42 U.S.C. § 247d–7e — Biomedical Advanced Research and Development Authority

(a) Definitions: This section defines key terms. "BARDA" means the Biomedical Advanced Research and Development Authority. The "Fund" is the Biodefense Medical Countermeasure Development Fund created in subsection (d). "Other transactions" means deals that aren't standard contracts, grants, or cooperative agreements. A "qualified countermeasure" and "qualified pandemic or epidemic product" have the meanings given in sections 247d–6a and 247d–6d. "Advanced research and development" means work done after basic research, focused on scaling up manufacturing to meet FDA approval requirements — this includes testing for approval, designing test models, improving manufacturing quality and surge capacity, extending shelf life, and other late-stage work the Secretary specifies. A "security countermeasure" has the meaning given in section 247d–6b. A "research tool" is a device, technology, biological material, reagent, animal model, software, or technique built to help discover, develop, or manufacture these countermeasures or products. A "program manager" is someone appointed to oversee and manage strategic projects under this section. "Person" includes individuals, partnerships, corporations, associations, and federal, state, or local government agencies. (b) Strategic plan for countermeasure research, development, and procurement: Within 6 months of December 19, 2006, the Secretary had to write and publish a strategic plan. The plan ties together biodefense and infectious-disease needs with research, innovation, manufacturing capacity, and buying countermeasures and products. The Secretary must spread the plan's information to people who could help carry it out, and must fold the plan into the National Health Security Strategy under section 300hh–1. The plan must guide: (A) HHS's research and development of countermeasures and products against biological, chemical, radiological, and nuclear threats and emerging infectious diseases; (B) innovation in technology that helps this research; (C) work to build and maintain domestic manufacturing surge capacity; and (D) HHS's purchasing of these countermeasures and products. (c) Biomedical Advanced Research and Development Authority: This subsection creates BARDA and describes what it does. (1) Establishment: BARDA is created inside HHS. (2) In general: Based on the strategic plan, the Secretary must speed up this research and development by (A) helping HHS work with other federal agencies, industry, and academia; (B) promoting the research, including building domestic manufacturing surge capacity; (C) connecting interested people with HHS staff who can advise them on FDA approval requirements; and (D) promoting innovation that cuts the time and cost of this research. (3) Director: BARDA is led by a Director the Secretary appoints. The Secretary hands the Director the authority needed to run the program, including awarding contracts, grants, and cooperative agreements. (4) Duties: The Secretary must do several things, organized by purpose. — Collaboration (A): Facilitate direct communication between HHS and relevant people about this research — including how to get funding, gathering data on potential countermeasures, discussing manufacturing surge capacity, and discussing eligibility for the priority review voucher program under the FDA law — without compromising national security. At least once a year, the Secretary must hold meetings with industry, academia, other agencies, and international partners, sponsor demonstrations of biodefense technology, and convene working groups as needed. The Secretary must also talk regularly with organizations getting manufacturing-capacity awards, help them coordinate with organizations getting research awards, and carry out the activities in section 247d–7f (the antitrust-exemption meetings). — Supporting advanced research and development (B): Keep searching for and calling for potential countermeasures and products; direct and coordinate HHS's research work; set up strategic initiatives to speed up research in priority unmet-need areas; award contracts, grants, cooperative agreements, and other transactions for this research; and award funding to build, maintain, and improve domestic manufacturing surge capacity so the country can quickly make these products during an emergency. — Facilitating advice (C): Connect interested people with HHS staff who can advise them on FDA regulatory requirements; give people funded under this section ongoing advice to help them get FDA approval faster; and consult with the FDA Commissioner to make sure manufacturing facilities funded under (B)(v) follow good manufacturing practices. — Supporting innovation (D): The Secretary may award contracts, grants, cooperative agreements, or other transactions like prize payments to promote innovation in manufacturing technology, research tools and devices, and strategic areas like rapid diagnostics, broad-spectrum antimicrobials, vaccine manufacturing, dose-sparing technology, and storage and transportation improvements. — Medical countermeasures innovation partner (E): The Secretary, through BARDA's Director, may make an agreement with an independent nonprofit to speed up countermeasure innovation using venture-capital-style methods, address urgent unmet needs, and advise innovators. To qualify, the nonprofit must be independent, have a track record connecting innovators with investors, have experience promoting new technology, be focused on the Secretary's identified problems, show ability to promote countermeasure development, have or be able to get relevant technical and regulatory expertise, and not be part of HHS itself. The Secretary favors nonprofits with a track record partnering with the federal government. Such a nonprofit is not treated as a federal agency. Under the agreement, BARDA's Director must tell the nonprofit what needs to be addressed, describe the work, give technical feedback and oversight, and make sure the nonprofit keeps competition fair. The agreement must require the nonprofit to have transparency and accountability policies, guard against conflicts of interest, report monthly on how it spends the money, and report quarterly on its progress. This work supplements, not replaces, BARDA's other activities, and it does not let the Secretary create a new HHS office for this purpose. The Secretary must give Congress the nonprofit's reports on request. Within 4 years of December 13, 2016, the Comptroller General must independently evaluate this program and report to Congress and the Secretary with recommendations. This subparagraph stops working after September 30, 2028. — Strategic initiatives (F): The Director may run strategic initiatives — building on existing programs and awarding contracts, grants, cooperative agreements, or other transactions — to