Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies; Availability, 26102 [E6-6706]

Download as PDF 26102 Federal Register / Vol. 71, No. 85 / Wednesday, May 3, 2006 / Notices 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. jlentini on PROD1PC65 with NOTICES 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 AGRYLIN (anagrelide), ARGATROBAN (argatroban), CLOLAR (clofarabine), and MERIDIA (sibutramine). These summaries are being made available consistent with 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, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6489, Silver Spring, MD 20993–0002, 301– 796–2200, e-mail: grace.carmouze@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of summaries of medical and clinical pharmacology reviews of pediatric studies conducted for AGRYLIN (anagrelide), ARGATROBAN (argatroban), CLOLAR (clofarabine), and MERIDIA (sibutramine). 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 VerDate Aug<31>2005 17:19 May 02, 2006 Jkt 208001 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 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 AGRYLIN (anagrelide), ARGATROBAN (argatroban), CLOLAR (clofarabine), and MERIDIA (sibutramine). 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: April 26, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–6706 Filed 5–2–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005D–0385] Guidance for Industry on Using Electronic Means to Distribute Certain Product Information; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry entitled ‘‘Guidance for Industry: Using Electronic Means to Distribute Certain Product Information’’ dated March 2006. The final guidance explains that persons can distribute certain product information, such as for PO 00000 Frm 00085 Fmt 4703 Sfmt 4703 recalls and product safety, by electronic means. We encourage the use of electronic communications for conveying all such important product safety information. We are making clear in this guidance that manufacturers and others may disseminate communications by electronic means, including e-mail or other electronic methods. DATES: Submit written or electronic comments on agency guidance documents at any time. ADDRESSES: Submit written requests for single copies of the guidance to the Office of Policy (HF–11), Office of the Commissioner, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one selfaddressed adhesive label to assist that office in processing your requests. Submit phone requests to 301–827– 3360. Submit written comments concerning the guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Jarilyn Dupont, Office of Policy (HF– 11), Office of the Commissioner, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 3360. SUPPLEMENTARY INFORMATION: I. Background On September 30, 2005, we published a notice of availability for a draft guidance entitled ‘‘Guidance for Industry: Using Electronic Means to Distribute Certain Product Information’’ (70 FR 57300). The draft guidance requested comments by November 29, 2005. We received comments from individuals, associations, companies that provide safety and drug notices, and the pharmaceutical industry. We have reviewed these comments and have modified the guidance in response to those comments. The timely dissemination of communications about recalls of FDAregulated products, important drug safety information, and other important product safety information is essential for the protection of the public health. We encourage manufacturers to provide such information in a timely manner to distributors, doctors, and others. Over the years, we have worked with manufacturers and distributors to promote the use of electronic methods of communication and encourage the E:\FR\FM\03MYN1.SGM 03MYN1

Agencies

[Federal Register Volume 71, Number 85 (Wednesday, May 3, 2006)]
[Notices]
[Page 26102]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-6706]



[[Page 26102]]

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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 AGRYLIN (anagrelide), 
ARGATROBAN (argatroban), CLOLAR (clofarabine), and MERIDIA 
(sibutramine). These summaries are being made available consistent with 
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, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 6489, Silver Spring, MD 20993-0002, 301-
796-2200, e-mail: grace.carmouze@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of summaries of medical and 
clinical pharmacology reviews of pediatric studies conducted for 
AGRYLIN (anagrelide), ARGATROBAN (argatroban), CLOLAR (clofarabine), 
and MERIDIA (sibutramine). 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 (the 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 AGRYLIN 
(anagrelide), ARGATROBAN (argatroban), CLOLAR (clofarabine), and 
MERIDIA (sibutramine). 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: April 26, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-6706 Filed 5-2-06; 8:45 am]
BILLING CODE 4160-01-S

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