US Codex
Pub. L.
Notes

Title IV — Accelerating Medical Countermeasure Advanced Research and Development

113th Congress · Approved Mar 13, 2013 · 127 Stat. 161

TITLE IV Accelerating Medical Countermeasure Advanced Research and Development

SEC. 401. Bioshield.

(a)
Procurement of Countermeasures.— Section 319F–2(c) of the Public Health Service Act (42 U.S.C. 247d–6b(c)) is amended—
(1)
in paragraph (1)(B)(i)(III)(bb), by striking “ eight years” and inserting “ 10 years”;
(2)
in paragraph (2)(C), by striking “ the designated congressional committees (as defined in paragraph (10))” and inserting “ the appropriate committees of Congress”;
(3)
in paragraph (5)(B)(ii), by striking “ eight years” and inserting “ 10 years”;
(4)
in subparagraph (C) of paragraph (6)—
(A)
in the subparagraph heading, by striking “ designated congressional committees” and inserting “ appropriate congressional committees”; and
(B)
by striking “ the designated congressional committees” and inserting “ the appropriate congressional committees”; and
(5)
in paragraph (7)(C)—
(A)
in clause (i)(I), by inserting “ including advanced research and development,” after “ as may reasonably be required,”;
(B)
in clause (ii)—
(i)
in subclause (III), by striking “ eight years” and inserting “ 10 years”; and
(ii)
by striking subclause (IX) and inserting the following:

“(IX) Contract terms.—The Secretary, in any contract for procurement under this section—

“(aa) may specify—

“(AA) the dosing and administration requirements for the countermeasure to be developed and procured;

“(BB) the amount of funding that will be dedicated by the Secretary for advanced research, development, and procurement of the countermeasure; and

“(CC) the specifications the countermeasure must meet to qualify for procurement under a contract under this section; and

“(bb) shall provide a clear statement of defined Government purpose limited to uses related to a security countermeasure, as defined in paragraph (1)(B).”

; and

(C)
by adding at the end the following:

“(viii) Flexibility.—In carrying out this section, the Secretary may, consistent with the applicable provisions of this section, enter into contracts and other agreements that are in the best interest of the Government in meeting identified security countermeasure needs, including with respect to reimbursement of the cost of advanced research and development as a reasonable, allowable, and allocable direct cost of the contract involved.”

(b)
Reauthorization of the Special Reserve Fund.— Section 319F–2 of the Public Health Service Act (42 U.S.C. 247d–6b) is amended—
(1)
in subsection (c)—
(A)
by striking “ special reserve fund under paragraph (10)” each place it appears and inserting “ special reserve fund as defined in subsection (h)”; and
(B)
by striking paragraphs (9) and (10); and
(2)
by adding at the end the following:

“(g) Special Reserve Fund.—

“(1) Authorization of appropriations.—In addition to amounts appropriated to the special reserve fund prior to the date of the enactment of this subsection, there is authorized to be appropriated, for the procurement of security countermeasures under subsection (c) and for carrying out section 319L (relating to the Biomedical Advanced Research and Development Authority), $2,800,000,000 for the period of fiscal years 2014 through 2018. Amounts appropriated pursuant to the preceding sentence are authorized to remain available until September 30, 2019.

“(2) Use of special reserve fund for advanced research and development.—The Secretary may utilize not more than 50 percent of the amounts authorized to be appropriated under paragraph (1) to carry out section 319L (related to the Biomedical Advanced Research and Development Authority). Amounts authorized to be appropriated under this subsection to carry out section 319L are in addition to amounts otherwise authorized to be appropriated to carry out such section.

“(3) Restrictions on use of funds.—Amounts in the special reserve fund shall not be used to pay costs other than payments made by the Secretary to a vendor for advanced development (under section 319L) or for procurement of a security countermeasure under subsection (c)(7).

