81_FR_46222 81 FR 46086 - Request for Nominations on the Tobacco Products Scientific Advisory Committee

81 FR 46086 - Request for Nominations on the Tobacco Products Scientific Advisory Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 136 (July 15, 2016)

Page Range46086-46087
FR Document2016-16739

The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative of the tobacco manufacturing industry to serve on the Tobacco Products Scientific Advisory Committee for the Center for Tobacco Products (CTP), notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative of the tobacco manufacturing industry to serve on the Tobacco Products Scientific Advisory Committee, and an alternate to this representative. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice.

Federal Register, Volume 81 Issue 136 (Friday, July 15, 2016)
[Federal Register Volume 81, Number 136 (Friday, July 15, 2016)]
[Notices]
[Pages 46086-46087]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-16739]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-1984]


Request for Nominations on the Tobacco Products Scientific 
Advisory Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is requesting that any 
industry organizations interested in participating in the selection of 
a nonvoting industry representative of the tobacco manufacturing 
industry to serve on the Tobacco Products Scientific Advisory Committee 
for the Center for Tobacco Products (CTP), notify FDA in writing. FDA 
is also requesting nominations for a nonvoting industry representative 
of the tobacco manufacturing industry to serve on the Tobacco Products 
Scientific Advisory Committee, and an alternate to this representative. 
A nominee may either be self-nominated or nominated by an organization 
to serve as a nonvoting industry representative. Nominations will be 
accepted for current vacancies effective with this notice.

DATES: Any industry organization interested in participating in the 
selection of an appropriate nonvoting member to represent industry 
interests must send a letter stating that interest to the FDA by August 
15, 2016 (see sections I and II of this document for further details). 
Concurrently, nomination materials for prospective candidates should be 
sent to FDA by August 15, 2016.

ADDRESSES: All statements of interest from industry organizations 
interested in participating in the selection process should be sent to 
Caryn Cohen (see FOR FURTHER INFORMATION CONTACT). All nominations for 
nonvoting industry representatives should be submitted electronically 
by accessing 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. Information about becoming a member of an 
FDA advisory committee can also be obtained by visiting FDA's Web site 
http://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: Caryn Cohen, Office of Science, Center 
for Tobacco Products, Food and Drug Administration, Center for Tobacco 
Products Document Control Center, Bldg. 71, Rm. G335, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 1-877-287-1373 (choose 
Option 5), email: [email protected].

SUPPLEMENTARY INFORMATION: The Agency intends to add nonvoting industry 
representatives to the following advisory committee.

I. CTP Advisory Committee, Tobacco Products Scientific Advisory 
Committee

    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. Selection Procedure

    Any industry organization interested in participating in the 
selection of an appropriate nonvoting member to represent industry 
interests should send a letter stating that interest to the FDA contact 
(see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of 
this document (see DATES). Within the subsequent 30 days, FDA will send 
a letter to each organization that has expressed an interest, attaching 
a complete list of all such organizations and a list of all nominees 
along with their current resumes. The letter will also state that it is 
the responsibility of the interested organizations to confer with one 
another and to select a candidate, within 60 days after the receipt of 
the FDA letter, to serve as the nonvoting member to represent industry 
interests for the committee. The interested organizations are not bound 
by the list of nominees in selecting a candidate. However, if no 
individual is selected within 60 days, the Commissioner will select the 
nonvoting member to represent industry interests.

