Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting Associated With Animal Drug and Animal Generic Drug User Fees, 3929-3931 [2020-01082]
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3929
Federal Register / Vol. 85, No. 15 / Thursday, January 23, 2020 / Notices
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
Number of
disclosures
per respondent
Number of
respondents
Activity/21 CFR section
Television
receiver
critical
component
warning—
1020.10(c)(4) ....................................................................
Cold cathode tubes—1020.20(c)(4) .....................................
Information on diagnostic x-ray systems—1020.30(g) ........
Statement of maximum line current of x-ray systems—
1020.30(g)(2) ....................................................................
Diagnostic x-ray system safety and technical information—
1020.30(h)(1) through (4) .................................................
Fluoroscopic x-ray system safety and technical information—1020.30(h)(5) and (6) and 1020.32(a)(1), (g), and
(j)(4) ..................................................................................
CT equipment—1020.33(c), (d), (g)(4), and (j) ...................
Cabinet x-ray systems information—1020.40(c)(9)(i) and
(ii) ......................................................................................
Microwave
oven
radiation
safety
instructions—
1030.10(c)(4) ....................................................................
Microwave oven safety information and instructions—
1030.10(c)(5)(i) through (iv) .............................................
Microwave oven warning labels—1030.10(c)(6)(iii) .............
Laser products information—1040.10(h)(1)(i) through (vi) ..
Laser product service information—1040.10(h)(2)(i) and (ii)
Medical laser product instructions—1040.11(a)(2) ..............
Sunlamp products instructions—1040.20 ............................
Mercury vapor lamp labeling—1040.30(c)(1)(ii) ..................
Mercury vapor lamp permanently affixed labels—
1040.30(c)(2) ....................................................................
Ultrasonic therapy products—1050.10(d)(1) through (d),
(f)(1), and (f)(2)(iii) ............................................................
Total ..............................................................................
Average
burden per
disclosure
Total annual
disclosures
Total hours 2
1
1
6
1
1
1
1
1
6
1
1
55
1
1
330
6
1
6
10
60
6
1
6
200
1,200
5
5
1
1
5
5
25
150
125
750
6
1
6
40
240
1
1
1
20
20
1
1
3
3
2
1
1
1
1
1
1
1
1
1
1
1
3
3
2
1
1
20
1
20
20
10
10
1
20
1
60
60
20
10
1
1
1
1
1
1
1
1
1
56
56
........................
........................
........................
........................
3,058
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 Total hours have been rounded.
Based on a review of the information
collection, we have made no
adjustments to our burden estimate.
Dated: January 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–01073 Filed 1–22–20; 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; Proposed Collection;
Comment Request; Reporting
Associated With Animal Drug and
Animal Generic Drug User Fees
AGENCY:
Food and Drug Administration,
jbell on DSKJLSW7X2PROD with NOTICES
HHS.
ACTION:
Notice.
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.
SUMMARY:
VerDate Sep<11>2014
17:13 Jan 22, 2020
Jkt 250001
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: Submit either electronic or
written comments on the collection of
information by March 23, 2020.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before March 23,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of March 23, 2020. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov 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 https://www.regulations.gov.
• 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’’).
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23JAN1
3930
Federal Register / Vol. 85, No. 15 / Thursday, January 23, 2020 / Notices
jbell on DSKJLSW7X2PROD with NOTICES
Written/Paper Submissions
Submit written/paper submissions as
follows:
• 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.
• 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 ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; 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
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• 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
https://www.regulations.gov. 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: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
VerDate Sep<11>2014
17:13 Jan 22, 2020
Jkt 250001
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov 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.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
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.
SUPPLEMENTARY INFORMATION:
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Frm 00040
Fmt 4703
Sfmt 4703
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
E:\FR\FM\23JAN1.SGM
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Federal Register / Vol. 85, No. 15 / Thursday, January 23, 2020 / Notices
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 document 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
3931
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.
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.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
FD&C Act Section; Activity
User fee cover sheets, by type:
740(a)(1); Animal Drug User Fee
cover sheet.
741; 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 ........
Number of
responses per
respondent
Number of
respondents
Average
burden per
response
Total annual
responses
Total hours
FDA 3546 ......
21
1
21
1 .....................
FDA 3728 ......
20
2
40
0.08 (5 minutes).
N/A .................
55
1
55
2 .....................
110
N/A .................
8
3.75
30
15
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).
N/A .................
N/A .................
5
69
1
1
5
69
0.5 (30 minutes).
2 .....................
2 .....................
10
138
N/A .................
N/A .................
1
1
1
1
1
1
2 .....................
2 .....................
2
2
N/A .................
1
1
1
2 .....................
2
Total ..........................................
........................
........................
........................
........................
........................
303
1 There
jbell on DSKJLSW7X2PROD with NOTICES
FDA form No.
21
3
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
VerDate Sep<11>2014
17:13 Jan 22, 2020
Jkt 250001
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
PO 00000
Frm 00041
Fmt 4703
Sfmt 9990
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: January 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–01082 Filed 1–22–20; 8:45 am]
BILLING CODE 4164–01–P
E:\FR\FM\23JAN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 15 (Thursday, January 23, 2020)]
[Notices]
[Pages 3929-3931]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01082]
-----------------------------------------------------------------------
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: Submit either electronic or written comments on the collection
of information by March 23, 2020.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before March 23, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of March 23, 2020. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
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 https://www.regulations.gov.
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'').
[[Page 3930]]
Written/Paper Submissions
Submit written/paper submissions as follows:
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.
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 ``Agency Information Collection Activities;
Proposed Collection; Comment Request; 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 https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
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 https://www.regulations.gov.
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov 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.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
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.
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
[[Page 3931]]
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 document
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.
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.
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 FDA 3728................. 20 2 40 0.08 (5 minutes)........ 3
Fee cover sheet.
Waiver and other requests, by type:
740(d)(1)(A); significant N/A...................... 55 1 55 2....................... 110
barrier 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 N/A...................... 69 1 69 2....................... 138
minor species.
740(d)(1)(E); small business... N/A...................... 1 1 1 2....................... 2
Request for reconsideration of N/A...................... 1 1 1 2....................... 2
a decision.
Request for review (user fee N/A...................... 1 1 1 2....................... 2
appeal officer).
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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: January 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-01082 Filed 1-22-20; 8:45 am]
BILLING CODE 4164-01-P
