Notice of a Meeting, 69772 [05-22788]

Download as PDF 69772 Federal Register / Vol. 70, No. 221 / Thursday, November 17, 2005 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Drug and Biological Product Consolidation; Investigational New Drug Application Number Conversion AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that the Center for Drug Evaluation and Research (CDER) will assign new numbers to a group of investigational new drug applications (INDs). In 2003, FDA transferred certain product oversight responsibilities from the Center for Biologics Evaluation and Research (CBER) to CDER. The consolidation of INDs transferred from CBER with CDER INDs resulted in INDs with duplicate numbers. To resolve this issue, CDER is renumbering some INDs that were submitted to CDER before the consolidation. This Federal Register notice serves to notify sponsors in lieu of sending letters to them. Information on CDER IND renumbering is available on the Internet at http://www.fda.gov/cder/regulatory/ applications/INDrenumbering.htm. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Samuel Y. Wu, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., bldg. WO22, rm. 1121, Silver Spring, MD 20993, 301–796– 0637. SUPPLEMENTARY INFORMATION: I. Therapeutic Biological Products Transferred to CDER On October 1, 2003, FDA transferred responsibility for regulating most therapeutic biologics, with certain exceptions (e.g., cell and gene therapy products and therapeutic vaccines), from the Office of Therapeutics Research and Review, CBER, to the Office of New Drugs, CDER, and the Office of Pharmaceutical Science, CDER (68 FR 38067, June 26, 2003). Applications for the therapeutic biological products now under CDER’s review—including INDs, biologics license applications, investigational device exemptions, and new drug applications—were transferred to CDER. For more information on the transfer of therapeutic biological products from CBER to CDER, see FDA’s Web site http://www.fda.gov/cber/transfer/ transfer.htm. VerDate Aug<31>2005 17:38 Nov 16, 2005 Jkt 208001 II. Duplicate IND Numbers The consolidation of INDs transferred from CBER to CDER has resulted in duplicate IND numbers. To resolve this issue, INDs numbered below 14,000 that were submitted to CDER before the consolidation will be assigned new numbers. To determine the new number, CDER has added 80,000 to the original IND number. For example, IND 8,999 will become IND 88,999 and IND 11,192 will become 91,192. INDs that were originally submitted to CBER and transferred to CDER will retain their numbers. III. Web Site for Information on Renumbered INDs FDA has created a Web site with more detailed information about the IND number conversion scheme. The Web site address is http://www.fda.gov/cder/ regulatory/applications/ INDrenumbering.htm. Dated: November 8, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–22802 Filed 11–16–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Notice of a Meeting Pursuant to Public Law 92–463, notice is hereby given of a meeting of the Substance Abuse and Mental Health Services Administration (SAMHSA) National Advisory Council in December 2005. The SAMHSA National Advisory Council will meet in an open session December 6 from 9 a.m. to 5:30 p.m. and on December 7 from 9 a.m. to 12:30 p.m. The meeting will include a SAMHSA Administrator’s Report, presentations on SAMHSA’s response to Hurricanes Katrina and Rita, discussions concerning issues on SAMHSA’s appropriation and budget, and discussions on current administrative, legislative and program developments. In addition, the recipients of two SAMHSA-funded model programs will describe their approaches to prevent and treat substance abuse and mental health disorders. On December 7, the Race Against Drugs Motorcar will be on display in the SAMHSA parking lot. Attendance by the public at the meeting will be limited to space available. Public comments are welcome. Please communicate with the individual listed as contact below to PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 make arrangements to comment or to request special accommodations for persons with disabilities. Substantive program information, a summary of the meeting, and a roster of Council members will be available, as soon as possible after the meeting, either by accessing the SAMHSA Council Web site, www.samhsa.gov/council/council, or may be obtained by communicating with the contact whose name and telephone number is listed below. The transcript for the meeting will also be available on the SAMHSA Council Web site within three weeks after the meeting. Committee Name: SAMHSA National Advisory Council. Date/Time: Tuesday, December 6, 2005, 9 a.m. to 5:30 p.m. (Open). Wednesday, December 7, 2005, 9 a.m. to 12:30 p.m. (Open). Place: 1 Choke Cherry Road, Sugarloaf and Seneca Conference Rooms, Rockville, Maryland 20857. Contact: Toian Vaughn, Executive Secretary, SAMHSA National Advisory Council and SAMHSA Committee Management Officer, 1 Choke Cherry Road, Room 8–1089, Rockville, Maryland 20857. Telephone: (240) 276– 2307; FAX: (240) 276–2220 and E-mail: toian.vaughn@samhsa.hhs.gov. Dated: November 10, 2005. Toian Vaughn, Executive Secretary, SAMHSA National, Advisory Council and SAMHSA Committee, Management Officer. [FR Doc. 05–22788 Filed 11–16–05; 8:45 am] BILLING CODE 4162–20–P DEPARTMENT OF HOMELAND SECURITY Coast Guard [COTP Mobile–05–051] Notice, Request for Comments; Letter of Recommendation, Gulf LNG Clean Energy Marine Terminal Project, Jackson County, MS Coast Guard, DHS. Request for comments; notice of public meeting. AGENCY: ACTION: SUMMARY: In accordance with the requirements in 33 CFR 127.009, the U.S. Coast Guard Captain of the Port (COTP) Mobile, AL is preparing a letter of recommendation as to the suitability of the Pascagoula Bar, Horn Island Pass, Lower Pascagoula, and Bayou Casotte Channels for liquefied natural gas (LNG) marine traffic. The letter of recommendation is in response to a letter of intent submitted by Gulf LNG E:\FR\FM\17NON1.SGM 17NON1

