Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies; Availability, 43440 [05-14747]

Download as PDF 43440 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 The draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent FDA’s current thinking on this topic.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 Comments The draft guidance is being distributed for comment purposes only and is not intended for implementation at this time.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persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding the draft guidance.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 A copy of the draft guidance and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.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 http://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 http://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 http:// 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 E:\FR\FM\27JYN1.SGM 27JYN1

Agencies

[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]


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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 
http://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 
http://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