Request for Nominations for Voting Members on a Public Advisory Committee; the Tobacco Products Scientific Advisory Committee, 46069-46070 [2017-21173]

Download as PDF Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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. asabaliauskas on DSKBBXCHB2PROD with NOTICES FOR FURTHER INFORMATION CONTACT: LaToya Bonner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002, 301– 796–9001, Fax: 301–847–8533, email: EMDAC@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 Web site 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 VerDate Sep<11>2014 16:49 Oct 02, 2017 Jkt 244001 modifications before coming to the meeting. SUPPLEMENTARY INFORMATION: Agenda: The committee will discuss the safety and efficacy of new drug application (NDA) 209637 for semaglutide injection, submitted by Novo Nordisk, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. 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 Web site 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 Web site 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. All electronic and written submissions submitted to the Docket (see the ADDRESSES section) on or before October 11, 2017, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 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 3, 2017. 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 4, 2017. 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 special accommodations due to a disability, please contact PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 46069 LaToya Bonner at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/ AdvisoryCommittees/ 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 26, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–21176 Filed 10–2–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–N–0001] Request for Nominations for Voting Members on a Public Advisory Committee; the Tobacco Products Scientific Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is requesting nominations for members to serve on the Tobacco Products Scientific Advisory Committee, Office of Science, Center for Tobacco Products. 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. DATES: Nominations received on or before December 4, 2017 will be given first consideration for membership on the Tobacco Products Scientific Advisory Committee. Nominations received after December 4, 2017 will be considered for nomination to the committee as later vacancies occur. ADDRESSES: All nominations for membership should be sent electronically by logging into the FDA Advisory 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. SUMMARY: E:\FR\FM\03OCN1.SGM 03OCN1 46070 Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices FOR FURTHER INFORMATION CONTACT: Regarding all nomination questions for membership: Caryn Cohen, Office of Science, Center for Tobacco Products, Food and Drug Administration, Center for Tobacco Products, Document Control Center, Building 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 1–877–287– 1373 (choose Option 5), TPSAC@ fda.hhs.gov. Information about becoming a member on an FDA advisory committee can also be obtained by visiting FDA’s Web site by using the following link: https://www.fda.gov/ AdvisoryCommittees/default.htm. FDA is requesting nomination for voting members on the Tobacco Products Scientific Advisory Committee. SUPPLEMENTARY INFORMATION: I. General Description of the Committee Duties 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. asabaliauskas on DSKBBXCHB2PROD with NOTICES II. Criteria for Voting Members The Committee consists of 12 members including the Chair. Members and the Chair are selected by the Commissioner or designee from among individuals knowledgeable in the fields of medicine, medical ethics, science, or technology involving the manufacture, evaluation, or use of tobacco products. Almost all non-Federal members of this committee serve as Special Government Employees. The Committee includes nine technically qualified voting members, selected by the Commissioner or designee. The nine voting members include seven members who are physicians, dentists, scientists, or health care professionals practicing in the area of oncology, pulmonology, cardiology, toxicology, pharmacology, addiction, or any other relevant specialty. The nine voting members also include one member who is an officer or employee of a State or local government or of the Federal Government, and one member who is a representative of the general public. Almost all non-Federal members of this committee serve as Special Government Employees. Members will be invited to serve for terms of up to 4 years. VerDate Sep<11>2014 16:49 Oct 02, 2017 Jkt 244001 III. Nomination Procedures Any interested person may nominate one or more qualified individuals for membership on the advisory committee. Self-nominations are also accepted. Nominations must include a current, ´ ´ complete resume or curriculum vitae for each nominee and a signed copy of the Acknowledgement and Consent form available at the FDA Advisory Nomination Portal (see ADDRESSES). Nominations must also specify the advisory committee for which the nominee is recommended. Nominations must also acknowledge that the nominee is aware of the nomination unless self-nominated. FDA will ask potential candidates to provide detailed information concerning such matters related to financial holdings, employment, and research grants and/or contracts to permit evaluation of possible sources of conflicts of interest. 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 27, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–21173 Filed 10–2–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–P–2530] Determination That SPECTAZOLE (Econazole Nitrate) Topical Cream, 1%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) has determined that SPECTAZOLE (econazole nitrate) topical cream, 1%, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements. FOR FURTHER INFORMATION CONTACT: Nisha Shah, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire SUMMARY: PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 Ave., Bldg. 51, Rm. 6222, Silver Spring, MD 20993–0002, 301–796–4455. SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98–417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the listed drug, which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the ‘‘Approved Drug Products with Therapeutic Equivalence Evaluations,’’ which is known generally as the Orange Book. Under FDA regulations, a drug is removed from the list if the Agency withdraws or suspends approval of the drug’s NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug. SPECTAZOLE (econazole nitrate) topical cream, 1%, is the subject of NDA 018751, held by Alvogen Malta Operations Ltd., and initially approved on December 23, 1982. SPECTAZOLE is indicated for topical application in the treatment of tinea pedis, tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Microsporum canis, Microsporum audouini, Microsporum gypseum, and Epidermophyton floccosum; in the treatment of cutaneous candidiasis; and in the treatment of tinea versicolor. SPECTAZOLE (econazole nitrate) topical cream, 1%, is currently listed in E:\FR\FM\03OCN1.SGM 03OCN1

