42 U.S.C. § 247d–6a | Authority for use of certain procedures regarding qualified countermeasure research and development activities

(a)

In general

(1)

Authority

section 247d–6(e) of this title section 285f of this titleIn conducting and supporting research and development activities regarding countermeasures under , 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 , if the activities concern qualified countermeasures.

(2)

Definitions

In this section:

(A)

Qualified countermeasure

section 321(g)(1) of title 21 section 262(i) of this title section 321(h) of title 21The term “qualified countermeasure” means a drug (as that term is defined by ), biological product (as that term is defined by ), or device (as that term is defined by ), that the Secretary determines to be a priority (consistent with sections 182(2) and 184(a) of title 6)—

(i)

to diagnose, mitigate, prevent, or treat harm from any biological agent (including organisms that cause an infectious disease) or toxin, chemical, radiological, or nuclear agent that may cause a public health emergency affecting national security;

(ii)

to diagnose, mitigate, prevent, or treat 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 this subparagraph; or

(iii)

is a product or technology intended to enhance the use or effect of a drug, biological product, or device described in clause (i) or (ii).

(B)

Infectious disease

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.

(3)

Interagency cooperation

(A)

In general

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.

(B)

Limitation

An agreement or undertaking under this paragraph shall not authorize another agency to exercise the authorities provided by this section.

(4)

Availability of facilities to the Secretary

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.

(5)

Transfers of qualified countermeasures

section 247d–6(e) of this titleEach agreement for an award of a grant, contract, or cooperative agreement under 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.

(b)

Expedited procurement authority

(1)

Increased simplified acquisition threshold for qualified countermeasure procurements

(A)

In general

section 134 of title 41 section 3101(b)(1)(A) of title 41For 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 , as applicable pursuant to , shall be deemed to be $25,000,000 in the administration, with respect to such procurement, of—

(i)

section 3305(a)(1) of title 41 and its implementing regulations; and

(ii)

section 3101(b)(1)(B) of title 41 and its implementing regulations.

(B)

Application of certain provisions

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):

(i)

Chapter 37 of title 40 (relating to contract work hours and safety standards).

(ii)

Section 8703(a) of title 41 .

(iii)

Section 4706 of title 41 (relating to the examination of contractor records).

(iv)

Section 3131 of title 40 (relating to bonds of contractors of public buildings or works).

(v)

Section 3901 of title 41 (relating to contingent fees to middlemen).

(vi)

Section 6962 of this title .

(vii)

Section 1354 of title 31 (relating to the limitation on the use of appropriated funds for contracts with entities not meeting veterans employment reporting requirements).

(C)

Internal controls to be instituted

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.

(D)

Authority to limit competition

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.

(2)

Procedures other than full and open competition

(A)

In general

section 3304(a)(1) of title 41In using the authority provided in 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”.

(B)

Relation to other authorities

The authority under subparagraph (A) is in addition to any other authority to use procedures other than competitive procedures.

(C)

Applicable government-wide regulations

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.

(3)

Increased micropurchase threshold

(A)

In general

section 1902 of title 41For a procurement described by paragraph (1), the amount specified in subsections (a), (d), and (e) of shall be deemed to be $15,000 in the administration of that section with respect to such procurement.

(B)

Internal controls to be instituted

The Secretary shall institute appropriate internal controls for purchases that are under this paragraph and that are greater than $2,500.

(C)

Exception to preference for purchase card mechanism

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.

(4)

Review

(A)

Review allowed

section 1491 of title 28 section 3556 of title 31Notwithstanding subsection (f), , and , review of a contracting agency decision relating to a procurement described in paragraph (1) may be had only by filing a protest—

(i)

with a contracting agency; or

(ii)

with the Comptroller General under subchapter V of chapter 35 of title 31.

(B)

Override of stay of contract award or performance committed to agency discretion

section 1491 of title 28 section 3553 of title 31Notwithstanding and , the following authorizations by the head of a procuring activity are committed to agency discretion:

(i)

section 3553(c)(2) of title 31 An authorization under to award a contract for a procurement described in paragraph (1) of this subsection.

(ii)

An authorization under section 3553(d)(3)(C) of such title to perform a contract for a procurement described in paragraph (1) of this subsection.

