Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Drug and Animal Generic Drug User Fee Submissions, 54620-54621 [2023-17260]
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54620
Federal Register / Vol. 88, No. 154 / Friday, August 11, 2023 / Notices
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; Animal Drug and
Animal Generic Drug User Fee
Submissions
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) 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 September
11, 2023.
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.
SUMMARY:
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, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Animal Drug and Animal Generic Drug
User Fee Submissions
lotter on DSK11XQN23PROD with NOTICES1
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
VerDate Sep<11>2014
16:59 Aug 10, 2023
Jkt 259001
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 can be found at https://
www.fda.gov/industry/fda-user-feeprograms/animal-drug-user-fee-actadufa, 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 https://
www.fda.gov/industry/fda-user-feeprograms/animal-generic-drug-user-feeact-agdufa, 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 the Center
for Veterinary Medicine (CVM)
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 CVM 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
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
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
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 https://www.fda.gov/
regulatory-information/search-fdaguidance-documents/cvm-gfi-170animal-drug-user-fees-and-fee-waiversand-reductions. 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 https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/cvm-gfi-199-animal-genericdrug-user-fees-and-fee-waivers-andreductions. 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
E:\FR\FM\11AUN1.SGM
11AUN1
Federal Register / Vol. 88, No. 154 / Friday, August 11, 2023 / Notices
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.
In the Federal Register of April 27,
2023 (88 FR 25658), we published a 60day notice soliciting public comment on
the proposed information collection.
54621
One general comment was received
encouraging FDA in its mission to
promote and protect animal health.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
FD&C Act section; activity
FDA form No.
User fee cover sheets, by
type:
740(a)(1); Animal Drug
User Fee cover sheet.
741(a)(1); Animal Generic Drug User Fee
cover sheet.
Waiver and other requests,
by type:
740(d)(1)(A); Significant
barrier to innovation.
740(d)(1)(B); Fees exceed cost.
740(d)(1)(C); Free
choice feeds.
740(d)(1)(D); Minor use
or minor species.
740(d)(1)(E); Small
business.
741(d)(1); Minor use or
minor species.
Request for reconsideration of a decision.
21 CFR 10.75; Appeal
of a decision.
Total ......................
1 There
Total annual
responses
Average burden per
response
Total hours
3546
15
1
15
1 .........................................
15
3728
22
2
44
0.08 (5 minutes) .................
3.5
N/A
65
1
65
2 .........................................
130
N/A
8
3.75
30
0.5 (30 minutes) .................
15
N/A
4
1
4
2 .........................................
8
N/A
73
1
73
2 .........................................
146
N/A
1
1
1
2 .........................................
2
N/A
2
1
2
2 .........................................
4
N/A
1
1
1
2 .........................................
2
N/A
1
1
1
2 .........................................
2
........................
........................
........................
........................
.............................................
327.5
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: August 8, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–17260 Filed 8–10–23; 8:45 am]
BILLING CODE 4164–01–P
lotter on DSK11XQN23PROD with NOTICES1
Number of
responses per
respondent
Number of
respondents
VerDate Sep<11>2014
16:59 Aug 10, 2023
Jkt 259001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–1006]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Devices;
Reports of Corrections and Removals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
FOR FURTHER INFORMATION CONTACT:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) 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 September
11, 2023.
ADDRESSES: To ensure that comments on
the information collection are received,
SUMMARY:
PO 00000
Frm 00057
Fmt 4703
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 0910–0359. Also include
the FDA docket number found in
brackets in the heading of this
document.
Sfmt 4703
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, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\11AUN1.SGM
11AUN1
]]>Agencies
[Federal Register Volume 88, Number 154 (Friday, August 11, 2023)]
[Notices]
[Pages 54620-54621]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17260]
[[Page 54620]]
-----------------------------------------------------------------------
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; Animal Drug and
Animal Generic Drug User Fee Submissions
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) 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 September 11, 2023.
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: 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,
[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.
Animal Drug and Animal Generic Drug User Fee Submissions
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 can be found at https://www.fda.gov/industry/fda-user-fee-programs/animal-drug-user-fee-act-adufa, 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 https://www.fda.gov/industry/fda-user-fee-programs/animal-generic-drug-user-fee-act-agdufa,
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 the Center for Veterinary Medicine (CVM) 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 CVM 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 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
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-170-animal-drug-user-fees-and-fee-waivers-and-reductions. 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 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-199-animal-generic-drug-user-fees-and-fee-waivers-and-reductions. 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
[[Page 54621]]
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.
In the Federal Register of April 27, 2023 (88 FR 25658), we
published a 60-day notice soliciting public comment on the proposed
information collection. One general comment was received encouraging
FDA in its mission to promote and protect animal health.
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 cover 3546 15 1 15 1........................... 15
sheet.
741(a)(1); Animal Generic Drug User 3728 22 2 44 0.08 (5 minutes)............ 3.5
Fee cover sheet.
Waiver and other requests, by type:
740(d)(1)(A); Significant barrier to N/A 65 1 65 2........................... 130
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 species. N/A 2 1 2 2........................... 4
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: August 8, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-17260 Filed 8-10-23; 8:45 am]
BILLING CODE 4164-01-P
