80 FR 22204 - Generic Drug User Fees; Public Meeting; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 76 (April 21, 2015)

Page Range		22204-22205
FR Document		2015-09091

The Food and Drug Administration (FDA) is announcing a public meeting on the Generic Drug User Fee Amendments of 2012 (GDUFA). The legislative authority for GDUFA expires at the end of September 2017. At that time, new legislation will be required for FDA to continue to collect generic drug user fees for future fiscal years. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that before FDA begins negotiations with the regulated industry on GDUFA reauthorization; we publish a notice in the Federal Register requesting public input on the reauthorization, hold a public meeting at which the public may present its views on the reauthorization, including specific suggestions for changes to the goals referred to in the Generic Drug User Fee Act Program Performance Goals and Procedures (i.e., the Commitment Letter), provide a period of 30 days after the public meeting to obtain written comments from the public, and publish the comments on FDA's Web site. FDA invites public comment on the GDUFA program and suggestions regarding the features FDA should propose for the next GDUFA program.

Federal Register, Volume 80 Issue 76 (Tuesday, April 21, 2015)

[Federal Register Volume 80, Number 76 (Tuesday, April 21, 2015)]
[Notices]
[Pages 22204-22205]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-09091]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0882]


Generic Drug User Fees; Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting on the Generic Drug User Fee Amendments of 2012 (GDUFA). The 
legislative authority for GDUFA expires at the end of September 2017. 
At that time, new legislation will be required for FDA to continue to 
collect generic drug user fees for future fiscal years. The Federal 
Food, Drug, and Cosmetic Act (the FD&C Act) requires that before FDA 
begins negotiations with the regulated industry on GDUFA 
reauthorization; we publish a notice in the Federal Register requesting 
public input on the reauthorization, hold a public meeting at which the 
public may present its views on the reauthorization, including specific 
suggestions for changes to the goals referred to in the Generic Drug 
User Fee Act Program Performance Goals and Procedures (i.e., the 
Commitment Letter), provide a period of 30 days after the public 
meeting to obtain written comments from the public, and publish the 
comments on FDA's Web site. FDA invites public comment on the GDUFA 
program and suggestions regarding the features FDA should propose for 
the next GDUFA program.

DATES: The public meeting will be held on June 15, 2015, from 9 a.m. to 
5 p.m. The public meeting may be extended or may end early depending on 
the level of public participation.

ADDRESSES: 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 20993-0002. 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, refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: Connie Wisner, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 1718, Silver Spring, MD 20993, 240-402-
7946, [email protected]; or Kimberly Giordano, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 1611, Silver Spring, MD 20993, 301-796-
1071, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    On July 9, 2012, the Food and Drug Administration Safety and 
Innovation Act, which included GDUFA (Pub. L. 112-144, title III), was 
signed into law by the President. GDUFA authorizes FDA to collect fees 
from drug companies that submit marketing applications for certain 
generic human drug applications, certain drug master files, and certain 
facilities. Designed to speed access to safe and effective generic 
drugs to the public, GDUFA requires that generic drug manufacturers pay 
user fees to finance critical and measurable generic drug program 
enhancements. GDUFA also requires that generic drug facilities around 
the world provide identification information annually to FDA.
    Additional information concerning GDUFA, including the text of the 
law, the Commitment Letter, key Federal Register documents, GDUFA-
related guidances, performance reports, and financial reports may be 
found on the FDA Web site at http://www.fda.gov/gdufa.

II. Purpose of Public Meeting

    FDA is announcing a public meeting on GDUFA. The authority for 
GDUFA expires at the end of September 2017. Without new legislation, 
FDA will no longer be able to collect user fees to fund the human 
generic drug review process. Section 744(C)(d)(2) (21 U.S.C. 379j-
43(d)(2)) of the FD&C Act requires that before FDA begins negotiations 
with the regulated industry on GDUFA reauthorization, we do the 
following: (1) Publish a notice in the Federal Register requesting 
public input on the reauthorization, (2) hold a public meeting at which 
the public may present its views on the reauthorization, including 
specific suggestions for changes to the goals referred to in the 
Commitment Letter, (3) provide a period of 30 days after the public 
meeting to obtain written comments from the public, and (4) publish the 
comments on the FDA Web site. This notice, the public meeting, the 30-
day comment period after the meeting, and the posting of the comments 
on the FDA Web site will satisfy these requirements. The purpose of the 
public meeting is to receive public input on the reauthorization of 
GDUFA, including specific suggestions for changes to the goals referred 
to in the Commitment Letter. FDA is interested in responses to the 
following two general questions and welcomes any other relevant 
information the public would like to share:
     What is your assessment of the overall performance of the 
GDUFA program to date?
     What aspects of GDUFA should be retained, changed, or 
discontinued to further strengthen and improve the program?
    In general, the meeting format will include presentations by FDA, 
scientific and academic experts, health care professionals, 
representatives of patient and consumer advocacy groups, the generic 
drug industry, and the general public. The amount of time available for 
public testimony will be determined by the number of persons who 
register to present at the meeting. A draft agenda and other background 
information for the public meeting will be posted at http://www.fda.gov/gdufa by June 8, 2015.

