[Federal Register Volume 74, Number 179 (Thursday, September 17, 2009)]
[Notices]
[Page 47805]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-22426]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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 
availability of a document entitled ``Guidance for Industry: 
Considerations for Allogeneic Pancreatic Islet Cell Products'' dated 
September 2009. The guidance document provides 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 guidance identifies 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). The guidance announced in this 
notice finalizes the draft guidance of the same title, dated May 2008.

DATES:  Submit written or electronic comments on agency guidances at 
any time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Office of Communication, Outreach and Development (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 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 guidance document.
    Submit written comments on the 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 document entitled 
``Guidance for Industry: Considerations for Allogeneic Pancreatic Islet 
Cell Products'' dated September 2009. The guidance document provides 
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 guidance identifies 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.
    In the Federal Register of May 22, 2008 (73 FR 29760), FDA 
announced the availability of the draft guidance of the same title, 
dated May 2008. FDA received a few comments on the draft guidance and 
those comments were considered as the guidance was finalized. The 
guidance announced in this notice finalizes the draft guidance dated 
May 2008.
    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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 
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    The 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

    Interested persons may, at any time, submit to the Division of 
Dockets Management (see ADDRESSES) written or electronic comments 
regarding the 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 brackets in the heading of this document. A copy of the 
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.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or http://www.regulations.gov.

    Dated: September 11, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-22426 Filed 9-16-09; 8:45 am]
BILLING CODE 4160-01-S