Request for Nominations on the Tobacco Products Scientific Advisory Committee-Small Business Pool, 58801-58802 [2022-20990]

Download as PDF Federal Register / Vol. 87, No. 187 / Wednesday, September 28, 2022 / Notices ACTION: Notice. DEPARTMENT OF HEALTH AND HUMAN SERVICES The Food and Drug Administration (FDA) is announcing a correction to the notice of meeting of the Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee. This meeting was announced in the Federal Register of September 2, 2022. The correction is being made to reflect a change to the sponsor’s name. There are no other changes. SUMMARY: James Swink, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5211, Silver Spring, MD 20993–0002, 301–796–6313, James.Swink@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). Please call the Information Line for up-to-date information on this meeting. In the Federal Register of September 2, 2022 (87 FR 54221), FDA announced that a meeting of the Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee would be held on October 20, 2022. On page 54222, in the second column, in the Agenda portion of the document, the second sentence ‘‘On October 20, 2022, the committee will discuss, make recommendations, and vote on clinical information related to the De Novo request for the AvertD Test sponsored by SolvD, Inc.’’ is changed to read as follows: ‘‘On October 20, 2022, the committee will discuss, make recommendations, and vote on clinical information related to the De Novo request for the AvertD Test sponsored by SOLVD Health.’’ This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees. Dated: September 22, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–20985 Filed 9–27–22; 8:45 am] lotter on DSK11XQN23PROD with NOTICES1 BILLING CODE 4164–01–P VerDate Sep<11>2014 18:06 Sep 27, 2022 Jkt 256001 [Docket No. FDA–2022–N–2186] Request for Nominations on the Tobacco Products Scientific Advisory Committee—Small Business Pool 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 must send a letter stating that interest to the FDA by October 28, 2022 (see sections I and II of this document for further details). Concurrently, nomination materials for prospective candidates should be sent to *FDA by October 28, 2022. 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 Serina Hunter-Thomas (see FOR FURTHER INFORMATION CONTACT). All nominations for nonvoting industry representatives may be submitted electronically by accessing the FDA Advisory Committee Membership Nomination Portal: https:// www.accessdata.fda.gov/scripts/ SUMMARY: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Food and Drug Administration PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 58801 FACTRSPortal/FACTRS/index.cfm. Information about becoming a member of an FDA advisory committee can also be obtained by visiting FDA’s website: https://www.fda.gov/ AdvisoryCommittees/default.htm. FOR FURTHER INFORMATION CONTACT: Serina Hunter-Thomas, 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), or by email: TPSAC@ fda.hhs.gov. The Agency intends to add nonvoting industry representative(s) to the following advisory committee: SUPPLEMENTARY INFORMATION: I. Tobacco Products Scientific Advisory Committee The Tobacco Products Scientific Advisory Committee (the Committee) advises the Commissioner of FDA (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 the following positions: 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 E:\FR\FM\28SEN1.SGM 28SEN1 58802 Federal Register / Vol. 87, No. 187 / Wednesday, September 28, 2022 / Notices 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 21, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–20990 Filed 9–27–22; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration lotter on DSK11XQN23PROD with NOTICES1 [Docket No. FDA–2022–D–2059] Providing Over-the-Counter Monograph Submissions in Electronic Format; Draft Guidance for Industry; Availability Food and Drug Administration, Department of Health and Human Services (HHS). AGENCY: VerDate Sep<11>2014 18:06 Sep 27, 2022 Jkt 256001 ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ‘‘Providing Over-the-Counter Monograph Submissions in Electronic Format.’’ This guidance provides information on providing electronic submissions to FDA under the Federal Food, Drug, and Cosmetic Act (FD&C Act). DATES: Submit either electronic or written comments on the draft guidance by November 28, 2022 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 Instructions: All submissions received must include the Docket No. FDA– 2022–D–2059 for ‘‘Providing Over-theCounter Monograph Submissions in Electronic Format.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240–402–7500. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https:// www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– E:\FR\FM\28SEN1.SGM 28SEN1

Agencies

[Federal Register Volume 87, Number 187 (Wednesday, September 28, 2022)]
[Notices]
[Pages 58801-58802]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-20990]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-2186]


Request for Nominations on the Tobacco Products Scientific 
Advisory Committee--Small Business Pool

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 must send a letter stating that 
interest to the FDA by October 28, 2022 (see sections I and II of this 
document for further details). Concurrently, nomination materials for 
prospective candidates should be sent to *FDA by October 28, 2022.

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 Serina Hunter-Thomas (see FOR FURTHER INFORMATION 
CONTACT). All nominations for nonvoting industry representatives may be 
submitted electronically by accessing the FDA Advisory Committee 
Membership Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm. Information about becoming a member of 
an FDA advisory committee can also be obtained by visiting FDA's 
website: https://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: Serina Hunter-Thomas, 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), or by email: [email protected].

SUPPLEMENTARY INFORMATION: The Agency intends to add nonvoting industry 
representative(s) to the following advisory committee:

I. Tobacco Products Scientific Advisory Committee

    The Tobacco Products Scientific Advisory Committee (the Committee) 
advises the Commissioner of FDA (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 the following 
positions: 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

[[Page 58802]]

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 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-20990 Filed 9-27-22; 8:45 am]
BILLING CODE 4164-01-P

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