[Federal Register Volume 73, Number 100 (Thursday, May 22, 2008)]
[Notices]
[Pages 29760-29761]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-11516]
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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Draft Guidance for Industry: Considerations for Allogeneic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 The draft guidance document is intended to provide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 The draft guidance is intended to provide assistance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draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Training, and Manufacturers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 The draft guidance may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to the draft guidance document.
Submit written comments on the draft guidance to the Division of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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