83_FR_46676 83 FR 46498 - Request for Nominations on the Tobacco Products Scientific Advisory Committee

83 FR 46498 - Request for Nominations on the Tobacco Products Scientific Advisory Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 178 (September 13, 2018)

Page Range46498-46499
FR Document2018-19922

The Food and Drug Administration (FDA or Agency) is requesting that any small business tobacco manufacturing industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Tobacco Products Scientific Advisory Committee for the Center for Tobacco Products notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to be included in a pool of individuals to represent the interests of the small business tobacco manufacturing industry on the Tobacco Products Scientific Advisory Committee. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. This position may be filled on a rotating, sequential basis by representatives of different small business tobacco manufacturers based on areas of expertise relevant to the topics being considered by the Advisory Committee. Nominations will be accepted for current vacancies effective with this notice.

Federal Register, Volume 83 Issue 178 (Thursday, September 13, 2018) 
[Federal Register Volume 83, Number 178 (Thursday, September 13, 2018)]
[Notices]
[Pages 46498-46499]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-19922]


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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.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is requesting 
that any small business tobacco manufacturing industry organizations 
interested in participating in the selection of a nonvoting industry 
representative to serve on the Tobacco Products Scientific Advisory 
Committee for the Center for Tobacco Products notify FDA in writing. 
FDA is also requesting nominations for nonvoting industry 
representatives to be included in a pool of individuals to represent 
the interests of the small business tobacco manufacturing industry on 
the Tobacco Products Scientific Advisory Committee. A nominee may 
either be self-nominated or nominated by an organization to serve as a 
nonvoting industry representative. This position may be filled on a 
rotating, sequential basis by representatives of different small 
business tobacco manufacturers based on areas of expertise relevant to 
the topics being considered by the Advisory Committee. Nominations will 
be accepted for current vacancies effective with this notice.

DATES: Any small business tobacco manufacturing industry organization 
interested in participating in the selection of appropriate nonvoting 
members to represent industry interests

[[Page 46499]]

must send a letter stating that interest to FDA by October 15, 2018, 
(see sections I and II of this document for further details). 
Concurrently, nomination materials for prospective candidates should be 
sent to FDA by October 15, 2018.

ADDRESSES: All statements of interest from small business tobacco 
manufacturing industry organizations interested in participating in the 
selection process of nonvoting industry representative nominations 
should be sent to Caryn Cohen (see FOR FURTHER INFORMATION CONTACT). 
All nominations for nonvoting industry representatives may be submitted 
electronically by accessing the FDA Advisory Committee Membership 
Nomination Portal at: 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 website at: https://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, 10903 New Hampshire Ave., Bldg. 71, 
Rm. G335, Silver Spring, MD 20993-0002, 1-877-287-1373 (choose Option 
5), [email protected].

SUPPLEMENTARY INFORMATION: The Agency intends to add a nonvoting 
industry representative to represent the interests of the small 
business tobacco manufacturing industry to the following advisory 
committee:

I. 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.
    The Committee includes three nonvoting members who represent 
industry interests. These members include one representative of the 
interests of the tobacco manufacturing industry; one representative of 
the interests of tobacco growers; and one representative of the 
interests of the small business tobacco manufacturing industry, which 
may be filled on a rotating, sequential basis by representatives of 
different small business tobacco manufacturers based on areas of 
expertise relevant to the topics being considered by the Advisory 
Committee.
    With this notice, nominations are sought for a pool of individuals, 
with varying areas of expertise, to represent the interests of the 
small business tobacco manufacturing industry on a rotating, sequential 
basis.

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, a 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 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: September 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19922 Filed 9-12-18; 8:45 am]
 BILLING CODE 4164-01-P

46498 Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices ACTION: Notice. modifications before coming to the disability, please contact Rakesh meeting. Raghuwanshi at least 7 days in advance SUMMARY: The Food and Drug of the meeting. Administration (FDA) announces a SUPPLEMENTARY INFORMATION: Agenda: The Science Board will hear FDA is committed to the orderly forthcoming public advisory committee conduct of its advisory committee meeting of the Science Board to the a response from the Center for Veterinary Medicine (CVM) to the meetings. Please visit our website at Food and Drug Administration. The https://www.fda.gov/Advisory Science Board provides advice to the recommendations made by the Science Board’s 2017 review of CVM’s National Committees/AboutAdvisoryCommittees/ Commissioner of Food and Drugs and ucm111462.htm for procedures on other appropriate officials on specific, Antibiotic Resistance Monitoring System program. The Science Board public conduct during advisory complex scientific and technical issues committee meetings. important to FDA and its mission, will also discuss potential hazards and nutritional considerations in the Notice of this meeting is given under including emerging issues within the the Federal Advisory Committee Act (5 scientific community. Additionally, the production of food derived from animal cell culture technologies. U.S.C. app. 2). Science Board provides advice to the Agency on keeping pace with technical FDA intends to make background Dated: September 10, 2018. and scientific developments including material available to the public no later Leslie Kux, in regulatory science, input into the than 2 business days before the meeting. Associate Commissioner for Policy. Agency’s research agenda, and on If FDA is unable to post the background [FR Doc. 2018–19906 Filed 9–12–18; 8:45 am] upgrading its scientific and research material on its website prior to the BILLING CODE 4164–01–P facilities and training opportunities. It meeting, the background material will will also provide, where requested, be made publicly available at the expert review of Agency sponsored location of the advisory committee DEPARTMENT OF HEALTH AND intramural and extramural scientific meeting, and the background material HUMAN SERVICES research programs. The meeting will be will be posted on FDA’s website after open to the public. the meeting. Background material is Food and Drug Administration available at https://www.fda.gov/ [Docket No. FDA–2016–N–1984] DATES: The meeting will be held on AdvisoryCommittees/Calendar/ October 22, 2018, from 8:30 a.m. to 4:30 default.htm. Scroll down to the p.m. Request for Nominations on the appropriate advisory committee meeting Tobacco Products Scientific Advisory ADDRESSES: FDA White Oak Campus, link. Committee 10903 New Hampshire Ave., Bldg. 31 Procedure: Interested persons may Conference Center, the Great Room (Rm. present data, information, or views, AGENCY: Food and Drug Administration, 1503, section A), Silver Spring, MD orally or in writing, on issues pending HHS. 20993. For those unable to attend in before the committee. Written ACTION: Notice. person, the meeting will also be submissions may be made to the contact webcast. The link for the webcast is person on or before October 15, 2018. SUMMARY: The Food and Drug available at https://collaboration. Oral presentations from the public will Administration (FDA or Agency) is fda.gov/scienceboard2018/. Answers to be scheduled between approximately requesting that any small business commonly asked questions including 3:30 p.m. and 4:30 p.m. Those tobacco manufacturing industry information regarding special individuals interested in making formal organizations interested in participating accommodations due to a disability, oral presentations should notify the in the selection of a nonvoting industry visitor parking, and transportation may contact person and submit a brief representative to serve on the Tobacco be accessed at: https://www.fda.gov/ statement of the general nature of the Products Scientific Advisory Committee AdvisoryCommittees/AboutAdvisory evidence or arguments they wish to for the Center for Tobacco Products Committees/ucm408555.htm. present, the names and addresses of notify FDA in writing. FDA is also FOR FURTHER INFORMATION CONTACT: proposed participants, and an requesting nominations for nonvoting Rakesh Raghuwanshi, Office of the indication of the approximate time industry representatives to be included Chief Scientist, Office of the requested to make their presentation on in a pool of individuals to represent the Commissioner, Food and Drug or before October 5, 2018. Time allotted interests of the small business tobacco Administration, 10903 New Hampshire for each presentation may be limited. If manufacturing industry on the Tobacco Ave., Bldg. 1, Rm. 3309, Silver Spring, the number of registrants requesting to Products Scientific Advisory MD 20993, 301–796–4769, speak is greater than can be reasonably Committee. A nominee may either be rakesh.raghuwanshi@fda.hhs.gov, or accommodated during the scheduled self-nominated or nominated by an FDA Advisory Committee Information open public hearing session, FDA may organization to serve as a nonvoting Line, 1–800–741–8138 (301–443–0572 conduct a lottery to determine the industry representative. This position in the Washington, DC area). A notice in speakers for the scheduled open public may be filled on a rotating, sequential the Federal Register about last minute hearing session. The contact person will basis by representatives of different modifications that impact a previously notify interested persons regarding their small business tobacco manufacturers announced advisory committee meeting request to speak by October 9, 2018. based on areas of expertise relevant to cannot always be published quickly Persons attending FDA’s advisory the topics being considered by the enough to provide timely notice. committee meetings are advised that the Advisory Committee. Nominations will daltland on DSKBBV9HB2PROD with NOTICES Therefore, you should always check the Agency is not responsible for providing be accepted for current vacancies Agency’s website at https:// access to electrical outlets. effective with this notice. www.fda.gov/AdvisoryCommittees/ FDA welcomes the attendance of the DATES: Any small business tobacco default.htm and scroll down to the public at its advisory committee manufacturing industry organization appropriate advisory committee meeting meetings and will make every effort to interested in participating in the link, or call the advisory committee accommodate persons with disabilities. selection of appropriate nonvoting information line to learn about possible If you require accommodations due to a members to represent industry interests VerDate Sep<11>2014 19:20 Sep 12, 2018 Jkt 244001 PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 E:\FR\FM\13SEN1.SGM 13SEN1

Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices 46499 must send a letter stating that interest to small business tobacco manufacturing This notice is issued under the FDA by October 15, 2018, (see sections industry, which may be filled on a Federal Advisory Committee Act (5 I and II of this document for further rotating, sequential basis by U.S.C. app. 2) and 21 CFR part 14, details). Concurrently, nomination representatives of different small relating to advisory committees. materials for prospective candidates business tobacco manufacturers based Dated: September 7, 2018. should be sent to FDA by October 15, on areas of expertise relevant to the Leslie Kux, 2018. topics being considered by the Advisory Committee. Associate Commissioner for Policy. ADDRESSES: All statements of interest With this notice, nominations are [FR Doc. 2018–19922 Filed 9–12–18; 8:45 am] from small business tobacco manufacturing industry organizations sought for a pool of individuals, with BILLING CODE 4164–01–P interested in participating in the varying areas of expertise, to represent selection process of nonvoting industry the interests of the small business tobacco manufacturing industry on a DEPARTMENT OF HEALTH AND representative nominations should be rotating, sequential basis. HUMAN SERVICES sent to Caryn Cohen (see FOR FURTHER INFORMATION CONTACT). All nominations II. Selection Procedure Food and Drug Administration for nonvoting industry representatives may be submitted electronically by Any industry organization interested in participating in the selection of an [Docket No. FDA–2011–N–0920] accessing the FDA Advisory Committee appropriate nonvoting member to Membership Nomination Portal at: Agency Information Collection represent industry interests should send https://www.accessdata.fda.gov/scripts/ Activities; Submission for Office of a letter stating that interest to the FDA FACTRSPortal/FACTRS/index.cfm or by Management and Budget Review; contact (see FOR FURTHER INFORMATION mail to Advisory Committee Oversight Comment Request; Current Good CONTACT) within 30 days of publication and Management Staff, Food and Drug Manufacturing Practice, Hazard of this document (see DATES). Within the Administration, 10903 New Hampshire Analysis, and Risk-Based Preventive subsequent 30 days, FDA will send a Ave., Bldg. 32, Rm. 5103, Silver Spring, Controls for Human Food letter to each organization that has MD 20993–0002. Information about expressed an interest, attaching a becoming a member of an FDA advisory AGENCY: Food and Drug Administration, complete list of all such organizations; committee can also be obtained by and a list of all nominees along with HHS. visiting FDA’s website at: https:// their current resumes. The letter will www.fda.gov/AdvisoryCommittees/ ACTION: Notice. also state that it is the responsibility of default.htm. the interested organizations to confer FOR FURTHER INFORMATION CONTACT: SUMMARY: The Food and Drug with one another and to select a Administration (FDA) is announcing Caryn Cohen, Office of Science, Center candidate, within 60 days after the for Tobacco Products, Food and Drug that a proposed collection of receipt of the FDA letter, to serve as the information has been submitted to the Administration, Center for Tobacco nonvoting member to represent industry Products Document Control Center, Office of Management and Budget interests for the committee. The (OMB) for review and clearance under 10903 New Hampshire Ave., Bldg. 71, interested organizations are not bound Rm. G335, Silver Spring, MD 20993– the Paperwork Reduction Act of 1995. by the list of nominees in selecting a 0002, 1–877–287–1373 (choose Option candidate. However, if no individual is DATES: Fax written comments on the 5), TPSAC@fda.hhs.gov. selected within 60 days, the