81_FR_73013 81 FR 72809 - Request for Nominations for Voting Members on a Public Advisory Committee; Food Advisory Committee

81 FR 72809 - Request for Nominations for Voting Members on a Public Advisory Committee; Food Advisory Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 204 (October 21, 2016)

Page Range72809-72810
FR Document2016-25497

The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Food Advisory Committee (the Committee), Office of Regulations, Policy, and Social Sciences, Center for Food Safety and Applied Nutrition. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.

Federal Register, Volume 81 Issue 204 (Friday, October 21, 2016)
[Federal Register Volume 81, Number 204 (Friday, October 21, 2016)]
[Notices]
[Pages 72809-72810]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-25497]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Request for Nominations for Voting Members on a Public Advisory 
Committee; Food Advisory Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is requesting 
nominations for voting members to serve on the Food Advisory Committee 
(the Committee), Office of Regulations, Policy, and Social Sciences, 
Center for Food Safety and Applied Nutrition.
    FDA seeks to include the views of women and men, members of all 
racial and ethnic groups, and individuals with and without disabilities 
on its advisory committees and, therefore, encourages nominations of 
appropriately qualified candidates from these groups.

DATES: Nominations received on or before December 20, 2016, will be 
given first consideration for membership on the Food Advisory 
Committee. Nominations received after December 20, 2016, will be 
considered for nomination to the committee as later vacancies occur.

ADDRESSES: All nominations for membership should be sent electronically 
by logging into the FDA Advisory Committee Membership Nomination 
Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm or by mail to Advisory Committee Oversight and Management 
Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
32, Rm. 5103, Silver Spring, MD 20993-0002.

FOR FURTHER INFORMATION CONTACT: Regarding all nomination questions for 
membership, the primary contact is: Karen Strambler, 5001 Campus Drive, 
Rm. 1C-008, College Park, MD 20740, email: [email protected], 
240-402-2589, Fax: 301-436-2367.
    Information about becoming a member on an FDA advisory committee 
can also be obtained by visiting FDA's Web site by using the following 
link: http://www.fda.gov/AdvisoryCommittees/default.htm.

SUPPLEMENTARY INFORMATION: FDA is requesting nomination for voting 
members on the Committee.

I. General Description of the Committee Duties

    The Committee reviews and evaluates emerging food safety, 
nutrition, and other food- or cosmetic-related health issues that FDA 
considers of primary importance for its food and cosmetics programs. 
The Committee may be charged with reviewing and evaluating available 
data and making recommendations on matters such as those relating to: 
(1) Broad scientific and technical food- or cosmetic-related issues, 
(2) the safety of food ingredients and new foods, (3) labeling of foods 
and cosmetics, (4) nutrient needs and nutritional adequacy, and (5) 
safe exposure limits for food contaminants. The Committee may also be 
asked to provide advice and make recommendations on ways of 
communicating to the public the potential risks associated with these 
issues and on approaches that might be considered for addressing the 
issues.

II. Criteria for Voting Members

    The Committee consists of a core of 15 voting members including the 
Chair. Members and the Chair are selected by the Commissioner of Food 
and Drugs (the Commissioner) designee from among authorities 
knowledgeable in the fields of physical sciences, biological and life 
sciences, food science, risk assessment, nutrition, food technology, 
molecular biology, epidemiology and other relevant scientific and 
technical disciplines. Members will be invited to serve for overlapping 
terms of up to 4 years. Almost all non-Federal members of this 
Committee serve as Special Government Employees. The core of voting 
members may include two technically qualified member(s), selected by 
the Commissioner or designee, who are identified with consumer 
interests and are recommended by either a consortium of consumer-
oriented organizations or other interested persons. In addition to the 
voting members, the Committee may include two non-voting member(s) who 
are identified with industry interests.

