Drug and Biological Product Consolidation; Investigational New Drug Application Number Conversion, 69772 [05-22802]

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 https://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 https://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 https://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

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[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: 05-22802]



[[Page 69772]]

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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.

ADDRESSES: Information on CDER IND renumbering is available on the 
Internet at https://www.fda.gov/cder/regulatory/applications/
INDrenumbering.htm.

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 
https://www.fda.gov/cber/transfer/transfer.htm.

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 https://
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

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