Document ID: FDA-2008-D-0659-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products
Posted Date: 2009-01-16T05:00Z

[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Draft Guidance for Industry: Current Good Tissue Practice (CGTP) 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 The draft guidance document 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this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 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ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 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 The draft guidance may 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to the draft guidance document.
    Submit written comments on the draft guidance to the Division of 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