III. Application Procedure

    Individuals may self-nominate and/or an organization may nominate 
one or more individuals to serve as a nonvoting industry 
representative. Contact information, current curriculum vitae, and the 
name of the committee of interest should be sent to the FDA Advisory 
Committee Membership Nomination Portal (see ADDRESSES) within 30 days 
of publication of this document (see DATES). FDA will forward all 
nominations to the organizations expressing interest in participating 
in the selection process for the committee. (Persons who nominate 
themselves as nonvoting industry representatives will not participate 
in the selection process.)
    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

[[Page 46087]]

nominations of appropriately qualified candidates from these groups.
    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: July 11, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-16739 Filed 7-14-16; 8:45 am]
 BILLING CODE 4164-01-P



                                                46086                            Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Notices

                                                fda.hhs.gov to receive an electronic                     ACTION:   Notice.                                     industry representatives to the following
                                                copy of the document. Please use the                                                                           advisory committee.
                                                document number 1400027 to identify                      SUMMARY:   The Food and Drug
                                                                                                         Administration (FDA) is requesting that               I. CTP Advisory Committee, Tobacco
                                                the guidance you are requesting.
                                                                                                         any industry organizations interested in              Products Scientific Advisory Committee
                                                IV. Paperwork Reduction Act of 1995                      participating in the selection of a                      The Tobacco Products Scientific
                                                   This draft guidance refers to                         nonvoting industry representative of the              Advisory Committee (the Committee)
                                                previously approved collections of                       tobacco manufacturing industry to serve               advises the Commissioner of Food and
                                                information found in FDA regulations                     on the Tobacco Products Scientific                    Drugs (the Commissioner) or designee in
                                                and guidance documents. These                            Advisory Committee for the Center for                 discharging responsibilities related to
                                                collections of information are subject to                Tobacco Products (CTP), notify FDA in                 the regulation of tobacco products. The
                                                review by the Office of Management and                   writing. FDA is also requesting                       Committee reviews and evaluates safety,
                                                Budget (OMB) under the Paperwork                         nominations for a nonvoting industry                  dependence, and health issues relating
                                                Reduction Act of 1995 (44 U.S.C. 3501–                   representative of the tobacco                         to tobacco products and provides
                                                3520). The collections of information in                 manufacturing industry to serve on the                appropriate advice, information, and
                                                21 CFR parts 801 and 809 have been                       Tobacco Products Scientific Advisory                  recommendations to the Commissioner.
                                                approved under OMB control number                        Committee, and an alternate to this                   II. Selection Procedure
                                                0910–0485; the collections of                            representative. A nominee may either be
                                                information in parts 50 and 56 have                      self-nominated or nominated by an                        Any industry organization interested
                                                been approved under OMB control                          organization to serve as a nonvoting                  in participating in the selection of an
                                                number 0910–0130; the collections of                     industry representative. Nominations                  appropriate nonvoting member to
                                                information in 21 CFR part 812 have                      will be accepted for current vacancies                represent industry interests should send
                                                been approved under OMB control                          effective with this notice.                           a letter stating that interest to the FDA
                                                number 0910–0078; the collections of                                                                           contact (see FOR FURTHER INFORMATION
                                                                                                         DATES: Any industry organization                      CONTACT) within 30 days of publication
                                                information in 21 CFR part 814 subparts                  interested in participating in the
                                                B and E have been approved under                                                                               of this document (see DATES). Within the
                                                                                                         selection of an appropriate nonvoting                 subsequent 30 days, FDA will send a
                                                OMB control number 0910–0231; the                        member to represent industry interests
                                                collections of information in 21 CFR                                                                           letter to each organization that has
                                                                                                         must send a letter stating that interest to           expressed an interest, attaching a
                                                part 814, subpart H, have been approved                  the FDA by August 15, 2016 (see
                                                under OMB control number 0910–0332;                                                                            complete list of all such organizations
                                                                                                         sections I and II of this document for                and a list of all nominees along with
                                                the collections of information in 21 CFR                 further details). Concurrently,
                                                part 807, subpart E, have been approved                                                                        their current resumes. The letter will
                                                                                                         nomination materials for prospective                  also state that it is the responsibility of
                                                under OMB control number 0901–0120;                      candidates should be sent to FDA by
                                                the collections of information in 21 CFR                                                                       the interested organizations to confer
                                                                                                         August 15, 2016.                                      with one another and to select a
