring of clinical and other research conducted in connection with OTC monograph drugs.
“(D) Safety activities with respect to OTC monograph drugs, including—
“(i) collecting, developing, and reviewing safety information on OTC monograph drugs, including adverse event reports;
“(ii) developing and using improved adverse event data-collection systems, including information technology systems; and
“(iii) developing and using improved analytical tools to assess potential safety risks, including access to external databases.
“(E) Other activities necessary for implementation of section 505G.
“(7) The term ‘OTC monograph order request’ means a request for an order submitted under section 505G(b)(5).
“(8) The term ‘Tier 1 OTC monograph order request’ means any OTC monograph order request not determined to be a Tier 2 OTC monograph order request.
“(9)
(A) The term ‘Tier 2 OTC monograph order request’ means, subject to subparagraph (B), an OTC monograph order request for—
“(i) the reordering of existing information in the drug facts label of an OTC monograph drug;
“(ii) the addition of information to the other information section of the drug facts label of an OTC monograph drug, as limited by section 201.66(c)(7) of title 21, Code of Federal Regulations (or any successor regulations);
“(iii) modification to the directions for use section of the drug facts label of an OTC monograph drug, if such changes conform to changes made pursuant to section 505G(c)(3)(A);
“(iv) the standardization of the concentration or dose of a specific finalized ingredient within a particular finalized monograph;
“(v) a change to ingredient nomenclature to align with nomenclature of a standards-setting organization; or
“(vi) addition of an interchangeable term in accordance with section 330.1 of title 21, Code of Federal Regulations (or any successor regulations).
“(B) The Secretary may, based on program implementation experience or other factors found appropriate by the Secretary, characterize any OTC monograph order request as a Tier 2 OTC monograph order request (including recharacterizing a request from Tier 1 to Tier 2) and publish such determination in a proposed order issued pursuant to section 505G.
“(10)
(A) The term ‘OTC monograph drug facility’ means a foreign or domestic business or other entity that—
“(i) is—
“(I) under one management, either direct or indirect; and
“(II) at one geographic location or address engaged in manufacturing or processing the finished dosage form of an OTC monograph drug;
“(ii) includes a finished dosage form manufacturer facility in a contractual relationship with the sponsor of one or more OTC monograph drugs to manufacture or process such drugs; and
“(iii) does not include a business or other entity whose only manufacturing or processing activities are one or more of the following: production of clinical research supplies, testing, or placement of outer packaging on packages containing multiple products, for such purposes as creating multipacks, when each monograph drug product contained within the overpackaging is already in a final packaged form prior to placement in the outer overpackaging.
“(B) For purposes of subparagraph (A)(i)(II), separate buildings or locations within close proximity are considered to be at one geographic location or address if the activities conducted in such buildings or locations are—
“(i) closely related to the same business enterprise;
“(ii) under the supervision of the same local management; and
“(iii) under a single FDA establishment identifier and capable of being inspected by the Food and Drug Administration during a single inspection.
“(C) If a business or other entity would meet criteria specified in subparagraph (A), but for being under multiple management, the business or other entity is deemed to constitute multiple facilities, one per management entity, for purposes of this paragraph.
“(11) The term ‘OTC monograph drug meeting’ means any meeting regarding the content of a proposed OTC monograph order request.
“(12) The term ‘person’ includes an affiliate of a person.
“(13) The terms ‘requestor’ and ‘sponsor’ have the meanings given such terms in section 505G.
“SEC. 744M. AUTHORITY TO ASSESS AND USE OTC MONOGRAPH FEES.
“(a) Types of Fees.—Beginning with fiscal year 2021, the Secretary shall assess and collect fees in accordance with this section as follows:
“(1) Facility fee.—
“(A) In general.—Each person that owns a facility identified as an OTC monograph drug facility on December 31 of the fiscal year or at any time during the preceding 12-month period shall be assessed an annual fee for each such facility as determined under subsection (c).
