81 FR 50531 - 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 147 (August 1, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 147 (August 1, 2016)
| Page Range | 50531-50532 | |
| FR Document | 2016-18085 |
[Federal Register Volume 81, Number 147 (Monday, August 1, 2016)] [Notices] [Pages 50531-50532] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-18085] ----------------------------------------------------------------------- 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) 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. 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 the FDA by August 31, 2016 (see sections I and II of this document for further details). Concurrently, nomination materials for prospective candidates should be sent to FDA by August 31, 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. CTP Advisory Committee 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. [[Page 50532]] 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 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 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: July 27, 2016. Janice M. Soreth, Acting Associate Commissioner, Special Medical Programs. [FR Doc. 2016-18085 Filed 7-29-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 147 / Monday, August 1, 2016 / Notices 50531
registration file, or via regular mail if Payments can be mailed to: Food and organization to serve as a nonvoting
email is not an option. The invoice will Drug Administration, P.O. Box 979033, industry representative. Nominations
contain information regarding the St. Louis, MO 63197–9000. If a check is will be accepted for current vacancies
obligation incurred, the amount owed, sent by a courier that requests a street effective with this notice.
and payment procedures. A facility will address, the courier can deliver the
not be registered as an outsourcing check to: U.S. Bank, Attn: Government DATES: Any industry organization
facility until it has paid the annual Lockbox 979033, 1005 Convention interested in participating in the
establishment fee under section 744K of Plaza, St. Louis, MO 63101. (Note: This selection of an appropriate nonvoting
the FD&C Act. Accordingly, it is U.S. Bank address is for courier delivery member to represent the interests of
important that facilities seeking to only. If you have any questions tobacco growers must send a letter
operate as outsourcing facilities pay all concerning courier delivery contact the stating that interest to the FDA by
fees immediately upon receiving an U.S. Bank at 314–418–4013). August 31, 2016 (see sections I and II of
invoice. If an entity does not pay the full 3. If paying with a wire transfer: Use this document for further details).
invoiced amount within 15 calendar the following account information when Concurrently, nomination materials for
days after FDA issues the invoice, FDA sending a wire transfer: New York prospective candidates should be sent to
will consider the submission of Federal Reserve Bank, U.S. Dept of FDA by August 31, 2016.
registration information to have been Treasury, TREAS NYC, 33 Liberty St., ADDRESSES: All statements of interest
withdrawn and adjust the invoice to New York, NY 10045, Acct. No. from industry organizations interested
reflect that no fee is due. 75060099, Routing No. 021030004, in participating in the selection process
Outsourcing facilities that registered SWIFT: FRNYUS33, Beneficiary: FDA, should be sent to Caryn Cohen (see FOR
in FY 2016 and wish to maintain their 8455 Colesville Rd., 14th Floor, Silver FURTHER INFORMATION CONTACT). All
status as an outsourcing facility in FY Spring, MD 20993–0002. The nominations for nonvoting industry
2017 must register during the annual originating financial institution may representatives should be submitted
registration period that lasts from charge a wire transfer fee. An electronically by accessing the FDA
October 1, 2016, to December 31, 2016. outsourcing facility should ask its Advisory Committee Membership
Failure to register and complete financial institution about the fee and Nomination Portal at: https://
payment by December 31, 2016, will add it to the payment to ensure that the www.accessdata.fda.gov/scripts/
result in a loss of status as an order is fully paid. The tax FACTRSPortal/FACTRS/index.cfm or by
outsourcing facility on January 1, 2017. identification number of FDA is 53– mail to Advisory Committee Oversight
Entities should submit their registration 0196965. and Management Staff, Food and Drug
information no later than December 10, Administration, 10903 New Hampshire
2016, to allow enough time for review Dated: July 27, 2016.
Leslie Kux, Ave., Bldg. 32, Rm. 5103, Silver Spring,
of the registration information, MD 20993–0002. Information about
invoicing, and payment of fees before Associate Commissioner for Policy.
becoming a member of an FDA advisory
the end of the registration period. [FR Doc. 2016–18093 Filed 7–29–16; 8:45 am]
committee can also be obtained by
BILLING CODE 4164–01–P
B. Re-Inspection Fee visiting FDA’s Web site at: http://
FDA will issue invoices for each re- www.fda.gov/AdvisoryCommittees/
inspection after the conclusion of the re- default.htm.
