81_FR_54258 81 FR 54101 - Request for Nominations on the Tobacco Products Scientific Advisory Committee

81 FR 54101 - 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 157 (August 15, 2016)

Page Range54101-54102
FR Document2016-19312

The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of a nonvoting member to represent the interests of tobacco growers 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 member to represent the interests of tobacco growers 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 157 (Monday, August 15, 2016) 
[Federal Register Volume 81, Number 157 (Monday, August 15, 2016)]
[Notices]
[Pages 54101-54102]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-19312]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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) is requesting that any 
industry organizations interested in participating in the selection of 
a nonvoting member to represent the interests of tobacco growers 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 member to represent the 
interests of tobacco growers 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

[[Page 54102]]

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 the interests 
of tobacco growers must send a letter stating that interest to FDA by 
September 14, 2016 (see sections I and II of this document for further 
details). Concurrently, nomination materials for prospective candidates 
should be sent to FDA by September 14, 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 
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 Web site at: 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. 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 the interests 
of tobacco growers 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 r[eacute]sum[eacute]s. 
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 the interests of tobacco growers 
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 the interests of tobacco growers.

III. Application Procedure

    Individuals may self-nominate and/or an organization may nominate 
one or more individuals to serve as a nonvoting member to represent the 
interests of tobacco growers. 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 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: August 9, 2016.
Janice M. Soreth,
Acting Associate Commissioner, Special Medical Programs.
[FR Doc. 2016-19312 Filed 8-12-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 157 / Monday, August 15, 2016 / Notices 54101 • Confidential Submissions—To FOR FURTHER INFORMATION CONTACT: document. Please use the document submit a comment with confidential Jismi Johnson, Center for Devices and number 1835 to identify the guidance information that you do not wish to be Radiological Health, Food and Drug you are requesting. made publicly available, submit your Administration, 10903 New Hampshire IV. Paperwork Reduction Act of 1995 comments only as a written/paper Ave., Bldg. 66, Rm. 1524, Silver Spring, submission. You should submit two MD 20993–0002, 301–796–6424. This guidance refers to previously copies total. One copy will include the SUPPLEMENTARY INFORMATION: approved collections of information. information you claim to be confidential These collections of information are I. Background subject to review by the Office of with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS FDA has developed this guidance Management and Budget (OMB) under CONFIDENTIAL INFORMATION.’’ The document to assist industry in preparing the Paperwork Reduction Act of 1995 Agency will review this copy, including premarket notification (510(k)) (44 U.S.C. 3501–3520). The collections the claimed confidential information, in submissions for electrosurgical devices of information in 21 CFR part 807, its consideration of comments. The intended for use in general surgery. subpart E have been approved under These devices are designed to cut and/ OMB control number 0910–0120; the second copy, which will have the or remove tissue and control bleeding collections of information in 21 CFR claimed confidential information through the use of high-frequency part 820 have been approved under redacted/blacked out, will be available electrical current. For the purpose of OMB control number 0910–0073; the for public viewing and posted on http:// this guidance, electrosurgical devices collections of information in 21 CFR www.regulations.gov. Submit both may also be called radiofrequency part 801 have been approved under copies to the Division of Dockets OMB control number 0910–0485; and Management. If you do not wish your devices or high-frequency devices. The scope of this document is limited to the the collections of information in the name and contact information to be guidance document ‘‘Requests for class II electrosurgical devices and made publicly available, you can Feedback on Medical Device accessories classified under 21 CFR provide this information on the cover Submissions: The Pre-Submission 878.4400, Electrosurgical cutting and sheet and not in the body of your Program and Meetings with Food and coagulation device and accessories. comments and you must identify this In the Federal Register of March 24, Drug Administration Staff’’ have been information as ‘‘confidential.’’ Any 2014 (79 FR 16008), FDA announced the approved under OMB control number information marked as ‘‘confidential’’ availability of the draft guidance. 0910–0756. will not be disclosed except in Interested persons were invited to Dated: August 9, 2016. accordance with 21 CFR 10.20 and other comment by June 23, 2014. A total of six applicable disclosure law. For more Leslie Kux, sets of comments were received. FDA Associate Commissioner for Policy. information about FDA’s posting of reviewed and considered all the public comments to public dockets, see 80 FR [FR Doc. 2016–19404 Filed 8–12–16; 8:45 am] comments received and revised sections 56469, September 18, 2015, or access of the guidance, where applicable. BILLING CODE 4164–01–P the information at: http://www.fda.gov/ regulatoryinformation/dockets/ II. Significance of Guidance default.htm. This guidance is being issued DEPARTMENT OF HEALTH AND consistent with FDA’s good guidance HUMAN SERVICES Docket: For access to the docket to read background documents or the practices regulation (21 CFR 10.115). Food and Drug Administration electronic and written/paper comments The guidance represents the current thinking of FDA on premarket [Docket No. FDA–2016–N–0001] received, go to http:// www.regulations.gov and insert the notification (510(k)) submissions for electrosurgical devices for general Request for Nominations on the docket number, found in brackets in the Tobacco Products Scientific Advisory heading of this document, into the surgery. It does not establish any rights for any person and is not binding on Committee ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets FDA or the public. You can use an AGENCY: Food and Drug Administration, Management, 5630 Fishers Lane, Rm. alternative approach if it satisfies the HHS. 1061, Rockville, MD 20852. requirements of the applicable statutes ACTION: Notice. and regulations. An electronic copy of the guidance SUMMARY: The Food and Drug document is available for download III. Electronic Access Administration (FDA) is requesting that from the Internet. See the Persons interested in obtaining a copy any industry organizations interested in SUPPLEMENTARY INFORMATION section for of the guidance may do so by participating in the selection of a information on electronic access to the downloading an electronic copy from nonvoting member to represent the guidance. Submit written requests for a the Internet. A search capability for all interests of tobacco growers to serve on single hard copy of the guidance Center for Devices and Radiological the Tobacco Products Scientific document entitled ‘‘Premarket Health guidance documents is available Advisory Committee for the Center for Notification (510(k)) Submissions for at http://www.fda.gov/MedicalDevices/ Tobacco Products (CTP), notify FDA in Electrosurgical Devices for General DeviceRegulationandGuidance/ writing. FDA is also requesting Surgery’’ to the Office of the Center GuidanceDocuments/default.htm. nominations for a nonvoting member to Director, Guidance and Policy Guidance documents are also available represent the interests of tobacco sradovich on DSK3GMQ082PROD with NOTICES Development, Center for Devices and at http://www.regulations.gov. Persons growers to serve on the Tobacco Radiological Health, Food and Drug unable to download an electronic copy Products Scientific Advisory Administration, 10903 New Hampshire of ‘‘Premarket Notification (510(k)) Committee, and an alternate to this Ave., Bldg. 66, Rm. 5431, Silver Spring, Submissions for Electrosurgical Devices representative. A nominee may either be MD 20993–0002. Send one self- for General Surgery’’ may send an email self-nominated or nominated by an addressed adhesive label to assist that request to CDRH-Guidance@fda.hhs.gov organization to serve as a nonvoting office in processing your request. to receive an electronic copy of the industry representative. Nominations VerDate Sep<11>2014 19:23 Aug 12, 2016 Jkt 238001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 E:\FR\FM\15AUN1.SGM 15AUN1

