Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting, 47821-47822 [2010-19484]
Download as PDF
<![CDATA[
Federal Register / Vol. 75, No. 152 / Monday, August 9, 2010 / Notices
sroberts on DSKD5P82C1PROD with NOTICES
Monday through Friday. Submission of
comments prior to the meeting is
strongly encouraged.
SUPPLEMENTARY INFORMATION:
I. Introduction
FDA is announcing its intention to
hold a public meeting related to generic
drug user fees. The number of generic
drug applications awaiting FDA action
and the median review time for such
applications have increased. The
Agency is soliciting comment on
whether to seek a user fee program that
would provide additional resources for
the review of human generic drug
applications, as well as what such a
program should look like. New
legislation would be required for FDA to
establish and collect user fees for
generic drugs, and FDA is initiating the
process for defining the scope and
structure of a generic drug user fee
program. As part of this process, FDA
will hold a public meeting to seek input
from stakeholders and the public on
generic drug user fees. In addition,
members of the public are encouraged to
submit written comments. FDA is
particularly interested in responses to
the following questions and welcomes
other pertinent information stakeholders
would like to share regarding the
application process for generic drugs:
1. How, if at all, should a generic drug
user fee program differ from FDA’s
existing user fee programs, including
the Prescription Drug User Fee Act
(PDUFA), the Animal Drug User Fee Act
(ADUFA), the Medical Device User Fee
and Modernization Act (MDUFMA) and
Tobacco Product User Fees?
(Information on these programs can be
found at https://www.fda.gov).
2. What should a generic drug user fee
program look like or how should a
generic user fee be structured? (User
fees for brand name drugs include a
one-time fee for a new drug application
and annual fees for marketed products
and facilities at which these products
are produced. Should the generic drug
fees follow the same structure? If not,
what are the unique aspects of the
generic drug industry or market that
should be considered and how might
these impact a proposed user fee plan?)
3. Are performance goals
recommended for FDA. If so, what
performance goals would you
recommend for FDA? If not, why not?
4. Should all applications pay the
same fees and be subject to the same
goals? (For example, should
applications for more complex products
pay a higher application fee to reflect
the additional regulatory efforts they
entail? Should such differences be
captured through differential goals?)
VerDate Mar<15>2010
17:01 Aug 06, 2010
Jkt 220001
5. Including applications for which
exclusivities would prevent current
marketing, and applications that are
awaiting responses from sponsors for
noted deficiencies, there is a current
queue of over 2,000 applications under
review, and approximately 800 new
applications submitted each year. How
should a generic drug user fee program
address applications currently awaiting
FDA review?
6. PDUFA currently supports
oversight of post-marketing safety of
drugs. What kind of support, if any,
should a generic user fee provide for
post-marketing safety?
II. Why Is FDA Undertaking This
Process?
An important responsibility of FDA is
to assess generic drug applications.
Generic drugs currently are used to fill
more than two-thirds of all prescriptions
dispensed in the United States and they
provide important cost-effective
alternatives to the American public.
Nonetheless, despite increasing
productivity on the part of FDA’s Office
of Generic Drugs, the number of
applications awaiting FDA action has
been steadily increasing, and the
median time for review of such
applications has grown.
Similar to user fees for brand name
human drugs, animal drugs, generic
animal drugs, and medical devices, the
intent of a generic drug user fee program
would be to provide additional revenues
so that FDA can hire more staff and
improve systems to support the generic
drug review process. FDA believes the
supplementary revenues from generic
drug user fees would allow the Agency
to review generic drug applications in a
timely manner and will provide
flexibility, adequacy, and predictability
in the funding of FDA’s review of
generic drug applications.
Although the President’s FY 2011
budget contains a generic drug user fee
program, new legislation would be
needed to put such fees into place. At
this time, generic drugs for humans are
the largest category of preapproval
products regulated by FDA and generic
drug applicants do not currently pay
any type of user fee. FDA believes that
the predictability, flexibility, and
adequacy of a funding stream from user
fees and the accompanying ability to
more efficiently review generic drug
applications would benefit the public
health, FDA, and the generic drug
industry.
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
47821
III. What Information Should You
Know About the Meeting?
