[Federal Register Volume 81, Number 125 (Wednesday, June 29, 2016)]
[Notices]
[Pages 42363-42364]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-15384]


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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Advisory Committees; Draft Guidance for the Public, Food and Drug 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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance entitled ``Procedures for Evaluating 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.'' This draft guidance addresses FDA's process, 
under Government-wide Federal regulations, for evaluating whether an 
advisory committee member has an appearance issue that raises concerns 
about the member's participation in an advisory committee meeting and 
describes FDA's process for determining whether to authorize a member 
with an appearance issue to participate in the advisory committee 
meeting. This draft guidance is not final nor is it in effect at this 
time.
    FDA is also requesting comment on whether FDA should request that 
each advisory committee member who has an appearance issue and who has 
received an authorization from FDA to participate in an advisory 
committee meeting voluntarily publicly disclose the authorization.

DATES: 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this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 27, 2016.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,

[[Page 42364]]

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 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.'' 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.

FOR FURTHER INFORMATION CONTACT: Michael Ortwerth, 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, 301-796-8220.

SUPPLEMENTARY INFORMATION: 

I. Background

    Advisory committees provide independent, expert advice to FDA on a 
range of issues affecting the public health. To protect the credibility 
and integrity of advisory committee advice, FDA screens advisory 
committee members carefully for two categories of potentially 
disqualifying interests or relationships: (1) Current financial 
interests that may create a recusal obligation under Federal conflict 
of interest laws (18 U.S.C. 208) and (2) other interests and 
relationships that do not create a recusal obligation under financial 
conflict of interest laws but may create the appearance that the member 
lacks impartiality (5 CFR 2635.502). This draft guidance addresses 
FDA's process for evaluating whether an advisory committee member has 
potentially disqualifying interests or relationships that fall into the 
second category of interests, which are known as appearance issues, 
under 5 CFR 2635.502. It also describes FDA's process for determining 
whether to authorize a member with an appearance issue to participate 
in an advisory committee meeting under 5 CFR 2635.502.
    In addition, FDA is seeking comment regarding public disclosure of 
such authorizations. Under Federal laws protecting the confidentiality 
of information, FDA may not itself disclose confidential information 
provided by advisory committee members related to appearance issues. 
FDA is soliciting comment on whether the agency should ask members with 
appearance issues who are authorized to participate in an advisory 
committee meeting to voluntarily publicly disclose authorization. The 
Agency will consider these comments in developing the final guidance 
document.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on the 
processes for evaluating appearance issues and granting an 
authorization. It does not create or confer any rights for or on any 
person and does not operate to bind FDA or the public. An alternative 
approach may be used if such approach satisfies the requirements of the 
applicable statute and regulations.

III. 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://www.fda.gov/RegulatoryInformation/Guidances/ucm122044.htm or http://www.regulations.gov.

    Dated: June 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-15384 Filed 6-28-16; 8:45 am]
 BILLING CODE 4164-01-P