President's Committee for People With Intellectual Disabilities; Notice of Meeting, 20344 [E7-7759]

Download as PDF 20344 Federal Register / Vol. 72, No. 78 / Tuesday April 24, 2007 / Notices Dated: April 18, 2007. Maryam Daneshvar, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E7–7732 Filed 4–23–07; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families President’s Committee for People With Intellectual Disabilities; Notice of Meeting AGENCY: President’s Committee for People with Intellectual Disabilities (PCPID), Administration for Children and Families, HHS. ACTION: Notice of quarterly meeting. Monday, May 14, 2007, from 9 a.m.–5 p.m. EST, and Tuesday, May 15, 2007, from 9 a.m.–2 p.m. EST. The meeting will be open to the public. ADDRESSES: The meeting will be held in Room 800 of the Hubert H. Humphrey Building, 200 Independence Ave., SW., Washington, DC 20201. Individuals who will need accommodations for a disability in order to attend the meeting (e.g., interpreting services, assistive listening devices, materials in alternative format such as large print or Braille) should notify Kodie Ruzicka via e-mail at kruzicka@acf.hhs.gov, or via telephone at 202–205–7989 no later than May 1, 2007. PCPID will attempt to meet requests made after that date, but cannot guarantee availability. All meeting sites are barrier free. Meeting Registration: The meeting is open to the public, but attendance is limited to the space available. Persons wishing to attend this meeting must register by contacting Kodie Ruzicka at the e-mail address or telephone number listed in the ADDRESSES section of this notice by 12 p.m. EST on May 11, 2007. For those unable to participate in person, audio of the Monday, May 14 proceedings may be accessed via telephone. Please use the above contact information for Kodie Ruzicka to obtain telephone and passcode information. Agenda: PCPID will meet to reappoint its members. They will also discuss possible content areas for the 2008 Report to the President and will divide into subcommittees for that purpose. FOR FURTHER INFORMATION CONTACT: Sally D. Atwater, Executive Director, President’s Committee for People with Intellectual Disabilities, The Aerospace Center, Suite 701, 370 L’Enfant Promenade, SW., Washington, DC jlentini on PROD1PC65 with NOTICES DATES: VerDate Aug<31>2005 18:32 Apr 23, 2007 Jkt 211001 20447. Telephone: 202–619–0634, fax: 202–205–9591. E-mail: satwater@acf.hhs.gov. SUPPLEMENTARY INFORMATION: PCPID acts in an advisory capacity to the President and the Secretary of Health and Human Services on a broad range of topics relating to programs, services and supports for persons with intellectual disabilities. PCPID, by Executive Order, is responsible for evaluating the adequacy of current practices in programs, services and supports for persons with intellectual disabilities, and for reviewing legislative proposals that impact the quality of life experienced by citizens with intellectual disabilities and their families. Dated: April 17, 2007. Sally D. Atwater, Executive Director, President’s Committee for People with Intellectual Disabilities. [FR Doc. E7–7759 Filed 4–23–07; 8:45 am] BILLING CODE 4184–01–P 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 CELEBREX (celecoxib), COLAZAL (balsalazide), ELOXATIN (oxaliplatin), EMTRIVA (emtricitabine), SUPRANE (desflurane), and TOPROL– XL (metoprolol). 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 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 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 CELEBREX (celecoxib), COLAZAL (balsalazide), ELOXATIN (oxaliplatin), EMTRIVA (emtricitabine), SUPRANE (desflurane), and TOPROL–XL (metoprolol). 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 summaries of medical and clinical pharmacology reviews of pediatric studies submitted in supplements for CELEBREX (celecoxib), COLAZAL (balsalazide), ELOXATIN (oxaliplatin), EMTRIVA (emtricitabine), SUPRANE (desflurane), and TOPROL– XL (metoprolol). See the SUPPLEMENTARY INFORMATION section for electronic access to the summaries. Copies are also available by mail (see ADDRESSES). E:\FR\FM\24APN1.SGM 24APN1

Agencies

[Federal Register Volume 72, Number 78 (Tuesday, April 24, 2007)]
[Notices]
[Page 20344]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-7759]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


President's Committee for People With Intellectual Disabilities; 
Notice of Meeting

AGENCY: President's Committee for People with Intellectual Disabilities 
(PCPID), Administration for Children and Families, HHS.

ACTION: Notice of quarterly meeting.

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DATES: Monday, May 14, 2007, from 9 a.m.-5 p.m. EST, and Tuesday, May 
15, 2007, from 9 a.m.-2 p.m. EST. The meeting will be open to the 
public.

ADDRESSES: The meeting will be held in Room 800 of the Hubert H. 
Humphrey Building, 200 Independence Ave., SW., Washington, DC 20201. 
Individuals who will need accommodations for a disability in order to 
attend the meeting (e.g., interpreting services, assistive listening 
devices, materials in alternative format such as large print or 
Braille) should notify Kodie Ruzicka via e-mail at 
kruzicka@acf.hhs.gov, or via telephone at 202-205-7989 no later than 
May 1, 2007. PCPID will attempt to meet requests made after that date, 
but cannot guarantee availability. All meeting sites are barrier free.
    Meeting Registration: The meeting is open to the public, but 
attendance is limited to the space available. Persons wishing to attend 
this meeting must register by contacting Kodie Ruzicka at the e-mail 
address or telephone number listed in the ADDRESSES section of this 
notice by 12 p.m. EST on May 11, 2007. For those unable to participate 
in person, audio of the Monday, May 14 proceedings may be accessed via 
telephone. Please use the above contact information for Kodie Ruzicka 
to obtain telephone and passcode information.
    Agenda: PCPID will meet to reappoint its members. They will also 
discuss possible content areas for the 2008 Report to the President and 
will divide into subcommittees for that purpose.

FOR FURTHER INFORMATION CONTACT: Sally D. Atwater, Executive Director, 
President's Committee for People with Intellectual Disabilities, The 
Aerospace Center, Suite 701, 370 L'Enfant Promenade, SW., Washington, 
DC 20447. Telephone: 202-619-0634, fax: 202-205-9591. E-mail: 
satwater@acf.hhs.gov.

SUPPLEMENTARY INFORMATION: PCPID acts in an advisory capacity to the 
President and the Secretary of Health and Human Services on a broad 
range of topics relating to programs, services and supports for persons 
with intellectual disabilities. PCPID, by Executive Order, is 
responsible for evaluating the adequacy of current practices in 
programs, services and supports for persons with intellectual 
disabilities, and for reviewing legislative proposals that impact the 
quality of life experienced by citizens with intellectual disabilities 
and their families.

    Dated: April 17, 2007.
Sally D. Atwater,
Executive Director, President's Committee for People with Intellectual 
Disabilities.
[FR Doc. E7-7759 Filed 4-23-07; 8:45 am]
BILLING CODE 4184-01-P