Source: https://www.law.cornell.edu/uscode/text/42/247d%E2%80%937e
Timestamp: 2019-03-23 00:31:31
Document Index: 778829708

Matched Legal Cases: ['§ 247', '§ 247', '§ 247', '§\u202f247', '§\u202f319', '§\u202f401', '§\u202f402', '§\u202f3082', '§\u202f301', '§\u202f815', '§\u202f921', '§\u202f6', '§\u202f6', '§\u202f6', '§\u202f3082', '§\u202f3084', '§\u202f402', '§\u202f402', '§\u202f402', '§\u202f402', '§\u202f402', '§\u202f402']

42 U.S. Code § 247d–7e - Biomedical Advanced Research and Development Authority | US Law | LII / Legal Information Institute
U.S. Code › Title 42 › Chapter 6A › Subchapter II › Part B › § 247d–7e
42 U.S. Code § 247d–7e - Biomedical Advanced Research and Development Authority
§ 247d–7e.
The term “BARDA” means the Biomedical Advanced Research and Development Authority.
The term “Fund” means the Biodefense Medical Countermeasure Development Fund established under subsection (d).
The term “other transactions” means transactions, other than procurement contracts, grants, and cooperative agreements, such as the Secretary of Defense may enter into under section 2371 of title 10.
The term “qualified countermeasure” has the meaning given such term in section 247d–6a of this title.
The term “qualified pandemic or epidemic product” has the meaning given the term in section 247d–6d of this title.
(A) In generalThe term “advanced research and development” means, with respect to a product that is or may become a qualified countermeasure or a qualified pandemic or epidemic product, activities that predominantly—
are conducted after basicresearch and preclinical development of the product; and
(B) Activities includedThe term under subparagraph (A) includes—
The term “security countermeasure” has the meaning given such term in section 247d–6b of this title.
The term “research tool” means a device, technology, biological material (including a cell line or an antibody), reagent, animal model, computer system, computer software, or analytical technique that is developed to assist in the discovery, development, or manufacture of qualified countermeasures or qualified pandemic or epidemic products.
The term “program manager” means an individual appointed to carry out functions under this section and authorized to provide project oversight and management of strategic initiatives.
The term “person” includes an individual, partnership, corporation, association, entity, or public or private corporation, and a Federal, State, or local government agency or department.
(2) ContentThe strategic plan under paragraph (1) shall guide—
(2) In generalBased upon the strategic plan described in subsection (b), the Secretary shall coordinate the acceleration of countermeasure and product advanced research and development by—
The BARDA shall be headed by a Director (referred to in this section as the “Director”) who shall be appointed by the Secretary and to whom the Secretary shall delegate such functions and authorities as necessary to implement this section, including the execution of procurement contracts, grants, and cooperative agreements pursuant to this section.
(A) CollaborationTo carry out the purpose described in paragraph (2)(A), the Secretary shall—
(i) facilitate and increase the expeditious and direct communication between the Department of Health and Human Services and relevant persons with respect to countermeasure and product advanced research and development, including by—
(ii) at least annually—
(B) Support advanced research and developmentTo carry out the purpose described in paragraph (2)(B), the Secretary shall—
(C) Facilitating adviceTo carry out the purpose described in paragraph (2)(C) the Secretary shall—
(D) Supporting innovationTo carry out the purpose described in paragraph (2)(D), the Secretary may award contracts, grants, and cooperative agreements, or enter into other transactions, such as prize payments, to promote—
(i) In generalTo support the purposes described in paragraph (2), the Secretary, acting through the Director of BARDA, may enter into an agreement (including through the use of grants, contracts, cooperative agreements, or other transactions as described in paragraph (5)) with an independent, nonprofit entity to—
foster and accelerate the development and innovation of medical countermeasures and technologies that may assist advanced research and the development of qualified countermeasures and qualified pandemic or epidemic products, including through the use of strategic venture capital practices and methods;
(I) In generalTo be eligible to enter into an agreement under clause (i) an entity shall—
be an independent, nonprofit entity;
be problem-driven and solution-focused based on the needs, requirements, and problems identified by the Secretary under clause (iv);
demonstrate the ability, or the potential ability, to promote the development of medical countermeasure products;
demonstrate expertise, or the capacity to develop or acquire expertise, related to technical and regulatory considerations with respect to medical countermeasures; and
not be within the Department of Health and Human Services.
