United States Food and Drug Administration
Voluntary Qualified Importer Program
SUPPORTING STATEMENT
Part A: Justification
1.
Circumstances
Making the Collection of Information Necessary
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 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.
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 PRA 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 part 10.115, which provides for public comment at any time.
Accordingly, we request approval for the information collection provisions contained in the guidance and Form FDA 4041, as discussed in this supporting statement.
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 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.
3. Use
of Improved Information Technology and Burden Reduction
FDA
leverages information technology systems to facilitate electronic
submissions of VQIP applications to FDA. To submit a VQIP
application, participants establish an online account on the FDA
Industry Systems Web site at www.access.fda.gov.
The information in the online account will auto populate into the
VQIP application (Form FDA 4041). Additional information on
completing and submitting a VQIP application is provided in Section G
of the guidance and the VQIP Portal User Guide
(https://www.fda.gov/media/113346/download).
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, but respondents should establish an online
account on the FDA Industry Systems Web site. Respondents can update
or change information in the online account at any time.
Once the application has been reviewed and approved by FDA, an email is sent to the main contact person specified in the VQIP application. Approved VQIP participants will receive an invoice sent via email to be paid prior to October 1st of the calendar year. Instructions and methods of payment may be found by visiting the Voluntary Qualified Importer Program User Fees page (https://www.fda.gov/industry/fda-user-fee-programs/voluntary-qualified-importer-program-user-fees) and selecting the current Federal Register Notice.
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, it imposes no undue burden on small entities. At
the same time, 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
guidance provides for an annual application process and the
establishment and maintenance of a quality assurance program (QAP).
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), we published a 60-day notice for
public comment in the Federal
Register of May 11,
2023 (88 FR 30315). No comments were received.
There are no incentives, payments or gifts associated with this information collection.
The Privacy Act of 1974
In preparing this Supporting Statement, we consulted our Privacy Office to ensure appropriate identification and handling of information collected.
This ICR collects personally identifiable information (PII). PII is collected in the context of the subject individuals’ professional capacity and the FDA-related work they perform for their employer (e.g., point of contact at a regulated entity). The PII submitted includes point of contact name, employer tax identification number, work email address, work telephone number, and work fax telephone number. FDA determined that although PII is collected, the collection is not subject to the Privacy Act of 1974 and the particular notice and other requirements of the Act do not apply. Specifically, the contractor or FDA does not use name or any other personal identifier to retrieve records from the information collected. Through appropriate webpage design, FDA limited submission fields and minimized the PII collected to protect the privacy of the individuals.
The Freedom of Information Act
12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate
We estimate the burden of the information collection as follows:
Table 1.—Estimated Annual Reporting Burden
|
|||||
Reporting Using FIS System VQIP Portal/Form FDA 4041 |
No. of Respondents |
No. of Responses per Respondent |
Total Annual Responses |
Average Burden per Response |
Total Hours |
Initial VQIP application |
5 |
1 |
5 |
180 |
900 |
Application Renewals – subsequent year |
6 |
1 |
6 |
20 |
120 |
Requests for reinstatement |
2 |
1 |
2 |
10 |
20 |
Total |
1,040 |
||||
Table 2.—Estimated Annual Recordkeeping Burden |
|||||
VQIP Participant Records Consistent with Implementing Guidance |
No. of Respondents |
No. of Responses per Respondent |
Total Annual Responses |
Average Burden per Response |
Total Hours |
Quality Assurance Program (QAP) preparation |
5 |
1 |
5 |
160 |
800 |
QAP maintenance and updates |
6 |
1 |
6 |
16 |
96 |
Total |
896 |
||||
The burden hour total for this ICR is 1,936 hours (1,040 + 896).
We assume the average burden required for the respective reporting and recordkeeping activities for both initial and continued participation in the program remain constant.
12b. Annualized Hour Burden Estimate
We assume an annualized cost to respondents commensurate with an average hourly wage of a GS-12/Step-1 level in the locality pay area of Washington-Baltimore in (2023 OPM schedule: $45.14/hour).1 Doubling this wage to account for fringe benefits, we calculate an average hourly cost of $90.28/hour for reporting and recordkeeping. We then multiply the total number of burden hours (1,936) by the average hourly cost, for a total cost estimate of $174,782.
VQIP Participant Reporting and Records Consistent with Implementing Guidance |
Total Burden Hours |
Hourly Wage Rate |
Total Respondent Costs |
Professional services commensurate with GS-12/Step-1 |
1.936 |
$90.28 |
$174,782
|
13.
Estimates of Other
Total Annual Cost Burden to Respondents and Recordkeepers
There
are no capital, start-up, operating, or maintenance costs associated
with this collection.
14.
Annualized Cost
to Federal Government
We assume, using FY 22-FY 23 appropriations request data, expenditure reporting, and allocated among our agency import program activities offset against the $6,000,000 in collected VQIP user fees, the cost to administer the VQIP program information collection is $3,435.47.
15.
Explanation for
Program Changes or Adjustments
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. This results in a decrease of 500 hours to the currently approved recordkeeping burden attributed to initial VQIP applications with additional information. We assume the average burden required for the respective reporting and recordkeeping activities for both initial and continued participation in the program remain constant.
16. Plans for Tabulation and Publication and Project Time Schedule
FDA
makes a publicly available list of approved VQIP importers on its
webpage at
https://www.fda.gov/food/importing-food-products-united-states/voluntary-qualified-importer-program-vqip-public-list-approved-vqip-importers.
VQIP importers may choose not to be listed. 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
FDA
will display the OMB expiration date as required by 5 CFR 1320.8. We
display the OMB expiration date as part of the Federal Industry
Systems landing page. The agency will continue its efforts to
increase the visibility of the PRA burden statement displayed in
electronic format as our allocated resources permit.
18.
Exceptions to
Certification for Paperwork Reduction Act Submissions
There
are no exceptions to the certification.
1 See OPM 2023 Salary Table at: https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/23Tables/html/DCB_h.aspx
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Author | Showalter, Rachel |
| File Modified | 0000-00-00 |
| File Created | 2023-08-18 |