Draft Guidance for Industry on Abbreviated New Drug Application Submissions-Refuse To Receive for Lack of Proper Justification of Impurity Limits; Availability, 55813-55814 [2014-22110]
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Federal Register / Vol. 79, No. 180 / Wednesday, September 17, 2014 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–1120]
Guidance for Industry on Abbreviated
New Drug Application Submissions—
Refuse-to-Receive Standards;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘ANDA Submissions—Refuseto-Receive Standards.’’ It finalizes the
draft guidance with the same name that
published on October 1, 2013. This
guidance is intended to assist applicants
preparing to submit to FDA abbreviated
new drug applications (ANDAs) and
related submissions (i.e., prior approval
supplements for new strengths). The
guidance represents the FDA’s current
thinking regarding the types of serious
deficiencies that may cause FDA to
refuse-to-receive the submission.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: 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, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
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.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Benjamin Chacko, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1673,
Silver Spring, MD 20993–0002, 240–
402–7924.
SUPPLEMENTARY INFORMATION:
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
I. Background
FDA is announcing the availability of
a guidance for industry entitled ‘‘ANDA
Submissions—Refuse-to-Receive
Standards.’’ This guidance is intended
to assist applicants preparing to submit
VerDate Sep<11>2014
18:24 Sep 16, 2014
Jkt 232001
to FDA ANDAs, and prior approval
supplements to ANDAs, for which the
applicant is seeking approval of a new
strength of the drug product. The
guidance highlights deficiencies that
may cause FDA to refuse-to-receive an
ANDA. A refuse-to-receive decision
indicates that FDA determined that an
ANDA is not sufficiently complete to
permit a substantive review.
Under the provisions of the Generic
Drug User Fee Amendments of 2012, the
Office of Generic Drugs (OGD) is tasked
with a number of activities, including
the development of ‘‘enhanced refusal
to receive standards for ANDAs and
other related submissions by the end of
year 1 of the program. . . .’’ Recent
data underscore the need for
improvement in the quality of original
ANDA submissions. Between 2009 and
2012, OGD refused to receive 497
ANDAs, primarily because the
submissions contained serious
deficiencies. FDA evaluates each
incoming ANDA individually to
determine whether its format and
content meet threshold standards to
permit a substantive review and thus
can be received by FDA. The Agency
cannot receive an ANDA unless it
contains the information required under
section 505(j) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(j)) and
related regulations (e.g., 21 CFR
314.101(b)(1)). This guidance explains
in some detail the kind of omissions
that can lead to a refuse-to-receive
determination. The guidance is
intended to assist applicants preparing
ANDAs and related submissions to help
improve the quality of those
submissions and ensure that their
format and content are sufficiently
complete to permit a substantive review.
This guidance finalizes the draft
guidance published in the Federal
Register on October 1, 2013 (78 FR
60292). Comments on the draft guidance
were considered while finalizing this
guidance. Specifically, certain changes
from the draft guidance include
clarifying the definitions of ‘‘major’’ and
‘‘minor’’ deficiencies, clarifying the
remedy process and period for minor
deficiencies, and providing a nonexhaustive list of minor deficiencies.
This guidance is being issued consistent
with FDA’s good guidance practices
regulation (21 CFR 10.115). The
guidance represents the Agency’s
current thinking on ‘‘ANDA
Submissions—Refuse-to-Receive
Standards.’’ It does not create or confer
any rights for or on any person and does
not operate to bind FDA or the public.
An alternative approach may be used if
such approach satisfies the
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
55813
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information that
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 in 21 CFR part 314 for
ANDA and related submissions has
been approved under OMB control
number 0910–0001.
III. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: September 11, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–22068 Filed 9–16–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–1292]
Draft Guidance for Industry on
Abbreviated New Drug Application
Submissions—Refuse To Receive for
Lack of Proper Justification of Impurity
Limits; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘ANDA
Submissions—Refuse to Receive for
Lack of Proper Justification of Impurity
Limits.’’ This draft guidance is intended
to assist applicants preparing to submit
SUMMARY:
E:\FR\FM\17SEN1.SGM
17SEN1
55814
Federal Register / Vol. 79, No. 180 / Wednesday, September 17, 2014 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
to FDA abbreviated new drug
applications (ANDAs) and related
submissions (i.e., prior approval
supplements) for which the applicant is
seeking approval of a new strength of
the drug product. The draft guidance
highlights deficiencies about impurity
information that may cause FDA to
refuse to receive an ANDA.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by November 17,
2014.
ADDRESSES: 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, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
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.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Giaquinto, 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.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘ANDA Submissions—Refuse to
Receive Lack of Proper Justification of
Impurity Limits.’’ This draft guidance is
intended to assist applicants preparing
to submit to FDA ANDAs, and prior
approval supplements to ANDAs, for
which the applicant is seeking approval
of a new strength of the drug product.
The draft guidance highlights serious
deficiencies in impurity information
that may cause FDA to refuse to receive
an ANDA. Specifically, these
deficiencies include: (1) Failing to
justify proposed limits for specified
identified impurities in drug substances
and drug products that are above
qualification thresholds; (2) failing to
justify proposed limits for specified
unidentified impurities that are above
VerDate Sep<11>2014
18:24 Sep 16, 2014
Jkt 232001
identification thresholds; and (3)
proposing limits for unspecified
impurities (e.g., any unknown impurity)
above identification thresholds.
