Post-Complete Response Letter Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants Under Generic Drug User Fee Amendments; Guidance for Industry; Availability, 62589-62590 [2018-26285]
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Federal Register / Vol. 83, No. 233 / Tuesday, December 4, 2018 / Notices
Cumulatively, the total estimated
burden is 12,086 annual hours, which
reflects a significant decrease. We base
this adjustment on our experience with
the information collection since its
establishment and implementation.
Dated: November 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–26295 Filed 12–3–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–5928]
Post-Complete Response Letter
Meetings Between the Food and Drug
Administration and Abbreviated New
Drug Application Applicants Under
Generic Drug User Fee Amendments;
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 final
guidance for industry entitled ‘‘PostComplete Response Letter Meetings
Between FDA and ANDA Applicants
Under GDUFA.’’ This guidance is
intended to clarify the criteria for
granting post-complete response letter
(CRL) meeting requests and the scope of
discussions for granted meeting
requests. This guidance provides
procedures that will promote wellmanaged post-CRL meetings and help
ensure that such meetings are scheduled
and conducted in accordance with the
commitments made by FDA in
connection with the reauthorization of
the Generic Drug User Fee Amendments
for Fiscal Years 2018–2022 (GDUFA II).
DATES: The announcement of the
guidance is published in the Federal
Register on December 4, 2018.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
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
the docket unchanged. Because your
VerDate Sep<11>2014
17:36 Dec 03, 2018
Jkt 247001
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–5928 for ‘‘Post-Complete
Response Letter Meetings Between FDA
and ANDA Applicants 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
PO 00000
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Fmt 4703
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62589
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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of this 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 guidance document.
FOR FURTHER INFORMATION CONTACT: Lisa
Bercu, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
240–402–6902.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled ‘‘PostComplete Response Letter Meetings
Between FDA and ANDA Applicants
Under GDUFA.’’ GDUFA was
reauthorized (GDUFA II) on August 18,
2017, in order to facilitate timely access
to high quality, affordable generic
medicines. In accordance with the
GDUFA Reauthorization Performance
Goals and Program Enhancements Fiscal
Years 2018–2022 (GDUFA II Goals or
Commitment Letter) that accompanied
the legislation, FDA committed to
schedule and conduct 90 percent of
post-CRL meetings within prescribed
time frames.
E:\FR\FM\04DEN1.SGM
04DEN1
62590
Federal Register / Vol. 83, No. 233 / Tuesday, December 4, 2018 / Notices
As described in the GDUFA II
Commitment Letter, post-CRL meetings
will be used by applicants ‘‘to seek
clarification concerning deficiencies
identified in a CRL.’’ Under GDUFA II,
post-CRL meetings are available for both
major and minor CRLs and for first and
subsequent review cycles. FDA will
grant any complete post-CRL meeting
request that satisfies the criteria
outlined in section IV of this guidance.
FDA will only grant post-CRL meeting
requests that pose questions to clarify
identified deficiencies. Other issues,
including questions requiring further
Agency review, disputes about
classification of complete response
amendments, or new information
submitted by the applicant, will not be
addressed in a post-CRL meeting.
This guidance finalizes the draft
guidance announced in the Federal
Register on October 16, 2017 (82 FR
48093). The Agency considered
comments on the draft guidance while
finalizing the guidance. Generally, we
revised the draft guidance to provide
clarifying information on the process for
submitting post-CRL meeting requests
and the criteria for granting post-CRL
meeting requests. Changes from the
draft guidance include information on
the process for an abbreviated new drug
application (ANDA) applicant to change
the list of meeting participants and
clarification on when a post-CRL
meeting request may be denied.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Post-Complete
Response Letter Meetings Between FDA
and ANDA Applicants 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 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 314 have been approved
under OMB control number 0910–0001.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
VerDate Sep<11>2014
17:36 Dec 03, 2018
Jkt 247001
Guidances/default.htm or https://
www.regulations.gov.
Dated: November 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–26285 Filed 12–3–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–E–4282]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; TRULANCE
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for TRULANCE and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of an application to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human drug
product.
SUMMARY:
Anyone with knowledge that any
of the dates as published (see the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by February 4, 2019.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
June 3, 2019. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
DATES:
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 February 4,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of February 4, 2019.
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.
ADDRESSES:
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
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–E–4282 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; TRULANCE.’’
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
E:\FR\FM\04DEN1.SGM
04DEN1
]]>Agencies
[Federal Register Volume 83, Number 233 (Tuesday, December 4, 2018)]
[Notices]
[Pages 62589-62590]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26285]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-D-5928]
Post-Complete Response Letter Meetings Between the Food and Drug
Administration and Abbreviated New Drug Application Applicants Under
Generic Drug User Fee Amendments; 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 final guidance for industry entitled ``Post-
Complete Response Letter Meetings Between FDA and ANDA Applicants Under
GDUFA.'' This guidance is intended to clarify the criteria for granting
post-complete response letter (CRL) meeting requests and the scope of
discussions for granted meeting requests. This guidance provides
procedures that will promote well-managed post-CRL meetings and help
ensure that such meetings are scheduled and conducted in accordance
with the commitments made by FDA in connection with the reauthorization
of the Generic Drug User Fee Amendments for Fiscal Years 2018-2022
(GDUFA II).
DATES: The announcement of the guidance is published in the Federal
Register on December 4, 2018.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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-5928 for ``Post-Complete Response Letter Meetings Between
FDA and ANDA Applicants 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: 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 this 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 guidance document.
FOR FURTHER INFORMATION CONTACT: Lisa Bercu, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20993-0002, 240-402-6902.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Post-Complete Response Letter Meetings Between FDA and ANDA
Applicants Under GDUFA.'' GDUFA was reauthorized (GDUFA II) on August
18, 2017, in order to facilitate timely access to high quality,
affordable generic medicines. In accordance with the GDUFA
Reauthorization Performance Goals and Program Enhancements Fiscal Years
2018-2022 (GDUFA II Goals or Commitment Letter) that accompanied the
legislation, FDA committed to schedule and conduct 90 percent of post-
CRL meetings within prescribed time frames.
[[Page 62590]]
As described in the GDUFA II Commitment Letter, post-CRL meetings
will be used by applicants ``to seek clarification concerning
deficiencies identified in a CRL.'' Under GDUFA II, post-CRL meetings
are available for both major and minor CRLs and for first and
subsequent review cycles. FDA will grant any complete post-CRL meeting
request that satisfies the criteria outlined in section IV of this
guidance. FDA will only grant post-CRL meeting requests that pose
questions to clarify identified deficiencies. Other issues, including
questions requiring further Agency review, disputes about
classification of complete response amendments, or new information
submitted by the applicant, will not be addressed in a post-CRL
meeting.
This guidance finalizes the draft guidance announced in the Federal
Register on October 16, 2017 (82 FR 48093). The Agency considered
comments on the draft guidance while finalizing the guidance.
Generally, we revised the draft guidance to provide clarifying
information on the process for submitting post-CRL meeting requests and
the criteria for granting post-CRL meeting requests. Changes from the
draft guidance include information on the process for an abbreviated
new drug application (ANDA) applicant to change the list of meeting
participants and clarification on when a post-CRL meeting request may
be denied.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Post-Complete Response Letter Meetings
Between FDA and ANDA Applicants 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 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 314 have been approved under
OMB control number 0910-0001.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.
Dated: November 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26285 Filed 12-3-18; 8:45 am]
BILLING CODE 4164-01-P
