42 U.S.C. § 247d-6a
In conducting and supporting research and development activities regarding countermeasures under section 247d-6(e) of this title, the Secretary may conduct and support such activities in accordance with this section and, in consultation with the Director of the National Institutes of Health, as part of the program under section 285f of this title, if the activities concern qualified countermeasures.
In this section:
The term "qualified countermeasure" means a drug (as that term is defined by section 321(g)(1) of title 21), biological product (as that term is defined by section 262(i) of this title), or device (as that term is defined by section 321(h) of title 21), that the Secretary determines to be a priority (consistent with sections 182(2) and 184(a) of title 6)-
The term "infectious disease" means a disease potentially caused by a pathogenic organism (including a bacteria, virus, fungus, or parasite) that is acquired by a person and that reproduces in that person.
In carrying out activities under this section, the Secretary is authorized, subject to subparagraph (B), to enter into interagency agreements and other collaborative undertakings with other agencies of the United States Government.
An agreement or undertaking under this paragraph shall not authorize another agency to exercise the authorities provided by this section.
In any grant, contract, or cooperative agreement entered into under the authority provided in this section with respect to a biocontainment laboratory or other related or ancillary specialized research facility that the Secretary determines necessary for the purpose of performing, administering, or supporting qualified countermeasure research and development, the Secretary may provide that the facility that is the object of such grant, contract, or cooperative agreement shall be available as needed to the Secretary to respond to public health emergencies affecting national security.
Each agreement for an award of a grant, contract, or cooperative agreement under section 247d-6(e) of this title for the development of a qualified countermeasure shall provide that the recipient of the award will comply with all applicable export-related controls with respect to such countermeasure.
For any procurement by the Secretary of property or services for use (as determined by the Secretary) in performing, administering, or supporting qualified countermeasure research or development activities under this section that the Secretary determines necessary to respond to pressing research and development needs under this section, the amount specified in section 134 of title 41, as applicable pursuant to section 3101(b)(1)(A) of title 41, shall be deemed to be $25,000,000 in the administration, with respect to such procurement, of-
Notwithstanding subparagraph (A) and the provision of law and regulations referred to in such subparagraph, each of the following provisions shall apply to procurements described in this paragraph to the same extent that such provisions would apply to such procurements in the absence of subparagraph (A):
The Secretary shall institute appropriate internal controls for procurements that are under this paragraph, including requirements with regard to documenting the justification for use of the authority in this paragraph with respect to the procurement involved.
In conducting a procurement under this paragraph, the Secretary may not use the authority provided for under subparagraph (A) to conduct a procurement on a basis other than full and open competition unless the Secretary determines that the mission of the BioShield Program under the Project BioShield Act of 2004 would be seriously impaired without such a limitation.
In using the authority provided in section 3304(a)(1) of title 41 to use procedures other than competitive procedures in the case of a procurement described in paragraph (1) of this subsection, the phrase "available from only one responsible source" in such section 3304(a)(1) shall be deemed to mean "available from only one responsible source or only from a limited number of responsible sources".
The authority under subparagraph (A) is in addition to any other authority to use procedures other than competitive procedures.
The Secretary shall implement this paragraph in accordance with government-wide regulations implementing such section 3304(a)(1) (including requirements that offers be solicited from as many potential sources as is practicable under the circumstances, that required notices be published, and that submitted offers be considered), as such regulations apply to procurements for which an agency has authority to use procedures other than competitive procedures when the property or services needed by the agency are available from only one responsible source or only from a limited number of responsible sources and no other type of property or services will satisfy the needs of the agency.
For a procurement described by paragraph (1), the amount specified in subsections (a), (d), and (e) of section 1902 of title 41 shall be deemed to be $15,000 in the administration of that section with respect to such procurement.
The Secretary shall institute appropriate internal controls for purchases that are under this paragraph and that are greater than $2,500.
No provision of law establishing a preference for using a Government purchase card method for purchases shall apply to purchases that are under this paragraph and that are greater than $2,500.
