Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting, 63929-63930 [2011-26588]
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Federal Register / Vol. 76, No. 199 / Friday, October 14, 2011 / Notices
tkelley on DSK3SPTVN1PROD with NOTICES
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 November 30, 2011.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. on December 7 and 8,
2011. Those individuals interested in
making 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 November 22, 2011. 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
November 23, 2011.
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 James Clark
at James.Clark@fda.hhs.gov or 301–796–
5293, 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: October 7, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–26558 Filed 10–13–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Joint Meeting of the Drug Safety and
Risk Management Advisory Committee
and the Dermatologic and Ophthalmic
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
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committees: Drug Safety and
Risk Management Advisory Committee
and Dermatologic and Ophthalmic
Drugs Advisory Committee.
General Function of the Committees:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on December 1, 2011, from 8 a.m.
to 5 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (rm.
1503), Silver Spring, MD 20993–0002.
Information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You’’, click
on ‘‘Public Meetings at the FDA White
Oak Campus’’. Please note that visitors
to the White Oak Campus must enter
through Bldg. 1.
Contact Person: Kristina Toliver,
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:
DSaRM@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), and follow the
prompts to the desired center or product
area. 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
PO 00000
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63929
possible modifications before coming to
the meeting.
Agenda: The Food and Drug
Administration Amendments Act of
2007 (Public Law 110–85) requires FDA
to bring, at least annually, one or more
drugs with Risk Evaluation and
Mitigation Strategies (REMS) with
Elements to Assure Safe Use (ETASU)
before its Drug Safety and Risk
Management Advisory Committee
(DSaRM). On December 1, 2011, the
DSaRM and the Dermatologic and
Ophthalmic Drugs Advisory Committees
will meet in joint session to discuss
REMS-related topics. During the
morning session, the committees will
discuss the REMS program for
isotretinoin, also known as iPLEDGE, as
an example of a REMS that has ETASU.
During the afternoon session, the
committees will discuss general issues
related to the impact of REMS with
ETASU on the health care system and
patient access, such as how programs
with ETASU can be better integrated
into existing health systems.
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 November 16, 2011.
Oral presentations from the public will
be scheduled between approximately
9:40 a.m. and 10:10 a.m. (for comments
related to iPLEDGE), and between 2:20
p.m. and 2:50 p.m. (for other REMSrelated comments). Those individuals
interested in making 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
November 7, 2011. 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
E:\FR\FM\14OCN1.SGM
14OCN1
63930
Federal Register / Vol. 76, No. 199 / Friday, October 14, 2011 / Notices
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 November 8, 2011.
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 Kristina
Toliver 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: October 11, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2011–26588 Filed 10–13–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources
and Services Administration (HRSA)
publishes abstracts of information
collection requests under review by the
Office of Management and Budget
(OMB), in compliance with the
Paperwork Reduction Act of 1995 (44
U.S.C. chapter 35). To request a copy of
the clearance requests submitted to
OMB for review, e-mail
paperwork@hrsa.gov or call the HRSA
Reports Clearance Office on (301) 443–
1129.
The following request has been
submitted to the Office of Management
and Budget for review under the
Paperwork Reduction Act of 1995:
Proposed Project: Bureau of Health
Professions (BHPr) Performance Data
Collection (OMB No. 0915–0061) —
[Revision]
This request is for approval from the
Office of Management and Budget
(OMB) of revised data collection
activities required for collection of data
at application, progress and
performance reporting for the Health
Resources and Services Administration
(HRSA), Bureau of Health Professions
(BHPr).
Over 40 BHPr programs award grants
to health professions schools and
training programs across the United
States to develop, expand, and enhance
training, and to strengthen the
distribution of the health workforce.
These programs are governed by the
Public Health Service Act (42 U.S.C. 292
et seq.), specifically Titles III, VII, and
VIII. Performance information is
collected in the HRSA Performance
Report for Grants and Cooperative
Agreements (PRGCA). This report was
formerly called the Uniform Progress
Report.
