§247d–7e. Biomedical Advanced Research and Development Authority — Inbound Citations
42 U.S.C. § 247d–7e
Cited by 20 provisions in release 119-102.
Citations to 42 U.S.C. § 247d–7e as a whole
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(2) ensure the appropriate involvement and consultation of Food and Drug Administration personnel in any flexible manufacturing activities carried out under section 247d–7e of title 42, including with respect to meeting regulatory requirements set forth in this chapter;
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(B) a countermeasure with respect to which the Biomedical Advanced Research and Development Authority has provided funding under section 247d–7e of title 42 for advanced research and development.
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(I) ensure that each countermeasure or product under consideration for procurement pursuant to this subsection receives the same consideration regardless of whether such countermeasure or product receives or had received funding under section 247d–7e of this title, including with respect to whether the countermeasure or product is most appropriate to meet the emergency health security needs of the United States;
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(ix) an assessment of whether the processes and procedures described by the Secretary pursuant to section 403(b) of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 are sufficient to ensure countermeasures and products under consideration for procurement pursuant to subsection (a) receive the same consideration regardless of whether such countermeasures and products receive or had received funding under section 247d–7e of this title, including with respect to whether such countermeasures and products are most appropriate to meet the emergency health security needs of the United States; and
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(1) In addition to amounts appropriated to the special reserve fund prior to March 13, 2013, there is authorized to be appropriated, for the procurement of security countermeasures under subsection (c) and for carrying out section 247d–7e of this title (relating to the Biomedical Advanced Research and Development Authority), $7,100,000,000 for the period of fiscal years 2019 through 2028, to remain available until expended.
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(2) The Secretary may utilize not more than 50 percent of the amounts authorized to be appropriated under paragraph (1) to carry out section 247d–7e of this title (related to the Biomedical Advanced Research and Development Authority). Amounts authorized to be appropriated under this subsection to carry out section 247d–7e of this title are in addition to amounts otherwise authorized to be appropriated to carry out such section.
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(3) 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 247d–7e of this title) or for procurement of a security countermeasure under subsection (c)(7).
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(5) The Secretary, acting through the Director of the Biomedical Advanced Research and Development Authority, shall carry out the programs funded by the special reserve fund (for the procurement of security countermeasures under subsection (c) and for carrying out section 247d–7e of this title), including the execution of procurement contracts, grants, and cooperative agreements pursuant to this section and section 247d–7e of this title.
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(c) Any term that is defined in section 247d–7e of this title and that is used in this section shall have the same meaning in this section as such term is given in section 247d–7e of this title.
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(C) the Biomedical Advanced Research and Development Authority pursuant to section 247d–7e of this title;
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(ii) the activities of the Department of Health and Human Services with respect to advanced research and development pursuant to section 247d–7e of this title; and
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(E) the strategic direction of, and activities related to, the sustainment of manufacturing surge capacity and capabilities for medical countermeasures pursuant to section 247d–7e of this title and the distribution and deployment of such countermeasures;
Citations to §247d–7e(a)
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(1) The term “advanced research and development” has the meaning given such term in section 247d–7e(a) of this title.
Citations to §247d–7e(a)(3)
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(D) enter into other transactions, as defined by section 247d–7e(a)(3) of this title, subject to paragraph (2).
Citations to §247d–7e(a)(6)
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(2) collaborate with the Director of the Biomedical Advanced Research and Development Authority with respect to the research conducted by centers described in subsection (a), including, as appropriate, providing any updates on the research advancements made by such centers, identifying any advanced research and development needs for such countermeasures, consistent with section 247d–7e(a)(6) of this title, and taking into consideration existing manufacturing capacity and future capacity needs for such medical products or technologies, including platform technologies, supported by the centers described in subsection (a).
Citations to §247d–7e(c)(4)(F)
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(A) accelerate and support the advanced research, development, manufacturing capacity, procurement, and stockpiling of countermeasures, including initiatives under section 247d–7e(c)(4)(F) of this title;
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(C) The Assistant Secretary for Preparedness and Response, in accordance with subsection (b)(7), shall document amounts expended for purposes of carrying out this subsection, including amounts appropriated under the heading “Public Health and Social Services Emergency Fund” under the heading “Office of the Secretary” under title II of division H of the Consolidated Appropriations Act, 2018 (Public Law 115–141) and allocated to carrying out section 247d–7e(c)(4)(F) of this title.
Citations to §247d–7e(d)
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(B) Amounts appropriated under this paragraph shall be used to supplement and not supplant funds provided under sections 247d–7e(d) and 247d–6b(g) of this title.
Citations to §247d–7e(e)(1)
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(2) The written agreement described in paragraph (1)(C) shall specify the time period for which paragraph (1) shall apply to the voluntarily disclosed information. Paragraph (1) shall not apply with respect to such information after the date specified in such agreement, but all other applicable legal protections, including the provisions of section 552 of title 5 and section 247d–7e(e)(1) of title 42, as applicable, shall continue to apply to such information. If no date is specified in the written agreement, paragraph (1) shall not apply with respect to such information for a period of more than 36 months.