[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, 
PRAStaff@fda.hhs.gov.

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.........
                                 -------------------------------------------------------------------------------
    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..................
                                 -------------------------------------------------------------------------------
    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

[[Page 35939]]

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]
BILLING CODE 4164-01-P


