[Federal Register Volume 82, Number 23 (Monday, February 6, 2017)]
[Notices]
[Pages 9383-9385]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-02412]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0366]


Agency Information Collection Activities: Proposed Collection; 
Comment Request; Collection of Nominations for Candidates To Serve on 
the Food and Drug Administration's Advisory Committees

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information and to 
allow 60 days for public comment in response to the notice. This notice 
solicits comments on the Agency's process for collecting nominations of 
candidates to serve on FDA's advisory committees.

DATES: Submit either electronic or written comments on the collection 
of information by April 7, 2017.

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-2017-N-0366 for ``Agency Information Collection Activities: 
Proposed Collection; Comment Request; Collection of Nominations for 
Candidates to Serve on FDA's Advisory Committees.'' 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: 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 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: FDA PRA Staff, Office of Operations, 
Food

[[Page 9384]]

and Drug Administration, Three White Flint North 10A63, 11601 Landsdown 
St., North Bethesda, MD 20852, [email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Process for Collecting Nominations of Candidates to Serve on FDA's 
Advisory Committees--OMB Control Number 0910--NEW

    FDA chooses to select advisory committee members through a 
nomination process.\1\ A person can self-nominate or be nominated by 
another individual. In order to identify and select qualified 
individuals to serve on its advisory committees, FDA has established an 
online portal, the FDA Advisory Committee Membership Application, to 
accept nominations of potential advisory committee members.
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    \1\ Key point and principle I. of Appendix A to Subpart C of 41 
CFR 102-3, the Federal Advisory Committee Management Final Rule 
notes that the Federal Advisory Committee Act does not specify the 
manner in which advisory committee members and staff must be 
appointed.
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    The FDA Advisory Committee Membership Application accepts 
applications for Academician/Practitioner, Consumer Representative, and 
Industry Representative membership types. Nominees who are nominated as 
scientific members should be technically qualified experts in the field 
(e.g., clinical medicine, engineering, biological and physical 
sciences, biostatistics, food sciences) and have experience 
interpreting complex data. Candidates must be able to analyze detailed 
scientific data and understand its public health significance. The 
nomination process has recently been made electronic and is available 
at http://accessdata.test.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm. To submit an application, prospective nominees should upload 
the following documents in PDF format: \2\ (1) Curriculum vitae (CV); 
(2) a written confirmation that the nominee(s) is aware of the 
nomination (unless self-nominated); and (3) letters of recommendation 
are also suggested.
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    \2\ 21 CFR 14.82(c).
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    For Consumer Representative applications, a cover letter that lists 
consumer or community organizations for which the candidate can 
demonstrate active participation is also recommended.
    These documents are collected in order to determine if the nominee 
has the expertise in the subject matter with which the committee is 
concerned and has diverse professional education, training, and 
experience so that the committee will reflect a balanced composition of 
sufficient scientific expertise to handle the problems that come before 
it (21 CFR 14.80(b)(1)(i)). In the case of Industry and Consumer 
Representatives, information is collected to assess the candidate's 
ability to represent all interested persons within the class which the 
member is selected to represent (21 CFR 14.86).
    Each nominee should be sure to review the Agency Web site for 
information on:
     Vacancies, Qualifications, and Experience for more details 
concerning vacancies on each committee and the qualifications and 
experience common for nominees. Vacancies are updated periodically; 
therefore, one or more vacancies listed may be in the nomination 
process or a final appointment may have been made.
     Potential Conflicts of Interest such as financial 
holdings, employment, and research grants and/or contracts in order to 
permit evaluation of possible sources of conflict of interest.
    Also, FDA asks that prospective nominees inform us of how they 
heard about the FDA Advisory Committees (e.g., attendance at a 
professional meeting, an article in a publication, our Web site, while 
speaking with a friend or colleague).
    To further the Agency's goals of promoting transparency regarding 
the advisory committee process, FDA will also require that nominees to 
serve on advisory committees submit a consent form authorizing FDA to 
publicly post to FDA's Web site the CV submitted as part of their 
nomination materials, if the nominee is selected to serve on an 
advisory committee. In the past, FDA generally has posted the CVs of 
FDA advisory committee members publicly on http://www.fda.gov/AdvisoryCommittees/after reviewing the CVs and redacting information 
that appeared to be confidential. However, in furtherance of FDA's goal 
of ensuring transparency regarding the qualifications of individuals 
selected to serve on FDA advisory committees, and in recognition that 
individual advisory committee members are best situated to evaluate the 
confidentiality of information contained in their CVs, including any 
considerations raised by their relationships and agreements with third 
parties, FDA will now be requiring that all CVs submitted as part of 
the nomination process for positions on FDA advisory committees be 
accompanied by a written consent form stating that, if the nominee is 
accepted as a member of an FDA advisory committee, the individual 
consents to the publication of the individual's CV to FDA's Web site, 
without FDA removing or redacting any information. The consent form 
requires that the nominee affirm that the CV does not include any 
confidential information, including information pertaining to third 
parties that the nominee is not permitted to disclose. A nominee will 
be required to submit a signed consent form as a part of the nomination 
package in order for the nomination to be considered complete.
    All nominations for new advisory committee members will be required 
to be submitted through FDA's Web site at https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm, or any 
successor system, and the submission will be required to be accompanied 
by the consent form, on or after the date of OMB approval for this 
information collection.
    An estimate of the burden of this collection is provided in table 
1. FDA

[[Page 9385]]

expects that 138.25 burden hours will be expended annually by 
respondents to the collection of information. FDA estimates that 553 
respondents will each submit 1 application for a total of 553 annual 
responses. We estimate each response will require an average of 0.25 
hours (15 minutes) for a total of 138.25 annual hours.
    Our estimate of 553 respondents is based on averaging the number of 
nomination submissions we have received over the past 5 fiscal years. 
In fiscal year (FY) 2011 we received 638 submissions; FY 2012, 603 
submissions; FY 2013, 622 submissions; FY 2014, 545 submissions; and FY 
2015, 357 submissions. We believe that each submission will require 15 
minutes based on our experience with the submission portal.

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                  Number of
    21 CFR Part 14; Subpart E--Members of        Number of      responses per     Total annual         Average burden per response         Total hours
             Advisory Committees                respondents       respondent       responses
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Advisory Committee Membership Applications..             553                1              553   0.25 (15 minutes).....................          138.25
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: February 1, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-02412 Filed 2-3-17; 8:45 am]
 BILLING CODE 4164-01-P