81_FR_42488 81 FR 42363 - 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Appearance Issues and Granting Authorizations for Participation in Food and Drug Administration Advisory Committees; Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food and Drug Administration Staff; Availability

81 FR 42363 - 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Appearance Issues and Granting Authorizations for Participation in Food and Drug Administration Advisory Committees; Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 125 (June 29, 2016)

Page Range42363-42364
FR Document2016-15384

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees; Guidance for the Public, FDA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 This draft guidance addresses FDA's process, under Government-wide Federal regulations, for evaluating whether an advisory committee member has an appearance issue that raises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 This draft guidance is not final nor is it in effect at this time.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.

Federal Register, Volume 81 Issue 125 (Wednesday, June 29, 2016) 
[Federal Register Volume 81, Number 125 (Wednesday, June 29, 2016)]
[Notices]
[Pages 42363-42364]
From the Federal Register Online  [www.thefederalregister.org]
[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Advisory Committees; Draft Guidance for the Public, Food and Drug 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.

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

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

Federal Register / Vol. 81, No. 125 / Wednesday, June 29, 2016 / Notices 42363 be addressed. Potential benefits such as For press inquiries, please contact the committee meeting. This draft guidance reduction of infection transmission and Office of Media Affairs at fdaoma@ is not final nor is it in effect at this time. increased access to testing will be fda.hhs.gov or 301–796–4540. FDA is also requesting comment on discussed as well. The committee will FDA welcomes the attendance of the whether FDA should request that each also make recommendations on clinical public at its advisory committee advisory committee member who has an study design, analytical study design, meetings and will make every effort to appearance issue and who has received and acceptable performance criteria accommodate persons with disabilities. an authorization from FDA to applicable to respiratory and STI If you require accommodations due to a participate in an advisory committee diagnostic devices. disability, please contact Artair Mallett, meeting voluntarily publicly disclose at Artair.Mallett.Mallett@fda.hhs.gov or the authorization. FDA intends to make background 301–796–9638 at least 7 days in advance DATES: Although you can comment on material available to the public no later of the meeting. any guidance at any time (see 21 CFR than 2 business days before the meeting. FDA is committed to the orderly If FDA is unable to post the background 10.115(g)(5)), to ensure that the Agency conduct of its advisory committee material on its Web site prior to the considers your comments on this draft meetings. Please visit our Web site at meeting, the background material will guidance before it begins work on the http://www.fda.gov/Advisory be made publicly available at the final version of the guidance, submit Committees/AboutAdvisoryCommittees/ location of the advisory committee either electronic or written comments ucm111462.htm for procedures on meeting, and the background material on the draft guidance by September 27, public conduct during advisory will be posted on FDA’s Web site after 2016. committee meetings. the meeting. Background material is Notice of this meeting is given under ADDRESSES: You may submit comments available at http://www.fda.gov/ the Federal Advisory Committee Act (5 as follows: AdvisoryCommittees/Calendar/ U.S.C. app. 2). default.htm. Scroll down to the Electronic Submissions Dated: June 23, 2016. appropriate advisory committee meeting Submit electronic comments in the link. Jill Hartzler Warner, following way: Procedure: Interested persons may Associate Commissioner for Special Medical • Federal eRulemaking Portal: http:// Programs. www.regulations.gov. Follow