Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies; Availability, 12182-12183 [E8-4426]

Download as PDF 12182 Federal Register / Vol. 73, No. 45 / Thursday, March 6, 2008 / Notices academic (but not government or industry) speakers, and other expenses. The fee for the 2-day meeting for registrants from industry is $350, and the fee for academic or government registrants is $175. Fees will be waived for invited speakers and moderators. The registration process will be handled by AASLD, which has extensive experience in planning, executing, and organizing educational meetings. Register online at https:// www.aasld.org. Although the NLC facility is spacious, registration will be on a first-come, first-served basis. If you would like to make an oral presentation during the open hour of the conference on March 27, 2008, you must register with Lana Pauls (see FOR FURTHER INFORMATION CONTACT) by close of business on March 14, 2008. To make a presentation, you will be asked to provide your name, title, business affiliation (if applicable), address, and type of organization you represent (e.g., industry, consumer organization). Persons registered to make an oral presentation should check in before the conference. If you need special accommodations because of a disability, please contact Lana Pauls at least 7 days before the conference. E. Conference Transcripts We will prepare a transcript of the conference presentations and discussions and will post it online along with copies of slides shown. The transcript will be available for review on the Internet at https://www.fda.gov/cder/ livertox approximately 30 days after the conference. mstockstill on PROD1PC66 with NOTICES III. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding the draft guidance and the issues and questions presented in this document or at the conference. 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 brackets in the heading of this document. Received comments may be seen in the Division Jkt 214001 IV. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/cder/guidance/ index.htm or https://www.fda.gov/ ohrms/dockets/default.htm. SUPPLEMENTARY INFORMATION: Dated: February 29, 2008. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E8–4361 Filed 3–5–08; 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: ACTION: Background information on the conference, registration information, the agenda, information about lodging, and other relevant information will be posted, as it becomes available, on the Internet at https://www.fda.gov/cder/ livertox and https://www.aasld.org. 16:57 Mar 05, 2008 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. Food and Drug Administration, HHS. D. Where Can I Find Out More About This Public Conference? VerDate Aug<31>2005 of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Please note that on January 15, 2008, the FDA Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic submissions will be accepted by FDA through FDMS only. 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 BETOPTIC (betaxolol), LAMICTAL (lamotrigine), LEVAQUIN (levofloxacin), RISPERDAL (risperidone), and TIMOLOL (timolol). 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. PO 00000 Frm 00113 Fmt 4703 Sfmt 4703 I. Background FDA is announcing the availability of summaries of medical and clinical pharmacology reviews of pediatric studies conducted for BETOPTIC (betaxolol), LAMICTAL (lamotrigine), LEVAQUIN (levofloxacin), RISPERDAL (risperidone), and TIMOLOL (timolol). 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 BETOPTIC (betaxolol), LAMICTAL (lamotrigine), LEVAQUIN (levofloxacin), RISPERDAL (risperidone), and TIMOLOL (timolol). 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. E:\FR\FM\06MRN1.SGM 06MRN1 Federal Register / Vol. 73, No. 45 / Thursday, March 6, 2008 / Notices Technology; 93.389, Research Infrastructure, 93.306, 93.333, National Institutes of Health, HHS) Dated: February 28, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 08–963 Filed 3–5–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4140–01–M Dated: February 29, 2008. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E8–4426 Filed 3–5–08; 8:45 am] Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. National Institutes of Health National Center for Research Resources; Notice of Closed Meetings mstockstill on PROD1PC66 with NOTICES Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Center for Research Resources Special Emphasis Panel; Comparative Medicine SEP–1 (08). Date: March 27, 2008. Time: 2 p.m. to 4 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 1 Democracy Plaza, 6701 Democracy Blvd., Room 1078, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Steven Birken, PhD, Scientific Review Officer, National Center for Research Resources, or National Institutes of Health, 6701 Democracy Boulevard, One Democracy Plaza, Room 1078, MSC 4874, Bethesda, MD 20892–4874, 301–435–0815, birkens@mail.nih.gov. Name of Committee: National Center for Research Resources Special Emphasis Panel; 2008 NCRR Loan Repayment Review. Date: April 24, 2008. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, One Democracy Plaza, 6701 Democracy Boulevard, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Bonnie Dunn, PhD, Scientific Review Officer, Office of Review, National Center for Research Resources, National Institutes of Health, 6701 Democracy Blvd., 1 Dem. Blvd., Rm. 1074, Bethesda, MD 20892–4874, (301) 435–0824, dunnbo@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research; 93.371, Biomedical VerDate Aug<31>2005 16:57 Mar 05, 2008 Jkt 214001 12183 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Child Health and Human Development; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Child Health and Human Development Special Emphasis Panel, Time Perception and Timed Performance in Autism. Date: March 11, 2008. Time: 3:15 p.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place National Institutes of Health, 6100 Executive Boulevard, 5B01, Rockville, MD 20852 (Telephone Conference Call). Contact Person: Carla T. Walls, PhD., Scientific Review Administrator, Division of Scientific Review, National Institute of Child Health, and Human Development, NIH, 6100 Executive Blvd., Room 5B01, Bethesda, MD 20892, (301) 435–6898, wallsc@mail.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.964, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93,209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS) Dated: February 28, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 08–957 Filed 3–5–08; 8:45 am] BILLING CODE 4140–01–M PO 00000 Frm 00114 Fmt 4703 Sfmt 4703 National Institutes of Health National Institute of Child Health and Human Development; Notice of Closed Meeting Name of Committee: National Institute of Child Health and Human Development Special Emphasis Panel; Innovation Therapies and Clinical Studies For Screenable Disorders. Date: March 28, 2008. Time: 12 p.m. to 1:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6100 Executive Boulevard, 5B01, Rockville, MD 20852 (Telephone Conference Call). Contact Person: Norman Chang, PhD., Scientific Review Administrator, Division of Scientific Review, National Institute of Child Health and Human Development, NIH, 6100 Executive Blvd., Room 5B01, Bethesda, MD 20892, (301) 496–1485, changn@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS) Dated: February 28, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 08–958 Filed 3–5–08; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Child Health and Human Development; Notice of Meetings Pursuant to section 10(a) of the Federal Advisory Committee Act, as E:\FR\FM\06MRN1.SGM 06MRN1

Agencies

[Federal Register Volume 73, Number 45 (Thursday, March 6, 2008)]
[Notices]
[Pages 12182-12183]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-4426]


-----------------------------------------------------------------------

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 BETOPTIC (betaxolol), 
LAMICTAL (lamotrigine), LEVAQUIN (levofloxacin), RISPERDAL 
(risperidone), and TIMOLOL (timolol). 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 
BETOPTIC (betaxolol), LAMICTAL (lamotrigine), LEVAQUIN (levofloxacin), 
RISPERDAL (risperidone), and TIMOLOL (timolol). 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 BETOPTIC (betaxolol), LAMICTAL (lamotrigine), LEVAQUIN 
(levofloxacin), RISPERDAL (risperidone), and TIMOLOL (timolol). 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.


[[Page 12183]]


    Dated: February 29, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-4426 Filed 3-5-08; 8:45 am]
BILLING CODE 4160-01-S

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.