Page:United States Statutes at Large Volume 120.djvu/2896

 PUBLIC LAW 109–417—DEC. 19, 2006

120 STAT. 2865

TITLE IV—PANDEMIC AND BIODEFENSE VACCINE AND DRUG DEVELOPMENT SEC. 401. BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY.

Title III of the Public Health Service Act (42 U.S.C. 241 et seq.) is amended by inserting after section 319K the following: ‘‘SEC. 319L. BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY.

42 USC 247d–7e.

‘‘(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, such as the Secretary of Defense may enter into under section 2371 of title 10, United States Code. ‘‘(4) QUALIFIED COUNTERMEASURE.—The term ‘qualified countermeasure’ has the meaning given such term in section 319F–1. ‘‘(5) QUALIFIED PANDEMIC OR EPIDEMIC PRODUCT.—The term ‘qualified pandemic or epidemic product’ has the meaning given the term in section 319F–3. ‘‘(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 or under section 351 of this Act. ‘‘(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 or under section 351 of this Act 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;

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