Abbreviated New Drug Applications Submissions-Refuse-To-Receive Standards: Questions and Answers; Draft Guidance for Industry; Availability, 46072-46073 [2017-21187]
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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This draft guidance is being issued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The draft guidance, when finalized, will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This draft guidance refers to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.
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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may obtain the draft guidance at either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Draft Guidance for Industry;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announcing the availability of a draft
guidance for industry entitled ‘‘ANDA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
03OCN1
Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices
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
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–5846 for ‘‘ANDA
Submissions—Refuse-to-Receive
Standards: Questions and Answers.’’
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
VerDate Sep<11>2014
16:49 Oct 02, 2017
Jkt 244001
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.fda.gov
/regulatoryinformation/dockets/
default.htm.
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:
PO 00000
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Fmt 4703
Sfmt 9990
46073
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘ANDA Submissions—Refuse-toReceive Standards: Questions and
Answers.’’ This draft guidance is
intended to assist applicants preparing
to submit 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-to-Receive Standards’’ and the
filing process, in general. 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
DMFs, product quality, and BE and
clinical reviews, and are intended to
clarify the deficiencies that may cause
FDA to RTR an ANDA. FDA evaluates
each submitted ANDA individually to
determine whether the Agency can
receive it for review. When FDA decides
to receive an ANDA, it means the
Agency has made a threshold
determination that the ANDA is a
substantially complete application (i.e.,
an ANDA that, on its face, is sufficiently
complete to permit a substantive
review). FDA’s regulations at 21 CFR
314.101 provide the regulatory authority
by which FDA may in certain cases, and
will in others, RTR an ANDA.
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—Refuse-toReceive Standards.’’ 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. 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. 2017–21187 Filed 10–2–17; 8:45 am]
BILLING CODE 4164–01–P
E:\FR\FM\03OCN1.SGM
03OCN1
]]>Agencies
[Federal Register Volume 82, Number 190 (Tuesday, October 3, 2017)]
[Notices]
[Pages 46072-46073]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21187]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
SUMMARY: 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-to-Receive 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
[[Page 46073]]
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-5846 for ``ANDA Submissions--Refuse-to-Receive Standards:
Questions and Answers.'' 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.fda.gov/regulatoryinformation/dockets/default.htm.
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--Refuse-to-Receive Standards: Questions and
Answers.'' This draft guidance is intended to assist applicants
preparing to submit 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-to-Receive Standards'' and the filing process, in
general. 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 DMFs, product quality, and BE and clinical
reviews, and are intended to clarify the deficiencies that may cause
FDA to RTR an ANDA. FDA evaluates each submitted ANDA individually to
determine whether the Agency can receive it for review. When FDA
decides to receive an ANDA, it means the Agency has made a threshold
determination that the ANDA is a substantially complete application
(i.e., an ANDA that, on its face, is sufficiently complete to permit a
substantive review). FDA's regulations at 21 CFR 314.101 provide the
regulatory authority by which FDA may in certain cases, and will in
others, RTR an ANDA.
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--Refuse-to-Receive Standards.'' 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. 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. 2017-21187 Filed 10-2-17; 8:45 am]
BILLING CODE 4164-01-P
