Notice: Guidance for Industry: Current Good Tissue Practice and 
Additional Requirements for Manufacturers of Human Cells, Tissues, and 
Cellular and Tissue-Based Products; Availability

Federal Register: Volume 76, Number 251 (Friday, December 30, 2011)
                  Pages 82308-82309

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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notice finalizes the draft guidance of the same title dated January 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]
BILLING CODE 4160-01-P