§ 247d-7e. Biomedical Advanced Research and Development Authority
(a)
Definitions
In this section:
(2)
Fund
The term “Fund” means the Biodefense Medical Countermeasure Development Fund established under subsection (d).
(4)
Qualified countermeasure
The term “qualified countermeasure” has the meaning given such term in section
247d–6a of this title.
(5)
Qualified pandemic or epidemic product
The term “qualified pandemic or epidemic product” has the meaning given the term in section
247d–6d of this title.
(6)
Advanced research and development
(A)
In general
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—
(B)
Activities included
The term under subparagraph (A) includes—
(i)
testing of the product to determine whether the product may be approved, cleared, or licensed under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] or under section
262 of this title for a use that is or may be the basis for such product becoming a qualified countermeasure or qualified pandemic or epidemic product, or to help obtain such approval, clearance, or license;
(iii)
activities to facilitate manufacture of the product on a commercial scale with consistently high quality, as well as to improve and make available new technologies to increase manufacturing surge capacity;
(7)
Security countermeasure
The term “security countermeasure” has the meaning given such term in section
247d–6b of this title.
(8)
Research tool
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.
(b)
Strategic plan for countermeasure research, development, and procurement
(1)
In general
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, 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.
(2)
Content
The strategic plan under paragraph (1) shall guide—
(A)
research and development, conducted or supported by the Department of Health and Human Services, of qualified countermeasures and qualified pandemic or epidemic products against possible biological, chemical, radiological, and nuclear agents and to emerging infectious diseases;
(c)
Biomedical Advanced Research and Development Authority
(1)
Establishment
There is established within the Department of Health and Human Services the Biomedical Advanced Research and Development Authority.
(2)
In general
Based upon the strategic plan described in subsection (b), the Secretary shall coordinate the acceleration of countermeasure and product advanced research and development by—
(A)
facilitating collaboration between the Department of Health and Human Services and other Federal agencies, relevant industries, academia, and other persons, with respect to such advanced research and development;
(3)
Director
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.
(4)
Duties
(A)
Collaboration
To carry out the purpose described in paragraph (2)(A), the Secretary shall—
(i)
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—
(ii)
at least annually—
(I)
convene meetings with representatives from relevant industries, academia, other Federal agencies, international agencies as appropriate, and other interested persons;
(B)
Support advanced research and development
To carry out the purpose described in paragraph (2)(B), the Secretary shall—
(i)
conduct ongoing searches for, and support calls for, potential qualified countermeasures and qualified pandemic or epidemic products;
(ii)
direct and coordinate the countermeasure and product advanced research and development activities of the Department of Health and Human Services;
(C)
Facilitating advice
To carry out the purpose described in paragraph (2)(C) the Secretary shall—
(i)
connect interested persons with the offices or employees authorized by the Secretary to advise such persons regarding the regulatory requirements under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] and under section
262 of this title related to the approval, clearance, or licensure of qualified countermeasures or qualified pandemic or epidemic products; and
(ii)
with respect to persons performing countermeasure and product advanced research and development funded under this section, enable such offices or employees to provide to the extent practicable such advice in a manner that is ongoing and that is otherwise designed to facilitate expeditious development of qualified countermeasures and qualified pandemic or epidemic products that may achieve such approval, clearance, or licensure.
(D)
Supporting innovation
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—
(5)
Transaction authorities
(A)
Other transactions
(i)
In general
The Secretary shall have the authority to enter into other transactions under this subsection in the same manner as the Secretary of Defense enters into such transactions under section
2371 of title
10.
(ii)
Limitations on authority
(I)
In general
Subsections (b), (c), and (h) of section
845 of the National Defense Authorization Act for Fiscal Year 1994 (10 U.S.C. 2371 note ) shall apply to other transactions under this subparagraph as if such transactions were for prototype projects described by subsection (a) of such section
845.
(II)
Written determinations required
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 $20,000,000 only upon a written determination by the senior procurement executive for the Department (as designated for purpose of section
414
(c) of title
41), that the use of such authority is essential to promoting the success of the project. The authority of the senior procurement executive under this subclause may not be delegated.
(B)
Expedited authorities
(i)
In general
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.
(ii)
Application of provisions
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.
(iii)
Authority to limit competition
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.
(iv)
Availability of data
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.
(D)
Milestone-based payments allowed
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.
(E)
Foreign nationals eligible
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.
(F)
Establishment of research centers
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
253
(c)(3) of title
41.
(6)
At-risk individuals
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, elderly, and other at-risk individuals.
(7)
Personnel authorities
(A)
Specially qualified scientific and professional personnel
(i)
In general
In addition to any other personnel authorities, the Secretary may—
(I)
without regard to those provisions of title 5 governing appointments in the competitive service, appoint highly qualified individuals to scientific or professional positions in BARDA, such as program managers, to carry out this section; and
(II)
compensate them in the same manner and subject to the same terms and conditions in which individuals appointed under section 9903 of such title are compensated, 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.
(ii)
Manner of exercise of authority
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.
(iii)
Term of appointment
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.
(d)
Fund
(1)
Establishment
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.
(e)
Inapplicability of certain provisions
(1)
Disclosure
(A)
In general
The Secretary shall withhold from disclosure under section
552 of title
5 specific technical data or scientific information that is created or obtained during the countermeasure and product advanced research and development carried out under subsection (c) that reveals significant and not otherwise publicly known vulnerabilities of existing medical or public health defenses against biological, chemical, nuclear, or radiological threats. Such information shall be deemed to be information described in section
552
(b)(3) of title
5.
(2)
Review
Notwithstanding section 14 of the Federal Advisory Committee Act, a working group of BARDA under this section and the National Biodefense Science Board under section
247d–7f 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.