81 FR 12430 - Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives; Public Hearing; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 46 (March 9, 2016)

Page Range		12430-12431
FR Document		2016-05221

The Food and Drug Administration (FDA or the Agency) 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) 2017 Regulatory Science Plan.

Federal Register, Volume 81 Issue 46 (Wednesday, March 9, 2016)

[Federal Register Volume 81, Number 46 (Wednesday, March 9, 2016)]
[Proposed Rules]
[Pages 12430-12431]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-05221]


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

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.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) 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) 2017 Regulatory Science Plan.

DATES:  The public hearing will be held on May 20, 2016, 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., Building 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.
    Comments: 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-2013-N-0402 for ``Generic Drug User Fee Amendments of 2012; 
Regulatory Science Initiatives; Public Hearing; Request for Comments.'' 
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.

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

[[Page 12431]]

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 modernize the generic drug program. 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. Purpose and Scope of the Public Hearing

    The purpose of the May public hearing is to obtain input from 
industry and other interested stakeholders on the identification of 
regulatory science priorities for FY 2017. To help fulfill FDA's 
mission, FDA is particularly interested in receiving input on the 
following topics:
    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 pre-approval development of generic 
drugs, including new methodologies for product design and 
manufacturing, and 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. Innovation in scientific approaches to evaluating the 
therapeutic equivalence of generic drug products throughout their 
lifecycle.
    4. Identification of high-impact public health issues involving 
generic drugs that can be addressed by the prioritized allocation of FY 
2017 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.
    FDA will consider all comments made at this hearing or received 
through the docket (see ADDRESSES) as it develops its FY 2017 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.
    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 
[email protected] by April 29, 2016. 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 29, 2016 (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. 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 6, 
2016. 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/r7qyz2eds95.
    Transcripts: Please be advised that as soon as a transcript is 
available, it will be accessible at http://www.regulations.gov or at 
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 hard copy or on CD-ROM, after submission of a Freedom of 
Information request. The Freedom of Information office address is 
available on the Agency's Web site at http://www.fda.gov.

III. 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), 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, 
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: March 3, 2016.
Leslie Kux,
Associate Commissioner for Policy.
 [FR Doc. 2016-05221 Filed 3-8-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 46 / Wednesday, March 9, 2016 / Proposed Rules 12431

Drug Administration, 10903 New 5. Identification of specific issues If you need special accommodations
Hampshire Ave., Bldg. 75, Rm. 4728, related to generic drug products where because of a disability, please contact
Silver Spring, MD 20993, 240–402– scientific recommendations and/or Thushi Amini (see FOR FURTHER
7958, email: Thushi.Amini@fda.hhs.gov; clarifications are needed in developing INFORMATION CONTACT) at least 7 days
or Robert Lionberger, Center for Drug and/or revising FDA’s guidance for before the hearing.
Evaluation and Research, Food and industry. Streaming Webcast of the Public
Drug Administration, 10903 New 6. Strategies for enhancing quality and Hearing: For those unable to attend in
Hampshire Ave., Bldg. 75, Rm. 4722, equivalence risk management during person, FDA will provide a live Webcast
Silver Spring, MD 20993, 240–402– generic drug product development, of the hearing. To join the hearing via
7957, email: during regulatory review, and/or the Webcast, please go to https://
Robert.Lionberger@fda.hhs.gov. throughout the drug product’s lifecycle. collaboration.fda.gov/r7qyz2eds95.
FDA will consider all comments made Transcripts: Please be advised that as
SUPPLEMENTARY INFORMATION:
at this hearing or received through the soon as a transcript is available, it will
I. Background docket (see ADDRESSES) as it develops its be accessible at http://
FY 2017 GDUFA Regulatory Science www.regulations.gov or at http://
In July 2012, Congress passed GDUFA
Plan. Additional information www.fda.gov/GDUFARegScience. It may
(Title III of the Food and Drug
concerning GDUFA, including the text be viewed at the Division of Dockets
Administration Safety and Innovation
of the law and the commitment letter, Management (see Comments). A
Act (Pub. L. 112–144)). GDUFA is
can be found at http://www.fda.gov/ transcript will also be available in either
designed to enhance public access to
gdufa. hard copy or on CD-ROM, after
safe, high-quality generic drugs and
Registration and Requests for Oral submission of a Freedom of Information
modernize the generic drug program. To
Presentations: The FDA Conference request. The Freedom of Information
support this goal, FDA agreed in the
Center at the White Oak location is a office address is available on the
GDUFA commitment letter to work with
Federal facility with security procedures Agency’s Web site at http://
industry and interested stakeholders on
and limited seating. Attendance will be www.fda.gov.
identifying regulatory science research
priorities specific to generic drugs for free and on a first-come, first-served III. Notice of Hearing Under 21 CFR
each fiscal year covered by GDUFA. The basis. If you wish to attend (either in Part 15
commitment letter outlines FDA’s person or by Webcast (see Streaming The Commissioner of Food and Drugs
performance goals and procedures Webcast of the Public Hearing)) and/or is announcing that the public hearing
under the GDUFA program for the years present at the hearing, please register for will be held in accordance with 21 CFR
2012–2017. The commitment letter can the hearing and/or make a request for part 15. The hearing will be conducted
be found at http://www.fda.gov/ oral presentations or comments by email by a presiding officer, who will be
downloads/ForIndustry/UserFees/ to GDUFARegulatoryScience@ accompanied by FDA senior
GenericDrugUserFees/UCM282505.pdf. fda.hhs.gov by April 29, 2016. The management from the Office of the
email should contain complete contact Commissioner and the Center for Drug
II. Purpose and Scope of the Public information for each attendee (i.e.,
Hearing Evaluation and Research. Under
name, title, affiliation, address, email § 15.30(f), the hearing is informal and
The purpose of the May public address, and telephone number). Those the rules of evidence do not apply. No
hearing is to obtain input from industry without email access can register by participant may interrupt the
and other interested stakeholders on the contacting Thushi Amini by April 29, presentation of another participant.
identification of regulatory science 2016 (see FOR FURTHER INFORMATION Only the presiding officer and panel
priorities for FY 2017. To help fulfill CONTACT).
members may pose questions; they may
FDA’s mission, FDA is particularly FDA will try to accommodate all question any person during or at the
interested in receiving input on the persons who wish to make a conclusion of each presentation. Public
following topics: presentation. Individuals wishing to hearings under part 15 are subject to
1. Opportunities for scientific or present should identify the number of FDA’s policy and procedures for
technical advancements that would help the topic, or topics, they wish to electronic media coverage of FDA’s
to overcome specific barriers for address. This will help FDA organize public administrative proceedings (21
industry that currently limit the the presentations. FDA will notify CFR part 10, subpart C). Under § 10.205,
availability of generic drug products. registered presenters of their scheduled representatives of the media may be
2. Innovative approaches to pre- presentation times. The time allotted for permitted, subject to certain limitations,
approval development of generic drugs, each presentation will depend on the to videotape, film, or otherwise record
including new methodologies for number of individuals who wish to FDA’s public administrative
product design and manufacturing, and speak. Once FDA notifies registered proceedings, including presentations by
design and conduct of in vitro, ex vivo, presenters of their scheduled times, they participants. The hearing will be
and clinical studies and identification of are encouraged to submit an electronic transcribed as stipulated in § 15.30(b)
scientifically robust strategies for copy of their presentation to (see Transcripts). To the extent that the
demonstration of bioequivalence for GDUFARegulatoryScience@fda.hhs.gov conditions for the hearing, as described
various product classes. on or before May 6, 2016. Persons in this notice, conflict with any
3. Innovation in scientific approaches registered to make an oral presentation provisions set out in part 15, this notice
Lhorne on DSK5TPTVN1PROD with PROPOSALS

to evaluating the therapeutic are encouraged to arrive at the hearing acts as a waiver of those provisions as
equivalence of generic drug products room early and check in at the onsite specified in § 15.30(h).
throughout their lifecycle. registration table to confirm their
4. Identification of high-impact public designated presentation time. An Dated: March 3, 2016.
health issues involving generic drugs agenda for the hearing and other Leslie Kux,
that can be addressed by the prioritized background materials will be made Associate Commissioner for Policy.
allocation of FY 2017 funding for available 5 days before the hearing at [FR Doc. 2016–05221 Filed 3–8–16; 8:45 am]
regulatory science research. http://www.fda.gov/GDUFARegScience. BILLING CODE 4164–01–P

VerDate Sep<11>2014 14:09 Mar 08, 2016 Jkt 238001 PO 00000 Frm 00009 Fmt 4702 Sfmt 9990 E:\FR\FM\09MRP1.SGM 09MRP1

Document Created: 2016-03-09 00:13:21
Document Modified: 2016-03-09 00:13:21

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Proposed Rules
Action		Notification of public hearing; request for comments.
Dates		The public hearing will be held on May 20, 2016, 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.
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]
FR Citation		81 FR 12430

81 FR 12430 - Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives; Public Hearing; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 46 (March 9, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration