Division B — Other Matters

118th Congress · Approved Sep 30, 2023 · 137 Stat. 71

DIVISION B Other Matters

TITLE I Extensions and Other Matters

SEC. 2101. Extension of Certain Provisions of the Compact of Free Association with the Federated States of Micronesia and the Federal Program and Services Agreements with the Federated States of Micronesia and the Republic of the Marshall Islands.

(a)

Grant and Other Financial Assistance.—

(1)

In general.— During the period beginning on October 1, 2023, and ending on November 17, 2023, any activities described in sections 211, 212, and 215 of the Compact of Free Association between the Government of the United States of America and the Government of the Federated States of Micronesia set forth in section 201(a) of the Compact of Free Association Amendments Act of 2003 (48 U.S.C. 1921 note; Public Law 108–188) shall, with the mutual consent of the Federated States of Micronesia, continue in the manner authorized and required for fiscal year 2023 under the agreements described in paragraphs (4) and (5) of section 462(b) of that Compact.

(2)

Funding.— There is appropriated, out of any money in the Treasury not otherwise appropriated, to carry out the activities authorized under paragraph (1) an amount equal to the pro rata portion of the amount appropriated for those activities for fiscal year 2023.

(b)

Federal Programs and Services.— During the period beginning on October 1, 2023, and ending on the date on which a new Federal programs and services agreement with the applicable country enters into force, any activities described in sections 131, 132, and 221(a) of the Compact of Free Association between the Government of the United States of America and the Government of the Federated States of Micronesia set forth in section 201(a) of the Compact of Free Association Amendments Act of 2003 (48 U.S.C. 1921 note; Public Law 108–188) and sections 131, 132, and 221(a) of the Compact of Free Association between the Government of the United States of America and the Government of the Republic of the Marshall Islands set forth in section 201(b) of that Act shall, with the mutual consent of the Federated States of Micronesia or the Republic of the Marshall Islands, as applicable, continue in the manner authorized and required for fiscal year 2023 under the agreement described in section 462(b)(1) of the Compact of Free Association between the Government of the United States of America and the Government of the Federated States of Micronesia set forth in section 201(a) of that Act and the agreement described in section 462(b)(1) of the Compact of Free Association between the Government of the United States of America and the Government of the Republic of the Marshall Islands set forth in section 201(b) of that Act, respectively.

SEC. 2102. Extension of Deadline to Promulgate Certain Regulations.

Section 413(a) of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 5373(a)) is amended—

(1)

in paragraph (2), by striking “ 21 months” and inserting “ 38 months”; and

(2)

in paragraph (3), by striking “ 30 months” and inserting “ 50 months”.

TITLE II Faa Extension

Subtitle A Federal Aviation Programs

SEC. 2201. Airport Improvement Program.

(a)

Authorization of Appropriations.— Section 48103(a) of title 49, United States Code, is amended—

(1)

in paragraph (5) by striking the “ and” at the end;

(2)

in paragraph (6) by striking the period at the end and inserting “ ; and”; and

(3)

by adding at the end the following:

“(7) $842,076,502 for the period beginning on October 1, 2023, and ending on December 31, 2023.”

(b)

Obligation Authority.— Subject to limitations specified in advance in appropriation Acts, sums made available pursuant to the amendment made by subsection (a) may be obligated at any time through September 30, 2024, and shall remain available until expended.

(c)

Program Implementation.— For purposes of calculating funding apportionments and meeting other requirements under sections 47114, 47115, 47116, and 47117 of title 49, United States Code, for the period beginning on October 1, 2023, and ending on December 31, 2023, the Administrator of the Federal Aviation Administration shall—

(1)

first calculate such funding apportionments on an annualized basis as if the total amount available under section 48103 of such title for fiscal year 2024 was $3,350,000,000; and

(2)

then reduce by 75 percent—

(A)

all funding apportionment amounts calculated under paragraph (1); and

(B)

amounts made available pursuant to subsections (b) and (f)(2) of section 47117 of such title.

(d)

Extension of Project Grant Authority.— Section 47104(c) of title 49, United States Code, is amended in the matter preceding paragraph (1) by striking “ September 30, 2023,” and inserting “ December 31, 2023,”.

(e)

Extension of Special Rule for Apportionments.— Section 47114(c)(1)(J) of title 49, United States Code, is amended by striking “ 2023 to” and inserting “ 2023, and for the period beginning on October 1, 2023, and ending on December 31, 2023, to”.

SEC. 2202. Extension of Expiring Authorities; Miscellaneous Authorizations.

(a)

Authority to Provide Insurance.— Section 44310(b) of title 49, United States Code, is amended by striking “ September 30, 2023” and inserting “ December 31, 2023”.

(b)

Unmanned Aircraft Test Ranges.— Section 44803(h) of title 49, United States Code, is amended by striking “ September 30, 2023” and inserting “ December 31, 2023”.

(c)

Special Authority for Certain Unmanned Aircraft Systems.— Section 44807(d) of title 49, United States Code, is amended by striking “ September 30, 2023” and inserting “ December 31, 2023”.

(d)

Extension of Airport Safety and Airspace Hazard Mitigation and Enforcement.— Section 44810(h) of title 49, United States Code, is amended by striking “ September 30, 2023” and inserting “ December 31, 2023”.