A. When and Where Will the Meeting
Occur? What Format Will FDA Use?
Through this notice, we are
announcing a public meeting to hear
stakeholder views on what features FDA
should propose for a generic drug user
fee program. We will conduct the
meeting on September 17, 2010, at the
Hilton Washington DC/Rockville and
Executive Meeting Center, see Location).
In general, the meeting format will
include presentations by FDA and
presentations by stakeholders and
members of the public who have
registered in advance to present at the
meeting. The amount of time available
for presentations will be determined by
the number of people who register to
make a presentation. We will also
provide an opportunity for
organizations and individuals to submit
written comments to the docket after the
meeting. FDA policy issues are beyond
the scope of this initiative. Accordingly,
the presentations should focus on
process and funding issues, and not
focus on policy issues.
B. Will Meeting Transcripts Be
Available?
Please be advised that as soon as a
transcript is available, it will be
accessible at https://www.regulations.
gov. 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. Written requests are to be sent
to Division of Freedom of Information
(HFI–35), Office of Management
Programs, Food and Drug
Administration, 5600 Fishers Lane, rm.
6–30, Rockville, MD 20857.
Dated: August 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–19537 Filed 8–6–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
Endocrinologic and Metabolic Drugs
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
E:\FR\FM\09AUN1.SGM
09AUN1
sroberts on DSKD5P82C1PROD with NOTICES
47822
Federal Register / Vol. 75, No. 152 / Monday, August 9, 2010 / Notices
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Endocrinologic
and Metabolic Drugs Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on September 15 and 16, 2010,
from 8 a.m. to 5 p.m.
Location: The Marriott Inn and
Conference Center, University of
Maryland University College (UMUC),
3501 University Blvd. East, Adelphi,
MD. The hotel telephone number is
301–985–7300.
Contact Person: Paul Tran, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave, Bldg. 31, rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, FAX: 301–847–8533, e-mail:
paul.tran@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014512536. Please call the Information
Line for up-to-date information on this
meeting. A notice in the Federal
Register about last minute modifications
that impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the agency’s Web
site and call the appropriate advisory
committee hot line/phone line to learn
about possible modifications before
coming to the meeting.
Agenda: On September 15, 2010, the
committee will discuss the results of the
Sibutramine Cardiovascular Outcomes
Trial (SCOUT) (M01–392), for new drug
application (NDA) 20–632, MERIDIA
(sibutramine hydrochloride
monohydrate) Capsules, sponsored by
Abbott Laboratories, for treatment of
obesity. The SCOUT study was a
randomized, double-blind, placebocontrolled trial, which is a kind of
clinical trial designed to provide data
with strong measures of accuracy and
reliability. The SCOUT trial evaluated
the potential benefits of weight loss
with MERIDIA on major cardiovascular
(heart and blood circulation) adverse
events. The preliminary results of the
SCOUT trial indicated that clinical trial
participants who received MERIDIA
instead of placebo (no active drug) had
a higher incidence of major
cardiovascular adverse events that was
statistically significant.
On September 16, 2010, the
committee will discuss the safety and
efficacy of new drug application (NDA)
VerDate Mar<15>2010
17:01 Aug 06, 2010
Jkt 220001
22–529, with the proposed trade name
LORQESS (lorcaserin hydrochloride)
Tablets, sponsored by Arena
Pharmaceuticals, Inc., as an adjunct to
diet and exercise for weight
management in patients with a body
mass index (BMI) of equal to or greater
than 30 kilograms (kg) per square meter,
or a BMI equal to or greater than 27 kg
per square meter if accompanied by
weight-related co-morbidities (which
include, for example: High blood
pressure, heart disease, or diabetes). The
BMI is a measure of body weight (mass)
based on a person’s weight and height,
and is a widely-used tool for doctors in
assessing optimum weights for a patient.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before August 31, 2010.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. on both days. Those
desiring to make formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before August
23, 2010. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by August 24, 2010.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Paul Tran at
least 7 days in advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: August 3, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2010–19484 Filed 8–6–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
U.S. Citizenship and Immigration
Services
Agency Information Collection
Activities: Form G–639, Extension of a
Currently Approved Information
Collection; Comment Request
30-Day Notice of Information
Collection Under Review: Form G–639,
Freedom of Information/Privacy Act
Request; OMB Control No. 1615–0102.
