Animal Drug User Fee Act; Recommendations; Request for Comments; Extension of Comment Period, 49380-49382 [2017-23172]
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49380
Federal Register / Vol. 82, No. 205 / Wednesday, October 25, 2017 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–P–0840]
Determination That OVRETTE
(Norgestrel) Tablet, 0.075 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Was Not Withdrawn From Sale for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 OVRETTE (norgestrel)
tablet, 0.075 milligrams (mg), was not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for norgestrel
tablet, 0.075 mg, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
Daniel Gottlieb, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6217,
Silver Spring, MD 20993–0002, 301–
796–6650.
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was withdrawn from sale for reasons of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).
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SUMMARY:
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A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
FDA’s approval of an ANDA that refers
to the listed drug (§ 314.161 (21 CFR
314.161)). FDA may not approve an
ANDA that does not refer to a listed
drug.
OVRETTE (norgestrel) tablet, 0.075
mg, is the subject of NDA 017031, held
by HRA Pharma and initially approved
on October 23, 1973. OVRETTE is
indicated for the prevention of
pregnancy in women.
OVRETTE (norgestrel) tablet, 0.075
mg, was discontinued from U.S.
distribution on June 7, 2005, and is
currently listed in the ‘‘Discontinued
Drug Product List’’ section of the Orange
Book.
The Weinberg Group submitted a
citizen petition dated February 8, 2017
(Docket No. FDA–2017–P–0840), under
21 CFR 10.30, requesting that the
Agency determine whether OVRETTE
(norgestrel) tablet, 0.075 mg, was
withdrawn from sale for reasons of
safety or effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that OVRETTE (norgestrel)
tablet, 0.075 mg, was not withdrawn
from sale for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that OVRETTE (norgestrel)
tablet, 0.075 mg, was withdrawn for
reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
OVRETTE (norgestrel) tablet, 0.075 mg,
from sale. We have also independently
evaluated relevant literature and data
for possible postmarketing adverse
events. We have found no information
that would indicate that this drug
product was withdrawn from sale for
reasons of safety or effectiveness.
Accordingly, the Agency will
continue to list OVRETTE (norgestrel)
tablet, 0.075 mg, in the ‘‘Discontinued
Drug Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ delineates, among other items,
drug products that have been
discontinued from marketing for reasons
other than safety or effectiveness.
ANDAs that refer to this drug product
may be approved by the Agency as long
as they meet all other legal and
regulatory requirements for the approval
of ANDAs. If FDA determines that
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labeling for this drug product should be
revised to meet current standards, the
Agency will advise ANDA applicants to
submit such labeling.
Dated: October 17, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–23125 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–0656]
Animal 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:
The Food and Drug
Administration (FDA or the Agency) is
announcing the availability of the
Animal Drug User Fee Act (ADUFA)
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 ADUFA 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 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.
SUMMARY:
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
E:\FR\FM\25OCN1.SGM
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Federal Register / Vol. 82, No. 205 / Wednesday, October 25, 2017 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
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–0656 for ‘‘Animal 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
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
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22:06 Oct 24, 2017
Jkt 244001
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:
I. Background
FDA is announcing the availability of
the proposed recommendations for the
reauthorization of ADUFA, which
authorizes FDA to collect user fees and
use them for the process of reviewing
new animal drug applications and
associated submissions. The authority
for ADUFA expires September 30, 2018.
Without new legislation, FDA will no
longer have the authority to collect user
fees to fund the new animal drug review
process for future fiscal years. Section
740A(d)(4) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 379j–13(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 (ADUFA IV), we
do the following: (1) Present the
recommendation 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
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49381
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 46503), 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
ADUFA IV Performance Goals and
Procedures Letter and a summary of
proposed statutory changes, as well as
post them at https://www.fda.gov/
ForIndustry/UserFees/AnimalDrugUser
FeeActADUFA/ucm042891.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 ADUFA IV
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 new animal drug applications
(NADAs).
Beginning October 1, 2018, all
applications and submissions under
section 512(b) and 571 of the FD&C Act
(21 U.S.C. 360b(b) and 21 U.S.C. 360ccc,
respectively) must be submitted to the
Agency electronically using the
eSubmitter tool.
The Agency will review and act on 90
percent of ‘‘Supplement-Changes Being
Effected’’ manufacturing supplemental
NADAs and reactivations submitted
according to § 514.8(b)(3)(vi) (21 CFR
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 180 days after
the submission date. All other
application and submission
performance goals will remain the same
as ADUFA III.
The Agency commits to working on
implementation of the United StatesEuropean Union Good Manufacturing
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49382
Federal Register / Vol. 82, No. 205 / Wednesday, October 25, 2017 / Notices
Practice Inspection Mutual Recognition
Agreement. All other commitments
related to pre-approval inspections will
remain the same as ADUFA III.
The Agency will review and act on 90
percent of qualifying Animal Drug
Availability Act (ADAA) combination
medicated feed applications within 60
days after the submission date when all
of the following conditions are met:
• Basic regulatory requirements for an
ADAA combination medicated feed
application has been met as outlined in
21 CFR 514.4(c)(2)(ii).
• A presubmission conference has
been conducted and either:
Æ No data (no tissue residue noninterference study is required) are
needed and this agreement is
documented in the memorandum of
conference for the presubmission
conference; or
Æ A justification for not conducting a
tissue residue non-interference study
has been submitted, reviewed, and
found acceptable under an
investigational new animal drug (INAD),
prior to the submission of the ADAA
combination medicated feed
application; or
Æ A tissue residue non-interference
study has been submitted, reviewed,
and found acceptable under an INAD,
prior to the submission of the ADAA
combination medicated feed
application.
• No effectiveness or target animal
safety data are required.
• No manufacturing data
requirements—sponsor can address in
meeting assay non-interference, but data
submission is not required.
• All other information is referenced
to previous drug experience reports.
• Sponsor makes submission and it
includes: Representative (Blue Bird)
labeling, Veterinary Feed Directive (if
applicable).
• Includes a request for categorical
exclusion from the need to prepare an
environmental assessment (EA); i.e., no
EA required.
• Reference to presubmission
conference.
• Right of reference (if applicable) to
NADA(s) not owned by the filing
sponsor of the ADAA combination
medicated feed application has been
received by the Agency.
The Agency will review and act on 90
percent of ADAA combination
medicated feed applications within 100
days for those applications accepted for
the 60-day timeframe and there is a
need for minor amendments.
If any of the above conditions cannot
be met, the ADAA combination
medicated feed application performance
metric will be placed in the original
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NADA application cohort with a 180day review timeframe.
The Agency will review and act on 90
percent of resubmissions of previously
completed Environmental Impact
technical sections within 60 days after
the submission date where:
• A categorical exclusion was issued;
• All other technical sections have
been submitted; and
• Information contained in the other
technical sections reveals a change in
the conditions of use of the previously
issued categorical exclusion.
The Agency will conduct 90 percent
of qualifying presubmission conferences
within a 60-day timeframe when all of
the following conditions are met:
• All background materials, including
presentations, have been submitted, and
• A complete agenda has been agreed
upon by the Agency and the sponsor.
A sponsor and the Agency can
mutually agree to exclude a particular
presubmission conference from this
performance goal. If a sponsor accepts a
date beyond the 60-day timeframe for
their scheduling purposes or is unable
to meet with the Agency on Agency
available dates, the submission will be
excluded from the presubmission
conference cohort.
The Agency will commence 90
percent of tissue residue method
demonstrations within 120 days of
completion of the 3-hour meeting
process or within 200 days from the
receipt of a submission that supports a
single laboratory validation tissue
residue method demonstration.
B. Inflation Adjuster and Workload
Adjuster
The inflation adjuster will remain the
same as for ADUFA III.
