Biomedical Advanced Research and Development Authority

In this section: 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. 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. The 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— The 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. Not later than 6 months after December 19, 2006, the Secretary shall develop and make public a strategic plan to integrate biodefense and emerging infectious disease requirements with the advanced research and development, strategic initiatives for innovation, support for domestic manufacturing surge capacity and capabilities, and the procurement of qualified countermeasures and qualified pandemic or epidemic products. The Secretary shall carry out such activities as may be practicable to disseminate the information contained in such plan to persons who may have the capacity to substantially contribute to the activities described in such strategic plan. The Secretary shall update and incorporate such plan as part of the National Health Security Strategy described in section 300hh–1 of this title. The strategic plan under paragraph (1) shall guide— There is established within the Department of Health and Human Services the Biomedical Advanced Research and Development Authority. Based 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. To carry out the purpose described in paragraph (2)(A), the Secretary shall— 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— at least annually— To carry out the purpose described in paragraph (2)(B), the Secretary shall— To carry out the purpose described in paragraph (2)(C) the Secretary shall— To 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— To 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— To be eligible to enter into an agreement under clause (i) an entity shall— In selecting an entity with which to enter into an agreement under clause (i), the Secretary shall place a high value on the demonstrated experience of the entity in partnering with the Federal Government to meet identified strategic needs. An entity that enters into an agreement under clause (i) shall not be deemed to be a Federal agency for any purpose, including for any purpose under title 5. Pursuant 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— ensure, as a condition of the agreement that the entity— Activities carried out under this subparagraph shall supplement, and not supplant, other activities carried out under this section. To prevent unnecessary duplication and target resources effectively, nothing in this subparagraph shall be construed to authorize the Secretary to establish within the Department of Health and Human Services an entity for the purposes of carrying out this subparagraph. Upon request, the Secretary shall provide to Congress the information provided to the Secretary under clause (iv)(V)(dd). Not later than 4 years after December 13, 2016, the Comptroller General of the United States shall conduct an independent evaluation, and submit to the Secretary and the appropriate committees of Congress a report, concerning the activities conducted under this subparagraph. Such report shall include recommendations with respect to any agreement or activities carried out pursuant to this subparagraph. This subparagraph shall have no force or effect after September 30, 2028. The Secretary, acting through the Director of BARDA, may implement strategic initiatives, including by building on existing programs and by awarding contracts, grants, and cooperative agreements, or entering into other transactions, to support innovative candidate products in preclinical and clinical development that address priority, naturally occurring and man-made threats that, as determined by the Secretary, pose a significant level of risk to national security based on the characteristics of a chemical, biological, radiological or nuclear threat, or existing capabilities to respond to such a threat (including medical response and treatment capabilities and manufacturing infrastructure). Such initiatives shall accelerate and support the advanced research, development, and procurement of countermeasures and products, as applicable, to address areas including— As a condition of receiving an award under subparagraph (B)(v), a recipient shall develop and submit to the Secretary annual reports related to the maintenance of such capacity and capabilities, including ensuring that such capacity and capabilities are able to support the rapid manufacture of countermeasures as required by the Secretary. The Secretary shall have the authority to enter into other transactions (as defined in subsection (a)(3)) under this subsection. To the maximum extent practicable, competitive procedures shall be used when entering into transactions to carry out projects under this subsection. 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 $100,000,000 only upon a written determination by the Assistant Secretary for Financial Resources, that the use of such authority is essential to promoting the success of the project. The authority of the Assistant Secretary for Financial Resources under this subclause may not be delegated. Notwithstanding clause (ii), the Secretary, shall, to the maximum extent practicable, use competitive procedures when entering into transactions to carry out projects under this subsection for purposes of a public health emergency declared by the Secretary under section 247d of this title. Any such transactions entered into during such public health emergency shall not be terminated solely due to the expiration of such public health emergency, if such public health emergency ends before the completion of the terms of such agreement. After the expiration of the public health emergency declared by the Secretary under section 247d of this title, the Secretary shall provide a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives regarding the use of any funds pursuant to the authority under subclause (I), including any outcomes, benefits, and risks associated with the use of such funds, and a description of the reasons for the use of such authority for the project or projects. The Secretary shall establish guidelines regarding the use of the authority under clause (i). Such guidelines shall include auditing requirements. 