
[Federal Register: September 17, 2009 (Volume 74, Number 179)]
[Notices]
[Page 47805]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17se09-49]

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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notice finalizes the draft guidance of the same title, dated May 2008.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
