Document ID: FDA-2008-D-0293-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products; Availability
Posted Date: 2008-05-22T04:00Z

[Federal Register: May 22, 2008 (Volume 73, Number 100)]
[Notices]               
[Page 29760-29761]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22my08-50]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0293]

 
Draft Guidance for Industry: Considerations for Allogeneic 
Pancreatic Islet Cell Products; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the

[[Page 29761]]

availability of a draft document entitled ``Guidance for Industry: 
Considerations for Allogeneic Pancreatic Islet Cell Products'' dated 
May 2008. The draft guidance document is intended to provide 
recommendations to manufacturers, sponsors, and clinical investigators 
involved in the transplantation of allogeneic pancreatic islet cell 
products for clinical investigations of the treatment of type 1 
diabetes mellitus. The draft guidance is intended to provide assistance 
by identifying the types of data and information obtained during 
investigational new drug studies that may be helpful in establishing 
the safety, purity, and potency of a biological product in a biologics 
license application (BLA).

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by August 20, 2008.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 
Assistance (HFM-40), Center for Biologics Evaluation and Research 
(CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, 
Rockville, MD 20852-1448. Send one self-addressed adhesive label to 
assist the office in processing your requests. The draft guidance may 
also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-
1800. See the SUPPLEMENTARY INFORMATION section for electronic access 
to the draft guidance document.
    Submit written comments on the draft guidance to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Valerie A. Butler, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft document entitled 
``Guidance for Industry: Considerations for Allogeneic Pancreatic Islet 
Cell Products'' dated May 2008. The draft guidance document is intended 
to provide recommendations to manufacturers, sponsors, and clinical 
investigators involved in the transplantation of allogeneic pancreatic 
islet cell products for clinical investigations of the treatment of 
type 1 diabetes mellitus. The draft guidance is intended to provide 
assistance with the types of data and information that may be obtained 
during investigational new drug studies to assist in establishing the 
safety, purity, and potency of a biological product in a BLA. However, 
the guidance is not intended to identify all of the product, 
preclinical, and clinical data that may be needed to successfully 
support a BLA.
    The draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent FDA's current thinking on this topic. It does 
not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternative approach may be used 
if such approach satisfies the requirement of the applicable statutes 
and regulations.

II. Paperwork Reduction Act of 1995

    The draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 211 has been approved under 
0910-0139; the collections of information in 21 CFR part 312 has been 
approved under 0910-0014; the collections of information in 21 CFR 
parts 601 and 610 have been approved under 0910-0338; and the 
collections of information in 21 CFR part 1271 has been approved under 
0910-0543 and 0910-0559.

III. Comments

    The draft guidance is being distributed for comment purposes only 
and is not intended for implementation at this time. Interested persons 
may submit to the Division of Dockets Management (see ADDRESSES) 
written or electronic comments regarding the draft guidance. Submit a 
single copy of electronic comments or two paper copies of any mailed 
comments, except that individuals may submit one paper copy. Comments 
are to be identified with the docket number found in the brackets in 
the heading of this document. A copy of the draft guidance and received 
comments are available for public examination in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/cber/guidelines.htm or http://
www.regulations.gov.

    Dated: May 13, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-11516 Filed 5-21-08; 8:45 am]

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