S.Amdt. 1035

1. Adds SEC. __. ADDITION TO PRIORITY LIST CONSIDERATIONS at the end of the bill

   Adds a section

   In S. 1082 · Reported to Senate

   If any provision of this Act, an amendment made this Act, or the application of such provision or amendment to any person or circumstance is held to be unconstitutional, the remainder of this Act, the amendments made by this Act, and the application of the provisions of such to any person or circumstances shall not be affected thereby. Amend the title so as to read: "To amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to reauthorize drug and device user fees and ensure the safety of medical products, and for other purposes.".

   Inserted: SEC. __. ADDITION TO PRIORITY LIST CONSIDERATIONS.

   Inserted: Section 409I of the Public Health Service Act (42 U.S.C. 284m), as amended by this Act, is further amended--

   Inserted: (1) by striking subsection (a)(2) and inserting the following:

   Inserted: "(2) Consideration of available information.--In developing and prioritizing the list under paragraph (1), the Secretary--

   Inserted: "(A) shall consider--

   Inserted: "(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;

   Inserted: "(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

   Inserted: "(iii) the adequacy of necessary infrastructure to conduct pediatric pharmacological research, including research networks and trained pediatric investigators; and

   Inserted: "(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

   Inserted: (2) in subsection (b), by striking "subsection (a)" and inserting "paragraphs (1) and (2)(A) of subsection (a)".

   Original wording

   At the end of the bill, insert the following:

Read automatically from the Congressional Record. Check the original before relying on it.

As printed