[Federal Register Volume 69, Number 149 (Wednesday, August 4, 2004)]
[Notices]
[Pages 47161-47162]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-17703]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Preliminary 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 ``Preliminary 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 identifies 23 drugs 
that will be reviewed at a scientific meeting on October 25 and 26, 
2004, in Bethesda, Maryland. At that time, the drugs will be discussed 
by the NIH, FDA, and a group of scientific experts to help identify 
those in most urgent need of study. It is anticipated that the final 
listing of drugs most in need of study for use by children to ensure 
their safety and efficacy will be selected from this preliminary 
listing and will be published in the Federal Register in January 2005. 
This will be the third annual list published by NIH. NIH will continue 
to update the list at least annually until the Act expires on October 
1, 2007.

DATES: The list is effective upon publication.

FOR FURTHER INFORMATION CONTACT: Dr. Tamar Lasky, National Institute of 
Child Health and Human Development, 6100 Executive Boulevard, Suite 
5C01G, Bethesda, MD 20892-7510, e-mail 
<[email protected]>, telephone 301-594-8670 (not a toll-
free number).

SUPPLEMENTARY INFORMATION: The NIH is providing notice of a 
``Preliminary 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 
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 pediatric populations; (2) whether 
additional information is needed; (3) whether new pediatric studies 
concerning the drug may produce health benefits in pediatric 
populations; and (4) whether reformulation of the drug is necessary. In 
developing this list, the NIH consulted with the FDA and experts in 
pediatric research and practice. A preliminary list of 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 drugs and indications that will be reviewed at a 
scientific meeting on October 25 and 26, 2004, to select drugs and 
indications to add to the list for which pediatric studies are most 
urgently needed:

Acetylcysteine--acetaminophen poisoning
Aclometasone diproprionate cream--dermatitis
Acyclovir--herpetic infections
Albendazole--Giardia infection
Amantadine--influenza
Cefuroxime--infections in children with sickle cell anemia
Cephalexin--acute, oral infections
Chlorothiazide--hypertension
Clarithromycin--oral infections in dental patients
Clonidine--autism, attention deficit disorder
Cyclosporine--heart transplant patients
Desonide ointment--dermatitis
Ethambutol--tuberculosis
Flecainide--life threatening ventricular arrhythmias
Griseofulvin--tinea capitis
Hydrochlorothiazide--hypertension
Hydrocortisone valerate ointment and cream--dermatitis
Hydroxychloroquine--lupus
Ivermectin--scabies
Malathion--lice
Methadone--opiate addicted neonates
Rimantidine--influenza
Sulfasalazine--juvenile rheumatoid arthritis

    Twelve additional drugs have been identified as having a sizeable 
number of studies published since 1990. These twelve drugs will receive 
extensive

[[Page 47162]]

systematic literature reviews and meta-analysis to assess the safety 
and efficacy questions that remain unstudied. The twelve drugs are:

Amoxicillin
Amoxicillin clavulanate potassium
Cefixime
Chloral Hydrate
Dexamethasone
Epinephrine
Fluconazole
Mebendazole
Methylprednisolone
Prednisolone
Prednisone
Trimethoprim

    The Foundation for the NIH, Inc., has referred four on-patent drugs 
to NIH. The feasibility and public health importance of studying these 
drugs will be reviewed at the scientific meeting on October 25 and 26, 
2004. The four on-patent drugs that have been referred by the 
Foundation for the NIH, Inc., for consideration for study are:

Bupropion
Morphine
Sevelamer
Zonisamide

    Individuals or organizations with comments, information, and 
current data regarding these drugs are requested to contact Dr. Tamar 
Lasky at NICHD (contact information above).

    Dated: July 28, 2004.
Elias A. Zerhouni,
Director, National Institutes of Health.
[FR Doc. 04-17703 Filed 8-3-04; 8:45 am]
BILLING CODE 4140-01-P