82 FR 46069 - Request for Nominations for Voting Members on a Public Advisory Committee; the Tobacco Products Scientific Advisory Committee
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 190 (October 3, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 190 (October 3, 2017)
| Page Range | 46069-46070 | |
| FR Document | 2017-21173 |
[Federal Register Volume 82, Number 190 (Tuesday, October 3, 2017)] [Notices] [Pages 46069-46070] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-21173] ----------------------------------------------------------------------- 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), [email protected]. 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
![Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices 46069
made publicly available, submit your modifications before coming to the LaToya Bonner at least 7 days in
comments only as a written/paper meeting. advance of the meeting.
submission. You should submit two FDA is committed to the orderly
SUPPLEMENTARY INFORMATION: conduct of its advisory committee
copies total. One copy will include the
information you claim to be confidential Agenda: The committee will discuss meetings. Please visit our Web site at
with a heading or cover note that states the safety and efficacy of new drug https://www.fda.gov/
‘‘THIS DOCUMENT CONTAINS application (NDA) 209637 for AdvisoryCommittees/
CONFIDENTIAL INFORMATION.’’ The semaglutide injection, submitted by AboutAdvisoryCommittees/
Agency will review this copy, including Novo Nordisk, as an adjunct to diet and ucm111462.htm for procedures on
the claimed confidential information, in exercise to improve glycemic control in public conduct during advisory
its consideration of comments. The adults with type 2 diabetes mellitus. committee meetings.
second copy, which will have the FDA intends to make background Notice of this meeting is given under
claimed confidential information material available to the public no later the Federal Advisory Committee Act (5
redacted/blacked out, will be available than 2 business days before the meeting. U.S.C. app. 2).
for public viewing and posted on If FDA is unable to post the background Dated: September 26, 2017.
https://www.regulations.gov. Submit material on its Web site prior to the Anna K. Abram,
both copies to the Dockets Management meeting, the background material will Deputy Commissioner for Policy, Planning,
Staff. If you do not wish your name and be made publicly available at the Legislation, and Analysis.
contact information to be made publicly location of the advisory committee [FR Doc. 2017–21176 Filed 10–2–17; 8:45 am]
available, you can provide this meeting, and the background material BILLING CODE 4164–01–P
information on the cover sheet and not will be posted on FDA’s Web site after
in the body of your comments and you the meeting. Background material is
must identify this information as available at https://www.fda.gov/ DEPARTMENT OF HEALTH AND
‘‘confidential.’’ Any information marked AdvisoryCommittees/Calendar/ HUMAN SERVICES
as ‘‘confidential’’ will not be disclosed default.htm. Scroll down to the
except in accordance with 21 CFR 10.20 appropriate advisory committee meeting Food and Drug Administration
and other applicable disclosure law. For link.
[Docket No. FDA–2017–N–0001]
more information about FDA’s posting Procedure: Interested persons may
of comments to public dockets, see 80 present data, information, or views, Request for Nominations for Voting
FR 56469, September 18, 2015, or access orally or in writing, on issues pending Members on a Public Advisory
the information at: https://www.gpo.gov/ before the committee. All electronic and Committee; the Tobacco Products
fdsys/pkg/FR-2015-09-18/pdf/2015- written submissions submitted to the Scientific Advisory Committee
23389.pdf. Docket (see the ADDRESSES section) on
or before October 11, 2017, will be AGENCY: Food and Drug Administration,
Docket: For access to the docket to provided to the committee. Oral HHS.
read background documents or the presentations from the public will be ACTION: Notice.
electronic and written/paper comments scheduled between approximately 1
received, go to https:// SUMMARY: The Food and Drug
p.m. and 2 p.m. Those individuals Administration (FDA) is requesting
www.regulations.gov and insert the interested in making formal oral
docket number, found in brackets in the nominations for members to serve on
presentations should notify the contact the Tobacco Products Scientific
heading of this document, into the person and submit a brief statement of
‘‘Search’’ box and follow the prompts Advisory Committee, Office of Science,
the general nature of the evidence or Center for Tobacco Products.
and/or go to the Dockets Management arguments they wish to present, the FDA seeks to include the views of
Staff, 5630 Fishers Lane, Rm. 1061, names and addresses of proposed women and men, members of all racial
Rockville, MD 20852. participants, and an indication of the and ethnic groups, and individuals with
FOR FURTHER INFORMATION CONTACT: approximate time requested to make and without disabilities on its advisory
LaToya Bonner, Center for Drug their presentation on or before October committees and, therefore, encourages
Evaluation and Research, Food and 3, 2017. Time allotted for each nominations of appropriately qualified
Drug Administration, 10903 New presentation may be limited. If the candidates from these groups.