collection of information by October 15, SUPPLEMENTARY INFORMATION: The Commissioner will select the nonvoting 2018. Agency intends to add a nonvoting member to represent industry interests. ADDRESSES: To ensure that comments on industry representative to represent the III. Application Procedure the information collection are received, interests of the small business tobacco Individuals may self-nominate and/or OMB recommends that written manufacturing industry to the following an organization may nominate one or comments be faxed to the Office of advisory committee: more individuals to serve as a nonvoting Information and Regulatory Affairs, I. Tobacco Products Scientific Advisory industry representative. Contact OMB, Attn: FDA Desk Officer, Fax: 202– Committee information, a current curriculum vitae, 395–7285, or emailed to oira_ The Tobacco Products Scientific and the name of the committee of submission@omb.eop.gov. All Advisory Committee (the Committee) interest should be sent to the FDA comments should be identified with the advises the Commissioner of Food and Advisory Committee Membership OMB control number 0910–0751. Also Drugs (the Commissioner) or designee in Nomination Portal (see ADDRESSES) include the FDA docket number found discharging responsibilities related to within 30 days of publication of this in brackets in the heading of this the regulation of tobacco products. The document (see DATES). FDA will forward document. Committee reviews and evaluates safety, all nominations to the organizations FOR FURTHER INFORMATION CONTACT: dependence, and health issues relating expressing interest in participating in JonnaLynn Capezzuto, Office of to tobacco products and provides the selection process for the committee. Operations, Food and Drug appropriate advice, information, and (Persons who nominate themselves as Administration, Three White Flint recommendations to the Commissioner. nonvoting industry representatives will North, 10A–12M, 11601 Landsdown St., The Committee includes three not participate in the selection process). daltland on DSKBBV9HB2PROD with NOTICES North Bethesda, MD 20852, 301–796– nonvoting members who represent FDA seeks to include the views of 3794, PRAStaff@fda.hhs.gov. industry interests. These members women, and men, members of all racial include one representative of the and ethnic groups and individuals with SUPPLEMENTARY INFORMATION: In interests of the tobacco manufacturing and without disabilities on its advisory compliance with 44 U.S.C. 3507, FDA industry; one representative of the committees and, therefore encourages has submitted the following proposed interests of tobacco growers; and one nominations of appropriately qualified collection of information to OMB for representative of the interests of the candidates from these groups. review and clearance. VerDate Sep<11>2014 19:20 Sep 12, 2018 Jkt 244001 PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 E:\FR\FM\13SEN1.SGM 13SEN1


Document Created: 2018-09-13 01:01:19
Document Modified: 2018-09-13 01:01:19
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 small business tobacco manufacturing industry organization interested in participating in the selection of appropriate nonvoting members to represent industry interests must send a letter stating that interest to FDA by October 15, 2018, (see sections I and II of this document for further details). Concurrently, nomination materials for prospective candidates should be sent to FDA by October 15, 2018.
ContactCaryn Cohen, Office of Science, Center for Tobacco Products, Food and Drug Administration, Center for Tobacco Products Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002, 1-877-287-1373 (choose Option 5), [email protected]
FR Citation83 FR 46498 
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