[Federal Register Volume 81, Number 132 (Monday, July 11, 2016)]
[Notices]
[Pages 44883-44885]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-16157]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1673]


Updating Abbreviated New Drug Application Labeling After the 
Marketing Application for the Reference Listed Drug Has Been Withdrawn; 
Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Updating 
ANDA Labeling After the Marketing Application for the Reference Listed 
Drug Has Been Withdrawn.'' This draft guidance describes a process for 
updating labeling for abbreviated new drug applications (ANDAs) in 
cases where FDA has withdrawn approval of the new drug application 
(NDA) for the ANDA's reference listed drug (RLD) for reasons other than 
safety or effectiveness. The process described in this guidance is 
intended to complement existing Agency authorities and processes.

DATES: Although you can comment on any guidance at any time (see 21 CFR

[[Page 44884]]

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 9, 2016.

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-2016-D-1673 for ``Updating ANDA Labeling After the Marketing 
Application for the Reference Listed Drug Has Been Withdrawn; Draft 
Guidance for Industry; Availability.'' 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 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: Emily Helms Williams, Office of 
Regulatory Policy, Center for Drug Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-
0002, 301-796-3381, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Updating ANDA Labeling After the Marketing Application for 
the Reference Listed Drug Has Been Withdrawn.'' This draft guidance 
describes a process for updating labeling for ANDAs in cases where FDA 
has withdrawn approval of the NDA for the ANDA's RLD for reasons other 
than safety or effectiveness.
    A generic drug is required to have the same labeling as the RLD at 
the time of approval, except for changes required because of 
differences approved under a suitability petition (see section 
505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) 
and 21 CFR 314.93) or because the generic drug and the RLD are 
``produced or distributed by different manufacturers'' (see section 
505(j)(2)(A)(v) of the FD&C Act and Sec.  314.94(a)(8)(iv) (21 CFR 
314.94(a)(8)(iv))). As a general matter, all holders of marketing 
applications for drug products have an ongoing obligation to ensure 
their product labeling is accurate, and not false or misleading. ANDA 
holders are expected to update their labeling after FDA has approved 
relevant changes to the labeling for the corresponding NDA RLD.
    Where approval of an NDA RLD has been withdrawn, the NDA holder can 
no longer update labeling for the withdrawn RLD. The labeling of ANDAs 
that rely on the withdrawn RLD might eventually become inaccurate and 
outdated, resulting in labeling that is false and/or misleading, for 
example. Likewise, new original ANDAs that rely on the withdrawn RLD 
might include proposed labeling based on the last approved RLD labeling 
that includes outdated information that is false and/or misleading. 
This draft guidance clarifies that consistent with the statute, where 
the RLD is withdrawn, certain labeling changes may continue to be made 
for pending ANDAs and marketed ANDAs. This draft guidance sets forth a 
process for making such changes. The process described in this guidance 
is intended to complement existing Agency authorities and processes.
    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

[[Page 44885]]

on the process for updating ANDA labeling after approval of the NDA for 
the RLD has been withdrawn. 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 
collections of information in Sec.  314.94(a)(8) and 21 CFR 314.97 have 
been approved under OMB Control No. 0910-0001.

III. 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: June 21, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-16157 Filed 7-8-16; 8:45 am]
BILLING CODE 4164-01-P