Referral of ZINECARD (dexrazoxane) and RELPAX (eletriptan) Written Requests for the Conduct of Pediatric Studies, 6081 [E6-1520]
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6081
Federal Register / Vol. 71, No. 24 / Monday, February 6, 2006 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
respondents
Type of survey
Internet survey
Annual frequency
per response
3,240
Total annual
responses
1
Hours per
response
3,240
Total hours
.25
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
prior experience with Internet panel
experiments similar to the study
proposed in this document.
Dated: January 30, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–1522 Filed 2–3–06; 8:45 am]
BILLING CODE 4160–01–S
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.
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).
SUMMARY:
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:
carmouzeg@cder.fda.gov.
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,
SUPPLEMENTARY INFORMATION:
rmajette on PROD1PC67 with NOTICES1
810
VerDate Aug<31>2005
16:32 Feb 03, 2006
Jkt 205001
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
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
In compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
Substance Abuse and Mental Health
Services Administration (SAMHSA)
will publish periodic summaries of
proposed projects. To request more
information on the proposed projects or
to obtain a copy of the information
collection plans, call the SAMHSA
Reports Clearance Officer on (240) 276–
1243.
Comments are invited on: (a) Whether
the proposed collections of information
are necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) ways to enhance the
E:\FR\FM\06FEN1.SGM
06FEN1
]]>Agencies
[Federal Register Volume 71, Number 24 (Monday, February 6, 2006)]
[Notices]
[Page 6081]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-1520]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: carmouzeg@cder.fda.gov.
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
