[Federal Register Volume 85, Number 24 (Wednesday, February 5, 2020)]
[Notices]
[Pages 6556-6559]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02248]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0144]


Agency Information Collection Activities; Proposed Collection; 
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 or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on FDA's Voluntary Qualified Importer Program 
(VQIP).

DATES: Submit either electronic or written comments on the collection 
of information by April 6, 2020.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before April 6, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of April 6, 2020. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:

[[Page 6557]]

     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2011-N-0144 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; FDA's Voluntary Qualified 
Importer Program.'' Received comments, those filed in a timely manner 
(see ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

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: Under the PRA (44 U.S.C. 3501-3521), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    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 (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.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 6558]]



                                                        Table 1--One-Time Recordkeeping Burden 1
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                                                                                         Number of
                  Information collection activity                       Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
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Quality Assurance Program (QAP) preparation........................             200                1              200              160           32,000
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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 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
                  Information collection activity                       Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per 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
 Information collection activity     Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per 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).

[[Page 6559]]



                                  Table 4--Estimated Annual Reporting Burden 1
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                                                     Number of
 Information collection activity     Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per 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 estimate that reflects this. Upon implementation of 
the VQIP, we will reevaluate our estimate for future OMB submission and 
revise it accordingly.

    Dated: January 29, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-02248 Filed 2-4-20; 8:45 am]
BILLING CODE 4164-01-P