Agencies

[Federal Register Volume 70, Number 221 (Thursday, November 17, 2005)]
[Notices]
[Page 69772]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-22788]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


Notice of a Meeting

    Pursuant to Public Law 92-463, notice is hereby given of a meeting 
of the Substance Abuse and Mental Health Services Administration 
(SAMHSA) National Advisory Council in December 2005.
    The SAMHSA National Advisory Council will meet in an open session 
December 6 from 9 a.m. to 5:30 p.m. and on December 7 from 9 a.m. to 
12:30 p.m. The meeting will include a SAMHSA Administrator's Report, 
presentations on SAMHSA's response to Hurricanes Katrina and Rita, 
discussions concerning issues on SAMHSA's appropriation and budget, and 
discussions on current administrative, legislative and program 
developments. In addition, the recipients of two SAMHSA-funded model 
programs will describe their approaches to prevent and treat substance 
abuse and mental health disorders. On December 7, the Race Against 
Drugs Motorcar will be on display in the SAMHSA parking lot.
    Attendance by the public at the meeting will be limited to space 
available. Public comments are welcome. Please communicate with the 
individual listed as contact below to make arrangements to comment or 
to request special accommodations for persons with disabilities.
    Substantive program information, a summary of the meeting, and a 
roster of Council members will be available, as soon as possible after 
the meeting, either by accessing the SAMHSA Council Web site, 
www.samhsa.gov/council/council, or may be obtained by communicating 
with the contact whose name and telephone number is listed below. The 
transcript for the meeting will also be available on the SAMHSA Council 
Web site within three weeks after the meeting.
    Committee Name: SAMHSA National Advisory Council.
    Date/Time: Tuesday, December 6, 2005, 9 a.m. to 5:30 p.m. (Open). 
Wednesday, December 7, 2005, 9 a.m. to 12:30 p.m. (Open).
    Place: 1 Choke Cherry Road, Sugarloaf and Seneca Conference Rooms, 
Rockville, Maryland 20857.
    Contact: Toian Vaughn, Executive Secretary, SAMHSA National 
Advisory Council and SAMHSA Committee Management Officer, 1 Choke 
Cherry Road, Room 8-1089, Rockville, Maryland 20857. Telephone: (240) 
276-2307; FAX: (240) 276-2220 and E-mail: toian.vaughn@samhsa.hhs.gov.

    Dated: November 10, 2005.
Toian Vaughn,
Executive Secretary, SAMHSA National, Advisory Council and SAMHSA 
Committee, Management Officer.
[FR Doc. 05-22788 Filed 11-16-05; 8:45 am]
BILLING CODE 4162-20-P