VQIP Supporting Statement 2016

FDA’s Voluntary Qualified Importer Program;
Guidance for Industry
OMB Control No. 0910-NEW
SUPPORTING STATEMENT
A. Justification
1. Circumstances Making the Collection of Information Necessary
The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) enables the Food and Drug
Administration (FDA or the agency) 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 also
requires FDA to establish a voluntary, fee-based program for the expedited review and
importation of foods from 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 in accordance with FDA’s program for Accreditation of ThirdParty Certification Bodies to Conduct Food Safety Audits and to Issue Certifications (see FDA’s
third-party certification regulations at 21 CFR part 1, subpart M), 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.
To implement this FSMA provision, FDA has developed guidance describing its policy
regarding participation in FDA’s Voluntary Qualified Importer Program (VQIP) by importers of
food for humans or animals. The guidance explains the benefits VQIP importers can expect to
receive; eligibility criteria for VQIP participation; instructions for completing a VQIP
application; conditions that may result in revocation of participation in VQIP; and criteria for
VQIP reinstatement following revocation. Accordingly FDA is requesting OMB approval of the
information collection provisions contained in the guidance entitled, “FDA’s
Voluntary Qualified Importer Program; Guidance for Industry.”
2. Purpose and Use of the Information Collection
Information collection provisions of the guidance facilitates expedited review and importation of
food offered for importation by importers who voluntarily agree to participate in VQIP, and
supports the establishment of an agency process, consistent with section 808 of the FD&C Act
(21 U.S.C. 384d), for the issuance of a facility certification to accompany a food offered for
importation by importers participating in VQIP.
Description of Respondents: Respondents to the collection of information are importers of
human or animal food.

3. Use of Improved Information Technology and Burden Reduction
The guidance does not specifically recommend the use of automated, electronic, mechanical, or
other technological techniques or other forms of information technology for use by firms.
Respondents may use whatever forms of information technology that bests assist them in
retaining the appropriate records and making them available to regulatory officials. VQIP
applications may be submitted electronically.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of any duplicative information collection.
5. Impact on Small Businesses or Other Small Entities
While the information collection provisions apply to small and large businesses alike, FDA aids
small businesses in complying with its requirements through the agency’s Regional Small
Business Representatives and through the scientific and administrative staffs within the agency.
FDA has provided a Small Business Guide on the agency’s website at
http://www.fda.gov/oc/industry/.
6. Consequences of Collecting the Information Less Frequently
The VQIP guidance provides for an annual application process and the establishment and
maintenance of a quality assurance program. We believe the frequency of collection imposes a
minimal burden on respondents while allowing the agency to effectively administer the program.
We believe less frequent collection would diminish the agency’s ability to ensure the safety of
food being imported into the United States.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances associated with this collection of information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside
the Agency
In accordance with 5 CFR 1320.8(d), FDA published a 60-day notice for public comment in the
Federal Register of June 5, 2015 (80 FR 32136), Docket no. FDA-2011-N-0144. In response to
the solicitation of comments regarding the information collection provisions, we received
multiple comments. Two comments suggested that FDA’s recordkeeping and reporting
estimates were too low. Because neither comment provided justification for why the burden
calculation might be too low or offered alternative calculations, we have retained our original
estimates noting that, upon implementation of the program, we will again invite public comment
on the information collection burden and make adjustments to our estimates accordingly. One
comment attributed costs to the information collection but did not provide a basis for the
calculations provided. We therefore have not adopted the comment, but again note that public
input will be solicited on the information collection upon implementation of the program.
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Finally, one comment objected to the provision regarding respondents obtaining a Dun &
Bradstreet (D&B) Data Universal Numbering System (DUNS) number and providing it to the
agency. We have determined that the DUNS number is an appropriate unique facility identifier
during Foreign Supplier Verification Program (FSVP) rulemaking. We expect that most VQIP
importers will also be FSVP importers and will have obtained a DUNS number.
9. Explanation of Any Payment or Gift to Respondents
FDA does not provide any payment or gifts to respondents.
10. Assurance of Confidentiality Provided to Respondents
FDA will protect confidential information in VQIP applications from disclosure, consistent with
applicable statutes and regulations, including 5 U.S.C. 552(b)(4), 18 U.S.C. 1905, and 21 CFR
part 20. We will share information in VQIP applications with other government agencies, such
as United States Customs and Border Protection (CBP), in accordance with applicable law. This
will allow CBP to recognize VQIP applicants and the VQIP foods they offer for entry into the
United States.
11. Justification for Sensitive Questions
The information collection does not include questions that are of a personally sensitive nature.
12. Estimates of Annualized Burden Hours and Costs
12 a. Annualized Hour Burden Estimate
Table 1 – Estimated One-Time Recordkeeping Burden1
Information Collection
Activity
Quality Assurance Program
(QAP) preparation
1

