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Full Text of this Amendment

SA 1043. Mr. REED (for himself and Mr. Dodd) submitted an amendment intended to be proposed to amendment SA 1035 submitted by Mr. Burr and intended to be proposed to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes; which was ordered to lie on the table; as follows:

In lieu of the matter proposed to be inserted, insert the following:
( ) Addition to Priority List Considerations.--
(1) IN GENERAL.--Section 409I of the Public Health Service Act (42 U.S.C. 284m), as amended by this Act, is amended--
(A) by striking subsection (a)(2) and inserting the following:
``(2) CONSIDERATION OF AVAILABLE INFORMATION.--In developing and prioritizing the list under paragraph (1), the Secretary--
``(A) shall consider--
``(i) therapeutic gaps in pediatrics that may include developmental pharmacology, pharmacogenetic determinants of drug response, metabolism of drugs and biologics in children, and pediatric clinical trials;
``(ii) particular pediatric diseases, disorders or conditions where more complete knowledge and testing of therapeutics, including drugs and biologics, may be beneficial in pediatric populations; and
``(iii) the adequacy of necessary infrastructure to conduct pediatric pharmacological research, including research networks and trained pediatric investigators; and
``(B) may consider the availability of qualified countermeasures (as defined in section 319F-1) and qualified pandemic or epidemic products (as defined in section 319F-3) to address the needs of pediatric populations, in consultation with the Assistant Secretary for Preparedness and Response.''; and
(B) in subsection (b), by striking ``subsection (a)'' and inserting ``paragraphs (1) and (2)(A) of subsection (a)''.
(2) BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY.--Section 319L(c)(6) of the Public Health Service Act (42 U.S.C. 247d-e(c)(6)) is amended by striking ``may give priority'' and inserting ``shall give priority''.

(As printed in the Congressional Record for the Senate on May 3, 2007.)