(c)

Authority to expedite peer review

(1)

In general

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—

(A)

that is for performing, administering, or supporting qualified countermeasure research and development activities; and

(B)

the amount of which is not greater than $1,500,000.

(2)

Subsequent phases of research

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.

(d)

Authority for personal services contracts

(1)

In general

section 3109 of title 5For 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 , 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.

(2)

Federal Tort Claims Act coverage

(A)

In general

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.

(B)

Exclusivity of remedy

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.

(C)

Recourse in case of gross misconduct or contract violation

(i)

In general

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.

(ii)

Venue

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.

(3)

Internal controls to be instituted

(A)

In general

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).

(B)

Determination of employee status to be final

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.

(4)

Number of personal services contracts limited

The number of experts and consultants whose personal services are obtained under paragraph (1) shall not exceed 30 at any time.

(e)

Streamlined personnel authority

(1)

In general

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.

(2)

Limitations

The authority provided for under paragraph (1) shall be exercised in a manner that—

(A)

recruits and appoints individuals based solely on their abilities, knowledge, and skills;

(B)

section 2302(b)(1) of title 5 does not discriminate for or against any applicant for employment on any basis described in ;

(C)

does not allow an official to appoint an individual who is a relative (as defined in section 3110(a)(3) of such title) of such official;

(D)

does not discriminate for or against an individual because of the exercise of any activity described in paragraph (9) or (10) of section 2302(b) of such title; and

(E)

accords a preference, among equally qualified persons, to persons who are preference eligibles (as defined in section 2108(3) of such title).

(3)

Internal controls to be instituted

The Secretary shall institute appropriate internal controls for appointments under this subsection.

(f)

Actions committed to agency discretion

Actions by the Secretary under the authority of this section are committed to agency discretion.

July 1, 1944, ch. 373 Pub. L. 108–276, § 2(a)July 21, 2004118 Stat. 835 Pub. L. 109–417, title IV, § 403(a)Dec. 19, 2006120 Stat. 2874 Pub. L. 113–5, title IV, § 402(g)(1)Mar. 13, 2013127 Stat. 195 Pub. L. 116–22, title VII, § 705(a)(1)June 24, 2019133 Stat. 964(, title III, § 319F–1, as added , , ; amended , , ; , , ; , , .)

Editorial Notes

References in Text

Pub. L. 108–276July 21, 2004118 Stat. 835 section 201 of this titleThe Project BioShield Act of 2004, referred to in subsec. (b)(1)(D), is , , . For complete classification of this Act to the Code, see Short Title of 2004 Amendments note set out under and Tables.

act Aug. 2, 1946, ch. 753 60 Stat. 842Aug. 2, 1946act June 25, 1948, ch. 646 62 Stat. 992The Federal Tort Claims Act, referred to in subsec. (d)(2), is title IV of , , 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 , was substantially repealed and reenacted as sections 1346(b) and 2671 et seq. of Title 28, Judiciary and Judicial Procedure, by , , 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.

Codification

section 134 of title 41 41 U.S.C. 403(11)section 3101(b)(1)(A) of title 41 41 U.S.C. 252a(a)Pub. L. 111–350, § 6(c)Jan. 4, 2011124 Stat. 3854In subsec. (b)(1)(A), “” substituted for “section 4(11) of the Office of Federal Procurement Policy Act ()” and “” substituted for “section 302A(a) of the Federal Property and Administrative Services Act of 1949 ()” on authority of , , , which Act enacted Title 41, Public Contracts.

section 3305(a)(1) of title 41 41 U.S.C. 253(g)(1)(A)Pub. L. 111–350, § 6(c)Jan. 4, 2011124 Stat. 3854In subsec. (b)(1)(A)(i), “” substituted for “section 303(g)(1)(A) of the Federal Property and Administrative Services Act of 1949 ()” on authority of , , , which Act enacted Title 41, Public Contracts.

section 3101(b)(1)(B) of title 41 41 U.S.C. 252a(b)Pub. L. 111–350, § 6(c)Jan. 4, 2011124 Stat. 3854In subsec. (b)(1)(A)(ii), “” substituted for “section 302A(b) of such Act ()” on authority of , , , which Act enacted Title 41, Public Contracts.

