82_FR_9406 82 FR 9383 - Agency Information Collection Activities: Proposed Collection; Comment Request; Collection of Nominations for Candidates To Serve on the Food and Drug Administration's Advisory Committees

82 FR 9383 - Agency Information Collection Activities: Proposed Collection; Comment Request; Collection of Nominations for Candidates To Serve on the Food and Drug Administration's Advisory Committees

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 23 (February 6, 2017)

Page Range9383-9385
FR Document2017-02412

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.

Federal Register, Volume 82 Issue 23 (Monday, February 6, 2017)
[Federal Register Volume 82, Number 23 (Monday, February 6, 2017)]
[Notices]
[Pages 9383-9385]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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

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, PRAStaff@fda.hhs.gov.

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



                                                                             Federal Register / Vol. 82, No. 23 / Monday, February 6, 2017 / Notices                                             9383

                                                advisory committee member’s CV is                       ACTION:   Notice.                                     marked and identified, as confidential,
                                                submitted to FDA. All information                                                                             if submitted as detailed in
                                                contained in the CV submission for                      SUMMARY:   The Food and Drug                          ‘‘Instructions.’’
                                                individuals who are selected for or                     Administration (FDA or Agency) is                        Instructions: All submissions received
                                                currently serving on an FDA advisory                    announcing an opportunity for public                  must include the Docket No. FDA–
                                                committee will be available for public                  comment on the proposed collection of                 2017–N–0366 for ‘‘Agency Information
                                                posting. Specifically, for nominees for                 certain information by the Agency.                    Collection Activities: Proposed
                                                positions on an FDA advisory                            Under the Paperwork Reduction Act of                  Collection; Comment Request;
                                                committee, the required consent will                    1995 (PRA), Federal Agencies are                      Collection of Nominations for
                                                state as follows:                                       required to publish notice in the                     Candidates to Serve on FDA’s Advisory
                                                                                                        Federal Register concerning each                      Committees.’’ Received comments will
                                                  If I am selected to serve on an advisory              proposed collection of information and
                                                committee, I consent to publication of my                                                                     be placed in the docket and, except for
                                                                                                        to allow 60 days for public comment in
                                                curriculum vitae (CV), and any subsequent                                                                     those submitted as ‘‘Confidential
                                                updates to my CV that I provide FDA, on                 response to the notice. This notice
                                                                                                                                                              Submissions,’’ publicly viewable at
                                                FDA’s Web site, without removing or                     solicits comments on the Agency’s
                                                                                                                                                              https://www.regulations.gov or at the
                                                redacting any information. My CV does not               process for collecting nominations of
                                                                                                                                                              Division of Dockets Management
                                                include any confidential information,                   candidates to serve on FDA’s advisory
                                                                                                                                                              between 9 a.m. and 4 p.m., Monday
                                                including information pertaining to third               committees.
                                                parties that I am not permitted to disclose.                                                                  through Friday.
                                                                                                        DATES: Submit either electronic or                       • Confidential Submissions—To
                                                For existing advisory committee                         written comments on the collection of                 submit a comment with confidential
                                                members who submit updated CVs, the                     information by April 7, 2017.                         information that you do not wish to be
                                                required consent will state as follows:                 ADDRESSES: You may submit comments                    made publicly available, submit your
                                                  I consent to publication of my curriculum             as follows:                                           comments only as a written/paper
                                                vitae (CV), and any subsequent updates to my                                                                  submission. You should submit two
                                                CV that I provide FDA, on FDA’s Web site,               Electronic Submissions
                                                                                                                                                              copies total. One copy will include the
                                                without removing or redacting any                         Submit electronic comments in the
                                                information. My CV does not include any
                                                                                                                                                              information you claim to be confidential
                                                                                                        following way:                                        with a heading or cover note that states
                                                confidential information, including                       • Federal eRulemaking Portal:
                                                information pertaining to third parties that I                                                                ‘‘THIS DOCUMENT CONTAINS
                                                am not permitted to disclose.
                                                                                                        https://www.regulations.gov. Follow the               CONFIDENTIAL INFORMATION.’’ The
                                                                                                        instructions for submitting comments.                 Agency will review this copy, including
                                                III. Date of Implementation                             Comments submitted electronically,                    the claimed confidential information, in
                                                                                                        including attachments, to https://                    its consideration of comments. The
                                                   All nominations for new advisory                     www.regulations.gov will be posted to
                                                committee members will be required to                                                                         second copy, which will have the
                                                                                                        the docket unchanged. Because your                    claimed confidential information
                                                be submitted through FDA’s Web site at                  comment will be made public, you are
                                                https://www.accessdata.fda.gov/scripts/                                                                       redacted/blacked out, will be available
                                                                                                        solely responsible for ensuring that your             for public viewing and posted on
                                                FACTRSPortal/FACTRS/index.cfm, or                       comment does not include any
                                                any successor system, and the                                                                                 https://www.regulations.gov. Submit
                                                                                                        confidential information that you or a                both copies to the Division of Dockets
                                                submission will be required to be                       third party may not wish to be posted,
                                                accompanied by the required consent                                                                           Management. If you do not wish your
                                                                                                        such as medical information, your or                  name and contact information to be
                                                form, on or after the date of OMB                       anyone else’s Social Security number, or
                                                approval for this information collection.                                                                     made publicly available, you can
                                                                                                        confidential business information, such               provide this information on the cover
                                                All updated CVs for existing advisory                   as a manufacturing process. Please note
                                                committee members will be required to                                                                         sheet and not in the body of your
                                                                                                        that if you include your name, contact                comments and you must identify this
                                                be submitted to FDA along with the                      information, or other information that
                                                required consent form after March 8,                                                                          information as ‘‘confidential.’’ Any
                                                                                                        identifies you in the body of your                    information marked as ‘‘confidential’’
                                                2017.                                                   comments, that information will be                    will not be disclosed except in
                                                  Dated: February 1, 2017.                              posted on https://www.regulations.gov.                accordance with 21 CFR 10.20 and other
                                                Leslie Kux,                                               • If you want to submit a comment                   applicable disclosure law. For more
                                                Associate Commissioner for Policy.                      with confidential information that you                information about FDA’s posting of
                                                [FR Doc. 2017–02411 Filed 2–3–17; 8:45 am]              do not wish to be made available to the               comments to public dockets, see 80 FR
                                                BILLING CODE 4164–01–P
                                                                                                        public, submit the comment as a                       56469, September 18, 2015, or access
                                                                                                        written/paper submission and in the                   the information at: http://www.fda.gov/
                                                                                                        manner detailed (see ‘‘Written/Paper                  regulatoryinformation/dockets/
                                                DEPARTMENT OF HEALTH AND                                Submissions’’ and ‘‘Instructions’’).                  default.htm.
                                                HUMAN SERVICES                                          Written/Paper Submissions                                Docket: For access to the docket to
                                                                                                          Submit written/paper submissions as                 read background documents or the
                                                Food and Drug Administration
                                                                                                        follows:                                              electronic and written/paper comments
                                                [Docket No. FDA–2017–N–0366]                              • Mail/Hand delivery/Courier (for                   received, go to https://
                                                                                                        written/paper submissions): Division of               www.regulations.gov and insert the
                                                Agency Information Collection                                                                                 docket number, found in brackets in the
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                                                Activities: Proposed Collection;                        Dockets Management (HFA–305), Food
                                                                                                        and Drug Administration, 5630 Fishers                 heading of this document, into the
                                                Comment Request; Collection of                                                                                ‘‘Search’’ box and follow the prompts
                                                Nominations for Candidates To Serve                     Lane, Rm. 1061, Rockville, MD 20852.
                                                                                                          • For written/paper comments                        and/or go to the Division of Dockets
                                                on the Food and Drug Administration’s                                                                         Management, 5630 Fishers Lane, Rm.
                                                                                                        submitted to the Division of Dockets
                                                Advisory Committees                                                                                           1061, Rockville, MD 20852.
                                                                                                        Management, FDA will post your
                                                AGENCY:    Food and Drug Administration,                comment, as well as any attachments,                  FOR FURTHER INFORMATION CONTACT: FDA
                                                HHS.                                                    except for information submitted,                     PRA Staff, Office of Operations, Food


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                                                9384                         Federal Register / Vol. 82, No. 23 / Monday, February 6, 2017 / Notices

                                                and Drug Administration, Three White                    Application, to accept nominations of                  research grants and/or contracts in order
                                                Flint North 10A63, 11601 Landsdown                      potential advisory committee members.                  to permit evaluation of possible sources
                                                St., North Bethesda, MD 20852,                             The FDA Advisory Committee                          of conflict of interest.
                                                PRAStaff@fda.hhs.gov.                                   Membership Application accepts                            Also, FDA asks that prospective
                                                                                                        applications for Academician/                          nominees inform us of how they heard
                                                SUPPLEMENTARY INFORMATION:       Under the
                                                                                                        Practitioner, Consumer Representative,                 about the FDA Advisory Committees
                                                PRA (44 U.S.C. 3501–3520), Federal
                                                                                                        and Industry Representative                            (e.g., attendance at a professional
                                                Agencies must obtain approval from the
                                                                                                        membership types. Nominees who are                     meeting, an article in a publication, our
                                                Office of Management and Budget                         nominated as scientific members should                 Web site, while speaking with a friend
                                                (OMB) for each collection of                            be technically qualified experts in the                or colleague).
                                                information they conduct or sponsor.                    field (e.g., clinical medicine,                           To further the Agency’s goals of
                                                ‘‘Collection of information’’ is defined                engineering, biological and physical                   promoting transparency regarding the
                                                in 44 U.S.C. 3502(3) and 5 CFR                          sciences, biostatistics, food sciences)                advisory committee process, FDA will
                                                1320.3(c) and includes Agency requests                  and have experience interpreting                       also require that nominees to serve on
                                                or requirements that members of the                     complex data. Candidates must be able                  advisory committees submit a consent
                                                public submit reports, keep records, or                 to analyze detailed scientific data and                form authorizing FDA to publicly post
                                                provide information to a third party.                   understand its public health                           to FDA’s Web site the CV submitted as
                                                Section 3506(c)(2)(A) of the PRA (44                    significance. The nomination process                   part of their nomination materials, if the
                                                U.S.C. 3506(c)(2)(A)) requires Federal                  has recently been made electronic and                  nominee is selected to serve on an
                                                Agencies to provide a 60-day notice in                  is available at http://                                advisory committee. In the past, FDA
                                                the Federal Register concerning each                    accessdata.test.fda.gov/scripts/                       generally has posted the CVs of FDA
                                                proposed collection of information,                     FACTRSPortal/FACTRS/index.cfm. To                      advisory committee members publicly
                                                including each proposed extension of an                 submit an application, prospective                     on http://www.fda.gov/
                                                existing collection of information,                     nominees should upload the following                   AdvisoryCommittees/after reviewing the
                                                before submitting the collection to OMB                 documents in PDF format: 2 (1)                         CVs and redacting information that
                                                for approval. To comply with this                       Curriculum vitae (CV); (2) a written                   appeared to be confidential. However,
                                                requirement, FDA is publishing notice                   confirmation that the nominee(s) is                    in furtherance of FDA’s goal of ensuring
                                                of the proposed collection of                           aware of the nomination (unless self-                  transparency regarding the
                                                information set forth in this document.                 nominated); and (3) letters of                         qualifications of individuals selected to
                                                   With respect to the following                        recommendation are also suggested.                     serve on FDA advisory committees, and
                                                collection of information, FDA invites                     For Consumer Representative                         in recognition that individual advisory
                                                comments on these topics: (1) Whether                   applications, a cover letter that lists                committee members are best situated to
                                                the proposed collection of information                  consumer or community organizations                    evaluate the confidentiality of
                                                is necessary for the proper performance                 for which the candidate can                            information contained in their CVs,
                                                of FDA’s functions, including whether                   demonstrate active participation is also               including any considerations raised by
                                                the information will have practical                     recommended.                                           their relationships and agreements with
                                                utility; (2) the accuracy of FDA’s                         These documents are collected in                    third parties, FDA will now be requiring
                                                estimate of the burden of the proposed                  order to determine if the nominee has                  that all CVs submitted as part of the
                                                collection of information, including the                the expertise in the subject matter with               nomination process for positions on
                                                validity of the methodology and                         which the committee is concerned and                   FDA advisory committees be
                                                assumptions used; (3) ways to enhance                   has diverse professional education,                    accompanied by a written consent form
                                                the quality, utility, and clarity of the                training, and experience so that the                   stating that, if the nominee is accepted
                                                information to be collected; and (4)                    committee will reflect a balanced                      as a member of an FDA advisory
                                                ways to minimize the burden of the                      composition of sufficient scientific                   committee, the individual consents to
                                                collection of information on                            expertise to handle the problems that                  the publication of the individual’s CV to
                                                respondents, including through the use                  come before it (21 CFR 14.80(b)(1)(i)). In             FDA’s Web site, without FDA removing
                                                of automated collection techniques,                     the case of Industry and Consumer                      or redacting any information. The
                                                when appropriate, and other forms of                    Representatives, information is                        consent form requires that the nominee
                                                information technology.                                 collected to assess the candidate’s                    affirm that the CV does not include any
                                                                                                        ability to represent all interested                    confidential information, including
                                                Process for Collecting Nominations of
                                                                                                        persons within the class which the                     information pertaining to third parties
                                                Candidates to Serve on FDA’s Advisory
                                                                                                        member is selected to represent (21 CFR                that the nominee is not permitted to
                                                Committees—OMB Control Number
                                                                                                        14.86).                                                disclose. A nominee will be required to
                                                0910—NEW
                                                                                                           Each nominee should be sure to                      submit a signed consent form as a part
                                                   FDA chooses to select advisory                       review the Agency Web site for                         of the nomination package in order for
                                                committee members through a                             information on:                                        the nomination to be considered
                                                nomination process.1 A person can self-                    • Vacancies, Qualifications, and                    complete.
                                                nominate or be nominated by another                     Experience for more details concerning                    All nominations for new advisory
                                                individual. In order to identify and                    vacancies on each committee and the                    committee members will be required to
                                                select qualified individuals to serve on                qualifications and experience common                   be submitted through FDA’s Web site at
                                                its advisory committees, FDA has                        for nominees. Vacancies are updated                    https://www.accessdata.fda.gov/scripts/
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                                                established an online portal, the FDA                   periodically; therefore, one or more                   FACTRSPortal/FACTRS/index.cfm, or
                                                Advisory Committee Membership                           vacancies listed may be in the                         any successor system, and the
                                                                                                        nomination process or a final                          submission will be required to be
                                                  1 Key point and principle I. of Appendix A to
                                                                                                        appointment may have been made.                        accompanied by the consent form, on or
                                                Subpart C of 41 CFR 102–3, the Federal Advisory            • Potential Conflicts of Interest such              after the date of OMB approval for this
                                                Committee Management Final Rule notes that the
                                                Federal Advisory Committee Act does not specify         as financial holdings, employment, and                 information collection.
                                                the manner in which advisory committee members                                                                    An estimate of the burden of this
                                                and staff must be appointed.                              2 21   CFR 14.82(c).                                 collection is provided in table 1. FDA


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                                                                              Federal Register / Vol. 82, No. 23 / Monday, February 6, 2017 / Notices                                                    9385

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

                                                                                                TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
                                                                                                                                          Number of
                                                   21 CFR Part 14; Subpart E—Members of Advisory                     Number of                             Total annual      Average burden
                                                                                                                                        responses per                                              Total hours
                                                                     Committees                                     respondents                             responses         per response
                                                                                                                                          respondent

                                                Advisory Committee Membership Applications .............                   553                 1                553         0.25 (15 minutes)        138.25
                                                   1 There   are no capital costs or operating and maintenance costs associated with this collection of information.


                                                  Dated: February 1, 2017.                                 Time: 8:00 a.m. to 6:00 p.m.                           Place: National Institutes of Health, 6701
                                                Leslie Kux,                                                Agenda: To review and evaluate grant                 Rockledge Drive, Bethesda, MD 20892
                                                                                                         applications.                                          (Virtual Meeting).
                                                Associate Commissioner for Policy.
                                                                                                           Place: National Institutes of Health, 6701             Contact Person: Kristin Kramer, Ph.D.,
                                                [FR Doc. 2017–02412 Filed 2–3–17; 8:45 am]                                                                      Scientific Review Officer, Center for
                                                                                                         Rockledge Drive, Bethesda, MD 20892
                                                BILLING CODE 4164–01–P                                   (Virtual Meeting).                                     Scientific Review, National Institutes of
                                                                                                           Contact Person: John Bishop, Ph.D.,                  Health, 6701 Rockledge Drive, Room 5205,
                                                                                                         Scientific Review Officer, Center for                  MSC 7846, Bethesda, MD 20892, (301) 437–
                                                DEPARTMENT OF HEALTH AND                                 Scientific Review, National Institutes of              0911, kramerkm@csr.nih.gov.
                                                HUMAN SERVICES                                           Health, 6701 Rockledge Drive, Room 5182,                 Name of Committee: Center for Scientific
                                                                                                         MSC 7844, Bethesda, MD 20892, (301) 408–               Review Special Emphasis Panel; Member
                                                National Institutes of Health                            9664, bishopj@csr.nih.gov.                             Conflict: Neural Trauma and Stroke.
                                                                                                                                                                  Date: March 1, 2017.
                                                                                                           Name of Committee: Center for Scientific               Time: 1:00 p.m. to 5:30 p.m.
                                                Center for Scientific Review; Notice of
                                                                                                         Review Special Emphasis Panel; PAR Panel:                Agenda: To review and evaluate grant
                                                Closed Meetings                                          Synthetic Psychoactive Drugs and Strategic             applications.
                                                  Pursuant to section 10(d) of the                       Approaches to Counteract their Deleterious               Place: National Institutes of Health, 6701
                                                Federal Advisory Committee Act, as                       Effects.                                               Rockledge Drive, Bethesda, MD 20892
                                                amended (5 U.S.C. App.), notice is                         Date: February 28, 2017.                             (Telephone Conference Call).
                                                                                                           Time: 2:00 p.m. to 4:30 p.m.                           Contact Person: Alexei Kondratyev, Ph.D.,
                                                hereby given of the following meetings.
                                                                                                           Agenda: To review and evaluate grant                 Scientific Review Officer, Center for
                                                  The meetings will be closed to the
                                                                                                         applications.                                          Scientific Review, National Institutes of
                                                public in accordance with the                              Place: National Institutes of Health, 6701           Health, 6701 Rockledge Drive, Room 5200,
                                                provisions set forth in sections                         Rockledge Drive, Bethesda, MD 20892                    MSC 7846, Bethesda, MD 20892, 301–435–
                                                552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,               (Virtual Meeting).                                     1785, kondratyevad@csr.nih.gov.
                                                as amended. The grant applications and                     Contact Person: Jasenka Borzan, Ph.D.,               (Catalogue of Federal Domestic Assistance
                                                the discussions could disclose                           Scientific Review Officer, Center for                  Program Nos. 93.306, Comparative Medicine;