support promising products in preclinical and clinical development that address serious chemical, biological, radiological, or nuclear threats to national security. These initiatives cover: (i) threats without enough approved countermeasures, or where a threat could become resistant to existing countermeasures; (ii) recurring pandemic threats like flu, including research, manufacturing, and stockpiling of pandemic products and related tools like platform technologies and virus samples; and (iii) threats that could cause worse treatment complications, such as drug-resistant pathogens. — Annual reports by award recipients (G): Anyone who gets a manufacturing-capacity award under (B)(v) must send the Secretary yearly reports on how they're maintaining that capacity, including their ability to quickly manufacture countermeasures when needed. (5) Transaction authorities: This paragraph gives the Secretary special contracting powers. — Other transactions (A): The Secretary can use "other transactions" (deals besides normal contracts, grants, and cooperative agreements) for projects under this subsection. The Secretary must use competitive procedures whenever practical. For a project expected to cost more than $100,000,000, this power can only be used if the Assistant Secretary for Financial Resources writes a determination that it's essential — and that authority can't be delegated to anyone else. During a declared public health emergency, the Secretary must still use competitive procedures when practical, but agreements made during the emergency don't automatically end just because the emergency ends. After the emergency ends, the Secretary must report to Senate and House committees on how this authority was used, including outcomes, benefits, and risks. The Secretary must write guidelines, including audit requirements, for using this power. — Expedited authorities (B): When awarding contracts, grants, cooperative agreements, or other transactions for research (B) or innovation (D) above, the Secretary gets the same expedited procurement powers, expedited peer review, and personal-services-contract authority given under section 247d–6a(b)–(d). The related rules on internal controls, limited review, Federal Tort Claims Act coverage for personal-services contractors, and the Secretary's discretion apply here too. The term "BioShield Program" in section 247d–6a(b)(1)(D) is read to mean this section's program instead. Anyone who gets an award under (B) or (D) must keep sharing data related to their research with the Secretary on an ongoing basis and on request. — Advance payments; advertising (C): The Secretary may waive the usual federal rules on advance payments and advertising if that's necessary to get the countermeasures or products. — Milestone-based payments allowed (D): The Secretary may pay awards based on hitting milestones. — Foreign nationals eligible (E): The Secretary may award contracts, grants, cooperative agreements, or other transactions to highly qualified foreign nationals outside the U.S., alone or with American partners, if it benefits the American people. — Establishment of research centers (F): The Secretary may check whether partnering with an existing research center makes sense. If not, the Secretary may set up one or more federally funded or university-affiliated research centers. — Government purpose (G): When awarding funding, the Secretary must clearly state the government purpose tied to the advanced-research activities in subsection (a)(6)(B). — Supporting warm-base and surge capacity (H): Under a manufacturing-capacity award, the Secretary may pay for activities needed to keep that capacity ready to quickly manufacture countermeasures, whether to prepare for or respond to a public health emergency or address other serious national security threats. The Secretary may also support use of that capacity under research awards to help maintain it. (6) At-risk individuals: The Secretary may prioritize researching countermeasures likely to be safe and effective for children, pregnant women, older adults, and other at-risk groups. (7) Personnel authorities: — Specially qualified scientific and professional personnel (A): The Secretary may hire highly qualified people — like program managers — into BARDA outside the normal competitive-service rules, and pay them the same way as certain other specially hired federal employees, without regard to standard classification and pay-grade rules. This power has the same limits as in section 247d–6a(e)(2), and the same term limits that apply to those other specially hired employees also apply here. — Special consultants (B): The Secretary may appoint special consultants under section 209(f). — Limitation (C): The Secretary can hire up to 100 people, or up to 50% of BARDA's total staff (whichever is less), under these two special hiring powers. The Secretary must report to Congress on this every two years. (d) Fund: (1) Establishment: This creates the Biodefense Medical Countermeasure Development Fund to help pay for this section, on top of other available money. (2) Funding: Congress authorized $611,700,000 per year for the Fund for fiscal years 2019 through 2023, available until spent. (e) Inapplicability of certain provisions: (1) Disclosure: Certain sensitive information — technical data from this research, security details of high-containment labs working with dangerous agents, and security/vulnerability assessments — is treated as exempt from public disclosure under the Freedom of Information Act. The Secretary must review this exempt status every 5 years (or sooner if needed). Starting one year after June 24, 2019, the Secretary must report yearly to Congress on how many times this exemption was used to withhold information and describe any FOIA requests denied because of it. This nondisclosure rule stops working after December 31, 2026. (2) Review: A BARDA working group or the National Biodefense Science Board (under section 247d–7g) each ends 5 years after being created, unless the Secretary extends it for one or more additional 5-year periods. (f) Independent evaluation: (1) Within 180 days of December 29, 2022, the Comptroller General must independently evaluate the flexible-manufacturing-capacity work under this section. (2) Within 1 year of December 29, 2022, the Comptroller General must report to Congress on that evaluation, covering: (A) how much flexible manufacturing capacity focuses on chemical, biological, radiological, and nuclear threats; (B) what the flexible manufacturing initiatives actually support; (C) whether these activities can secure top technical expertise and meet surge-capacity needs for new and emerging threats; and (D) plans for sustaining this manufacturing work long-term, including regular checks on award recipients' ability to rapidly manufacture countermeasures, and recommendations for fixing any problems.