[Federal Register Volume 81, Number 185 (Friday, September 23, 2016)]
[Notices]
[Pages 65653-65655]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22936]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1399]


Procedures for Evaluating Appearance Issues and Granting 
Authorizations for Participation in Food and Drug Administration 
Advisory Committees; Draft Guidance for the Public, Food and Drug 
Administration Advisory Committee Members, and Food and Drug 
Administration Staff; Availability; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending the 
comment period for the notice that

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appeared in the Federal Register of June 29, 2016. In the notice, FDA 
requested comments on ``Procedures for Evaluating Appearance Issues and 
Granting Authorizations for Participation in FDA Advisory Committees; 
Guidance for the Public, FDA Advisory Committee Members, and FDA 
Staff'' and on whether FDA should request that each advisory committee 
member, who receives an authorization from FDA on an appearance issue 
so that they may participate in an advisory committee meeting, 
voluntarily publicly disclose the authorization. The Agency is taking 
this action due to errors displayed on the FDA Web site pertaining to 
this guidance.

DATES: FDA is extending the comment period for the notice that 
published on June 29, 2016 (81 FR 42363) by an additional 60 days. 
Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comments on 
this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by November 26, 2016.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-2016-D-1399 for ``Procedures for Evaluating Appearance Issues and 
Granting Authorizations for Participation in FDA Advisory Committees; 
Guidance for the Public, FDA Advisory Committee Members, and FDA 
Staff.'' 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.
    Submit written requests for a single hard copy of the draft 
guidance entitled ``Procedures for Evaluating Appearance Issues and 
Granting Authorizations for Participation in FDA Advisory Committees; 
Guidance for the Public, FDA Advisory Committee Members, and FDA 
Staff'' to the Advisory Committee Oversight and Management Staff, 
Office of Special Medical Programs, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993-0002. 
Send one self-addressed adhesive label to assist that office in 
processing your request. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Janine M. Morris, Office of Special 
Medical Products, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 32, Rm. 5114, Silver Spring, MD 20993-0002, 301-796-5706.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 29, 2016, FDA published a notice 
with a 90-day comment period to request comments on the draft guidance 
and public disclosure of authorizations described in this guidance.
    The Agency has decided to allow for a 60-day extension of the 
comment period for the notice. The FDA Web site that displayed the 
posting of this guidance indicated, in error, that the guidance was not 
open for comment. The Agency was concerned that individuals visiting 
the FDA Web site and interested in providing comments may not have 
known that the document was available for comment under the docket 
found at http://www.regulations.gov.
    FDA is therefore extending the comment period for the notice for an 
additional 60 days, until November 26, 2016. The Agency believes that a 
60-day extension allows adequate time for interested persons to submit 
comments without compromising timely publication of the final guidance.

II. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by downloading an electronic copy from the Internet at either http:/
/

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www.fda.gov/RegulatoryInformation/Guidances/ucm122045.htm or http://www.regulations.gov.

    Dated: September 19, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-22936 Filed 9-22-16; 8:45 am]
 BILLING CODE 4164-01-P