 III. Meeting Attendance and Participation

    FDA is seeking participation (i.e., attendance and oral 
presentations) at the public meeting by all interested parties, 
including but not limited to scientific and academic experts, health 
care professionals, representatives of patient and consumer advocacy 
groups, the generic drug industry, and the general public. If you wish 
to attend the meeting, please email your registration information to 
[email protected] by June 1, 2015. Your email should 
contain complete contact information for each attendee, including name, 
title, affiliation, address, email address, and telephone number. 
Registration is free and is on a first-come, first-served basis. Early 
registration is recommended because seating is limited. Registrants 
will receive confirmation once they have been accepted. If registration 
becomes full prior to the meeting, FDA will place a notice on http://www.fda.gov/gdufa. Onsite registration on the day of the

[[Page 22205]]

meeting will be based on space availability.
    If you wish to present at the meeting, please include your 
presentation materials along with your registration information to 
[email protected] by June 1, 2015. Early requests for oral 
presentations are recommended due to possible space and time 
limitations. FDA will accommodate as many requests for oral 
presentations as possible and will do so on a first-come, first-served 
basis. The time allotted for presentations may depend on the number of 
persons who wish to speak. Those requesting to present will receive 
confirmation once they have been accepted. If presentations exceed time 
and space limitations prior to the meeting, FDA will place a notice on 
http://www.fda.gov/gdufa. Onsite requests for oral presentations on the 
day of the meeting will be based on time and space availability. If the 
entire meeting time is not needed, FDA may end the public meeting 
early.
    If you need special accommodations because of a disability, please 
contact Connie Wisner or Kimberly Giordano (see FOR FURTHER INFORMATION 
CONTACT) by June 8, 2015.
    For those unable to attend in person, FDA will provide a live Adobe 
Connect Webcast of the meeting. In order to connect to the Webcast, you 
must have Adobe Connect. To join the meeting via the Adobe Connect 
Webcast, please go to: https://collaboration.fda.gov/gdufaii.

IV. Comments

    Regardless of participation at the public meeting, interested 
persons may submit either electronic or written comments regarding this 
document. To ensure consideration, all comments should be received by 
July 15, 2015. Submission of comments prior to the meeting is strongly 
encouraged.
    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 all comments with the docket number found in the 
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.

V. Transcripts

    Please be advised that as soon as a transcript is available, it 
will be accessible at http://www.regulations.gov and http://www.fda.gov/gdufa. It may be viewed at the Division of Dockets 
Management (see section IV). A transcript also will be available in 
either hard copy or on CD-ROM upon 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.

    Dated: April 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-09091 Filed 4-20-15; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 76 / Tuesday, April 21, 2015 / Notices 22205

