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U.S. Department of Health and Human Services

Drugs

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Federal Register Notice (68FR48402) (issued 8/13/2003)

[Federal Register: August 13, 2003 (Volume 68, Number 156)]
[Notices]
[Page 48402]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13au03-105]

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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 BestPharmaceuticals@mail.nih.gov, 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