(iv) DirectionPursuant to an agreement entered into under this subparagraph, the Secretary, acting through the Director of BARDA, shall provide direction to the entity that enters into an agreement under clause (i). As part of this agreement the Director of BARDA shall—
(V) ensure, as a condition of the agreement that the entity—
has in place a comprehensive set of policies that demonstrate a commitment to transparency and accountability;
protects against conflicts of interest through a comprehensive set of policies that address potential conflicts of interest, ethics, disclosure, and reporting requirements;
provides monthly accounting on the use of funds provided under such agreement; and
provides on a quarterly basis, reports regarding the progress made toward meeting the identified needs set forth in the agreement.
This subparagraph shall have no force or effect after September 30, 2022.
Subsections (b), (c), and (h) of section 845 [1] of the National Defense Authorization Act for Fiscal Year 1994 (10 U.S.C. 2371 note) shall apply to other transactions under this subparagraph as if such transactions were for prototype projects described by subsection (a) of such section 845.
The authority of this subparagraph may be exercised for a project that is expected to cost the Department of Health and Human Services in excess of $20,000,000 only upon a written determination by the senior procurement executive for the Department (as designated for purpose of section 1702(c) of title 41), that the use of such authority is essential to promoting the success of the project. The authority of the senior procurement executive under this subclause may not be delegated.
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.
In carrying out the functions under this section, the Secretary may give priority to the advanced research and development of qualified countermeasures and qualified pandemic or epidemic products that are likely to be safe and effective with respect to children, pregnant women, elderly, and other at-risk individuals.
(i) In generalIn addition to any other personnel authorities, the Secretary may—
The term limitations described in section 9903(c) of title 5 shall apply to appointments under this subparagraph, except that the references to the “Secretary” and to the “Department of Defense’s national security missions” shall be deemed to be to the Secretary of Health and Human Services and to the mission of the Department of Health and Human Services under this section.
There is established the Biodefense Medical Countermeasure DevelopmentFund, which shall be available to carry out this section in addition to such amounts as are otherwise available for this purpose.
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.
The Secretary shall withhold from disclosure under section 552 of title 5 specific technical data or scientific information that is created or obtained during the countermeasure and product advanced research and development carried out under subsection (c) that reveals significant and not otherwise publicly known vulnerabilities of existing medical or public health defenses against biological, chemical, nuclear, or radiological threats. Such information shall be deemed to be information described in section 552(b)(3) of title 5.
This paragraph shall cease to have force or effect on the date that is 12 years after December 19, 2006.
Notwithstanding section 14 of the Federal Advisory Committee Act, a working group of BARDA under this section and the National Biodefense Science Board under section 247d–7f of this title shall each terminate on the date that is 5 years after the date on which each such group or Board, as applicable, was established. Such 5-year period may be extended by the Secretary for one or more additional 5-year periods if the Secretary determines that any such extension is appropriate.
(2) ReportNot later than 1 year after March 13, 2013, 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—
(C) the ability of flexible manufacturing activities carried out under this section to—
(July 1, 1944, ch. 373, title III, § 319L, as added Pub. L. 109–417, title IV, § 401, Dec. 19, 2006, 120 Stat. 2865; amended Pub. L. 113–5, title IV, § 402(a)–(d), (f), Mar. 13, 2013, 127 Stat. 194, 195; Pub. L. 114–255, div. A, title III, §§ 3082(b), 3084, Dec. 13, 2016, 130 Stat. 1141.)