the present data, information, or views, [FR Doc. 2016–15362 Filed 6–28–16; 8:45 am] orally or in writing, on issues pending instructions for submitting comments. before the committee. Written BILLING CODE 4164–01–P Comments submitted electronically, submissions may be made to the contact including attachments, to http:// person on or before August 2, 2016. Oral www.regulations.gov will be posted to DEPARTMENT OF HEALTH AND the docket unchanged. Because your presentations from the public will be HUMAN SERVICES scheduled between approximately 1 comment will be made public, you are p.m. and 2 p.m. Those individuals Food and Drug Administration solely responsible for ensuring that your interested in making formal oral comment does not include any [Docket No. FDA–2016–D–1399] confidential information that you or a presentations should notify the contact person and submit a brief statement of third party may not wish to be posted, Procedures for Evaluating Appearance such as medical information, your or the general nature of the evidence or Issues and Granting Authorizations for arguments they wish to present, the anyone else’s Social Security number, or Participation in Food and Drug confidential business information, such names and addresses of proposed Administration Advisory Committees; participants, and an indication of the as a manufacturing process. Please note Draft Guidance for the Public, Food that if you include your name, contact approximate time requested to make and Drug Administration Advisory their presentation on or before July 15, information, or other information that Committee Members, and Food and identifies you in the body of your 2016. Time allotted for each Drug Administration Staff; Availability presentation may be limited. If the comments, that information will be number of registrants requesting to AGENCY: Food and Drug Administration, posted on http://www.regulations.gov. speak is greater than can be reasonably HHS. • If you want to submit a comment accommodated during the scheduled ACTION: Notice. with confidential information that you open public hearing session, FDA may do not wish to be made available to the conduct a lottery to determine the SUMMARY: The Food and Drug public, submit the comment as a speakers for the scheduled open public Administration (FDA) is announcing the written/paper submission and in the hearing session. The contact person will availability of a draft guidance entitled manner detailed (see ‘‘Written/Paper notify interested persons regarding their ‘‘Procedures for Evaluating Appearance Submissions’’ and ‘‘Instructions’’). request to speak by July 21, 2016. Issues and Granting Authorizations for Participation in FDA Advisory Written/Paper Submissions Persons attending FDA’s advisory Committees; Guidance for the Public, Submit written/paper submissions as committee meetings are advised that the FDA Advisory Committee Members, and follows: Agency is not responsible for providing FDA Staff.’’ This draft guidance • Mail/Hand delivery/Courier (for access to electrical outlets. addresses FDA’s process, under written/paper submissions): Division of FDA is establishing a docket for Government-wide Federal regulations, Dockets Management (HFA–305), Food public comment on this document. The for evaluating whether an advisory and Drug Administration, 5630 Fishers mstockstill on DSK3G9T082PROD with NOTICES docket number is FDA–2016–N–1660. committee member has an appearance Lane, Rm. 1061, Rockville, MD 20852. The docket will close on September 16, issue that raises concerns about the • For written/paper comments 2016. Comments received on or before member’s participation in an advisory submitted to the Division of Dockets July 26, 2016, will be provided to the committee meeting and describes FDA’s Management, FDA will post your committee. Comments received after process for determining whether to comment, as well as any attachments, that date will be taken into authorize a member with an appearance except for information submitted, consideration by the Agency. issue to participate in the advisory marked and identified, as confidential, VerDate Sep<11>2014 17:18 Jun 28, 2016 Jkt 238001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\29JNN1.SGM 29JNN1

