Animal Generic Drug User Fee Act; Recommendations; Request for Comments; Extension of Comment Period, 49377-49379 [2017-23173]
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Federal Register / Vol. 82, No. 205 / Wednesday, October 25, 2017 / Notices
statutes and regulations. This guidance
is not subject to Executive Order 12866.
III. Electronic Access
Persons interested in obtaining a copy
of the guidance may do so by
downloading an electronic copy from
the internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.fda.gov/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/default.htm or
https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Deciding When to Submit a 510(k)
for a Change to an Existing Device’’ may
send an email request to CDRHGuidance@fda.hhs.gov to receive an
electronic copy of the document. Please
use the document number 1500054 to
identify the guidance you are
requesting.
sradovich on DSK3GMQ082PROD with NOTICES
IV. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR part 820 are approved under
OMB control number 0910–0073; the
collections of information in 21 CFR
part 807, subpart E are approved under
OMB control number 0910–0120; the
collections of information in 21 CFR
part 803 have been approved under
OMB control number 0910–0437; and
the collections of information in 21 CFR
parts 801 and 809 are approved under
OMB control number 0910–0485.
2. ‘‘Suggested Format for Developing and
Responding to Deficiencies in
Accordance with the Least Burdensome
Provisions of FDAMA,’’ dated November
2, 2000, available at: https://
www.fda.gov/downloads/Medical
Devices/DeviceRegulationandGuidance/
GuidanceDocuments/ucm073680.pdf.
Dated: October 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–23197 Filed 10–24–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0655]
Animal Generic Drug User Fee Act;
Recommendations; Request for
Comments; Extension of Comment
Period
AGENCY:
Food and Drug Administration,
HHS.
Notice of availability; request
for comments; extension of comment
period.
ACTION:
V. References
The following references are on
display in the Dockets Management
Staff (see ADDRESSES) and are available
for viewing by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday; they are also available
electronically at https://
www.regulations.gov. FDA has verified
the Web site addresses, as of the date
this document publishes in the Federal
Register, but Web sites are subject to
change over time.
The Food and Drug
Administration (FDA or the Agency) is
announcing the availability of the
Animal Generic Drug User Fee Act
(AGDUFA) reauthorization draft
recommendations and extending the
comment period to allow interested
persons 30 days to submit comments on
these draft recommendations.
DATES: FDA is extending the comment
period on the AGDUFA reauthorization
and draft recommendations. Submit
either electronic or written comments
on the draft recommendations by
November 24, 2017.
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 November 24,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of November 24, 2017.
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.
1. ‘‘The Least Burdensome Provisions of the
FDA Modernization Act of 1997:
Concept and Principles,’’ dated October
4, 2002, available at: https://
www.fda.gov/downloads/Medical
Devices/DeviceRegulationandGuidance/
GuidanceDocuments/ucm085999.pdf.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
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SUMMARY:
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49377
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’’).
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–
2011–N–0655 for ‘‘Animal Generic Drug
User Fee Act; Recommendations;
Request for Comments; Extension of
Comment Period’’ 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
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Federal Register / Vol. 82, No. 205 / Wednesday, October 25, 2017 / Notices
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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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:
Cassie Ravo, Center for Veterinary
Medicine (HFV–10), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–6866,
cassie.ravo@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
sradovich on DSK3GMQ082PROD with NOTICES
I. Background
FDA is announcing the availability of
the proposed recommendations for the
reauthorization of AGDUFA, which
authorizes FDA to collect user fees and
use them for the process of reviewing
generic new animal drug applications
and associated submissions. The
authority for AGDUFA expires
September 30, 2018. Without new
legislation, FDA will no longer have the
authority to collect user fees to fund the
generic new animal drug review process
for future fiscal years. Section 742(d)(4)
of the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 379j–
22(d)(4)) requires that, after holding
negotiations with regulated industry
and periodic consultations with
stakeholders, and before transmitting
the Agency’s final recommendation to
Congress for the reauthorized program
(AGDUFA III), we do the following: (1)
Present the recommendations to the
relevant Congressional committees, (2)
publish such recommendations in the
Federal Register, (3) provide for a
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period of 30 days for the public to
provide written comments on such
recommendations, (4) hold a meeting at
which the public may present its views
on such recommendations, and (5)
consider such public views and
comments and revise such
recommendations as necessary. In the
Federal Register of October 5, 2017 (82
FR 46506), we announced a public
meeting to be held on November 2,
2017. In that notice we stated that we
intended to publish in the Federal
Register the full text of the proposed
AGDUFA III Performance Goals and
Procedures Letter and a summary of
proposed statutory changes, as well as
post them at https://www.fda.gov/For
Industry/UserFees/AnimalGenericDrug
UserFeeActAGDUFA/ucm270232.htm,
before the public meeting and would
provide for a period of 30 days for the
public to provide written comments.
