Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies; Availability, 344 [E6-22517]

Download as PDF 344 Federal Register / Vol. 72, No. 2 / Thursday, January 4, 2007 / Notices indicated or the offices of the Board of Governors not later than January 26, 2006. A. Federal Reserve Bank of St. Louis (Glenda Wilson, Community Affairs Officer) 411 Locust Street, St. Louis, Missouri 63166-2034: 1. Enterprise Financial Services Corp., Clayton, Missouri; to acquire 100 percent of the voting shares of Clayco Banc Corporation, DeSoto, Kansas, and thereby indirectly acquire Great American Bank, DeSoto, Kansas. Board of Governors of the Federal Reserve System, December 28, 2006. Jennifer J. Johnson, Secretary of the Board. [FR Doc. E6–22532 Filed 1–3–07; 8:45 am] BILLING CODE 6210–01–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. mstockstill on PROD1PC61 with NOTICES 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 AZOPT (brinzolamide), BETAXON (levobetaxolol), and GLEEVEC (imatinib). These summaries are being made available consistent with the Best Pharmaceuticals for Children Act (the 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. Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6460, Silver Spring, MD 20993–0002, 301– 796–0700, e-mail: grace.carmouze@fda.hhs.gov. National Vaccine Injury Compensation Program; List of Petitions Received I. Background AGENCY: FDA is announcing the availability of summaries of medical and clinical pharmacology reviews of pediatric studies conducted for AZOPT (brinzolamide), BETAXON (levobetaxolol), and GLEEVEC (imatinib). 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 AZOPT (brinzolamide), BETAXON (levobetaxolol), and GLEEVEC (imatinib). 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. FOR FURTHER INFORMATION CONTACT: Grace Carmouze, Center for Drug BILLING CODE 4160–01–S 15:51 Jan 03, 2007 Jkt 211001 Health Resources and Services Administration SUPPLEMENTARY INFORMATION: Dated: December 22, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–22517 Filed 1–3–07; 8:45 am] VerDate Aug<31>2005 DEPARTMENT OF HEALTH AND HUMAN SERVICES PO 00000 Frm 00019 Fmt 4703 Sfmt 4703 Health Resources and Services Administration, HHS. ACTION: Notice. SUMMARY: The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (‘‘the Program’’), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions. FOR FURTHER INFORMATION CONTACT: For information about requirements for filing petitions, and the Program in general, contact the Clerk, United States Court of Federal Claims, 717 Madison Place, NW., Washington, DC 20005, (202) 357–6400. For information on HRSA’s role in the Program, contact the Director, National Vaccine Injury Compensation Program, 5600 Fishers Lane, Room 11C–26, Rockville, MD 20857; (301) 443–6593. SUPPLEMENTARY INFORMATION: The Program provides a system of no-fault compensation for certain individuals who have been injured by specified childhood vaccines. Subtitle 2 of Title XXI of the PHS Act, 42 U.S.C. 300aa– 10 et seq., provides that those seeking compensation are to file a petition with the U.S. Court of Federal Claims and to serve a copy of the petition on the Secretary of Health and Human Services, who is named as the respondent in each proceeding. The Secretary has delegated his responsibility under the Program to HRSA. The Court is directed by statute to appoint special masters who take evidence, conduct hearings as appropriate, and make initial decisions as to eligibility for, and amount of, compensation. A petition may be filed with respect to injuries, disabilities, illnesses, conditions, and deaths resulting from vaccines described in the Vaccine Injury Table (the Table) set forth at Section 2114 of the PHS Act or as set forth at 42 CFR 100.3, as applicable. This Table E:\FR\FM\04JAN1.SGM 04JAN1

Agencies

[Federal Register Volume 72, Number 2 (Thursday, January 4, 2007)]
[Notices]
[Page 344]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-22517]


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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 AZOPT (brinzolamide), 
BETAXON (levobetaxolol), and GLEEVEC (imatinib). These summaries are 
being made available consistent with the Best Pharmaceuticals for 
Children Act (the 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. 6460, Silver Spring, MD 20993-0002, 301-
796-0700, 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 AZOPT 
(brinzolamide), BETAXON (levobetaxolol), and GLEEVEC (imatinib). 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 AZOPT (brinzolamide), BETAXON (levobetaxolol), and 
GLEEVEC (imatinib). 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: December 22, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-22517 Filed 1-3-07; 8:45 am]
BILLING CODE 4160-01-S

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