§247d–6a. Authority for use of certain procedures regarding qualified countermeasure research and development activities — Inbound Citations
42 U.S.C. § 247d–6a
Cited by 29 provisions in release 119-102.
Citations to 42 U.S.C. § 247d–6a as a whole
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(6) With respect to a drug that is a qualified countermeasure (as defined in section 247d–6a of title 42), a security countermeasure (as defined in section 247d–6b of title 42), or a qualified pandemic or epidemic product (as defined in section 247d–6d of title 42), the Secretary shall solicit input from the Assistant Secretary for Preparedness and Response regarding the need for and, from the Director of the Biomedical Advanced Research and Development Authority regarding the conduct of, pediatric studies under this section.
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(C) For a drug that is a qualified countermeasure (as defined in section 247d–6a of title 42), a security countermeasure (as defined in section 247d–6b of title 42), or a qualified pandemic or epidemic product (as defined in section 247d–6d of title 42), in addition to any action with respect to such drug under subparagraph (A) or (B), the Secretary shall notify the Assistant Secretary for Preparedness and Response and the Director of the Biomedical Advanced Research and Development Authority of all pediatric studies in the written request issued by the Commissioner of Food and Drugs.
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(ii) in the case of a drug development tool that may be used to support the development of a qualified countermeasure, security countermeasure, or qualified pandemic or epidemic product, as defined in sections 319F–1, 319F–2, and 319F–3, respectively, of the Public Health Service Act [42 U.S.C. 247d–6a, 247d–6b, 247d–6d], any information that the Secretary determines has a significant potential to affect national security.
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(2) the term “qualified countermeasure” has the meaning given such term in section 247d–6a of title 42;
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(5) establish within the Food and Drug Administration a team of experts on manufacturing and regulatory activities (including compliance with current Good Manufacturing Practice) to provide both off-site and on-site technical assistance to the manufacturers of qualified countermeasures (as defined in section 247d–6a of title 42), security countermeasures (as defined in section 247d–6b of title 42), or vaccines, at the request of such a manufacturer and at the discretion of the Secretary, if the Secretary determines that a shortage or potential shortage may occur in the United States in the supply of such vaccines or countermeasures and that the provision of such assistance would be beneficial in helping alleviate or avert such shortage.
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(3) The terms “qualified countermeasure”, “security countermeasure”, and “qualified pandemic or epidemic product” have the meanings given such terms in sections 319F–1, 319F–2, and 319F–3, respectively, of the Public Health Service Act [42 U.S.C. 247d–6a, 247d–6b, 247d–6d].
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(C) facilitate and accelerate, as applicable, advanced research and development of security countermeasures (as defined in section 247d–6b of this title), qualified countermeasures (as defined in section 247d–6a of this title), or qualified pandemic or epidemic products (as defined in section 247d–6d of this title), that are applicable to the public health emergency or potential public health emergency under paragraph (1);
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(4) The Secretary shall ensure timely and accurate recommended utilization guidelines for qualified countermeasures (as defined in section 247d–6a of this title), qualified pandemic and epidemic products (as defined in section 247d–6d of this title), and security countermeasures (as defined in subsection (c)), including for such products in the stockpile.
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(4) The term “qualified countermeasure” has the meaning given such term in section 247d–6a of this title.
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(i) In awarding contracts, grants, and cooperative agreements, and in entering into other transactions under subparagraph (B) or (D) of paragraph (4), the Secretary shall have the expedited procurement authorities, the authority to expedite peer review, and the authority for personal services contracts, supplied by subsections (b), (c), and (d) of section 247d–6a of this title.
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(ii) Provisions in such section 247d–6a of this title that apply to such authorities and that require institution of internal controls, limit review, provide for Federal Tort Claims Act coverage of personal services contractors, and commit decisions to the discretion of the Secretary shall apply to the authorities as exercised pursuant to this paragraph.
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(A) The Secretary, in coordination with the Attorney General and the Secretary of Homeland Security, may conduct meetings and consultations with persons engaged in the development of a security countermeasure (as defined in section 247d–6b of this title), a qualified countermeasure (as defined in section 247d–6a of this title), or a qualified pandemic or epidemic product (as defined in section 247d–6d of this title) for the purpose of the development, manufacture, distribution, purchase, or storage of a countermeasure or product. The Secretary may convene such meeting or consultation at the request of the Secretary of Homeland Security, the Attorney General, the Chairman of the Federal Trade Commission (referred to in this section as the “Chairman”), or any interested person, or upon initiation by the Secretary. The Secretary shall give prior notice of any such meeting or consultation, and the topics to be discussed, to the Attorney General, the Chairman, and the Secretary of Homeland Security.