This notice announces the availability
of these draft recommendations and
extends the comment period to
November 24, 2017 to provide for a
period of 30 days for the public to
comment on these draft
recommendations. After the public
meeting and closing of the comment
period, we will revise the draft
recommendations as necessary. In
addition, the Agency will present the
draft recommendations to the
Congressional committees.
II. Proposed AGDUFA III
Recommendations
A. Enhancing the Process for Premarket
Review
We are proposing the following
changes to the performance
commitments previously established to
further enhance the process for review
of generic new animal drug
applications.
Beginning October 1, 2018, all
applications and submissions under
section 512(b) of the FD&C Act (21
U.S.C. 360b(b)) must be submitted to the
Agency electronically using the
eSubmitter tool.
The Agency will review and act on 90
percent of original abbreviated new
animal drug applications (ANADAs)
within 240 days (180-day review plus
60-day administrative review) after the
submission date. An application is
incomplete if it would require
additional data or information to enable
the Agency to complete a
comprehensive review of the
application and reach a decision on the
issue(s) presented in the application. If
the Agency determines that the
deficiencies are not substantial, the
Agency will review and act on 90
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percent of reactivated applications
within 120 days (60-day review plus 60day administrative review) after the
reactivated ANADA submission date.
This shorter review time for reactivated
ANADAs for which the deficiencies are
determined not to be substantial is not
intended to prevent the use of minor
amendments during Agency review of
an application. If the Agency determines
that the deficiencies are substantial or
new substantial information is
provided, the Agency will review and
act on 90 percent of reactivated
applications within 240 days (180-day
review plus 60-day administrative
review) after the reactivated ANADA
submission date.
The Agency will review and act on 90
percent of administrative ANADAs
(ANADAs submitted after all scientific
decisions have been made in the generic
investigational new animal drug
(JINAD) process, i.e., prior to the
submission of the ANADA) within 60
days after the submission date.
Paragraph IV certification applications
(section 512(n)(1)(H)(iv) of the FD&C
Act) submitted as administrative
ANADAs will be excluded from the
administrative ANADA cohort.
The Agency will review and act on 90
percent of Prior Approval
manufacturing supplemental ANADAs
within 180 days after the submission
date. A Prior Approval manufacturing
supplemental ANADA includes: One or
more major manufacturing changes
according to § 514.8(b)(2)(ii) (21 CFR
514.8(b)(2)(ii)) and in accordance with
Guidance for Industry #83, ‘‘Chemistry,
Manufacturing, and Controls Changes to
an Approved NADA or ANADA’’; and
changes submitted as ‘‘SupplementChanges Being Effected in 30 Days’’ that
require prior approval according to
§ 514.8(b)(3)(v)(A). If a Prior Approval
supplement does not clearly identify
any major manufacturing changes, the
Prior Approval supplement will be
designated by the Agency as a
‘‘Supplement—Changes Being Effected’’
with a 270-day review goal (see
‘‘Supplement—Changes Being Effected
Manufacturing Supplemental ANADAs
and Reactivations’’ below).
A submission is incomplete if it
requires additional data or information
to enable the Agency to complete a
comprehensive review of the
submission and reach a decision on the
issue(s) presented in the submission. If
the Agency determines that the
deficiencies are not substantial for
manufacturing supplements requiring
prior approval, the Agency will allow
the manufacturing supplements to be
resubmitted as ‘‘Supplement-Changes
Being Effected in 30 Days’’ as described
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in § 514.8(b)(3) and the drug made with
the change can be distributed 30 days
after the resubmission according to
§ 514.8(b)(3)(iv). The Agency will
review and act on 90 percent of these
reactivated manufacturing supplements
within 270 days after the resubmission
date of a complete submission. If the
Agency determines that the deficiencies
remain substantial or new substantial
information is provided, prior approval
is required according to
§ 514.8(b)(3)(v)(A). The Agency will
review and act on 90 percent of these
reactivated manufacturing supplements
within 180 days after the resubmission
date of a complete submission.
