Document ID: FDA-2014-D-1856-0001
Agency: fda
Document Type: Proposed Rule
Title: Human Cells, Tissues, and Cellular and Tissue-Based Products From Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry; Availability
Posted Date: 2014-12-24T05:00Z

[Federal Register Volume 79, Number 247 (Wednesday, December 24, 2014)]
[Proposed Rules]
[Pages 77414-77415]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-30142]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1271

[Docket No. FDA-2014-D-1856]

Human Cells, Tissues, and Cellular and Tissue-Based Products From 
Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; request for comments on draft guidance.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft document entitled ``Human Cells, Tissues, and 
Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: 
Regulatory Considerations; Draft Guidance for Industry'' dated December 
2014. The draft guidance document provides sponsors, clinicians, and 
other establishments that manufacture and use adipose tissue, with 
recommendations for complying with the regulatory framework for HCT/Ps. 
For purposes of applying the HCT/P regulatory framework, FDA considers 
connective tissue, including adipose tissue, to be a structural tissue. 
This draft guidance is not final nor is it in effect at this time.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by February 23, 2015.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Outreach, and Development, 
Center for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver 
Spring, MD 20993-0002 or to the Office of the Center Director, Guidance 
and Policy Development, Center for Devices and Radiological Health 
(CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Rm. 5431, Silver Spring, MD 20993-0002 or you may send an email 
request to the Office of Combination Products at combination@fda.gov. 
If you are submitting a written request, send one self-addressed 
adhesive label to assist that office in processing your request. The 
draft guidance may also be obtained by mail by calling CBER at 1-800-
835-4709 or 240-402-7800. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance document.
    Submit electronic comments on the draft 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 J. Churchyard, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 
240-402-7911; or Angela Krueger, Office of Device Evaluation, Center 
for Devices and Radiological Health, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 66, Rm. 1666, Silver Spring, MD 20993-
0002, 301-796-6380; or Leigh Hayes, Office of Combination Products, 
Office of the Commissioner, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 32, Rm. 5127, Silver Spring, MD 20993-0002, 
email: combination@fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft document entitled 
``Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) 
from Adipose Tissue: Regulatory Considerations; Draft Guidance for 
Industry'' dated December 2014. FDA has recently received numerous 
inquiries regarding HCT/Ps from adipose tissues. This draft guidance 
document provides sponsors, clinicians, and other establishments that 
manufacture and use HCT/Ps from adipose tissue with the Agency's 
current

[[Page 77415]]

thinking with respect to regulatory considerations for adipose tissue.
    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 1271 have been approved under 
OMB control number 0910-0543.

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 either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets 
Management (see ADDRESSES). It is only necessary to send one set of 
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, and will be posted to the docket 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/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm or http://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/default.htm or http://www.regulations.gov. Persons unable to download an electronic copy of 
the draft guidance entitled ``Human Cells, Tissues, and Cellular and 
Tissue-Based Products from Adipose Tissue: Regulatory Considerations; 
Draft Guidance for Industry,'' may send an email request to CDRH-guidance@fda.hhs.gov to receive an electronic copy of the document.

    Dated: December 18, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-30142 Filed 12-23-14; 8:45 am]
BILLING CODE 4164-01-P