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Full Text of this Amendment
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.)