Acceptability of Draft Labeling To Support Abbreviated New Drug Application Approval; Guidance for Industry; Availability, 60387-60389 [2015-25351]
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60387
Federal Register / Vol. 80, No. 193 / Tuesday, October 6, 2015 / Notices
Description—which defines adverse
events of interest in the retail pharmacy
setting—is available. Other elements of
the Common Formats, including
aggregate reports and technical
specifications, will be developed
following revision of the Common
Formats for Retail Pharmacy based on
public comment and NQF advice.
Information on how to comment and
provide feedback on the Common
Formats for Retail Pharmacy is available
at the NQF Web site: https://www.quality
forum.org/Project_Pages/Common_
Formats_for_Patient_Safety_Data.aspx.
Commenting on HAI Module for
Common Formats for Surveillance
Common Formats addressing all
QSRS modules—except for those for
HAIs—were made available for public
comment in 2014. During the
intervening time, AHRQ was able to
consult with CDC in order to refine the
HAI module. When integrated with the
remaining modules of QSRS, the HAI
module will allow completion of the
first version of QSRS.
The Agency is specifically interested
in obtaining feedback from both the
private and public sectors on the HAI
module for Common Formats for
Surveillance. Only the Event
Description—which defines six HAI
adverse events of interest—is available.
Based on public comment and NQF
advice, AHRQ will finalize this module,
which will be incorporated into QSRS
software. Information on how to
comment and provide feedback on the
HAI module is available at the NQF
Web site: https://www.qualityforum.org/
Project_Pages/Common_Formats_for_
Patient_Safety_Data.aspx.
AHRQ appreciates the time and effort
individuals invest in providing
comments. The Agency will review and
consider all feedback received to help
guide the development of a revised
version. The process for updating and
refining the formats will continue to be
an iterative one.
Future versions of the Common
Formats are planned to be developed for
additional ambulatory settings, such as
ambulatory surgery centers and
physician and practitioner offices. More
information on the Common Formats
can be obtained through AHRQ’s PSO
Web site: https://www.pso.ahrq.gov/.
Sharon B. Arnold,
AHRQ Deputy Director.
[FR Doc. 2015–25364 Filed 10–5–15; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: National Youth in Transition
Database and Youth Outcome Survey.
OMB No.: 0970–0340.
Description: The Foster Care
Independence Act of 1999 (42 U.S.C.
1305 et seq.) as amended by Public Law
106–169 requires State child welfare
agencies to collect and report to the
Administration on Children and
Families (ACF) data on the
characteristics of youth receiving
independent living services and
information regarding their outcomes.
The regulation implementing the
National Youth in Transition Database,
listed in 45 CFR 1356.80, contains
standard data collection and reporting
requirements for States to meet the law’s
requirements. ACF will use the
information collected under the
regulation to track independent living
services, assess the collective outcomes
of youth, and potentially to evaluate
State performance with regard to those
outcomes consistent with the law’s
mandate.
Respondents: State agencies that
administer the John H. Chafee Foster
Care Independence Program.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
Youth Outcome Survey ...................................................................................
Data File ..........................................................................................................
tkelley on DSK3SPTVN1PROD with NOTICES
Estimated Total Annual Burden
Hours: 202,630
Additional Information
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer. All
requests should be identified by the title
of the information collection. Email
address: infocollection@acf.hhs.gov.
OMB Comment
OMB is required to make a decision
concerning the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
VerDate Sep<11>2014
18:31 Oct 05, 2015
Jkt 238001
Number of
responses per
respondent
20,667
52
Average
burden hours
per response
1
2
Total burden
hours
0.50
1,849
is best assured of having its full effect
if OMB receives it within 30 days of
publication. Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Fax: 202–395–7285,
Email: OIRA_SUBMISSION@
OMB.EOP.GOV, Attn: Desk Officer for
the Administration for Children and
Families.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Robert Sargis,
Reports Clearance Officer.