The proposed data collection satisfies
statutory and programmatic
requirements for performance
measurement and evaluation (including
specific Title III, VII and VIII
requirements), as well as Government
Performance and Results Act (GPRA)
Number of
respondents
Instrument
Responses
per
respondent
requirements. The Affordable Care Act
(Pub. L. 111–148) impacted a broad
range of health workforce programs
administered by BHPr. It reauthorized
most of these programs and, in some
cases, expanded eligibility, modified
program activities, and/or established
new requirements. The Affordable Care
Act also created new health professions
programs. Therefore, it was necessary to
reexamine BHPr’s existing performance
measures to ensure that they address
these changes, meet evolving program
management needs, and respond to
emerging workforce concerns.
The proposed data collection will
enhance analysis and reporting of
grantee training activities and
education, outcomes, and intended
practice locations. Data collected from
these grant programs will also provide
a description of the program activities of
more than 2,000 reporting grantees to
better inform policymakers on the
barriers, opportunities, and outcomes
involved in health care workforce
development. The proposed measures
focus on five key outcomes:
(1) Increasing the workforce supply of
diverse well-educated practitioners;
(2) influencing the distribution of
practitioners to practice in underserved
and rural areas;
(3) enhancing the quality of
education;
(4) diversifying the pipeline for new
health professionals; and,
(5) supporting educational
infrastructure to increase the capacity to
train more health professionals.
Revisions include improving
performance management at three levels
of measurement: individual-level,
program-specific and program clusterlevel. Data collection revisions will also
require the collection of some baseline
data at the grant application and award
stages.
The annual estimate of burden is as
follows:
Total
responses
Hours per
response
Total burden
hours
2500
1500
800
1
1
1
2500
1500
800
9
10
5
22,500
15,000
4,000
Total ..............................................................................
tkelley on DSK3SPTVN1PROD with NOTICES
Application ............................................................................
Program Aggregate Data Collection ....................................
Individual-level Data Collection ............................................
........................
........................
........................
........................
41,500
Written comments and
recommendations concerning the
proposed information collection should
be sent within 30 days of this notice to
the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov
or by fax to 202–395–6974. Please direct
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all correspondence to the ‘‘attention of
the desk officer for HRSA.’’
PO 00000
Dated: October 7, 2011.
Reva Harris,
Acting Director, Division of Policy and
Information Coordination.
[FR Doc. 2011–26591 Filed 10–13–11; 8:45 am]
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]]>Agencies
[Federal Register Volume 76, Number 199 (Friday, October 14, 2011)]
[Notices]
[Pages 63929-63930]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-26588]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Joint Meeting of the Drug Safety and Risk Management Advisory
Committee and the Dermatologic and Ophthalmic 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 of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committees: Drug Safety and Risk Management Advisory
Committee and Dermatologic and Ophthalmic Drugs Advisory Committee.
General Function of the Committees: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
Date and Time: The meeting will be held on December 1, 2011, from 8
a.m. to 5 p.m.
Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993-
0002. Information regarding special accommodations due to a disability,
visitor parking, and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/default.htm; under the heading
``Resources for You'', click on ``Public Meetings at the FDA White Oak
Campus''. Please note that visitors to the White Oak Campus must enter
through Bldg. 1.
Contact Person: Kristina Toliver, 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: DSaRM@fda.hhs.gov, or FDA Advisory Committee Information
Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), and
follow the prompts to the desired center or product area. 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: The Food and Drug Administration Amendments Act of 2007
(Public Law 110-85) requires FDA to bring, at least annually, one or
more drugs with Risk Evaluation and Mitigation Strategies (REMS) with
Elements to Assure Safe Use (ETASU) before its Drug Safety and Risk
Management Advisory Committee (DSaRM). On December 1, 2011, the DSaRM
and the Dermatologic and Ophthalmic Drugs Advisory Committees will meet
in joint session to discuss REMS-related topics. During the morning
session, the committees will discuss the REMS program for isotretinoin,
also known as iPLEDGE, as an example of a REMS that has ETASU. During
the afternoon session, the committees will discuss general issues
related to the impact of REMS with ETASU on the health care system and
patient access, such as how programs with ETASU can be better
integrated into existing health systems.
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
November 16, 2011. Oral presentations from the public will be scheduled
between approximately 9:40 a.m. and 10:10 a.m. (for comments related to
iPLEDGE), and between 2:20 p.m. and 2:50 p.m. (for other REMS-related
comments). Those individuals interested in making 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 November 7, 2011. 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
[[Page 63930]]
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 November 8, 2011.
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 Kristina Toliver 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: October 11, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-26588 Filed 10-13-11; 8:45 am]
BILLING CODE 4160-01-P