“(B) Exceptions.—
“(i) Facilities that cease activities.—A fee shall not be assessed under subparagraph (A) if the identified OTC monograph drug facility—
“(I) has ceased all activities related to OTC monograph drugs prior to December 31 of the year immediately preceding the applicable fiscal year; and
“(II) has updated its registration to reflect such change under the requirements for drug establishment registration set forth in section 510.
“(ii) Contract manufacturing organizations.—The amount of the fee for a contract manufacturing organization facility shall be equal to two-thirds of the amount of the fee for an OTC monograph drug facility that is not a contract manufacturing organization facility.
“(C) Amount.—The amount of fees established under subparagraph (A) shall be established under subsection (c).
“(D) Due date.—
“(i) For first program year.—For fiscal year 2021, the facility fees required under subparagraph (A) shall be due on the later of—
“(I) the first business day of July of 2020; or
“(II) 45 calendar days after publication of the Federal Register notice provided for under subsection (c)(4)(A).
“(ii) Subsequent fiscal years.—For each fiscal year after fiscal year 2021, the facility fees required under subparagraph (A) shall be due on the later of—
“(I) the first business day of June of such year; or
“(II) the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees under this section for such year.
“(2) OTC monograph order request fee.—
“(A) In general.—Each person that submits an OTC monograph order request shall be subject to a fee for an OTC monograph order request. The amount of such fee shall be—
“(i) for a Tier 1 OTC monograph order request, $500,000, adjusted for inflation for the fiscal year (as determined under subsection (c)(1)(B)); and
“(ii) for a Tier 2 OTC monograph order request, $100,000, adjusted for inflation for the fiscal year (as determined under subsection (c)(1)(B)).
“(B) Due date.—The OTC monograph order request fees required under subparagraph (A) shall be due on the date of submission of the OTC monograph order request.
“(C) Exception for certain safety changes.—A person who is named as the requestor in an OTC monograph order shall not be subject to a fee under subparagraph (A) if the Secretary finds that the OTC monograph order request seeks to change the drug facts labeling of an OTC monograph drug in a way that would add to or strengthen—
“(i) a contraindication, warning, or precaution;
“(ii) a statement about risk associated with misuse or abuse; or
“(iii) an instruction about dosage and administration that is intended to increase the safe use of the OTC monograph drug.
“(D) Refund of fee if order request is recategorized as a tier 2 otc monograph order request.—If the Secretary determines that an OTC monograph request initially characterized as Tier 1 shall be re-characterized as a Tier 2 OTC monograph order request, and the requestor has paid a Tier 1 fee in accordance with subparagraph (A)(i), the Secretary shall refund the requestor the difference between the Tier 1 and Tier 2 fees determined under subparagraphs (A)(i) and (A)(ii), respectively.
“(E) Refund of fee if order request refused for filing or withdrawn before filing.—The Secretary shall refund 75 percent of the fee paid under subparagraph (B) for any order request which is refused for filing or was withdrawn before being accepted or refused for filing.
“(F) Fees for order requests previously refused for filing or withdrawn before filing.—An OTC monograph order request that was submitted but was refused for filing, or was withdrawn before being accepted or refused for filing, shall be subject to the full fee under subparagraph (A) upon being resubmitted or filed over protest.
“(G) Refund of fee if order request withdrawn.—If an order request is withdrawn after the order request was filed, the Secretary may refund the fee or a portion of the fee if no substantial work was performed on the order request after the application was filed. The Secretary shall have the sole discretion to refund a fee or a portion of the fee under this subparagraph. A determination by the Secretary concerning a refund under this subparagraph shall not be reviewable.
“(3) Refunds.—
“(A) In general.—Other than refunds provided pursuant to any of subparagraphs (D) through (G) of paragraph (2), the Secretary shall not refund any fee paid under paragraph (1) except as provided in subparagraph (B).
“(B) Disputes concerning fees.—To qualify for the return of a fee claimed to have been paid in error under paragraph (1) or (2), a person shall submit to the Secretary a written request justifying such return within 180 calendar days after such fee was paid.
