Sec. 402. Biomedical Advanced Research and Development Authority

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Section 319L(c)(4) of the Public Health Service Act (42 U.S.C. 247d–7e(c)(4)) is amended— 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 in subparagraph (D)(iii), by striking and vaccine manufacturing technologies and inserting vaccine-manufacturing technologies, dose-sparing technologies, efficacy-increasing technologies, and platform technologies .

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: 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. . 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: 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 2013 through 2017, such amounts to remain available until expended. . 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 11 years . 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 11-year . This subsection shall take effect as if enacted on December 17, 2012. Section 319L of the Public Health Service Act ( 42 U.S.C. 247d–7e ) is amended by adding at the end the following: 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. 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— the extent to which flexible manufacturing capacity under this section is dedicated to chemical, biological, radiological, and nuclear threats; the activities supported by flexible manufacturing initiatives; and the ability of flexible manufacturing activities carried out under this section to— secure and leverage leading technical expertise with respect to countermeasure advanced research, development, and manufacturing processes; and meet the surge manufacturing capacity needs presented by novel and emerging threats, including chemical, biological, radiological, and nuclear agents. . Section 319F–1(a)(2)(A) of the Public Health Service Act (42 U.S.C. 247d–6a(a)(2)(A)) is amended— in the matter preceding clause (i), by striking to— and inserting — ; in clause (i)— by striking diagnose and inserting to diagnose ; and by striking ; or and inserting a semicolon; in clause (ii)— by striking diagnose and inserting to diagnose ; and by striking the period at the end and inserting ; or ; and by adding at the end the following: 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). . Section 319F–3(i)(7)(A) of the Public Health Service Act (42 U.S.C. 247d–6d(i)(7)(A)) is amended— in clause (i)(II), by striking ; or and inserting ; ; in clause (ii), by striking ; and and inserting ; or ; and by adding at the end the following: 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 . Section 319F–3(i) of the Public Health Service Act (42 U.S.C. 247d–6d(i)) is amended— in paragraph (1)(C), by inserting , 564A, or 564B after 564 ; and in paragraph (7)(B)(iii), by inserting , 564A, or 564B after 564 .

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42 USC 247d–7e(c)(4)
42 USC 247d–7e(c)(5)
42 USC 247d–7e(d)(2)
42 USC 247d–7e(e)(1)(C)
42 USC 247d–6a
42 USC 247d–7e
42 USC 247d–6a(a)(2)(A)
42 USC 247d–6d(i)(7)(A)
42 USC 247d–6d(i)

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Sec. 402

Biomedical Advanced Research and Development Authority

Cite42 USC 247d–7e(c)(4)

Cite42 USC 247d–7e(c)(5)

Cite42 USC 247d–7e(d)(2)

Cite42 USC 247d–7e(e)(1)(C)

Cite42 USC 247d–6a

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