The Federal Food, Drug, and Cosmetic Act, referred to in subsecs. (a)(6)(A)(ii), (B)(i) and (c)(2)(C), (4)(B)(iii), (C)(i), is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended, which is classified generally to chapter 9 (§ 301 et seq.) of Title 21, Food and Drugs. For complete classification of this Act to the Code, see section 301 of Title 21 and Tables.
Section 405 of the Pandemic and All-Hazards Preparedness Act, referred to in subsec. (c)(4)(A)(iii), is section 405 of Pub. L. 109–417, which is set out as a note under section 247d–6a of this title.
Section 845 of the National Defense Authorization Act for Fiscal Year 1994, referred to in subsec. (c)(5)(A)(ii)(I), is section 845 of Pub. L. 103–160, which was formerly set out as a note under section 2371 of Title 10, Armed Forces, prior to repeal by Pub. L. 114–92, div. A, title VIII, § 815(c), Nov. 25, 2015, 129 Stat. 896. See section 2371b of Title 10.
The Federal Tort Claims Act, referred to in subsec. (c)(5)(B)(ii), is title IV of act Aug. 2, 1946, ch. 753, 60 Stat. 842, which was classified principally to chapter 20 (§§ 921, 922, 931–934, 941–946) of former Title 28, Judicial Code and Judiciary. Title IV of act Aug. 2, 1946, was substantially repealed and reenacted as sections 1346(b) and 2671 et seq. of Title 28, Judiciary and Judicial Procedure, by act June 25, 1948, ch. 646, 62 Stat. 992, the first section of which enacted Title 28. The Federal Tort Claims Act is also commonly used to refer to chapter 171 of Title 28, Judiciary and Judicial Procedure. For complete classification of title IV to the Code, see Tables. For distribution of former sections of Title 28 into the revised Title 28, see Table at the beginning of Title 28.
In subsec. (c)(5)(A)(ii)(II), “section 1702(c) of title 41” substituted for “section 16(c) of the Office of Federal Procurement Policy Act (41 U.S.C. 414(c))” on authority of Pub. L. 111–350, § 6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.
In subsec. (c)(5)(C), “section 6101 of title 41” substituted for “section 3709 of the Revised Statutes of the United States (41 U.S.C. 5)” on authority of Pub. L. 111–350, § 6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.
In subsec. (c)(5)(F), “section 3304(a)(3) of title 41” substituted for “section 303(c)(3) of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 253(c)(3))” on authority of Pub. L. 111–350, § 6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.
Subsec. (c)(3). Pub. L. 114–255, § 3082(b), inserted “, including the execution of procurement contracts, grants, and cooperative agreements pursuant to this section” before period at end.
Subsec. (c)(4)(E). Pub. L. 114–255, § 3084, added subpar. (E).
2013—Subsec. (c)(4)(B)(iii). Pub. L. 113–5, § 402(a)(1), inserted “(which may include advanced research and development for purposes of fulfilling requirements under the Federal Food, Drug, and Cosmetic Act or section 262 of this title)” after “research and development”.
Subsec. (c)(4)(D)(iii). Pub. L. 113–5, § 402(a)(2), substituted “vaccine-manufacturing technologies, dose-sparing technologies, efficacy-increasing technologies, and platform technologies” for “and vaccine manufacturing technologies”.
Subsec. (c)(5)(G). Pub. L. 113–5, § 402(b), added subpar. (G).
Subsec. (d)(2). Pub. L. 113–5, § 402(c), amended par. (2) generally. Prior to amendment, text read as follows: “To carry out the purposes of this section, there are authorized to be appropriated to the Fund—
Subsec. (e)(1)(C). Pub. L. 113–5, § 402(d), substituted “12 years” for “7 years”.
Subsec. (f). Pub. L. 113–5, § 402(f), added subsec. (f).