No. of
Recordkeepers

No. of
Total One- Avg. Burden
Total
Records per
Time
per
Hours
Recordkeeper Records
Recordkeeping
200
1
200
160
32,000

There are no capital costs or operating and maintenance costs associated with this collection of information.

We estimate it will take a VQIP applicant no longer than 10 hours to develop its Quality
Assurance Program (QAP), including compiling its company profile, organizational structure,
corporate quality policy statement, procedures for QAP implementation, food safety and food
defense policies and procedures, and procedures for record retention. 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)
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(21 CFR part 121). 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 Burden1
Information
Collection Activity

Number of
Recordkeepers

No. of Records per Total Annual
Recordkeeper
Records

Avg. Burden per
Recordkeeping

Total
Hours

QAP modification
200
1
200
16
3,200
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. 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). The VQIP food defense
security criterion is similar to the Food Defense Plan requirement under § 121.126 (21 CFR
121.126) in the IA regulation. Under the IA regulation, the food defense plan must include the
written identification of actionable process steps, focused mitigation strategies, procedures for
monitoring, corrective action procedures, and verification procedures. Therefore, we estimate
that, on average, it would take 40 hours for an applicant to prepare the food defense portion of
the VQIP QAP.
Table 3 – Estimated One-Time Reporting Burden1
Information Collection
Activity

No. of
Respondents

No. of
Responses per
Respondent

Total
One-Time
Responses
100
100

Avg. Burden
per Response

Initial VQIP application
100
1
80
Initial VQIP application
100
1
100
w/additional information
TOTAL
1
There are no capital or operating and maintenance costs associated with the collection of information.

Total
Hours
8,000
10,000
18,000

The guidance will inform food importers of application procedures for VQIP. We estimate that
up to 200 qualified importers will be accepted in the first 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).

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Table 4 – Estimated Annual Reporting Burden1
Information Collection Activity

Subsequent year VQIP
application
Request to reinstate
participation
TOTAL
1

No. of
Respondents

No. of
Responses per
Respondent

200
2

Total
Avg.
Total
Annual
Burden per
Hours
Responses
Response
1
200
20
4,000
1

2

10

20
4,020

There are no capital or operating and maintenance costs associated with the 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. 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.
12 b. Annualized Cost Burden Estimate
FDA estimates an annualized cost to respondents based on an average hourly wage equivalent to
a GS-12/Step-1 level in the locality pay area of Washington-Baltimore in 2012, approximately
$35.88/hour. Doubling this wage to account for overhead costs, FDA estimates the average
hourly cost to be $71.76/hour. Thus, the overall estimated annualized cost incurred by the
respondents for the information collection contained in the guidance is approximately $3,300 (46
x 71.76).
13. Estimates of Other Total Annual Cost Burden to Respondents and Record Keepers
There are no capital, start-up, operating, or maintenance costs associated with this collection.
14. Annualized Cost to Federal Government
At this time the agency estimates no annualized cost to the Federal government for the
information collection. Under FSMA the agency has issued several regulations estimating
associated costs. We believe that costs associated with the administration of VQIP will be
absorbed by the other agency programs established under these regulations.
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15. Explanation for Program Changes or Adjustments
This is a new information collection request.
16. Plans for Tabulation and Publication and Project Time Schedule
FDA will post a publicly available list of approved VQIP importers on its webpage at
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm
448728.htm. VQIP importers may choose not to be listed on the VQIP importers list. A VQIP
importer’s decision to opt out of being listed on the publicly available list of approved VQIP
importers will not have any effect on its participation. The agency has no plans for publication of
information from this information collection.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
Display of the expiration date for OMB approval of the information collection is appropriate.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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