The Agency will review and act on 90
percent of ‘‘Supplement-Changes Being
Effected’’ manufacturing supplemental
ANADAs and reactivations submitted
according to § 514.8(b)(3)(vi) and in
accordance with Guidance for Industry
#83, ‘‘Chemistry, Manufacturing, and
Controls Changes to an Approved
NADA or ANADA,’’ including
manufacturing changes not requiring
prior approval according to
§ 514.8(b)(3)(iv), within 270 days after
the submission date.
The Agency will review and act on 90
percent of JINAD study submissions
within 180 days after the submission
date.
A submission is incomplete if it
would require additional data or
information to enable the Agency to
complete a comprehensive review of the
study submission and reach a decision
on the issue(s) presented in the
submission. If the Agency determines
that the deficiencies are not substantial,
the Agency will review and act on 90
percent of resubmitted JINAD study
submissions within 60 days after the
receipt date of a complete study
submission. This shorter review time for
resubmitted JINAD study submissions is
not intended to prevent the use of minor
amendments during Agency review of a
study submission. If the Agency
determines that the deficiencies are
substantial or new substantial
information is provided, the Agency
will review and act on 90 percent of
resubmitted JINAD study submissions
within 180 days after the receipt date of
a complete study submission.
The Agency will review and act on 90
percent of JINAD submissions
consisting of protocols without
substantial data, that the Agency and
the sponsor consider to be an essential
part of the basis for making the decision
to approve or not approve an ANADA
or supplemental ANADA, within 75
days after the submission date.
The Agency will allow comparability
protocols as described in § 514.8(b)(2)(v)
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to be submitted as protocols without
substantial data in a JINAD file. The
Agency will review and act on 90
percent of JINAD submissions
consisting of protocols without
substantial data within 75 days after the
submission date of the protocol. For
potentially more complex comparability
protocols, for example sterile process
validation protocols, the sponsor should
discuss and have Agency concurrence
regarding the appropriate filing strategy.
The Agency will continue to allow
two-phased Chemistry, Manufacturing,
and Controls technical section
submissions under the JINAD process.
The Agency and regulated industry
are committed to improving the review
and business processes that will
facilitate the timely scheduling and
conducting of pre-approval inspections
(PAIs). To improve the timeliness and
predictability of foreign PAIs, sponsors
may voluntarily submit: (1) At the
beginning of the calendar year, a list of
foreign manufacturing facilities that are
specified in an abbreviated application,
supplemental abbreviated application,
or generic investigational file and may
be subject to foreign PAIs for the
following fiscal year; and (2) a
notification 30 days prior to submitting
an abbreviated application, a
supplemental abbreviated application,
or generic investigational file that
informs the Agency that the application
includes a foreign manufacturing
facility. Should any changes to the
annual list occur after its submission to
the Agency, the sponsor may provide
the updated information to the Agency.
The Agency will keep a record of the
number of foreign PAIs conducted for
abbreviated applications, along with the
average time for completing the PAIs,
and include this information in its
annual performance report. The time for
completing the PAI is understood to
mean the time from the inspection
scheduling request through notification
to the Center for Veterinary Medicine
(CVM) of inspectional findings.
The Agency and regulated industry
agree that the use of both formal
meetings (e.g., pre-submission
conferences, workshops) and informal
communication by both parties is
critical to ensure high submission
quality such that the above performance
goals can be achieved.
Consumer Price Index less food and
energy.
The workload adjustment will
continue to be calculated per CVM
Program Policy and Procedures Manual
1243.3022, except that, for purposes of
calculating the workload adjustment, it
is agreed to reset the base years to fiscal
year (FY) 2014 through FY 2018. There
will be no workload adjustment for FY
2019. Workload adjustments are onetime adjustments and are calculated
annually.
B. Inflation Adjuster and Workload
Adjuster
Dated: October 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
The Agency and regulated industry
agree to change the current fixed 4
percent inflation adjuster to a variable
inflation adjuster calculated using
payroll cost and benefits and the
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C. Offset Provision and Excess
Collections
The proposal adds financial flexibility
by eliminating the final year offset of the
over collections provision and making
any excess collections available to
enhance the review process in real time.
