Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting, 73850-73851 [E7-25124]
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Federal Register / Vol. 72, No. 248 / Friday, December 28, 2007 / Notices
indicators) to evaluate care provided to
CMS’ beneficiaries except for
demonstration projects residing in other
components.
• Assures that the Agency’s qualityrelated activities (survey and
certification, technical assistance,
beneficiary information, payment
policies and provider/plan incentives)
are fully and effectively integrated in
the Field. Carries out the Health Care
Quality Improvement Program for the
Medicare, Medicaid, and CLIA
programs.
• Assists in the specification and
operational refinement of an integrated
CMS quality information system, which
includes tools for measuring the
coordination of care between health care
settings; analyzes data supplied by that
system to identify opportunities to
improve care and assess success of
improvement interventions.
• Enforces the requirements of
participation for providers and plans in
the Medicare, Medicaid, and CLIA
programs. Recommends revisions of the
requirements based on statutory change
and input from other components.
• Operates the Medicare Quality
Improvement Organization and End
Stage Renal Disease Network program,
providing policies and procedures,
contract design, program coordination,
and leadership in selected projects.
• Identifies, prioritizes and develops
content for clinical and health related
aspects of CMS’ Consumer Information
Strategy; and collaborates with other
components to develop comparative
provider and plan performance
information for consumer choices.
• Assists in the preparation of the
scientific, clinical and procedural basis
for, and recommends to the
Administrator decisions regarding,
coverage of new and established
technologies and services. Maintains
liaison with other Departmental
components regarding the safety and
effectiveness of technologies and
services; prepares the scientific and
clinical basis for, and recommends
approaches to, quality-related medical
review activities of contractors and
payment policies.
• Serves as the focal point for all CMS
Field activities relating to CLIA and the
survey and certification of health
facilities with States and Local
governments (including the Territories).
• Implements, evaluates and refines
standardized provider performance
measures used within provider
certification programs. Supports States
in their use of standardized measures
for provider feedback and quality
improvement activities. Implements and
supports the data collection and
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analysis systems needed by States to
administer the certification program.
• Serves as the Consortium focal
point for emergency preparedness for
the Field.
• Provides oversight in the areas of
human resource procurement and
logistics.
• Ensures the effective management
of the Agency’s information technology
and information systems and resources
in the Field.
• Implements the privacy and
confidentiality policies pertaining to the
collection, use, and release of
individually identifiable data.
• Proactively establishes, manages,
and fosters partnerships within the
Consortium with State and Local
governments, providers and provider
associations, beneficiaries and their
representatives, and the media that are
focused on CMS’ goals and objectives.
• Serves as the primary point of
contact to appropriate members of
Congress, State Governors, Federal,
State, and Local officials and Tribal
governments on matters concerning the
Medicare and Medicaid programs.
• Oversees the coordination and
integration of CMS’ activities with other
Federal, State, Local, and private health
care agencies and organizations.
• Counsels, advises, and collaborates
with top Agency officials on policy
matters and major considerations in
developing, implementing, and
coordinating CMS’ programs as they
interrelate in addressing national and
regional strategies.
• Advises OA on special problems as
they relate to national initiatives and
programs and as they impact major
constituents or their key representatives.
• Promotes accountability,
communication, coordination and
facilitation of cooperative corporate
decision-making among CMS top senior
staff on management, operational and
programmatic issues cross-cutting
organizational components with diverse
functions and activities.
Dated: November 23, 2007.
Charlene Frizzera,
Chief Operating Officer, Centers for Medicare
& Medicaid Services.
[FR Doc. E7–25305 Filed 12–27–07; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Cellular, Tissue and Gene Therapies
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
Frm 00094
Fmt 4703
Sfmt 4703
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). At least one portion of the
meeting will be closed to the public.
Name of Committee: Cellular, Tissue
and Gene Therapies 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 by teleconference on February 5,
2008, from 12 noon to approximately
3:15 p.m. Eastern Time.
