Request for Nominations on the Tobacco Products Scientific Advisory Committee, 50531-50532 [2016-18085]
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Federal Register / Vol. 81, No. 147 / Monday, August 1, 2016 / Notices
registration file, or via regular mail if
email is not an option. The invoice will
contain information regarding the
obligation incurred, the amount owed,
and payment procedures. A facility will
not be registered as an outsourcing
facility until it has paid the annual
establishment fee under section 744K of
the FD&C Act. Accordingly, it is
important that facilities seeking to
operate as outsourcing facilities pay all
fees immediately upon receiving an
invoice. If an entity does not pay the full
invoiced amount within 15 calendar
days after FDA issues the invoice, FDA
will consider the submission of
registration information to have been
withdrawn and adjust the invoice to
reflect that no fee is due.
Outsourcing facilities that registered
in FY 2016 and wish to maintain their
status as an outsourcing facility in FY
2017 must register during the annual
registration period that lasts from
October 1, 2016, to December 31, 2016.
Failure to register and complete
payment by December 31, 2016, will
result in a loss of status as an
outsourcing facility on January 1, 2017.
Entities should submit their registration
information no later than December 10,
2016, to allow enough time for review
of the registration information,
invoicing, and payment of fees before
the end of the registration period.
Payments can be mailed to: Food and
Drug Administration, P.O. Box 979033,
St. Louis, MO 63197–9000. If a check is
sent by a courier that requests a street
address, the courier can deliver the
check to: U.S. Bank, Attn: Government
Lockbox 979033, 1005 Convention
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U.S. Bank address is for courier delivery
only. If you have any questions
concerning courier delivery contact the
U.S. Bank at 314–418–4013).
3. If paying with a wire transfer: Use
the following account information when
sending a wire transfer: New York
Federal Reserve Bank, U.S. Dept of
Treasury, TREAS NYC, 33 Liberty St.,
New York, NY 10045, Acct. No.
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Spring, MD 20993–0002. The
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add it to the payment to ensure that the
order is fully paid. The tax
identification number of FDA is 53–
0196965.
Dated: July 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–18093 Filed 7–29–16; 8:45 am]
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B. Re-Inspection Fee
FDA will issue invoices for each reinspection after the conclusion of the reinspection, via email to the email
address indicated in the registration file
or via regular mail if email is not an
option. Invoices must be paid within 30
days.
BILLING CODE 4164–01–P
C. Fee Payment Procedures
1. The preferred payment method is
online using electronic check
(Automated Clearing House (ACH) also
known as eCheck) or credit card
(Discover, VISA, MasterCard, American
Express). Secure electronic payments
can be submitted using the User Fees
Payment Portal at https://
userfees.fda.gov/pay. Once you search
for your invoice, click ‘‘Pay Now’’ to be
redirected to Pay.gov. Note that
electronic payment options are based on
the balance due. Payment by credit card
is available for balances less than
$25,000. If the balance exceeds this
amount, only the ACH option is
available. Payments must be drawn on
U.S bank accounts as well as U.S. credit
cards.
2. If paying with a paper check:
Checks must be in U.S. currency from
a U.S. bank and made payable to the
Food and Drug Administration.
Request for Nominations on the
Tobacco Products Scientific Advisory
Committee
VerDate Sep<11>2014
20:16 Jul 29, 2016
Jkt 238001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–1984]
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
organization to serve as a nonvoting
industry representative. Nominations
will be accepted for current vacancies
effective with this notice.
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.
DATES:
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: https://
www.fda.gov/AdvisoryCommittees/
default.htm.
ADDRESSES:
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: TPSAC@fda.hhs.gov.
The
Agency intends to add nonvoting
industry representatives to the following
advisory committee:
SUPPLEMENTARY INFORMATION:
Notice.
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
SUMMARY:
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50531
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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.
E:\FR\FM\01AUN1.SGM
01AUN1
50532
Federal Register / Vol. 81, No. 147 / Monday, August 1, 2016 / Notices
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.
sradovich on DSK3GMQ082PROD with NOTICES
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
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Jkt 238001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Opportunity to Co-sponsor an Office
on Women’s Health Awards Ceremony
and Event for its 25th Anniversary
Department of Health and
Human Services, Office of the Secretary,
Office of the Assistant Secretary for
Health, Office on Women’s Health.