42364 Federal Register / Vol. 81, No. 125 / Wednesday, June 29, 2016 / Notices if submitted as detailed in Submit written requests for a single advisory committee meeting to ‘‘Instructions.’’ hard copy of the draft guidance entitled voluntarily publicly disclose Instructions: All submissions received ‘‘Procedures for Evaluating Appearance authorization. The Agency will consider must include the Docket No. FDA– Issues and Granting Authorizations for these comments in developing the final 2016–D–1399 for ‘‘Procedures for Participation in FDA Advisory guidance document. Evaluating Appearance Issues and Committees; Guidance for the Public, Granting Authorizations for II. Significance of Guidance FDA Advisory Committee Members, and Participation in Food and Drug FDA Staff’’ to the Advisory Committee This draft guidance is being issued Administration Advisory Committees; Oversight and Management Staff, Office consistent with FDA’s good guidance Draft Guidance for the Public, Food and of Special Medical Programs, Food and practices regulation (21 CFR 10.115). Drug Administration Advisory Drug Administration, 10903 New The draft guidance, when finalized, will Committee Members, and Food and Hampshire Ave., Bldg. 32, Rm. 5103, represent the Agency’s current thinking Drug Administration Staff; Silver Spring, MD 20993–0002. Send on the processes for evaluating Availability.’’ Received comments will one self-addressed adhesive label to appearance issues and granting an be placed in the docket and, except for assist that office in processing your authorization. It does not create or those submitted as ‘‘Confidential request. confer any rights for or on any person Submissions,’’ publicly viewable at and does not operate to bind FDA or the FOR FURTHER INFORMATION CONTACT: http://www.regulations.gov or at the public. An alternative approach may be Division of Dockets Management Michael Ortwerth, Advisory Committee Oversight and Management Staff, Office used if such approach satisfies the between 9 a.m. and 4 p.m., Monday requirements of the applicable statute through Friday. of Special Medical Programs, Food and Drug Administration, 10903 New and regulations. • Confidential Submissions—To submit a comment with confidential Hampshire Ave., Bldg. 32, Rm. 5103, III. Electronic Access information that you do not wish to be Silver Spring, MD 20993–0002, 301– Persons interested in obtaining a copy made publicly available, submit your 796–8220. of the draft guidance may do so by comments only as a written/paper SUPPLEMENTARY INFORMATION: downloading an electronic copy from submission. You should submit two I. Background the Internet at either http:// copies total. One copy will include the www.fda.gov/RegulatoryInformation/ information you claim to be confidential Advisory committees provide Guidances/ucm122044.htm or http:// with a heading or cover note that states independent, expert advice to FDA on a www.regulations.gov. ‘‘THIS DOCUMENT CONTAINS range of issues affecting the public health. To protect the credibility and Dated: June 23, 2016. CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including integrity of advisory committee advice, Leslie Kux, the claimed confidential information, in FDA screens advisory committee Associate Commissioner for Policy. its consideration of comments. The members carefully for two categories of [FR Doc. 2016–15384 Filed 6–28–16; 8:45 am] second copy, which will have the potentially disqualifying interests or BILLING CODE 4164–01–P claimed confidential information relationships: (1) Current financial redacted/blacked out, will be available interests that may create a recusal for public viewing and posted on http:// obligation under Federal conflict of DEPARTMENT OF HEALTH AND www.regulations.gov. Submit both interest laws (18 U.S.C. 208) and (2) HUMAN SERVICES copies to the Division of Dockets other interests and relationships that do Management. If you do not wish your not create a recusal obligation under Food and Drug Administration name and contact information to be financial conflict of interest laws but [Docket No. FDA–2016–N–0001] made publicly available, you can may create the appearance that the provide this information on the cover member lacks impartiality (5 CFR Anesthetic and Analgesic Drug sheet and not in the body of your 2635.502). This draft guidance Products Advisory Committee and the comments and you must identify this addresses FDA’s process for evaluating Drug Safety and Risk Management information as ‘‘confidential.’’ Any whether an advisory committee member Advisory Committee; Notice of Meeting information marked as ‘‘confidential’’ has potentially disqualifying interests or relationships that fall into the second AGENCY: Food and Drug Administration, will not be disclosed except in accordance with 21 CFR 10.20 and other category of interests, which are known HHS. applicable disclosure law. For more as appearance issues, under 5 CFR ACTION: Notice. information about FDA’s posting of 2635.502. It also describes FDA’s process for determining whether to SUMMARY: The Food and Drug comments to public dockets, see 80 FR authorize a member with an appearance Administration (FDA) announces a 56469, September 18, 2015, or access issue to participate in an advisory forthcoming public advisory committee the information at: http://www.fda.gov/ committee meeting under 5 CFR meeting of the Anesthetic and Analgesic regulatoryinformation/dockets/ 2635.502. Drug Products Advisory Committee and default.htm. Docket: For access to the docket to In addition, FDA is seeking comment the Drug Safety and Risk Management read background documents or the regarding public disclosure of such Advisory Committee. The general electronic and written/paper comments authorizations. Under Federal laws function of the committees is to provide received, go to http:// protecting the confidentiality of advice and recommendations to the mstockstill on DSK3G9T082PROD with NOTICES www.regulations.gov and insert the information, FDA may not itself disclose Agency on FDA’s regulatory issues. At docket number, found in brackets in the confidential information provided by least one portion of the meeting will be heading of this document, into the advisory committee members related to closed to the public. ‘‘Search’’ box and follow the prompts appearance issues. FDA is soliciting DATES: The meeting will be held on and/or go to the Division of Dockets comment on whether the agency should August 4, 2016, from 8 a.m. to 5 p.m. Management, 5630 Fishers Lane, Rm. ask members with appearance issues ADDRESSES: FDA White Oak Campus, 1061, Rockville, MD 20852. who are authorized to participate in an 10903 New Hampshire Ave., Bldg. 31 VerDate Sep<11>2014 17:18 Jun 28, 2016 Jkt 238001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\29JNN1.SGM 29JNN1


Document Created: 2018-02-08 07:43:06
Document Modified: 2018-02-08 07:43:06
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesAlthough 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.
ContactMichael 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.
FR Citation81 FR 42363 
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