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(B) may consider the availability of qualified countermeasures (as defined in section 247d–6a of this title), security countermeasures (as defined in section 247d–6b of this title), and qualified pandemic or epidemic products (as defined in section 247d–6d of this title) to address the needs of pediatric populations, in consultation with the Assistant Secretary for Preparedness and Response, consistent with the purposes of this section.
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(B) For purposes of this paragraph, the term “countermeasures” has the same meaning as the terms “qualified countermeasures” under section 247d–6a of this title, “qualified pandemic and epidemic products” under section 247d–6d of this title, and “security countermeasures” under section 247d–6b of this title.
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(3) Oversee advanced research, development, and procurement of qualified countermeasures (as defined in section 247d–6a of this title), security countermeasures (as defined in section 247d–6b of this title), and qualified pandemic or epidemic products (as defined in section 247d–6d of this title).
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(7) Develop, and update not later than March 15 of each year, a coordinated 5-year budget plan based on the medical countermeasure priorities described in subsection (d), including with respect to chemical, biological, radiological, and nuclear agent or agents that may present a threat to the Nation, including such agents that are novel or emerging infectious diseases, and the corresponding efforts to develop qualified countermeasures (as defined in section 247d–6a of this title), security countermeasures (as defined in section 247d–6b of this title), and qualified pandemic or epidemic products (as defined in section 247d–6d of this title) for each such threat. Each such plan shall—(A) include consideration of the entire medical countermeasures enterprise, including—(i) basic research and advanced research and development;(ii) approval, clearance, licensure, and authorized uses of products;(iii) procurement, stockpiling, maintenance, and potential replenishment (including manufacturing capabilities) of all products in the Strategic National Stockpile;(iv) the availability of technologies that may assist in the advanced research and development of countermeasures and opportunities to use such technologies to accelerate and navigate challenges unique to countermeasure research and development; and(v) potential deployment, distribution, and utilization of medical countermeasures; development of clinical guidance and emergency use instructions for the use of medical countermeasures; and, as applicable, potential postdeployment activities related to medical countermeasures;(B) inform prioritization of resources and include measurable outputs and outcomes to allow for the tracking of the progress made toward identified priorities;(C) identify medical countermeasure life-cycle costs to inform planning, budgeting, and anticipated needs within the continuum of the medical countermeasure enterprise consistent with section 247d–6b of this title;(D) identify the full range of anticipated medical countermeasure needs related to research and development, procurement, and stockpiling, including the potential need for indications, dosing, and administration technologies, and other countermeasure needs as applicable and appropriate;(E) be made available, not later than March 15 of each year, to the Committee on Appropriations and the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Appropriations and the Committee on Energy and Commerce of the House of Representatives; and(F) not later than March 15 of each year, be made publicly available in a manner that does not compromise national security.
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(A) describe the chemical, biological, radiological, and nuclear agent or agents that may present a threat to the Nation and the corresponding efforts to develop qualified countermeasures (as defined in section 247d–6a of this title), security countermeasures (as defined in section 247d–6b of this title), or qualified pandemic or epidemic products (as defined in section 247d–6d of this title) for each threat;
Citations to §247d–6a(a)(2)
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(k) The Secretary may waive any requirement of this section with respect to a qualified countermeasure (as defined in section 247d–6a(a)(2) of title 42) to which a requirement under this section has been applied, if the Secretary determines that such waiver is required to mitigate the effects of, or reduce the severity of, the circumstances under which—(1) a determination described in subparagraph (A), (B), or (C) of section 360bbb–3(b)(1) of this title has been made by the Secretary of Homeland Security, the Secretary of Defense, or the Secretary, respectively; or(2) the identification of a material threat described in subparagraph (D) of section 360bbb–3(b)(1) of this title has been made pursuant to section 247d–6b of title 42.
