[Federal Register Volume 68, Number 156 (Wednesday, August 13, 2003)]
[Notices]
[Page 48402]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-20558]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


List of Additional Drugs for Which Pediatric Studies Are Needed

ACTION: Notice.

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SUMMARY: The National Institutes of Health (NIH) is providing notice of 
a ``List of Additional Drugs for Which Pediatric Studies Are Needed.'' 
This listing extends the initial list published in the Federal Register 
on January 21, 2003 (Volume 68, Number 13, pages 2789-2790). The NIH 
has developed the list in consultation with the Food and Drug 
Administration (FDA) and pediatric experts, as mandated by section 409I 
of the Best Pharmaceuticals for Children Act (BPCA), Public Law 107-
109. This list prioritizes additional drugs most in need of study for 
use by children to ensure their safety and efficacy. It will be updated 
regularly until the Act expires on October 1, 2007.

DATES: This list is effective upon publication.

FOR FURTHER INFORMATION CONTACT: Dr. Donald Mattison, National 
Institute of Child Health and Human Development, 6100 Executive 
Boulevard, Room 4B-100, Rockville, MD, 20892, e-mail 
[email protected], telephone 301-496-5097 (not a toll-
free number).

SUPPLEMENTARY INFORMATION:

Background

    The NIH is providing notice of a ``List of Additional Drugs for 
Which Pediatric Studies Are Needed.'' On January 4, 2002, President 
Bush signed into law the Best Pharmaceuticals for Children Act (BPCA). 
The BPCA mandates that the NIH in consultation with the FDA and experts 
in pediatric research shall develop, prioritize, and publish on at 
least an annual basis a list of approved drugs for which pediatric 
studies are needed. For inclusion on the list, an approved drug must 
meet the following criteria: (1) There is an approved application under 
section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(j)); or (2) there is a submitted application that could be approved 
under the criteria of section 505(j) of the Federal Food, Drug, and 
Cosmetic Act; or (3) there is no patent protection or market 
exclusivity protection under the Federal Food, Drug, and Cosmetic Act; 
or (4) there is a referral for inclusion on the list under section 
505A(d)(4)(c); and additional studies are needed to assess the safety 
and effectiveness of the use of the drug in the pediatric population. 
The BPCA further stipulates that in developing and prioritizing the 
list, the NIH shall consider, for each drug on the list: (1) The 
availability of information concerning the safe and effective use of 
the drug in the pediatric population; (2) whether additional 
information is needed; (3) whether new pediatric studies concerning the 
drug may produce health benefits in the pediatric population; and (4) 
whether reformulation of the drug is necessary.
    In developing this addition to the initial list published on 
January 21, 2003, the NIH consulted with the FDA, the American Academy 
of Pediatrics, the United States Pharmacopoeia and other experts in 
pediatric research. A preliminary list of certain off-patent drugs was 
drafted and categorized as a function of indication and use. The drugs 
were then prioritized based on frequency of use in the pediatric 
population, severity of the condition being treated, and potential for 
providing a health benefit in the pediatric population.
    Following are the additional drugs for which pediatric studies are 
most urgently needed:

Ampicillin/sulbactam.
Diazoxide.
Isoflurane.
Lindane.
Meropenem.
Metoclopramide.
Piperacillin/tazobactam.
Promethazine.

    Dated: August 4, 2003.
Elias A. Zerhouni,
Director, National Institutes of Health.
[FR Doc. 03-20558 Filed 8-12-03; 8:45 am]
BILLING CODE 4140-01-P