Agencies

[Federal Register Volume 82, Number 190 (Tuesday, October 3, 2017)]
[Notices]
[Pages 46069-46070]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21173]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0001]

Request for Nominations for Voting Members on a Public Advisory
Committee; the Tobacco Products Scientific Advisory Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is requesting
nominations for members to serve on the Tobacco Products Scientific
Advisory Committee, Office of Science, Center for Tobacco Products.
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.

DATES: Nominations received on or before December 4, 2017 will be given
first consideration for membership on the Tobacco Products Scientific
Advisory Committee. Nominations received after December 4, 2017 will be
considered for nomination to the committee as later vacancies occur.

ADDRESSES: All nominations for membership should be sent electronically
by logging into the FDA Advisory 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.

[[Page 46070]]

FOR FURTHER INFORMATION CONTACT: Regarding all nomination questions for
membership: Caryn Cohen, Office of Science, Center for Tobacco
Products, Food and Drug Administration, Center for Tobacco Products,
Document Control Center, Building 71, Rm. G335, 10903 New Hampshire
Ave., Silver Spring, MD 20993-0002, 1-877-287-1373 (choose Option 5),
TPSAC@fda.hhs.gov.
Information about becoming a member on an FDA advisory committee
can also be obtained by visiting FDA's Web site by using the following
link: https://www.fda.gov/AdvisoryCommittees/default.htm.

SUPPLEMENTARY INFORMATION: FDA is requesting nomination for voting
members on the Tobacco Products Scientific Advisory Committee.

I. General Description of the Committee Duties

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. Criteria for Voting Members

The Committee consists of 12 members including the Chair. Members
and the Chair are selected by the Commissioner or designee from among
individuals knowledgeable in the fields of medicine, medical ethics,
science, or technology involving the manufacture, evaluation, or use of
tobacco products. Almost all non-Federal members of this committee
serve as Special Government Employees. The Committee includes nine
technically qualified voting members, selected by the Commissioner or
designee. The nine voting members include seven members who are
physicians, dentists, scientists, or health care professionals
practicing in the area of oncology, pulmonology, cardiology,
toxicology, pharmacology, addiction, or any other relevant specialty.
The nine voting members also include one member who is an officer or
employee of a State or local government or of the Federal Government,
and one member who is a representative of the general public. Almost
all non-Federal members of this committee serve as Special Government
Employees. Members will be invited to serve for terms of up to 4 years.

III. Nomination Procedures

Any interested person may nominate one or more qualified
individuals for membership on the advisory committee. Self-nominations
are also accepted. Nominations must include a current, complete
r[eacute]sum[eacute] or curriculum vitae for each nominee and a signed
copy of the Acknowledgement and Consent form available at the FDA
Advisory Nomination Portal (see ADDRESSES). Nominations must also
specify the advisory committee for which the nominee is recommended.
Nominations must also acknowledge that the nominee is aware of the
nomination unless self-nominated. FDA will ask potential candidates to
provide detailed information concerning such matters related to
financial holdings, employment, and research grants and/or contracts to
permit evaluation of possible sources of conflicts of interest.
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 27, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-21173 Filed 10-2-17; 8:45 am]
BILLING CODE 4164-01-P

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