82 FR 54289 - Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 221 (November 17, 2017)

Page Range		54289-54290
FR Document		2017-24839

The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception.'' The guidance document provides tissue establishments and health care professionals with FDA's current thinking on the scope of an exception set forth in the human cells, tissues, and cellular and tissue-based products (HCT/Ps) regulations.

Federal Register, Volume 82 Issue 221 (Friday, November 17, 2017)

[Federal Register Volume 82, Number 221 (Friday, November 17, 2017)]
[Rules and Regulations]
[Pages 54289-54290]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-24839]



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Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / 
Rules and Regulations

[[Page 54289]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1271

[Docket No. FDA-2014-D-1584]


Same Surgical Procedure Exception: Questions and Answers 
Regarding the Scope of the Exception; Guidance for Industry; 
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 document entitled ``Same Surgical Procedure 
Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the 
Scope of the Exception.'' The guidance document provides tissue 
establishments and health care professionals with FDA's current 
thinking on the scope of an exception set forth in the human cells, 
tissues, and cellular and tissue-based products (HCT/Ps) regulations.

DATES: The announcement of the guidance is published in the Federal 
Register on November 17, 2017.

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-2014-D-1584 for ``Same Surgical Procedure Exception under 21 CFR 
1271.15(b): Questions and Answers Regarding the Scope of the 
Exception.'' 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.
     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.thefederalregister.org/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.
    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: Lori J. 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.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled ``Same 
Surgical

[[Page 54290]]

Procedure Exception under 21 CFR 1271.15(b): Questions and Answers 
Regarding the Scope of the Exception.'' The guidance provides tissue 
establishments and health care professionals with FDA's current 
thinking on the scope of the exception set forth in part 1271 (21 CFR 
part 1271), specifically the exception set forth in Sec.  1271.15(b) 
(21 CFR 1271.15(b)). This guidance does not address the other 
exceptions in Sec.  1271.15. The guidance, presented in question and 
answer format, provides FDA's current interpretation of this regulation 
and includes examples based on inquiries received by the Agency since 
the final rule entitled ``Human Cells, Tissues, and Cellular and 
Tissue-Based Products; Establishment Registration and Listing'' 
published in the Federal Register of January 19, 2001 (66 FR 5447).
    In the Federal Register of October 23, 2014 (79 FR 63348), FDA 
announced the availability of the draft guidance of the same title. 
Additionally, in the Federal Register of December 24, 2014 (79 FR 
77414), FDA announced the availability of the draft guidance entitled 
``Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) 
from Adipose Tissue: Regulatory Considerations; Draft Guidance for 
Industry'' dated December 2014 (Adipose Draft Guidance).
    In the Federal Register of October 30, 2015, FDA reopened the 
comment period for three HCT/P-related draft guidances (80 FR 66847, 
66849, and 66844, respectively) and announced the availability of 
another HCT/P-related draft guidance (80 FR 66850). Comments on the 
four HCT/P-related guidances were requested by April 29, 2016. Lastly, 
in the Federal Register of October 30, 2015 (80 FR 66845), FDA 
announced a 1-day part 15 (21 CFR part 15) public hearing to obtain 
input on the four HCT/P-related guidances to be held on April 13, 2016.
    Due to considerable interest in the public hearing and to give 
stakeholders additional time to provide comments to the Agency, on 
February 29, 2016, FDA announced that the hearing was postponed. In the 
Federal Register of April 22, 2016 (81 FR 23661 and 81 FR 23664, 
respectively), FDA announced the rescheduled part 15 hearing date of 
September 12 and 13, 2016, and an extension of the comment period from 
April 29, 2016, until September 27, 2016, on the four HCT/P-related 
guidances. Also in the Federal Register of April 22, 2016 (81 FR 
23708), FDA announced a public workshop to be held on September 8, 
2016, on the ``Scientific Evidence in Development of HCT/Ps Subject to 
Premarket Approval.''
    FDA received numerous comments on the draft guidance and the 
Adipose Draft Guidance in response to the request for comments, and 
those comments were considered in developing the final guidance. The 
guidance announced in this notification finalizes the draft guidance of 
the same title dated October 2014. This guidance also finalizes certain 
material related to adipose tissue that was included in the Adipose 
Draft Guidance.
    The material in this guidance related to adipose tissue, together 
with the material in the final guidance entitled ``Regulatory 
Considerations for Human Cell, Tissues, and Cellular and Tissue-Based 
Products: Minimal Manipulation and Homologous Use; Guidance for 
Industry and Food and Drug Administration Staff'' dated November 2017 
(Minimal Manipulation and Homologous Use Guidance) related to adipose 
tissue, supersedes the Adipose Draft Guidance. Accordingly, FDA does 
not intend to finalize the Adipose Draft Guidance, which is now 
withdrawn.
    Elsewhere in this issue of the Federal Register, FDA is announcing 
the availability of the Minimal Manipulation and Homologous Use 
Guidance.
    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 ``Same Surgical Procedure Exception under 21 
CFR 1271.15(b): Questions and Answers Regarding the Scope of the 
Exception.'' 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

    The 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 guidance at 
either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: November 13, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-24839 Filed 11-16-17; 8:45 am]
BILLING CODE 4164-01-P

54290 Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Rules and Regulations

Procedure Exception under 21 CFR HCT/Ps Subject to Premarket default.htm or https://
1271.15(b): Questions and Answers Approval.’’ www.regulations.gov.
Regarding the Scope of the Exception.’’ FDA received numerous comments on Dated: November 13, 2017.
The guidance provides tissue the draft guidance and the Adipose
Anna K. Abram,
establishments and health care Draft Guidance in response to the
request for comments, and those Deputy Commissioner for Policy, Planning,
professionals with FDA’s current Legislation, and Analysis.
thinking on the scope of the exception comments were considered in
[FR Doc. 2017–24839 Filed 11–16–17; 8:45 am]
set forth in part 1271 (21 CFR part developing the final guidance. The
guidance announced in this notification BILLING CODE 4164–01–P
1271), specifically the exception set
forth in § 1271.15(b) (21 CFR finalizes the draft guidance of the same
1271.15(b)). This guidance does not title dated October 2014. This guidance
also finalizes certain material related to DEPARTMENT OF HEALTH AND
address the other exceptions in HUMAN SERVICES
§ 1271.15. The guidance, presented in adipose tissue that was included in the
question and answer format, provides Adipose Draft Guidance. Food and Drug Administration
FDA’s current interpretation of this The material in this guidance related
regulation and includes examples based to adipose tissue, together with the
21 CFR Part 1271
on inquiries received by the Agency material in the final guidance entitled
since the final rule entitled ‘‘Human ‘‘Regulatory Considerations for Human [Docket No. FDA–2017–D–6146]
Cells, Tissues, and Cellular and Tissue- Cell, Tissues, and Cellular and Tissue-
Based Products: Minimal Manipulation Regulatory Considerations for Human
Based Products; Establishment
and Homologous Use; Guidance for Cells, Tissues, and Cellular and
Registration and Listing’’ published in
Industry and Food and Drug Tissue-Based Products: Minimal
the Federal Register of January 19, 2001
Administration Staff’’ dated November Manipulation and Homologous Use;
(66 FR 5447).
2017 (Minimal Manipulation and Guidance for Industry and Food and
In the Federal Register of October 23, Drug Administration Staff; Availability
2014 (79 FR 63348), FDA announced the Homologous Use Guidance) related to
availability of the draft guidance of the adipose tissue, supersedes the Adipose AGENCY: Food and Drug Administration,
same title. Additionally, in the Federal Draft Guidance. Accordingly, FDA does HHS.
Register of December 24, 2014 (79 FR not intend to finalize the Adipose Draft ACTION: Notification of availability.
77414), FDA announced the availability Guidance, which is now withdrawn.
of the draft guidance entitled ‘‘Human Elsewhere in this issue of the Federal SUMMARY: The Food and Drug
Cells, Tissues, and Cellular and Tissue- Register, FDA is announcing the Administration (FDA or Agency) is
Based Products (HCT/Ps) from Adipose availability of the Minimal announcing the availability of a
Tissue: Regulatory Considerations; Draft Manipulation and Homologous Use document entitled ‘‘Regulatory
Guidance for Industry’’ dated December Guidance. Considerations for Human Cells,
This guidance is being issued Tissues, and Cellular and Tissue-Based
2014 (Adipose Draft Guidance).
consistent with FDA’s good guidance Products: Minimal Manipulation and
In the Federal Register of October 30,
practices regulation (21 CFR 10.115). Homologous Use; Guidance for Industry
2015, FDA reopened the comment
