[Federal Register Volume 78, Number 90 (Thursday, May 9, 2013)]
[Proposed Rules]
[Pages 27113-27115]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-11007]



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 public comments.


    The Food and Drug Administration (FDA or the Agency) is announcing 
a public meeting that will provide an overview of the current status of 
the 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 stakeholders--
as it fulfills its statutory requirement 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 meeting into account in 
developing the fiscal year (FY) 2014 Regulatory Science Plan.

DATES: Date and Time: The public meeting will be held on June 21, 2013, 
from 9 a.m. to 5 p.m. Submit electronic or written requests to make 
oral presentations and comments by June 7, 2013. Electronic or written 
comments will be accepted after the public meeting until July 19, 2013, 
but submission of comments before the meeting is strongly encouraged.
    Location: The public meeting 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. 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.
    Comments: Submit electronic comments 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. Identify comments with the docket number found in 
brackets in the heading of this document.
    Transcripts: Transcripts of the public meeting will be available 
for review at the Division of Dockets Management and on the Internet 
at: http://www.regulations.gov approximately 30 days after the public 
meeting. A live Webcast of this public meeting will be available at: 
    Contact Persons: Thushi Amini, Center for Drug Evaluation and 
Research, Food and Drug Administration, 7500 Standish Pl., MPN-2, Rm. 
N-142, Rockville, MD 20855, 240-276-8433, email: 
Thushi.Amini@fda.hhs.gov; or Robert Lionberger, Center for Drug 
Evaluation and Research, Food and Drug Administration, 7519 Standish 
Pl., MPN-4, Rm. 3015A, Rockville, MD 20855, 240-276-9315, email: 


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 to reduce costs to industry. To support this goal, FDA agreed in 
the GDUFA commitment letter to the FY 2013 Regulatory Science Plan, and 
to consult

[[Page 27114]]

with industry and the public in order to create an annual list of 
regulatory science initiatives specific to research on generic drugs 
for each subsequent year covered by GDUFA. The FY 2013 Regulatory 
Science Plan consisted of the following research topics:

1. Bioequivalence of local acting, orally inhaled drug products
2. Bioequivalence of local acting topical dermatological drug products
3. Bioequivalence of local acting gastrointestinal drug products
4. Quality by design of generic drug products
5. Modeling and simulation
6. Pharmacokinetic studies and evaluation of anti-epileptic drugs
7. Excipient effects on permeability and absorption of Biopharmaceutics 
Classification System Class 3 drugs
8. Product- and patient-related factors affecting switchability of 
drug-device combinations
9. Postmarketing surveillance of generic drug usage patterns and 
adverse events
10. Evaluation of drug product physical attributes on patient 
11. Postmarketing assessment of generic drugs and their brand-name 
12. Physicochemical characterization of complex drug substances
13. Develop a risk-based understanding of potential adverse impacts to 
drug product quality resulting from changes in active pharmaceutical 
ingredients manufacturing and controls

II. Purpose and Scope of the Public Meeting

    The purpose of the public meeting is to provide a forum for the 
public to provide recommendations to FDA related to regulatory science 
initiatives in generic drug research. FDA is requesting input from 
industry and other stakeholders as it develops the FY 2014 Regulatory 
Science Plan for generic drug research, with a focus on the following:

1. Identification of current regulatory science challenges that limit 
the availability of generic drug products
2. Regulatory science approaches to improve the preapproval evaluation 
of therapeutic equivalence of generic drug products
3. Postapproval regulatory science approaches to ensure the therapeutic 
equivalence of approved generic drug products
4. Prioritization of FY 2014 regulatory science research topics for 
generic drug products based on public health impact
5. Areas where additional draft guidance is needed to clarify FDA 
recommendations on complex generic drug product development

    FDA will consider all comments made at this meeting or received 
through the docket (see section V, Request for Comments) as it develops 
its FY 2014 GDUFA Regulatory Science Plan. Additional information 
concerning GDUFA, including the text of the law and the letter in which 
the Agency describes its commitments may be found on the FDA Web site 
at http://www.fda.gov/gdufa.

III. Attendance, Registration, and 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 
and/or present at the meeting, please register for the meeting and/or 
make a request for oral presentation by email to 
GDUFARegulatoryScience@fda.hhs.gov by June 7, 2013. The email should 
contain complete contact information for each attendee, including name, 
title, affiliation, address, email address, and telephone number. Those 
without email access may register by contacting Thushi Amini by June 7, 
2013 (see Contact Persons).
    If you need special accommodations because of a disability, please 
contact Thushi Amini or Robert Lionberger (see Contact Persons) at 
least 7 days before the meeting. For those unable to attend in person, 
FDA will provide a Webcast to the meeting. To join the meeting via the 
Webcast, please go to: https://collaboration.fda.gov/regscipart15/.
    FDA will try to accommodate all persons who wish to make a 
presentation. These individuals should identify the section and the 
number of each question they wish to address (see section II) in their 
presentation to help FDA organize the presentations. FDA will notify 
registered presenters of their scheduled presentation times. The time 
allotted for presentations will depend on the number of individuals who 
wish to speak. Persons registered to make an oral presentation should 
check in before the meeting and are encouraged to arrive early to 
ensure the designated order of presentation times. An agenda for the 
meeting and other background material will be made available 5 days 
before the meeting at http://www.fda.gov/Drugs/NewsEvents/ucm344710.htm. Once FDA notifies registered presenters of their 
scheduled times, they should submit an electronic copy of their 
presentation to GDUFARegulatoryScience@fda.hhs.gov on or before June 
14, 2013.

IV. 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 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 electronic 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 section VI). 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).

V. Request for 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 (see Comments). 
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.

VI. 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 made available in either hardcopy or on CD-ROM upon submission 
of a Freedom of Information

[[Page 27115]]

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.

    Dated: May 3, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2013-11007 Filed 5-8-13; 8:45 am]