Notwithstanding subsection (f), section 1491 of title 28, and section 3556 of title 31, review of a contracting agency decision relating to a procurement described in paragraph (1) may be had only by filing a protest-
Notwithstanding section 1491 of title 28 and section 3553 of title 31, the following authorizations by the head of a procuring activity are committed to agency discretion:
The Secretary may, as the Secretary determines necessary to respond to pressing qualified countermeasure research and development needs under this section, employ such expedited peer review procedures (including consultation with appropriate scientific experts) as the Secretary, in consultation with the Director of NIH, deems appropriate to obtain assessment of scientific and technical merit and likely contribution to the field of qualified countermeasure research, in place of the peer review and advisory council review procedures that would be required under sections 241(a)(3), 284(b)(1)(B), 284(b)(2), 284a(a)(3)(A), 289a, and 289c of this title, as applicable to a grant, contract, or cooperative agreement-
The Secretary's determination of whether to employ expedited peer review with respect to any subsequent phases of a research grant, contract, or cooperative agreement under this section shall be determined without regard to the peer review procedures used for any prior peer review of that same grant, contract, or cooperative agreement. Nothing in the preceding sentence may be construed to impose any requirement with respect to peer review not otherwise required under any other law or regulation.
For the purpose of performing, administering, or supporting qualified countermeasure research and development activities, the Secretary may, as the Secretary determines necessary to respond to pressing qualified countermeasure research and development needs under this section, obtain by contract (in accordance with section 3109 of title 5, but without regard to the limitations in such section on the period of service and on pay) the personal services of experts or consultants who have scientific or other professional qualifications, except that in no case shall the compensation provided to any such expert or consultant exceed the daily equivalent of the annual rate of compensation for the President.
A person carrying out a contract under paragraph (1), and an officer, employee, or governing board member of such person, shall, subject to a determination by the Secretary, be deemed to be an employee of the Department of Health and Human Services for purposes of claims under sections 1346(b) and 2672 of title 28 for money damages for personal injury, including death, resulting from performance of functions under such contract.
The remedy provided by subparagraph (A) shall be exclusive of any other civil action or proceeding by reason of the same subject matter against the entity involved (person, officer, employee, or governing board member) for any act or omission within the scope of the Federal Tort Claims Act.
Should payment be made by the United States to any claimant bringing a claim under this paragraph, either by way of administrative determination, settlement, or court judgment, the United States shall have, notwithstanding any provision of State law, the right to recover against any entity identified in subparagraph (B) for that portion of the damages so awarded or paid, as well as interest and any costs of litigation, resulting from the failure of any such entity to carry out any obligation or responsibility assumed by such entity under a contract with the United States or from any grossly negligent or reckless conduct or intentional or willful misconduct on the part of such entity.
The United States may maintain an action under this subparagraph against such entity in the district court of the United States in which such entity resides or has its principal place of business.
The Secretary shall institute appropriate internal controls for contracts under this subsection, including procedures for the Secretary to make a determination of whether a person, or an officer, employee, or governing board member of a person, is deemed to be an employee of the Department of Health and Human Services pursuant to paragraph (2).
A determination by the Secretary under subparagraph (A) that a person, or an officer, employee, or governing board member of a person, is or is not deemed to be an employee of the Department of Health and Human Services shall be final and binding on the Secretary and the Attorney General and other parties to any civil action or proceeding.
The number of experts and consultants whose personal services are obtained under paragraph (1) shall not exceed 30 at any time.
In addition to any other personnel authorities, the Secretary may, as the Secretary determines necessary to respond to pressing qualified countermeasure research and development needs under this section, without regard to those provisions of title 5 governing appointments in the competitive service, and without regard to the provisions of chapter 51 and subchapter III of chapter 53 of such title relating to classification and General Schedule pay rates, appoint professional and technical employees, not to exceed 30 such employees at any time, to positions in the National Institutes of Health to perform, administer, or support qualified countermeasure research and development activities in carrying out this section.
The authority provided for under paragraph (1) shall be exercised in a manner that-
The Secretary shall institute appropriate internal controls for appointments under this subsection.
Actions by the Secretary under the authority of this section are committed to agency discretion.
42 U.S.C. § 247d-6a
EDITORIAL NOTES
REFERENCES IN TEXTThe Project BioShield Act of 2004, referred to in subsec. (b)(1)(D), is Pub. L. 108-276, 118 Stat. 835. For complete classification of this Act to the Code, see Short Title of 2004 Amendments note set out under section 201 of this title and Tables.The Federal Tort Claims Act, referred to in subsec. (d)(2), 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.
