80 FR 66847 - Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry; Reopening of the Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 210 (October 30, 2015)

Page Range		66847-66848
FR Document		2015-27707

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document entitled ``Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry'' announced in the Federal Register of October 23, 2014.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 additional time to submit comments and any new information.

Federal Register, Volume 80 Issue 210 (Friday, October 30, 2015)

[Federal Register Volume 80, Number 210 (Friday, October 30, 2015)]
[Proposed Rules]
[Pages 66847-66848]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-27707]

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

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Regarding the Scope of the Exception; Draft Guidance for Industry;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Exception; Draft Guidance for Industry'' announced in the Federal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DATES: Submit either electronic or written comments on the draft
guidance by April 29, 2016.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: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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 http://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 http://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: http://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 http://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

Federal Register / Vol. 80, No. 210 / Friday, October 30, 2015 / Proposed Rules 66847

provides those who manufacture and your presentation so that FDA can the electronic media may be permitted,
use adipose tissue with consider that information in organizing subject to certain limitations, to
recommendations for complying with the presentations. Individuals and videotape, film or otherwise record
the regulatory framework for HCT/Ps. organizations with common interests FDA’s public administrative
Elsewhere in this issue of the Federal should consolidate or coordinate their proceedings, including presentations by
Register, FDA is announcing the presentations and request time for a participants. The hearing will be
availability of the Homologous Use Draft joint presentation. FDA will do its best transcribed as stipulated in § 15.30(b)
Guidance which provides to accommodate requests to speak and (see section VI). To the extent that the
recommendations for applying the will determine the amount of time conditions for the hearing, as described
§ 1271.10(a)(2) homologous use allotted for each oral presentation, and in this document, conflict with any
criterion, and is also announcing the the approximate time that each oral provisions set out in part 15, this
reopening of the comment periods on presentation is scheduled to begin. FDA document acts as a waiver of those
the Same Surgical Procedure Exception, will notify registered presenters of their provisions as specified in § 15.30(h).
Minimal Manipulation, and Adipose scheduled times, and make available an
Tissue Draft Guidances. agenda at http://www.fda.gov/ VI. Transcripts
III. Purpose and Scope of the Public BiologicsBloodVaccines/NewsEvents/ Please be advised that as soon as a
Hearing WorkshopsMeetingsConferences/ transcript is available, it will be
ucm462125.htm on or before February accessible at www.regulations.gov and
The purpose of this public hearing is 5, 2016. Once FDA notifies registered http://www.fda.gov/
to obtain comments on these four draft presenters of their scheduled times, BiologicsBloodVaccines/NewsEvents/
guidances. FDA is seeking feedback, presenters should submit an electronic WorkshopsMeetingsConferences/
both general and specific, from a broad copy of their presentation to ucm462125.htm. It may be viewed at the
group of stakeholders, including HCT/P CBERPublicEvents@fda.hhs.gov by Division of Dockets Management, Food
manufacturers, tissue establishments, March 11, 2016. and Drug Administration, 5630 Fishers
biological and device product If you need special accommodations Lane, Rm. 1061, Rockville, MD 20852. A
manufacturers, health care because of a disability, please contact transcript will also be available in either
professionals, clinicians, biomedical Sherri Revell or Loni Warren Henderson hardcopy or on CD–ROM, after
researchers, and the public. For at 240–402–7800 at least 7 days before submission of a Freedom of Information
example, FDA would like comments on the meeting. request. The Freedom of Information
the scope of each guidance, including A link to the live Web cast of this office address is available on the
the particular topics covered, the public hearing will be available at Agency’s Web site at http://
particular questions posed, whether http://www.fda.gov/ www.fda.gov.
there are additional issues for which BiologicsBloodVaccines/NewsEvents/
they seek guidance, and whether FDA’s WorkshopsMeetingsConferences/ Dated: October 27, 2015.
recommendations for each topic are ucm462125.htm on the day of the public Leslie Kux,
sufficiently clear and consistent within hearing. A video record of the public Associate Commissioner for Policy.
and across documents to provide hearing will be available at http:// [FR Doc. 2015–27703 Filed 10–29–15; 8:45 am]
meaningful guidance to stakeholders. In www.fda.gov/BiologicsBloodVaccines/ BILLING CODE 4164–01–P
addition, FDA welcomes any comments NewsEvents/
that will enhance the usefulness and WorkshopsMeetingsConferences/
clarity of these documents. ucm462125.htm following the meeting. DEPARTMENT OF HEALTH AND
FDA recommends that comments A video record of the public hearing HUMAN SERVICES
exclude discussion of products which will be available at the same Web site
do not meet the definition of an HCT/ address for 1 year. Food and Drug Administration
P, such as platelet rich plasma. FDA
also recommends that stakeholders V. Notice of Hearing Under 21 CFR Part 21 CFR Part 1271
coordinate comments when possible in 15
[Docket No. FDA–2014–D–1584]
order to allow for presentation of a wide The Commissioner of Food and Drugs
range of perspectives within the allotted is announcing that the public hearing Same Surgical Procedure Exception:
time of the meeting. will be held in accordance with part 15 Questions and Answers Regarding the
(21 CFR part 15). The hearing will be Scope of the Exception; Draft
IV. Attendance and Registration conducted by a presiding officer, Guidance for Industry; Reopening of
The FDA Conference Center at the accompanied by FDA senior the Comment Period
White Oak location is a Federal facility management from the Office of the
with security procedures and limited Commissioner and the Center for AGENCY: Food and Drug Administration,
seating. Attendance is free and will be Biologics Evaluation and Research. HHS.
on a first-come, first-served basis. Under § 15.30(f), the hearing is Notification; reopening of the
ACTION:
Individuals who wish to present at the informal and the rules of evidence do comment period.
public hearing must register by sending not apply. No participant may interrupt
an email to CBERPublicEvents@ the presentation of another participant. SUMMARY: The Food and Drug
fda.hhs.gov on or before January 8, Only the presiding officer and panel Administration (FDA) is reopening the
tkelley on DSK3SPTVN1PROD with PROPOSALS

2016, and provide complete contact members may question any person comment period for the draft document
information, including name, title, during or at the conclusion of each entitled ‘‘Same Surgical Procedure
affiliation, address, email, and phone presentation. Public hearings under part Exception: Questions and Answers
number. Those without email access 15 are subject to FDA’s policy and Regarding the Scope of the Exception;
may register by contacting Sherri Revell procedures for electronic media Draft Guidance for Industry’’ announced
or Loni Warren Henderson at 240–402– coverage of FDA’s public administrative in the Federal Register of October 23,
7800. You should identify each proceedings (21 CFR part 10, subpart C). 2014. FDA is reopening the comment
guidance you wish to comment on in Under 21 CFR 10.205, representatives of period to allow interested persons

VerDate Sep<11>2014 16:29 Oct 29, 2015 Jkt 238001 PO 00000 Frm 00007 Fmt 4702 Sfmt 4702 E:\FR\FM\30OCP1.SGM 30OCP1

Document Created: 2015-12-14 15:29:59
Document Modified: 2015-12-14 15:29:59

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		Proposed Rules
Action		Notification; reopening of the comment period.
Dates		Submit either electronic or written comments on the draft guidance by April 29, 2016.
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		80 FR 66847

80 FR 66847 - Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry; Reopening of the Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 210 (October 30, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration