Formal Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants of Complex Products Under Generic Drug User Fee Act; Draft Guidance for Industry; Availability, 46071-46072 [2017-21190]
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Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices
the ‘‘Discontinued Drug Product List’’
section of the Orange Book.
Lachman Consultant Services, Inc.
submitted a citizen petition dated April
21, 2017 (Docket No. FDA–2017–P–
2530), under 21 CFR 10.30, requesting
that the Agency determine whether
SPECTAZOLE (econazole nitrate)
topical cream, 1%, was withdrawn from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 SPECTAZOLE (econazole
nitrate) topical cream, 1%, was not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that SPECTAZOLE
(econazole nitrate) topical cream, 1%,
was withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
SPECTAZOLE (econazole nitrate)
topical cream, 1%, from sale. We have
also independently evaluated relevant
literature and data for possible
postmarketing adverse events. We have
reviewed the available evidence and
determined that this drug product was
not withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list SPECTAZOLE
(econazole nitrate) topical cream, 1%, 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. FDA will not
begin procedures to withdraw approval
of approved ANDAs that refer to this
drug product. Additional ANDAs for
this drug product may also 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 labeling for this drug
product should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: September 27, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–21174 Filed 10–2–17; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
16:49 Oct 02, 2017
Jkt 244001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–5739]
Formal Meetings Between the Food
and Drug Administration and
Abbreviated New Drug Application
Applicants of Complex Products Under
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 ‘‘Formal
Meetings Between FDA and ANDA
Applicants of Complex Products Under
GDUFA.’’ This draft guidance describes
an enhanced pathway for discussions
between FDA and a prospective
applicant preparing to submit (or an
applicant that has submitted) to FDA an
abbreviated new drug application
(ANDA) for a complex product.
Specifically, this draft guidance
provides information on requesting and
conducting product development
meetings, pre-submission meetings, and
mid-review-cycle meetings with FDA.
This draft guidance will assist
applicants in generating and submitting
a meeting request and the associated
meeting package to FDA for complex
products to be submitted under the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) and as contemplated in the
commitments made by FDA in
connection with the reauthorization of
the Generic Drug User Fee Amendments
for Fiscal Years (FYs) 2018–2022
(GDUFA II).
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:
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
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
PO 00000
Frm 00038
Fmt 4703
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46071
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 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–5739 for ‘‘Formal Meetings
Between FDA and ANDA Applicants of
Complex Products Under GDUFA; Draft
Guidance for Industry; Availability.’’
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
E:\FR\FM\03OCN1.SGM
03OCN1
46072
Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices
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 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:
asabaliauskas on DSKBBXCHB2PROD with NOTICES
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Formal Meetings Between FDA and
ANDA Applicants of Complex Products
Under GDUFA.’’ This draft guidance
describes an enhanced pathway for
discussions between FDA and an
applicant (or prospective applicant)
preparing to submit an ANDA for a
complex product to FDA. Specifically,
this draft guidance provides information
on requesting and conducting product
development meetings, pre-submission
meetings, and mid-review-cycle
meetings with FDA.
VerDate Sep<11>2014
16:49 Oct 02, 2017
Jkt 244001
This draft guidance reflects a unified
approach to all formal meetings between
FDA and ANDA applicants or
prospective ANDA applicants for
complex products. This draft guidance
is intended to assist ANDA applicants
and prospective ANDA applicants in
generating and submitting to FDA a
meeting request and the associated
meeting package for these complex
products, as defined in this guidance, to
be submitted under section 505(j) of the
FD&C Act (21 U.S.C 355(j)) and as
contemplated in GDUFA II.
As part of the commitments FDA
made in connection with GDUFA II,
FDA agreed to develop a program to
assist ANDA applicants and prospective
ANDA applicants of complex products
before the submission of an ANDA to
FDA. As stated in the ‘‘GDUFA
Reauthorization Performance Goals and
Program Enhancements Fiscal Years
2018–2022’’ (GDUFA II Goals or
Commitment Letter), this pre-ANDA
program is intended to:
. . . clarify regulatory expectations for
prospective applicants early in product
development, assist applicants to develop
more complete submissions, promote a more
efficient and effective ANDA review process,
and reduce the number of review cycles
required to obtain ANDA approval,
particularly for [complex products](GDUFA
II Commitment Letter at 14).
To facilitate development of complex
products that may be submitted in an
ANDA, FDA and industry agreed to a
series of meetings between ANDA
applicants and prospective ANDA
applicants and FDA to discuss the
proposed complex product and support
submission of a high-quality,
approvable ANDA.
In addition to developing a robust
pre-ANDA program, FDA agreed to
respond to requests for and conduct
meetings related to the development of
complex products submitted on or after
October 1, 2017, within specific
timeframes.
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 ‘‘Formal Meetings Between FDA and
ANDA Applicants of Complex Products
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.
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
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 collection of
information has been approved under
OMB control number 0910–0797.
III. Electronic Access
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 28, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–21190 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–5846]
Abbreviated New Drug Applications
Submissions—Refuse-To-Receive
Standards: Questions and Answers;
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—Refuse-to-Receive
Standards: Questions and Answers.’’
This draft guidance is intended to assist
applicants preparing to submit
abbreviated new drug applications
(ANDAs) and certain prior approval
supplements (PASs) to ANDAs. This
guidance provides answers to questions
we have received from applicants
regarding the guidance for industry,
‘‘ANDA Submissions—Refuse-toReceive Standards’’ (RTR Standards
guidance). The questions and answers
address general issues about the
organization of an ANDA, filing
decisions made by FDA, the review of
and deficiencies related to Drug Master
Files (DMFs), product quality, and
bioequivalence (BE) and clinical
reviews, and are intended to clarify the
deficiencies that may cause FDA to
refuse to receive (RTR) an ANDA.
DATES: Submit either electronic or
written comments on the draft guidance
by December 4, 2017 to ensure that the
SUMMARY:
E:\FR\FM\03OCN1.SGM
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Agencies
[Federal Register Volume 82, Number 190 (Tuesday, October 3, 2017)]
[Notices]
[Pages 46071-46072]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21190]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-D-5739]
Formal Meetings Between the Food and Drug Administration and
Abbreviated New Drug Application Applicants of Complex Products Under
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 ``Formal
Meetings Between FDA and ANDA Applicants of Complex Products Under
GDUFA.'' This draft guidance describes an enhanced pathway for
discussions between FDA and a prospective applicant preparing to submit
(or an applicant that has submitted) to FDA an abbreviated new drug
application (ANDA) for a complex product. Specifically, this draft
guidance provides information on requesting and conducting product
development meetings, pre-submission meetings, and mid-review-cycle
meetings with FDA. This draft guidance will assist applicants in
generating and submitting a meeting request and the associated meeting
package to FDA for complex products to be submitted under the Federal
Food, Drug, and Cosmetic Act (FD&C Act) and as contemplated in the
commitments made by FDA in connection with the reauthorization of the
Generic Drug User Fee Amendments for Fiscal Years (FYs) 2018-2022
(GDUFA II).
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 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-5739 for ``Formal Meetings Between FDA and ANDA Applicants
of Complex Products Under GDUFA; Draft Guidance for Industry;
Availability.'' 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
[[Page 46072]]
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 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 ``Formal Meetings Between FDA and ANDA Applicants of Complex
Products Under GDUFA.'' This draft guidance describes an enhanced
pathway for discussions between FDA and an applicant (or prospective
applicant) preparing to submit an ANDA for a complex product to FDA.
Specifically, this draft guidance provides information on requesting
and conducting product development meetings, pre-submission meetings,
and mid-review-cycle meetings with FDA.
This draft guidance reflects a unified approach to all formal
meetings between FDA and ANDA applicants or prospective ANDA applicants
for complex products. This draft guidance is intended to assist ANDA
applicants and prospective ANDA applicants in generating and submitting
to FDA a meeting request and the associated meeting package for these
complex products, as defined in this guidance, to be submitted under
section 505(j) of the FD&C Act (21 U.S.C 355(j)) and as contemplated in
GDUFA II.
As part of the commitments FDA made in connection with GDUFA II,
FDA agreed to develop a program to assist ANDA applicants and
prospective ANDA applicants of complex products before the submission
of an ANDA to FDA. As stated in the ``GDUFA Reauthorization Performance
Goals and Program Enhancements Fiscal Years 2018-2022'' (GDUFA II Goals
or Commitment Letter), this pre-ANDA program is intended to:
. . . clarify regulatory expectations for prospective applicants
early in product development, assist applicants to develop more
complete submissions, promote a more efficient and effective ANDA
review process, and reduce the number of review cycles required to
obtain ANDA approval, particularly for [complex products](GDUFA II
Commitment Letter at 14).
To facilitate development of complex products that may be submitted
in an ANDA, FDA and industry agreed to a series of meetings between
ANDA applicants and prospective ANDA applicants and FDA to discuss the
proposed complex product and support submission of a high-quality,
approvable ANDA.
In addition to developing a robust pre-ANDA program, FDA agreed to
respond to requests for and conduct meetings related to the development
of complex products submitted on or after October 1, 2017, within
specific timeframes.
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 ``Formal
Meetings Between FDA and ANDA Applicants of Complex Products 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.
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
collection of information has been approved under OMB control number
0910-0797.
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 28, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-21190 Filed 10-2-17; 8:45 am]
BILLING CODE 4164-01-P