Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry; Reopening of the Comment Period, 66847-66848 [2015-27707]

Download as PDF Federal Register / Vol. 80, No. 210 / Friday, October 30, 2015 / Proposed Rules provides those who manufacture and use adipose tissue with recommendations for complying with the regulatory framework for HCT/Ps. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the Homologous Use Draft Guidance which provides recommendations for applying the § 1271.10(a)(2) homologous use criterion, and is also announcing the reopening of the comment periods on the Same Surgical Procedure Exception, Minimal Manipulation, and Adipose Tissue Draft Guidances. tkelley on DSK3SPTVN1PROD with PROPOSALS III. Purpose and Scope of the Public Hearing The purpose of this public hearing is to obtain comments on these four draft guidances. FDA is seeking feedback, both general and specific, from a broad group of stakeholders, including HCT/P manufacturers, tissue establishments, biological and device product manufacturers, health care professionals, clinicians, biomedical researchers, and the public. For example, FDA would like comments on the scope of each guidance, including the particular topics covered, the particular questions posed, whether there are additional issues for which they seek guidance, and whether FDA’s recommendations for each topic are sufficiently clear and consistent within and across documents to provide meaningful guidance to stakeholders. In addition, FDA welcomes any comments that will enhance the usefulness and clarity of these documents. FDA recommends that comments exclude discussion of products which do not meet the definition of an HCT/ P, such as platelet rich plasma. FDA also recommends that stakeholders coordinate comments when possible in order to allow for presentation of a wide range of perspectives within the allotted time of the meeting. IV. Attendance and Registration The FDA Conference Center at the White Oak location is a Federal facility with security procedures and limited seating. Attendance is free and will be on a first-come, first-served basis. Individuals who wish to present at the public hearing must register by sending an email to CBERPublicEvents@ fda.hhs.gov on or before January 8, 2016, and provide complete contact information, including name, title, affiliation, address, email, and phone number. Those without email access may register by contacting Sherri Revell or Loni Warren Henderson at 240–402– 7800. You should identify each guidance you wish to comment on in VerDate Sep<11>2014 16:29 Oct 29, 2015 Jkt 238001 your presentation so that FDA can consider that information in organizing the presentations. Individuals and organizations with common interests should consolidate or coordinate their presentations and request time for a joint presentation. FDA will do its best to accommodate requests to speak and will determine the amount of time allotted for each oral presentation, and the approximate time that each oral presentation is scheduled to begin. FDA will notify registered presenters of their scheduled times, and make available an agenda at https://www.fda.gov/ BiologicsBloodVaccines/NewsEvents/ WorkshopsMeetingsConferences/ ucm462125.htm on or before February 5, 2016. Once FDA notifies registered presenters of their scheduled times, presenters should submit an electronic copy of their presentation to CBERPublicEvents@fda.hhs.gov by March 11, 2016. If you need special accommodations because of a disability, please contact Sherri Revell or Loni Warren Henderson at 240–402–7800 at least 7 days before the meeting. A link to the live Web cast of this public hearing will be available at https://www.fda.gov/ BiologicsBloodVaccines/NewsEvents/ WorkshopsMeetingsConferences/ ucm462125.htm on the day of the public hearing. A video record of the public hearing will be available at https:// www.fda.gov/BiologicsBloodVaccines/ NewsEvents/ WorkshopsMeetingsConferences/ ucm462125.htm following the meeting. A video record of the public hearing will be available at the same Web site address for 1 year. V. Notice of Hearing Under 21 CFR Part 15 The Commissioner of Food and Drugs is announcing that the public hearing will be held in accordance with part 15 (21 CFR part 15). The hearing will be conducted by a presiding officer, accompanied by FDA senior management from the Office of the Commissioner and the Center for Biologics Evaluation and Research. Under § 15.30(f), the hearing is informal and the rules of evidence do not apply. No participant may interrupt the presentation of another participant. Only the presiding officer and panel members may question any person during or at the conclusion of each presentation. Public hearings under part 15 are subject to FDA’s policy and procedures for electronic media coverage of FDA’s public administrative proceedings (21 CFR part 10, subpart C). Under 21 CFR 10.205, representatives of PO 00000 Frm 00007 Fmt 4702 Sfmt 4702 66847 the electronic media may be permitted, subject to certain limitations, to videotape, film or otherwise record FDA’s public administrative proceedings, including presentations by participants. The hearing will be transcribed as stipulated in § 15.30(b) (see section VI). To the extent that the conditions for the hearing, as described in this document, conflict with any provisions set out in part 15, this document acts as a waiver of those provisions as specified in § 15.30(h). VI. Transcripts Please be advised that as soon as a transcript is available, it will be accessible at www.regulations.gov and https://www.fda.gov/ BiologicsBloodVaccines/NewsEvents/ WorkshopsMeetingsConferences/ ucm462125.htm. It may be viewed at the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. A transcript will also be available in either hardcopy or on CD–ROM, after submission of a Freedom of Information request. The Freedom of Information office address is available on the Agency’s Web site at https:// www.fda.gov. Dated: October 27, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–27703 Filed 10–29–15; 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–2014–D–1584] Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS. Notification; reopening of the comment period. ACTION: The Food and Drug Administration (FDA) is reopening the comment period for the draft document entitled ‘‘Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry’’ announced in the Federal Register of October 23, 2014. FDA is reopening the comment period to allow interested persons SUMMARY: E:\FR\FM\30OCP1.SGM 30OCP1 66848 Federal Register / Vol. 80, No. 210 / Friday, October 30, 2015 / Proposed Rules additional time to submit comments and any new information. DATES: Submit either electronic or written comments on the draft guidance by April 29, 2016. ADDRESSES: You may submit comments 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’’). tkelley on DSK3SPTVN1PROD with PROPOSALS Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, 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: Questions and Answers Regarding the Scope of the Exception; Draft 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 Division of Dockets Management VerDate Sep<11>2014 16:29 Oct 29, 2015 Jkt 238001 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 Division of Dockets Management. 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.fda.gov/ regulatoryinformation/dockets/ default.htm. 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 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 In the Federal Register of October 23, 2014 (79 FR 63348), FDA announced the availability of a draft document entitled ‘‘Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry’’ dated October 2014. The draft guidance PO 00000 Frm 00008 Fmt 4702 Sfmt 9990 is intended for tissue establishments and health care professionals and discusses one of the exceptions for establishments from certain regulatory requirements. Interested persons were originally given until December 22, 2014, to comment on the draft guidance. Elsewhere in this issue of the Federal Register, FDA is announcing four other related documents. In a separate document, FDA is announcing a public hearing entitled ‘‘Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or TissueBased Products; Public Hearing; Request for Comments’’ (part 15 hearing) to be held on April 13, 2016, to provide stakeholders with the opportunity to discuss FDA’s policy on regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps) related to the four draft guidances on the following topics: Homologous use, same surgical procedure exception, minimal manipulation, and adipose tissue. In a separate document, FDA is announcing the availability of a draft document entitled ‘‘Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and FDA Staff.’’ In separate documents, FDA is also reopening the comment periods to FDA’s public dockets on the previously issued draft guidance documents on the following topics related to HCT/Ps: Minimal manipulation (Docket No. FDA–2014–D–1696) and adipose tissue (Docket No. FDA–2014–D–1856). II. Reopening of Comment Period Following publication of the October 23, 2014, notice of availability, FDA received a request to allow interested persons additional time to comment. In conjunction with the part 15 hearing and announcement of availability of the homologous use draft guidance, FDA is reopening the comment period to allow potential respondents to thoroughly evaluate and address pertinent issues. The same surgical procedure exception draft guidance and other related guidances (homologous use, minimal manipulation, adipose tissue) all deal with the interpretation of the regulations under 21 CFR part 1271 that will be addressed as part of the part 15 hearing. Dated: October 27, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–27707 Filed 10–29–15; 8:45 am] BILLING CODE 4164–01–P E:\FR\FM\30OCP1.SGM 30OCP1

