[Federal Register Volume 85, Number 128 (Thursday, July 2, 2020)]
[Notices]
[Pages 39917-39918]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14263]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0145]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Reporting Associated 
With Animal Drug and Animal Generic Drug User Fees

AGENCY: Food and Drug Administration, Health and Human Services (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 August 3, 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 0910-0540. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[email protected].

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.

Reporting Associated With Animal Drug and Animal Generic Drug User 
Fees--21 U.S.C. 379j-12 and 379j-21

OMB Control Numbers 0910-0540--Extension

    This information collection supports FDA's animal drug and animal 
generic drug user fee programs. The Animal Drug User Fee Act of 2003 
(ADUFA) (Pub. L. 108-130) amended the Federal Food, Drug, and Cosmetic 
Act (FD&C Act) by adding section 740 of the FD&C Act (21 U.S.C 379j-
12), which requires that FDA assess and collect user fees with respect 
to new animal drug applications for certain applications, products, 
establishments, and sponsors. It also requires the Agency to grant a 
waiver from, or a reduction of, those fees in certain circumstances. 
The Animal Generic Drug User Fee Act of 2008 (AGDUFA) (Pub. L. 110-316) 
added section 741 of the FD&C Act (21 U.S.C. 379j-21), which 
establishes three different kinds of user fees: (1) Fees for certain 
types of abbreviated applications for generic new animal drugs; (2) 
annual fees for certain generic new animal drug products; and (3) 
annual fees for certain sponsors of abbreviated applications for 
generic new animal drugs and/or investigational submissions for generic 
new animal drugs (21 U.S.C. 379j-21(a)). On August 14, 2018, H.R. 5554, 
the Animal Drug and Animal Generic Drug User Fee Amendments of 2018, 
was signed into law to reauthorize the ADUFA and AGDUFA programs 
administered by FDA.
    Sponsors of new animal drug applications prepare and submit user 
fee cover sheets. 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 ensure 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, results in the generation of a unique payment 
identification number used by FDA to track the payment. The information 
collected is used by FDA's Center for Veterinary Medicine (CVM) to 
initiate the administrative screening of new animal drug applications 
and supplements. The information collection associated with the Animal 
Drug User Fee cover sheet currently is approved under OMB control 
number 0910-0539.
    Sponsors of abbreviated new animal drug applications also prepare 
and submit user fee cover sheets. The Animal Generic Drug User Fee 
cover sheet (Form FDA 3728) similarly is designed to collect the 
minimum necessary information to determine whether a fee is required 
for review of an application, to determine the amount of the fee 
required, and to ensure that each animal generic drug user fee payment 
is appropriately linked to the abbreviated new animal drug application 
for which payment is made. The form, when completed electronically, 
results in the generation of a unique payment identification number 
used by FDA to track the payment. The information collected is used by 
CVM to initiate the administrative screening of abbreviated new animal 
drug applications. The information collection associated with the 
Animal Generic Drug User Fee cover sheet currently is approved under 
OMB control number 0910-0632.
    FDA has also developed a guidance for industry (GFI) #170 entitled 
``Animal Drug User Fees and Fee Waivers and Reductions.'' This guidance 
provides guidance on the types of fees FDA is authorized to collect 
under section 740 of the FD&C Act, and how to request waivers and 
reductions from these fees. Further, this guidance also describes what 
information FDA recommends be submitted in support of a request for a 
fee waiver or reduction; how to submit such a request; and FDA's 
process for reviewing requests. FDA uses the information submitted by 
respondents to determine whether to grant the requested fee waiver or 
reduction. The information collection associated with GFI #170 
currently is approved under OMB control number 0910-0540.
    The information collection provisions approved under OMB control 
numbers 0910-0539, 0910-0540, and 0910-0632 are similar in that they 
support FDA's animal drug and animal generic drug user fee programs. 
Thus, with this notice, FDA proposes to consolidate these collections 
of information into one OMB control number for government efficiency 
and to allow the public to look to one OMB control number for all 
reporting associated with FDA's animal drug and animal generic drug 
user fee programs. Because we are proposing to combine all reporting 
associated with FDA's animal drug user fees into one collection, we are 
consolidating the burden under OMB control number 0910-0540 and 
discontinuing OMB control numbers 0910-0539 and 0910-0632.

[[Page 39918]]

    Description of Respondents: Respondents to this collection of 
information are new animal drug applicants and abbreviated new animal 
drug applicants. In addition, requests for waivers or reductions of 
user fees may be submitted by a person responsible for paying or 
potentially responsible for paying any of the animal drug user fees 
assessed, including application fees, product fees, establishment fees, 
or sponsor fees.
    In the Federal Register of January 23, 2020 (85 FR 3929), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                 Number of
    FD&C act section; activity            FDA form No.           Number of     responses per   Total  annual      Average burden  per       Total hours
                                                                respondents     respondent       responses             response
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                                                             User Fee Cover Sheets, by Type
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740(a)(1); Animal Drug User Fee    FDA 3546.................              21               1              21  1.........................              21
 Cover Sheet.
741; Animal Generic Drug User Fee  FDA 3728.................              20               2              40  0.08 (5 minutes)..........               3
 Cover Sheet.
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                                                           Waivers and Other Requests, by Type
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740(d)(1)(A); significant barrier  N/A......................              55               1              55  2.........................             110
 to innovation.
740(d)(1)(B); fees exceed cost...  N/A......................               8            3.75              30  0.5 (30 minutes)..........              15
740(d)(1)(C); free-choice feeds..  N/A......................               5               1               5  2.........................              10
740(d)(1)(D); minor use or minor   N/A......................              69               1              69  2.........................             138
 species.
740(d)(1)(E); small business.....  N/A......................               1               1               1  2.........................               2
Request for reconsideration of a   N/A......................               1               1               1  2.........................               2
 decision.
Request for review (user fee       N/A......................               1               1               1  2.........................               2
 appeal officer).
                                                             -------------------------------------------------------------------------------------------
    Total........................  .........................  ..............  ..............  ..............  ..........................             303
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    For the purpose of this consolidation, we rely on our previous 
estimates of the number of user fee cover sheet and waiver and other 
request submissions. We estimate 21 respondents will each submit 1 
Animal Drug User Fee cover sheet (Form FDA 3546) for a total of 21 
responses. We estimate 20 respondents will each submit 2 Animal Generic 
Drug User Fee cover sheets (Form FDA 3728) for a total of 40 responses. 
Our estimate of the number of waiver and other request submissions is 
detailed in table 1. These estimates are consistent with our previous 
estimates except for the row labeled, Request for review (user fee 
appeal officer), for which we have increased the estimated number of 
respondents from zero to one and the average burden per response from 0 
to 2 hours to correct the error in our previous submission. We base our 
estimates of the average burden per response on our experience with the 
submission of similar cover sheets and waiver and other requests.
    The information collection reflects an increase in burden by an 
additional 26 hours and 62 responses due to the consolidation of the 
information collections covered by OMB control numbers 0910-0539, 
``Animal Drug User Fee Cover Sheet,'' and 0910-0632, ``Animal Generic 
Drug User Fee Cover Sheet'' and the correction of the error in our 
previous submission.

    Dated: June 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-14263 Filed 7-1-20; 8:45 am]
BILLING CODE 4164-01-P