Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies; Availability, 43440 [05-14747]
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Federal Register / Vol. 70, No. 143 / Wednesday, July 27, 2005 / Notices
Industry: Nucleic Acid Testing (NAT)
for Human Immunodeficiency Virus
Type 1 (HIV–1) and Hepatitis C Virus
(HCV): Testing, Product Disposition,
and Donor Deferral and Reentry’’ dated
July 2005. There has been a dramatic
reduction during the past decade in the
transmission of HIV–1 and HCV by
human blood and blood components.
The reduction is a result of the
implementation of sensitive tests for
viral antibody, antigen (for HIV–1), and
nucleic acids, and the use of effective
virus removal and inactivation methods.
The sources of remaining risk of HIV–
1 and HCV transmission are markernegative ‘‘window period’’ donations,
donors infected with immunovariant
viral strains, persistent antibodynegative (immunosilent) carriers, and
laboratory test procedure errors.
Because donations during the window
period constitute most of the risk of
HIV–1 and HCV transmission, measures
to close the ‘‘window period’’ further
could reduce significantly the low
residual risk of HIV–1 and HCV
transmission by human blood and blood
components. Studies using
seroconversion panels indicate the
value of NAT in reducing the ‘‘window
period’’ for HIV–1 and HCV.
The draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent FDA’s current thinking on this
topic. It does not create or confer any
rights for or on any person and does not
operate to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the requirement
of the applicable statutes and
regulations.
II. Comments
The draft guidance is being
distributed for comment purposes only
and is not intended for implementation
at this time. Interested persons may
submit to the Division of Dockets
Management (see ADDRESSES) written or
electronic comments regarding the draft
guidance. Submit written or electronic
comments to ensure adequate
consideration in preparation of the final
guidance. Submit a single copy of
electronic comments or two paper
copies of any mailed comments, except
that individuals may submit one paper
copy. Comments are to be identified
with the docket number found in the
brackets in the heading of this
document. A copy of the draft guidance
and received comments are available for
public examination in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
VerDate jul<14>2003
19:40 Jul 26, 2005
Jkt 205001
III. Electronic Access
Persons with access to the Internet
may obtain the guidance at either http:/
/www.fda.gov/cber/guidelines.htm or
https://www.fda.gov/ohrms/dockets/
default.htm.
Dated: July 19, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–14746 Filed 7–26–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Summaries of Medical and Clinical
Pharmacology Reviews of Pediatric
Studies; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of summaries of medical
and clinical pharmacology reviews of
pediatric studies submitted in
supplements for ADDERALL XR (mixed
salts of a single-entity amphetamine
product), AVANDIA (rosiglitazone),
AVAPRO (irbesartan), RAPAMUNE
(sirolimus), and ZOFRAN
(ondansetron). These summaries are
being made available consistent with
section 9 of the Best Pharmaceuticals for
Children Act (BPCA). For all pediatric
supplements submitted under the
BPCA, the BPCA requires FDA to make
available to the public a summary of the
medical and clinical pharmacology
reviews of the pediatric studies
conducted for the supplement.
ADDRESSES: Submit written requests for
single copies of the summaries to the
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857. Please specify by
product name which summary or
summaries you are requesting. Send one
self-addressed adhesive label to assist
that office in processing your requests.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the
summaries.
FOR FURTHER INFORMATION CONTACT:
Grace Carmouze, Center for Drug
Evaluation and Research (HFD–960),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–594–7337, e-mail:
carmouzeg@cder.fda.gov.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
I. Background
FDA is announcing the availability of
summaries of medical and clinical
pharmacology reviews of pediatric
studies conducted for ADDERALL XR
(mixed salts of a single-entity
amphetamine product), AVANDIA
(rosiglitazone), AVAPRO (irbesartan),
RAPAMUNE (sirolimus), and ZOFRAN
(ondansetron). The summaries are being
made available consistent with section 9
of the BPCA (Public Law 107–109).
Enacted on January 4, 2002, the BPCA
reauthorizes, with certain important
changes, the pediatric exclusivity
program described in section 505A of
the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355a). Section 505A of
the act, permits certain applications to
obtain 6 months of marketing
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.