“(4) Report.—Not later than 30 days after any date on which the Secretary determines that the amount of funds in the special reserve fund available for procurement is less than $1,500,000,000, the Secretary shall submit to the appropriate committees of Congress a report detailing the amount of such funds available for procurement and the impact such reduction in funding will have—

“(A) in meeting the security countermeasure needs identified under this section; and

“(B) on the annual Public Health Emergency Medical Countermeasures Enterprise and Strategy Implementation Plan (pursuant to section 2811(d)).

“(h) Definitions.—In this section:

“(1) The term ‘advanced research and development’ has the meaning given such term in section 319L(a).

“(2) The term ‘special reserve fund’ means the ‘Biodefense Countermeasures’ appropriations account, any appropriation made available pursuant to section 521(a) of the Homeland Security Act of 2002, and any appropriation made available pursuant to subsection (g)(1).”

SEC. 402. Biomedical Advanced Research and Development Authority.

(a)
Duties.— Section 319L(c)(4) of the Public Health Service Act (42 U.S.C. 247d–7e(c)(4)) is amended—
(1)
in subparagraph (B)(iii), by inserting “ (which may include advanced research and development for purposes of fulfilling requirements under the Federal Food, Drug, and Cosmetic Act or section 351 of this Act)” after “ development”; and
(2)
in subparagraph (D)(iii), by striking “ and vaccine manufacturing technologies” and inserting “ vaccine-manufacturing technologies, dose-sparing technologies, efficacy-increasing technologies, and platform technologies”.
(b)
Transaction Authorities.— Section 319L(c)(5) of the Public Health Service Act (42 U.S.C. 247d–7e(c)(5)) is amended by adding at the end the following:

“(G) Government purpose.—In awarding contracts, grants, and cooperative agreements under this section, the Secretary shall provide a clear statement of defined Government purpose related to activities included in subsection (a)(6)(B) for a qualified countermeasure or qualified pandemic or epidemic product.”

(c)
Fund.— Paragraph (2) of section 319L(d) of the Public Health Service Act (42 U.S.C. 247d–7e(d)(2)) is amended to read as follows:

“(2) Funding.—To carry out the purposes of this section, there is authorized to be appropriated to the Fund $415,000,000 for each of fiscal years 2014 through 2018, such amounts to remain available until expended.”

(d)
Continued Inapplicability of Certain Provisions.— Section 319L(e)(1)(C) of the Public Health Service Act (42 U.S.C. 247d–7e(e)(1)(C)) is amended by striking “ 7 years” and inserting “ 12 years”.
(e)
Extension of Limited Antitrust Exemption.—
(1)
In general.— Section 405(b) of the Pandemic and All-Hazards Preparedness Act (42 U.S.C. 247d–6a note) is amended by striking “ 6-year” and inserting “ 12-year”.
(2)
Effective date.— This subsection shall take effect as if enacted on December 17, 2012.
(f)
Independent Evaluation.— Section 319L of the Public Health Service Act (42 U.S.C. 247d–7e) is amended by adding at the end the following:

“(f) Independent Evaluation.—

“(1) In general.—Not later than 180 days after the date of enactment of this subsection, the Comptroller General of the United States shall conduct an independent evaluation of the activities carried out to facilitate flexible manufacturing capacity pursuant to this section.

“(2) Report.—Not later than 1 year after the date of enactment of this subsection, the Comptroller General of the United States shall submit to the appropriate committees of Congress a report concerning the results of the evaluation conducted under paragraph (1). Such report shall review and assess—

“(A) the extent to which flexible manufacturing capacity under this section is dedicated to chemical, biological, radiological, and nuclear threats;

“(B) the activities supported by flexible manufacturing initiatives; and

“(C) the ability of flexible manufacturing activities carried out under this section to—

“(i) secure and leverage leading technical expertise with respect to countermeasure advanced research, development, and manufacturing processes; and

“(ii) meet the surge manufacturing capacity needs presented by novel and emerging threats, including chemical, biological, radiological, and nuclear agents.”

(g)
Definitions.—
(1)
Qualified countermeasure.— Section 319F–1(a)(2)(A) of the Public Health Service Act (42 U.S.C. 247d–6a(a)(2)(A)) is amended—
(A)
in the matter preceding clause (i), by striking “ to—” and inserting “ —”;
(B)
in clause (i)—
(i)
by striking “ diagnose” and inserting “ to diagnose”; and
(ii)
by striking “ ; or” and inserting a semicolon;
(C)
in clause (ii)—
(i)
by striking “ diagnose” and inserting “ to diagnose”; and
(ii)
by striking the period at the end and inserting “ ; or”; and
(D)
by adding at the end the following:

“(iii) is a product or technology intended to enhance the use or effect of a drug, biological product, or device described in clause (i) or (ii).”

(2)
Qualified pandemic or epidemic product.— Section 319F–3(i)(7)(A) of the Public Health Service Act (42 U.S.C. 247d–6d(i)(7)(A)) is amended—
(A)
in clause (i)(II), by striking “ ; or” and inserting “ ;”;
(B)
in clause (ii), by striking “ ; and” and inserting “ ; or”; and
(C)
by adding at the end the following:

“(iii) a product or technology intended to enhance the use or effect of a drug, biological product, or device described in clause (i) or (ii); and”

(3)
Technical amendments.— Section 319F–3(i) of the Public Health Service Act (42 U.S.C. 247d–6d(i)) is amended—
(A)
in paragraph (1)(C), by inserting “ , 564A, or 564B” after “ 564”; and
(B)
in paragraph (7)(B)(iii), by inserting “ , 564A, or 564B” after “ 564”.

SEC. 403. Strategic National Stockpile.

Section 319F–2 of the Public Health Service Act (42 U.S.C. 247d–6b) is amended—
(1)
in subsection (a)—
(A)
in paragraph (1)—
(i)
by inserting “ consistent with section 2811” before “ by the Secretary to be appropriate”; and
(ii)
by inserting before the period at the end of the second sentence the following: “ and shall submit such review annually to the appropriate congressional committees of jurisdiction to the extent that disclosure of such information does not compromise national security”; and
(B)
in paragraph (2)(D), by inserting before the semicolon at the end the following: “ and that the potential depletion of countermeasures currently in the stockpile is identified and appropriately addressed, including through necessary replenishment”; and
(2)
in subsection (f)(1), by striking “ $640,000,000 for fiscal year 2002, and such sums as may be necessary for each of fiscal years 2003 through 2006. Such authorization is in addition to amounts in the special reserve fund referred to in subsection (c)(10)(A).” and inserting “ $533,800,000 for each of fiscal years 2014 through 2018. Such authorization is in addition to amounts in the special reserve fund referred to in subsection (h).”.

SEC. 404. National Biodefense Science Board.

Section 319M(a) of the Public Health Service Act (42 U.S.C. 247d–f(a)) is amended—
(1)
in paragraph (2)—
(A)
in subparagraph (D)—
(i)
in clause (i), by striking “ and” at the end;
(ii)
in clause (ii), by striking the period and inserting a semicolon; and
(iii)
by adding at the end the following:

“(iii) one such member shall be an individual with pediatric subject matter expertise; and

“(iv) one such member shall be a State, tribal, territorial, or local public health official.”

; and

(B)
by adding at the end the following flush sentence: “Nothing in this paragraph shall preclude a member of the Board from satisfying two or more of the requirements described in subparagraph (D).”; and
(2)
in paragraph (5)—
(A)
in subparagraph (B), by striking “ and” at the end;
(B)
in subparagraph (C), by striking the period and inserting “ ; and”; and
(C)
by adding at the end the following:

“(D) provide any recommendation, finding, or report provided to the Secretary under this paragraph to the appropriate committees of Congress.”