Request for Nominations on the Tobacco Products Scientific Advisory Committee, 46498-46499 [2018-19922]

Download as PDF 46498 ACTION: Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices Notice. The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Science Board to the Food and Drug Administration. The Science Board provides advice to the Commissioner of Food and Drugs and other appropriate officials on specific, complex scientific and technical issues important to FDA and its mission, including emerging issues within the scientific community. Additionally, the Science Board provides advice to the Agency on keeping pace with technical and scientific developments including in regulatory science, input into the Agency’s research agenda, and on upgrading its scientific and research facilities and training opportunities. It will also provide, where requested, expert review of Agency sponsored intramural and extramural scientific research programs. The meeting will be open to the public. DATES: The meeting will be held on October 22, 2018, from 8:30 a.m. to 4:30 p.m. ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503, section A), Silver Spring, MD 20993. For those unable to attend in person, the meeting will also be webcast. The link for the webcast is available at https://collaboration. fda.gov/scienceboard2018/. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/ AdvisoryCommittees/AboutAdvisory Committees/ucm408555.htm. FOR FURTHER INFORMATION CONTACT: Rakesh Raghuwanshi, Office of the Chief Scientist, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 3309, Silver Spring, MD 20993, 301–796–4769, rakesh.raghuwanshi@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s website at https:// www.fda.gov/AdvisoryCommittees/ default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible daltland on DSKBBV9HB2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 19:20 Sep 12, 2018 Jkt 244001 modifications before coming to the meeting. SUPPLEMENTARY INFORMATION: Agenda: The Science Board will hear a response from the Center for Veterinary Medicine (CVM) to the recommendations made by the Science Board’s 2017 review of CVM’s National Antibiotic Resistance Monitoring System program. The Science Board will also discuss potential hazards and nutritional considerations in the production of food derived from animal cell culture technologies. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s website after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before October 15, 2018. Oral presentations from the public will be scheduled between approximately 3:30 p.m. and 4:30 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before October 5, 2018. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by October 9, 2018. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 disability, please contact Rakesh Raghuwanshi at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://www.fda.gov/Advisory Committees/AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: September 10, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–19906 Filed 9–12–18; 8:45 am] BILLING CODE 4164–01–P 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. 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 SUMMARY: E:\FR\FM\13SEN1.SGM 13SEN1 Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices daltland on DSKBBV9HB2PROD with NOTICES 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), TPSAC@fda.hhs.gov. 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 VerDate Sep<11>2014 19:20 Sep 12, 2018 Jkt 244001 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. PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 46499 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0920] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. SUMMARY: Fax written comments on the collection of information by October 15, 2018. DATES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202– 395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0751. Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796– 3794, PRAStaff@fda.hhs.gov. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: E:\FR\FM\13SEN1.SGM 13SEN1

Agencies

[Federal Register Volume 83, Number 178 (Thursday, September 13, 2018)]
[Notices]
[Pages 46498-46499]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

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

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

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