80_FR_71045 80 FR 70825 - Request for Nominations for Voting Members on a Public Advisory Committee; Tobacco Products Scientific Advisory Committee

80 FR 70825 - Request for Nominations for Voting Members on a Public Advisory Committee; Tobacco Products Scientific Advisory Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 220 (November 16, 2015)

Page Range70825-70826
FR Document2015-28847

The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Tobacco Products Scientific Advisory Committee, Office of Science, Center for Tobacco Products. 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 80 Issue 220 (Monday, November 16, 2015)
[Federal Register Volume 80, Number 220 (Monday, November 16, 2015)]
[Notices]
[Pages 70825-70826]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-28847]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0394]


Request for Nominations for Voting Members on a Public Advisory 
Committee; Tobacco Products Scientific 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 Tobacco Products 
Scientific Advisory Committee, Office of Science, Center for Tobacco 
Products.
    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 January 15, 2016 will be given 
first consideration for membership on the Tobacco Products Scientific 
Advisory Committee. Nominations received after January 15, 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: http://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:
    Caryn Cohen, Office of Science, Center for Tobacco Products, Food 
and Drug Administration, Center for Tobacco Products, Document Control 
Center, Building 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, 
MD 20993-0002, 1-877-287-1373 (choose Option 5), FAX: 240-276-3655, 
TPSAC@fda.hhs.gov.
    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 nominations for voting 
members on the Tobacco Products Scientific Advisory Committee.

I. General Description of the Committee Duties

    The Tobacco Products Scientific Advisory Committee (the Committee) 
advises the Commissioner of Food and Drugs (the Commissioner) or 
designee in discharging responsibilities related to the regulation of 
tobacco products. The Committee reviews and evaluates safety, 
dependence, and health issues relating to tobacco products and provides 
appropriate advice, information, and recommendations to the 
Commissioner.

II. Criteria for Voting Members

    The Committee consists of 12 members including the Chair. Members 
and the Chair are selected by the Commissioner or designee from among 
individuals knowledgeable in the fields of medicine, medical ethics, 
science, or technology involving the manufacture, evaluation, or use of 
tobacco products. Almost all non-Federal members of this committee 
serve as Special Government Employees. Members will be invited to serve 
for terms of up to 4 years. The Committee includes nine technically 
qualified voting members, selected by the Commissioner or designee. The 
nine voting members include seven members who are physicians, dentists, 
scientists, or health care professionals practicing in the area of 
oncology, pulmonology, cardiology, toxicology, pharmacology, addiction, 
or any other relevant specialty. The nine voting members also include 
one member who is an officer or employee of a state or local government 
or of the Federal Government, and one member who is a representative of 
the general public.

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 70826]]

specify the advisory committee for which the nominee is 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: November 9, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-28847 Filed 11-13-15; 8:45 am]
BILLING CODE 4164-01-P



                                                                         Federal Register / Vol. 80, No. 220 / Monday, November 16, 2015 / Notices                                           70825

                                              discontinued product(s), including the                  1–800–741–8138 (301–443–0572 in the                   New Hampshire Ave., Silver Spring, MD
                                              product NDC number(s), and stating that                 Washington DC area), and follow the                   20993–0002, 1–877–287–1373 (choose
                                              the manufacturing and/or distribution of                prompts to the desired center or product              Option 5), FAX: 240–276–3655,
                                              the product(s) have been discontinued.                  area. Please call the Information Line for            TPSAC@fda.hhs.gov.
                                              The letter should be sent electronically                up-to-date information on this meeting.                 Information about becoming a
                                              to Barbara Wise (see FOR FURTHER                          Dated: November 9, 2015.
                                                                                                                                                            member on an FDA advisory committee
                                              INFORMATION CONTACT). FDA plans to                                                                            can also be obtained by visiting FDA’s
                                                                                                      Leslie Kux,
                                              rely on its existing records, including its                                                                   Web site by using the following link:
                                                                                                      Associate Commissioner for Policy.                    http://www.fda.gov/
                                              drug listing records, the results of any
                                                                                                      [FR Doc. 2015–28846 Filed 11–13–15; 8:45 am]          AdvisoryCommittees/default.htm.
                                              future inspections, or other available
                                              information, when it targets violative                  BILLING CODE 4164–01–P                                SUPPLEMENTARY INFORMATION: FDA is
                                              products for enforcement action.                                                                              requesting nominations for voting
                                                                                                                                                            members on the Tobacco Products
                                              IV. Reformulated Products                               DEPARTMENT OF HEALTH AND                              Scientific Advisory Committee.
                                                FDA cautions firms against                            HUMAN SERVICES
                                                                                                                                                            I. General Description of the Committee
                                              reformulating products into unapproved                  Food and Drug Administration                          Duties
                                              new drugs and marketing under the
                                              same name or substantially the same                     [Docket No. FDA–2009–N–0394]                             The Tobacco Products Scientific
                                              name (including a new name that                                                                               Advisory Committee (the Committee)
                                              contains the old name). Reformulated                    Request for Nominations for Voting                    advises the Commissioner of Food and
                                              products marketed under a name                          Members on a Public Advisory                          Drugs (the Commissioner) or designee in
                                              previously identified with a different                  Committee; Tobacco Products                           discharging responsibilities related to
                                              active ingredient or combinations of                    Scientific Advisory Committee                         the regulation of tobacco products. The
                                              active ingredients have the potential to                AGENCY:    Food and Drug Administration,              Committee reviews and evaluates safety,
                                              confuse health care practitioners and                   HHS.                                                  dependence, and health issues relating
                                              harm patients.                                                                                                to tobacco products and provides
                                                                                                      ACTION:   Notice.                                     appropriate advice, information, and
                                                Dated: November 9, 2015.
                                                                                                      SUMMARY:   The Food and Drug                          recommendations to the Commissioner.
                                              Leslie Kux,
                                                                                                      Administration (FDA) is requesting                    II. Criteria for Voting Members
                                              Associate Commissioner for Policy.
                                                                                                      nominations for voting members to
                                              [FR Doc. 2015–28853 Filed 11–13–15; 8:45 am]                                                                     The Committee consists of 12
                                                                                                      serve on the Tobacco Products Scientific
                                              BILLING CODE 4164–01–P                                                                                        members including the Chair. Members
                                                                                                      Advisory Committee, Office of Science,
                                                                                                                                                            and the Chair are selected by the
                                                                                                      Center for Tobacco Products.