ACTION:
The Department of Homeland
Security, U.S. Citizenship and
Immigration Services (USCIS) will be
submitting the following information
collection request to the Office of
Management and Budget (OMB) for
review and clearance in accordance
with the Paperwork Reduction Act of
1995. The information collection was
previously published in the Federal
Register on May 4, 2010, at 75 FR
23785, allowing for a 60-day public
comment period. USCIS did not receive
any comments for this information
collection.
The purpose of this notice is to allow
an additional 30 days for public
comments. Comments are encouraged
and will be accepted until September 8,
2010. This process is conducted in
accordance with 5 CFR 1320.10.
Written comments and/or suggestions
regarding the item(s) contained in this
notice, especially regarding the
estimated public burden and associated
response time, should be directed to the
Department of Homeland Security
(DHS), and to the Office of Management
and Budget (OMB) USCIS Desk Officer.
Comments may be submitted to: USCIS,
E:\FR\FM\09AUN1.SGM
09AUN1
]]>Agencies
[Federal Register Volume 75, Number 152 (Monday, August 9, 2010)]
[Notices]
[Pages 47821-47822]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-19484]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
Endocrinologic and Metabolic Drugs Advisory Committee; Notice of
Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
This notice announces a forthcoming meeting of a public advisory
committee
[[Page 47822]]
of the Food and Drug Administration (FDA). The meeting will be open to
the public.
Name of Committee: Endocrinologic and Metabolic Drugs Advisory
Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on September 15 and 16,
2010, from 8 a.m. to 5 p.m.
Location: The Marriott Inn and Conference Center, University of
Maryland University College (UMUC), 3501 University Blvd. East,
Adelphi, MD. The hotel telephone number is 301-985-7300.
Contact Person: Paul Tran, Center for Drug Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave, Bldg. 31, rm.
2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-8533, e-
mail: paul.tran@fda.hhs.gov, or FDA Advisory Committee Information
Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code
3014512536. Please call the Information Line for up-to-date information
on this meeting. A notice in the Federal Register about last minute
modifications that impact a previously announced advisory committee
meeting cannot always be published quickly enough to provide timely
notice. Therefore, you should always check the agency's Web site and
call the appropriate advisory committee hot line/phone line to learn
about possible modifications before coming to the meeting.
Agenda: On September 15, 2010, the committee will discuss the
results of the Sibutramine Cardiovascular Outcomes Trial (SCOUT) (M01-
392), for new drug application (NDA) 20-632, MERIDIA (sibutramine
hydrochloride monohydrate) Capsules, sponsored by Abbott Laboratories,
for treatment of obesity. The SCOUT study was a randomized, double-
blind, placebo-controlled trial, which is a kind of clinical trial
designed to provide data with strong measures of accuracy and
reliability. The SCOUT trial evaluated the potential benefits of weight
loss with MERIDIA on major cardiovascular (heart and blood circulation)
adverse events. The preliminary results of the SCOUT trial indicated
that clinical trial participants who received MERIDIA instead of
placebo (no active drug) had a higher incidence of major cardiovascular
adverse events that was statistically significant.
On September 16, 2010, the committee will discuss the safety and
efficacy of new drug application (NDA) 22-529, with the proposed trade
name LORQESS (lorcaserin hydrochloride) Tablets, sponsored by Arena
Pharmaceuticals, Inc., as an adjunct to diet and exercise for weight
management in patients with a body mass index (BMI) of equal to or
greater than 30 kilograms (kg) per square meter, or a BMI equal to or
greater than 27 kg per square meter if accompanied by weight-related
co-morbidities (which include, for example: High blood pressure, heart
disease, or diabetes). The BMI is a measure of body weight (mass) based
on a person's weight and height, and is a widely-used tool for doctors
in assessing optimum weights for a patient.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
August 31, 2010. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. on both days. Those desiring to
make formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before August 23, 2010. Time allotted for
each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by August 24, 2010.
Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Paul Tran at least 7
days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: August 3, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-19484 Filed 8-6-10; 8:45 am]
BILLING CODE 4160-01-S