In addition, the proposal provides
authority for the Secretary of Health and
Human Services when setting fees to
reduce a calculated workload
adjustment up to the amount of excess
collections in the second preceding
fiscal year. The first fiscal year this
provision could be applied while setting
fees is fiscal year 2021.
D. Impact of AGDUFA III Changes on
User Fee Revenue
The FY 2019 baseline for AGDUFA III
is $18,336,340. For each year from FY
2020 through FY 2023, the annual
statutory revenue amounts established
in section 741(b) of the FD&C Act (21
U.S.C. 379j–21(b)) will be further
adjusted according to the new statutory
provision for the inflation adjuster and
may be further adjusted by the workload
adjuster, if applicable.
The planned total 5-year revenue for
AGDUFA I was $27,100,000. The
planned total 5-year revenue for
AGDUFA II was $38,100,000, which
also included one-time information
technology funding in the amount of
$850,000 for FY 2014. It is estimated
that the planned total 5-year revenue for
AGDUFA III will be $95,000,000.
The fee revenue distribution in
AGDUFA III will remain the same as
AGDUFA II: 25 percent in application
fees; 37.5 percent in product fees; and
37.5 percent in sponsor fees.
[FR Doc. 2017–23173 Filed 10–24–17; 8:45 am]
BILLING CODE 4164–01–P
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]]>Agencies
[Federal Register Volume 82, Number 205 (Wednesday, October 25, 2017)]
[Notices]
[Pages 49377-49379]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23173]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0655]
Animal Generic Drug User Fee Act; Recommendations; Request for
Comments; Extension of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability; request for comments; extension of
comment period.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the availability of the Animal Generic Drug User Fee Act
(AGDUFA) reauthorization draft recommendations and extending the
comment period to allow interested persons 30 days to submit comments
on these draft recommendations.
DATES: FDA is extending the comment period on the AGDUFA
reauthorization and draft recommendations. Submit either electronic or
written comments on the draft recommendations by November 24, 2017.
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 November 24, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of November 24, 2017. 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'').
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-2011-N-0655 for ``Animal Generic Drug User Fee Act;
Recommendations; Request for Comments; Extension of Comment Period''
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
[[Page 49378]]
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.gpo.gov/fdsys/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: Cassie Ravo, Center for Veterinary
Medicine (HFV-10), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-402-6866, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of the proposed recommendations
for the reauthorization of AGDUFA, which authorizes FDA to collect user
fees and use them for the process of reviewing generic new animal drug
applications and associated submissions. The authority for AGDUFA
expires September 30, 2018. Without new legislation, FDA will no longer
have the authority to collect user fees to fund the generic new animal
drug review process for future fiscal years. Section 742(d)(4) of the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 379j-
22(d)(4)) requires that, after holding negotiations with regulated
industry and periodic consultations with stakeholders, and before
transmitting the Agency's final recommendation to Congress for the
reauthorized program (AGDUFA III), we do the following: (1) Present the
recommendations to the relevant Congressional committees, (2) publish
such recommendations in the Federal Register, (3) provide for a period
of 30 days for the public to provide written comments on such
recommendations, (4) hold a meeting at which the public may present its
views on such recommendations, and (5) consider such public views and
comments and revise such recommendations as necessary. In the Federal
Register of October 5, 2017 (82 FR 46506), we announced a public
meeting to be held on November 2, 2017. In that notice we stated that
we intended to publish in the Federal Register the full text of the
proposed AGDUFA III Performance Goals and Procedures Letter and a
summary of proposed statutory changes, as well as post them at https://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/ucm270232.htm, before the public meeting and would provide for a period
of 30 days for the public to provide written comments. This notice
announces the availability of these draft recommendations and extends
the comment period to November 24, 2017 to provide for a period of 30
days for the public to comment on these draft recommendations. After
the public meeting and closing of the comment period, we will revise
the draft recommendations as necessary. In addition, the Agency will
present the draft recommendations to the Congressional committees.
II. Proposed AGDUFA III Recommendations
A. Enhancing the Process for Premarket Review
We are proposing the following changes to the performance
commitments previously established to further enhance the process for
review of generic new animal drug applications.