Citations to §247d–6a(b)(1)
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(J) identify the use of authority and activities undertaken pursuant to sections 247d–6a(b)(1), 247d–6a(b)(2), 247d–6a(b)(3), 247d–6a(c), 247d–6a(d), 247d–6a(e), 247d–6b(c)(7)(C)(iii), 247d–6b(c)(7)(C)(iv), and 247d–6b(c)(7)(C)(v) of this title, and subsections (a)(1), (b)(1), and (e) of section 564 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360bbb–3], by summarizing—(i) the particular actions that were taken under the authorities specified, including, as applicable, the identification of the threat agent, emergency, or the biomedical countermeasure with respect to which the authority was used;(ii) the reasons underlying the decision to use such authorities, including, as applicable, the options that were considered and rejected with respect to the use of such authorities;(iii) the number of, nature of, and other information concerning the persons and entities that received a grant, cooperative agreement, or contract pursuant to the use of such authorities, and the persons and entities that were considered and rejected for such a grant, cooperative agreement, or contract, except that the report need not disclose the identity of any such person or entity;(iv) whether, with respect to each procurement that is approved by the President under section 247d–6b(c)(6) of this title, a contract was entered into within one year after such approval by the President; and(v) with respect to section 247d–6a(d) of this title, for the 2-year period for which the report is submitted, the number of persons who were paid amounts totaling $100,000 or greater and the number of persons who were paid amounts totaling at least $50,000 but less than $100,000; and
Citations to §247d–6a(b)(1)(D)
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(iii) For purposes of applying section 247d–6a(b)(1)(D) of this title to this paragraph, the phrase “BioShield Program under the Project BioShield Act of 2004” shall be deemed to mean the countermeasure and product advanced research and development program under this section.
Citations to §247d–6a(b)(2)
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(J) identify the use of authority and activities undertaken pursuant to sections 247d–6a(b)(1), 247d–6a(b)(2), 247d–6a(b)(3), 247d–6a(c), 247d–6a(d), 247d–6a(e), 247d–6b(c)(7)(C)(iii), 247d–6b(c)(7)(C)(iv), and 247d–6b(c)(7)(C)(v) of this title, and subsections (a)(1), (b)(1), and (e) of section 564 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360bbb–3], by summarizing—(i) the particular actions that were taken under the authorities specified, including, as applicable, the identification of the threat agent, emergency, or the biomedical countermeasure with respect to which the authority was used;(ii) the reasons underlying the decision to use such authorities, including, as applicable, the options that were considered and rejected with respect to the use of such authorities;(iii) the number of, nature of, and other information concerning the persons and entities that received a grant, cooperative agreement, or contract pursuant to the use of such authorities, and the persons and entities that were considered and rejected for such a grant, cooperative agreement, or contract, except that the report need not disclose the identity of any such person or entity;(iv) whether, with respect to each procurement that is approved by the President under section 247d–6b(c)(6) of this title, a contract was entered into within one year after such approval by the President; and(v) with respect to section 247d–6a(d) of this title, for the 2-year period for which the report is submitted, the number of persons who were paid amounts totaling $100,000 or greater and the number of persons who were paid amounts totaling at least $50,000 but less than $100,000; and
Citations to §247d–6a(b)(3)
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(J) identify the use of authority and activities undertaken pursuant to sections 247d–6a(b)(1), 247d–6a(b)(2), 247d–6a(b)(3), 247d–6a(c), 247d–6a(d), 247d–6a(e), 247d–6b(c)(7)(C)(iii), 247d–6b(c)(7)(C)(iv), and 247d–6b(c)(7)(C)(v) of this title, and subsections (a)(1), (b)(1), and (e) of section 564 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360bbb–3], by summarizing—(i) the particular actions that were taken under the authorities specified, including, as applicable, the identification of the threat agent, emergency, or the biomedical countermeasure with respect to which the authority was used;(ii) the reasons underlying the decision to use such authorities, including, as applicable, the options that were considered and rejected with respect to the use of such authorities;(iii) the number of, nature of, and other information concerning the persons and entities that received a grant, cooperative agreement, or contract pursuant to the use of such authorities, and the persons and entities that were considered and rejected for such a grant, cooperative agreement, or contract, except that the report need not disclose the identity of any such person or entity;(iv) whether, with respect to each procurement that is approved by the President under section 247d–6b(c)(6) of this title, a contract was entered into within one year after such approval by the President; and(v) with respect to section 247d–6a(d) of this title, for the 2-year period for which the report is submitted, the number of persons who were paid amounts totaling $100,000 or greater and the number of persons who were paid amounts totaling at least $50,000 but less than $100,000; and
Citations to §247d–6a(c)
