Document ID: FDA-2013-N-0500-0081
Agency: fda
Document Type: Proposed Rule
Title: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products; Public Meeting; Request for Comments;
Reopening of the Comment Period
Posted Date: 2015-02-18T05:00Z

[Federal Register Volume 80, Number 32 (Wednesday, February 18, 2015)]
[Proposed Rules]
[Pages 8577-8578]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-03211]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 314 and 601

[Docket No. FDA-2013-N-0500]

Supplemental Applications Proposing Labeling Changes for Approved 
Drugs and Biological Products; Public Meeting; Request for Comments; 
Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments; reopening of 
the comment period.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a 1-day 
public meeting entitled ``Supplemental Applications Proposing Labeling 
Changes for Approved Drugs and Biological Products.'' The purpose of 
the meeting is to provide a public forum for FDA to listen to comments 
on the proposed rule on ``changes being effected'' supplements that was 
published in the Federal Register of November 13, 2013, and 
alternatives offered to this proposed rule. FDA is also reopening the 
comment period for the proposed rule to receive submissions of 
additional written comments on the proposed rule as well as alternative 
proposals presented during the public meeting.

DATES: Meeting. The public meeting will be held on March 27, 2015, from 
8 a.m. to 5 p.m. Registration to attend the meeting must be received by 
March 20, 2015. See the SUPPLEMENTARY INFORMATION section for 
information on how to register for the meeting.
    Comments. The comment period for the proposed rule publilshed 
November 13, 2013 (78 FR 67985), is reopened. Submit either electronic 
or written comments regarding proposed alternatives to the proposed 
rule by April 27, 2015.

ADDRESSES: The public meeting will be held at the FDA White Oak Campus, 
10903 New Hampshire Ave, Building 31 Conference Center, the Great Room 
(Rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public 
meeting participants (non-FDA employees) is through Building 1 where 
routine security check procedures will be performed. For parking and 
security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    You may submit comments by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper submissions): 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Docket No. 
FDA-2013-N-0500 for the proposed rule. All comments received may be 
posted without change to http://www.regulations.gov, including any 
personal information provided. For additional information on submitting 
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION 
section of this document.
    Docket: For access to the docket to read background documents or 
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.

FOR FURTHER INFORMATION CONTACT: Ellen Molinaro, Center for Drug 
Evaluation and Research, Food and Drug Administration, Bldg. 51, Rm. 
6218, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-
3601, FAX: 301-847-8440.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of November 13, 2013 (78 FR 67985), FDA 
proposed regulations to revise and clarify procedures for application 
holders of an approved drug or biological product to change the product 
labeling to reflect certain types of newly acquired safety-related 
information in advance of FDA's review of the change by submitting a 
changes being effected (CBE-0) supplement to FDA. The need to promptly 
communicate certain safety-related labeling changes based on newly 
acquired information is the basis for the ``changes being effected'' 
exception to the general requirement for FDA approval of revised 
labeling prior to distribution. The proposed rule, if finalized, would 
enable abbreviated new drug application (ANDA) holders for generic 
drugs to update product labeling promptly to reflect certain types of 
newly acquired safety-related information, irrespective of whether the 
revised labeling differs from that of the corresponding reference 
listed drug (RLD or brand drug) upon submission of a CBE-0 supplement 
to FDA. FDA's proposed revisions to its regulations to allow generic 
drug manufacturers to update product labeling through CBE-0 supplements 
in the same manner as brand drug manufacturers are intended to improve 
communication of important, newly acquired drug safety information to 
health care professionals and the public. For further information about 
this and other proposed regulatory changes described in the proposed 
rule, see 78 FR 67985.
    FDA received numerous comments on the proposed rule from a diverse 
group of stakeholders, including comments proposing alternative 
approaches to communicating newly acquired safety-related information 
in a multisource environment. In November 2014, FDA received a request 
from two trade associations for a listening meeting with FDA to present 
an alternative to the proposed regulatory changes described in the 
proposed rule that they described as intended to meet shared public 
health goals regarding multisource drugs (see Ref. 1). In December 
2014, an explanatory statement accompanying the Consolidated and 
Further Continuing Appropriations Act, 2015

[[Page 8578]]

(Pub. L. 113-235), supported a listening meeting between FDA and the 
regulated industries to consider alternative solutions to the proposed 
rule on safety labeling that will meet all public health goals relating 
to multisource drugs (see https://www.congress.gov/congressional-record/2014/12/11/house-section/article/H9307-1) (FDA has verified the 
Web site address, but FDA is not responsible for any subsequent changes 
to the Web site after this document publishes in the Federal Register).
    In view of these requests and to promote transparency, FDA will 
hold a public meeting at which any stakeholders may present or comment 
on the proposed rule or any alternative proposals intended to improve 
communication of important newly acquired drug safety information to 
health care professionals and the public.
    In addition, FDA is reopening the comment period for the proposed 
rule (78 FR 67985) until April 27, 2015, to receive submissions of 
additional written comments on the proposed rule as well as alternative 
proposals presented during the public meeting.

II. Registration and Requests for Oral Presentations

    If you would like to attend the public meeting, please register for 
the meeting by email to CBESupplements.PublicMeeting@fda.hhs.gov by 
March 20, 2015. The email should contain complete contact information 
for each attendee (including name, title, firm name or affiliation, 
address, email, telephone and fax numbers). Those without email access 
can register by contacting Ellen Molinaro (see FOR FURTHER INFORMATION 
CONTACT) by March 20, 2015. There is no fee to register for the 
meeting, and registration will be on a first-come, first-served basis. 
Early registration is recommended because seating is limited. Onsite 
registration on the day of the meeting also will be permitted on a 
space-available basis beginning at 7:30 a.m.
    Individuals who wish to present at the public meeting must register 
on or before March 16, 2015, and provide complete contact information, 
including name, title, firm name or affiliation, address, email, 
telephone and fax numbers. You should provide a brief description of 
your presentation, and indicate the approximate desired length of your 
presentation, so that FDA can consider these in organizing the 
presentations. FDA will do its best to accommodate requests to speak 
and will determine the amount of time allotted to each presenter and 
the approximate time that each oral presentation is scheduled to begin. 
After reviewing the presentation requests, FDA will notify each 
participant before the meeting of the amount of time available and the 
approximate time their presentation is scheduled to begin. If time 
permits, individuals or organizations that did not register in advance 
may be granted the opportunity to make a presentation. An agenda will 
be posted on the FDA Web site at http://www.fda.gov/Drugs/NewsEvents/ucm431265.htm prior to the meeting. Presenters are encouraged to submit 
a copy of their presentation and related written material to the docket 
(see ``Comments'') in advance of the public meeting.
    If you need special accommodations because of a disability, please 
contact Ellen Molinaro (see FOR FURTHER INFORMATION CONTACT) at least 7 
days in advance.

III. Streaming Webcast of the Public Meeting

    This public meeting will also be Webcast. Information about how to 
view the live Webcast of this meeting will be posted on the FDA Web 
site at http://www.fda.gov/Drugs/NewsEvents/ucm431265.htm prior to the 
meeting.

IV. Comments

    Interested persons may submit either electronic comments regarding 
proposed alternatives to the proposed rule to http://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 http://www.regulations.gov.
    Electronic or written comments will be accepted after the public 
meeting until April 27, 2015.

V. Transcripts

    Please be advised that as soon as possible after a transcript of 
the public meeting is available, it will be accessible at http://www.regulations.gov. It may be viewed at the Division of Dockets 
Management (see ADDRESSES). A transcript will also be available in 
either hardcopy or on CD-ROM, after submission of a Freedom of 
Information request. Written requests are to be sent to the Division of 
Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 
Parklawn Dr., Element Bldg., Rockville, MD 20857.

VI. Reference

    The following reference has been placed on display in the Division 
of Dockets Management (see ADDRESSES), and may be seen by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. Letter dated November 14, 2014, from Mr. Neas (GPhA) and Mr. 
Castellani (PhRMA) to Dr. Hamburg (FDA) regarding request for listening 
meeting on Expedited Agency Review proposal.

    Dated: February 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03211 Filed 2-17-15; 8:45 am]
BILLING CODE 4164-01-P