Document ID: FDA-2013-N-0402-0019
Agency: fda
Document Type: Proposed Rule
Title: Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives;
Public Hearing; Request for Comments
Posted Date: 2014-02-26T05:00Z

[Federal Register Volume 79, Number 38 (Wednesday, February 26, 2014)]
[Proposed Rules]
[Pages 10740-10742]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-03986]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 15

[Docket No. FDA-2013-N-0402]

Generic Drug User Fee Amendments of 2012; Regulatory Science 
Initiatives; Public Hearing; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of public hearing; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
hearing that will provide an overview of the current status of 
regulatory science initiatives for generic drugs and an opportunity for 
public input on research priorities in this area. FDA is seeking this 
input from a variety of stakeholders--industry, academia, patient 
advocates, professional societies, and other interested parties--as it 
fulfills its commitment under the Generic Drug User Fee Amendments of 
2012 (GDUFA) to develop an annual list of regulatory science 
initiatives specific to generic drugs. FDA will take the information it 
obtains from the public hearing into account in developing the fiscal 
year (FY) 2015 Regulatory Science Plan.

DATES: The public hearing will be held on May 16, 2014, from 9 a.m. to 
5 p.m. The public hearing may be extended or may end early depending on 
the level of public participation.

ADDRESSES: The public hearing will be held at the FDA White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room 
(Rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public 
hearing 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.

FOR FURTHER INFORMATION CONTACT: Thushi Amini, Center for Drug 
Evaluation and Research, Food and

[[Page 10741]]

Drug Administration, 7520 Standish Pl., MPN-1, Rm. 1444, Rockville, MD 
20855, 240-276-8810, email: Thushi.Amini@fda.hhs.gov; or Robert 
Lionberger, Center for Drug Evaluation and Research, Food and Drug 
Administration, 7520 Standish Pl., MPN-1, Rm. 1449, Rockville, MD 
20855, 240-276-8619, email: Robert.Lionberger@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Registration and Requests for Oral 
Presentations: The FDA Conference Center at the White Oak location is a 
Federal facility with security procedures and limited seating. 
Attendance will be free and on a first-come, first-served basis. If you 
wish to attend (either in person or by Webcast (see Streaming Webcast 
of the Public Hearing)) and/or present at the hearing, please register 
for the hearing and/or make a request for oral presentations or 
comments by email to GDUFARegulatoryScience@fda.hhs.gov by April 25, 
2014. The email should contain complete contact information for each 
attendee (i.e., name, title, affiliation, address, email address, and 
telephone number). Those without email access can register by 
contacting Thushi Amini by April 25, 2014 (see Contact Person).
    FDA will try to accommodate all persons who wish to make a 
presentation. Individuals wishing to present should identify the number 
of the topic, or topics, they wish to address (see section IV). This 
will help FDA organize the presentations. FDA will notify registered 
presenters of their scheduled presentation times. The time allotted for 
each presentation will depend on the number of individuals who wish to 
speak. Once FDA notifies registered presenters of their scheduled 
times, they are encouraged to submit an electronic copy of their 
presentation to GDUFARegulatoryScience@fda.hhs.gov on or before May 9, 
2014. Persons registered to make an oral presentation are encouraged to 
arrive at the hearing room early and check in at the onsite 
registration table to confirm their designated presentation time. An 
agenda for the hearing and other background materials will be made 
available 5 days before the hearing at http://www.fda.gov/Drugs/NewsEvents/ucm344710.htm.
    If you need special accommodations because of a disability, please 
contact Thushi Amini (see Contact Person) at least 7 days before the 
hearing.
    Streaming Webcast of the Public Hearing: For those unable to attend 
in person, FDA will provide a live Webcast of the hearing. To join the 
hearing via the Webcast, please go to https://collaboration.fda.gov/regscipart15/.
    Comments: Regardless of attendance at the public hearing, 
interested persons may submit either electronic comments to http://www.regulations.gov or written comments to the Division of Dockets 
Management (HFA-305), 5600 Fishers Lane, Rm. 1061, Rockville, MD 20857. 
The deadline for submitting comments to the docket is June 13, 2014. 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.
    Transcripts: Please be advised that as soon as a transcript is 
available, it will be accessible at http://www.regulations.gov. It may 
also be viewed at the Division of Dockets Management (see Comments). 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.