                                                part 820 have been approved under
                                                                                                         ADDRESSES: All statements of interest                 candidate, within 60 days after the
                                                OMB control number 0910–0073; the
                                                                                                         from industry organizations interested                receipt of the FDA letter, to serve as the
                                                collections of information in 21 CFR
                                                                                                         in participating in the selection process             nonvoting member to represent industry
                                                part 601 have been approved under
                                                                                                         should be sent to Caryn Cohen (see FOR                interests for the committee. The
                                                OMB control number 0910–0338; the
                                                                                                         FURTHER INFORMATION CONTACT). All                     interested organizations are not bound
                                                collections of information in 21 CFR
                                                                                                         nominations for nonvoting industry                    by the list of nominees in selecting a
                                                part 312 have been approved under
                                                                                                         representatives should be submitted                   candidate. However, if no individual is
                                                OMB control number 0910–0014; the
                                                                                                         electronically by accessing the FDA                   selected within 60 days, the
                                                collections of information in 21 CFR
                                                                                                         Advisory Committee Membership                         Commissioner will select the nonvoting
                                                part 314 have been approved under
                                                                                                         Nomination Portal: https://                           member to represent industry interests.
                                                OMB control number 0910–0001; and
                                                                                                         www.accessdata.fda.gov/scripts/
                                                the collections of information resulting                                                                       III. Application Procedure
                                                                                                         FACTRSPortal/FACTRS/index.cfm or by
                                                from special protocol assessments have                                                                            Individuals may self-nominate and/or
                                                                                                         mail to Advisory Committee Oversight
                                                been approved under OMB control                                                                                an organization may nominate one or
                                                                                                         and Management Staff, Food and Drug
                                                number 0910–0470.                                                                                              more individuals to serve as a nonvoting
                                                                                                         Administration, 10903 New Hampshire
                                                  Dated: July 11, 2016.                                  Ave., Bldg. 32, Rm. 5103, Silver Spring,              industry representative. Contact
                                                Leslie Kux,                                              MD 20993–0002. Information about                      information, current curriculum vitae,
                                                Associate Commissioner for Policy.                       becoming a member of an FDA advisory                  and the name of the committee of
                                                [FR Doc. 2016–16735 Filed 7–14–16; 8:45 am]              committee can also be obtained by                     interest should be sent to the FDA
                                                BILLING CODE 4164–01–P                                   visiting FDA’s Web site http://                       Advisory Committee Membership
                                                                                                         www.fda.gov/AdvisoryCommittees/                       Nomination Portal (see ADDRESSES)
                                                                                                         default.htm.                                          within 30 days of publication of this
                                                DEPARTMENT OF HEALTH AND                                                                                       document (see DATES). FDA will forward
                                                                                                         FOR FURTHER INFORMATION CONTACT:                      all nominations to the organizations
                                                HUMAN SERVICES
                                                                                                         Caryn Cohen, Office of Science, Center                expressing interest in participating in
                                                Food and Drug Administration                             for Tobacco Products, Food and Drug                   the selection process for the committee.
                                                                                                         Administration, Center for Tobacco
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                                                                                                                                                               (Persons who nominate themselves as
                                                [Docket No. FDA–2016–N–1984]                             Products Document Control Center,                     nonvoting industry representatives will
                                                                                                         Bldg. 71, Rm. G335, 10903 New                         not participate in the selection process.)
                                                Request for Nominations on the                           Hampshire Ave., Silver Spring, MD
                                                Tobacco Products Scientific Advisory                                                                              FDA seeks to include the views of
                                                                                                         20993–0002, 1–877–287–1373 (choose                    women and men, members of all racial
                                                Committee                                                Option 5), email: TPSAC@fda.hhs.gov.                  and ethnic groups, and individuals with
                                                AGENCY:    Food and Drug Administration,                 SUPPLEMENTARY INFORMATION: The                        and without disabilities on its advisory
                                                HHS.                                                     Agency intends to add nonvoting                       committees and, therefore, encourages


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                                                                                 Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Notices                                           46087

                                                nominations of appropriately qualified                     • If you want to submit a comment                   comments to public dockets, see 80 FR
                                                candidates from these groups.                            with confidential information that you                56469, September 18, 2015, or access
                                                  This notice is issued under the                        do not wish to be made available to the               the information at: http://www.fda.gov/
                                                Federal Advisory Committee Act (5                        public, submit the comment as a                       regulatoryinformation/dockets/
                                                U.S.C. app. 2) and 21 CFR part 14,                       written/paper submission and in the                   default.htm.
                                                relating to advisory committees.                         manner detailed (see ‘‘Written/Paper                     Docket: For access to the docket to
                                                  Dated: July 11, 2016.                                  Submissions’’ and ‘‘Instructions’’).                  read background documents or the
                                                Leslie Kux,                                                                                                    electronic and written/paper comments
                                                                                                         Written/Paper Submissions
                                                Associate Commissioner for Policy.                                                                             received, go to http://
                                                                                                            Submit written/paper submissions as                www.regulations.gov and insert the
                                                [FR Doc. 2016–16739 Filed 7–14–16; 8:45 am]              follows:                                              docket number, found in brackets in the
                                                BILLING CODE 4164–01–P                                      • Mail/Hand delivery/Courier (for                  heading of this document, into the
                                                                                                         written/paper submissions): Division of               ‘‘Search’’ box and follow the prompts
                                                                                                         Dockets Management (HFA–305), Food                    and/or go to the Division of Dockets
                                                DEPARTMENT OF HEALTH AND                                 and Drug Administration, 5630 Fishers
                                                HUMAN SERVICES                                                                                                 Management, 5630 Fishers Lane, Rm.
                                                                                                         Lane, Rm. 1061, Rockville, MD 20852.                  1061, Rockville, MD 20852.
                                                                                                            • For written/paper comments                          Submit written requests for single
                                                Food and Drug Administration                             submitted to the Division of Dockets                  copies of this guidance to the Center for
                                                [Docket No. FDA–2009–D–0508]                             Management, FDA will post your                        Tobacco Products, Food and Drug
                                                                                                         comment, as well as any attachments,                  Administration, Document Control
                                                Registration and Product Listing for                     except for information submitted,
                                                Owners and Operators of Domestic                                                                               Center, 10903 New Hampshire Ave.,
                                                                                                         marked and identified, as confidential,               Bldg. 71, Rm. G335, Silver Spring, MD
                                                Tobacco Product Establishments;                          if submitted as detailed in
                                                Guidance for Industry; Availability                                                                            20993–0002. Send one self-addressed
                                                                                                         ‘‘Instructions.’’                                     adhesive label to assist that office in
                                                AGENCY:    Food and Drug Administration,                    Instructions: All submissions received
                                                                                                                                                               processing your request or include a fax
                                                HHS.                                                     must include the Docket No. FDA–
                                                                                                                                                               number to which the guidance
                                                                                                         2009–D–0508 for ‘‘Registration and
                                                ACTION:   Notice of availability.                                                                              document may be sent. See the
                                                                                                         Product Listing for Owners and
                                                                                                                                                               SUPPLEMENTARY INFORMATION section for
                                                SUMMARY:   The Food and Drug                             Operators of Domestic Tobacco Product
                                                                                                         Establishments.’’ Received comments                   information on electronic access to the
                                                Administration (FDA) is announcing the                                                                         guidance.
                                                availability of a revised guidance for                   will be placed in the docket and, except
                                                                                                         for those submitted as ‘‘Confidential                 FOR FURTHER INFORMATION CONTACT:
                                                industry entitled ‘‘Registration and
                                                                                                         Submissions,’’ publicly viewable at                   Katherine Collins, Center for Tobacco
                                                Product Listing for Owners and
                                                                                                         http://www.regulations.gov or at the                  Products, Food and Drug