(e)

Competitive Access Reporting Requirement.— Section 47107(r)(3) of title 49, United States Code, is amended by striking “ October 1, 2023” and inserting “ January 1, 2024”.

(f)

Marshall Islands, Micronesia, and Palau.— Section 47115(i) of title 49, United States Code, is amended by inserting “ , and for the period beginning on October 1, 2023, and ending on December 31, 2023” after “ fiscal years 2018 through 2023”.

(g)

Supplemental Discretionary Funds.— Section 47115(j)(4)(A) of title 49, United States Code, is amended by inserting at the end the following:

“(vi) $140,401,803 for the period beginning on October 1, 2023, and ending on December 31, 2023.”

(h)

Compatible Land Use Planning and Projects by State and Local Governments.— Section 47141(f) of title 49, United States Code, is amended by striking “ September 30, 2023” and inserting “ December 31, 2023”.

(i)

Non-movement Area Surveillance Pilot Program.— Section 47143(c) of title 49, United States Code, is amended by striking “ October 1, 2023” and inserting “ January 1, 2024”.

(j)

Weather Reporting Programs.— Section 48105 of title 49, United States Code, is amended by adding at the end the following:

“(5) $9,803,278 for the period beginning on October 1, 2023, and ending on December 31, 2023.”

(k)

Learning Period.— Section 50905(c)(9) of title 51, United States Code, is amended by striking “ October 1, 2023” and inserting “ January 1, 2024”.

(l)

Midway Island Airport.— Section 186(d) of the Vision 100—Century of Aviation Reauthorization Act (Public Law 108–176; 117 Stat. 2518) is amended by inserting “ and for the period beginning on October 1, 2023, and ending on December 31, 2023,” after “ fiscal years 2018 through 2023”.

(m)

Final Order Establishing Mileage and Adjustment Eligibility.— Section 409(d) of the Vision 100—Century of Aviation Reauthorization Act (49 U.S.C. 41731 note) is amended by striking “ September 30, 2023” and inserting “ December 31, 2023”.

(n)

Contract Weather Observers.— Section 2306(b) of the FAA Extension, Safety, and Security Act of 2016 (Public Law 114–190; 130 Stat. 641) is amended by striking “ October 1, 2023” and inserting “ January 1, 2024”.

(o)

Remote Tower Pilot Program.— Section 161(a)(10) of the FAA Reauthorization Act of 2018 (49 U.S.C. 47104 note) is amended by striking “ September 30, 2023” and inserting “ December 31, 2023”.

(p)

Airport Access Roads in Remote Locations; Storage Facilities for Snow Removal Equipment.— Section 162 of the FAA Reauthorization Act of 2018 (49 U.S.C. 47102 note) is amended by inserting “ and for the period beginning on October 1, 2023, and ending on December 31, 2023” after “ fiscal years 2018 through 2023”.

(q)

UAS Remote Detection and Identification Pilot Program.— Section 372(d) of the FAA Reauthorization Act of 2018 (49 U.S.C. 44810 note) is amended by striking “ September 30, 2023” and inserting “ December 31, 2023”.

(r)

Advisory Committee for Aviation Consumer Protection.— Section 411(h) of the FAA Modernization and Reform Act of 2012 (49 U.S.C. 42301 note) is amended by striking “ September 30, 2023” and inserting “ December 31, 2023”.

(s)

Aviation Consumer Advocate.— Section 424(e) of the FAA Reauthorization Act of 2018 (49 U.S.C. 42302 note) is amended by striking “ September 30, 2023” and inserting “ December 31, 2023”.

(t)

Advisory Committee on Air Travel Needs of Passengers With Disabilities.— Section 439(g) of the FAA Reauthorization Act of 2018 (49 U.S.C. 41705 note) is amended by striking “ September 30, 2023” and inserting “ December 31, 2023”.

(u)

Enhanced Traffic Services.— Section 547(e) of the FAA Reauthorization Act of 2018 (49 U.S.C. 40103 note) is amended by striking “ September 30, 2023” and inserting “ December 31, 2023”.

(v)

Pilot Program for Redevelopment of Airport Properties.— Section 822(k) of the FAA Modernization and Reform Act of 2012 (49 U.S.C. 47141 note) is amended by striking “ September 30, 2023” and inserting “ December 31, 2023”.

SEC. 2203. Federal Aviation Administration Operations.

Section 106(k) of title 49, United States Code, is amended—

(1)

in paragraph (1)—

(A)

in subparagraph (E) by striking “ and” at the end;

(B)

in subparagraph (F) by striking the period at the end and inserting “ ; and”; and

(C)

by inserting after subparagraph (F) the following:

“(G) $2,995,027,322 for the period beginning on October 1, 2023, and ending on December 31, 2023.”

; and

(2)

in paragraph (3) by inserting “ and for the period beginning on October 1, 2023, and ending on December 31, 2023” after “ fiscal years 2018 through 2023”.

SEC. 2204. Air Navigation Facilities and Equipment.

Section 48101(a) of title 49, United States Code, is amended by adding at the end the following:

“(7) $740,273,224 for the period beginning on October 1, 2023, and ending on December 31, 2023.”

SEC. 2205. Research, Engineering, and Development.

