[Federal Register Volume 76, Number 251 (Friday, December 30, 2011)]
[Notices]
[Pages 82308-82309]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-33572]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0659]
Guidance for Industry: Current Good Tissue Practice and
Additional Requirements for Manufacturers of Human Cells, Tissues, and
Cellular and Tissue-Based 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: Current
Good Tissue Practice (CGTP) and Additional Requirements for
Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based
Products (HCT/Ps)'' dated December 2011. The guidance document provides
recommendations to establishments for complying with CGTP and
additional requirements for manufacturers of HCT/Ps. The guidance is
intended for any HCT/P establishment that performs a manufacturing step
and is responsible for complying with CGTP requirements. The guidance
also addresses whether the establishment registration and HCT/P listing
requirements apply in certain instances. The guidance announced in this
notice finalizes the draft guidance of the same title dated January
2009.
DATES: Submit either electronic or written 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 that 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 electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Lori Jo Churchyard, 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: Current Good Tissue Practice (CGTP) and
Additional Requirements for Manufacturers of Human Cells, Tissues, and
Cellular and Tissue-Based Products (HCT/Ps)'' dated December 2011. The
guidance provides recommendations for complying with the CGTP
requirements under part 1271 (21 CFR part 1271), subpart D, and
additional requirements for manufacturers of HCT/Ps under part 1271,
subpart E. The guidance is intended for any HCT/P establishment that
performs a manufacturing step and is responsible for complying with
CGTP requirements. However, at this time, part 1271, subpart D (with
the exceptions of Sec. Sec. 1271.150(c) and 1271.155) and subpart E do
not apply to reproductive HCT/P establishments regulated solely under
section 361 of the Public Health Service Act (42 U.S.C. 264) (the PHS
Act). In consideration of the input FDA received from stakeholders,
this guidance provides recommendations for establishments that
manufacture HCT/Ps that meet the criteria listed in Sec. 1271.10 and
are regulated solely under section 361 of the PHS Act and the
regulations in part 1271. CGTP requirements also apply to HCT/Ps
regulated as drugs, devices, and/or biological products under section
351 of the PHS Act (42 U.S.C. 262) and/or the Federal Food, Drug, and
Cosmetic Act (see Sec. 1271.1(b)(2)). The guidance also addresses
whether the establishment registration and HCT/P listing requirements
under part 1271, subparts A and B, apply in certain instances.
In the Federal Register of January 16, 2009 (74 FR 3055), FDA
announced the availability of the draft guidance of the same title
dated January 2009. FDA received numerous comments on the draft
guidance, and those comments were considered as the guidance was
finalized. In addition, editorial changes were made to improve clarity.
The guidance announced in this notice finalizes the draft guidance
dated January 2009.
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.
[[Page 82309]]
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 1271 have been approved under
OMB control number 0910-0543, and the collections of information in 21
CFR part 820 have been approved under OMB control number 0910-0073.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen 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/Guidances/default.htm or http://www.regulations.gov.
Dated: December 15, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-33572 Filed 12-29-11; 8:45 am]
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