Agencies

[Federal Register Volume 80, Number 210 (Friday, October 30, 2015)]
[Proposed Rules]
[Pages 66847-66848]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27707]


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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; Draft Guidance for Industry; 
Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; reopening of the comment period.

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

SUMMARY: The Food and Drug Administration (FDA) is reopening the 
comment period for the draft document entitled ``Same Surgical 
Procedure Exception: Questions and Answers Regarding the Scope of the 
Exception; Draft Guidance for Industry'' announced in the Federal 
Register of October 23, 2014. FDA is reopening the comment period to 
allow interested persons

[[Page 66848]]

additional time to submit comments and any new information.

DATES: Submit either electronic or written comments on the draft 
guidance by April 29, 2016.

ADDRESSES: You may submit comments 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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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: Questions and 
Answers Regarding the Scope of the Exception; Draft 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 Division of Dockets Management 
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 Division of Dockets Management. 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.fda.gov/regulatoryinformation/dockets/default.htm.
    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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

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

    In the Federal Register of October 23, 2014 (79 FR 63348), FDA 
announced the availability of a draft document entitled ``Same Surgical 
Procedure Exception under 21 CFR 1271.15(b): Questions and Answers 
Regarding the Scope of the Exception; Draft Guidance for Industry'' 
dated October 2014. The draft guidance is intended for tissue 
establishments and health care professionals and discusses one of the 
exceptions for establishments from certain regulatory requirements. 
Interested persons were originally given until December 22, 2014, to 
comment on the draft guidance.
    Elsewhere in this issue of the Federal Register, FDA is announcing 
four other related documents. In a separate document, FDA is announcing 
a public hearing entitled ``Draft Guidances Relating to the Regulation 
of Human Cells, Tissues, or Cellular or Tissue-Based Products; Public 
Hearing; Request for Comments'' (part 15 hearing) to be held on April 
13, 2016, to provide stakeholders with the opportunity to discuss FDA's 
policy on regulation of human cells, tissues, and cellular and tissue-
based products (HCT/Ps) related to the four draft guidances on the 
following topics: Homologous use, same surgical procedure exception, 
minimal manipulation, and adipose tissue.
    In a separate document, FDA is announcing the availability of a 
draft document entitled ``Homologous Use of Human Cells, Tissues, and 
Cellular and Tissue-Based Products; Draft Guidance for Industry and FDA 
Staff.''
    In separate documents, FDA is also reopening the comment periods to 
FDA's public dockets on the previously issued draft guidance documents 
on the following topics related to HCT/Ps: Minimal manipulation (Docket 
No. FDA-2014-D-1696) and adipose tissue (Docket No. FDA-2014-D-1856).

II. Reopening of Comment Period

    Following publication of the October 23, 2014, notice of 
availability, FDA received a request to allow interested persons 
additional time to comment. In conjunction with the part 15 hearing and 
announcement of availability of the homologous use draft guidance, FDA 
is reopening the comment period to allow potential respondents to 
thoroughly evaluate and address pertinent issues. The same surgical 
procedure exception draft guidance and other related guidances 
(homologous use, minimal manipulation, adipose tissue) all deal with 
the interpretation of the regulations under 21 CFR part 1271 that will 
be addressed as part of the part 15 hearing.

    Dated: October 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27707 Filed 10-29-15; 8:45 am]
BILLING CODE 4164-01-P
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