Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception; Guidance for Industry; Availability, 54289-54290 [2017-24839]

Download as PDF 54289 Rules and Regulations Federal Register Vol. 82, No. 221 Friday, November 17, 2017 This section of the FEDERAL REGISTER contains regulatory documents having general applicability and legal effect, most of which are keyed to and codified in the Code of Federal Regulations, which is published under 50 titles pursuant to 44 U.S.C. 1510. The Code of Federal Regulations is sold by the Superintendent of Documents. 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. 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: rmajette on DSKBCKNHB2PROD with RULES SUMMARY: 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 VerDate Sep<11>2014 13:56 Nov 16, 2017 Jkt 244001 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 PO 00000 Frm 00001 Fmt 4700 Sfmt 4700 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/201523389.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 E:\FR\FM\17NOR1.SGM 17NOR1 rmajette on DSKBCKNHB2PROD with RULES 54290 Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Rules and Regulations 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 § 1271.15(b) (21 CFR 1271.15(b)). This guidance does not address the other exceptions in § 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 TissueBased 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 TissueBased 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 VerDate Sep<11>2014 13:56 Nov 16, 2017 Jkt 244001 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 TissueBased 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/ GuidanceCompliance RegulatoryInformation/Guidances/ PO 00000 Frm 00002 Fmt 4700 Sfmt 4700 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 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. The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ‘‘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.’’ The guidance provides human cells, tissues, and cellular and tissuebased product (HCT/P) manufacturers, healthcare providers, and FDA staff, with FDA’s current thinking on the regulatory criteria of minimal manipulation and homologous use. The guidance is intended to improve stakeholders’ understanding of the definitions of minimal manipulation and homologous use and how the regulatory criteria apply to their HCT/ Ps. It also informs manufacturers, healthcare providers, and other interested persons that the Agency generally intends to exercise enforcement discretion over the next 36 months under limited conditions, with respect to the investigational new drug (IND) application and premarket approval (biologics license application (BLA)) requirements, for certain HCT/ Ps. 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: SUMMARY: E:\FR\FM\17NOR1.SGM 17NOR1

Agencies

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



========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents 
having general applicability and legal effect, most of which are keyed 
to and codified in the Code of Federal Regulations, which is published 
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents. 

========================================================================


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.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.
    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