III. Nomination Procedures

    Any interested person may nominate one or more qualified 
individuals for membership on the advisory committee. Self-nominations 
are also accepted. Nominations must include a current, complete 
r[eacute]sum[eacute] or curriculum vitae for each nominee, including 
current business address and/or home address, telephone number, and 
email address if available. Nominations must also

[[Page 72810]]

specify the advisory committee for which the nominee recommended. 
Nominations must also acknowledge that the nominee is aware of the 
nomination unless self-nominated. FDA will ask potential candidates to 
provide detailed information concerning such matters related to 
financial holdings, employment, and research grants and/or contracts to 
permit evaluation of possible sources of conflicts of interest.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: October 18, 2016.
Janice M. Soreth,
Acting Associate Commissioner, Special Medical Programs.
[FR Doc. 2016-25497 Filed 10-20-16; 8:45 am]
BILLING CODE 4164-01-P



                                                                                         Federal Register / Vol. 81, No. 204 / Friday, October 21, 2016 / Notices                                                      72809

                                                    sometimes been sent for the wrong                                    identified DHCP letters that were sent                 hours to prepare and send DHCP letters
                                                    reasons.                                                             and the identity of each sponsor sending               in accordance with the guidance.
                                                       In addition to content and format                                 out a DHCP letter for each year. We                      In the Federal Register of March 10,
                                                    recommendations for each type of DHCP                                estimate that we will receive                          2016 (81 FR 12734), we published a 60-
                                                    letter, the guidance also includes advice                            approximately 25 DHCP Letters                          day notice requesting public comment
                                                    on consulting with FDA to develop a                                  annually from approximately 18                         on the proposed extension of this
                                                    DHCP letter, when to send a letter, what                             application holders. FDA professionals                 collection of information. No comments
                                                    type of letter to send, and conducting an                            familiar with DHCP letters and with the
                                                    assessment of the letter’s impact.                                                                                          were received.
                                                                                                                         recommendations in the guidance                          FDA estimates the annual reporting
                                                       Based on a review of FDA’s Document
                                                    Archiving, Reporting and Regulatory                                  estimate that it should take an                        burden of this collection of information
                                                    Tracking System for 2012 to 2015, we                                 application holder approximately 100                   as follows:
                                                                                                              TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
                                                                                                                                                            Number of re-                          Average bur-
                                                                                                                                          Number of re-                        Total annual
                                                                                        Activity                                                             sponses per                            den per re-    Total hours
                                                                                                                                           spondents                            responses
                                                                                                                                                              respondent                          sponse (hours)

                                                    Annual average ....................................................................        18                  1.4              25                 100           2,500
                                                       1 There    are no capital costs or operating and maintenance costs associated with this collection of information.


