[Federal Register Volume 70, Number 221 (Thursday, November 17, 2005)]
[Notices]
[Page 69772]
From the Federal Register Online via the Government Publishing 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.

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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 http://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 
http://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 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