                                                                                                         FDA seeks to include the views of                  Commissioner or designee from among
                                              DEPARTMENT OF HEALTH AND                                women and men, members of all racial                  individuals knowledgeable in the fields
                                              HUMAN SERVICES                                          and ethnic groups, and individuals with               of medicine, medical ethics, science, or
                                                                                                      and without disabilities on its advisory              technology involving the manufacture,
                                              Food and Drug Administration                                                                                  evaluation, or use of tobacco products.
                                                                                                      committees and, therefore encourages
                                              [Docket No. FDA–2015–N–0001]                            nominations of appropriately qualified                Almost all non-Federal members of this
                                                                                                      candidates from these groups.                         committee serve as Special Government
                                              Gastroenterology and Urology Devices                                                                          Employees. Members will be invited to
                                                                                                      DATES: Nominations received on or
                                              Panel of the Medical Devices Advisory                                                                         serve for terms of up to 4 years. The
                                                                                                      before January 15, 2016 will be given                 Committee includes nine technically
                                              Committee; Amendment of Notice
                                                                                                      first consideration for membership on                 qualified voting members, selected by
                                              AGENCY:    Food and Drug Administration,                the Tobacco Products Scientific                       the Commissioner or designee. The nine
                                              HHS.                                                    Advisory Committee. Nominations                       voting members include seven members
                                              ACTION:   Notice.                                       received after January 15, 2016 will be               who are physicians, dentists, scientists,
                                                                                                      considered for nomination to the                      or health care professionals practicing
                                              SUMMARY:   The Food and Drug                            committee as later vacancies occur.                   in the area of oncology, pulmonology,
                                              Administration (FDA) is canceling the                   ADDRESSES: All nominations for                        cardiology, toxicology, pharmacology,
                                              November 18, 2015, session and                          membership should be sent                             addiction, or any other relevant
                                              postponing the November 19, 2015,                       electronically by logging into the FDA                specialty. The nine voting members also
                                              session of the Gastroenterology and                     Advisory Committee Membership                         include one member who is an officer
                                              Urology Devices Panel meeting. The                      Nomination Portal: http://                            or employee of a state or local
                                              meeting was announced in the Federal                    www.accessdata.fda.gov/scripts/                       government or of the Federal
                                              Register of October 7, 2015 (80 FR                      FACTRSPortal/FACTRS/index.cfm or by                   Government, and one member who is a
                                              60686). The November 19, 2015, session                  mail to Advisory Committee Oversight                  representative of the general public.
                                              has been postponed due to the                           and Management Staff, Food and Drug
                                              cancellation of the November 18, 2015,                  Administration, 10903 New Hampshire                   III. Nomination Procedures
                                              meeting. Future meeting dates will be                   Ave., Bldg. 32, Rm. 5103, Silver Spring,                 Any interested person may nominate
                                              announced in the Federal Register.                      MD 20993–0002.                                        one or more qualified individuals for
                                              FOR FURTHER INFORMATION CONTACT:                        FOR FURTHER INFORMATION CONTACT:                      membership on the advisory committee.
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                                              Patricio Garcia, Center for Devices and                 Regarding all nomination questions for                Self-nominations are also accepted.
                                              Radiological Health, Food and Drug                      membership, the primary contact is:                   Nominations must include a current,
                                              Administration, 10903 New Hampshire                        Caryn Cohen, Office of Science,                    complete résumé or curriculum vitae for
                                              Ave., Bldg. 66, Rm. 1535, Silver Spring                 Center for Tobacco Products, Food and                 each nominee, including current
                                              MD 20993–0002, patricio.garcia@                         Drug Administration, Center for                       business address and/or home address,
                                              fda.hhs.gov, 301–796–6875, or FDA                       Tobacco Products, Document Control                    telephone number, and email address if
                                              Advisory Committee Information Line,                    Center, Building 71, Rm. G335, 10903                  available. Nominations must also


