[Federal Register Volume 68, Number 13 (Tuesday, January 21, 2003)]
[Notices]
[Pages 2789-2790]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-1250]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


List of 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 Drugs for Which Pediatric Studies Are Needed.'' The NIH 
developed the list in consultation with the Food and Drug 
Administration (FDA) and pediatric experts, as mandated by the Best 
Pharmaceuticals for Children Act (BPCA). This list prioritizes certain 
drugs most in need of study for use by children to ensure their safety 
and efficacy. The NIH will update the list annually until the Act 
expires on October 1, 2007.

DATES: The 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: The NIH is providing notice of a ``List of 
Drugs for Which Pediatric Studies Are Needed'', as authorized under 
Section 3, Pub. L. 107-109 (42 U.S.C. 409I). On January 4, 2002, 
President Bush signed into law the Best Pharmaceuticals for Children 
Act (BPCA). The BPCA mandates that not later than one year after the 
date of enactment, the NIH in

[[Page 2790]]

consultation with the FDA and experts in pediatric research shall 
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 is 
an approved application under section 505(j) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355(j)); (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; (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 initial list, 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 off-patent 
drugs was drafted and categorized as a function of indication and use. 
The drugs were than 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 is the list of drugs for which pediatric studies are most 
urgently needed:
Azithromycin
Baclofen
Bumetanide
Dobutamine
Dopamine
Furosemide
Heparin
Lithium
Lorazepam
Rifampin
Sodium Nitroprusside
Spironolactone

    Dated: January 9, 2003.
Ruth L. Kirschstein,
Deputy Director, NIH.
[FR Doc. 03-1250 Filed 1-17-03; 8:45 am]
BILLING CODE 4140-01-M