The workload adjustment will
continue to be calculated per Center for
Veterinary Medicine Program Policy
and Procedures Manual 1243.3022,
except that, for purposes of calculating
the workload adjustment, it has been
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.
C. Offset Provision and Excess
Collections
The proposal adds financial flexibility
by eliminating the final year offset of
over collections provision and making
any excess collections available to
enhance the review process in real time.
The proposal provides authority for the
Secretary of Health and Human Services
(the Secretary) when setting fees to
reduce a calculated workload
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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 FY 2021. Likewise, the proposal
also provides authority to the Secretary
to reduce an increase in fees to recover
a shortfall in collections in a preceding
year (after 2018) by any remaining prior
year excess collections not already
applied for purposes of reducing fee
increases.
D. Impact of ADUFA IV Enhancements
on User Fee Revenue
The FY 2019 baseline for ADUFA IV
is $30,331,240, which includes a
$400,000 one-time cost for information
technology enhancement. 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 by the inflation
adjuster, the workload adjuster, if
applicable, and will include $900,000
per year for tissue method trials.
The total 5-year revenue planned for
ADUFA I was $47,000,000. The total 5year revenue planned for ADUFA II was
$98,000,000. The total 5-year revenue
planned for ADUFA III was
$114,000,000. It is estimated that the
total 5-year revenue for ADUFA IV will
be $150,000,000.
The fee revenue distribution in
ADUFA IV will remain the same as
ADUFA III: 20 percent from application
fees; 27 percent from product fees; 26
percent from establishment fees; and 27
percent from sponsor fees.
Dated: October 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–23172 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–2016–D–2021]
Deciding When To Submit a 510(k) for
a Software Change to an Existing
Device; Guidance for Industry and
Food and Drug Administration Staff;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the
guidance entitled ‘‘Deciding When to
Submit a 510(k) for a Software Change
SUMMARY:
E:\FR\FM\25OCN1.SGM
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]]>Agencies
[Federal Register Volume 82, Number 205 (Wednesday, October 25, 2017)]
[Notices]
[Pages 49380-49382]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23172]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0656]
Animal 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 Drug User Fee Act (ADUFA)
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 ADUFA 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 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
[[Page 49381]]
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-0656 for ``Animal 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 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 ADUFA, which authorizes FDA to collect user
fees and use them for the process of reviewing new animal drug
applications and associated submissions. The authority for ADUFA
expires September 30, 2018. Without new legislation, FDA will no longer
have the authority to collect user fees to fund the new animal drug
review process for future fiscal years. Section 740A(d)(4) of the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 379j-
13(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 (ADUFA IV), we do the following: (1) Present the
recommendation 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 46503), 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 ADUFA IV Performance Goals and Procedures Letter and a summary
of proposed statutory changes, as well as post them at https://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/ucm042891.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 ADUFA IV 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 new animal drug applications (NADAs).
Beginning October 1, 2018, all applications and submissions under
section 512(b) and 571 of the FD&C Act (21 U.S.C. 360b(b) and 21 U.S.C.
360ccc, respectively) must be submitted to the Agency electronically
using the eSubmitter tool.
The Agency will review and act on 90 percent of ``Supplement-
Changes Being Effected'' manufacturing supplemental NADAs and
reactivations submitted according to Sec. 514.8(b)(3)(vi) (21 CFR
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 180 days after the
submission date. All other application and submission performance goals
will remain the same as ADUFA III.
The Agency commits to working on implementation of the United
States-European Union Good Manufacturing
[[Page 49382]]
Practice Inspection Mutual Recognition Agreement. All other commitments
related to pre-approval inspections will remain the same as ADUFA III.
The Agency will review and act on 90 percent of qualifying Animal
Drug Availability Act (ADAA) combination medicated feed applications
within 60 days after the submission date when all of the following
conditions are met:
Basic regulatory requirements for an ADAA combination
medicated feed application has been met as outlined in 21 CFR
514.4(c)(2)(ii).