Hampshire Ave., Bldg. 31, Rm. 2417, number of registrants requesting to DATES: Nominations received on or
Silver Spring, MD 20993–0002, 301– speak is greater than can be reasonably before December 4, 2017 will be given
796–9001, Fax: 301–847–8533, email: accommodated during the scheduled first consideration for membership on
EMDAC@fda.hhs.gov, or FDA Advisory open public hearing session, FDA may the Tobacco Products Scientific
Committee Information Line, 1–800– conduct a lottery to determine the Advisory Committee. Nominations
741–8138 (301–443–0572 in the speakers for the scheduled open public received after December 4, 2017 will be
Washington, DC area). A notice in the hearing session. The contact person will considered for nomination to the
Federal Register about last minute notify interested persons regarding their committee as later vacancies occur.
modifications that impact a previously request to speak by October 4, 2017. ADDRESSES: All nominations for
announced advisory committee meeting Persons attending FDA’s advisory membership should be sent
committee meetings are advised that the
asabaliauskas on DSKBBXCHB2PROD with NOTICES
cannot always be published quickly electronically by logging into the FDA
enough to provide timely notice. Agency is not responsible for providing Advisory Nomination Portal: https://
Therefore, you should always check the access to electrical outlets. www.accessdata.fda.gov/scripts/
Agency’s Web site at https:// FDA welcomes the attendance of the FACTRSPortal/FACTRS/index.cfm or by
www.fda.gov/AdvisoryCommittees/ public at its advisory committee mail to Advisory Committee Oversight
default.htm and scroll down to the meetings and will make every effort to and Management Staff, Food and Drug
appropriate advisory committee meeting accommodate persons with disabilities. Administration, 10903 New Hampshire
link, or call the advisory committee If you require special accommodations Ave., Bldg. 32, Rm. 5103, Silver Spring,
information line to learn about possible due to a disability, please contact MD 20993–0002.
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![46070 Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices
FOR FURTHER INFORMATION CONTACT: III. Nomination Procedures Ave., Bldg. 51, Rm. 6222, Silver Spring,
Regarding all nomination questions for Any interested person may nominate MD 20993–0002, 301–796–4455.
membership: Caryn Cohen, Office of one or more qualified individuals for SUPPLEMENTARY INFORMATION: In 1984,
Science, Center for Tobacco Products, membership on the advisory committee. Congress enacted the Drug Price
Food and Drug Administration, Center Self-nominations are also accepted. Competition and Patent Term
for Tobacco Products, Document Nominations must include a current, Restoration Act of 1984 (Pub. L. 98–417)
Control Center, Building 71, Rm. G335, complete résumé or curriculum vitae for (the 1984 amendments), which
10903 New Hampshire Ave., Silver each nominee and a signed copy of the authorized the approval of duplicate
Spring, MD 20993–0002, 1–877–287– Acknowledgement and Consent form versions of drug products under an
1373 (choose Option 5), TPSAC@ available at the FDA Advisory ANDA procedure. ANDA applicants
fda.hhs.gov. Nomination Portal (see ADDRESSES). must, with certain exceptions, show that
Information about becoming a Nominations must also specify the the drug for which they are seeking
member on an FDA advisory committee advisory committee for which the approval contains the same active
can also be obtained by visiting FDA’s nominee is recommended. Nominations ingredient in the same strength and
Web site by using the following link: must also acknowledge that the dosage form as the listed drug, which is
https://www.fda.gov/ nominee is aware of the nomination a version of the drug that was
AdvisoryCommittees/default.htm. unless self-nominated. FDA will ask previously approved. ANDA applicants
potential candidates to provide detailed do not have to repeat the extensive
SUPPLEMENTARY INFORMATION: FDA is clinical testing otherwise necessary to
information concerning such matters
requesting nomination for voting gain approval of a new drug application
related to financial holdings,
members on the Tobacco Products (NDA).
employment, and research grants and/or
Scientific Advisory Committee. The 1984 amendments include what
contracts to permit evaluation of
I. General Description of the Committee possible sources of conflicts of interest. is now section 505(j)(7) of the Federal
Duties This notice is issued under the Food, Drug, and Cosmetic Act (21 U.S.C.