“(4) Notice.—Within the timeframe specified in subsection (c), the Secretary shall publish in the Federal Register the amount of the fees under paragraph (1) for such fiscal year.
“(b) Fee Revenue Amounts.—
“(1) Fiscal year 2021.—For fiscal year 2021, fees under subsection (a)(1) shall be established to generate a total facility fee revenue amount equal to the sum of—
“(A) the annual base revenue for fiscal year 2021 (as determined under paragraph (3));
“(B) the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(2)); and
“(C) additional direct cost adjustments (as determined under subsection (c)(3)).
“(2) Subsequent fiscal years.—For each of the fiscal years 2022 through 2025, fees under subsection (a)(1) shall be established to generate a total facility fee revenue amount equal to the sum of—
“(A) the annual base revenue for the fiscal year (as determined under paragraph (3));
“(B) the dollar amount equal to the inflation adjustment for the fiscal year (as determined under subsection (c)(1));
“(C) the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(2));
“(D) additional direct cost adjustments (as determined under subsection (c)(3)); and
“(E) additional dollar amounts for each fiscal year as follows:
“(i) $7,000,000 for fiscal year 2022.
“(ii) $6,000,000 for fiscal year 2023.
“(iii) $7,000,000 for fiscal year 2024.
“(iv) $3,000,000 for fiscal year 2025.
“(3) Annual base revenue.—For purposes of paragraphs (1)(A) and (2)(A), the dollar amount of the annual base revenue for a fiscal year shall be—
“(A) for fiscal year 2021, $8,000,000; and
“(B) for fiscal years 2022 through 2025, the dollar amount of the total revenue amount established under this subsection for the previous fiscal year, not including any adjustments made under subsection (c)(2) or (c)(3).
“(c) Adjustments; Annual Fee Setting.—
“(1) Inflation adjustment.—
“(A) In general.—For purposes of subsection (b)(2)(B), the dollar amount of the inflation adjustment to the annual base revenue for fiscal year 2022 and each subsequent fiscal year shall be equal to the product of—
“(i) such annual base revenue for the fiscal year under subsection (b)(2); and
“(ii) the inflation adjustment percentage under subparagraph (C).
“(B) OTC monograph order request fees.—For purposes of subsection (a)(2), the dollar amount of the inflation adjustment to the fee for OTC monograph order requests for fiscal year 2022 and each subsequent fiscal year shall be equal to the product of—
“(i) the applicable fee under subsection (a)(2) for the preceding fiscal year; and
“(ii) the inflation adjustment percentage under subparagraph (C).
“(C) Inflation adjustment percentage.—The inflation adjustment percentage under this subparagraph for a fiscal year is equal to—
“(i) for each of fiscal years 2022 and 2023, the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data; and
“(ii) for each of fiscal years 2024 and 2025, the sum of—
“(I) the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 years of the preceding 4 fiscal years, multiplied by the proportion of personnel compensation and benefits costs to total costs of OTC monograph drug activities for the first 3 years of the preceding 4 fiscal years; and
“(II) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of OTC monograph drug activities for the first 3 years of the preceding 4 fiscal years.
“(2) Operating reserve adjustment.—
“(A) In general.—For fiscal year 2021 and subsequent fiscal years, for purposes of subsections (b)(1)(B) and (b)(2)(C), the Secretary may, in addition to adjustments under paragraph (1), further increase the fee revenue and fees if such an adjustment is necessary to provide operating reserves of carryover user fees for OTC monograph drug activities for not more than the number of weeks specified in subparagraph (B).
“(B) Number of weeks.—The number of weeks specified in this subparagraph is—
“(i) 3 weeks for fiscal year 2021;
“(ii) 7 weeks for fiscal year 2022;
“(iii) 10 weeks for fiscal year 2023;
“(iv) 10 weeks for fiscal year 2024; and
“(v) 10 weeks for fiscal year 2025.
