Disease, Disability, and Injury Prevention and Control, 17967 [E9-8947]

Download as PDF rmajette on PRODPC74 with NOTICES Federal Register / Vol. 74, No. 74 / Monday, April 20, 2009 / Notices Agenda: To discuss the annual strategic plan updating process and services and supports activities. Place: In Person: National Institutes of Health, William H. Natcher Conference Center, 45 Center Drive/Building 45, Conference Rooms E1/E2, Bethesda Campus, Bethesda, MD 20892. Videocast: https://videocast.nih.gov. Contact Person: Ms. Lina Perez, Office of Autism Research Coordination, Office of the Director, National Institute of Mental Health, NIH, 6001 Executive Boulevard, Bethesda, MD 20892–9669, (301) 443–6040. IACCpublicinquiries@mail.nih.gov. Any member of the public interested in presenting oral comments to the Committee should notify the Contact Person listed on this notice at least 10 days in advance of the meeting. Interested individuals and representatives of organizations should submit a letter of intent, a brief description of the organization represented, and a written/electronic copy of the oral presentation in advance of the meeting. Only one representative of an organization will be allowed to present oral comments and presentations will be limited to a maximum of five minutes. Both printed and electronic copies are requested following the presentation for the public record. In addition, any interested person may submit written comments to the Committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. NIH has instituted stringent security procedures for entrance onto the NIH campus. All visitors must enter through the NIH Gateway Center. This center combines visitor parking, non-commercial vehicle inspection and visitor ID processing, all in one location. The NIH will process all visitors in vehicles or as pedestrians. You will be asked to submit to a vehicle or personal inspection and will be asked to state the purpose of your visit. Visitors over 15 years of age must provide a form of government-issued ID such as a driver’s license or passport. All visitors should be prepared to have their personal belongings inspected and to go through metal detection inspection. When driving to NIH, plan some extra time to get through the security checkpoints. Be aware that visitor parking lots on the NIH campus can fill up quickly. The NIH campus is also accessible via the metro Red Line, Medical Center Station. The Natcher Conference Center is a 5-minute walk from the Medical Center Metro Station. Additional NIH campus visitor information is available at: https://www.nih.gov/about/ visitor/index.htm. Information about the IACC and a registration link for this meeting are available on the Web site: https:// www.iacc.hhs.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.242, Mental Health Research Grants; 93.281, Scientist Development Award, Scientist Development Award for Clinicians, and Research Scientist Award; VerDate Nov<24>2008 15:02 Apr 17, 2009 Jkt 217001 93.282, Mental Health National Research Service Awards for Research Training, National Institutes of Health, HHS) Dated: April 13, 2009. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–9033 Filed 4–17–09; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel: Pilot Lifestyle Interventions for Pregestational Diabetes or Gestational Diabetes, Potential Extramural Project, PEP 2009– R–02 Correction: This notice was published in the Federal Register on March 25, 2009, Volume 74, Number 56, page 12873. The original notice was published with an incorrect Potential Extramural Project number. Contact Person for More Information: Linda Shelton, Public Health Analyst, Coordinating Center for Health and Information Service, Office of the Director, CDC, 1600 Clifton Road NE., Mailstop E21, Atlanta, GA 30333. Telephone (404) 498–1194. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: April 9, 2009. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E9–8947 Filed 4–17–09; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–N–0143] Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 17967 SUMMARY: The Food and Drug Administration (FDA) is announcing a public meeting to obtain input on developing Risk Evaluation and Mitigation Strategies (REMS) for certain opioid drugs. The REMS would be intended to ensure that the benefits of these drugs continue to outweigh certain risks. The agency has long been concerned about adverse events associated with this class of drug and has taken steps in cooperation with drug manufacturers to address these risks. We intend to use the agency’s REMS authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to mitigate the risks of these drugs. The purpose of the public meeting is to receive information and comments on this topic. DATES: The public meeting will be held on May 27 and 28, 2009, from 8 a.m. to 5 p.m. Register to attend the meeting by May 15, 2009. See section III of this document for information on how to register or make an oral presentation at the meeting. Written or electronic comments will be accepted until June 30, 2009. ADDRESSES: The public meeting will be held at the Hilton Washington, DC North/Gaithersburg Hotel, 620 Perry Pkwy., Gaithersburg, MD 20877. Submit written comments 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.regulations.gov. All comments should be identified with the docket number found in brackets in the heading of this document. Transcripts of the meeting will be available for review at the Division of Dockets Management and on the Internet at https:// www.regulations.gov approximately 30 days after the meeting. FOR FURTHER INFORMATION CONTACT: Theresa (Terry) Martin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6184, Silver Spring, MD 20993–0002, 301– 796–3448, FAX: 301–847–8752, or Anne Henig, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg 51, rm. 6176, Silver Spring, MD 20993–0002, 301–796–3442, FAX: 301–847–8753, email: OpioidREMS@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background FDAAA (Public Law 110–85) created section 505–1 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355–1). Under section 505–1 of the act, E:\FR\FM\20APN1.SGM 20APN1

Agencies

[Federal Register Volume 74, Number 74 (Monday, April 20, 2009)]
[Notices]
[Page 17967]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-8947]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Disease, Disability, and Injury Prevention and Control

    Special Emphasis Panel: Pilot Lifestyle Interventions for 
Pregestational Diabetes or Gestational Diabetes, Potential Extramural 
Project, PEP 2009-R-02
    Correction: This notice was published in the Federal Register on 
March 25, 2009, Volume 74, Number 56, page 12873. The original notice 
was published with an incorrect Potential Extramural Project number.
    Contact Person for More Information: Linda Shelton, Public Health 
Analyst, Coordinating Center for Health and Information Service, Office 
of the Director, CDC, 1600 Clifton Road NE., Mailstop E21, Atlanta, GA 
30333. Telephone (404) 498-1194.
    The Director, Management Analysis and Services Office, has been 
delegated the authority to sign Federal Register notices pertaining to 
announcements of meetings and other committee management activities, 
for both CDC and the Agency for Toxic Substances and Disease Registry.

    Dated: April 9, 2009.
Elaine L. Baker,
Director, Management Analysis and Services Office, Centers for Disease 
Control and Prevention.
[FR Doc. E9-8947 Filed 4-17-09; 8:45 am]
BILLING CODE 4163-18-P

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