Location: National Institutes of
Health, Building 29B, Conference Room
C, 9000 Rockville Pike, Bethesda, MD.
This meeting will be held by
teleconference. The public is welcome
to attend the meeting at the specified
location. A speakerphone will be
provided at the specified location for
public participation in the meeting, on
site. Important information about
transportation and directions to the NIH
campus, parking, and security
procedures is available on the Internet
at https://www.nih.gov/about/visitor/
index.htm. Visitors must show two
forms of identification, one of which
must be a government-issued photo
identification such as a Federal
employee badge, driver’s license,
passport, green card, etc. If you are
planning to drive to and park on the
NIH campus, you must enter at the
South Dr. entrance of the campus which
is located on Wisconsin Ave. (the
Medical Center Metro entrance), and
allow extra time for vehicle inspection.
Detailed information about security
procedures is located at https://
www.nih.gov/about/visitorsecurity.htm.
Because of the limited available parking,
visitors are encouraged to use public
transportation.
Contact Person: Gail Dapolito or
Danielle Cubbage, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 1401 Rockville
Pike, Rockville, MD, 20852, 301–827–
0314, or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area), code 3014512389. 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
E:\FR\FM\28DEN1.SGM
28DEN1
mstockstill on PROD1PC66 with NOTICES
Federal Register / Vol. 72, No. 248 / Friday, December 28, 2007 / Notices
line/phone line to learn about possible
modifications before coming to the
meeting.
Agenda: On February 5, 2008, the
committee will meet in open session to
hear updates of research programs in the
Division of Therapeutic Proteins and the
Division of Monoclonal Antibodies,
Office of Biotechnology Products,
Center for Drug Evaluation and
Research, FDA.
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 will
be 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: On February 5, 2008, from
12 noon to approximately 2:30 p.m., the
meeting is open to the public. 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 January 29, 2008.
Oral presentations from the public will
be scheduled between approximately
1:30 p.m. and 2:30 p.m. 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 January 21, 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 person
regarding their request to speak by
January 22, 2008.
Closed Committee Deliberations: On
February 5, 2008, from approximately
2:30 p.m. to 3:15p.m., the meeting will
be closed to permit discussion where
disclosure would constitute a clearly
unwarranted invasion of personal
privacy (5 U.S.C. 552b(c)(6)). The
committee will discuss reports of
intramural research programs and issues
related to personnel progress and
promotion.
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22:27 Dec 27, 2007
Jkt 214001
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 Gail Dapolito
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: December 18, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7–25124 Filed 12–27–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D–0481]
Draft Prescription Drug User Fee Act IV
Information Technology Plan;
Availability for Comment
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability for public comment of the
draft information technology (IT) plan
entitled ‘‘Prescription Drug User Fee Act
(PDUFA) IV Information Technology
Plan.’’ This plan is intended to provide
regulated industry and other
stakeholders with information on FDA’s
vision and plan for improving the
automation of business processes and
maintaining information systems that
support the process for the review of
human drug applications to achieve the
objectives defined in the PDUFA
Performance Goals.
DATES: Submit written or electronic
comments on the draft IT plan by
February 22, 2008.
ADDRESSES: Submit written requests for
single copies of the draft plan to the
Office of the Chief Information Officer
(HFA–080), Food and Drug
Administration, 5600 Fishers Lane,
PO 00000
Frm 00095
Fmt 4703
Sfmt 4703
73851
Rockville, MD 20857. Send one selfaddressed adhesive label to assist that
office in processing your requests.
Submit written comments on the draft
IT plan to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to either https://
www.fda.gov/dockets/ecomments or
https://www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the document.
