Abbreviated New Drug Applications Submissions-Amendments To Abbreviated New Drug Applications Under the Generic Drug User Fee Act; Draft Guidance for Industry; Availability, 46066-46068 [2017-21175]
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46066
Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices
asabaliauskas on DSKBBXCHB2PROD with NOTICES
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/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: Sam
Raney, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 75, Rm. 4706, Silver Spring,
MD 20993, 240–402–7967, email:
Sameersingh.Raney@fda.hhs.gov; or
Markham Luke, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4712,
Silver Spring, MD 20993, 301–796–
5556, email: Markham.Luke@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The conventional approach to
establish bioequivalence (BE) for most
topical dermatological generic drug
products relies upon clinical endpoint
BE studies. The risk of failing to
demonstrate BE due to the relative
insensitivity of these clinical endpoint
studies, combined with their burden
and length, may represent a barrier to
generic drug development and may
adversely impact patient access to some
topical dermatological generic drug
products. FDA is evaluating alternative
BE approaches for topical
dermatological generic drug products,
using methods that are more efficient,
and also more sensitive and
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reproducible. FDA believes that these
BE approaches would benefit from
public discussion.
II. Topics for Discussion at the Public
Workshop
This public workshop will focus on a
discussion of current regulatory science
initiatives intended to foster the
development of topical dermatological
generic drug products, examining
alternative BE approaches that may be
more efficient and less risky than
traditional approaches. FDA is also
interested in receiving public input
about any barriers that may limit the use
of such alternative BE approaches in the
development of topical dermatological
generic drug products. Public input is
also sought about strategies to overcome
these barriers.
III. Participating in the Public
Workshop
Registration: Persons interested in
attending this public workshop must
register online at https://
survey.co1.qualtrics.com/jfe/form/SV_
9YQDLZJRjXtYiXz. Please provide
complete contact information for each
attendee, including name, title,
affiliation, address, email, and
telephone.
Registration is free and based on
space availability, with priority given to
early registrants. Persons interested in
attending this public workshop must
register by October 13, 2017, midnight,
Eastern Time. Early registration is
recommended because seating is
limited; therefore, FDA may limit the
number of participants from each
organization.
If you need special accommodations
due to a disability, please contact Sam
Raney (see FOR FURTHER INFORMATION
CONTACT) no later than October 13, 2017.
Requests for Oral Presentations:
During online registration you may
indicate if you wish to present during a
public comment session, and which
topic(s) you wish to address. We will do
our best to accommodate requests to
make public comments. Individuals and
organizations with common interests are
urged to consolidate or coordinate their
presentations, and to request time for a
joint presentation, or to submit requests
for designated representatives to
participate in the focused sessions.
Following the close of registration, we
will determine the amount of time
allotted to each presenter and the
approximate time each oral presentation
is to begin, and will select and notify
participants by October 16, 2017. All
requests to make oral presentations
must be received by the close of
registration on October 9, 2017. If
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selected for presentation, any
presentation materials must be emailed
to GDUFARegulatoryScience@
fda.hhs.gov no later than October 13,
2017. No commercial or promotional
material will be permitted to be
presented or distributed at the public
workshop.
Streaming webcast of the public
workshop: This public workshop will
also be webcast. A live webcast of this
workshop will be viewable at https://
collaboration.fda.gov/ogddermaldrug/
on the day of the workshop.
If you have never attended a Connect
Pro event before, test your connection at
https://collaboration.fda.gov/common/
help/en/support/meeting_test.htm. To
get a quick overview of the Connect Pro
program, visit https://www.adobe.com/
go/connectpro_overview. FDA has
verified the Web site addresses in this
document, as of the date this document
publishes in the Federal Register, but
Web sites are subject to change over
time.
Transcripts: Please be advised that as
soon as a transcript of the public
workshop is available, it will be
accessible at https://
www.regulations.gov. It may be viewed
at the Dockets Management Staff (see
ADDRESSES). A link to the transcript will
also be available on the internet at
https://www.fda.gov/Drugs/NewsEvents/
ucm557252.htm.
Dated: September 28, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–21186 Filed 10–2–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–5670]
Abbreviated New Drug Applications
Submissions—Amendments To
Abbreviated New Drug Applications
Under the Generic Drug User Fee Act;
Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘ANDA
Submissions—Amendments to
Abbreviated New Drug Applications
Under GDUFA.’’ This draft guidance is
intended to explain to applicants how
SUMMARY:
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the review goals established as part of
the Generic Drug User Fee Amendments
Reauthorization of 2017 (GDUFA II)
apply to amendments to abbreviated
new drug applications (ANDAs) and
prior approval supplements (PASs) to
FDA under the Federal Food, Drug, and
Cosmetic Act (FD&C Act). This draft
guidance describes amendment
classifications and categories and
explains how amendment submissions
may affect an application’s review goal
dates. The draft guidance also describes
how FDA will review amendments
submitted to ANDAs and PASs received
prior to October 1, 2017, the effective
date to implement the GDUFA II review
goals.
