Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting, 39017-39018 [E8-15471]
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Federal Register / Vol. 73, No. 131 / Tuesday, July 8, 2008 / Notices
NCIPC IRG, CDC, 4770 Buford Highway, NE.,
M/S F–62, Atlanta, Georgia 30341, telephone
770–488–4281.
This notice is published less than 15 days
before the meeting due to administrative
requirements to reschedule the meeting and
to ensure that reviewers would be available
on that date. The Director, Management
Analysis and Services Office has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities for both
CDC and the Agency for Toxic Substances
and Disease Registry.
Dated: June 30, 2008.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E8–15399 Filed 7–7–08; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
ebenthall on PRODPC60 with NOTICES
Request for Nominations of
Candidates To Serve on the Board of
Scientific Counselors, National Center
for Environmental Health/Agency for
Toxic Substances and Disease
Registry, Centers for Disease Control
and Prevention, Department of Health
and Human Services
The National Center for
Environmental Health/Agency for Toxic
Substances and Disease Registry (NCEH/
ATSDR) is soliciting nominations for
possible membership on the Board of
Scientific Counselors. This Board
provides advice and guidance to the
Secretary, HHS; the Director, CDC; and
the Director, NCEH/ATSDR, regarding
program goals, objectives, strategies, and
priorities in fulfillment of the agencies’
mission to protect and promote people’s
health. The Board provides advice and
guidance to help NCEH/ATSDR work
more efficiently and effectively with its
various constituents and to fulfill its
mission in protecting America’s health.
Nominations are being sought for
individuals who have expertise and
qualifications necessary to contribute to
the accomplishments of the Board’s
objectives. Nominees will be selected
from experts having experience in
preventing human diseases and
disabilities caused by environmental
conditions. Experts in the disciplines of
toxicology, epidemiology,
environmental or occupational
medicine, behavioral science, risk
assessment, exposure assessment, and
experts in public health and other
related disciplines will be considered.
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15:11 Jul 07, 2008
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Consideration is given to representation
from diverse geographic areas, gender,
ethnic and minority groups, and the
disabled. Members may be invited to
serve up to four-year terms. Nominees
must be U.S. citizens.
The following information must be
submitted for each candidate: Name,
affiliation, address, telephone number,
and current curriculum vitae. E-mail
addresses are requested if available.
Nominations should be sent, in
writing, and postmarked by October 31,
2008 to: Sandra Malcom, Committee
Management Specialist, NCEH/ATSDR,
Centers for Disease Control and
Prevention, 4770 Buford Highway (MSF61), Chamblee, Georgia 30341.
Telephone and facsimile submissions
cannot be accepted.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities for both CDC and
the National Center for Environmental
Health/Agency for Toxic Substances
and Disease Registry.
Dated: June 30, 2008.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E8–15429 Filed 7–7–08; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Peripheral and Central Nervous
System 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 Committee : Peripheral and
Central Nervous System 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 August 6 and 7, 2008, from 8
a.m. to5 p.m.
Location : Hilton Washington DC/
Silver Spring, The Ballrooms, 8727
Colesville Rd., Silver Spring, MD. The
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39017
hotel telephone number is 301–589–
5200.
Contact Person : Diem-Kieu Ngo,
Center for Drug Evaluation and Research
(HFD–21), Food and Drug
Administration, 5600 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm.
1093) Rockville, MD 20857, 301–827–
7001, FAX: 301–827–6776, e-mail:
diem.ngo@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014512543. 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 August 6, 2008, the
committee will discuss new drug
application (NDA) 20-427, vigabatrin,
Ovation Pharmaceuticals, Inc., for the
proposed indication of adjunctive
therapy for the treatment of refractory
complex partial seizures in adults. On
August 7, 2008, the committee will
discuss NDA 22–006, vigabatrin,
Ovation Pharmaceuticals, Inc., for the
proposed indication of treatment of
infantile spasms.
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/ohrms/
dockets/ac/acmenu.htm, click on the
year 2008 and 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 July 23, 2008. 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
E:\FR\FM\08JYN1.SGM
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39018
Federal Register / Vol. 73, No. 131 / Tuesday, July 8, 2008 / Notices
approximate time requested to make
their presentation on or before July 15,
2008. 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 July 16, 2008.
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 Diem-Kieu
Ngo 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/oc/advisory/
default.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: June 26, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8–15471 Filed 7–7–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
ebenthall on PRODPC60 with NOTICES
Agency Information Collection
Activities: Proposed Collection;
Comment Request
In compliance with the requirement
for the opportunity for public comment
on proposed data collection projects
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and draft instruments, e-mail
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15:11 Jul 07, 2008
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paperwork@hrsa.gov or call the HRSA
Reports Clearance Officer on (301) 443–
1129.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology.
