[Federal Register Volume 68, Number 182 (Friday, September 19, 2003)]
[Notices]
[Page 54912]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-23905]



[[Page 54912]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Pediatric Pharmaceutical Usage--Request for Comment

AGENCY: National Institutes of Health, DHHS.

ACTION: Notice.

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SUMMARY: The National Institute of Child Health and Human Development 
(NICHD) of the National Institutes of Health (NIH) is interested in 
identifying and obtaining information on prescription drug use in 
pediatric and young adult populations, neonates to age 18. This notice 
is a request for information and not a Request for Proposal (RFP) or 
solicitation.

SUPPLEMENTARY INFORMATION:

Background

    On January 4, 2002, President George W. Bush signed into law the 
Best Pharmaceuticals for Children Act (BPCA), Pub. L. 107-109. The BPCA 
mandates that the NIH, in consultation with the Food and Drug 
Administration (FDA) and experts in pediatric research, develop, 
prioritize, and publish an annual list of certain approved drugs for 
which pediatric studies are needed. For inclusion on the list, an 
approved drug must meet the following criteria: (1) There must be an 
approved application under section 505(j) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355(j)); or (2) there must be 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 must be no 
patent protection or market exclusivity protection under the Federal 
Food, Drug, and Cosmetic Act; or (4) there must be a referral for 
inclusion on the list under section 505A(d)(4)(c) of the Federal Food, 
Drug, and Cosmetic Act; and, in the case of drugs referred to in 
criteria (1), (2), or (3), additional studies must be 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.
    Recently, NIH, in consultation with the FDA and other experts in 
pharmaceutical use and pediatric research, developed a preliminary list 
of certain off-patent drugs that it 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. This initial listing was published in the Federal Register 
on January 21, 2003 (68 FR 2789).

Current Data Needs

    To further support the development of a list of drugs that need 
studies in pediatric populations, the NICHD is seeking information on 
current usage, in terms of frequency, prevalence, duration, indication 
and (possibly) toxicity, of drugs in pediatric populations. The NICHD 
will use the available databases and analyses to prioritize drugs to be 
further tested in these populations.

ADDRESSES: Any organization with data on prescriptions written and 
filled for pediatric populations is requested to contact NICHD with a 
complete statement of what is available and any associated costs for 
access to the database and analyses of the data. Specifically, 
organizations with such data, or expertise analyzing such data, should 
contact Tamar Lasky, Ph.D., NICHD, Mailstop 7510, 6100 Executive 
Boulevard, Rockville, MD 20892, 301-594-8670, 
[email protected],gov.
    Due Date: Organizations providing information on prescriptions 
written and filled for pediatric populations should contact Dr. Tamar 
Lasky on or before November 18, 2003.

    Dated: September 11, 2003.
Elias A. Zerhouni,
Director, National Institutes of Health.
[FR Doc. 03-23905 Filed 9-18-03; 8:45 am]
BILLING CODE 4140-01-P