Beginning October 1, 2018, all applications and submissions under
section 512(b) of the FD&C Act (21 U.S.C. 360b(b)) must be submitted to
the Agency electronically using the eSubmitter tool.
The Agency will review and act on 90 percent of original
abbreviated new animal drug applications (ANADAs) within 240 days (180-
day review plus 60-day administrative review) after the submission
date. An application is incomplete if it would require additional data
or information to enable the Agency to complete a comprehensive review
of the application and reach a decision on the issue(s) presented in
the application. If the Agency determines that the deficiencies are not
substantial, the Agency will review and act on 90 percent of
reactivated applications within 120 days (60-day review plus 60-day
administrative review) after the reactivated ANADA submission date.
This shorter review time for reactivated ANADAs for which the
deficiencies are determined not to be substantial is not intended to
prevent the use of minor amendments during Agency review of an
application. If the Agency determines that the deficiencies are
substantial or new substantial information is provided, the Agency will
review and act on 90 percent of reactivated applications within 240
days (180-day review plus 60-day administrative review) after the
reactivated ANADA submission date.
The Agency will review and act on 90 percent of administrative
ANADAs (ANADAs submitted after all scientific decisions have been made
in the generic investigational new animal drug (JINAD) process, i.e.,
prior to the submission of the ANADA) within 60 days after the
submission date. Paragraph IV certification applications (section
512(n)(1)(H)(iv) of the FD&C Act) submitted as administrative ANADAs
will be excluded from the administrative ANADA cohort.
The Agency will review and act on 90 percent of Prior Approval
manufacturing supplemental ANADAs within 180 days after the submission
date. A Prior Approval manufacturing supplemental ANADA includes: One
or more major manufacturing changes according to Sec. 514.8(b)(2)(ii)
(21 CFR 514.8(b)(2)(ii)) and in accordance with Guidance for Industry
#83, ``Chemistry, Manufacturing, and Controls Changes to an Approved
NADA or ANADA''; and changes submitted as ``Supplement-Changes Being
Effected in 30 Days'' that require prior approval according to Sec.
514.8(b)(3)(v)(A). If a Prior Approval supplement does not clearly
identify any major manufacturing changes, the Prior Approval supplement
will be designated by the Agency as a ``Supplement--Changes Being
Effected'' with a 270-day review goal (see ``Supplement--Changes Being
Effected Manufacturing Supplemental ANADAs and Reactivations'' below).
A submission is incomplete if it requires additional data or
information to enable the Agency to complete a comprehensive review of
the submission and reach a decision on the issue(s) presented in the
submission. If the Agency determines that the deficiencies are not
substantial for manufacturing supplements requiring prior approval, the
Agency will allow the manufacturing supplements to be resubmitted as
``Supplement-Changes Being Effected in 30 Days'' as described
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in Sec. 514.8(b)(3) and the drug made with the change can be
distributed 30 days after the resubmission according to Sec.
514.8(b)(3)(iv). The Agency will review and act on 90 percent of these
reactivated manufacturing supplements within 270 days after the
resubmission date of a complete submission. If the Agency determines
that the deficiencies remain substantial or new substantial information
is provided, prior approval is required according to Sec.
514.8(b)(3)(v)(A). The Agency will review and act on 90 percent of
these reactivated manufacturing supplements within 180 days after the
resubmission date of a complete submission.
The Agency will review and act on 90 percent of ``Supplement-
Changes Being Effected'' manufacturing supplemental ANADAs and
reactivations submitted according to Sec. 514.8(b)(3)(vi) and in
accordance with Guidance for Industry #83, ``Chemistry, Manufacturing,
and Controls Changes to an Approved NADA or ANADA,'' including
manufacturing changes not requiring prior approval according to Sec.
514.8(b)(3)(iv), within 270 days after the submission date.
The Agency will review and act on 90 percent of JINAD study
submissions within 180 days after the submission date.
A submission is incomplete if it would require additional data or
information to enable the Agency to complete a comprehensive review of
the study submission and reach a decision on the issue(s) presented in
the submission. If the Agency determines that the deficiencies are not
substantial, the Agency will review and act on 90 percent of
resubmitted JINAD study submissions within 60 days after the receipt
date of a complete study submission. This shorter review time for
resubmitted JINAD study submissions is not intended to prevent the use
of minor amendments during Agency review of a study submission. If the
Agency determines that the deficiencies are substantial or new
substantial information is provided, the Agency will review and act on
90 percent of resubmitted JINAD study submissions within 180 days after
the receipt date of a complete study submission.
