Request for Nominations on the Tobacco Products Scientific Advisory Committee-Small Business Pool, 54323-54324 [2023-17149]
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54323
Federal Register / Vol. 88, No. 153 / Thursday, August 10, 2023 / Notices
delays at the point of import entry.
Importers interested in applying can
start their application (Form FDA 4041)
by submitting a notice of intent to
participate after setting up an account
through the FDA Industry Systems (FIS)
website at https://www.access.fda.gov,
which includes a VQIP Portal User
Guide. To participate, importers must
meet eligibility criteria and pay a user
fee that covers costs associated with
FDA’s administration of the program.
Consistent with section 743(b)(1) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 379j–31(b)(1)),
FDA annually publishes a schedule of
fees applicable to VQIP in the Federal
Register.
Respondents to the information
collection are persons that bring food, or
cause food to be brought, from a foreign
country into the customs territory of the
United States (section 806 of the FD&C
Act (21 U.S.C. 384b)) as a VQIP
importer. A VQIP importer can be
located outside the United States.
Persons who may be a VQIP importer
include the manufacturer, owner,
consignee, and importer of record of a
food, provided that the importer can
meet all the criteria for participation.
To assist respondents with the
information collection, we developed
the guidance document entitled ‘‘FDA’s
Voluntary Qualified Importer Program’’
(issued November 2016, updated July
2023 to change the Paperwork
Reduction Act burden statement
address), available at https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents/
guidance-industry-fdas-voluntaryqualified-importer-program. The
guidance document is prepared in a
question-and-answer format and
discusses eligibility criteria; includes
instruction for completing a VQIP
application; explains conditions that
may result in revocation of participation
as well as criteria for reinstatement; and
communicates benefits VQIP importers
can expect to receive under the
program. The guidance also discusses
preparation of the ‘‘Quality Assurance
Program (QAP),’’ a compilation of
written policies and procedures used to
ensure adequate control over the safety
and security of foods being imported.
The guidance document was developed
and issued consistent with FDA good
guidance practice regulations in 21 CFR
10.115, which provides for public
comment at any time.
In the Federal Register of May 11,
2023 (88 FR 30315), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Reporting using FIS VQIP portal/form FDA 4041
Average
burden per
response
Total annual
responses
Total hours
Initial VQIP application .........................................................
Application Renewals—subsequent year ............................
Requests for reinstatement ..................................................
5
6
2
1
1
1
5
6
2
180
20
10
900
120
20
Total ..............................................................................
........................
........................
........................
........................
1,040
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
VQIP participant records consistent with
implementing guidance
Number of
records per
recordkeeper
Average
burden per
recordkeeping
Total annual
records
Total hours
Quality Assurance Program (QAP) preparation ..................
QAP maintenance and updates ...........................................
5
6
1
1
5
6
160
16
800
96
Total ..............................................................................
........................
........................
........................
........................
896
1 There
ddrumheller on DSK120RN23PROD with NOTICES1
Number of
recordkeepers
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the
information collection reflects an
overall adjustment decrease of 1,844
hours and a corresponding decrease of
18 responses. Since our last request for
OMB approval of the information
collection, we have adjusted our
estimate of the number of respondents
based on actual participation in the
program. We assume the average burden
required for the respective reporting and
recordkeeping activities for both initial
and continued participation in the
program remain constant.
Dated: August 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–17150 Filed 8–9–23; 8:45 am]
BILLING CODE 4164–01–P
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.
VerDate Sep<11>2014
17:28 Aug 09, 2023
Jkt 259001
PO 00000
Frm 00035
Fmt 4703
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ACTION:
Notice.
The Food and Drug
Administration (FDA) 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
SUMMARY:
E:\FR\FM\10AUN1.SGM
10AUN1
54324
Federal Register / Vol. 88, No. 153 / Thursday, August 10, 2023 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
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 September 11, 2023, (see
sections I and II of this document for
further details). Concurrently,
nomination materials for prospective
candidates should be sent to FDA by
September 11, 2023.
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 CAPT 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: TPSAC@
fda.hhs.gov.
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
VerDate Sep<11>2014
17:28 Aug 09, 2023
Jkt 259001
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 representing
the interests of the tobacco
manufacturing industry, one
representative representing the interests
of tobacco growers, and one
representative representing 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.
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.
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
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.
Food and Drug Administration
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
PO 00000
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Fmt 4703
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Dated: August 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–17149 Filed 8–9–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2010–N–0583]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Radioactive Drug
Research Committees
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by September
11, 2023.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0053. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Rachel Showalter, Office of Operations,
Food and Drug Administration, Three
SUMMARY:
E:\FR\FM\10AUN1.SGM
10AUN1
]]>Agencies
[Federal Register Volume 88, Number 153 (Thursday, August 10, 2023)]
[Notices]
[Pages 54323-54324]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17149]
-----------------------------------------------------------------------
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) 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
[[Page 54324]]
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 September 11, 2023, (see sections I and II of
this document for further details). Concurrently, nomination materials
for prospective candidates should be sent to FDA by September 11, 2023.
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 CAPT 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
representing the interests of the tobacco manufacturing industry, one
representative representing the interests of tobacco growers, and one
representative representing 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 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: August 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-17149 Filed 8-9-23; 8:45 am]
BILLING CODE 4164-01-P