DATES: Submit either electronic or
written comments on the draft guidance
by December 4, 2017 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
asabaliauskas on DSKBBXCHB2PROD with NOTICES
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
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Jkt 244001
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–
2017–D–5670 for ‘‘ANDA
Submissions—Amendments to
Abbreviated New Drug Applications
Under GDUFA.’’ Received comments
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: 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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)). Submit written requests
for single copies of the draft guidance to
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46067
the Division of Drug Information, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Giaquinto Friedman, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1670,
Silver Spring, MD 20993–0002, 240–
402–7930, elizabeth.giaquinto@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘ANDA Submissions—Amendments to
Abbreviated New Drug Applications
Under GDUFA.’’ This guidance is
intended to assist applicants preparing
to submit amendments to ANDAs or
PASs to FDA under section 505(j) of the
FD&C Act (21 U.S.C. 355(j)) by
explaining how the review goals
established as part of GDUFA II apply
to these submissions. In accordance
with the ‘‘GDUFA Reauthorization
Performance Goals and Program
Enhancements Fiscal Years 2018–2022’’
(GDUFA II Commitment Letter,
available at: https://www.fda.gov/
downloads/ForIndustry/UserFees/
GenericDrugUserFees/UCM525234.pdf),
FDA agreed to certain review goals and
procedures for the review of
amendments pending as of or received
on or after the GDUFA II effective date.
The GDUFA II Commitment Letter
reflects significant changes in the
classification of and review goals for
amendments to ANDAs and PASs under
the Generic Drug User Fee Amendments
of 2012 (GDUFA I). Under GDUFA I,
amendments were classified into a
complex tier system based on the
following factors:
• Whether the amendment was
solicited (submitted in response to a
complete response letter) or unsolicited
(submitted on the applicant’s own
initiative).
• Whether the amendment was major
or minor.
• The number of amendments
submitted to the ANDA or PAS.
• Whether an inspection was
necessary to support the information
contained in the amendment.
GDUFA II simplified the amendment
review goals and no longer subjects
them to a tier system; however, review
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Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices
goals are still dependent on several
factors. In general, under GDUFA II,
amendments will be designated as
either standard or priority, will be
classified as major or minor, and will
receive a goal date based on the factors
discussed in the draft guidance,
including whether a preapproval
inspection is needed. When finalized,
this draft guidance will replace the
December 2001 guidance for industry
‘‘Major, Minor, and Telephone
Amendments to Abbreviated New Drug
Applications.’’ This draft guidance
supersedes the July 2014 draft guidance
for industry ‘‘ANDA Submissions—
Amendments and Easily Correctable
Deficiencies Under GDUFA.’’
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘ANDA Submissions—Amendments
to Abbreviated New Drug Applications
Under GDUFA.’’ It does not establish
any rights for any person and is not
binding on FDA or the public. You can
use an alternative approach if it satisfies
the requirements of the applicable
statutes and regulations. This guidance
is not subject to Executive Order 12866.
II. Paperwork Reduction Act of 1995
This draft 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 314.96 have
been approved under OMB control
number 0910–0001.
III. Electronic Access
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: September 27, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–21175 Filed 10–2–17; 8:45 am]
BILLING CODE 4164–01–P
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Jkt 244001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–5891]
Endocrinologic and Metabolic Drugs
Advisory Committee; Notice of
Meeting; Establishment of a Public
Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA or Agency)
announces a forthcoming public
advisory committee meeting of the
Endocrinologic and Metabolic Drugs
Advisory Committee. The general
function of the committee is to provide
advice and recommendations to the
Agency on FDA’s regulatory issues. The
meeting will be open to the public. FDA
is establishing a docket for public
comment on this document.
DATES: The public meeting will be held
on October 18, 2017, from 8 a.m. to 5
p.m.
ADDRESSES: Tommy Douglas Conference
Center, the Ballroom, 10000 New
Hampshire Ave., Silver Spring, MD
20903. The conference center’s
telephone number is 240–645–4000.
Answers to commonly asked questions
about FDA Advisory Committee
meetings may be accessed at https://
www.fda.gov/AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm. Information about the
Tommy Douglas Conference Center can
be accessed at: https://
www.tommydouglascenter.com/.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2017–N–5891.
The docket will close on October 17,
2017. Submit either electronic or
written comments on this public
meeting by October 17, 2017. Late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before October 17,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of October 17, 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.
Comments received on or before
October 11, 2017, will be provided to
the committee. Comments received after
SUMMARY:
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that date will be taken into
consideration by the Agency. You may
submit comments as follows:
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–
2017–N–5891for ‘‘Endocrinologic and
Metabolic Drugs Advisory Committee;
Notice of Meeting; Establishment of a
Public Docket; Request for Comments.’’
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
E:\FR\FM\03OCN1.SGM
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]]>Agencies
[Federal Register Volume 82, Number 190 (Tuesday, October 3, 2017)]
[Notices]
[Pages 46066-46068]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21175]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-D-5670]
Abbreviated New Drug Applications Submissions--Amendments To
Abbreviated New Drug Applications Under the Generic Drug User Fee Act;
Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``ANDA
Submissions--Amendments to Abbreviated New Drug Applications Under
GDUFA.'' This draft guidance is intended to explain to applicants how
[[Page 46067]]
the review goals established as part of the Generic Drug User Fee
Amendments Reauthorization of 2017 (GDUFA II) apply to amendments to
abbreviated new drug applications (ANDAs) and prior approval
supplements (PASs) to FDA under the Federal Food, Drug, and Cosmetic
Act (FD&C Act). This draft guidance describes amendment classifications
and categories and explains how amendment submissions may affect an
application's review goal dates. The draft guidance also describes how
FDA will review amendments submitted to ANDAs and PASs received prior
to October 1, 2017, the effective date to implement the GDUFA II review
goals.
DATES: Submit either electronic or written comments on the draft
guidance by December 4, 2017 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
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-2017-D-5670 for ``ANDA Submissions--Amendments to Abbreviated New
Drug Applications Under GDUFA.'' Received comments 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: 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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)). Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD
20993-0002. Send one self-addressed adhesive label to assist that
office in processing your requests. See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Elizabeth Giaquinto Friedman, Center
for Drug Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 75, Rm. 1670, Silver Spring, MD 20993-0002,
240-402-7930, elizabeth.giaquinto@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``ANDA Submissions--Amendments to Abbreviated New Drug
Applications Under GDUFA.'' This guidance is intended to assist
applicants preparing to submit amendments to ANDAs or PASs to FDA under
section 505(j) of the FD&C Act (21 U.S.C. 355(j)) by explaining how the
review goals established as part of GDUFA II apply to these
submissions. In accordance with the ``GDUFA Reauthorization Performance
Goals and Program Enhancements Fiscal Years 2018-2022'' (GDUFA II
Commitment Letter, available at: https://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM525234.pdf), FDA agreed to
certain review goals and procedures for the review of amendments
pending as of or received on or after the GDUFA II effective date.
The GDUFA II Commitment Letter reflects significant changes in the
classification of and review goals for amendments to ANDAs and PASs
under the Generic Drug User Fee Amendments of 2012 (GDUFA I). Under
GDUFA I, amendments were classified into a complex tier system based on
the following factors:
Whether the amendment was solicited (submitted in response
to a complete response letter) or unsolicited (submitted on the
applicant's own initiative).
Whether the amendment was major or minor.
The number of amendments submitted to the ANDA or PAS.
Whether an inspection was necessary to support the
information contained in the amendment.
GDUFA II simplified the amendment review goals and no longer
subjects them to a tier system; however, review
[[Page 46068]]
goals are still dependent on several factors. In general, under GDUFA
II, amendments will be designated as either standard or priority, will
be classified as major or minor, and will receive a goal date based on
the factors discussed in the draft guidance, including whether a
preapproval inspection is needed. When finalized, this draft guidance
will replace the December 2001 guidance for industry ``Major, Minor,
and Telephone Amendments to Abbreviated New Drug Applications.'' This
draft guidance supersedes the July 2014 draft guidance for industry
``ANDA Submissions--Amendments and Easily Correctable Deficiencies
Under GDUFA.''
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``ANDA
Submissions--Amendments to Abbreviated New Drug Applications Under
GDUFA.'' It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.
This guidance is not subject to Executive Order 12866.
II. Paperwork Reduction Act of 1995
This draft 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 314.96 have been approved under
OMB control number 0910-0001.
III. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.
Dated: September 27, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-21175 Filed 10-2-17; 8:45 am]
BILLING CODE 4164-01-P
