Notice2023-08946
Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting Associated With Animal Drug and Animal Generic Drug User Fees
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
April 27, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 the information collection provisions of FDA's animal drug and animal generic drug user fee programs.
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 81 (Thursday, April 27, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 81 (Thursday, April 27, 2023)]
[Notices]
[Pages 25658-25660]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-08946]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-0145]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Reporting Associated With Animal Drug and Animal
Generic Drug User Fees
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 the information collection provisions of
FDA's animal drug and animal generic drug user fee programs.
DATES: Either electronic or written comments on the collection of
information must be submitted by June 26, 2023.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 26, 2023. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2020-N-0145 for ``Reporting Associated With Animal Drug and Animal
Generic Drug User Fees.'' 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
<a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
[[Page 25659]]
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, 240-402-7500.
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,
<a href="/cdn-cgi/l/email-protection#9fcfcddeccebfef9f9dff9fbfeb1f7f7ecb1f8f0e9"><span class="__cf_email__" data-cfemail="4e1e1c0f1d3a2f28280e282a2f6026263d60292138">[email protected]</span></a>.
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.
Animal Drug and Animal Generic Drug User Fee Programs
OMB Control Number 0910-0540--Extension
This information collection helps support implementation of the
Animal Drug User Fee Act of 2003 (ADUFA) (Pub. L. 108-130) and Animal
Generic Drug User Fee Act of 2008 (AGDUFA) (Pub. L. 110-316),
established in sections 740 and 741 of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 379j-12 and 21 U.S.C. 379j-21),
respectively. Under ADUFA, FDA assesses and collects user fees for
certain new animal drug applications and supplements, products,
establishments, and sponsors of new animal drug applications and/or
investigational new animal drug file submissions. The ADUFA program is
currently reauthorized through September 30, 2023, and FDA efforts to
engage interested stakeholders in the 2023 reauthorization is ongoing.
More information regarding the ADUFA program can be found at <a href="https://www.fda.gov/industry/fda-user-fee-programs/animal-drug-user-fee-act-adufa">https://www.fda.gov/industry/fda-user-fee-programs/animal-drug-user-fee-act-adufa</a>, including current user fee rates applicable to animal drug
submissions. Under AGDUFA, FDA assesses and collects user fees for
certain abbreviated (generic) new animal drug applications and
supplements, products, and sponsors of generic new animal drug
applications and/or generic investigational new animal drug file
submissions. The AGDUFA program is currently reauthorized through
September 30, 2023, and FDA efforts to engage interested stakeholders
in the 2023 reauthorization is ongoing. More information regarding the
AGDUFA program can be found at <a href="https://www.fda.gov/industry/fda-user-fee-programs/animal-generic-drug-user-fee-act-agdufa">https://www.fda.gov/industry/fda-user-fee-programs/animal-generic-drug-user-fee-act-agdufa</a>, including current
user fee rates applicable to generic animal drug submissions.
These user fee program resources support FDA's responsibilities to
ensure that new animal drugs are safe and effective for animals, as
well as ensuring the safety of food from treated animals.
Sponsors of new animal drug applications complete a user fee cover
sheet and submit it through CVM's eSubmitter. 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, the Center) to initiate the administrative screening of new
animal drug applications and supplements.
Similarly, sponsors of abbreviated new animal drug applications
also complete a user fee cover sheet and submit it through CVM's
eSubmitter. The AGDUFA cover sheet (Form FDA 3728) is also 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.
Both sections 740 and 741 of the FD&C Act provide for waivers,
reductions, and exemptions of fees. To assist respondents with
submitting
[[Page 25660]]
requests for waivers or reductions of ADUFA user fees, we developed
guidance for industry (GFI) #170 entitled ``Animal Drug User Fees and
Fee Waivers and Reductions'' (April 2023), available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-170-animal-drug-user-fees-and-fee-waivers-and-reductions">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-170-animal-drug-user-fees-and-fee-waivers-and-reductions</a>. This
document discusses the types of fees FDA is authorized to collect under
section 740 of the FD&C Act, and how to request waivers or 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, a request for reconsideration of denial of a fee waiver or
reduction request, or an appeal of the denial decision in accordance
with 21 CFR 10.75; how to submit such a request or appeal; and FDA's
process for reviewing such requests or appeals.
Similarly, we developed guidance for industry (GFI) #199 entitled
``Animal Generic Drug User Fees and Fee Waivers and Reductions'' (May
2009), available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-199-animal-generic-drug-user-fees-and-fee-waivers-and-reductions">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-199-animal-generic-drug-user-fees-and-fee-waivers-and-reductions</a>. This document discusses the types of fees
FDA is authorized to collect under section 741(a)(1) of the FD&C Act,
and how to request waivers or 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, a request for
reconsideration of denial of a fee waiver or reduction request, or an
appeal of the denial decision in accordance with 21 CFR 10.75; how to
submit such a request or appeal; and FDA's process for reviewing such
requests or appeals.
We use the information submitted by respondents to determine
whether requests for waiver or reduction of user fees, reconsideration
requests, or appeals may be granted.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
FD&C Act section; activity FDA form No. Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
User fee cover sheets, by type
--------------------------------------------------------------------------------------------------------------------------------------------------------
740(a)(1); Animal Drug User Fee FDA 3546.............. 15 1 15 1.......................... 15
cover sheet.
741(a)(1); Animal Generic Drug User FDA 3728.............. 22 2 44 .08 (5 minutes)............ 3.5
Fee cover sheet.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Waiver and other requests, by type
--------------------------------------------------------------------------------------------------------------------------------------------------------
740(d)(1)(A); significant barrier N/A................... 65 1 65 2.......................... 130
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................... 4 1 4 2.......................... 8
740(d)(1)(D); minor use or minor N/A................... 73 1 73 2.......................... 146
species.
740(d)(1)(E); small business....... N/A................... 1 1 1 2.......................... 2
741(d)(1); minor use or minor N/A................... 2 1 2 2.......................... 4
species.
Request for reconsideration of a N/A................... 1 1 1 2.......................... 2
decision.
21 CFR 10.75; Appeal of a decision. N/A................... 1 1 1 2.......................... 2
--------------------------------------------------------------------------------------------
Total.......................... ...................... .............. .............. .............. ........................... 327.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the information collection reflects an
overall increase. We attribute this adjustment to an increase in the
number of submissions we have received since our last evaluation. The
total number of annual responses is based on the average number of
submissions received by FDA in fiscal years 2019 to 2021. The estimated
time we attribute to the hours per response is based on our experience
with the various submissions and reflects the average burden we
attribute to all respondents.
Dated: April 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-08946 Filed 4-26-23; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on April 27, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.