“(C) Decrease.—If the Secretary has carryover balances for such process in excess of 10 weeks of the operating reserves referred to in subparagraph (A), the Secretary shall decrease the fee revenue and fees referred to in such subparagraph to provide for not more than 10 weeks of such operating reserves.
“(D) Rationale for adjustment.—If an adjustment under this paragraph is made, the rationale for the amount of the increase or decrease (as applicable) in fee revenue and fees shall be contained in the annual Federal Register notice under paragraph (4) establishing fee revenue and fees for the fiscal year involved.
“(3) Additional direct cost adjustment.—The Secretary shall, in addition to adjustments under paragraphs (1) and (2), further increase the fee revenue and fees for purposes of subsection (b)(2)(D) by an amount equal to—
“(A) $14,000,000 for fiscal year 2021;
“(B) $7,000,000 for fiscal year 2022;
“(C) $4,000,000 for fiscal year 2023;
“(D) $3,000,000 for fiscal year 2024; and
“(E) $3,000,000 for fiscal year 2025.
“(4) Annual fee setting.—
“(A) Fiscal year 2021.—The Secretary shall, not later than the second Monday in May of 2020—
“(i) establish OTC monograph drug facility fees for fiscal year 2021 under subsection (a), based on the revenue amount for such year under subsection (b) and the adjustments provided under this subsection; and
“(ii) publish fee revenue, facility fees, and OTC monograph order requests in the Federal Register.
“(B) Subsequent fiscal years.—The Secretary shall, for each fiscal year that begins after September 30, 2021, not later than the second Monday in March that precedes such fiscal year—
“(i) establish for such fiscal year, based on the revenue amounts under subsection (b) and the adjustments provided under this subsection—
“(I) OTC monograph drug facility fees under subsection (a)(1); and
“(II) OTC monograph order request fees under subsection (a)(2); and
“(ii) publish such fee revenue amounts, facility fees, and OTC monograph order request fees in the Federal Register.
“(d) Identification of Facilities.—Each person that owns an OTC monograph drug facility shall submit to the Secretary the information required under this subsection each year. Such information shall, for each fiscal year—
“(1) be submitted as part of the requirements for drug establishment registration set forth in section 510; and
“(2) include for each such facility, at a minimum, identification of the facility’s business operation as that of an OTC monograph drug facility.
“(e) Effect of Failure To Pay Fees.—
“(1) OTC monograph drug facility fee.—
“(A) In general.—Failure to pay the fee under subsection (a)(1) within 20 calendar days of the due date as specified in subparagraph (D) of such subsection shall result in the following:
“(i) The Secretary shall place the facility on a publicly available arrears list.
“(ii) All OTC monograph drugs manufactured in such a facility or containing an ingredient manufactured in such a facility shall be deemed misbranded under section 502(ff).
“(B) Application of penalties.—The penalties under this paragraph shall apply until the fee established by subsection (a)(1) is paid.
“(2) Order requests.—An OTC monograph order request submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for filing by the Secretary until all fees owed by such person under this section have been paid.
“(3) Meetings.—A person subject to fees under this section shall be considered ineligible for OTC monograph drug meetings until all such fees owed by such person have been paid.
“(f) Crediting and Availability of Fees.—
“(1) In general.—Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for OTC monograph drug activities.
“(2) Collections and appropriation acts.—
“(A) In general.—Subject to subparagraph (C), the fees authorized by this section shall be collected and available in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation, for such fiscal year.
“(B) Use of fees and limitation.—The fees authorized by this section shall be available to defray increases in the costs of the resources allocated for OTC monograph drug activities (including increases in such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such activities), only if the Secretary allocates for such purpose an amount for such fiscal year (excluding amounts from fees collected under this section) no less than $12,000,000, multiplied by the adjustment factor applicable to the fiscal year involved under subsection (c)(1).