Section 48102(a) of title 49, United States Code, is amended—

(1)

in paragraph (14), by striking “ and”;

(2)

in paragraph (15) by striking the period at the end and inserting “ ; and”; and

(3)

by adding at the end the following:

“(16) $64,098,360 for the period beginning on October 1, 2023, and ending on December 31, 2023.”

SEC. 2206. Small Community Air Service.

(a)

Essential Air Service Authorization.— Section 41742(a)(2) of title 49, United States Code, is amended by striking “ 2023” and inserting “ 2023, and $89,191,486 for the period beginning on October 1, 2023, and ending on December 31, 2023,”.

(b)

Airports Not Receiving Sufficient Service.— Section 41743(e)(2) of title 49, United States Code, is amended by inserting “ , and $2,513,661 for the period beginning on October 1, 2023, and ending on December 31, 2023,” after “ fiscal years 2018 through 2023”.

Subtitle B Aviation Revenue Provisions

SEC. 2211. Expenditure Authority from Airport and Airway Trust Fund.

(a)

In General.— Section 9502(d)(1) of the Internal Revenue Code of 1986 is amended—

(1)

in the matter preceding subparagraph (A) by striking “ October 1, 2023” and inserting “ January 1, 2024”; and

(2)

in subparagraph (A) by striking the semicolon at the end and inserting “ or title II of division B of the Continuing Appropriations Act, 2024 and Other Extensions Act;”.

(b)

Conforming Amendment.— Section 9502(e)(2) of such Code is amended by striking “ October 1, 2023” and inserting “ January 1, 2024”.

SEC. 2212. Extension of Taxes Funding Airport and Airway Trust Fund.

(a)

Fuel Taxes.— Section 4081(d)(2)(B) of the Internal Revenue Code of 1986 is amended by striking “ September 30, 2023” and inserting “ December 31, 2023”.

(b)

Ticket Taxes.—

(1)

Persons.— Section 4261(k)(1)(A)(ii) of such Code is amended by striking “ September 30, 2023” and inserting “ December 31, 2023”.

(2)

Property.— Section 4271(d)(1)(A)(ii) of such Code is amended by striking “ September 30, 2023” and inserting “ December 31, 2023”.

(c)

Fractional Ownership Programs.—

(1)

Fuel tax.— Section 4043(d) of such Code is amended by striking “ September 30, 2023” and inserting “ December 31, 2023”.

(2)

Treatment as noncommercial aviation.— Section 4083(b) of such Code is amended by striking “ October 1, 2023” and inserting “ January 1, 2024”.

(3)

Exemption from ticket tax.— Section 4261(j) of such Code is amended by striking “ September 30, 2023” and inserting “ December 31, 2023”.

Subtitle C Expiring Counter-UAS Authorities

SEC. 2221. Protection of Certain Facilities and Assets from Unmanned Aircraft.

Section 210G(i) of the Homeland Security Act of 2002 (6 U.S.C. 124n(i)) is amended by striking “ on the date that is 4 years after the date of enactment of this section” and inserting “ on November 18, 2023”.

TITLE III Health and Human Services

Subtitle A Animal Drug and Animal Generic Drug User Fee Amendments

CHAPTER 1 Fees Relating to Animal Drugs

SEC. 2301. Short Title; Finding.

(a)

Short Title.— This chapter may be cited as the “Animal Drug User Fee Amendments of 2023”.

(b)

Finding.— Congress finds that the fees authorized by the amendments made in this chapter will be dedicated toward expediting the animal drug development process and the review of new and supplemental animal drug applications and investigational animal drug submissions as set forth in the goals identified for purposes of part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–11 et seq.), in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Energy and Commerce of the House of Representatives and the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate as set forth in the Congressional Record.

SEC. 2302. Definitions.

Section 739 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–11) is amended—

(1)

in paragraph (3), by striking “ national drug code” and inserting “ National Drug Code”; and

(2)

by amending paragraph (8)(I) to read as follows:

“(I) The activities necessary for implementation of the United States and European Union Mutual Recognition Agreement for Pharmaceutical Good Manufacturing Practice Inspections, and the United States and United Kingdom Mutual Recognition Agreement Sectoral Annex for Pharmaceutical Good Manufacturing Practices, and other mutual recognition agreements, with respect to animal drug products subject to review, including implementation activities prior to and following product approval.”

SEC. 2303. Authority to Assess and Use Animal Drug Fees.

(a)

In General.— Section 740(a)(1)(A)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 12(a)(1)(A)(ii)) is amended—

(1)

in subclause (I), by striking “ and” at the end;

(2)

in subclause (II), by striking the period at the end and inserting “ ; and”; and

(3)

by adding at the end the following:

“(III) an application for conditional approval under section 571 of a new animal drug for which an animal drug application submitted under section 512(b)(1) has been previously approved under section 512(d)(1) for another intended use.”

(b)

Fee Revenue Amounts.— Section 740(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–12(b)(1)) is amended to read as follows:

“(1) In general.—Subject to subsections (c), (d), (f), and (g), for each of fiscal years 2024 through 2028, the fees required under subsection (a) shall be established to generate a total revenue amount of $33,500,000.”

