0539 ss 7-24-2017-1

FOOD AND DRUG ADMINISTRATION
Animal Drug User Fee Cover Sheet
OMB Control No. 0910-0539
SUPPORTING STATEMENT
Terms of Clearance: None.
A. Justification
1. Circumstances Making the Collection of Information Necessary
Under section 740 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21
U.S.C. 379j-12), the Food and Drug Administration (FDA) has the authority to assess and
collect application fees from each person who submits certain new animal drug
applications or certain supplemental animal drug applications. The Animal Drug User
Fee cover sheet (Form FDA 3546) is designed to collect the minimum necessary
information to determine whether a fee is required for the review of an application or
supplement or whether an application fee waiver was granted, to determine the amount of
the fee required, and to assure that each animal drug user fee payment is appropriately
linked to the animal drug application for which payment is made. The form, when
completed electronically, will result in the generation of a unique payment identification
number used by FDA to track the payment. FDA's Center for Veterinary Medicine and
FDA's Office of Management will use the information collected to initiate the
administrative screening of new animal drug applications and supplements to determine
whether the payment has been received.
We request extension of OMB approval of the information collection provisions of the
Animal Drug User Fee cover sheet (Form FDA 3546).
2. Purpose and Use of the Information Collection
As noted, the Animal Drug User Fee cover sheet (Form FDA 3546) is designed to collect
the minimum necessary information to determine whether a fee is required for the review
of an application or supplement or whether an application fee waiver was granted, to
determine the amount of the fee required, and to assure that each animal drug user fee
payment is appropriately linked to the animal drug application for which payment is
made. The form, when completed electronically, will result in the generation of a unique
payment identification number used by FDA to track the payment. FDA's Center for
Veterinary Medicine and FDA's Office of Management will use the information collected
to initiate the administrative screening of new animal drug applications and supplements
to determine whether the payment has been received.

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3. Use of Improved Information Technology and Burden Reduction
Form 3546 is an electronic form within an agency information technology system that
determines the amount of user fee owed based on information the user submits. All
submitters must prepare Form FDA 3546 online (100%). There is no paper version of the
format that can be filled out. After preparation of the form, 90% of submitters choose to
submit their ADUFA Cover Sheet on Form FDA 3546 electronically as part of an
electronic application. The remaining 10% of submitters choose to print their ADUFA
Cover Sheet on Form FDA 3546 and submit it with a paper application. Form FDA 3546
is electronically fillable and fileable. The form does not require a signature so it is not
electronically signable. Instead, users are identified by their user name and password.
4. Efforts to Identify Duplication and Use of Similar Information
FDA is the only agency that requires this information. The required information is not
available from any other source.
5. Impact on Small Businesses or Other Small Entities
Section 740(d)(1)(E) of the FD&C Act provides that FDA shall grant a waiver from or a
reduction of one or more of the fees where FDA finds that the sponsor involved is a small
business submitting its first animal drug application to [FDA] for review. A "small
business" is one that has fewer than 500 employees, including employees of affiliates.
Section 740(d)(3)(A) of the FD&C Act. FDA developed a guidance entitled “Guidance
for Industry: Animal Drug User Fees and Fee Waivers and Reductions.” This document
provides guidance on, among other subjects, how to request waivers and reductions from
FDA's animal drug user fees. In addition, we assist small businesses to meet the
requirements of the FD&C Act through our Regional Small Business Representatives and
through the scientific and administrative staff within the Center. FDA estimates that
approximately 2 of the affected firms are small businesses.
6. Consequences of Collecting the Information Less Frequently
Data collection occurs occasionally. If this information is not collected, FDA would not
be able to link payment of an application fee with an application that has been submitted.
The review of an application would not begin because concurrent submission of user fees
with applications is required.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances associated with this collection of information.

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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 October 21, 2016 (81 FR 72810). No comments were received.
9. Explanation of Any Payment or Gift to Respondents
We do not provide any payments or gifts to respondents.
10. Assurance of Confidentiality Provided to Respondents
We expect that new animal drug applications and supplements will contain trade secret
and confidential commercial information. As a result, all files are maintained in a
secured area. Confidentiality of the information submitted under these reporting
requirements is protected under 21 CFR 514.11. Only information that is releasable
under the agency’s regulations in 21 CFR part 20 would be released to the public. This
information is also safeguarded by section 301(j) of the FD&C Act and would be
protected from disclosure under the Freedom of Information Act (FOIA) under sections
552(a) and (b) (5 U.S.C. 552(a) and (b)).
11. Justification for Sensitive Questions
This information collection does not involve questions of a personally sensitive nature.
12. Estimates of Annualized Burden Hours and Costs
12 a. Annualized Hour Burden Estimate
FDA estimates the burden of this collection of information as follows:

FD&C Act section;
description

740(a)(1); Animal
Drug User Fee
cover sheet

Table 1.--Estimated Annual Reporting Burden1
FDA
Number of Number of
Total
Form
Respondents Responses
Annual
No.
per
Responses
Respondent
FDA
21
1
21
3546

Average
Burden
per
Response
1

Total
Hours

21

The estimates in table 1 are based on our experience with new animal drug applications
and supplemental animal drug applications and the average number of Animal Drug User
Fee cover sheets submitted during fiscal years 2013-2015. We estimate 21 respondents
will each submit a cover sheet (Form FDA 3546), for a total of 21 responses. We
calculate a reporting burden of 1 hour per response, for a total of 21 hours.

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12 b. Annualized Cost Burden Estimate

Type of Respondent
Compliance Officer

1

Total Burden Hours
21

Hourly Wage Rate
$47.87

Total Cost
$1005.27

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May 2015 National Industry-Specific Occupational Employment and Wage Estimates, US Department of Labor, Bureau of
Labor Statistics, Compliance Officers 13-1041 (https://www.bls.gov/oes/current/oes131041.htm) $36.82 hourly wage plus 30%
adjusted for benefits.

FDA estimates that the total annual cost to respondents will be $1005.27 (21 hours x
$47.87 per hour). The cost to respondents is based on the salary of a compliance officer,
at a pay rate of $47.87 per hour, who is responsible for filling out, signing, and
submitting the request. This salary estimate includes benefits but no overhead costs.
13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital
Costs
There are no capital, start-up, operating, or maintenance costs associated with this
information collection.
14. Annualized Cost to the Federal Government
We estimate the cost to the Federal government to respond to the current level of Animal
Drug User Fee cover sheets is approximately $39,860. This is based on the salary of half
an FTE at the GS-12/Step 1 level in the locality pay area of Washington-BaltimoreArlington in 2017 ($79,720 /year) (0.5 FTE x $79,720 = $39,860).
15. Explanation for Program Changes or Adjustments
The collection includes an adjustment in the agency estimate. We have increased both
the number of annual hours and responses by 4 to reflect an increase in submissions to
the agency.
16. Plans for Tabulation and Publication and Project Time Schedule
Section 704(d)(3)(C) of the FD&C Act requires FDA to periodically publish in the
Federal Register a list of persons making small business certifications. We have no plans
to tabulate and publish other information from this information collection.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
We are not seeking an exemption from displaying the expiration date for OMB approval.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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