meeting will be based on space transcript also will be available in either download from the Internet. See the
availability. hard copy or on CD–ROM upon SUPPLEMENTARY INFORMATION section for
If you wish to present at the meeting, submission of a Freedom of Information information on electronic access to the
please include your presentation request. Send written requests to the guidance. Submit written requests for a
materials along with your registration Division of Freedom of Information single hard copy of the draft guidance
information to GenericDrugPolicy@ (ELEM–1029), Food and Drug document entitled ‘‘Acceptance of
fda.hhs.gov by June 1, 2015. Early Administration, 12420 Parklawn Dr., Medical Device Clinical Data from
requests for oral presentations are Element Bldg., Rockville, MD 20857. Studies Conducted Outside the United
recommended due to possible space and States; Draft Guidance for Industry and
Dated: April 15, 2015.
time limitations. FDA will Food and Drug Administration Staff’’ to
Leslie Kux,
accommodate as many requests for oral the Office of the Center Director,
presentations as possible and will do so Associate Commissioner for Policy.
Guidance and Policy Development,
on a first-come, first-served basis. The [FR Doc. 2015–09091 Filed 4–20–15; 8:45 am]
Center for Devices and Radiological
time allotted for presentations may BILLING CODE 4164–01–P Health, Food and Drug Administration,
depend on the number of persons who 10903 New Hampshire Ave., Bldg. 66,
wish to speak. Those requesting to Rm. 5431, Silver Spring, MD 20993–
present will receive confirmation once DEPARTMENT OF HEALTH AND
0002 or the Office of Communication,
they have been accepted. If HUMAN SERVICES
Outreach and Development, Center for
presentations exceed time and space Biologics Evaluation and Research
Food and Drug Administration
limitations prior to the meeting, FDA (CBER), Food and Drug Administration,
will place a notice on http:// [Docket No. FDA–2015–D–0975] 10903 New Hampshire Avenue, Bldg.
www.fda.gov/gdufa. Onsite requests for 71, Rm. 3128, Silver Spring, MD 20993.
oral presentations on the day of the Acceptance of Medical Device Clinical Send one self-addressed adhesive label
meeting will be based on time and space Data From Studies Conducted Outside to assist that office in processing your
availability. If the entire meeting time is the United States; Draft Guidance for request.
not needed, FDA may end the public Industry and Food and Drug Submit electronic comments on the
meeting early. Administration Staff; Availability draft guidance to http://
If you need special accommodations AGENCY: Food and Drug Administration, www.regulations.gov. Submit written
because of a disability, please contact HHS. comments to the Division of Dockets
Connie Wisner or Kimberly Giordano Management (HFA–305), Food and Drug
ACTION: Notice.
(see FOR FURTHER INFORMATION CONTACT) Administration, 5630 Fishers Lane, Rm.
by June 8, 2015. SUMMARY: The Food and Drug 1061, Rockville, MD 20852. Identify
For those unable to attend in person, Administration (FDA or Agency) is comments with the docket number
FDA will provide a live Adobe Connect announcing the availability of the draft found in brackets in the heading of this
Webcast of the meeting. In order to guidance entitled ‘‘Acceptance of document.
connect to the Webcast, you must have Medical Device Clinical Data from FOR FURTHER INFORMATION CONTACT:
Adobe Connect. To join the meeting via Studies Conducted Outside the United Aaliyah Eaves-Leaños, Center for
the Adobe Connect Webcast, please go States; Draft Guidance for Industry and Devices and Radiological Health, Food
to: https://collaboration.fda.gov/gdufaii. Food and Drug Administration Staff.’’ and Drug Administration, 10903 New
IV. Comments This draft guidance articulates FDA’s Hampshire Ave., Bldg. 66, Rm. 5420,
current policy of accepting scientifically Silver Spring, MD 20993–0002, 301–
Regardless of participation at the valid clinical data obtained from foreign
public meeting, interested persons may 796–2948. For questions regarding this
clinical studies in support of premarket document concerning devices regulated
submit either electronic or written submissions for devices. The guidance
comments regarding this document. To by CBER, contact Stephen Ripley, 10903
describes special considerations that New Hampshire Ave., Bldg. 71, Rm.
ensure consideration, all comments apply when using such data, including
should be received by July 15, 2015. 7301, Silver Spring, MD 20993–0002,
applicability to populations within the 240–402–7911.
Submission of comments prior to the United States and study design issues
meeting is strongly encouraged. SUPPLEMENTARY INFORMATION:
and provides recommendations to assist
Submit electronic comments to I. Background
sponsors in ensuring their data are
http://www.regulations.gov. Submit
adequate under applicable FDA On July 9, 2012, the President signed
written comments to the Division of
standards to support approval or into law the Food and Drug
Dockets Management (HFA–305), Food
clearance of the device in the United Administration Safety and Innovation
and Drug Administration, 5630 Fishers
States. This guidance is not intended to Act (FDASIA), Public Law 112–144
Lane, rm. 1061, Rockville, MD 20852.
announce new policy, but to describe (2012), adding a new provision, section
Identify all comments with the docket
FDA’s existing approach to this topic. 569B, to the Federal Food, Drug, and
number found in the brackets in the
This draft guidance is not final nor is it Cosmetic Act (FD&C Act) codifying
heading of this document. Received
in effect at this time. FDA’s longstanding policy of accepting
comments may be seen in the Division
of Dockets Management between 9 a.m. DATES: Although you can comment on adequate, ethically-derived,
and 4 p.m., Monday through Friday. any guidance at any time (see 21 CFR scientifically valid data without regard
10.115(g)(5)), to ensure that the Agency to where a clinical study is conducted.
V. Transcripts
tkelley on DSK3SPTVN1PROD with NOTICES

considers your comment on this draft Sponsors may choose to conduct
Please be advised that as soon as a guidance before it begins work on the multinational clinical studies under a
transcript is available, it will be final version of the guidance, submit variety of scenarios. FDA acknowledges,
accessible at http://www.regulations.gov either electronic or written comments however, that certain challenges exist in
and http://www.fda.gov/gdufa. It may be on the draft guidance by July 20, 2015. using data derived from studies of
viewed at the Division of Dockets ADDRESSES: An electronic copy of the devices from sites from outside the
Management (see section IV). A guidance document is available for United States (OUS) to support an FDA

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Document Created: 2015-12-16 08:33:27
Document Modified: 2015-12-16 08:33:27

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		Notices
Action		Notice of public meeting; request for comments.
Dates		The public meeting will be held on June 15, 2015, from 9 a.m. to 5 p.m. The public meeting may be extended or may end early depending on the level of public participation.
Contact		Connie Wisner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1718, Silver Spring, MD 20993, 240-402- 7946, [email protected]; or Kimberly Giordano, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1611, Silver Spring, MD 20993, 301-796- 1071, [email protected]
FR Citation		80 FR 22204

80 FR 22204 - Generic Drug User Fees; Public Meeting; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 76 (April 21, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration