[Federal Register Volume 79, Number 246 (Tuesday, December 23, 2014)]
[Notices]
[Pages 77012-77013]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-30011]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1696]


Minimal Manipulation of Human Cells, Tissues, and Cellular- and 
Tissue-Based Products; Draft Guidance for Industry and Food and Drug 
Administration Staff; 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 ``Minimal Manipulation of 
Human Cells, Tissues, and Cellular- and Tissue-Based Products; Draft 
Guidance for Industry and Food and Drug Administration Staff.'' The 
draft guidance document provides human cells, tissues, and cellular- 
and tissue-based product (HCT/P) manufacturers, healthcare providers, 
and FDA staff with recommendations for meeting the criterion of 
``minimal manipulation'' as it applies to HCT/Ps. The draft guidance, 
when finalized, is intended to supersede the document entitled 
``Guidance for Industry and FDA Staff: Minimal Manipulation of 
Structural Tissue Jurisdictional Update'' dated September 2006. 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draft guidance is not final nor is it in effect at this time.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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by February 23, 2015.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Outreach and Development, 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 (OCP) at 
combination@fda.gov. If you are submitting a written request, 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 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: Melissa Segal, 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, Hub 5129, Silver Spring, MD 20993-0002, 301-796-8938.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft document entitled 
``Minimal Manipulation of Human Cells, Tissues, and Cellular- and 
Tissue-Based Products; Draft Guidance for Industry and Food and Drug 
Administration Staff.'' The draft guidance document provides HCT/P 
manufacturers, healthcare providers, and FDA staff with recommendations 
for meeting the 21 CFR 1271.10(a)(1) criterion of minimal manipulation. 
The draft guidance, when finalized, is intended to supersede the 
document entitled ``Guidance for Industry and FDA Staff: Minimal 
Manipulation of Structural Tissue Jurisdictional Update'' dated 
September 2006. Note that FDA intends to publish a separate draft 
guidance document on the criterion described in Sec.  1271.10(a)(2), 
the HCT/P is intended for homologous use only as reflected by the 
labeling, advertising, or other indications of the manufacturer's 
objective intent.
    HCT/Ps are defined in Sec.  1271.3(d) as articles containing or 
consisting of human cells or tissues that are intended for 
implantation, transplantation, infusion, or transfer into a human 
recipient. FDA has implemented a risk-based approach to the regulation 
of HCT/Ps. Under the authority of section 361 of the Public Health 
Service (PHS) Act (42 U.S.C. 264), FDA established regulations for all 
HCT/Ps to prevent the introduction, transmission, and spread of 
communicable diseases. These regulations can be found in part 1271. 
HCT/Ps are regulated solely under section 361 of the PHS Act and part 
1271, if they meet all of the following criteria (21 CFR 1271.10(a)):
     The HCT/P is minimally manipulated;
     The HCT/P is intended for homologous use only, as 
reflected by the labeling, advertising, or other indications of the 
manufacturer's objective intent;
     The manufacture of the HCT/P does not involve the 
combination of the cells or tissues with another article, except for 
water, crystalloids, or a sterilizing, preserving, or storage agent, 
provided that the addition of water, crystalloids, or the sterilizing, 
preserving, or storage

[[Page 77013]]

agent does not raise new clinical safety concerns with respect to the 
HCT/P; and
     Either:
    [cir] The HCT/P does not have a systemic effect and is not 
dependent upon the metabolic activity of living cells for its primary 
function, or
    [cir] The HCT/P has a systemic effect or is dependent upon the 
metabolic activity of living cells for its primary function, and is for 
the following uses:
    [ssquf] Autologous,
    [ssquf] Allogeneic, in a first-degree or second-degree blood 
relative, or
    [ssquf] Reproductive.
    If an HCT/P does not meet all of the criteria set out under Sec.  
1271.10(a), the HCT/P will be regulated as a drug, device, and/or 
biological product under the Federal Food, Drug, and Cosmetic Act, and/
or section 351 of the PHS Act (42 U.S.C. 262).
    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 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 ``Minimal Manipulation of Human 
Cells, Tissues, and Cellular- and Tissue-Based Products; Draft Guidance 
for Industry and FDA Staff'' may send an email request to CDRH-guidance@fda.hhs.gov to receive an electronic copy of the document.

    Dated: December 17, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-30011 Filed 12-22-14; 8:45 am]
BILLING CODE 4164-01-P