Proposed Project: Ryan White HIV/
AIDS Program: Client Level Data
Reporting System: New
The Client-Level Data Reporting
System (CLDRS), created in 2008 by the
Health Resources and Services
Administration (HRSA), is designed to
collect information from grantees, as
well as their subcontracted service
providers, funded under Parts A, B, C,
D, and F of the Ryan White HIV/AIDS
Treatment Modernization Act of 2006
(Ryan White HIV/AIDS Program). The
Ryan White HIV/AIDS Program
provides the Federal HIV/AIDS
Programs in the Public Health Service
(PHS) Act under Title XXVI, with the
flexibility to respond effectively to the
changing HIV epidemic. Its emphasis is
on providing life-saving and lifeextending services for people living
with HIV/AIDS across the country, and
on targeting resources to areas that have
the greatest needs.
All Program Parts of the Ryan White
HIV/AIDS Program specify HRSA’s
responsibilities in the administration of
grant funds, the allocation of funds, the
evaluation of programs for the
population served, and the
improvement of the quality of care.
Accurate records of the providers
receiving Ryan White HIV/AIDS
Program funding, the services provided,
and the clients served continue to be
critical to the implementation of the
legislation and thus are necessary for
HRSA to fulfill its responsibilities.
Currently, the HIV/AIDS Bureau
(HAB) requires that all Ryan White HIV/
AIDS Program-funded grantees and their
contracted service providers report
aggregate data annually using the Ryan
White Data Report. Agencies report data
related to the service provider, clients,
service visits provided/clients served,
client demographics, and health
insurance payments. The limitations of
aggregate data are twofold: First,
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because they lack client identifiers,
aggregate data by definition cannot be
merged and unduplicated across service
providers within a given geographic
area. As a result, grantees, and
ultimately HAB, cannot obtain accurate
counts of the number of individuals
served by the Ryan White HIV/AIDS
Program. Second, aggregate data cannot
be analyzed with the detail that is
required to assess quality of care or to
sufficiently account for the use of Ryan
White HIV/AIDS Program funds.
A well designed and supported client
level data reporting system, using a
unique identifier that will be encrypted
before transfer, would provide the
grantee and HRSA with the requisite
information to assess quality of care and
unmet needs, and the ability to more
accurately and efficiently report these
figures to HAB and other funding
agencies. In addition, HAB will be able
to characterize accurately the number of
clients served by the Ryan White HIV/
AIDS Program and the outcomes of the
program services on a national scale.
The ability to perform detailed analyses
will be possible only if organizations
submit data associated with encrypted
client identifiers. These unique
identifiers must be able to link data for
clients across Ryan White HIV/AIDS
Program-funded grantees and their
subcontracted service providers.
The CLDRS provides data on the
characteristics of Ryan White HIV/AIDS
Program-funded grantees, their
contracted service providers, and the
clients being served with program
funds. It is intended to support clinical
quality management, performance
measurement, service delivery, and
client monitoring at both the system and
client levels. The reporting system
consists of two online data forms, the
Grantee Information Form and the
Service Provider Form. A data file
containing the client level data elements
will be submitted with the two online
data forms on a semi-annual basis.
The new legislation specifies
increased grantee accountability and
linking performance to budget. The
CLDRS will be used to ensure
compliance with the requirements of the
reauthorized legislation, evaluate the
progress of programs, monitor grantee
and provider performance, measure the
Government Performance and Result
Act (GPRA) and the Performance
Assessment Rating Tool (PART) goals,
and meet reporting responsibilities to
the Department, Congress, and OMB. In
addition to meeting the goal of
accountability to Congress, clients,
advocacy groups, and the general
public, information collected through
the CLDRS is critical for HRSA, State
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[Federal Register Volume 73, Number 131 (Tuesday, July 8, 2008)]
[Notices]
[Pages 39017-39018]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-15471]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Peripheral and Central Nervous System 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 Committee : Peripheral and Central Nervous System 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 August 6 and 7, 2008,
from 8 a.m. to5 p.m.
Location : Hilton Washington DC/Silver Spring, The Ballrooms, 8727
Colesville Rd., Silver Spring, MD. The hotel telephone number is 301-
589-5200.
Contact Person : Diem-Kieu Ngo, Center for Drug Evaluation and
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm. 1093) Rockville, MD 20857,
301-827-7001, FAX: 301-827-6776, e-mail: diem.ngo@fda.hhs.gov, or FDA
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in
the Washington, DC area), code 3014512543. 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 August 6, 2008, the committee will discuss new drug
application (NDA) 20-427, vigabatrin, Ovation Pharmaceuticals, Inc.,
for the proposed indication of adjunctive therapy for the treatment of
refractory complex partial seizures in adults. On August 7, 2008, the
committee will discuss NDA 22-006, vigabatrin, Ovation Pharmaceuticals,
Inc., for the proposed indication of treatment of infantile spasms.
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/ohrms/dockets/ac/acmenu.htm, click on
the year 2008 and 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 July
23, 2008. 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
[[Page 39018]]
approximate time requested to make their presentation on or before July
15, 2008. 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 July 16, 2008.
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 Diem-Kieu Ngo 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/oc/advisory/
default.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: June 26, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-15471 Filed 7-7-08; 8:45 am]
BILLING CODE 4160-01-S
