[Federal Register: January 16, 2009 (Volume 74, Number 11)]
[Notices]
[Page 3055-3056]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16ja09-101]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0659]
Draft Guidance for Industry: Current Good Tissue Practice (CGTP)
and Additional Requirements for Manufacturers of Human Cells, Tissues,
and Cellular and Tissue-Based Products (HCT[sol]Ps); 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 draft document entitled ``Guidance for Industry:
Current Good Tissue Practice (CGTP) and Additional Requirements for
Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based
Products (HCT[sol]Ps)'' dated January 2009. The draft guidance document
provides establishments that manufacture HCT[sol]Ps with
recommendations for complying with CGTP requirements.
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this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance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 April 16, 2009.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Training, and Manufacturers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 The draft guidance may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to the draft guidance document.
Submit written comments on the draft guidance to the Division of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: Brenda R. Friend, 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: Current Good Tissue Practice (CGTP) and
Additional Requirements for Manufacturers of Human Cells, Tissues, and
Cellular and Tissue-Based Products (HCT[sol]Ps)'' dated January 2009.
This guidance provides establishments that manufacture HCT[sol]Ps with
recommendations for complying with CGTP requirements under part 1271
(21 CFR Part 1271), subpart D (Current Good Tissue Practice), and
requirements under part 1271, subpart E (Additional Requirements for
Establishments Described in Sec. 1271.10). This guidance also
addresses whether the establishment registration and HCT[sol]P listing
requirements under part 1271, subparts A and B apply in certain
instances.
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
This 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 part 1271, subparts D and E, and
Sec. Sec. 1271.10 and 1271.21 have been approved under OMB Control No.
0910-0543.
[[Page 3056]]
III. Commentsuidance 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: January 13, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-919 Filed 1-15-09; 8:45 am]
BILLING CODE 4160-01-S