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. 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. 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. The Secretary shall require that, as a condition of being awarded a contract, grant, cooperative agreement, or other transaction under subparagraph (B) or (D) of paragraph (4), a person make available to the Secretary on an ongoing basis, and submit upon request to the Secretary, all data related to or resulting from countermeasure and product advanced research and development carried out pursuant to this section. The Secretary may waive the requirements of section 3324(a) of title 31 or section 6101 of title 41 upon the determination by the Secretary that such waiver is necessary to obtain countermeasures or products under this section. In awarding contracts, grants, and cooperative agreements, and in entering into other transactions, under this section, the Secretary may use milestone-based awards and payments. The Secretary may under this section award contracts, grants, and cooperative agreements to, and may enter into other transactions with, highly qualified foreign national persons outside the United States, alone or in collaboration with American participants, when such transactions may inure to the benefit of the American people. The Secretary may assess the feasibility and appropriateness of establishing, through contract, grant, cooperative agreement, or other transaction, an arrangement with an existing research center in order to achieve the goals of this section. If such an agreement is not feasible and appropriate, the Secretary may establish one or more federally-funded research and development centers, or university-affiliated research centers, in accordance with section 3304(a)(3) of title 41. 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. Pursuant to an award under subparagraph (B)(v),11 So in original. Probably should be “paragraph (4)(B)(v),”. the Secretary may make payments for activities necessary to maintain domestic manufacturing surge capacity and capabilities supported under such award to ensure that such capacity and capabilities are able to support the rapid manufacture of countermeasures as required by the Secretary to prepare for, or respond to, an existing or potential public health emergency or otherwise address threats that pose a significant level of risk to national security. The Secretary may support the utilization of such capacity and capabilities under awards for countermeasure and product advanced research and development, as appropriate, to provide for the maintenance of such capacity and capabilities. 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, older adults, and other at-risk individuals with relevant characteristics that warrant consideration during the process of researching and developing such countermeasures and products. In addition to any other personnel authorities, the Secretary may— 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. 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. In carrying out this section, the Secretary may appoint special consultants pursuant to section 209(f) of this title. The Secretary may hire up to 100 highly qualified individuals, or up to 50 percent of the total number of employees, whichever is less, under the authorities provided for in subparagraphs (A) and (B). The Secretary shall report to Congress on a biennial basis on the implementation of this subparagraph. There is established the Biodefense Medical Countermeasure Development Fund, 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 $611,700,000 for each of fiscal years 2019 through 2023, such amounts to remain available until expended. Information described in clause (ii) shall be deemed to be information described in section 552(b)(3) of title 5. The information described in this clause is information relevant to programs of the Department of Health and Human Services that could compromise national security and reveal significant and not otherwise publicly known vulnerabilities of existing medical or public health defenses against chemical, biological, radiological, or nuclear threats, and is comprised of— Information subject to nondisclosure under subparagraph (A) shall be reviewed by the Secretary every 5 years, or more frequently as determined necessary by the Secretary, to determine the relevance or necessity of continued nondisclosure. One year after June 24, 2019, and annually thereafter, the Secretary shall report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on the number of instances in which the Secretary has used the authority under this subsection to withhold information from disclosure, as well as the nature of any request under section 552 of title 5 that was denied using such authority. This paragraph shall cease to have force or effect after December 31, 2026. Notwithstanding section 1013 of title 5, a working group of BARDA under this section and the National Biodefense Science Board under section 247d–7g 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. Not later than 180 days after December 29, 2022, 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 December 29, 2022, 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 ability of flexible manufacturing activities carried out under this section to—