Under the provisions of the Generic
Drug User Fee Amendments of 2012, the
Office of Generic Drugs (OGD) is tasked
with a number of activities, including
the development of ‘‘enhanced refusal
to receive standards for ANDAs and
other related submissions by the end of
year 1 of the program. . . .’’ Recent
data underscore the need for
improvement in the quality of original
ANDA submissions. Between 2009 and
2012, OGD refused to receive 497
ANDAs, primarily because the
submissions contained serious
deficiencies. FDA evaluates each
incoming ANDA individually to
determine whether its format and
content meet threshold criteria to permit
a substantive review and thus can be
received by FDA. The Agency cannot
receive an ANDA unless it contains the
information required under section
505(j) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(j)) and
related regulations (e.g., 21 CFR
314.101(b)(1)). FDA issued the draft
guidance for industry ‘‘ANDA
Submissions—Refuse-to-Receive
Standards’’ to explain in some detail the
kind of omissions that can lead to a
refuse-to-receive determination. This
guidance is being issued concurrently
with the final version of the guidance
for industry, ‘‘ANDA Submissions—
Refuse to Receive Standards.’’ FDA
intends to develop additional guidance
documents further clarifying the
enhanced refusal to receive standards.
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 Agency’s current thinking
on ‘‘ANDA Submissions—Refuse to
Receive for Lack of Proper Justification
for Impurity Limits.’’ It does not create
or confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach 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 collections
of information in 21 CFR 314.94 have
been approved under 0910–0001.
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
III. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: September 11, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–22110 Filed 9–16–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Cardiovascular and Renal Drugs
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Cardiovascular
and Renal Drugs Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on October 30, 2014, from 8 a.m.
to 5:30 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993–
0002. Information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You,’’ click
on ‘‘Public Meetings at the FDA White
E:\FR\FM\17SEN1.SGM
17SEN1
Agencies
[Federal Register Volume 79, Number 180 (Wednesday, September 17, 2014)]
[Notices]
[Pages 55813-55814]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22110]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-1292]
Draft Guidance for Industry on Abbreviated New Drug Application
Submissions--Refuse To Receive for Lack of Proper Justification of
Impurity Limits; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``ANDA
Submissions--Refuse to Receive for Lack of Proper Justification of
Impurity Limits.'' This draft guidance is intended to assist applicants
preparing to submit
[[Page 55814]]
to FDA abbreviated new drug applications (ANDAs) and related
submissions (i.e., prior approval supplements) for which the applicant
is seeking approval of a new strength of the drug product. The draft
guidance highlights deficiencies about impurity information that may
cause FDA to refuse to receive an ANDA.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by November 17, 2014.
ADDRESSES: 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, 10903 New Hampshire Ave., Bldg.
51, Rm. 2201, 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.
Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Elizabeth Giaquinto, 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.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``ANDA Submissions--Refuse to Receive Lack of Proper
Justification of Impurity Limits.'' This draft guidance is intended to
assist applicants preparing to submit to FDA ANDAs, and prior approval
supplements to ANDAs, for which the applicant is seeking approval of a
new strength of the drug product. The draft guidance highlights serious
deficiencies in impurity information that may cause FDA to refuse to
receive an ANDA. Specifically, these deficiencies include: (1) Failing
to justify proposed limits for specified identified impurities in drug
substances and drug products that are above qualification thresholds;
(2) failing to justify proposed limits for specified unidentified
impurities that are above identification thresholds; and (3) proposing
limits for unspecified impurities (e.g., any unknown impurity) above
identification thresholds.
Under the provisions of the Generic Drug User Fee Amendments of
2012, the Office of Generic Drugs (OGD) is tasked with a number of
activities, including the development of ``enhanced refusal to receive
standards for ANDAs and other related submissions by the end of year 1
of the program. . . .'' Recent data underscore the need for improvement
in the quality of original ANDA submissions. Between 2009 and 2012, OGD
refused to receive 497 ANDAs, primarily because the submissions
contained serious deficiencies. FDA evaluates each incoming ANDA
individually to determine whether its format and content meet threshold
criteria to permit a substantive review and thus can be received by
FDA. The Agency cannot receive an ANDA unless it contains the
information required under section 505(j) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(j)) and related regulations (e.g., 21
CFR 314.101(b)(1)). FDA issued the draft guidance for industry ``ANDA
Submissions--Refuse-to-Receive Standards'' to explain in some detail
the kind of omissions that can lead to a refuse-to-receive
determination. This guidance is being issued concurrently with the
final version of the guidance for industry, ``ANDA Submissions--Refuse
to Receive Standards.'' FDA intends to develop additional guidance
documents further clarifying the enhanced refusal to receive standards.
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 Agency's current thinking on ``ANDA
Submissions--Refuse to Receive for Lack of Proper Justification for
Impurity Limits.'' It does not create or confer any rights for or on
any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach 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
collections of information in 21 CFR 314.94 have been approved under
0910-0001.
III. Comments
Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.
Dated: September 11, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22110 Filed 9-16-14; 8:45 am]
BILLING CODE 4164-01-P