(c)

Annual Fee Setting; Adjustments.—

(1)

Annual fee setting.— Section 740(c)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–12(c)(1)) is amended to read as follows:

“(1) Annual fee setting.—Not later than 60 days before the start of each fiscal year beginning after September 30, 2023, the Secretary shall—

“(A) establish for that fiscal year animal drug application fees, supplemental animal drug application fees, animal drug sponsor fees, animal drug establishment fees, and animal drug product fees based on the revenue amounts established under subsection (b) and the adjustments provided under this subsection; and

“(B) publish such fee revenue amounts and fees in the Federal Register.”

(2)

Inflation adjustment.— Section 740(c)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–12(c)(2)) is amended—

(A)

in subparagraph (A)—

(i)

in the matter preceding clause (i), by striking “ 2020” and inserting “ 2025”; and

(ii)

in clause (iii), by striking “ Baltimore” and inserting “ Arlington-Alexandria”; and

(B)

in subparagraph (B), by striking “ 2020” and inserting “ 2025”.

(3)

Workload adjustments.— Section 740(c)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–12(c)(3)) is amended—

(A)

in subparagraph (A)—

(i)

in the matter preceding clause (i)—

(I)

by striking “ 2020” and inserting “ 2025”; and

(II)

by striking “ subparagraphs (B) and (C)” and inserting “ subparagraph (B)”;

(ii)

in clause (i) by striking “ and” at the end; and

(iii)

by striking clause (ii) and inserting the following:

“(ii) such adjustment shall be made for each fiscal year that the adjustment determined by the Secretary is greater than 3 percent, except for the first fiscal year that the adjustment is greater than 3 percent; and

“(iii) the Secretary shall publish in the Federal Register notice under paragraph (1) the amount of such adjustment and the supporting methodologies.”

(B)

by striking subparagraph (B); and

(C)

by redesignating subparagraph (C) as subparagraph (B).

(4)

Final year adjustment.— Section 740(c)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–12(c)(4)) is amended to read as follows:

“(4) Operating reserve adjustment.—

“(A) In general.—For fiscal year 2025 and each subsequent fiscal year, after the fee revenue amount established under subsection (b) is adjusted in accordance with paragraphs (2) and (3), the Secretary shall—

“(i) increase the fee revenue amount for such fiscal year, if necessary to provide an operating reserve of not less than 12 weeks; or

“(ii) if the Secretary has an operating reserve in excess of the number of weeks specified in subparagraph (C) for that fiscal year, the Secretary shall decrease the fee revenue amount to provide not more than the number of weeks specified in subparagraph (C) for that fiscal year.

“(B) Carryover user fees.—For purposes of this paragraph, the operating reserve of carryover user fees for the process for the review of animal drug applications does not include carryover user fees that have not been appropriated.

“(C) Number of weeks of operating reserves.—The number of weeks of operating reserves specified in this subparagraph is—

“(i) 22 weeks for fiscal year 2025;

“(ii) 20 weeks for fiscal year 2026;

“(iii) 18 weeks for fiscal year 2027; and

“(iv) 16 weeks for fiscal year 2028.

“(D) Publication.—If an adjustment to the operating reserve is made under this paragraph, the Secretary shall publish in the Federal Register notice under paragraph (1) the rationale for the amount of the adjustment and the supporting methodologies.”

(d)

Exemption From Fees.— Section 740(d)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–12(d)(4)) is amended to read as follows:

“(4) Exemption from fees.—Fees under paragraphs (2), (3), and (4) of subsection (a) shall not apply with respect to any person who is the named applicant or sponsor of an animal drug application, supplemental animal drug application, or investigational animal drug submission if such application or submission involves the intentional genomic alteration of an animal that is intended to produce a drug, device, or biological product subject to fees under section 736, 738, 744B, or 744H.”

(e)

Crediting and Availability of Fees.—

(1)

Authorization of appropriations.— Section 740(g)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–12(g)(3)) is amended by striking “ 2019 through 2023” and inserting “ 2024 through 2028”.

(2)

Collection shortfalls.— Section 740(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–12(g)) is amended—

(A)

in paragraph (3), by striking “ and paragraph (5)”; and

(B)

by striking paragraph (5).

SEC. 2304. Reauthorization; Reporting Requirements.

Section 740A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–13) is amended—

(1)

in subsection (a), by striking “ 2018” and inserting “ 2023”;

(2)

by striking “ 2019” each place it appears in subsections (a) and (b) and inserting “ 2024”; and

(3)

in subsection (d)—

(A)

in paragraph (1), by striking “ 2023” and inserting “ 2028”; and

(B)

in paragraph (5), by striking “ 2023” and inserting “ 2028”.

SEC. 2305. Savings Clause.

Notwithstanding the amendments made by this chapter, part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–11 et seq.), as in effect on the day before the date of enactment of this chapter, shall continue to be in effect with respect to animal drug applications and supplemental animal drug applications (as defined in such part as of such day) that on or after October 1, 2018, but before October 1, 2023, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2024.

SEC. 2306. Effective Date.

The amendments made by this chapter shall take effect on October 1, 2023, or the date of the enactment of this Act, whichever is later, except that fees under part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–11 et seq.), as amended by this chapter, shall be assessed for animal drug applications and supplemental animal drug applications received on or after October 1, 2023, regardless of the date of the enactment of this Act.

SEC. 2307. Sunset Dates.

(a)

Authorization.— Sections 739 and 740 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 21 U.S.C. 379j–11; 379j–12) shall cease to be effective October 1, 2028.

(b)

Reporting Requirements.— Section 740A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–13) shall cease to be effective January 31, 2029.

(c)

Previous Sunset Provision.— Effective October 1, 2023, subsections (a) and (b) of section 107 of the Animal Drug User Fee Amendments of 2018 (Public Law 115–234) are repealed.

CHAPTER 2 Fees Relating to Generic Animal Drugs

SEC. 2311. Short Title; Finding.

(a)

Short Title.— This chapter may be cited as the “Animal Generic Drug User Fee Amendments of 2023”.

(b)

Finding.— Congress finds that the fees authorized by the amendments made in this chapter will be dedicated toward expediting the generic new animal drug development process and the review of abbreviated applications for generic new animal drugs, supplemental abbreviated applications for generic new animal drugs, and investigational submissions for generic new animal drugs as set forth in the goals identified for purposes of part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21 et seq.), in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Energy and Commerce of the House of Representatives and the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate as set forth in the Congressional Record.

SEC. 2312. Authority to Assess and Use Generic New Animal Drug Fees.

(a)

Generic Investigational New Animal Drug File Fee.— Section 741(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21(a)) is amended by adding at the end the following:

“(4) Generic investigational new animal drug file fee.—

“(A) In general.—

“(i) New file request.—Each person that submits a request to establish a generic investigational new animal drug file on or after October 1, 2023, shall be assessed a fee as established under subsection (c).

“(ii) New submission to established file.—Each person that makes a submission to a generic investigational new animal drug file on or after October 1, 2023, where such file was established prior to October 1, 2023, shall be assessed a fee for the first submission on or after October 1, 2023, as established under subsection (c).

“(B) Payment.—

“(i) New file request.—The fee required by subparagraph (A)(i) shall be due upon submission of the request to establish the generic investigational new animal drug file.

“(ii) New submission to established file.—The fee required by subparagraph (A)(ii) shall be due upon the first submission to the generic investigational new animal drug file.

“(C) Exceptions.—

“(i) Terminating an existing generic investigational new animal drug file.—If a person makes a submission to the generic investigational new animal drug file to terminate that file, the person shall not be subject to a fee under subparagraph (A)(ii) for that submission.

“(ii) Transferring an existing generic investigational new animal drug file.—If a person makes a submission to the generic investigational new animal drug file to transfer that file to a different generic new animal drug sponsor, the person shall not be subject to a fee under subparagraph (A)(ii) for that submission.”

(b)

Fee Revenue Amounts.— Section 741(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 21(b)) is amended—

(1)

in paragraph (1)—

(A)

by striking “ 2019 through 2023” and inserting “ 2024 through 2028”; and

(B)

by striking “ $18,336,340” and inserting “ $25,000,000”; and

(2)

in paragraph (2)—

(A)

in subparagraph (A)—

(i)

by striking “ 25 percent” and inserting “ 20 percent”; and

(ii)

by inserting before the semicolon at the end the following: “ and fees under subsection (a)(4) (relating to generic investigational new animal drug files)”;

(B)

in subparagraph (B), by striking “ 37.5 percent” and inserting “ 40 percent”; and

(C)

in subparagraph (C), by striking “ 37.5 percent” and inserting “ 40 percent”.

(c)

Annual Fee Setting; Adjustments.—

(1)

Annual fee setting.— Section 741(c)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21(c)(1)) is amended to read as follows:

“(1) Annual fee setting.—The Secretary shall establish, not later than 60 days before the start of each fiscal year beginning after September 30, 2023, for that fiscal year—

“(A) abbreviated application fees that are based on the revenue amounts established under subsection (b), the adjustments provided under this subsection, and the amount of fees anticipated to be collected under subsection (a)(4) during that fiscal year;

“(B) generic new animal drug sponsor fees, and generic new animal drug product fees, based on the revenue amounts established under subsection (b) and the adjustments provided under this subsection; and

“(C) a generic investigational new animal drug file fee of $50,000 for each request or submission described in subsection (a)(4)(A).”

(2)

Inflation adjustment.— Section 741(c)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21(c)(2)) is amended—

(A)

in subparagraph (A)—

(i)

in the matter preceding clause (i), by striking “ 2020” and inserting “ 2025”; and

(ii)

in clause (iii), by striking “ Baltimore” and inserting “ Arlington-Alexandria”; and

(B)

in subparagraph (B), by striking “ 2020” and inserting “ 2025”.

(3)

Workload adjustment.— Section 741(c)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21(c)(3)) is amended—

(A)

in subparagraph (A)—

(i)

in the matter preceding clause (i), by striking “ 2020” and inserting “ 2025”;

(ii)

in clause (i)—

(I)

by striking “ and investigational generic new animal drug protocol submissions” and inserting “ investigational generic new animal drug protocol submissions, requests to establish a generic investigational new animal drug file, and generic investigational new animal drug meeting requests”; and

(II)

by striking “ ; and” and inserting a semicolon;

(iii)

by redesignating clause (ii) as clause (iii); and

(iv)

by inserting after clause (i) the following:

“(ii) if the workload adjustment calculated by the Secretary under clause (i) exceeds 25 percent, the Secretary shall use 25 percent for the adjustment; and”

; and

(B)

in subparagraph (B), by striking “ 2021 through 2023” and inserting “ 2026 through 2028”.

(4)

Final year adjustment.— Section 741(c)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21(c)(4)) is amended—

(A)

by striking “ 2023” each place it appears and inserting “ 2028”; and

(B)

by striking “ 2024” and inserting “ 2029”.

(d)

Fee Waiver or Reduction; Exemption From Fees.— Subsection (d) of section 741 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21) is amended to read as follows:

“(d) Fee Waiver or Reduction.—The Secretary shall grant a waiver from, or a reduction of, one or more fees assessed under subsection (a) where the Secretary finds that the generic new animal drug is intended solely to provide for a minor use or minor species indication.”

(e)

Effect of Failure to Pay Fees.— Section 741(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21(e)) is amended by striking “ The Secretary may discontinue” and inserting “ A request to establish a generic investigational new animal drug file that is submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for action by the Secretary until all fees owed by such person have been paid. The Secretary may discontinue”.

(f)

Assessment of Fees.— Section 741(f)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 21(f)(2)) is amended by striking “ sponsors, and generic new animal drug products at any time” and inserting “ products, generic new animal drug sponsors, and generic investigational new animal drug files at any time”.

(g)

Crediting and Availability of Fees.— Section 741(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21(g)) is amended—

(1)

in paragraph (3), by striking “ 2019 through 2023” and inserting “ 2024 through 2028”;

(2)

by striking the second paragraph (4) (relating to Offset), as added by section 202 of the Animal Generic Drug User Fee Amendments of 2013 (Public Law 113–14); and

(3)

by adding at the end the following:

“(5) Recovery of collection shortfalls.—The amount of fees otherwise authorized to be collected under this section shall be increased—

“(A) for fiscal year 2026, by the amount, if any, by which the amount collected under this section and appropriated for fiscal year 2024 falls below the amount of fees authorized for fiscal year 2024 under paragraph (3);

“(B) for fiscal year 2027, by the amount, if any, by which the amount collected under this section and appropriated for fiscal year 2025 falls below the amount of fees authorized for fiscal year 2025 under paragraph (3); and

“(C) for fiscal year 2028, by the amount, if any, by which the amount collected under this section and appropriated for fiscal years 2026 and 2027 (including estimated collections for fiscal year 2027) falls below the amount of fees authorized for such fiscal years under paragraph (3).”

(h)

Definitions.— Section 741(k) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21(k)) is amended—

(1)

by redesignating paragraphs (8), (9), (10), and (11) as paragraphs (9), (10), (11), and (13), respectively;

(2)

by inserting after paragraph (7) the following:

“(8) Generic investigational new animal drug meeting request.—The term ‘generic investigational new animal drug meeting request’ means a request submitted by a generic new animal drug sponsor to meet with the Secretary to discuss an investigational submission for a generic new animal drug.”

(3)

in paragraph (11) (as so redesignated), by adding at the end the following:

“(I) The activities necessary for exploration and implementation of the United States and European Union Mutual Recognition Agreement for Pharmaceutical Good Manufacturing Practice Inspections, and the United States and United Kingdom Mutual Recognition Agreement Sectoral Annex for Pharmaceutical Good Manufacturing Practices, and other mutual recognition agreements, with respect to generic new animal drug products subject to review, including implementation activities prior to and following product approval.”

; and

(4)

by inserting after paragraph (11) (as so redesignated) the following:

“(12) Request to establish a generic investigational new animal drug file.—The term ‘request to establish a generic investigational new animal drug file’ means the submission to the Secretary of a request to establish a generic investigational new animal drug file to contain investigational submissions for a generic new animal drug.”

SEC. 2313. Reauthorization; Reporting Requirements.

Section 742 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–22) is amended—

(1)

in subsection (a), by striking “ 2018” and inserting “ 2023”;

(2)

by striking “ 2019” each place it appears in subsections (a) and (b) and inserting “ 2024”; and

(3)

in subsection (d), by striking “ 2023” each place it appears and inserting “ 2028”.

SEC. 2314. Savings Clause.

Notwithstanding the amendments made by this chapter, part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21 et seq.), as in effect on the day before the date of enactment of this chapter, shall continue to be in effect with respect to abbreviated applications for a generic new animal drug and supplemental abbreviated applications for a generic new animal drug (as defined in such part as of such day) that on or after October 1, 2018, but before October 1, 2023, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2024.

SEC. 2315. Effective Date.

The amendments made by this chapter shall take effect on October 1, 2023, or the date of the enactment of this Act, whichever is later, except that fees under part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21 et seq.), as amended by this chapter, shall be assessed for abbreviated applications for a generic new animal drug and supplemental abbreviated applications for a generic new animal drug received on or after October 1, 2023, regardless of the date of enactment of this Act.

SEC. 2316. Sunset Dates.

(a)

Authorization.— Section 741 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21) shall cease to be effective October 1, 2028.

(b)

Reporting Requirements.— Section 742 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 22) shall cease to be effective January 31, 2029.

(c)

Previous Sunset Provision.— Effective October 1, 2023, subsections (a) and (b) of section 206 of the Animal Generic Drug User Fee Amendments of 2018 (Public Law 115–234) are repealed.

Subtitle B Public Health Extenders

SEC. 2321. Extension for Community Health Centers, National Health Service Corps, and Teaching Health Centers That Operate Gme Programs.

(a)

Teaching Health Centers That Operate Graduate Medical Education Programs.— Section 340H(g) of the Public Health Service Act (42 U.S.C. 256h(g)) is amended—

(1)

by striking “ and $126,500,000” and inserting “ $126,500,000”; and

(2)

by inserting “ and $16,635,616 for the period beginning on October 1, 2023, and ending on November 17, 2023,” before “ to remain available”.

(b)

Extension for Community Health Centers.— Section 10503(b)(1)(F) of the Patient Protection and Affordable Care Act (42 U.S.C. 254b–2(b)(1)(F)) is amended—

(1)

by striking “ and $4,000,000,000” and inserting “ , $4,000,000,000”; and

(2)

by inserting “ , and $526,027,397 for the period beginning on October 1, 2023, and ending on November 17, 2023” before the semicolon.

(c)

Extension for the National Health Service Corps.— Section 10503(b)(2) of the Patient Protection and Affordable Care Act (42 U.S.C. 254b–2(b)(2)) is amended—

(1)

in subparagraph (G), by striking “ and” at the end;

(2)

in subparagraph (H), by striking the period at the end and inserting “ ; and”; and

(3)

by adding at the end the following:

“(I) $40,767,123 for the period beginning on October 1, 2023, and ending on November 17, 2023.”

(d)

Application of Provisions.— Amounts appropriated pursuant to the amendments made by this section shall be subject to the requirements contained in Public Law 117–328 for funds for programs authorized under sections 330 through 340 of the Public Health Service Act (42 U.S.C. 254b et seq.).

(e)

Technical and Conforming Amendment.— Section 3014(h)(4) of title 18, United States Code, is amended—

(1)

by striking “ Other Extensions Act,,” and inserting “ Other Extensions Act,”; and

(2)

by striking “ and section 301(d) of division BB of the Consolidated Appropriations Act, 2021.” and inserting “ section 301(d) of division BB of the Consolidated Appropriations Act, 2021, and section 2321(d) of the Continuing Appropriations Act, 2024 and Other Extensions Act”.

SEC. 2322. Extension of Special Diabetes Programs.

(a)

Extension of Special Diabetes Programs for Type I Diabetes.— Section 330B(b)(2) of the Public Health Service Act (42 U.S.C. 254c–2(b)(2)) is amended—

(1)

in subparagraph (C), by striking “ and” at the end;

(2)

in subparagraph (D), by striking the period and inserting “ ; and”; and

(3)

by adding at the end the following:

“(E) $19,726,027 for the period beginning on October 1, 2023, and ending on November 17, 2023, to remain available until expended.”

(b)

Extending Funding for Special Diabetes Programs for Indians.— Section 330C(c)(2) of the Public Health Service Act (42 U.S.C. 254c–3(c)(2)) is amended—

(1)

in subparagraph (C), by striking “ and” at the end;

(2)

in subparagraph (D), by striking the period and inserting “ ; and”; and

(3)

by adding at the end the following:

“(E) $19,726,027 for the period beginning on October 1, 2023, and ending on November 17, 2023, to remain available until expended.”

Subtitle C Necessary Authorities To Respond to Threats

SEC. 2331. Extension of Authority to Make Certain Appointments of National Disaster Medical System Personnel.

Section 2812(c)(4)(B) of the Public Health Service Act (42 U.S.C. 300hh–11(c)(4)(B)) is amended by striking “ September 30, 2023” and inserting “ November 17, 2023”.

SEC. 2332. Temporary Reassignment of State and Local Personnel During a Public Health Emergency.

Section 319(e)(8) of the Public Health Service Act (42 U.S.C. 247d(e)(8)) is amended by striking “ September 30, 2023” and inserting “ November 17, 2023”.

SEC. 2333. Extension of National Advisory Committees.

(a)

National Advisory Committee on Children and Disasters.— Section 2811A(g) of the Public Health Service Act (42 U.S.C. 300hh–10b(g)) is amended by striking “ September 30, 2023” and inserting “ November 17, 2023”.

(b)

National Advisory Committee on Seniors and Disasters.— Section 2811B(g)(1) of the Public Health Service Act (42 U.S.C. 300hh–10c(g)(1)) is amended by striking “ September 30, 2023” and inserting “ November 17, 2023”.

(c)

National Advisory Committee on Individuals With Disabilities and Disasters.— Section 2811C(g)(1) of the Public Health Service Act (42 U.S.C. 300hh–10d(g)(1)) is amended by striking “ September 30, 2023” and inserting “ November 17, 2023”.

Subtitle D Medicaid

SEC. 2341. Dsh Delay.

Section 1923(f)(7)(A) of the Social Security Act (42 U.S.C. 1396r–4(f)(7)(A)) is amended—

(1)

in clause (i)—

(A)

in the matter preceding subclause (I), by striking “ For each of fiscal years 2024 through 2027” and inserting “ For the period beginning November 18, 2023, and ending September 30, 2024, and for each of fiscal years 2025 through 2027”; and

(B)

in subclauses (I) and (II), by inserting “ or period” after “ the fiscal year” each place it appears; and

(2)

in clause (ii), by striking “ for each of fiscal years 2024 through 2027” and inserting “ for the period beginning November 18, 2023, and ending September 30, 2024, and for each of fiscal years 2025 through 2027.”.

SEC. 2342. Mif Reduction.

Section 1941(b)(3)(A) of the Social Security Act (42 U.S.C. 1396w–1(b)(3)(A)) is amended by striking “ $7,000,000,000” and inserting “ $6,357,117,810”.

Subtitle E Human Services

SEC. 2351. Extension of Child and Family Services Programs.

Activities authorized by part B of title IV of the Social Security Act shall continue through November 17, 2023, in the manner authorized for fiscal year 2023, and out of any money in the Treasury of the United States not otherwise appropriated, there are hereby appropriated such sums as may be necessary for such purpose.

SEC. 2352. Sexual Risk Avoidance Education Extension.

Section 510 of the Social Security Act (42 U.S.C. 710) is amended—

(1)

in subsection (a)—

(A)

in paragraph (1)—

(i)

in the matter preceding subparagraph (A)—

(I)

by inserting “ and for the period beginning on October 1, 2023, and ending on November 17, 2023” after “ 2023”; and

(II)

by inserting “ (or, with respect to such period, for fiscal year 2024)” after “ for the fiscal year”; and

(ii)

in subparagraph (A), by inserting “ or period” after “ fiscal year” each place it appears; and

(B)

in paragraph (2)—

(i)

in subparagraph (A), by inserting “ and with respect to fiscal year 2024, for the period described in paragraph (1)” after “ 2023”; and

(ii)

in subparagraph (B)(i), by inserting “ (or, with respect to fiscal year 2024, for the period described in paragraph (1))” after “ for the fiscal year”; and

(2)

in subsection (f)—

(A)

in paragraph (1), by inserting “ , and for the period beginning on October 1, 2023, and ending on November 17, 2023, an amount equal to the pro rata portion of the amount appropriated for the corresponding period for fiscal year 2023” after “ 2023”; and

(B)

in paragraph (2), by inserting “ and for the period described in paragraph (1),” after “ 2023,”.

SEC. 2353. Personal Responsibility Education Extension.

Section 513 of the Social Security Act (42 U.S.C. 713) is amended—

(1)

in subsection (a)—

(A)

in paragraph (1)—

(i)

in subparagraph (A)—

(I)

in the matter preceding clause (i), by inserting “ and for the period beginning on October 1, 2023, and ending on November 17, 2023” after “ 2023”; and

(II)

in clause (i), by inserting “ or period” after “ for the fiscal year”;

(ii)

in subparagraph (B)(i), by inserting the following after the period: “ The previous sentence shall not apply with respect to State allotments under this paragraph for the period beginning on October 1, 2023, and ending on November 17, 2023.”; and

(iii)

in subparagraph (C)(i)—

(I)

by inserting “ or the period described in subparagraph (A)” after “ for a fiscal year”; and

(II)

by inserting “ or period” after “ the fiscal year”;

(B)

in paragraph (3)—

(i)

by inserting “ or the period described in paragraph (1)(A)” after “ for a fiscal year”; and

(ii)

by inserting “ or period” after “ such fiscal year”; and

(C)

in paragraph (4)—

(i)

by inserting “ and for the period described in paragraph (1)(A)” after “ fiscal years 2010 through 2023”;

(ii)

by inserting “ and for the period so described” after “ fiscal years 2012 through 2023”; and

(iii)

by inserting “ or the period so described” after “ for a fiscal year”;

(2)

in subsection (c)—

(A)

in each of paragraphs (1) and (2), by striking “ From” and inserting “ Subject to paragraph (3), from”; and

(B)

by adding at the end the following:

“(3) Exception.—Paragraphs (1) and (2) shall not apply with respect to any amount appropriated under subsection (f) for the period described in subsection (a)(1)(A).”

; and

(3)

in subsection (f), by inserting “ , and for the period beginning on October 1, 2023, and ending on November 17, 2023, an amount equal to the pro rata portion of the amount appropriated for the corresponding period for fiscal year 2023” after “ 2023”.

TITLE IV Budgetary Effects

SEC. 2401. Budgetary Effects.

(a)

Statutory Paygo Scorecards.— The budgetary effects of this division shall not be entered on either PAYGO scorecard maintained pursuant to section 4(d) of the Statutory Pay-As-You-Go Act of 2010.

(b)

Senate Paygo Scorecards.— The budgetary effects of this division shall not be entered on any PAYGO scorecard maintained for purposes of section 4106 of H. Con. Res. 71 (115th Congress).

(c)

Classification of Budgetary Effects.— Notwithstanding Rule 3 of the Budget Scorekeeping Guidelines set forth in the joint explanatory statement of the committee of conference accompanying Conference Report 105–217 and section 250(c)(8) of the Balanced Budget and Emergency Deficit Control Act of 1985, the budgetary effects of this division shall not be estimated—

(1)

for purposes of section 251 of such Act;

(2)

for purposes of an allocation to the Committee on Appropriations pursuant to section 302(a) of the Congressional Budget Act of 1974; and

(3)

for purposes of paragraph (4)(C) of section 3 of the Statutory Pay-As-You-Go Act of 2010 as being included in an appropriation Act.