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, 39917-39918 [2020-14263]
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Federal Register / Vol. 85, No. 128 / Thursday, July 2, 2020 / Notices
Consistent with the PRA, our current
estimate of the burden of the
information collection is based on our
evaluation over the past 3 years.
However, in light of recent consumption
of products from the SNS, we expect
future adjustments may be necessary
and invite specific comment in this
regard.
Dated: June 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–14267 Filed 7–1–20; 8:45 am]
BILLING CODE 4164–01–P
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
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
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.
SUMMARY:
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.
ADDRESSES:
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, PRAStaff@
fda.hhs.gov.
khammond on DSKJM1Z7X2PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
21:18 Jul 01, 2020
Jkt 250001
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
PO 00000
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Fmt 4703
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39917
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.
E:\FR\FM\02JYN1.SGM
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39918
Federal Register / Vol. 85, No. 128 / Thursday, July 2, 2020 / Notices
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
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:
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-
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
FD&C act section; activity
Number of
respondents
FDA form No.
Number of
responses per
respondent
Total
annual
responses
Average burden
per response
Total hours
User Fee Cover Sheets, by Type
740(a)(1); Animal Drug User Fee Cover Sheet .......
741; Animal Generic Drug User Fee Cover Sheet ..
FDA 3546 .............
FDA 3728 .............
21
20
1
2
21
40
1 ..............................
0.08 (5 minutes) ......
21
3
Waivers 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 ....................................
Request for reconsideration of a decision ...............
Request for review (user fee appeal officer) ...........
Total ..................................................................
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1 There
N/A
N/A
N/A
N/A
N/A
N/A
N/A
.......................
.......................
.......................
.......................
.......................
.......................
.......................
55
8
5
69
1
1
1
1
3.75
1
1
1
1
1
55
30
5
69
1
1
1
2 ..............................
0.5 (30 minutes) ......
2 ..............................
2 ..............................
2 ..............................
2 ..............................
2 ..............................
110
15
10
138
2
2
2
...............................
........................
........................
........................
..................................
303
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.
VerDate Sep<11>2014
21:18 Jul 01, 2020
Jkt 250001
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–P–1072]
Determination That ZOVIRAX
(Acyclovir) Oral Capsules, 200
Milligrams, Was Not Withdrawn From
Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that ZOVIRAX (acyclovir)
oral capsules, 200 milligrams (mg), was
not withdrawn from sale for reasons of
safety or effectiveness. This
determination means that FDA will not
begin procedures to withdraw approval
of abbreviated new drug applications
(ANDAs) that refer to this drug product,
and it will also allow FDA to continue
to approve ANDAs that refer to the
product as long as they meet relevant
legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT:
Jessica Tierney, Center for Drug
Evaluation and Research, Food and
SUMMARY:
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6213,
Silver Spring, MD 20993–0002, 301–
796–9120, Jessica.Tierney@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
E:\FR\FM\02JYN1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
User Fee Cover Sheets, by Type
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Waivers and Other Requests, by Type
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
