§ 247d–7e. Biomedical Advanced Research and Development Authority

§ 247d–7e. Biomedical Advanced Research and Development Authority

(a) Definitions In this section:

(1) BARDA The term “BARDA” means the Biomedical Advanced Research and Development Authority.

(2) Fund The term “Fund” means the Biodefense Medical Countermeasure Development Fund established under subsection (d).

(3) Other transactions The term “other transactions” means transactions, other than procurement contracts, grants, and cooperative agreements.

(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—

(i) are conducted after basic research and preclinical development of the product; and

(ii) are related to manufacturing the product on a commercial scale and in a form that satisfies the regulatory requirements under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] or under section 262 of this title.

(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;

(ii) design and development of tests or models, including animal models, for such testing;

(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;

(iv) activities to support, maintain, and improve domestic manufacturing surge capacity and capabilities, as appropriate, including through the utilization of advanced manufacturing and platform technologies, to increase the availability of products that are or may become qualified countermeasures or qualified pandemic or epidemic products;

(v) activities to improve the shelf-life of the product or technologies for administering the product; and

(vi) such other activities as are part of the advanced stages of testing, refinement, improvement, manufacturing, or preparation of the product for such use and as are specified by the Secretary.

(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.

(9) Program manager The term “program manager” means an individual appointed to carry out functions under this section and authorized to provide project oversight and management of strategic initiatives.

(10) Person The term “person” includes an individual, partnership, corporation, association, entity, or public or private corporation, and a Federal, State, or local government agency or department.

(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, support for domestic manufacturing surge capacity and capabilities, 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;

(B) innovation in technologies that may assist advanced research and development of qualified countermeasures and qualified pandemic or epidemic products (such research and development referred to in this section as “countermeasure and product advanced research and development”);

(C) activities to support, maintain, and improve domestic manufacturing surge capacity and capabilities, as appropriate, including through the utilization of advanced manufacturing and platform technologies, to increase the availability of products that are or may become qualified countermeasures or qualified pandemic or epidemic products; and

(D) procurement of such qualified countermeasures and qualified pandemic or epidemic products by such Department.

(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;

(B) promoting countermeasure and product advanced research and development, including through the establishment and maintenance of domestic manufacturing surge capacity and capabilities, consistent with subsection (a)(6)(B)(iv);

(C) facilitating contacts between interested persons and the offices or employees authorized by the Secretary to advise such persons regarding requirements under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] and under section 262 of this title; and

(D) promoting innovation to reduce the time and cost of countermeasure and product 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, including the execution of procurement contracts, grants, and cooperative agreements pursuant to 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—

(I) facilitating such communication regarding the processes for procuring such advanced research and development with respect to qualified countermeasures and qualified pandemic or epidemic products of interest;

(II) soliciting information about and data from research on potential qualified countermeasures and qualified pandemic or epidemic products and related technologies;

(III) facilitating such communication, as appropriate, regarding manufacturing surge capacity and capabilities with respect to qualified countermeasures and qualified pandemic or epidemic products to prepare for, or respond to, a public health emergency or potential public health emergency; and

(IV) facilitating such communication, as appropriate and in a manner that does not compromise national security, with respect to potential eligibility for the material threat medical countermeasure priority review voucher program under section 565A of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360bbb–4a];

(ii) at least annually—

(I) convene meetings with representatives from relevant industries, academia, other Federal agencies, international agencies as appropriate, and other interested persons;

(II) sponsor opportunities to demonstrate the operation and effectiveness of relevant biodefense countermeasure technologies; and

(III) convene such working groups on countermeasure and product advanced research and development as the Secretary may determine are necessary to carry out this section;

(iii) communicate regularly with entities in receipt of an award pursuant to subparagraph (B)(v), and facilitate communication between such entities and other entities in receipt of an award pursuant to subparagraph (B)(iv), as appropriate, for purposes of planning and response regarding the availability of countermeasures and the maintenance of domestic manufacturing surge capacity and capabilities, including any planned uses of such capacity and capabilities in the near- and mid-term, and identification of any significant challenges related to the long-term maintenance of such capacity and capabilities; and

(iv) carry out the activities described in section 247d–7f of this title.

(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;

(iii) establish strategic initiatives to accelerate countermeasure and product advanced research and development (which may include advanced research and development for purposes of fulfilling requirements under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] or section 262 of this title) and innovation in such areas as the Secretary may identify as priority unmet need areas;

(iv) award contracts, grants, cooperative agreements, and enter into other transactions, for countermeasure and product advanced research and development; and

(v) award contracts, grants, and cooperative agreements and enter into other transactions to support, maintain, and improve domestic manufacturing surge capacity and capabilities, including through supporting flexible or advanced manufacturing, to ensure that additional capacity is available to rapidly manufacture products that are or may become qualified countermeasures or qualified pandemic or epidemic products in the event of a public health emergency declaration or significant potential for a public health emergency.

(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;

(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; and

(iii) consult with the Commissioner of Food and Drugs, pursuant to section 565(b)(2) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360bbb–4(b)(2)], to ensure that facilities performing manufacturing, pursuant to an award under subparagraph (B)(v), are in compliance with applicable requirements under such Act and this chapter, as appropriate, including current good manufacturing practice pursuant to section 501(a)(2)(B) of the Food, Drug, and Cosmetic Act [21 U.S.C. 351(a)(2)(B)]; and

(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—

(i) innovation in technologies that may assist countermeasure and product advanced research and development, including to improve manufacturing capacities and capabilities for medical countermeasures;

(ii) research on and development of research tools and other devices and technologies; and

(iii) research to promote strategic initiatives, such as rapid diagnostics, broad spectrum antimicrobials, vaccine-manufacturing technologies, dose-sparing technologies, efficacy-increasing technologies, platform technologies, technologies to administer countermeasures, and technologies to improve storage and transportation of countermeasures.

(E) Medical countermeasures innovation partner

(i) In general To support the purposes described in paragraph (2), the Secretary, acting through the Director of BARDA, may enter into an agreement (including through the use of grants, contracts, cooperative agreements, or other transactions as described in paragraph (5)) with an independent, nonprofit entity to—

(I) foster and accelerate the development and innovation of medical countermeasures and technologies that may assist advanced research and the development of qualified countermeasures and qualified pandemic or epidemic products, including through the use of strategic venture capital practices and methods;

(II) promote the development of new and promising technologies that address urgent medical countermeasure needs, as identified by the Secretary;

(III) address unmet public health needs that are directly related to medical countermeasure requirements, such as novel antimicrobials for multidrug resistant organisms and multiuse platform technologies for diagnostics, prophylaxis, vaccines, and therapeutics; and

(IV) provide expert consultation and advice to foster viable medical countermeasure innovators, including helping qualified countermeasure innovators navigate unique industry challenges with respect to developing chemical, biological, radiological, and nuclear countermeasure products.

(ii) Eligibility

(I) In general To be eligible to enter into an agreement under clause (i) an entity shall—

(aa) be an independent, nonprofit entity;

(bb) have a demonstrated record of being able to create linkages between innovators and investors and leverage such partnerships and resources for the purpose of addressing identified strategic needs of the Federal Government;

(cc) have experience in promoting novel technology innovation;

(dd) be problem-driven and solution-focused based on the needs, requirements, and problems identified by the Secretary under clause (iv);

(ee) demonstrate the ability, or the potential ability, to promote the development of medical countermeasure products;

(ff) demonstrate expertise, or the capacity to develop or acquire expertise, related to technical and regulatory considerations with respect to medical countermeasures; and

(gg) not be within the Department of Health and Human Services.

(II) Partnering experience In selecting an entity with which to enter into an agreement under clause (i), the Secretary shall place a high value on the demonstrated experience of the entity in partnering with the Federal Government to meet identified strategic needs.

(iii) Not agency An entity that enters into an agreement under clause (i) shall not be deemed to be a Federal agency for any purpose, including for any purpose under title 5.

(iv) Direction Pursuant to an agreement entered into under this subparagraph, the Secretary, acting through the Director of BARDA, shall provide direction to the entity that enters into an agreement under clause (i). As part of this agreement the Director of BARDA shall—

(I) communicate the medical countermeasure needs, requirements, and problems to be addressed by the entity under the agreement;

(II) develop a description of work to be performed by the entity under the agreement;

(III) provide technical feedback and appropriate oversight over work carried out by the entity under the agreement, including subsequent development and partnerships consistent with the needs and requirements set forth in this subparagraph;

(IV) ensure fair consideration of products developed under the agreement in order to maintain competition to the maximum practical extent, as applicable and appropriate under applicable provisions of this section; and

(V) ensure, as a condition of the agreement that the entity—

(aa) has in place a comprehensive set of policies that demonstrate a commitment to transparency and accountability;

(bb) protects against conflicts of interest through a comprehensive set of policies that address potential conflicts of interest, ethics, disclosure, and reporting requirements;

(cc) provides monthly accounting on the use of funds provided under such agreement; and

(dd) provides on a quarterly basis, reports regarding the progress made toward meeting the identified needs set forth in the agreement.

(v) Supplement not supplant Activities carried out under this subparagraph shall supplement, and not supplant, other activities carried out under this section.

(vi) No establishment of entity To prevent unnecessary duplication and target resources effectively, nothing in this subparagraph shall be construed to authorize the Secretary to establish within the Department of Health and Human Services an entity for the purposes of carrying out this subparagraph.