I. Background

    In July 2012, Congress passed GDUFA (Title III of the Food and Drug 
Administration Safety and Innovation Act (Pub. L. 112-144)). GDUFA is 
designed to enhance public access to safe, high-quality generic drugs 
and reduce costs to industry. To support this goal, FDA agreed in the 
GDUFA commitment letter to work with industry and interested 
stakeholders on identifying regulatory science research priorities 
specific to generic drugs for each fiscal year covered by GDUFA. The 
commitment letter outlines FDA's performance goals and procedures under 
the GDUFA program for the years 2012-2017. The commitment letter can be 
found at http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM282505.pdf.

II. FY 2013 Regulatory Science Priorities

    The FY 2013 regulatory science research priorities list was 
developed by FDA and industry and included in the GDUFA commitment 
letter. To implement the FY 2013 priorities list, the Office of Generic 
Drugs awarded $17 million in external contracts and grants to initiate 
new research studies during FY 2013. Four million dollars were 
allocated to support internal research related to generic drugs. This 
includes rapid response capabilities through equipment for FDA labs and 
support for laboratory research fellows at FDA, as well as research 
fellows to work on data analysis and coordination of internal 
activities with external grants and contracts.

III. FY 2014 Regulatory Science Priorities

    On June 21, 2013, the Office of Generic Drugs held a public hearing 
to gain input in developing the FY 2014 regulatory science priorities 
list. This list was prepared based on internal Center for Drug 
Evaluation and Research discussions, comments received from this public 
hearing, and comments submitted to the public docket.
    The FY 2014 Regulatory Science Priorities are as follows:
    1. Postmarket evaluation of generic drugs,
    2. Equivalence of complex products,
    3. Equivalence of locally acting products,
    4. Therapeutic equivalence evaluation and standards, and
    5. Computational and analytical tools.

For more information on these topic areas, please visit http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/ucm370952.htm.

IV. Purpose and Scope of the May 16, 2014, Public Hearing

    The purpose of the May 2014 public hearing is to obtain input from 
industry and other interested stakeholders on the identification of 
regulatory science priorities for FY 2015. To help fulfill FDA's 
mission, FDA is particularly interested in receiving input on the 
following topics:
    1. Current regulatory science challenges that limit the 
availability of generic drugs,
    2. Regulatory science approaches to improve the preapproval 
evaluation of therapeutic equivalence of generic drugs,
    3. Postapproval regulatory science approaches to ensure the 
therapeutic equivalence of approved generic drugs,
    4. Prioritization of FY 2015 regulatory science research topics for 
generic drugs based on public health impact, and
    5. The need for additional or revised draft guidance to clarify 
FDA's scientific recommendations related to generic drug development.
    FDA will consider all comments made at this hearing or received 
through the docket (see Comments) as it develops its FY 2015 GDUFA 
Regulatory Science Plan. Additional information concerning GDUFA, 
including the text

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of the law and the commitment letter can be found on the FDA Web site 
at http://www.fda.gov/gdufa.

V. Notice of Hearing Under 21 CFR Part 15

    The Commissioner of Food and Drugs is announcing that the public 
hearing will be held in accordance with part 15 (21 CFR Part 15). The 
hearing will be conducted by a presiding officer, who will be 
accompanied by FDA senior management from the Office of the 
Commissioner and the Center for Drug Evaluation and Research. Under 
Sec.  15.30(f), the hearing is informal and the rules of evidence do 
not apply. No participant may interrupt the presentation of another 
participant. Only the presiding officer and panel members may pose 
questions; they may question any person during or at the conclusion of 
each presentation. Public hearings under part 15 are subject to FDA's 
policy and procedures for electronic media coverage of FDA's public 
administrative proceedings (part 10, subpart C) (21 CFR Part 10, 
subpart C)). Under Sec.  10.205, representatives of the media may be 
permitted, subject to certain limitations, to videotape, film, or 
otherwise record FDA's public administrative proceedings, including 
presentations by participants. The hearing will be transcribed as 
stipulated in Sec.  15.30(b) (see Transcripts). To the extent that the 
conditions for the hearing, as described in this notice, conflict with 
any provisions set out in part 15, this notice acts as a waiver of 
those provisions as specified in Sec.  15.30(h).

    Dated: February 19, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03986 Filed 2-25-14; 8:45 am]
BILLING CODE 4160-01-P