DEPARTMENT OF HEALTH AND
inspection, via email to the email HUMAN SERVICES FOR FURTHER INFORMATION CONTACT:
address indicated in the registration file Caryn Cohen, Office of Science, Center
or via regular mail if email is not an Food and Drug Administration
for Tobacco Products, Food and Drug
option. Invoices must be paid within 30 [Docket No. FDA–2016–N–1984] Administration, Center for Tobacco
days. Products, Document Control Center,
C. Fee Payment Procedures Request for Nominations on the Bldg. 71, Rm. G335, 10903 New
Tobacco Products Scientific Advisory Hampshire Ave., Silver Spring, MD
1. The preferred payment method is Committee 20993–0002, 1–877–287–1373 (choose
online using electronic check
Option 5), email: TPSAC@fda.hhs.gov.
(Automated Clearing House (ACH) also AGENCY: Food and Drug Administration,
known as eCheck) or credit card HHS. SUPPLEMENTARY INFORMATION: The
(Discover, VISA, MasterCard, American ACTION: Notice. Agency intends to add nonvoting
Express). Secure electronic payments industry representatives to the following
can be submitted using the User Fees SUMMARY: The Food and Drug advisory committee:
Payment Portal at https:// Administration (FDA) is requesting that
userfees.fda.gov/pay. Once you search any industry organizations interested in I. CTP Advisory Committee
for your invoice, click ‘‘Pay Now’’ to be participating in the selection of a Tobacco Products Scientific Advisory
redirected to Pay.gov. Note that nonvoting member to represent the Committee
electronic payment options are based on interests of tobacco growers to serve on
the balance due. Payment by credit card the Tobacco Products Scientific The Tobacco Products Scientific
is available for balances less than Advisory Committee for the Center for Advisory Committee (the Committee)
$25,000. If the balance exceeds this Tobacco Products (CTP), notify FDA in advises the Commissioner of Food and
writing. FDA is also requesting Drugs (the Commissioner) or designee in
sradovich on DSK3GMQ082PROD with NOTICES
amount, only the ACH option is
available. Payments must be drawn on nominations for a nonvoting member to discharging responsibilities related to
U.S bank accounts as well as U.S. credit represent the interests of tobacco the regulation of tobacco products. The
cards. growers to serve on the Tobacco Committee reviews and evaluates safety,
2. If paying with a paper check: Products Scientific Advisory dependence, and health issues relating
Checks must be in U.S. currency from Committee, and an alternate to this to tobacco products and provides
a U.S. bank and made payable to the representative. A nominee may either be appropriate advice, information, and
Food and Drug Administration. self-nominated or nominated by an recommendations to the Commissioner.
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![50532 Federal Register / Vol. 81, No. 147 / Monday, August 1, 2016 / Notices
II. Selection Procedure DEPARTMENT OF HEALTH AND of the event and other event planning,
HUMAN SERVICES coordination, and logistics in
Any industry organization interested
partnership with the OWH staff. In
in participating in the selection of an Opportunity to Co-sponsor an Office addition the co-sponsor will be
appropriate nonvoting member to on Women’s Health Awards Ceremony responsible for the event venue and any
represent the interests of tobacco and Event for its 25th Anniversary food and beverages.
growers should send a letter stating that
interest to the FDA contact (see FOR AGENCY: Department of Health and Eligibility for Co-Sponsorship
FURTHER INFORMATION CONTACT) within Human Services, Office of the Secretary, To be eligible, a potential co-sponsor
30 days of publication of this document Office of the Assistant Secretary for shall:
(see DATES). Within the subsequent 30 Health, Office on Women’s Health. 1. Have a demonstrated
days, FDA will send a letter to each ACTION: Notice. understanding, commitment, and
organization that has expressed an experience in improving the health of
interest, attaching a complete list of all SUMMARY: Pursuant to 42 U.S.C. 300u, women and girls;
such organizations; and a list of all 42 U.S.C. 300u–2, and 42 U.S.C. 237a 2. Participate substantively in the co-
nominees along with their current (3509 of the Patient Protection and sponsored activity, not just provide
resumes. The letter will also state that Affordable Care Act), notice is given funding or logistical support; and
it is the responsibility of the interested that the Office on Women’s Health 3. Have an organizational or corporate
organizations to confer with one another (OWH) is soliciting proposals from non- mission that is consistent with OWH
and to select a candidate, within 60 federal public and private sector entities and HHS.
days after the receipt of the FDA letter, to co-sponsor the OWH Anniversary Each co-sponsorship proposal shall
to serve as the nonvoting member to Celebration event in the Washington, contain a description of: (1) The entity
represent the interests of tobacco DC area in late September, 2016. or organization’s background and
growers for the committee. The DATES: Representatives of eligible history, (2) its ability to satisfy the co-
interested organizations are not bound organizations should submit sponsorship criteria detailed above, and
by the list of nominees in selecting a expressions of interest no later than 6:00 (3) its proposed involvement in the co-
candidate. However, if no individual is p.m. EST on August 16, 2016. sponsored activity. The selected co-
selected within 60 days, the sponsoring organization(s) shall furnish
ADDRESSES: Expressions of interest
Commissioner will select the nonvoting the necessary personnel, materials,
should be directed electronically to
member to represent the interests of services, and facilities to administer its
Valerie.Borden@hhs.gov or mailed to responsibility for the event. These
tobacco growers. the Office on Women’s Health, Office of duties will be outlined in a co-
III. Application Procedure the Assistant Secretary for Health, sponsorship agreement with OWH that
Department of Health and Human will set forth the details of the co-
Individuals may self-nominate and/or Services, 200 Independence Avenue
an organization may nominate one or sponsored activity, including the
SW., Room 730F.3, Washington, DC requirements that any fees collected by
more individuals to serve as a nonvoting 20201. Attention: Valerie Borden.
member to represent the interests of the co-sponsor shall be limited to the
FOR FURTHER INFORMATION CONTACT: amount necessary to cover the co-
tobacco growers. Contact information,
Questions may be directed to Valerie sponsor’s related meeting expenses.
current curriculum vitae, and the name
Borden, Office on Women’s Health, 200 Evaluation Criteria: After engaging in
of the committee of interest should be
Independence Avenue SW, Room exploratory discussions with potential
sent to the FDA Advisory Committee
730F.3, Washington, DC 20201. Email: co-sponsors that respond to this notice,
Membership Nomination Portal (see
Valerie.Borden@hhs.gov. the OWH will select the co-sponsor or
ADDRESSES) within 30 days of
publication of this document (see SUPPLEMENTARY INFORMATION: The OWH co-sponsors using the following
DATES). FDA will forward all was established in 1991 to improve the evaluation criteria:
health of American women by (1) Qualifications and capability to
nominations to the organizations
advancing and coordinating a fulfill co-sponsorship responsibilities;
expressing interest in participating in (2) Creativity related to enhancing the
the selection process for the committee. comprehensive women’s health agenda
throughout the Department of Health event;
(Persons who nominate themselves as (3) Potential for reaching and
nonvoting industry representatives will and Human Service (HHS). The OWH
provides national leadership and generating attendees from among key
not participate in the selection process.) stakeholders, including federal, state
FDA seeks to include the views of coordination to improve the health of
and local policymakers, other health
women and men, members of all racial women and girls through policy,
officials, non-profits interested in
and ethnic groups, and individuals with education, and model programs. The
women’s health, and underserved/
and without disabilities on its advisory office fulfills its mission by advancing
special populations;
committees and, therefore encourages policy and issuing competitive contracts (4) Experience with events;
nominations of appropriately qualified and grants to an array of community, (5) Past or current work specific to
candidates from these groups. academic, and other organizations at the women’s health;
This notice is issued under the national and community levels. This (6) Personnel names, professional
Federal Advisory Committee Act (5 year marks the office’s 25th anniversary. qualifications, and specific expertise
U.S.C. app. 2) and 21 CFR part 14, The event will feature a panel with event planning;
discussion focusing on the future of
sradovich on DSK3GMQ082PROD with NOTICES
relating to advisory committees. (7) Availability and description of
women’s health. It will also feature an facilities to support the event, including
Dated: July 27, 2016. award ceremony for organizations and office space, information technology,
Janice M. Soreth, partners who helped improve the health and telecommunication resources; and,
Acting Associate Commissioner, Special and well-being of women and girls in (9) Proposed plan for managing an
Medical Programs. the U.S. over the past 25 years. event with the OWH.
[FR Doc. 2016–18085 Filed 7–29–16; 8:45 am] The co-sponsor will assist with the Expressions of interest should outline
BILLING CODE 4164–01–P development of the substantive content eligibility in response to the
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Document Created: 2016-07-30 06:25:36
Document Modified: 2016-07-30 06:25:36
| 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 | 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 the FDA by August 31, 2016 (see sections I and II of this document for further details). Concurrently, nomination materials for prospective candidates should be sent to FDA by August 31, 2016. | |
| 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] | |
| FR Citation | 81 FR 50531 |
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