[Federal Register Volume 80, Number 210 (Friday, October 30, 2015)]
[Proposed Rules]
[Pages 66850-66851]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27704]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1271

[Docket No. FDA-2015-D-3581]


Homologous Use 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Based Products; Draft Guidance for Industry and Food and Drug 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: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft document entitled ``Homologous Use of Human 
Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance 
for Industry and FDA Staff.'' The draft guidance document provides 
human cells, tissues, and cellular and tissue-based product (HCT/P) 
manufacturers, health care providers, and FDA staff, with 
recommendations for applying the criterion of ``homologous use'' as it 
applies to HCT/Ps. The interpretation and application of the homologous 
use criterion and related definitions have been of considerable 
interest to industry stakeholders since they were first proposed during 
the Agency's rulemaking on HCT/Ps.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 29, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2015-D-3581 for ``Homologous Use of Human Cells, Tissues, and 
Cellular and Tissue-Based Products; Draft Guidance for Industry and FDA 
Staff; Availability.'' Received comments will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at http://www.regulations.gov or at the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    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,

[[Page 66851]]

Rm. 5431, Silver Spring MD 20993-0002, or you may send an email request 
to the Office of Combination Products at [email protected]. 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 240-402-8010. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Lori 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. 5125, Silver Spring, MD 20993-0002, 301-796-8938.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft document entitled 
``Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based 
Products; Draft Guidance for Industry and FDA Staff.'' The draft 
guidance document provides HCT/P manufacturers, health care providers, 
and FDA staff, with recommendations for applying the Sec.  
1271.10(a)(2) (21 CFR 1271.10(a)(2)) criterion of homologous use. This 
guidance will improve stakeholders' understanding of the definition of 
homologous use in Sec.  1271.3(c), and how to apply the regulatory 
criterion in Sec.  1271.10(a)(2) to their HCT/P.
    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 under 
part 1271 for all HCT/Ps to prevent the introduction, transmission, and 
spread of communicable diseases. HCT/Ps are regulated solely under 
section 361 of the PHS Act and 21 CFR part 1271, if they meet the 
criteria provided under Sec.  1271.10(a).
    If an HCT/P does not meet all of the criteria set out under Sec.  
1271.10(a), and does not meet one of the exceptions in Sec.  1271.15, 
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 ``Homologous Use of 
Human Cells, Tissues, and Cellular and Tissue-Based Products.'' It does 
not establish any rights for any person and is not binding on FDA or 
the public. You can use an alternative approach if it satisfies the 
requirement of the applicable statutes and regulations.
    In a separate document published elsewhere in this issue of the 
Federal Register, FDA is announcing a public hearing entitled ``Draft 
Guidances Relating to the Regulation of Human Cells, Tissues or 
Cellular or Tissue-Based Products; Public Hearing; Request for 
Comments'' to be held on April 13, 2016, to provide stakeholders with 
the opportunity to discuss FDA's policy on regulation of HCT/Ps related 
to the four draft guidances on the following topics: Homologous use, 
same surgical procedure exception, minimal manipulation, and adipose 
tissue.
    In separate documents published elsewhere in this issue of the 
Federal Register, FDA is also reopening the comment periods to FDA's 
public dockets on the previously issued draft guidance documents on the 
following topics related to HCT/Ps: Minimal manipulation (Docket No. 
FDA-2014-D-1696), adipose tissue (Docket No. FDA-2014-D-1856), and same 
surgical procedure exception (Docket No. FDA-2014-D-1584).

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. 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 ``Homologous Use of Human Cells, Tissues, 
and Cellular and Tissue-Based Products; Draft Guidance for Industry and 
FDA Staff'' may send an email request to [email protected] to 
receive an electronic copy of the document.

    Dated: October 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27704 Filed 10-29-15; 8:45 am]
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