[Federal Register Volume 71, Number 24 (Monday, February 6, 2006)]
[Notices]
[Page 6081]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-1520]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0032]


Referral of ZINECARD (dexrazoxane) and RELPAX (eletriptan) 
Written Requests for the Conduct of Pediatric Studies

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
referral of ZINECARD (dexrazoxane) and RELPAX (eletriptan) Written 
Requests for the conduct of pediatric studies to the Foundation for the 
National Institutes of Health (the Foundation). FDA referred the 
ZINECARD (dexrazoxane) and RELPAX (eletriptan) Written Requests to the 
Foundation on August 29, 2005, and is publishing this notice of the 
referrals in accordance with the Best Pharmaceuticals for Children Act 
(BPCA).

FOR FURTHER INFORMATION CONTACT:  Grace Carmouze, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 21, rm. 1613, Silver Spring, MD 20993-0002, 301-
796-2200, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: In accordance with section 4 of the BPCA 
(Public Law 107-109), FDA is announcing the referral to the Foundation 
of the written requests for the conduct of pediatric studies for 
ZINECARD (dexrazoxane) and RELPAX (eletriptan). Enacted on January 4, 
2002, the BPCA reauthorizes, with certain important changes, the 
exclusivity incentive program described in section 505A of the Federal 
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355a). Section 505A 
of the act permits certain applications to obtain 6 months of 
exclusivity if, in accordance with the requirements of the statute, the 
sponsor submits requested information relating to the use of the drug 
in the pediatric population.
    The BPCA established additional mechanisms for obtaining 
information on the safe and effective use of drugs in pediatric 
patients. Specifically, section 4 of the BPCA amends section 505A(d) of 
the act to create a referral process to obtain studies for drugs that 
have patent or exclusivity protection, but for which the sponsor has 
declined to conduct the pediatric studies in response to a written 
request by FDA. Under section 4 of the BPCA, if the Secretary of Health 
and Human Services (the Secretary) determines that there is a 
continuing need for the pediatric studies described in the written 
request and the sponsors of the products with patent or exclusivity 
protection have declined to conduct the studies, the Secretary shall 
refer the drug to the Foundation, established under section 499 of the 
Public Health Service Act (42 U.S.C. 290(b)), for the conduct of the 
pediatric studies described in the written request (21 U.S.C. 
355a(d)(4)(B)(i)). In addition, the BPCA requires public notice of the 
name of the drug, name of the manufacturer, and indications to be 
studied under the referrals (21 U.S.C. 355a(d)(4)(B)(ii)).
    In accordance with section 4 of the BPCA, FDA is announcing that on 
August 29, 2005, it referred to the Foundation the written requests for 
pediatric studies for ZINECARD (dexrazoxane) and RELPAX (eletriptan). 
On July 14, 2004, FDA issued a written request for pediatric studies to 
Pfizer, Inc., the holder of approved applications for RELPAX 
(eletriptan) that have market exclusivity. The studies described in the 
written request were for the acute treatment of migraines in 
adolescents. Pfizer, Inc., declined to conduct the requested studies. 
FDA has determined that there is a continuing need for information 
relating to the use of RELPAX (eletriptan) in the pediatric population.
    On June 17, 2004, FDA issued a written request for pediatric 
studies to Pfizer, Inc., the holder of approved applications for 
ZINECARD (dexrazoxane) that have market exclusivity. The studies 
described in the written request were for cardioprotection in children 
receiving doxorubicin therapy. Pfizer, Inc., declined to conduct the 
requested studies. FDA has determined that there is a continuing need 
for information relating to the use of ZINECARD (dexrazoxane) in the 
pediatric population.

    Dated: January 27, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-1520 Filed 2-3-06; 8:45 am]
BILLING CODE 4160-01-S