CODIFICATIONIn subsec. (b)(1)(A), "section 134 of title 41" substituted for "section 4(11) of the Office of Federal Procurement Policy Act (41 U.S.C. 403(11))" and "section 3101(b)(1)(A) of title 41" substituted for "section 302A(a) of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 252a(a))" on authority of Pub. L. 111-350, §6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.In subsec. (b)(1)(A)(i), "section 3305(a)(1) of title 41" substituted for "section 303(g)(1)(A) of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 253(g)(1)(A))" on authority of Pub. L. 111-350, §6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.In subsec. (b)(1)(A)(ii), "section 3101(b)(1)(B) of title 41" substituted for "section 302A(b) of such Act (41 U.S.C. 252a(b))" on authority of Pub. L. 111-350, §6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.In subsec. (b)(1)(B)(ii), "Section 8703(a) of title 41" substituted for "Subsections (a) and (b) of section 7 of the Anti-Kickback Act of 1986 (41 U.S.C. 57(a) and (b))" on authority of Pub. L. 111-350, §6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.In subsec. (b)(1)(B)(iii), "Section 4706 of title 41" substituted for "Section 304C of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 254d)" on authority of Pub. L. 111-350, §6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.In subsec. (b)(1)(B)(v), "Section 3901 of title 41" substituted for "Subsection (a) of section 304 of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 254(a))" on authority of Pub. L. 111-350, §6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.In subsec. (b)(2)(A), "section 3304(a)(1) of title 41" substituted for "section 303(c)(1) of title III of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 253(c)(1))" and "such section 3304(a)(1)" substituted for "such section 303(c)(1)" on authority of Pub. L. 111-350, §6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.In subsec. (b)(2)(C), "such section 3304(a)(1)" substituted for "such section 303(c)(1)" on authority of Pub. L. 111-350, §6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.In subsec. (b)(3)(A), "subsections (a), (d), and (e) of section 1902 of title 41" substituted for "subsections (c), (d), and (f) of section 32 of the Office of Federal Procurement Policy Act (41 U.S.C. 428)" on authority of Pub. L. 111-350, §6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.
AMENDMENTS2019-Subsec. (a)(1), (5). Pub. L. 116-22 substituted "section 247d-6(e) of this title" for "section 247d-6(h) of this title".2013-Subsec. (a)(2)(A). Pub. L. 113-5 struck out "to" before dash at end of introductory provisions, inserted "to" before "diagnose" in cls. (i) and (ii), and added cl. (iii). 2006-Subsec. (a)(2). Pub. L. 109-417 added par. (2) and struck out heading and text of former par. (2). Text read as follows: "For purposes of this section, the term 'qualified countermeasure' means a drug (as that term is defined by section 321(g)(1) of title 21), biological product (as that term is defined by section 262(i) of this title), or device (as that term is defined by section 321(h) of title 21) that the Secretary determines to be a priority (consistent with sections 182(2) and 184(a) of title 6) to- "(A) treat, identify, or prevent harm from any biological, chemical, radiological, or nuclear agent that may cause a public health emergency affecting national security; or"(B) treat, identify, or prevent harm from a condition that may result in adverse health consequences or death and may be caused by administering a drug, biological product, or device that is used as described in subparagraph (A)."
STATUTORY NOTES AND RELATED SUBSIDIARIES
RULE OF CONSTRUCTION Pub. L. 108-276, §2(e), July 21, 2004, 118 Stat. 842, provided that: "Nothing in this section [enacting this section and amending sections 247d-6, 287a-2, and 300aa-6 of this title] has any legal effect on sections 302(2), 302(4), 304(a), or 304(b) of the Homeland Security Act of 2002 [6 U.S.C. 182(2), (4), 184(a), (b)] ."
COLLABORATION AND COORDINATION Pub. L. 109-417, title IV, §405, Dec. 19, 2006, 120 Stat. 2875, as amended by Pub. L. 113-5, §402(e)(1), Mar. 13, 2013, 127 Stat. 195; Pub. L. 116-22, title VII, §701(e)(1)(A), (B), June 24, 2019, 133 Stat. 961, which authorized the Secretary of Health and Human Services, in coordination with the Attorney General and the Secretary of Homeland Security, to conduct meetings with persons engaged in the development of a security countermeasure, a qualified countermeasure, or a qualified pandemic or epidemic product, in such a manner to ensure that no national security, confidential commercial, or proprietary information is disclosed outside the meeting, and exempted from antitrust laws conduct pursuant to a written agreement executed at such a meeting approved by the Attorney General and the Chairman of the Federal Trade Commission, was redesignated as section 319L-1 of act July 1, 1944, ch. 373, known as the Public Health Service Act, by Pub. L. 116-22, title VII, §701(e)(1)(C), (D), June 24, 2019, 133 Stat. 961, and editorially reclassified as section 247d-7f of this title.
