Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Qualified Importer Program, 54322-54323 [2023-17150]
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Federal Register / Vol. 88, No. 153 / Thursday, August 10, 2023 / Notices
paper-based methods, electronic
methods, or both)?
• If not currently exchanging data
with trading partners in a fully
electronic manner, will you be able to
in the near future? If not, what are the
barriers? Elaborate on why or how, as
appropriate. Please specify issues
related to:
• accessibility of necessary software
and hardware;
• cost to obtain, install, and maintain
necessary software and hardware,
particularly if it is prohibitively
expensive;
• integration of necessary software
and hardware into business practices,
such as with wholesale distributors;
• other relevant information related
to feasibility of dispensers with 25 or
fewer full-time employees to conduct
interoperable, electronic tracing of
product at the package level.
• What type of software systems and
hardware do you currently utilize to
facilitate the electronic exchange of
DSCSA-related data for transactions of
products?
• What new or modified software
systems and hardware do you anticipate
putting in place to comply with the
interoperable, electronic tracing
requirements?
• How likely are you to change and
upgrade your existing software systems
that are already in use so that you can
comply with the interoperable,
electronic tracing requirements?
• Have you or do you plan to connect
your system(s) with your trading
partner(s) (e.g., manufacturer(s),
repackager(s), or wholesale
distributor(s)) in order to facilitate
electronic DSCSA-related data
exchange? If so, have you experienced
technical issues when attempting to
establish connectivity? If not, how do
you or how do you plan to manage
electronic DSCSA-related data received
from an upstream trading partner (e.g.,
maintain the data in your dispenser
system or use a third-party agreement
for another entity to confidentially
maintain the DSCSA-related data on
your behalf (e.g., use of a secure web
portal provided by your wholesale
distributor))?
• Have you considered data integrity
and security concerns when establishing
agreements with third-party entities
(e.g., solution providers or wholesale
distributors) for electronic data
exchange and maintenance?
• Have you ever received transaction
information from a trading partner, such
as your wholesale distributor, that does
not match the product that you
received? If so, how long did it take to
resolve the discrepancy on average?
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17:28 Aug 09, 2023
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What if any unique challenges arose
from these situations? How often does
this happen?
• If you currently routinely scan a 2D
data matrix barcode, how often do you
receive a 2D data matrix barcode of the
product identifier that cannot be
scanned or read? Why are you unable to
scan or read the 2D data matrix barcode
(e.g., barcode quality, scanner
performance, software issue) and what
is your process for handling these
situations, including when manual steps
are taken by your staff when an
automated process was inadequate or
failed?
• If you currently routinely scan the
2D data matrix barcode, how often you
encounter a 2D data matrix barcode
with missing or inaccurate data? What
are the reasons for this and what is your
process for handling these situations,
including when manual steps are taken
by your staff when an automated
process was inadequate or failed?
• What new demands do you expect
the DSCSA requirements in section
582(g)(1) of the FD&C Act to have on
your current staff resources?
• How long do you expect it will take
to train staff on the new requirements,
how to use any new software or
hardware, and any process changes?
What additional resources do you
anticipate needing to comply with the
interoperable, electronic tracing
requirements?
• Are there additional challenges not
already identified when
operationalizing new systems and
processes for interoperable, electronic
tracing of products at the package level
required under section 582(g)(1) of the
FD&C Act (i.e., enhanced product
tracing or enhanced verification)?
Stakeholders may provide other
relevant information that may inform
the development of the small dispenser
assessment under the DSCSA.
Dated: August 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–17140 Filed 8–9–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–1529]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Voluntary Qualified
Importer Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) 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 0910–0840. Also include
the FDA docket number found in
brackets in the heading of this
document.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Rachel Showalter, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 240–994–7399, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Voluntary Qualified Importer Program
OMB Control Number 0910–0840—
Extension
This information collection supports
implementation of FDA’s Voluntary
Qualified Importer Program (VQIP), a
voluntary fee-based program that
provides expedited review and import
entry of human and animal foods into
the United States. Program participants
may import products to the United
States with greater speed and
predictability, avoiding unexpected
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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.
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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
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]]>Agencies
[Federal Register Volume 88, Number 153 (Thursday, August 10, 2023)]
[Notices]
[Pages 54322-54323]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17150]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-1529]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Voluntary Qualified
Importer Program
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) 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 0910-0840. 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 White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Voluntary Qualified Importer Program
OMB Control Number 0910-0840--Extension
This information collection supports implementation of FDA's
Voluntary Qualified Importer Program (VQIP), a voluntary fee-based
program that provides expedited review and import entry of human and
animal foods into the United States. Program participants may import
products to the United States with greater speed and predictability,
avoiding unexpected
[[Page 54323]]
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-voluntary-qualified-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
Reporting using FIS VQIP portal/ Number of responses per Total annual Average burden Total hours
form FDA 4041 respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Initial VQIP application........ 5 1 5 180 900
Application Renewals--subsequent 6 1 6 20 120
year...........................
Requests for reinstatement...... 2 1 2 10 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 Number of Average burden
consistent with implementing Number of records per Total annual per Total hours
guidance recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Quality Assurance Program (QAP) 5 1 5 160 800
preparation....................
QAP maintenance and updates..... 6 1 6 16 96
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 896
----------------------------------------------------------------------------------------------------------------
\1\ There 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