FOR FURTHER INFORMATION CONTACT:
Suzanne Mitri, Office of the Chief
Information Officer, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–255–6700.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing for public
comment the availability of the draft IT
plan entitled ‘‘Prescription Drug User
Fee Act (PDUFA) IV Information
Technology Plan.’’ This plan is intended
to provide regulated industry and other
stakeholders with information on FDA’s
vision and plan for improving the
automation of business processes and
maintaining information systems that
support the process for the review of
human drug applications to achieve the
objectives defined in section XIV,
Information Technology Goals, of the
PDUFA Performance Goals (https://
www.fda.gov/oc/pdufa4/
pdufa4goals.html).
On September 27, 2007, President
Bush signed into law the Food and Drug
Administration Amendments Act of
2007, which includes the
reauthorization and expansion of
PDUFA. The reauthorization of PDUFA
will significantly broaden and upgrade
the agency’s drug safety program,
increase resources for review of
television drug advertising, and
facilitate more efficient development of
safe and effective new medications for
the American public. The
reauthorization also includes
Information Technology Goals that are
divided into four subsections:
Objectives, Communications and
Technical Interactions, Standards and
IT Plan, and Metrics and Measures. In
addition, there are information
technology goals associated with the
upgrade of the agency’s drug safety
program in section VIII, Enhancement
and Modernization of the FDA Drug
Safety System.
The objectives of the PDUFA IV IT
Goals are to move FDA towards the
long-term goal of an automated
standards-based information technology
environment for the exchange, review,
E:\FR\FM\28DEN1.SGM
28DEN1
]]>Agencies
[Federal Register Volume 72, Number 248 (Friday, December 28, 2007)]
[Notices]
[Pages 73850-73851]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-25124]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Cellular, Tissue and Gene Therapies 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). At least one
portion of the meeting will be closed to the public.
Name of Committee: Cellular, Tissue and Gene Therapies 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 by teleconference on
February 5, 2008, from 12 noon to approximately 3:15 p.m. Eastern Time.
Location: National Institutes of Health, Building 29B, Conference
Room C, 9000 Rockville Pike, Bethesda, MD. This meeting will be held by
teleconference. The public is welcome to attend the meeting at the
specified location. A speakerphone will be provided at the specified
location for public participation in the meeting, on site. Important
information about transportation and directions to the NIH campus,
parking, and security procedures is available on the Internet at http:/
/www.nih.gov/about/visitor/index.htm. Visitors must show two forms of
identification, one of which must be a government-issued photo
identification such as a Federal employee badge, driver's license,
passport, green card, etc. If you are planning to drive to and park on
the NIH campus, you must enter at the South Dr. entrance of the campus
which is located on Wisconsin Ave. (the Medical Center Metro entrance),
and allow extra time for vehicle inspection. Detailed information about
security procedures is located at https://www.nih.gov/about/
visitorsecurity.htm. Because of the limited available parking, visitors
are encouraged to use public transportation.
Contact Person: Gail Dapolito or Danielle Cubbage, Center for
Biologics Evaluation and Research, Food and Drug Administration, 1401
Rockville Pike, Rockville, MD, 20852, 301-827-0314, or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), code 3014512389. 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
[[Page 73851]]
line/phone line to learn about possible modifications before coming to
the meeting.
Agenda: On February 5, 2008, the committee will meet in open
session to hear updates of research programs in the Division of
Therapeutic Proteins and the Division of Monoclonal Antibodies, Office
of Biotechnology Products, Center for Drug Evaluation and Research,
FDA.
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 will be
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: On February 5, 2008, from 12 noon to approximately 2:30
p.m., the meeting is open to the public. 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 January 29, 2008. Oral presentations from the
public will be scheduled between approximately 1:30 p.m. and 2:30 p.m.
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 January 21, 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
person regarding their request to speak by January 22, 2008.
Closed Committee Deliberations: On February 5, 2008, from
approximately 2:30 p.m. to 3:15p.m., the meeting will be closed to
permit discussion where disclosure would constitute a clearly
unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). The
committee will discuss reports of intramural research programs and
issues related to personnel progress and promotion.
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 Gail Dapolito 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: December 18, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-25124 Filed 12-27-07; 8:45 am]
BILLING CODE 4160-01-S