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(J) identify the use of authority and activities undertaken pursuant to sections 247d–6a(b)(1), 247d–6a(b)(2), 247d–6a(b)(3), 247d–6a(c), 247d–6a(d), 247d–6a(e), 247d–6b(c)(7)(C)(iii), 247d–6b(c)(7)(C)(iv), and 247d–6b(c)(7)(C)(v) of this title, and subsections (a)(1), (b)(1), and (e) of section 564 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360bbb–3], by summarizing—(i) the particular actions that were taken under the authorities specified, including, as applicable, the identification of the threat agent, emergency, or the biomedical countermeasure with respect to which the authority was used;(ii) the reasons underlying the decision to use such authorities, including, as applicable, the options that were considered and rejected with respect to the use of such authorities;(iii) the number of, nature of, and other information concerning the persons and entities that received a grant, cooperative agreement, or contract pursuant to the use of such authorities, and the persons and entities that were considered and rejected for such a grant, cooperative agreement, or contract, except that the report need not disclose the identity of any such person or entity;(iv) whether, with respect to each procurement that is approved by the President under section 247d–6b(c)(6) of this title, a contract was entered into within one year after such approval by the President; and(v) with respect to section 247d–6a(d) of this title, for the 2-year period for which the report is submitted, the number of persons who were paid amounts totaling $100,000 or greater and the number of persons who were paid amounts totaling at least $50,000 but less than $100,000; and
Citations to §247d–6a(d)
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(J) identify the use of authority and activities undertaken pursuant to sections 247d–6a(b)(1), 247d–6a(b)(2), 247d–6a(b)(3), 247d–6a(c), 247d–6a(d), 247d–6a(e), 247d–6b(c)(7)(C)(iii), 247d–6b(c)(7)(C)(iv), and 247d–6b(c)(7)(C)(v) of this title, and subsections (a)(1), (b)(1), and (e) of section 564 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360bbb–3], by summarizing—(i) the particular actions that were taken under the authorities specified, including, as applicable, the identification of the threat agent, emergency, or the biomedical countermeasure with respect to which the authority was used;(ii) the reasons underlying the decision to use such authorities, including, as applicable, the options that were considered and rejected with respect to the use of such authorities;(iii) the number of, nature of, and other information concerning the persons and entities that received a grant, cooperative agreement, or contract pursuant to the use of such authorities, and the persons and entities that were considered and rejected for such a grant, cooperative agreement, or contract, except that the report need not disclose the identity of any such person or entity;(iv) whether, with respect to each procurement that is approved by the President under section 247d–6b(c)(6) of this title, a contract was entered into within one year after such approval by the President; and(v) with respect to section 247d–6a(d) of this title, for the 2-year period for which the report is submitted, the number of persons who were paid amounts totaling $100,000 or greater and the number of persons who were paid amounts totaling at least $50,000 but less than $100,000; and
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(v) with respect to section 247d–6a(d) of this title, for the 2-year period for which the report is submitted, the number of persons who were paid amounts totaling $100,000 or greater and the number of persons who were paid amounts totaling at least $50,000 but less than $100,000; and
Citations to §247d–6a(e)
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(J) identify the use of authority and activities undertaken pursuant to sections 247d–6a(b)(1), 247d–6a(b)(2), 247d–6a(b)(3), 247d–6a(c), 247d–6a(d), 247d–6a(e), 247d–6b(c)(7)(C)(iii), 247d–6b(c)(7)(C)(iv), and 247d–6b(c)(7)(C)(v) of this title, and subsections (a)(1), (b)(1), and (e) of section 564 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360bbb–3], by summarizing—(i) the particular actions that were taken under the authorities specified, including, as applicable, the identification of the threat agent, emergency, or the biomedical countermeasure with respect to which the authority was used;(ii) the reasons underlying the decision to use such authorities, including, as applicable, the options that were considered and rejected with respect to the use of such authorities;(iii) the number of, nature of, and other information concerning the persons and entities that received a grant, cooperative agreement, or contract pursuant to the use of such authorities, and the persons and entities that were considered and rejected for such a grant, cooperative agreement, or contract, except that the report need not disclose the identity of any such person or entity;(iv) whether, with respect to each procurement that is approved by the President under section 247d–6b(c)(6) of this title, a contract was entered into within one year after such approval by the President; and(v) with respect to section 247d–6a(d) of this title, for the 2-year period for which the report is submitted, the number of persons who were paid amounts totaling $100,000 or greater and the number of persons who were paid amounts totaling at least $50,000 but less than $100,000; and
Citations to §247d–6a(e)(2)
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(2) The Secretary shall exercise the authority under paragraph (1) in a manner that is consistent with the limitations described in section 247d–6a(e)(2) of this title.
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(ii) The authority provided for in this subparagraph shall be exercised subject to the same limitations described in section 247d–6a(e)(2) of this title.