A presubmission conference has been conducted and either:
[cir] No data (no tissue residue non-interference study is
required) are needed and this agreement is documented in the memorandum
of conference for the presubmission conference; or
[cir] A justification for not conducting a tissue residue non-
interference study has been submitted, reviewed, and found acceptable
under an investigational new animal drug (INAD), prior to the
submission of the ADAA combination medicated feed application; or
[cir] A tissue residue non-interference study has been submitted,
reviewed, and found acceptable under an INAD, prior to the submission
of the ADAA combination medicated feed application.
No effectiveness or target animal safety data are
required.
No manufacturing data requirements--sponsor can address in
meeting assay non-interference, but data submission is not required.
All other information is referenced to previous drug
experience reports.
Sponsor makes submission and it includes: Representative
(Blue Bird) labeling, Veterinary Feed Directive (if applicable).
Includes a request for categorical exclusion from the need
to prepare an environmental assessment (EA); i.e., no EA required.
Reference to presubmission conference.
Right of reference (if applicable) to NADA(s) not owned by
the filing sponsor of the ADAA combination medicated feed application
has been received by the Agency.
The Agency will review and act on 90 percent of ADAA combination
medicated feed applications within 100 days for those applications
accepted for the 60-day timeframe and there is a need for minor
amendments.
If any of the above conditions cannot be met, the ADAA combination
medicated feed application performance metric will be placed in the
original NADA application cohort with a 180-day review timeframe.
The Agency will review and act on 90 percent of resubmissions of
previously completed Environmental Impact technical sections within 60
days after the submission date where:
A categorical exclusion was issued;
All other technical sections have been submitted; and
Information contained in the other technical sections
reveals a change in the conditions of use of the previously issued
categorical exclusion.
The Agency will conduct 90 percent of qualifying presubmission
conferences within a 60-day timeframe when all of the following
conditions are met:
All background materials, including presentations, have
been submitted, and
A complete agenda has been agreed upon by the Agency and
the sponsor.
A sponsor and the Agency can mutually agree to exclude a particular
presubmission conference from this performance goal. If a sponsor
accepts a date beyond the 60-day timeframe for their scheduling
purposes or is unable to meet with the Agency on Agency available
dates, the submission will be excluded from the presubmission
conference cohort.
The Agency will commence 90 percent of tissue residue method
demonstrations within 120 days of completion of the 3-hour meeting
process or within 200 days from the receipt of a submission that
supports a single laboratory validation tissue residue method
demonstration.
B. Inflation Adjuster and Workload Adjuster
The inflation adjuster will remain the same as for ADUFA III.
The workload adjustment will continue to be calculated per Center
for Veterinary Medicine Program Policy and Procedures Manual 1243.3022,
except that, for purposes of calculating the workload adjustment, it
has been 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 over collections provision and making any excess
collections available to enhance the review process in real time. The
proposal provides authority for the Secretary of Health and Human
Services (the Secretary) 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 FY 2021. Likewise, the proposal
also provides authority to the Secretary to reduce an increase in fees
to recover a shortfall in collections in a preceding year (after 2018)
by any remaining prior year excess collections not already applied for
purposes of reducing fee increases.
D. Impact of ADUFA IV Enhancements on User Fee Revenue
The FY 2019 baseline for ADUFA IV is $30,331,240, which includes a
$400,000 one-time cost for information technology enhancement. 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 by the inflation adjuster, the workload
adjuster, if applicable, and will include $900,000 per year for tissue
method trials.
The total 5-year revenue planned for ADUFA I was $47,000,000. The
total 5-year revenue planned for ADUFA II was $98,000,000. The total 5-
year revenue planned for ADUFA III was $114,000,000. It is estimated
that the total 5-year revenue for ADUFA IV will be $150,000,000.
The fee revenue distribution in ADUFA IV will remain the same as
ADUFA III: 20 percent from application fees; 27 percent from product
fees; 26 percent from establishment fees; and 27 percent from sponsor
fees.
Dated: October 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-23172 Filed 10-24-17; 8:45 am]
BILLING CODE 4164-01-P
