[Federal Register Volume 85, Number 114 (Friday, June 12, 2020)]
[Notices]
[Pages 35937-35939]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12755]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0144]
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.
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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 July 13, 2020.
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: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[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.
Agency Information Collection Activities; Proposed Collection; Comment
Request; FDA's Voluntary Qualified Importer Program
OMB Control Number 0910-0840--Extension
The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353)
enables FDA to better protect public health by helping to ensure the
safety and security of the food supply. It enables FDA to focus more on
preventing food safety problems rather than relying primarily on
reacting to problems after they occur. FSMA recognizes the important
role industry plays in ensuring the safety of the food supply,
including the adoption of modern systems of preventive controls in food
production. Under FSMA, those that import food have a responsibility to
ensure that their suppliers produce food that meets U.S. safety
standards.
FSMA also requires FDA to establish a voluntary, fee-based program
for the expedited review and importation of foods by importers who
achieve and maintain a high level of control over the safety and
security of their supply chains. This control includes importation of
food from facilities that have been certified under FDA's accredited
third-party certification program, as well as other measures that
support a high level of confidence in the safety and security of the
food they import. Expedited entry incentivizes importers to adopt a
robust system of supply chain management and further benefits public
health by allowing FDA to focus its resources on food entries that pose
a higher risk to public health.
Section 302 of FSMA amended the Federal Food, Drug, and Cosmetic
Act (FD&C Act) by adding new section 806, Voluntary Qualified Importer
Program (VQIP) (21 U.S.C. 384b). Section 806(a)(1) of the FD&C Act
directs FDA to establish this voluntary program for the expedited
review and importation of food, and to establish a process for the
issuance of a facility certification to accompany food offered for
importation by importers participating in VQIP. Section 806(a)(2)
directs FDA to issue a guidance document related to participation in,
revocation of such participation in, reinstatement in, and compliance
with VQIP. Accordingly, in the Federal Register of November 14, 2016
(81 FR 79502), FDA published a notice announcing the availability of a
final guidance for industry entitled ``FDA's Voluntary Qualified
Importer Program.'' The guidance is available from our website at:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-fdas-voluntary-qualified-importer-program.
In the Federal Register of February 5, 2020 (85 FR 6556) we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received. We estimate the
burden of the information collection as follows:
Table 1--One-Time Recordkeeping Burden \1\
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Number of Average
Information collection activity Number of responses per Total annual burden per Total hours
respondents respondent responses response
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Quality Assurance Program (QAP) 200 1 200 160 32,000
preparation....................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our one-time
recordkeeping burden estimate. On average, the preparation of a QAP by
a VQIP applicant is estimated at approximately 160 hours (110 + 40 +
10). In estimation of the one-time recordkeeping burden to prepare a
QAP manual, we assume that VQIP importers do not already have a similar
manual in place (e.g., food safety plan under the Current Good
Manufacturing Practice and Hazard Analysis and Risk-Based Preventive
Controls for Human Food regulation (21 CFR part 117); food defense plan
under the Focused Mitigation Strategies to Protect Food Against
Intentional Adulteration regulation (IA regulation) (21 CFR part 121)).
We continue to use the recordkeeping burden of preparing a food safety
plan under part 117, 110 hours, as a proxy for the burden to prepare
QAP Food Safety Policies and Procedures. We continue to estimate that,
on average, it would take 40 hours for an applicant to prepare the food
defense portion of the VQIP QAP, similar to the estimated burden for
preparing a food defense plan under the IA regulation. We also continue
to
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estimate it will take a VQIP applicant no longer than 10 hours to
develop the portion of its QAP that includes compiling its company
profile, organizational structure, corporate quality policy statement,
documentation of contracts, and procedures for record retention.
Therefore, the one-time recordkeeping burden for 200 VQIP applicants to
prepare QAPs is estimated at 32,000 hours (200 applicants x 160 hours/
applicant) (see table 1). To the extent that some importers do have QAP
manuals in place, the burden would be overestimated.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Average
Information collection activity Number of responses per Total annual burden per Total hours
respondents respondent responses response
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QAP Modification................ 200 1 200 16 3,200
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
A VQIP importer is expected to update its QAP on an ongoing basis.
Based on a review of the information collection since our last request
for OMB approval, we have made no adjustments to our annual
recordkeeping burden estimate. We estimate it would take 10 percent of
the effort to prepare the QAP, or 16 hours, to update the QAP each
year. Therefore, we estimate the annual recordkeeping burden of
modification of the QAP for 200 VQIP importers at 3,200 hours (200
importers x 16 hours/importer).
Table 3--Estimated One-Time Reporting Burden \1\
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Number of Average
Information collection activity Number of responses per Total annual burden per Total hours
respondents respondent responses response
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Initial VQIP application........ 100 1 100 80 8,000
Initial VQIP application w/ 100 1 100 100 10,000
additional information.........
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Total....................... .............. .............. .............. .............. 18,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The guidance informs food importers of application procedures for
VQIP. Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our one-time
reporting burden estimate. As we are still in the process of
implementing this program, we continue to estimate that up to 200
qualified importers will be accepted in the upcoming year of VQIP. We
estimate that it will take 80 person-hours to compile all the relevant
information and complete the application for the VQIP program. For the
purpose of this analysis, we assume that 50 percent of all applications
received will require additional information and it would take an
additional 20 person-hours by the importer to provide that information.
Therefore, we estimate that 100 importers will spend 8,000 hours (80
hours/importer x 100 importers) and 100 importers will spend 10,000
hours (100 hours/importer x 100 importers) to submit their initial VQIP
applications for a total one-time reporting burden of 18,000 hours (see
table 3).
Table 4--Estimated Annual Reporting Burden \1\
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Number of Average
Information collection activity Number of responses per Total annual burden per Total hours
respondents respondent responses response
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Subsequent Year VQIP Application 200 1 200 20 4,000
Request to Reinstate 2 1 2 10 20
Participation..................
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Total....................... .............. .............. .............. .............. 4,020
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The guidance states that each VQIP participant will submit to FDA a
notice of intent to participate in VQIP on an annual basis. Based on a
review of the information collection since our last request for OMB
approval, we have made no adjustments to our annual reporting burden
estimate. We expect that each of the expected 200 importers in VQIP
would apply in the subsequent year to participate in VQIP. We expect
that an application to participate in VQIP in a subsequent year will
take significantly less time to prepare than the initial application.
We use 25 percent of the amount of effort to prepare and submit the
initial application for acceptance in VQIP. Therefore, it is expected
that, on average, each VQIP importer will spend 20 hours to complete
and submit a VQIP application for each subsequent year. The annual
burden of completing a subsequent year application to participate in
VQIP status by 200 importers is estimated at 4,000 hours (200
applications x 20 hours/application) (see table 4).
Finally, we have added to the VQIP estimated annual reporting
burden an estimate of the burden associated with importers' requests to
reinstate participation in VQIP after their participation is revoked.
We believe most participants will not need to use this provision, and
we have included an
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estimate that reflects this. Upon implementation of the VQIP, we will
reevaluate our estimate for future OMB submission and revise it
accordingly.
Dated: June 3, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-12755 Filed 6-11-20; 8:45 am]
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