Document ID: FDA-2022-D-0563-0002
Agency: fda
Document Type: Rule
Title: Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products: Small Entity Compliance Guide; Availability
Posted Date: 2022-11-01T04:00Z

[Federal Register Volume 87, Number 210 (Tuesday, November 1, 2022)]
[Rules and Regulations]
[Pages 65681-65682]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23573]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1271

[Docket No. FDA-2022-D-0563]

Regulation of Human Cells, Tissues, and Cellular and Tissue-Based 
Products: Small Entity Compliance Guide; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing the availability of a final guidance entitled ``Regulation 
of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/
Ps): Small Entity Compliance Guide.'' The small entity compliance guide 
(SECG) is intended to help small entity establishments that manufacture 
HCT/Ps better understand the comprehensive regulatory framework for 
HCT/Ps set forth in the regulations and comply with certain HCT/P-
related final rules. The SECG announced in this notice supersedes the 
SECG of the same title dated August 2007.

DATES: The announcement of the guidance is published in the Federal 
Register on November 1, 2022.

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-2022-D-0563 for ``Regulation of Human Cells, Tissues, and Cellular 
and Tissue-Based Products (HCT/Ps): Small Entity Compliance Guide.'' 
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.
    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 SECG 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 that 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 SECG.

FOR FURTHER INFORMATION CONTACT: Myrna Hanna, 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.

SUPPLEMENTARY INFORMATION:

[[Page 65682]]

I. Background

    FDA is announcing the availability of a document entitled 
``Regulation of Human Cells, Tissues, and Cellular and Tissue-Based 
Products (HCT/Ps): Small Entity Compliance Guide.'' The SECG is 
intended to help small entity establishments that manufacture HCT/Ps 
better understand the comprehensive regulatory framework for HCT/Ps, 
set forth in part 1271 (21 CFR part 1271). The SECG announced in this 
notice supersedes the SECG of the same title dated August 2007.
    The SECG reflects the amendments of part 1271 based on the 
following: (1) the final rule published in the Federal Register of June 
22, 2016 (81 FR 40512), which amended certain regulations regarding 
donor eligibility, including the screening and testing of donors of 
particular HCT/Ps; and (2) the final rule published in the Federal 
Register of August 31, 2016 (81 FR 60170), which amended the 
regulations governing drug establishment registration and drug listing 
and included amendments to certain establishment registration and 
listing regulations for HCT/Ps.
    In compliance with section 212 of the Small Business Regulatory 
Enforcement Fairness Act (Pub. L. 104-121, as amended by Pub. L. 110-
28), we are making available the SECG to explain the actions that a 
small entity must take to comply with the final rules.
    We are issuing the SECG as level 2 guidance consistent with our 
good guidance practices regulation (21 CFR 10.115(c)(2)). The SECG 
represents the current thinking of FDA on this topic. 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

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections 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 for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in 21 CFR part 207 have been approved under OMB control 
number 0910-0045; the collections of information in 21 CFR part 607 
have been approved under OMB control number 0910-0052; the collections 
of information in 21 CFR part 807 have been approved under OMB control 
number 0910-0625; the collections of information in 21 CFR part 812 
have been approved under OMB control number 0910-0078; and 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 SECG at https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: October 24, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-23573 Filed 10-31-22; 8:45 am]
BILLING CODE 4164-01-P