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                                              70826                                Federal Register / Vol. 80, No. 220 / Monday, November 16, 2015 / Notices

                                              specify the advisory committee for                                          the public during the review and                         notify the scholar or S2S participant,
                                              which the nominee is recommended.                                           approval period.                                         and the NHSC logistics contractor
                                              Nominations must also acknowledge                                           DATES: Comments on this ICR should be                    regarding travel arrangements and
                                              that the nominee is aware of the                                            received no later than December 16,                      authorization of the funding for the site
                                              nomination unless self-nominated. FDA                                       2015.                                                    visit or relocation.
                                              will ask potential candidates to provide                                                                                                Need and Proposed Use of the
                                                                                                                          ADDRESSES: Submit your comments,
                                              detailed information concerning such                                                                                                 Information: This information will
                                                                                                                          including the Information Collection
                                              matters related to financial holdings,                                                                                               facilitate NHSC scholar and S2S
                                                                                                                          Request Title, to the desk officer for
                                              employment, and research grants and/or                                                                                               clinicians’ receipt of federal travel funds
                                                                                                                          HRSA, either by email to OIRA_
                                              contracts to permit evaluation of                                                                                                    that are used to visit high-need NHSC
                                                                                                                          submission@omb.eop.gov or by fax to
                                              possible sources of conflicts of interest.                                                                                           sites. The Travel Request Worksheet is
                                                                                                                          202–395–5806.
                                                This notice is issued under the                                                                                                    also used to initiate the relocation
                                              Federal Advisory Committee Act (5                                           FOR FURTHER INFORMATION CONTACT: To
                                                                                                                          request a copy of the clearance requests                 process after an NHSC scholar or S2S
                                              U.S.C. app. 2) and 21 CFR part 14,                                                                                                   participant has successfully been
                                              relating to advisory committees.                                            submitted to OMB for review, email the
                                                                                                                          HRSA Information Collection Clearance                    matched to an approved practice site.
                                                Dated: November 9, 2015.                                                  Officer at paperwork@hrsa.gov or call                    This information will be used by the
                                              Leslie Kux,                                                                 (301) 443–1984.                                          NHSC in order to make travel
                                              Associate Commissioner for Policy.                                                                                                   arrangements for NHSC scholar and S2S
                                                                                                                          SUPPLEMENTARY INFORMATION:
                                                                                                                                                                                   clinicians to potential practice sites and
                                              [FR Doc. 2015–28847 Filed 11–13–15; 8:45 am]                                   Information Collection Request Title:
                                                                                                                                                                                   to assist them in relocation
                                              BILLING CODE 4164–01–P                                                      National Health Service Corps Scholar/
                                                                                                                                                                                   arrangements once clinicians have
                                                                                                                          Students to Service Travel Worksheet.
                                                                                                                                                                                   secured employment at one of these
                                                                                                                             OMB No. 0915–0278—Extension.
                                              DEPARTMENT OF HEALTH AND                                                       Abstract: Clinicians participating in                 sites.
                                              HUMAN SERVICES                                                              the HRSA National Health Service                            Likely Respondents: Clinicians
                                                                                                                          Corps (NHSC) Scholarship Program and                     participating in the National Health
                                              Health Resources and Services                                               the Students to Service (S2S) Loan                       Service Corps Scholarship Program and
                                              Administration                                                              Repayment Program use the online                         the Students to Service Loan Repayment
                                                                                                                          Travel Request Worksheet to receive                      Program
                                              Agency Information Collection                                                                                                           Statement: Burden in this context
                                                                                                                          travel funds from the federal
                                              Activities: Submission to OMB for                                                                                                    means the time expended by persons to
                                                                                                                          government to visit eligible NHSC sites
                                              Review and Approval; Public Comment                                                                                                  generate, maintain, retain, disclose or
                                                                                                                          to which they may be assigned in
                                              Request                                                                                                                              provide the information requested. This
                                                                                                                          accordance with the Public Health
                                              AGENCY: Health Resources and Services                                       Service Act (PHSA), section 331(c)(1).                   includes the time needed to review
                                              Administration, HHS.                                                           The travel approval process is                        instructions; to develop, acquire, install
                                              ACTION: Notice.                                                             initiated when an NHSC scholar or S2S                    and utilize technology and systems for
                                                                                                                          participant notifies the NHSC of an                      the purpose of collecting, validating and
                                              SUMMARY:   In compliance with Section                                       impending interview at one or more                       verifying information, processing and
                                              3507(a)(1)(D) of the Paperwork                                              NHSC-approved practice sites. The                        maintaining information, and disclosing
                                              Reduction Act of 1995, the Health                                           Travel Request Worksheet is also used                    and providing information; to train
                                              Resources and Services Administration                                       to initiate the relocation process after an              personnel and to be able to respond to
                                              (HRSA) has submitted an Information                                         NHSC scholar or S2S participant has                      a collection of information; to search
                                              Collection Request (ICR) to the Office of                                   successfully been matched to an                          data sources; to complete and review
                                              Management and Budget (OMB) for                                             approved practice site in accordance                     the collection of information; and to
                                              review and approval. Comments                                               with the PHSA, section 331(c)(3). Upon                   transmit or otherwise disclose the
                                              submitted during the first public review                                    receipt of the Travel Request Worksheet,                 information. The total annual burden
                                              of this ICR will be provided to OMB.                                        the NHSC will review and approve or                      hours estimated for this ICR are
                                              OMB will accept further comments from                                       disapprove the request and promptly                      summarized in the table below.

                                                                                                                  TOTAL ESTIMATED ANNUALIZED BURDEN-HOURS
                                                                                                                                                                                                       Average
                                                                                                                                                                 Number of
                                                                                                                                             Number of                               Total           burden per     Total burden
                                                                                  Form name                                                                    responses per
                                                                                                                                            respondents                           responses           response         hours
                                                                                                                                                                 respondent                           (in hours)

                                              Travel Request Worksheet ..................................................                                250                 2              500             .0667             33
                                              Total .....................................................................................                250                 2              500             .0667             33



                                              Jackie Painter,
                                              Director, Division of the Executive Secretariat.
                                              [FR Doc. 2015–29140 Filed 11–13–15; 8:45 am]
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                                              BILLING CODE 4165–15–P




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Document Created: 2015-12-14 14:13:24
Document Modified: 2015-12-14 14:13:24
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 January 15, 2016 will be given first consideration for membership on the Tobacco Products Scientific Advisory Committee. Nominations received after January 15, 2016 will be considered for nomination to the committee as later vacancies occur.
ContactRegarding all nomination questions for membership, the primary contact is:
FR Citation80 FR 70825 

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