54102 Federal Register / Vol. 81, No. 157 / Monday, August 15, 2016 / Notices will be accepted for current vacancies growers should send a letter stating that DEPARTMENT OF HEALTH AND effective with this notice. interest to the FDA contact (see FOR HUMAN SERVICES DATES: Any industry organization FURTHER INFORMATION CONTACT) within interested in participating in the 30 days of publication of this document Food and Drug Administration selection of an appropriate nonvoting (see DATES). Within the subsequent 30 member to represent the interests of days, FDA will send a letter to each [Docket No. FDA–2014–D–0218] tobacco growers must send a letter organization that has expressed an stating that interest to FDA by interest, attaching a complete list of all Premarket Notification Submissions September 14, 2016 (see sections I and such organizations, and a list of all for Bipolar Electrosurgical Vessel II of this document for further details). nominees along with their current Sealers for General Surgery; Guidance Concurrently, nomination materials for for Industry and Food and Drug résumés. The letter will also state that prospective candidates should be sent to Administration Staff; Availability it is the responsibility of the interested FDA by September 14, 2016. organizations to confer with one another AGENCY: Food and Drug Administration, ADDRESSES: All statements of interest and to select a candidate, within 60 HHS. from industry organizations interested days after the receipt of the FDA letter, in participating in the selection process ACTION: Notice of availability. to serve as the nonvoting member to should be sent to Caryn Cohen (see FOR represent the interests of tobacco SUMMARY: The Food and Drug FURTHER INFORMATION CONTACT). All growers for the committee. The Administration (FDA or Agency) is nominations for nonvoting industry interested organizations are not bound announcing the availability of the representatives should be submitted by the list of nominees in selecting a guidance entitled ‘‘Premarket electronically by accessing the FDA candidate. However, if no individual is Notification (510(k)) Submissions for Advisory Committee Membership selected within 60 days, the Bipolar Electrosurgical Vessel Sealers Nomination Portal at: https:// Commissioner will select the nonvoting for General Surgery.’’ FDA has www.accessdata.fda.gov/scripts/ member to represent the interests of developed this guidance document to FACTRSPortal/FACTRS/index.cfm or by tobacco growers. assist industry in preparing premarket mail to Advisory Committee Oversight notification (510(k)) submissions for and Management Staff, Food and Drug III. Application Procedure bipolar electrosurgical vessel sealers Administration, 10903 New Hampshire intended for use in general surgery. Ave., Bldg. 32, Rm. 5103, Silver Spring, Individuals may self-nominate and/or MD 20993–0002. Information about DATES: Submit either electronic or an organization may nominate one or becoming a member of an FDA advisory more individuals to serve as a nonvoting written comments on this guidance at committee can also be obtained by any time. General comments on Agency member to represent the interests of visiting FDA’s Web site at: http:// guidance documents are welcome at any tobacco growers. Contact information, www.fda.gov/AdvisoryCommittees/ time. current curriculum vitae, and the name default.htm. of the committee of interest should be ADDRESSES: You may submit comments FOR FURTHER INFORMATION CONTACT: sent to the FDA Advisory Committee as follows: Caryn Cohen, Office of Science, Center Membership Nomination Portal (see Electronic Submissions for Tobacco Products, Food and Drug ADDRESSES) within 30 days of Administration, Center for Tobacco Submit electronic comments in the publication of this document (see following way: Products, Document Control Center, DATES). FDA will forward all Bldg. 71, Rm. G335, 10903 New • Federal eRulemaking Portal: http:// nominations to the organizations www.regulations.gov. Follow the Hampshire Ave., Silver Spring, MD expressing interest in participating in 20993–0002, 1–877–287–1373 (choose instructions for submitting comments. the selection process for the committee. Comments submitted electronically, Option 5), email: TPSAC@fda.hhs.gov. (Persons who nominate themselves as including attachments, to http:// SUPPLEMENTARY INFORMATION: The nonvoting industry representatives will www.regulations.gov will be posted to Agency intends to add nonvoting not participate in the selection process.) the docket unchanged. Because your industry representatives to the following FDA seeks to include the views of comment will be made public, you are advisory committee: women, and men, members of all racial solely responsible for ensuring that your I. Tobacco Products Scientific Advisory and ethnic groups, and individuals with comment does not include any Committee and without disabilities on its advisory confidential information that you or a The Tobacco Products Scientific committees and, therefore encourages third party may not wish to be posted, Advisory Committee (the Committee) nominations of appropriately qualified such as medical information, your or advises the Commissioner of Food and candidates from these groups. anyone else’s Social Security number, or Drugs (the Commissioner) or designee in confidential business information, such This notice is issued under the as a manufacturing process. Please note discharging responsibilities related to Federal Advisory Committee Act (5 that if you include your name, contact the regulation of tobacco products. The U.S.C. app. 2) and 21 CFR part 14, information, or other information that Committee reviews and evaluates safety, relating to advisory committees. identifies you in the body of your dependence, and health issues relating to tobacco products and provides Dated: August 9, 2016. comments, that information will be posted on http://www.regulations.gov. sradovich on DSK3GMQ082PROD with NOTICES appropriate advice, information, and Janice M. Soreth, recommendations to the Commissioner. • If you want to submit a comment Acting Associate Commissioner, Special Medical Programs. with confidential information that you II. Selection Procedure do not wish to be made available to the [FR Doc. 2016–19312 Filed 8–12–16; 8:45 am] Any industry organization interested public, submit the comment as a in participating in the selection of an BILLING CODE 4164–01–P written/paper submission and in the appropriate nonvoting member to manner detailed (see ‘‘Written/Paper represent the interests of tobacco Submissions’’ and ‘‘Instructions’’). VerDate Sep<11>2014 19:23 Aug 12, 2016 Jkt 238001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\15AUN1.SGM 15AUN1


Document Created: 2016-08-13 02:21:57
Document Modified: 2016-08-13 02:21:57
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 the interests of tobacco growers must send a letter stating that interest to FDA by September 14, 2016 (see sections I and II of this document for further details). Concurrently, nomination materials for prospective candidates should be sent to FDA by September 14, 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 54101 
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