Header:
UNITED STATES CODE SERVICE
TITLE 42. THE PUBLIC HEALTH AND WELFARE
CHAPTER 6A. THE PUBLIC HEALTH SERVICE
GENERAL POWERS AND DUTIES
FEDERAL-STATE COOPERATION
Date:
01/17/2012
Document:
§ 247d-6a. Authority for use of certain procedures regarding qualified countermeasure research and development activities
(a) In general.
(1) Authority. In conducting and supporting research and development activities regarding countermeasures under section 319F(h) [42 USCS § 247d-6(h)], 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 446 [42 USCS § 285f], if the activities concern qualified countermeasures.
(2) Definitions. In this section:
(A) Qualified countermeasure. The term "qualified countermeasure" means a drug (as that term is defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1))), biological product (as that term is defined by section 351(i) of this Act (42 U.S.C. 262(i))), or device (as that term is defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))), that the Secretary determines to be a priority (consistent with sections 302(2) and 304(a) of the Homeland Security Act of 2002 [6 USCS §§ 182(2) and 184(a)])--
(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. Each agreement for an award of a grant, contract, or cooperative agreement under section 319F(h) [42 USCS § 247d-6(h)] 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. 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 4(11) of the Office of Federal Procurement Policy Act (41 U.S.C. 403(11)) [41 USCS § 134], as applicable pursuant to section 302A(a) of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 252a(a)) [41 USCS § 3101(b)(1)(A)], shall be deemed to be $ 25,000,000 in the administration, with respect to such procurement, of--
(i) section 303(g)(1)(A) of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 253(g)(1)(A)) [41 USCS § 3305(a)(1)] and its implementing regulations; and
(ii) section 302A(b) of such Act (41 U.S.C. 252a(b)) [41 USCS § 3101(b)(1)(B)] 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, United States Code [40 USCS §§ 3701 et seq.] (relating to contract work hours and safety standards).
(ii) Subsections (a) and (b) of section 7 of the Anti-Kickback Act of 1986 (41 U.S.C. 57(a) and (b)) [41 USCS § 8703(a)].
(iii) Section 304C of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 254d) [41 USCS § 4706] (relating to the examination of contractor records).
(iv) Section 3131 of title 40 [40 USCS § 3131], United States Code (relating to bonds of contractors of public buildings or works).
(v) Subsection (a) of section 304 of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 254(a)) [41 USCS § 3901] (relating to contingent fees to middlemen).
(vi) Section 6002 of the Solid Waste Disposal Act (42 U.S.C. 6962).
(vii) Section 1354 of title 31, United States Code (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. In using the authority provided in section 303(c)(1) of title III of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 253(c)(1)) [41 USCS § 3304(a)(1)] 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 303(c)(1) [41 USCS § 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 303(c)(1) [41 USCS § 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. For a procurement described by paragraph (1), the amount specified in subsections (c), (d), and (f) of section 32 of the Office of Federal Procurement Policy Act (41 U.S.C. 428) [41 USCS § 1902] 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. Notwithstanding subsection (f), section 1491 of title 28 [28 USCS § 1491], United States Code, and section 3556 of title 31 of such Code [31 USCS § 3556], 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, United States Code [31 USCS §§ 3551 et seq.].
(B) Override of stay of contract award or performance committed to agency discretion. Notwithstanding section 1491 of title 28 [28 USCS § 1491], United States Code, and section 3553 of title 31 of such Code [31 USCS § 3553(c)(2)], the following authorizations by the head of a procuring activity are committed to agency discretion:
(i) An authorization under section 3553(c)(2) of title 31 [31 USCS § 3553(c)(2)], United States Code, 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 [31 USCS § 3553(d)(3)(C)] 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 301(a)(3), 405(b)(1)(B), 405(b)(2), 406(a)(3)(A), 492, and 494 [42 USCS §§ 241(a)(3), 284(b)(1)(B), (b)(2), 284a(a)(3)(A), 289a-1, and 289c], 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. 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, United States Code, 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, United States Code, 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, United States Code, governing appointments in the competitive service, and without regard to the provisions of chapter 51 and subchapter III of chapter 53 of such title [5 USCS §§ 5101 et seq. and 5331 et seq.] 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) does not discriminate for or against any applicant for employment on any basis described in section 2302(b)(1) of title 5, United States Code;
(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.
|