The guidance represents the current and Food and Drug Administration
period for three HCT/P-related draft
thinking of FDA on ‘‘Same Surgical Staff.’’ The guidance provides human
guidances (80 FR 66847, 66849, and
Procedure Exception under 21 CFR cells, tissues, and cellular and tissue-
66844, respectively) and announced the
1271.15(b): Questions and Answers based product (HCT/P) manufacturers,
availability of another HCT/P-related
Regarding the Scope of the Exception.’’ healthcare providers, and FDA staff,
draft guidance (80 FR 66850).
It does not establish any rights for any with FDA’s current thinking on the
Comments on the four HCT/P-related
person and is not binding on FDA or the regulatory criteria of minimal
guidances were requested by April 29,
public. You can use an alternative manipulation and homologous use. The
2016. Lastly, in the Federal Register of
approach if it satisfies the requirements guidance is intended to improve
October 30, 2015 (80 FR 66845), FDA
of the applicable statutes and stakeholders’ understanding of the
announced a 1-day part 15 (21 CFR part
regulations. This guidance is not subject definitions of minimal manipulation
15) public hearing to obtain input on the
to Executive Order 12866. and homologous use and how the
four HCT/P-related guidances to be held
on April 13, 2016. II. Paperwork Reduction Act of 1995 regulatory criteria apply to their HCT/
Due to considerable interest in the Ps. It also informs manufacturers,
The guidance refers to previously healthcare providers, and other
public hearing and to give stakeholders approved collections of information
additional time to provide comments to interested persons that the Agency
found in FDA regulations. These generally intends to exercise
the Agency, on February 29, 2016, FDA collections of information are subject to
announced that the hearing was enforcement discretion over the next 36
review by the Office of Management and months under limited conditions, with
postponed. In the Federal Register of Budget (OMB) under the Paperwork
April 22, 2016 (81 FR 23661 and 81 FR respect to the investigational new drug
Reduction Act of 1995 (44 U.S.C. 3501– (IND) application and premarket
23664, respectively), FDA announced 3520). The collections of information in
the rescheduled part 15 hearing date of approval (biologics license application
part 1271 have been approved under (BLA)) requirements, for certain HCT/
September 12 and 13, 2016, and an OMB control number 0910–0543.
extension of the comment period from Ps.
III. Electronic Access
rmajette on DSKBCKNHB2PROD with RULES

April 29, 2016, until September 27, DATES: The announcement of the
2016, on the four HCT/P-related Persons with access to the internet guidance is published in the Federal
guidances. Also in the Federal Register may obtain the guidance at either Register on November 17, 2017.
of April 22, 2016 (81 FR 23708), FDA https://www.fda.gov/ ADDRESSES: You may submit either
announced a public workshop to be BiologicsBloodVaccines/ electronic or written comments on
held on September 8, 2016, on the GuidanceCompliance Agency guidances at any time as
‘‘Scientific Evidence in Development of RegulatoryInformation/Guidances/ follows:

VerDate Sep<11>2014 13:56 Nov 16, 2017 Jkt 244001 PO 00000 Frm 00002 Fmt 4700 Sfmt 4700 E:\FR\FM\17NOR1.SGM 17NOR1

Document Created: 2017-11-17 05:14:59
Document Modified: 2017-11-17 05:14:59

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Notification of availability.
Dates		The announcement of the guidance is published in the Federal Register on November 17, 2017.
Contact		Lori J. 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.
FR Citation		82 FR 54289

82 FR 54289 - Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 221 (November 17, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration