[Federal Register Volume 85, Number 140 (Tuesday, July 21, 2020)]
[Rules and Regulations]
[Pages 43989-43990]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15718]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1271

[Docket No. FDA-2017-D-6146]


Regulatory Considerations for Human Cells, Tissues, and Cellular 
and Tissue-Based Products: Minimal Manipulation and Homologous Use; 
Guidance for Industry and Food and Drug Administration Staff; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance for industry and FDA staff 
entitled ``Regulatory Considerations for Human Cells, Tissues, and 
Cellular and Tissue-Based Products: Minimal Manipulation and Homologous 
Use.'' The guidance does not alter FDA's current thinking on the 
regulatory criteria of minimal manipulation and homologous use for 
human cells, tissues, and cellular and tissue-based product (HCT/P). 
The guidance announced in this notice supersedes the guidance of the 
same title dated November 2017 and corrected December 2017. The 
guidance revises section V of the November 2017 guidance to communicate 
that the Agency is extending the period of time during which FDA 
intends to exercise enforcement discretion regarding certain regulatory 
requirements for certain HCT/Ps; this time period will run through May 
31, 2021, instead of November 30, 2020.

DATES: The announcement of the guidance is published in the Federal 
Register on July 21, 2020.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2017-D-6146 for ``Regulatory Considerations for Human Cells, 
Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation 
and Homologous Use.'' Received comments will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

[[Page 43990]]

    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the 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. Send 
one self-addressed adhesive label to assist the office in processing 
your requests. The 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 guidance document.

FOR FURTHER INFORMATION CONTACT: Jessica Walker Udechukwu, 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 Andrew Yeatts, Office of Device Evaluation, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Rm. 5510, Silver Spring, MD 20993-0002, 
301-796-4539; 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, 301-796-8938.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a document entitled 
``Regulatory Considerations for Human Cells, Tissues, Cellular and 
Tissue-Based Products: Minimal Manipulation and Homologous Use.'' This 
guidance is being issued consistent with FDA's good guidance practices 
regulation (Sec.  10.115 (21 CFR 10.115)). The Agency is soliciting 
public comment, but is implementing this guidance immediately, because 
the Agency has determined that prior public participation is not 
feasible or appropriate. Although this guidance document is immediately 
in effect, it remains subject to comment in accordance with FDA's good 
guidance practices regulation.
    The guidance does not alter FDA's current thinking on the 
regulatory criteria of minimal manipulation and homologous use for 
human cells, tissues, and cellular and tissue-based product (HCT/P) as 
described in the November 2017 guidance of the same name and corrected 
in December 2017. The only substantive change to this guidance is to 
revise section V of the November 2017 guidance to communicate that FDA 
intends to exercise enforcement discretion for certain regulatory 
requirements for certain HCT/Ps for a longer period of time, i.e., 
through May 31, 2021, instead of November 30, 2020. This will give 
manufacturers additional time to determine if they need to submit an 
investigational new drug (IND) or marketing application and, if such an 
application is needed, to prepare the IND or marketing application. 
Such additional time is warranted in light of the Coronavirus Disease 
2019 (COVID-19) public health emergency, which has presented unique 
challenges in recruiting clinical trial participants and carrying out 
clinical trials.
    As described in the guidance, FDA generally intends to exercise 
enforcement discretion with respect to the IND and the premarket 
approval requirements for HCT/Ps that do not meet one or more of the 21 
CFR 1271.10(a) criteria, provided that use of the HCT/P does not raise 
reported safety concerns or potential significant safety concerns. FDA 
intends to continue to focus enforcement actions on products with 
higher risk, including based on the route and site of administration.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (Sec.  10.115(g)(2)). The guidance represents the 
current thinking of FDA on ``Regulatory Considerations for Human Cells, 
Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation 
and Homologous Use.'' 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 requirements of the applicable statutes 
and regulations.

II. Paperwork Reduction Act of 1995

    This guidance contains no collection of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required.
    However, this guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by OMB under the PRA. The collections of 
information in 21 CFR part 1271 have been approved under OMB control 
number 0910-0543.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances; https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products; https://www.fda.gov/combination-products/guidance-regulatory-information; or https://www.regulations.gov.

    Dated: July 15, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15718 Filed 7-20-20; 8:45 am]
BILLING CODE 4164-01-P