The Agency will review and act on 90 percent of JINAD submissions
consisting of protocols without substantial data, that the Agency and
the sponsor consider to be an essential part of the basis for making
the decision to approve or not approve an ANADA or supplemental ANADA,
within 75 days after the submission date.
The Agency will allow comparability protocols as described in Sec.
514.8(b)(2)(v) to be submitted as protocols without substantial data in
a JINAD file. The Agency will review and act on 90 percent of JINAD
submissions consisting of protocols without substantial data within 75
days after the submission date of the protocol. For potentially more
complex comparability protocols, for example sterile process validation
protocols, the sponsor should discuss and have Agency concurrence
regarding the appropriate filing strategy.
The Agency will continue to allow two-phased Chemistry,
Manufacturing, and Controls technical section submissions under the
JINAD process.
The Agency and regulated industry are committed to improving the
review and business processes that will facilitate the timely
scheduling and conducting of pre-approval inspections (PAIs). To
improve the timeliness and predictability of foreign PAIs, sponsors may
voluntarily submit: (1) At the beginning of the calendar year, a list
of foreign manufacturing facilities that are specified in an
abbreviated application, supplemental abbreviated application, or
generic investigational file and may be subject to foreign PAIs for the
following fiscal year; and (2) a notification 30 days prior to
submitting an abbreviated application, a supplemental abbreviated
application, or generic investigational file that informs the Agency
that the application includes a foreign manufacturing facility. Should
any changes to the annual list occur after its submission to the
Agency, the sponsor may provide the updated information to the Agency.
The Agency will keep a record of the number of foreign PAIs
conducted for abbreviated applications, along with the average time for
completing the PAIs, and include this information in its annual
performance report. The time for completing the PAI is understood to
mean the time from the inspection scheduling request through
notification to the Center for Veterinary Medicine (CVM) of
inspectional findings.
The Agency and regulated industry agree that the use of both formal
meetings (e.g., pre-submission conferences, workshops) and informal
communication by both parties is critical to ensure high submission
quality such that the above performance goals can be achieved.
B. Inflation Adjuster and Workload Adjuster
The Agency and regulated industry agree to change the current fixed
4 percent inflation adjuster to a variable inflation adjuster
calculated using payroll cost and benefits and the Consumer Price Index
less food and energy.
The workload adjustment will continue to be calculated per CVM
Program Policy and Procedures Manual 1243.3022, except that, for
purposes of calculating the workload adjustment, it is agreed to reset
the base years to fiscal year (FY) 2014 through FY 2018. There will be
no workload adjustment for FY 2019. Workload adjustments are one-time
adjustments and are calculated annually.
C. Offset Provision and Excess Collections
The proposal adds financial flexibility by eliminating the final
year offset of the over collections provision and making any excess
collections available to enhance the review process in real time. In
addition, the proposal provides authority for the Secretary of Health
and Human Services when setting fees to reduce a calculated workload
adjustment up to the amount of excess collections in the second
preceding fiscal year. The first fiscal year this provision could be
applied while setting fees is fiscal year 2021.
D. Impact of AGDUFA III Changes on User Fee Revenue
The FY 2019 baseline for AGDUFA III is $18,336,340. For each year
from FY 2020 through FY 2023, the annual statutory revenue amounts
established in section 741(b) of the FD&C Act (21 U.S.C. 379j-21(b))
will be further adjusted according to the new statutory provision for
the inflation adjuster and may be further adjusted by the workload
adjuster, if applicable.
The planned total 5-year revenue for AGDUFA I was $27,100,000. The
planned total 5-year revenue for AGDUFA II was $38,100,000, which also
included one-time information technology funding in the amount of
$850,000 for FY 2014. It is estimated that the planned total 5-year
revenue for AGDUFA III will be $95,000,000.
The fee revenue distribution in AGDUFA III will remain the same as
AGDUFA II: 25 percent in application fees; 37.5 percent in product
fees; and 37.5 percent in sponsor fees.
Dated: October 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-23173 Filed 10-24-17; 8:45 am]
BILLING CODE 4164-01-P