                                                confidential trade secrets or commercial                 Scientific Review, National Institutes of              93.333, Clinical Research, 93.306, 93.333,
                                                property such as patentable material,                    Health, 6701 Rockledge Drive, Room 4214                93.337, 93.393–93.396, 93.837–93.844,
                                                and personal information concerning                      MSC 7814, Bethesda, MD 20892–7814, 301–                93.846–93.878, 93.892, 93.893, National
                                                individuals associated with the grant                    435–1787, borzanj@csr.nih.gov.                         Institutes of Health, HHS)
                                                applications, the disclosure of which                      Name of Committee: Center for Scientific               Dated: January 30, 2017.
                                                would constitute a clearly unwarranted                   Review Special Emphasis Panel; PAR16–095:              Sylvia L. Neal,
                                                invasion of personal privacy.                            Biopsychosocial Mechanisms in the                      Program Analyst, Office of Federal Advisory
                                                                                                         Management of Chronic Conditions.                      Committee Policy.
                                                  Name of Committee: Center for Scientific                 Date: February 28–March 1, 2017.
                                                Review Special Emphasis Panel; PAR–14–                     Time: 12:00 p.m. to 5:00 p.m.                        [FR Doc. 2017–02385 Filed 2–3–17; 8:45 am]
                                                355 Panel: Pregnancy in Women With                         Agenda: To review and evaluate grant                 BILLING CODE 4140–01–P
                                                Disabilities (R01).                                      applications.
                                                  Date: February 27, 2017.                                 Place: National Institutes of Health, 6701
                                                  Time: 12:00 p.m. to 4:00 p.m.                                                                                 DEPARTMENT OF HEALTH AND
                                                                                                         Rockledge Drive, Bethesda, MD 20892
                                                  Agenda: To review and evaluate grant
                                                applications.
                                                                                                         (Virtual Meeting).                                     HUMAN SERVICES
                                                  Place: National Institutes of Health, 6701               Contact Person: Unja Hayes, Ph.D.,
                                                Rockledge Drive, Bethesda, MD 20892                      Scientific Review Officer, National Institutes         National Institutes of Health
                                                (Telephone Conference Call).                             of Health, Center for Scientific Review, 6701
                                                  Contact Person: Martha L. Hare, RN, Ph.D.,             Rockledge Drive, Bethesda, MD 20892, 301–              Eunice Kennedy Shriver National
                                                Scientific Review Officer, Center for                    435–1037, unja.hayes@nih.gov.                          Institute of Child Health & Human
                                                Scientific Review, National Institutes of                  Name of Committee: Center for Scientific             Development; Notice of Closed
sradovich on DSK3GMQ082PROD with NOTICES




                                                Health, 6701 Rockledge Drive, Room 3154,                 Review Special Emphasis Panel; PAR16–212:              Meetings
                                                MSC 7770, Bethesda, MD 20892, (301) 451–                 Cognitive Neuroscience and Assessment of
                                                8504, harem@mail.nih.gov.                                Cancer Treatment-Related Cognitive                       Pursuant to section 10(d) of the
                                                  Name of Committee: Center for Scientific               Impairment.                                            Federal Advisory Committee Act, as
                                                Review Special Emphasis Panel; Member                      Date: March 1, 2017.                                 amended (5 U.S.C. App.), notice is
                                                Conflict: Pain and Chemosensory                            Time: 9:00 a.m. to 5:00 p.m.                         hereby given of the following meetings.
                                                Mechanisms.                                                Agenda: To review and evaluate grant                   The meetings will be closed to the
                                                  Date: February 28–March 1, 2017.                       applications.                                          public in accordance with the


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Document Created: 2017-02-04 00:25:02
Document Modified: 2017-02-04 00:25:02
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.
DatesSubmit either electronic or written comments on the collection of information by April 7, 2017.
ContactFDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]
FR Citation82 FR 9383 

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