                                                      Dated: October 17, 2016.                                           Advisory Committee Membership                          recommendations on ways of
                                                    Leslie Kux,                                                          Nomination Portal: https://                            communicating to the public the
                                                    Associate Commissioner for Policy.                                   www.accessdata.fda.gov/scripts/                        potential risks associated with these
                                                    [FR Doc. 2016–25481 Filed 10–20–16; 8:45 am]                         FACTRSPortal/FACTRS/index.cfm or by                    issues and on approaches that might be
                                                    BILLING CODE 4164–01–P
                                                                                                                         mail to Advisory Committee Oversight                   considered for addressing the issues.
                                                                                                                         and Management Staff, Food and Drug
                                                                                                                                                                                II. Criteria for Voting Members
                                                                                                                         Administration, 10903 New Hampshire
                                                    DEPARTMENT OF HEALTH AND                                             Ave., Bldg. 32, Rm. 5103, Silver Spring,                  The Committee consists of a core of
                                                    HUMAN SERVICES                                                       MD 20993–0002.                                         15 voting members including the Chair.
                                                                                                                         FOR FURTHER INFORMATION CONTACT:                       Members and the Chair are selected by
                                                    Food and Drug Administration                                         Regarding all nomination questions for                 the Commissioner of Food and Drugs
                                                    [Docket No. FDA–2016–N–0001]                                         membership, the primary contact is:                    (the Commissioner) designee from
                                                                                                                         Karen Strambler, 5001 Campus Drive,                    among authorities knowledgeable in the
                                                    Request for Nominations for Voting                                   Rm. 1C–008, College Park, MD 20740,                    fields of physical sciences, biological
                                                    Members on a Public Advisory                                         email: karen.strambler@fda.hhs.gov,                    and life sciences, food science, risk
                                                    Committee; Food Advisory Committee                                   240–402–2589, Fax: 301–436–2367.                       assessment, nutrition, food technology,
                                                                                                                           Information about becoming a                         molecular biology, epidemiology and
                                                    AGENCY:       Food and Drug Administration,                          member on an FDA advisory committee                    other relevant scientific and technical
                                                    HHS.                                                                 can also be obtained by visiting FDA’s                 disciplines. Members will be invited to
                                                    ACTION:     Notice.                                                  Web site by using the following link:                  serve for overlapping terms of up to 4
                                                                                                                         http://www.fda.gov/                                    years. Almost all non-Federal members
                                                    SUMMARY:   The Food and Drug                                         AdvisoryCommittees/default.htm.                        of this Committee serve as Special
                                                    Administration (FDA) is requesting                                                                                          Government Employees. The core of
                                                                                                                         SUPPLEMENTARY INFORMATION: FDA is
                                                    nominations for voting members to                                                                                           voting members may include two
                                                                                                                         requesting nomination for voting
                                                    serve on the Food Advisory Committee                                                                                        technically qualified member(s),
                                                                                                                         members on the Committee.
                                                    (the Committee), Office of Regulations,                                                                                     selected by the Commissioner or
                                                    Policy, and Social Sciences, Center for                              I. General Description of the Committee                designee, who are identified with
                                                    Food Safety and Applied Nutrition.                                   Duties                                                 consumer interests and are
                                                       FDA seeks to include the views of                                    The Committee reviews and evaluates                 recommended by either a consortium of
                                                    women and men, members of all racial                                 emerging food safety, nutrition, and                   consumer-oriented organizations or
                                                    and ethnic groups, and individuals with                              other food- or cosmetic-related health                 other interested persons. In addition to
                                                    and without disabilities on its advisory                             issues that FDA considers of primary                   the voting members, the Committee may
                                                    committees and, therefore, encourages                                importance for its food and cosmetics                  include two non-voting member(s) who
                                                    nominations of appropriately qualified                               programs. The Committee may be                         are identified with industry interests.
                                                    candidates from these groups.                                        charged with reviewing and evaluating
                                                    DATES: Nominations received on or
                                                                                                                                                                                III. Nomination Procedures
                                                                                                                         available data and making
                                                    before December 20, 2016, will be given                              recommendations on matters such as                        Any interested person may nominate
                                                    first consideration for membership on                                those relating to: (1) Broad scientific and            one or more qualified individuals for
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                    the Food Advisory Committee.                                         technical food- or cosmetic-related                    membership on the advisory committee.
                                                    Nominations received after December                                  issues, (2) the safety of food ingredients             Self-nominations are also accepted.
                                                    20, 2016, will be considered for                                     and new foods, (3) labeling of foods and               Nominations must include a current,
                                                    nomination to the committee as later                                 cosmetics, (4) nutrient needs and                      complete résumé or curriculum vitae for
                                                    vacancies occur.                                                     nutritional adequacy, and (5) safe                     each nominee, including current
                                                    ADDRESSES: All nominations for                                       exposure limits for food contaminants.                 business address and/or home address,
                                                    membership should be sent                                            The Committee may also be asked to                     telephone number, and email address if
                                                    electronically by logging into the FDA                               provide advice and make                                available. Nominations must also


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                                                    72810                         Federal Register / Vol. 81, No. 204 / Friday, October 21, 2016 / Notices

                                                    specify the advisory committee for                      including attachments, to http://                     claimed confidential information
                                                    which the nominee recommended.                          www.regulations.gov will be posted to                 redacted/blacked out, will be available
                                                    Nominations must also acknowledge                       the docket unchanged. Because your                    for public viewing and posted on http://
                                                    that the nominee is aware of the                        comment will be made public, you are                  www.regulations.gov. Submit both
                                                    nomination unless self-nominated. FDA                   solely responsible for ensuring that your             copies to the Division of Dockets
                                                    will ask potential candidates to provide                comment does not include any                          Management. If you do not wish your
                                                    detailed information concerning such                    confidential information that you or a                name and contact information to be
                                                    matters related to financial holdings,                  third party may not wish to be posted,                made publicly available, you can
                                                    employment, and research grants and/or                  such as medical information, your or                  provide this information on the cover
                                                    contracts to permit evaluation of                       anyone else’s Social Security number, or              sheet and not in the body of your
                                                    possible sources of conflicts of interest.              confidential business information, such               comments and you must identify this
                                                      This notice is issued under the                       as a manufacturing process. Please note               information as ‘‘confidential.’’ Any
                                                    Federal Advisory Committee Act (5                       that if you include your name, contact                information marked as ‘‘confidential’’
                                                    U.S.C. app. 2) and 21 CFR part 14,                      information, or other information that                will not be disclosed except in
                                                    relating to advisory committees.                        identifies you in the body of your                    accordance with 21 CFR 10.20 and other
                                                      Dated: October 18, 2016.
                                                                                                            comments, that information will be                    applicable disclosure law. For more
                                                                                                            posted on http://www.regulations.gov.                 information about FDA’s posting of
                                                    Janice M. Soreth,                                         • If you want to submit a comment                   comments to public dockets, see 80 FR
                                                    Acting Associate Commissioner, Special                  with confidential information that you
                                                    Medical Programs.                                                                                             56469, September 18, 2015, or access
                                                                                                            do not wish to be made available to the               the information at: http://www.fda.gov/
                                                    [FR Doc. 2016–25497 Filed 10–20–16; 8:45 am]            public, submit the comment as a                       regulatoryinformation/dockets/
                                                    BILLING CODE 4164–01–P                                  written/paper submission and in the                   default.htm.
                                                                                                            manner detailed (see ‘‘Written/Paper                     Docket: For access to the docket to
                                                                                                            Submissions’’ and ‘‘Instructions’’).                  read background documents or the
                                                    DEPARTMENT OF HEALTH AND
                                                    HUMAN SERVICES                                          Written/Paper Submissions                             electronic and written/paper comments
                                                                                                                                                                  received, go to http://
                                                                                                               Submit written/paper submissions as                www.regulations.gov and insert the
                                                    Food and Drug Administration                            follows:                                              docket number, found in brackets in the
                                                    [Docket No. FDA–2010–N–0600]                               • Mail/Hand delivery/Courier (for
                                                                                                                                                                  heading of this document, into the
                                                                                                            written/paper submissions): Division of
                                                                                                                                                                  ‘‘Search’’ box and follow the prompts
                                                    Agency Information Collection                           Dockets Management (HFA–305), Food
                                                                                                                                                                  and/or go to the Division of Dockets
                                                    Activities; Proposed Collection;                        and Drug Administration, 5630 Fishers
                                                                                                                                                                  Management, 5630 Fishers Lane, Rm.
                                                    Comment Request; Animal Drug User                       Lane, Rm. 1061, Rockville, MD 20852.
                                                                                                               • For written/paper comments                       1061, Rockville, MD 20852.
                                                    Fee Cover Sheet
                                                                                                            submitted to the Division of Dockets                  FOR FURTHER INFORMATION CONTACT: FDA
                                                    AGENCY:    Food and Drug Administration,                Management, FDA will post your                        PRA Staff, Office of Operations, Food
                                                    HHS.                                                    comment, as well as any attachments,                  and Drug Administration, Three White
                                                    ACTION:   Notice.                                       except for information submitted,                     Flint North, 10A63, 11601 Landsdown
                                                                                                            marked and identified, as confidential,               St., North Bethesda, MD 20852,
                                                    SUMMARY:  The Food and Drug                                                                                   PRAStaff@fda.hhs.gov.
                                                                                                            if submitted as detailed in
                                                    Administration (FDA) is announcing an                                                                         SUPPLEMENTARY INFORMATION: Under the
                                                                                                            ‘‘Instructions.’’
                                                    opportunity for public comment on the                      Instructions: All submissions received             PRA (44 U.S.C. 3501–3520), Federal
                                                    proposed collection of certain                          must include the Docket No. FDA–                      Agencies must obtain approval from the
                                                    information by the Agency. Under the                    2010–N–0600 for ‘‘Agency Information                  Office of Management and Budget
                                                    Paperwork Reduction Act of 1995 (the                    Collection Activities; Proposed                       (OMB) for each collection of
                                                    PRA), Federal Agencies are required to                  Collection; Comment Request; Animal                   information they conduct or sponsor.
                                                    publish notice in the Federal Register                  Drug User Fee Cover Sheet.’’ Received                 ‘‘Collection of information’’ is defined
                                                    concerning each proposed collection of                  comments will be placed in the docket                 in 44 U.S.C. 3502(3) and 5 CFR
                                                    information, including each proposed                    and, except for those submitted as                    1320.3(c) and includes Agency requests
                                                    extension of an existing collection of                  ‘‘Confidential Submissions,’’ publicly                or requirements that members of the
                                                    information, and to allow 60 days for                   viewable at http://www.regulations.gov                public submit reports, keep records, or
                                                    public comment in response to the                       or at the Division of Dockets                         provide information to a third party.
                                                    notice. This notice solicits comments on                Management between 9 a.m. and 4 p.m.,                 Section 3506(c)(2)(A) of the PRA (44
                                                    the information collection requirements                 Monday through Friday.                                U.S.C. 3506(c)(2)(A)) requires Federal
                                                    of the Animal Drug User Fee cover                          • Confidential Submissions—To                      Agencies to provide a 60-day notice in
                                                    sheet.                                                  submit a comment with confidential                    the Federal Register concerning each
                                                    DATES:  Submit either electronic or                     information that you do not wish to be                proposed collection of information,
                                                    written comments on the collection of                   made publicly available, submit your                  including each proposed extension of an
                                                    information by December 20, 2016.                       comments only as a written/paper                      existing collection of information,
                                                    ADDRESSES: You may submit comments                      submission. You should submit two                     before submitting the collection to OMB
                                                                                                            copies total. One copy will include the               for approval. To comply with this
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                    as follows:
                                                                                                            information you claim to be confidential              requirement, FDA is publishing notice
                                                    Electronic Submissions                                  with a heading or cover note that states              of the proposed collection of
                                                      Submit electronic comments in the                     ‘‘THIS DOCUMENT CONTAINS                              information set forth in this document.
                                                    following way:                                          CONFIDENTIAL INFORMATION.’’ The                          With respect to the following
                                                      • Federal eRulemaking Portal: http://                 Agency will review this copy, including               collection of information, FDA invites
                                                    www.regulations.gov. Follow the                         the claimed confidential information, in              comments on these topics: (1) Whether
                                                    instructions for submitting comments.                   its consideration of comments. The                    the proposed collection of information
                                                    Comments submitted electronically,                      second copy, which will have the                      is necessary for the proper performance


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Document Created: 2018-02-13 16:35:52
Document Modified: 2018-02-13 16:35:52
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.
DatesNominations received on or before December 20, 2016, will be given first consideration for membership on the Food Advisory Committee. Nominations received after December 20, 2016, will be considered for nomination to the committee as later vacancies occur.
ContactRegarding all nomination questions for membership, the primary contact is: Karen Strambler, 5001 Campus Drive, Rm. 1C-008, College Park, MD 20740, email: [email protected], 240-402-2589, Fax: 301-436-2367.
FR Citation81 FR 72809 

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