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Pediatric Pharmaceutical Usage-Request for Comment

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Information about this document as published in the Federal Register.

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National Institutes of Health, DHHS.




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.

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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.


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, bestpharmaceuticals@mail.nih,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.

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Dated: September 11, 2003.

Elias A. Zerhouni,

Director, National Institutes of Health.

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[FR Doc. 03-23905 Filed 9-18-03; 8:45 am]