[Federal Register Volume 80, Number 43 (Thursday, March 5, 2015)]
[Proposed Rules]
[Pages 11966-11968]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-05018]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 15

[Docket No. FDA-2014-N-1168]


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.

-----------------------------------------------------------------------

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) 2016 Regulatory Science Plan.

DATES: The public hearing will be held on June 5, 2015, 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.
    Registration and Requests for Oral Presentations: The FDA 
Conference Center at the White Oak location is a

[[Page 11967]]

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 [email protected] by May 15, 
2015. The email should contain complete contact information for each 
attendee (i.e., name, title, affiliation, address, email address, 
telephone number, and priority number(s)). Those without email access 
can register by contacting Thushi Amini by May 15, 2015 (see For 
Further Information Contact).
    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 V under 
Supplementary Information). 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 
[email protected] on or before May 22, 2015. 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/GDUFARegScience.
    If you need special accommodations because of a disability, please 
contact Thushi Amini (see For Further Information Contact) 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/gdufa2012/.
    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 26, 2015. 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 or 
http://www.fda.gov/GDUFARegScience. It may 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. Send written requests to the Division of Freedom 
of Information (ELEM-1029), Food and Drug Administration, 12420 
Parklawn Dr., Element Bldg., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Thushi Amini, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 4728, Silver Spring, MD 20993; 240-402-
7958, email: [email protected]; or Robert Lionberger, Center for 
Drug Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 4722, Silver Spring, MD 20993, 240-402-
7957, email: [email protected].

SUPPLEMENTARY INFORMATION:

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 
priorities list can be found at http://www.fda.gov/GDUFARegScience. To 
implement the FY 2014 priorities list, the Office of Generic Drugs 
awarded $17 million in external contracts and grants to initiate new 
research studies during FY 2014. A list of FY 2014 awarded studies can 
be found at http://www.fda.gov/GDUFARegScience.

IV. FY 2015 Regulatory Science Priorities

    On May 16, 2014, the Office of Generic Drugs held a public meeting 
to allow public input in developing the FY 2015 regulatory science 
priorities list. The FY 2015 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
5. Computational and Analytical Tools

    For more information on these topic areas, please visit 
www.fda.gov/GDUFARegScience. The Office of Generic Drugs is currently 
developing research studies to support the FY 2015 priorities list. 
Funding opportunities for collaborations will be posted in March 2015 
at www.fda.gov/GDUFARegScience.

V. Purpose and Scope of the June 5, 2015, Public Hearing

    The purpose of the June public hearing is to obtain input from 
industry and other interested stakeholders on the identification of 
regulatory science priorities for FY 2016. To help fulfill FDA's 
mission, FDA is particularly interested in receiving input on the 
following topics:

[[Page 11968]]

    1. Opportunities for scientific or technical advancements that 
would help to overcome specific barriers for industry that currently 
limit the availability of generic drug products.
    2. Innovative approaches to preapproval development of generic 
drugs, including new methodologies for design and conduct of in vitro, 
ex vivo, and clinical studies and identification of scientifically 
robust strategies for demonstration of bioequivalence for various 
product classes.
    3. Innovations in scientific approaches to evaluating the 
therapeutic equivalence of generic drug products through later stages 
of their lifecycle following initial approval.
    4. Identification of high-impact public health issues involving 
generic drugs that can be addressed by the prioritized allocation of FY 
2016 funding for regulatory science research.
    5. Identification of specific issues related to generic drug 
products where scientific recommendations and/or clarifications are 
needed in developing and/or revising FDA's guidance for industry.
    6. Strategies for enhancing quality and equivalence risk management 
during generic drug product development, during regulatory review, and/
or throughout the drug product's lifecycle following initial approval.
    FDA will consider all comments made at this hearing or received 
through the docket (see Comments under ADDRESSES) as it develops its FY 
2016 GDUFA Regulatory Science Plan. Additional information concerning 
GDUFA, including the text of the law and the commitment letter, can be 
found at http://www.fda.gov/gdufa.

VI. 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 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) (21 CFR 
15.30), 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 (21 CFR part 10, subpart C). Under Sec.  
10.205 (21 CFR 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 under ADDRESSES). To the extent that the 
conditions for the hearing, as described in this document, conflict 
with any provisions set out in part 15, this document acts as a waiver 
of those provisions as specified in Sec.  15.30(h).

    Dated: February 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05018 Filed 3-4-15; 8:45 am]
 BILLING CODE 4164-01-P