Document ID: FDA-2015-D-3378-0001
Agency: fda
Document Type: Notice
Title: Acceptability of Draft Labeling To Support Abbreviated New Drug
Application Approval; Guidance for Industry; Availability
Posted Date: 2015-10-06T04:00Z

[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]

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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.

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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: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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 http://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 http://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: http://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 http://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 http://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 http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://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