One of the provisions the BPCA
added to the pediatric exclusivity
program pertains to the dissemination of
pediatric information. Specifically, for
all pediatric supplements submitted
under the BPCA, the BPCA requires
FDA to make available to the public a
summary of the medical and clinical
pharmacology reviews of pediatric
studies conducted for the supplement
(21 U.S.C. 355a(m)(1)). The summaries
are to be made available not later than
180 days after the report on the
pediatric study is submitted to FDA (21
U.S.C. 355a(m)(1)). Consistent with this
provision of the BPCA, FDA has posted
on the Internet at https://www.fda.gov/
cder/pediatric/index.htm, summaries of
medical and clinical pharmacology
reviews of pediatric studies submitted
in supplements for ADDERALL XR
(mixed salts of a single-entity
amphetamine product), AVANDIA
(rosiglitazone), AVAPRO (irbesartan),
RAPAMUNE (sirolimus), and ZOFRAN
(ondansetron). Copies are also available
by mail (see ADDRESSES).
II. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.fda.gov/cder/pediatric/index.htm.
Dated: July 20, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–14747 Filed 7–26–05; 8:45 am]
BILLING CODE 4160–01–S
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[Federal Register Volume 70, Number 143 (Wednesday, July 27, 2005)]
[Notices]
[Page 43440]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-14747]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Summaries of Medical and Clinical Pharmacology Reviews of
Pediatric Studies; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of summaries of medical and clinical pharmacology reviews
of pediatric studies submitted in supplements for ADDERALL XR (mixed
salts of a single-entity amphetamine product), AVANDIA (rosiglitazone),
AVAPRO (irbesartan), RAPAMUNE (sirolimus), and ZOFRAN (ondansetron).
These summaries are being made available consistent with section 9 of
the Best Pharmaceuticals for Children Act (BPCA). For all pediatric
supplements submitted under the BPCA, the BPCA requires FDA to make
available to the public a summary of the medical and clinical
pharmacology reviews of the pediatric studies conducted for the
supplement.
ADDRESSES: Submit written requests for single copies of the summaries
to the Division of Drug Information (HFD-240), Center for Drug
Evaluation and Research, Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857. Please specify by product name which summary
or summaries you are requesting. Send one self-addressed adhesive label
to assist that office in processing your requests. See the
SUPPLEMENTARY INFORMATION section for electronic access to the
summaries.
FOR FURTHER INFORMATION CONTACT: Grace Carmouze, Center for Drug
Evaluation and Research (HFD-960), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-7337, e-mail:
carmouzeg@cder.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of summaries of medical and
clinical pharmacology reviews of pediatric studies conducted for
ADDERALL XR (mixed salts of a single-entity amphetamine product),
AVANDIA (rosiglitazone), AVAPRO (irbesartan), RAPAMUNE (sirolimus), and
ZOFRAN (ondansetron). The summaries are being made available consistent
with section 9 of the BPCA (Public Law 107-109). Enacted on January 4,
2002, the BPCA reauthorizes, with certain important changes, the
pediatric exclusivity program described in section 505A of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355a). Section 505A of the act,
permits certain applications to obtain 6 months of marketing
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.
One of the provisions the BPCA added to the pediatric exclusivity
program pertains to the dissemination of pediatric information.
Specifically, for all pediatric supplements submitted under the BPCA,
the BPCA requires FDA to make available to the public a summary of the
medical and clinical pharmacology reviews of pediatric studies
conducted for the supplement (21 U.S.C. 355a(m)(1)). The summaries are
to be made available not later than 180 days after the report on the
pediatric study is submitted to FDA (21 U.S.C. 355a(m)(1)). Consistent
with this provision of the BPCA, FDA has posted on the Internet at
https://www.fda.gov/cder/pediatric/index.htm, summaries of medical and
clinical pharmacology reviews of pediatric studies submitted in
supplements for ADDERALL XR (mixed salts of a single-entity amphetamine
product), AVANDIA (rosiglitazone), AVAPRO (irbesartan), RAPAMUNE
(sirolimus), and ZOFRAN (ondansetron). Copies are also available by
mail (see ADDRESSES).
II. Electronic Access
Persons with access to the Internet may obtain the document at
https://www.fda.gov/cder/pediatric/index.htm.
Dated: July 20, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-14747 Filed 7-26-05; 8:45 am]
BILLING CODE 4160-01-S
