[Federal Register Volume 82, Number 172 (Thursday, September 7, 2017)]
[Notices]
[Pages 42349-42350]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-18737]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-4386]


Deviation Reporting for Human Cells, Tissues, and Cellular and 
Tissue-Based Products; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a document entitled ``Deviation Reporting for Human 
Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely 
Under Section 361 of the Public Health Service Act and 21 CFR part 
1271; Guidance for Industry.'' The guidance document provides 
establishments that manufacture non-reproductive human cells, tissues, 
and cellular and tissue-based products (HCT/Ps), regulated solely under 
the Public Health Service Act (PHS Act) and under FDA regulations, with 
recommendations and relevant examples for complying with the 
requirements to investigate and report HCT/P deviations. The guidance 
announced in this notice finalizes the draft guidance of the same title 
dated December 2015.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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-2015-D-4386 for ``Deviation Reporting for Human Cells, Tissues, and 
Cellular and Tissue-Based Products Regulated Solely Under Section 361 
of the Public Health Service Act and 21 CFR part

[[Page 42350]]

1271; Guidance for Industry.'' 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.
    <bullet> 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.gpo.gov/fdsys/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.
    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: Tami Belouin, 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: 

I. Background

    FDA is announcing the availability of a document entitled 
``Deviation Reporting for Human Cells, Tissues, and Cellular and 
Tissue-Based Products Regulated Solely Under Section 361 of the Public 
Health Service Act and 21 CFR part 1271; Guidance for Industry.'' The 
document provides establishments that manufacture HCT/Ps, regulated 
solely under section 361 of the PHS Act and the regulations under 21 
CFR part 1271, with recommendations and relevant examples for complying 
with the requirements under 21 CFR 1271.350(b) to investigate and 
report HCT/P deviations. The examples provided in the guidance are 
intended to illustrate those HCT/P deviations that have been most 
frequently reported to FDA, CBER.
    The guidance does not apply to reproductive HCT/Ps or to HCT/Ps 
regulated under 21 CFR part 1270 and recovered before May 25, 2005. The 
guidance does not apply to healthcare professionals who implant, 
transplant, infuse, or transfer HCT/Ps into recipients. The guidance 
also does not apply to HCT/Ps that are regulated as drugs, devices, 
and/or biological products under section 351 of the PHS Act and/or the 
Federal Food, Drug, and Cosmetic Act, nor does it apply to 
investigational HCT/Ps subject to an investigational new drug 
application or an investigational device exemption.
    In the Federal Register of December 24, 2015 (80 FR 80364), FDA 
announced the availability of the draft guidance of the same title 
dated December 2015. FDA received a few comments on the draft guidance 
and those comments were considered as the guidance was finalized. A 
summary of changes includes additional examples and editorial changes 
to improve clarity. The guidance announced in this notice finalizes the 
draft guidance dated December 2015.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Deviation Reporting for Human Cells, 
Tissues, and Cellular and Tissue-Based Products Regulated Solely Under 
section 361 of the Public Health Service Act and 21 CFR part 1271.'' 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. This guidance 
is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This 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. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: August 23, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-18737 Filed 9-6-17; 8:45 am]
BILLING CODE 4164-01-P