ACTION:
10,334
192,296
[FR Doc. 2015–25370 Filed 10–5–15; 8:45 am]
BILLING CODE 4184–01–P
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
Food and Drug Administration
[Docket No. FDA–2015–D–3378]
Acceptability of Draft Labeling To
Support Abbreviated New Drug
Application Approval; Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a
guidance for industry entitled
‘‘Acceptability of Draft Labeling to
Support ANDA Approval.’’
SUMMARY:
E:\FR\FM\06OCN1.SGM
06OCN1
60388
Federal Register / Vol. 80, No. 193 / Tuesday, October 6, 2015 / Notices
This guidance provides
recommendations and information
related to the submission of proposed
labeling with abbreviated new drug
applications (ANDAs). It explains FDA’s
interpretation of the regulatory
provision related to submission of
copies of applicants’ proposed labeling
and clarifies that FDA’s Office of
Generic Drugs (OGD) will accept draft
labeling and does not require the
submission of final printed labeling
(FPL) in order to approve an ANDA.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: You may submit comments
as follows:
tkelley on DSK3SPTVN1PROD 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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
VerDate Sep<11>2014
18:31 Oct 05, 2015
Jkt 238001
2015–D–3378 for ‘‘Acceptability of Draft
Labeling to Support ANDA Approval,
Guidance for Industry.’’ 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 Division of Dockets
Management 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 Division of Dockets
Management. 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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. 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
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
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:
Tamara Coley, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002, 240–402–6903.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Acceptability of Draft Labeling to
Support ANDA Approval.’’ This
guidance is being issued consistent with
FDA’s Good Guidance Practices (GGP)
regulation (§ 10.115 (21 CFR 10.115)).
This guidance is being implemented
without prior public comment because
the Agency has determined that prior
public participation is not feasible or
appropriate (§ 10.115(g)(2)). The Agency
made this determination because the
guidance presents a less burdensome
policy consistent with the public health.
Although this guidance document is
immediately in effect, it remains subject
to comment in accordance with the
Agency’s GGP regulation.
This guidance provides
recommendations and information
related to the submission of copies of
proposed labeling with ANDAs under
section 505(j)(2)(A)(v) (21 U.S.C.
355(j)(2)(A)(v)) of the Federal Food,
Drug, and Cosmetic Act and FDA’s
implementing regulations (21 CFR
314.94(a)(8)). This guidance clarifies
that OGD will accept and approve
ANDAs based on draft labeling.
In the past, OGD generally asked
applicants to submit copies of FPL as
opposed to draft labeling before
receiving ANDA approval. OGD
generally requested FPL before
approving ANDAs because this version
of the labeling reflected an accurate
presentation of both the content and the
formatting of the labeling.
As ANDA labeling submissions have
evolved over time, particularly with
respect to the submission of electronic
versions of labeling, OGD has found that
draft versions of labeling can enable an
appropriate labeling review before FPL
is produced.
Given changes in submission
practices and the applicable regulations
over time, OGD is clarifying that it will
approve ANDAs on the basis of draft
E:\FR\FM\06OCN1.SGM
06OCN1
Federal Register / Vol. 80, No. 193 / Tuesday, October 6, 2015 / Notices
labeling, provided that OGD is able to
make a determination that the draft
labeling complies with applicable
requirements (other than editorial or
similar minor deficiencies).
The guidance represents the Agency’s
current thinking on the acceptability of
draft labeling to support ANDA
approval. 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. 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 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–25351 Filed 10–5–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–D–3390]
Electronic Common Technical
Document Technical Conformance
Guide; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of an Electronic Common
Technical Document (eCTD) Technical
Conformance Guide, Version 1.0. The
eCTD Technical Conformance Guide
supplements the guidance for industry
entitled ‘‘Providing Regulatory
Submissions in Electronic Format—
Certain Human Pharmaceutical Product
Applications and Related Submissions
Using the eCTD Specification’’ and
provides specifications,
recommendations, and general
considerations on how to submit eCTDbased electronic submissions to the
Center for Drug Evaluation and Research
(CDER) or the Center for Biologics
Evaluation and Research (CBER).