Federal Advisory Committee Act (5 355(j)(7)), which requires FDA to
The Tobacco Products Scientific U.S.C. app. 2) and 21 CFR part 14, publish a list of all approved drugs.
Advisory Committee (the Committee) relating to advisory committees. FDA publishes this list as part of the
advises the Commissioner of Food and ‘‘Approved Drug Products with
Dated: September 27, 2017.
Drugs (the Commissioner) or designee in Therapeutic Equivalence Evaluations,’’
discharging responsibilities related to Anna K. Abram,
which is known generally as the Orange
the regulation of tobacco products. The Deputy Commissioner for Policy, Planning,
Book. Under FDA regulations, a drug is
Committee reviews and evaluates safety, Legislation, and Analysis.
removed from the list if the Agency
dependence, and health issues relating [FR Doc. 2017–21173 Filed 10–2–17; 8:45 am]
withdraws or suspends approval of the
to tobacco products and provides BILLING CODE 4164–01–P
drug’s NDA or ANDA for reasons of
appropriate advice, information, and safety or effectiveness or if FDA
recommendations to the Commissioner. determines that the listed drug was
DEPARTMENT OF HEALTH AND
II. Criteria for Voting Members withdrawn from sale for reasons of
HUMAN SERVICES
safety or effectiveness (21 CFR 314.162).
The Committee consists of 12 Food and Drug Administration A person may petition the Agency to
members including the Chair. Members determine, or the Agency may
and the Chair are selected by the [Docket No. FDA–2017–P–2530] determine on its own initiative, whether
Commissioner or designee from among a listed drug was withdrawn from sale
Determination That SPECTAZOLE
individuals knowledgeable in the fields for reasons of safety or effectiveness.
(Econazole Nitrate) Topical Cream, 1%,
of medicine, medical ethics, science, or This determination may be made at any
Was Not Withdrawn From Sale for
technology involving the manufacture, time after the drug has been withdrawn
Reasons of Safety or Effectiveness
evaluation, or use of tobacco products. from sale, but must be made prior to
Almost all non-Federal members of this AGENCY: Food and Drug Administration, approving an ANDA that refers to the
committee serve as Special Government HHS. listed drug (§ 314.161 (21 CFR 314.161)).
Employees. The Committee includes ACTION: Notice. FDA may not approve an ANDA that
nine technically qualified voting does not refer to a listed drug.
members, selected by the Commissioner SUMMARY: The Food and Drug SPECTAZOLE (econazole nitrate)
or designee. The nine voting members Administration (FDA or Agency) has topical cream, 1%, is the subject of NDA
include seven members who are determined that SPECTAZOLE 018751, held by Alvogen Malta
physicians, dentists, scientists, or health (econazole nitrate) topical cream, 1%, Operations Ltd., and initially approved
care professionals practicing in the area was not withdrawn from sale for reasons on December 23, 1982. SPECTAZOLE is
of oncology, pulmonology, cardiology, of safety or effectiveness. This indicated for topical application in the
toxicology, pharmacology, addiction, or determination means that FDA will not treatment of tinea pedis, tinea cruris,
any other relevant specialty. The nine begin procedures to withdraw approval and tinea corporis caused by
voting members also include one of abbreviated new drug applications Trichophyton rubrum, Trichophyton
(ANDAs) that refer to this drug product,
asabaliauskas on DSKBBXCHB2PROD with NOTICES
member who is an officer or employee mentagrophytes, Trichophyton
of a State or local government or of the and it will allow FDA to continue to tonsurans, Microsporum canis,
Federal Government, and one member approve ANDAs that refer to the Microsporum audouini, Microsporum
who is a representative of the general product as long as they meet relevant gypseum, and Epidermophyton
public. Almost all non-Federal members legal and regulatory requirements. floccosum; in the treatment of
of this committee serve as Special FOR FURTHER INFORMATION CONTACT: cutaneous candidiasis; and in the
Government Employees. Members will Nisha Shah, Center for Drug Evaluation treatment of tinea versicolor.
be invited to serve for terms of up to 4 and Research, Food and Drug SPECTAZOLE (econazole nitrate)
years. Administration, 10903 New Hampshire topical cream, 1%, is currently listed in
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Document Created: 2017-10-03 01:01:32
Document Modified: 2017-10-03 01:01:32
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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. | |
| 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), [email protected] | |
| FR Citation | 82 FR 46069 |
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