ACTION: Notice.
AGENCY:
Pursuant to 42 U.S.C. 300u,
42 U.S.C. 300u–2, and 42 U.S.C. 237a
(3509 of the Patient Protection and
Affordable Care Act), notice is given
that the Office on Women’s Health
(OWH) is soliciting proposals from nonfederal public and private sector entities
to co-sponsor the OWH Anniversary
Celebration event in the Washington,
DC area in late September, 2016.
DATES: Representatives of eligible
organizations should submit
expressions of interest no later than 6:00
p.m. EST on August 16, 2016.
ADDRESSES: Expressions of interest
should be directed electronically to
Valerie.Borden@hhs.gov or mailed to
the Office on Women’s Health, Office of
the Assistant Secretary for Health,
Department of Health and Human
Services, 200 Independence Avenue
SW., Room 730F.3, Washington, DC
20201. Attention: Valerie Borden.
FOR FURTHER INFORMATION CONTACT:
Questions may be directed to Valerie
Borden, Office on Women’s Health, 200
Independence Avenue SW, Room
730F.3, Washington, DC 20201. Email:
Valerie.Borden@hhs.gov.
SUPPLEMENTARY INFORMATION: The OWH
was established in 1991 to improve the
health of American women by
advancing and coordinating a
comprehensive women’s health agenda
throughout the Department of Health
and Human Service (HHS). The OWH
provides national leadership and
coordination to improve the health of
women and girls through policy,
education, and model programs. The
office fulfills its mission by advancing
policy and issuing competitive contracts
and grants to an array of community,
academic, and other organizations at the
national and community levels. This
year marks the office’s 25th anniversary.
The event will feature a panel
discussion focusing on the future of
women’s health. It will also feature an
award ceremony for organizations and
partners who helped improve the health
and well-being of women and girls in
the U.S. over the past 25 years.
The co-sponsor will assist with the
development of the substantive content
SUMMARY:
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of the event and other event planning,
coordination, and logistics in
partnership with the OWH staff. In
addition the co-sponsor will be
responsible for the event venue and any
food and beverages.
Eligibility for Co-Sponsorship
To be eligible, a potential co-sponsor
shall:
1. Have a demonstrated
understanding, commitment, and
experience in improving the health of
women and girls;
2. Participate substantively in the cosponsored activity, not just provide
funding or logistical support; and
3. Have an organizational or corporate
mission that is consistent with OWH
and HHS.
Each co-sponsorship proposal shall
contain a description of: (1) The entity
or organization’s background and
history, (2) its ability to satisfy the cosponsorship criteria detailed above, and
(3) its proposed involvement in the cosponsored activity. The selected cosponsoring organization(s) shall furnish
the necessary personnel, materials,
services, and facilities to administer its
responsibility for the event. These
duties will be outlined in a cosponsorship agreement with OWH that
will set forth the details of the cosponsored activity, including the
requirements that any fees collected by
the co-sponsor shall be limited to the
amount necessary to cover the cosponsor’s related meeting expenses.
Evaluation Criteria: After engaging in
exploratory discussions with potential
co-sponsors that respond to this notice,
the OWH will select the co-sponsor or
co-sponsors using the following
evaluation criteria:
(1) Qualifications and capability to
fulfill co-sponsorship responsibilities;
(2) Creativity related to enhancing the
event;
(3) Potential for reaching and
generating attendees from among key
stakeholders, including federal, state
and local policymakers, other health
officials, non-profits interested in
women’s health, and underserved/
special populations;
(4) Experience with events;
(5) Past or current work specific to
women’s health;
(6) Personnel names, professional
qualifications, and specific expertise
with event planning;
(7) Availability and description of
facilities to support the event, including
office space, information technology,
and telecommunication resources; and,
(9) Proposed plan for managing an
event with the OWH.
Expressions of interest should outline
eligibility in response to the
E:\FR\FM\01AUN1.SGM
01AUN1
Agencies
[Federal Register Volume 81, Number 147 (Monday, August 1, 2016)]
[Notices]
[Pages 50531-50532]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: https://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: TPSAC@fda.hhs.gov.
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