DATES: Although you can comment on
this notice at any time, to ensure that
the Agency considers your comments,
submit either electronic or written
comments by November 20, 2015.
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:31 Oct 05, 2015
Jkt 238001
ADDRESSES:
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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2015–D–3390 for ‘‘Electronic Common
Technical Document Technical
Conformance Guide.’’ 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 Division of Dockets
Management 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
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
60389
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 Division of Dockets
Management. 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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Submit written requests for single
copies of the documents 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 or the
Office of Communication, Outreach and
Development, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Avenue, Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests.
Ron
Fitzmartin, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 1192, Silver Spring,
MD 20993–0002, ronald.fitzmartin@
fda.hhs.gov; or Stephen Ripley, Center
for Biologics Evaluation and Research,
Food and Drug Administration, Bldg.
FOR FURTHER INFORMATION CONTACT:
E:\FR\FM\06OCN1.SGM
06OCN1
]]>Agencies
[Federal Register Volume 80, Number 193 (Tuesday, October 6, 2015)]
[Notices]
[Pages 60387-60389]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25351]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-D-3378]
Acceptability of Draft Labeling To Support Abbreviated New Drug
Application Approval; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a guidance for industry entitled ``Acceptability of
Draft Labeling to Support ANDA Approval.''
[[Page 60388]]
This guidance provides recommendations and information related to
the submission of proposed labeling with abbreviated new drug
applications (ANDAs). It explains FDA's interpretation of the
regulatory provision related to submission of copies of applicants'
proposed labeling and clarifies that FDA's Office of Generic Drugs
(OGD) will accept draft labeling and does not require the submission of
final printed labeling (FPL) in order to approve an ANDA.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: 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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2015-D-3378 for ``Acceptability of Draft Labeling to Support ANDA
Approval, Guidance for Industry.'' 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 Division of Dockets Management 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 Division of Dockets Management. 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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852. 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.
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: Tamara Coley, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, 240-402-6903.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Acceptability of Draft Labeling to Support ANDA Approval.''
This guidance is being issued consistent with FDA's Good Guidance
Practices (GGP) regulation (Sec. 10.115 (21 CFR 10.115)). This
guidance is being implemented without prior public comment because the
Agency has determined that prior public participation is not feasible
or appropriate (Sec. 10.115(g)(2)). The Agency made this determination
because the guidance presents a less burdensome policy consistent with
the public health. Although this guidance document is immediately in
effect, it remains subject to comment in accordance with the Agency's
GGP regulation.
This guidance provides recommendations and information related to
the submission of copies of proposed labeling with ANDAs under section
505(j)(2)(A)(v) (21 U.S.C. 355(j)(2)(A)(v)) of the Federal Food, Drug,
and Cosmetic Act and FDA's implementing regulations (21 CFR
314.94(a)(8)). This guidance clarifies that OGD will accept and approve
ANDAs based on draft labeling.
In the past, OGD generally asked applicants to submit copies of FPL
as opposed to draft labeling before receiving ANDA approval. OGD
generally requested FPL before approving ANDAs because this version of
the labeling reflected an accurate presentation of both the content and
the formatting of the labeling.
As ANDA labeling submissions have evolved over time, particularly
with respect to the submission of electronic versions of labeling, OGD
has found that draft versions of labeling can enable an appropriate
labeling review before FPL is produced.
Given changes in submission practices and the applicable
regulations over time, OGD is clarifying that it will approve ANDAs on
the basis of draft
[[Page 60389]]
labeling, provided that OGD is able to make a determination that the
draft labeling complies with applicable requirements (other than
editorial or similar minor deficiencies).
The guidance represents the Agency's current thinking on the
acceptability of draft labeling to support ANDA approval. 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. 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 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-25351 Filed 10-5-15; 8:45 am]
BILLING CODE 4164-01-P