“(C) Compliance.—The Secretary shall be considered to have met the requirements of subparagraph (B) in any fiscal year if the costs funded by appropriations and allocated for OTC monograph drug activities are not more than 15 percent below the level specified in such subparagraph.
“(D) Provision for early payments in subsequent years.—Payment of fees authorized under this section for a fiscal year (after fiscal year 2021), prior to the due date for such fees, may be accepted by the Secretary in accordance with authority provided in advance in a prior year appropriations Act.
“(3) Authorization of appropriations.—For each of the fiscal years 2021 through 2025, there is authorized to be appropriated for fees under this section an amount equal to the total amount of fees assessed for such fiscal year under this section.
“(g) Collection of Unpaid Fees.—In any case where the Secretary does not receive payment of a fee assessed under subsection (a) within 30 calendar days after it is due, such fee shall be treated as a claim of the United States Government subject to subchapter II of chapter 37 of title 31, United States Code.
“(h) Construction.—This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employers, and advisory committees not engaged in OTC monograph drug activities, be reduced to offset the number of officers, employees, and advisory committees so engaged.
“SEC. 744N. REAUTHORIZATION; REPORTING REQUIREMENTS.
“(a) Performance Report.—Beginning with fiscal year 2021, and not later than 120 calendar days after the end of each fiscal year thereafter for which fees are collected under this part, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 3861(b) of the CARES Act during such fiscal year and the future plans of the Food and Drug Administration for meeting such goals.
“(b) Fiscal Report.—Not later than 120 calendar days after the end of fiscal year 2021 and each subsequent fiscal year for which fees are collected under this part, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected for such fiscal year.
“(c) Public Availability.—The Secretary shall make the reports required under subsections (a) and (b) available to the public on the internet website of the Food and Drug Administration.
“(d) Reauthorization.—
“(1) Consultation.—In developing recommendations to present to the Congress with respect to the goals described in subsection (a), and plans for meeting the goals, for OTC monograph drug activities for the first 5 fiscal years after fiscal year 2025, and for the reauthorization of this part for such fiscal years, the Secretary shall consult with—
“(A) the Committee on Energy and Commerce of the House of Representatives;
“(B) the Committee on Health, Education, Labor, and Pensions of the Senate;
“(C) scientific and academic experts;
“(D) health care professionals;
“(E) representatives of patient and consumer advocacy groups; and
“(F) the regulated industry.
“(2) Public review of recommendations.—After negotiations with the regulated industry, the Secretary shall—
“(A) present the recommendations developed under paragraph (1) to the congressional committees specified in such paragraph;
“(B) publish such recommendations in the Federal Register;
“(C) provide for a period of 30 calendar days for the public to provide written comments on such recommendations;
“(D) hold a meeting at which the public may present its views on such recommendations; and
“(E) after consideration of such public views and comments, revise such recommendations as necessary.
“(3) Transmittal of recommendations.—Not later than January 15, 2025, the Secretary shall transmit to the Congress the revised recommendations under paragraph (2), a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments.”
“(h) Approval of Guarantee Program During the COVID–19 Crisis.—
“(1) In general.—For purposes of the congressional joint resolution of approval provided for in subsections (c)(1) and (2) and (d), notwithstanding any other provision of this section, the Federal Deposit Insurance Corporation is approved upon enactment of this Act to establish a program provided for in subsection (a), provided that any such program and any such guarantee shall terminate not later than December 31, 2020.
“(2) Maximum amount.—Any debt guarantee program authorized by this subsection shall include a maximum amount of outstanding debt that is guaranteed.”
“(F) Reporting information during covid–19 pandemic.—
“(i) Definitions.—In this subsection:
“(I) Accommodation.—The term ‘accommodation’ includes an agreement to defer 1 or more payments, make a partial payment, forbear any delinquent amounts, modify a loan or contract, or any other assistance or relief granted to a consumer who is affected by the coronavirus disease 2019 (COVID–19) pandemic during the covered period.
“(II) Covered period.—The term ‘covered period’ means the period beginning on January 31, 2020 and ending on the later of—
“(aa) 120 days after the date of enactment of this subparagraph; or
“(bb) 120 days after the date on which the national emergency concerning the novel coronavirus disease (COVID–19) outbreak declared by the President on March 13, 2020 under the National Emergencies Act (50 U.S.C. 1601 et seq.) terminates.
“(ii) Reporting.—Except as provided in clause (iii), if a furnisher makes an accommodation with respect to 1 or more payments on a credit obligation or account of a consumer, and the consumer makes the payments or is not required to make 1 or more payments pursuant to the accommodation, the furnisher shall—
“(I) report the credit obligation or account as current; or
“(II) if the credit obligation or account was delinquent before the accommodation—
“(aa) maintain the delinquent status during the period in which the accommodation is in effect; and
“(bb) if the consumer brings the credit obligation or account current during the period described in item (aa), report the credit obligation or account as current.
“(iii) Exception.—Clause (ii) shall not apply with respect to a credit obligation or account of a consumer that has been charged-off.”
“TITLE VI— CORONAVIRUS RELIEF FUND
“SEC. 601. CORONAVIRUS RELIEF FUND.
“(a) Appropriation.—
“(1) In general.—Out of any money in the Treasury of the United States not otherwise appropriated, there are appropriated for making payments to States, Tribal governments, and units of local government under this section, $150,000,000,000 for fiscal year 2020.
“(2) Reservation of funds.—Of the amount appropriated under paragraph (1), the Secretary shall reserve—
“(A) $3,000,000,000 of such amount for making payments to the District of Columbia, the Commonwealth of Puerto Rico, the United States Virgin Islands, Guam, the Commonwealth of the Northern Mariana Islands, and American Samoa; and
“(B) $8,000,000,000 of such amount for making payments to Tribal governments.
“(b) Authority to Make Payments.—
“(1) In general.—Subject to paragraph (2), not later than 30 days after the date of enactment of this section, the Secretary shall pay each State and Tribal government, and each unit of local government that meets the condition described in paragraph (2), the amount determined for the State, Tribal government, or unit of local government, for fiscal year 2020 under subsection (c).
“(2) Direct payments to units of local government.—If a unit of local government of a State submits the certification required by subsection (e) for purposes of receiving a direct payment from the Secretary under the authority of this paragraph, the Secretary shall reduce the amount determined for that State by the relative unit of local government population proportion amount described in subsection (c)(5) and pay such amount directly to such unit of local government.
“(c) Payment Amounts.—
“(1) In general.—Subject to paragraph (2), the amount paid under this section for fiscal year 2020 to a State that is 1 of the 50 States shall be the amount equal to the relative population proportion amount determined for the State under paragraph (3) for such fiscal year.
“(2) Minimum payment.—
“(A) In general.—No State that is 1 of the 50 States shall receive a payment under this section for fiscal year 2020 that is less than $1,250,000,000.
“(B) Pro rata adjustments.—The Secretary shall adjust on a pro rata basis the amount of the payments for each of the 50 States determined under this subsection without regard to this subparagraph to the extent necessary to comply with the requirements of subparagraph (A).
“(3) Relative population proportion amount.—For purposes of paragraph (1), the relative population proportion amount determined under this paragraph for a State for fiscal year 2020 is the product of—
“(A) the amount appropriated under paragraph (1) of subsection (a) for fiscal year 2020 that remains after the application of paragraph (2) of that subsection; and
“(B) the relative State population proportion (as defined in paragraph (4)).
“(4) Relative state population proportion defined.—For purposes of paragraph (3)(B), the term ‘relative State population proportion’ means, with respect to a State, the quotient of—
“(A) the population of the State; and
“(B) the total population of all States (excluding the District of Columbia and territories specified in subsection (a)(2)(A)).
“(5) Relative unit of local government population proportion amount.—For purposes of subsection (b)(2), the term ‘relative unit of local government population proportion amount’ means, with respect to a unit of local government and a State, the amount equal to the product of—
“(A) 45 percent of the amount of the payment determined for the State under this subsection (without regard to this paragraph); and
“(B) the amount equal to the quotient of—
“(i) the population of the unit of local government; and
“(ii) the total population of the State in which the unit of local government is located.
“(6) District of columbia and territories.—The amount paid under this section for fiscal year 2020 to a State that is the District of Columbia or a territory specified in subsection (a)(2)(A) shall be the amount equal to the product of—
“(A) the amount set aside under subsection (a)(2)(A) for such fiscal year; and
“(B) each such District’s and territory’s share of the combined total population of the District of Columbia and all such territories, as determined by the Secretary.
“(7) Tribal governments.—From the amount set aside under subsection (a)(2)(B) for fiscal year 2020, the amount paid under this section for fiscal year 2020 to a Tribal government shall be the amount the Secretary shall determine, in consultation with the Secretary of the Interior and Indian Tribes, that is based on increased expenditures of each such Tribal government (or a tribally-owned entity of such Tribal government) relative to aggregate expenditures in fiscal year 2019 by the Tribal government (or tribally-owned entity) and determined in such manner as the Secretary determines appropriate to ensure that all amounts available under subsection (a)(2)(B) for fiscal year 2020 are distributed to Tribal governments.
“(8) Data.—For purposes of this subsection, the population of States and units of local governments shall be determined based on the most recent year for which data are available from the Bureau of the Census.
“(d) Use of Funds.—A State, Tribal government, and unit of local government shall use the funds provided under a payment made under this section to cover only those costs of the State, Tribal government, or unit of local government that—
“(1) are necessary expenditures incurred due to the public health emergency with respect to the Coronavirus Disease 2019 (COVID–19);
“(2) were not accounted for in the budget most recently approved as of the date of enactment of this section for the State or government; and
“(3) were incurred during the period that begins on March 1, 2020, and ends on December 30, 2020.
“(e) Certification.—In order to receive a payment under this section, a unit of local government shall provide the Secretary with a certification signed by the Chief Executive for the unit of local government that the local government’s proposed uses of the funds are consistent with subsection (d).
“(f) Inspector General Oversight; Recoupment.—
“(1) Oversight authority.—The Inspector General of the Department of the Treasury shall conduct monitoring and oversight of the receipt, disbursement, and use of funds made available under this section.
“(2) Recoupment.—If the Inspector General of the Department of the Treasury determines that a State, Tribal government, or unit of local government has failed to comply with subsection (d), the amount equal to the amount of funds used in violation of such subsection shall be booked as a debt of such entity owed to the Federal Government. Amounts recovered under this subsection shall be deposited into the general fund of the Treasury.
“(3) Appropriation.—Out of any money in the Treasury of the United States not otherwise appropriated, there are appropriated to the Office of the Inspector General of the Department of the Treasury, $35,000,000 to carry out oversight and recoupment activities under this subsection. Amounts appropriated under the preceding sentence shall remain available until expended.
“(4) Authority of inspector general.—Nothing in this subsection shall be construed to diminish the authority of any Inspector General, including such authority as provided in the Inspector General Act of 1978 (5 U.S.C. App.).
“(g) Definitions.—In this section:
“(1) Indian tribe.—The term ‘Indian Tribe’ has the meaning given that term in section 4(e) of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 5304(e)).
“(2) Local government.—The term ‘unit of local government’ means a county, municipality, town, township, village, parish, borough, or other unit of general government below the State level with a population that exceeds 500,000.
“(3) Secretary.—The term ‘Secretary’ means the Secretary of the Treasury.
“(4) State.—The term ‘State’ means the 50 States, the District of Columbia, the Commonwealth of Puerto Rico, the United States Virgin Islands, Guam, the Commonwealth of the Northern Mariana Islands, and American Samoa.
“(5) Tribal government.—The term ‘Tribal government’ means the recognized governing body of an Indian Tribe.”