                                                Operators of Domestic Tobacco Product
                                                                                                         Division of Dockets Management                        Administration, Document Control
                                                Establishments.’’ This guidance is
                                                intended to assist persons making                        between 9 a.m. and 4 p.m., Monday                     Center, 10903 New Hampshire Ave.,
                                                tobacco product establishment                            through Friday.                                       Bldg. 71, Rm. G335, Silver Spring, MD
                                                registration and product listing                            • Confidential Submissions—To                      20993–0002, email: CTPRegulations@
                                                submissions to FDA.                                      submit a comment with confidential                    fda.hhs.gov.
                                                DATES: Submit either electronic or                       information that you do not wish to be                SUPPLEMENTARY INFORMATION:
                                                written comments on Agency guidances                     made publicly available, submit your
                                                                                                         comments only as a written/paper                      I. Background
                                                at any time.
                                                                                                         submission. You should submit two                        FDA is announcing the availability of
                                                ADDRESSES: You may submit comments
                                                as follows:                                              copies total. One copy will include the               a revised guidance for industry entitled,
                                                                                                         information you claim to be confidential              ‘‘Registration and Product Listing for
                                                Electronic Submissions                                   with a heading or cover note that states              Owners and Operators of Domestic
                                                  Submit electronic comments in the                      ‘‘THIS DOCUMENT CONTAINS                              Tobacco Product Establishments.’’ This
                                                following way:                                           CONFIDENTIAL INFORMATION.’’ The                       guidance is intended to assist persons
                                                  • Federal eRulemaking Portal: http://                  Agency will review this copy, including               making tobacco product establishment
                                                www.regulations.gov. Follow the                          the claimed confidential information, in              registration and product listing
                                                instructions for submitting comments.                    its consideration of comments. The                    submissions to FDA. We are issuing this
                                                Comments submitted electronically,                       second copy, which will have the                      guidance consistent with our good
                                                including attachments, to http://                        claimed confidential information                      guidance practices (GGP) regulation
                                                www.regulations.gov will be posted to                    redacted/blacked out, will be available               (§ 10.115 (21 CFR 10.115)). We are
                                                the docket unchanged. Because your                       for public viewing and posted on http://              implementing this guidance without
                                                comment will be made public, you are                     www.regulations.gov. Submit both                      prior public comment because we have
                                                solely responsible for ensuring that your                copies to the Division of Dockets                     determined that prior public
                                                comment does not include any                             Management. If you do not wish your                   participation is not feasible or
                                                confidential information that you or a                   name and contact information to be                    appropriate given the requirement that
                                                third party may not wish to be posted,                   made publicly available, you can                      registration and listing submissions be
                                                such as medical information, your or                     provide this information on the cover                 submitted by December 31, 2016
                                                anyone else’s Social Security number, or                 sheet and not in the body of your                     (§ 10.115(g)(2)). We made this
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                                                confidential business information, such                  comments and you must identify this                   determination because the guidance
                                                as a manufacturing process. Please note                  information as ‘‘confidential.’’ Any                  presents a less burdensome policy
                                                that if you include your name, contact                   information marked as ‘‘confidential’’                consistent with the public health.
                                                information, or other information that                   will not be disclosed except in                       Although this guidance document is
                                                identifies you in the body of your                       accordance with 21 CFR 10.20 and other                immediately in effect, it remains subject
                                                comments, that information will be                       applicable disclosure law. For more                   to comment in accordance with FDA’’s
                                                posted on http://www.regulations.gov.                    information about FDA’s posting of                    GGP regulation.


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Document Created: 2016-07-15 02:53:34
Document Modified: 2016-07-15 02:53:34
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.
DatesAny industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests must send a letter stating that interest to the FDA by August 15, 2016 (see sections I and II of this document for further details). Concurrently, nomination materials for prospective candidates should be sent to FDA by August 15, 2016.
ContactCaryn Cohen, Office of Science, Center for Tobacco Products, Food and Drug Administration, Center for Tobacco Products Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 1-877-287-1373 (choose Option 5), email: [email protected]
FR Citation81 FR 46086 

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