OUTREACH Pub. L. 108-276, §6, July 21, 2004, 118 Stat. 862, provided that: "The Secretary of Health and Human Services shall develop outreach measures to ensure to the extent practicable that diverse institutions, including Historically Black Colleges and Universities and those serving large proportions of Black or African Americans, American Indians, Appalachian Americans, Alaska Natives, Asians, Native Hawaiians, other Pacific Islanders, Hispanics or Latinos, or other underrepresented populations, are meaningfully aware of available research and development grants, contracts, cooperative agreements, and procurements conducted under sections 2 and 3 of this Act [enacting this section and section 320 of Title 6, Domestic Security, amending sections 247d-6, 247d-6b, 287a-2, and 300aa-6 of this title and sections 312 and 313 of Title 6, renumbering section 300hh-12 of this title as section 247d-6b of this title, and enacting provisions set out as notes under this section and section 247d-6b of this title]."
RECOMMENDATION FOR EXPORT CONTROLS ON CERTAIN BIOMEDICAL COUNTERMEASURES Pub. L. 108-276, §7, July 21, 2004, 118 Stat. 863, provided that: "Upon the award of any grant, contract, or cooperative agreement under section 2 or 3 of this Act [enacting this section and section 320 of Title 6, Domestic Security, amending sections 247d-6, 247d-6b, 287a-2, and 300aa-6 of this title and sections 312 and 313 of Title 6, renumbering section 300hh-12 of this title as section 247d-6b of this title, and enacting provisions set out as notes under this section and section 247d-6b of this title] for the research, development, or procurement of a qualified countermeasure or a security countermeasure (as those terms are defined in this Act [see Short Title of 2004 Amendments note set out under section 201 of this title]), the Secretary of Health and Human Services shall, in consultation with the heads of other appropriate Federal agencies, determine whether the countermeasure involved in such grant, contract, or cooperative agreement is subject to existing export-related controls and, if not, may make a recommendation to the appropriate Federal agency or agencies that such countermeasure should be included on the list of controlled items subject to such controls."
ENSURING COORDINATION, COOPERATION AND THE ELIMINATION OF UNNECESSARY DUPLICATION IN PROGRAMS DESIGNED TO PROTECT THE HOMELAND FROM BIOLOGICAL, CHEMICAL, RADIOLOGICAL, AND NUCLEAR AGENTS Pub. L. 108-276, §8, July 21, 2004, 118 Stat. 863, provided that:"(a) ENSURING COORDINATION OF PROGRAMS.-The Secretary of Health and Human Services, the Secretary of Homeland Security, and the Secretary of Defense shall ensure that the activities of their respective Departments coordinate, complement, and do not unnecessarily duplicate programs to identify potential domestic threats from biological, chemical, radiological or nuclear agents, detect domestic incidents involving such agents, analyze such incidents, and develop necessary countermeasures. The aforementioned Secretaries shall further ensure that information and technology possessed by the Departments relevant to these activities are shared with the other Departments."(b) DESIGNATION OF AGENCY COORDINATION OFFICER.-The Secretary of Health and Human Services, the Secretary of Homeland Security, and the Secretary of Defense shall each designate an officer or employee of their respective Departments who shall coordinate, through regular meetings and communications, with the other aforementioned Departments such programs and activities carried out by their Departments."
- Service
- The term "Service" means the Public Health Service;
- project
- The terms "federally assisted housing" and "project" mean-(A) a public housing project (as such term is defined in section 3(b) of the United States Housing Act of 1937 [42 U.S.C. 1437a(b)] );(B) housing for which project-based assistance is provided under section 8 of the United States Housing Act of 1937 [42 U.S.C. 1437f] ;(C) housing that is assisted under section 1701q of title 12;(D) housing that is assisted under section 1701q of title 12, as such section existed before November 28, 1990;(E) housing financed by a loan or mortgage insured under section 1715l(d)(3) of title 12 that bears interest at a rate determined under the proviso of section 1715l(d)(5) of title 12;(F) housing insured, assisted, or held by the Secretary or a State or State agency under section 1715z-1 of title 12;(G) housing constructed or substantially rehabilitated pursuant to assistance provided under section 8(b)(2) of the United States Housing Act of 1937 [42 U.S.C. 1437f(b)(2)], as in effect before October 1, 1983, that is assisted under a contract for assistance under such section; and(H) housing that is assisted under section 8013 1 of this title.
- Director
- the term "Director" means the Chief Executive Officer of the Corporation for National and Community Service,
- Secretary
- the term "Secretary" means- (A) the Secretary of Education for purposes of subtitle A (other than section 3201),(B) the Secretary of Agriculture for purposes of the amendments made by section 3201, and(C) the Secretary of Health and Human Services for purposes of subtitle B,
- drug
- the term "drug" means- (A) a beverage containing alcohol,(B) a controlled substance, or(C) a controlled substance analogue,