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Federal Register / Vol. 71, No.

24 / Monday, February 6, 2006 / Notices 6081

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1


No. of Annual frequency Total annual Hours per
Type of survey Total hours
respondents per response responses response

Internet survey 3,240 1 3,240 .25 810

Total 810
1There are no capital costs or operating and maintenance costs associated with this collection of information.

FDA’s burden estimate is based on the BPCA reauthorizes, with certain is a continuing need for information
prior experience with Internet panel important changes, the exclusivity relating to the use of RELPAX
experiments similar to the study incentive program described in section (eletriptan) in the pediatric population.
proposed in this document. 505A of the Federal Food, Drug, and On June 17, 2004, FDA issued a
Dated: January 30, 2006. Cosmetic Act (the act) (21 U.S.C. 355a). written request for pediatric studies to
Section 505A of the act permits certain Pfizer, Inc., the holder of approved
Jeffrey Shuren,
applications to obtain 6 months of applications for ZINECARD
Assistant Commissioner for Policy.
exclusivity if, in accordance with the (dexrazoxane) that have market
[FR Doc. E6–1522 Filed 2–3–06; 8:45 am] requirements of the statute, the sponsor exclusivity. The studies described in the
BILLING CODE 4160–01–S submits requested information relating written request were for
to the use of the drug in the pediatric cardioprotection in children receiving
population. doxorubicin therapy. Pfizer, Inc.,
DEPARTMENT OF HEALTH AND The BPCA established additional declined to conduct the requested
HUMAN SERVICES mechanisms for obtaining information studies. FDA has determined that there
on the safe and effective use of drugs in is a continuing need for information
Food and Drug Administration
pediatric patients. Specifically, section relating to the use of ZINECARD
[Docket No. 2006N–0032] 4 of the BPCA amends section 505A(d) (dexrazoxane) in the pediatric
of the act to create a referral process to population.
Referral of ZINECARD (dexrazoxane) obtain studies for drugs that have patent
and RELPAX (eletriptan) Written Dated: January 27, 2006.
or exclusivity protection, but for which
Requests for the Conduct of Pediatric Jeffrey Shuren,
the sponsor has declined to conduct the
Studies pediatric studies in response to a Assistant Commissioner for Policy.
written request by FDA. Under section [FR Doc. E6–1520 Filed 2–3–06; 8:45 am]
AGENCY: Food and Drug Administration,
HHS. 4 of the BPCA, if the Secretary of Health BILLING CODE 4160–01–S
and Human Services (the Secretary)
ACTION: Notice.
determines that there is a continuing
need for the pediatric studies described DEPARTMENT OF HEALTH AND
SUMMARY: The Food and Drug
in the written request and the sponsors HUMAN SERVICES
Administration (FDA) is announcing the
referral of ZINECARD (dexrazoxane) of the products with patent or
Substance Abuse and Mental Health
and RELPAX (eletriptan) Written exclusivity protection have declined to
Services Administration
Requests for the conduct of pediatric conduct the studies, the Secretary shall
studies to the Foundation for the refer the drug to the Foundation, Agency Information Collection
National Institutes of Health (the established under section 499 of the Activities: Proposed Collection;
Foundation). FDA referred the Public Health Service Act (42 U.S.C. Comment Request
ZINECARD (dexrazoxane) and RELPAX 290(b)), for the conduct of the pediatric
(eletriptan) Written Requests to the studies described in the written request In compliance with Section
Foundation on August 29, 2005, and is (21 U.S.C. 355a(d)(4)(B)(i)). In addition, 3506(c)(2)(A) of the Paperwork
publishing this notice of the referrals in the BPCA requires public notice of the Reduction Act of 1995 concerning
accordance with the Best name of the drug, name of the opportunity for public comment on
Pharmaceuticals for Children Act manufacturer, and indications to be proposed collections of information, the
(BPCA). studied under the referrals (21 U.S.C. Substance Abuse and Mental Health
355a(d)(4)(B)(ii)). Services Administration (SAMHSA)
FOR FURTHER INFORMATION CONTACT: In accordance with section 4 of the will publish periodic summaries of
Grace Carmouze, Center for Drug BPCA, FDA is announcing that on proposed projects. To request more
Evaluation and Research, Food and August 29, 2005, it referred to the information on the proposed projects or
Drug Administration, 10903 New Foundation the written requests for to obtain a copy of the information
Hampshire Ave., Bldg. 21, rm. 1613, pediatric studies for ZINECARD collection plans, call the SAMHSA
Silver Spring, MD 20993–0002, 301– (dexrazoxane) and RELPAX (eletriptan). Reports Clearance Officer on (240) 276–
796–2200, e-mail: On July 14, 2004, FDA issued a written 1243.
carmouzeg@cder.fda.gov. request for pediatric studies to Pfizer, Comments are invited on: (a) Whether
SUPPLEMENTARY INFORMATION: In Inc., the holder of approved the proposed collections of information
accordance with section 4 of the BPCA applications for RELPAX (eletriptan) are necessary for the proper
rmajette on PROD1PC67 with NOTICES1

(Public Law 107–109), FDA is that have market exclusivity. The performance of the functions of the
announcing the referral to the studies described in the written request agency, including whether the
Foundation of the written requests for were for the acute treatment of information shall have practical utility;
the conduct of pediatric studies for migraines in adolescents. Pfizer, Inc., (b) the accuracy of the agency’s estimate
ZINECARD (dexrazoxane) and RELPAX declined to conduct the requested of the burden of the proposed collection
(eletriptan). Enacted on January 4, 2002, studies. FDA has determined that there of information; (c) ways to enhance the

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