Section 8703(a) of title 41 41 U.S.C. 57(a)Pub. L. 111–350, § 6(c)Jan. 4, 2011124 Stat. 3854In subsec. (b)(1)(B)(ii), “” substituted for “Subsections (a) and (b) of section 7 of the Anti-Kickback Act of 1986 ( and (b))” on authority of , , , which Act enacted Title 41, Public Contracts.

Section 4706 of title 41 41 U.S.C. 254d Pub. L. 111–350, § 6(c)Jan. 4, 2011124 Stat. 3854In subsec. (b)(1)(B)(iii), “” substituted for “Section 304C of the Federal Property and Administrative Services Act of 1949 ()” on authority of , , , which Act enacted Title 41, Public Contracts.

Section 3901 of title 41 41 U.S.C. 254(a)Pub. L. 111–350, § 6(c)Jan. 4, 2011124 Stat. 3854In subsec. (b)(1)(B)(v), “” substituted for “Subsection (a) of section 304 of the Federal Property and Administrative Services Act of 1949 ()” on authority of , , , which Act enacted Title 41, Public Contracts.

section 3304(a)(1) of title 41 41 U.S.C. 253(c)(1)Pub. L. 111–350, § 6(c)Jan. 4, 2011124 Stat. 3854In subsec. (b)(2)(A), “” substituted for “section 303(c)(1) of title III of the Federal Property and Administrative Services Act of 1949 ()” and “such section 3304(a)(1)” substituted for “such section 303(c)(1)” on authority of , , , which Act enacted Title 41, Public Contracts.

Pub. L. 111–350, § 6(c)Jan. 4, 2011124 Stat. 3854In subsec. (b)(2)(C), “such section 3304(a)(1)” substituted for “such section 303(c)(1)” on authority of , , , which Act enacted Title 41, Public Contracts.

section 1902 of title 41 41 U.S.C. 428 Pub. L. 111–350, § 6(c)Jan. 4, 2011124 Stat. 3854In subsec. (b)(3)(A), “subsections (a), (d), and (e) of ” substituted for “subsections (c), (d), and (f) of section 32 of the Office of Federal Procurement Policy Act ()” on authority of , , , which Act enacted Title 41, Public Contracts.

Amendments

Pub. L. 116–22 section 247d–6(e) of this title section 247d–6(h) of this title2019—Subsec. (a)(1), (5). substituted “” for “”.

Pub. L. 113–52013—Subsec. (a)(2)(A). struck out “to” before dash at end of introductory provisions, inserted “to” before “diagnose” in cls. (i) and (ii), and added cl. (iii).

Pub. L. 109–417 section 321(g)(1) of title 21 section 262(i) of this title section 321(h) of title 212006—Subsec. (a)(2). 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 ), biological product (as that term is defined by ), or device (as that term is defined by ) 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, 2004118 Stat. 842

6 U.S.C. 182(2)“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 [, (4), 184(a), (b)].”

, , , provided that:

Collaboration and Coordination

Pub. L. 109–417, title IV, § 405Dec. 19, 2006120 Stat. 2875 Pub. L. 113–5, § 402(e)(1)Mar. 13, 2013127 Stat. 195 Pub. L. 116–22, title VII, § 701(e)(1)(A)June 24, 2019133 Stat. 961 act July 1, 1944, ch. 373 Pub. L. 116–22, title VII, § 701(e)(1)(C)June 24, 2019133 Stat. 961 section 247d–7f of this title, , , as amended by , , ; , (B), , , 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 , known as the Public Health Service Act, by , (D), , , and editorially reclassified as .

Outreach

Pub. L. 108–276, § 6July 21, 2004118 Stat. 862

section 320 of Title 6 section 300hh–12 of this title section 247d–6b of this title section 247d–6b of this title“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 , 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 as , and enacting provisions set out as notes under this section and ].”

, , , provided that:

Recommendation for Export Controls on Certain Biomedical Countermeasures

Pub. L. 108–276, § 7July 21, 2004118 Stat. 863

section 320 of Title 6 section 300hh–12 of this title section 247d–6b of this title section 247d–6b of this title section 201 of this title“Upon the award of any grant, contract, or cooperative agreement under section 2 or 3 of this Act [enacting this section and , 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 as , and enacting provisions set out as notes under this section and ] 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 ]), 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.”

, , , provided that:

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, § 8July 21, 2004118 Stat. 863

“(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.”

, , , provided that: