National Center for Environmental Health/Agency for Toxic Substances and Disease Registry, 22051-22052 [05-8497]
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Federal Register / Vol. 70, No. 81 / Thursday, April 28, 2005 / Notices
Management Analysis and Services Office,
CDC, pursuant to Pub. L. 92–463.
Agenda items are subject to change as
priorities dictate.
Name: Subcommittee on Intimate Partner
Violence and Sexual Assault (SIPVSA).
Time and Date: 10 a.m.–11:30 a.m., June 8,
2005.
Place: Crowne Plaza Hotel AtlantaBuckhead, 3377 Peachtree Road, NE.,
Atlanta, GA 30326.
Status: Open to the public, limited only by
the space available.
Purpose: To advise and make
recommendations to the full advisory
committee and the Director, NCIPC,
regarding feasible goals for prevention and
control of domestic and sexual violence. The
SIPVSA will make recommendations
regarding strategies, objectives, and priorities
in programs, policies and research.
Matters To Be Discussed: The SIPVSA will
discuss strategies for examining models for
integration of intimate partner violence and
sexual assault prevention into broader public
health infrastructure and strategies.
Name: Advisory Committee for Injury
Prevention and Control.
Time and Dates:
1 p.m.–5:30 p.m., June 8, 2005;
8:30 a.m.–3:30 p.m., June 9, 2005.
Place: Crowne Plaza Hotel AtlantaBuckhead, 3377 Peachtree Road, NE.,
Atlanta, GA 30326.
Status:
Closed: 1 p.m.–1:45 p.m., June 8, 2005.
Open: 1:45 p.m.–5:30 p.m., June 8, 2005;
Open: 8:30 a.m.–3:30 p.m., June 9, 2005.
Purpose: The Committee advises and
makes recommendations to the Secretary,
Health and Human Services, the Director,
CDC, and the Director, NCIPC, regarding
feasible goals for the prevention and control
of injury. The Committee makes
recommendations regarding policies,
strategies, objectives, and priorities, and
reviews progress toward injury prevention
and control.
Matters To Be Discussed: Prior to the full
committee meeting, there will be a brief
meeting conducted by conference call of the
Working Group on Injury Control and
Infrastructure Enhancement, a group formed
to report to the full committee identifying
gaps and suggesting ways to enhance injury
prevention efforts.
The working group will focus on defining
injury infrastructure and developing a simple
mechanism to assess current efforts
underway throughout the injury field to
enhance that infrastructure. Starting at 1
p.m., June 8, through 1:45 p.m., the full
committee will vote on the results of
secondary review. This portion of the
meeting will be closed to the public in
accordance with provisions set forth in
section 552(b)(4) and (6), title 5 U.S.C., and
the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Following the closed session, the meeting
will open to the public for an update on
Center activities from the Director, NCIPC;
reports from the Subcommittees and Working
Group; state infrastructure development; and
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discussion on how NCIPC can support the
recommendations of CDC’s Futures Initiative.
Agenda items are subject to change as
priorities dictate.
For Further Information Contact: Ms.
Louise Galaska, Executive Secretary, ACIPC,
NCIPC, CDC, 4770 Buford Highway, NE., M/
S K02, Atlanta, Georgia 30341–3724,
telephone (770) 488–4694.
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: April 21, 2005.
B. Kathy Skipper,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. 05–8499 Filed 4–27–05; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
National Center for Injury Prevention
and Control Initial Review Group
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC) announce
the following meeting:
Name: National Center for Injury
Prevention and Control (NCIPC) Initial
Review Group (IRG).
Times and Dates:
1 p.m.–5:30 p.m., May 23, 2005;
8:30 a.m.–5:30 p.m., May 24, 2005;
8:30 a.m.–5:30 p.m., May 25, 2005.
Place: The Initial Review Group will
originate at the Hilton Atlanta Airport and
Towers, 1031 Virginia Avenue, Atlanta,
Georgia 30354.
Status:
Open: 1 p.m.–1:30 p.m., May 23, 2005.
Closed: 1:30 p.m.–5:30 p.m., May 23, 2005;
Closed: 8:30 a.m.–5:30 p.m., May 24, 2005;
Closed: 8:30 a.m.–5:30 p.m., May 25, 2005.
Purpose: This group is charged with
providing advice and guidance to the
Secretary of Health and Human Services and
the Director, CDC, concerning the scientific
and technical merit of grant and cooperative
agreement applications received from
academic institutions and other public and
private profit and nonprofit organizations,
including State and local government
agencies, to conduct specific injury research
that focuses on prevention and control and
supports Injury Control Research Centers
(ICRCs).
Matters To Be Discussed: Agenda items
include an overview of the injury program,
discussion of the review process and
panelists’ responsibilities, and the review of
and vote on applications. Beginning at 1:30
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22051
p.m., May 23, through 5:30 p.m., May 25, the
Group will review individual research
cooperative agreement in response to
announcement: #05018, Cooperative
Agreement Program for the National
Academic Centers of Excellence. This
meeting will be closed to the public in
accordance with provisions set forth in
section 552b(c)(4) and (6), Title 5 U.S.C., and
the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Pub. L. 92–463.
Agenda items are subject to change as
priorities dictate.
For More Information Contact: Gwendolyn
H. Cattledge, Ph.D., M.S.E.H., Executive
Secretary, NCIPC IRG, CDC, 4770 Buford
Highway, NE., M/S K02, Atlanta, Georgia
30341–3724, telephone (770) 488–4655.
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: April 21, 2005.
B. Kathy Skipper,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. 05–8500 Filed 4–27–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
National Center for Environmental
Health/Agency for Toxic Substances
and Disease Registry
The Board of Scientific Counselors
(BSC), Centers for Disease Control and
Prevention (CDC), National Center for
Environmental Health/Agency for Toxic
Substances and Disease Registry (NCEH/
ATSDR).
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC) and the
National Center for Environmental
Health/Agency for Toxic Substances
Disease Registry (ATSDR) announce the
following committee meeting:
Name: Board of Scientific Counselors,
National Center for Environmental
Health/Agency for Toxic Substances
and Disease Registry.
Times and Dates: 8:30 a.m.–5 p.m.,
May 19, 2005. 8 a.m.–12:15 p.m., May
20, 2005.
Place: CDC facility, 1825 Century
Boulevard, Atlanta, GA 30345.
Status: Open to the public for
observation, limited only by the space
available. The meeting room
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Federal Register / Vol. 70, No. 81 / Thursday, April 28, 2005 / Notices
accommodates approximately 100
people.
Purpose: The Secretary, and by
delegation, the Director of the Centers
for Disease Control and Prevention and
the Administrator of the National Center
for Environmental Health/Agency for
Toxic Substances and Disease Registry,
are authorized under section 301(42
U.S.C. 241) and section 311 (42 U.S.C.
243) of the Public Health Service Act, as
amended, to (1) conduct, encourage,
cooperate with, and assist other
appropriate public authorities, scientific
institutions, and scientists in the
conduct of research, investigations,
experiments, demonstrations, and
studies relating to the causes, diagnosis,
treatment, control, and prevention of
physical and mental diseases and other
impairments; (2) assist states and their
political subdivisions in the prevention
of infectious diseases and other
preventable conditions and in the
promotion of health and well being; and
(3) train state and local personnel in
health work. The Board of Scientific
Counselors, NCEH/ATSDR provides
advice and guidance to the Secretary,
HHS; the Director, CDC and
Administrator, ATSDR; 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 that will assist NCEH/ATSDR
in ensuring scientific quality,
timeliness, utility, and dissemination of
results. The Board also provides
guidance to help NCEH/ATSDR work
more efficiently and effectively with its
various constituents and to fulfill its
mission in protecting America’s health.
Matters to be Discussed: The agenda
items for the meeting on May 19–20,
2004, will include but are not limited to
an update on future initiatives for
Environmental Health and Injury
Prevention; presentation on Places
Goals and Research Agenda; an update
on the state of NCEH/ATSDR; review of
the ATSDR Draft Dioxin Soil Policy
Guideline; presentation on asbestos;
discussion on the criteria for ‘‘DeListing’’ chemicals from the CDC’s
National Report on Human Exposure to
Environmental Chemicals; a discussion
on the 3rd National Report on Human
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Exposure to Environmental Chemicals
and upates by the subcommittees and
workgroup.
Agenda items are tentative and
subject to change.
Contact Person for More Information:
Individuals interested in attending the
meeting, please contact Sandra Malcom,
Committee Management Specialist,
NCEH/ATSDR, 1600 Clifton Road, Mail
Stop E–28, Atlanta, GA 30303;
telephone (404) 498–0003, Fax (404)
498–0059; e-mail: smalcom@cdc.gov.
The deadline for notification of
attendance is May 13, 2005.
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: April 21, 2005.
B. Kathy Skipper,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. 05–8497 Filed 4–27–05; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0143]
High Chemical Co. et al.; Proposal to
Withdraw Approval of 13 New Drug
Applications; Opportunity for a
Hearing; Reissuance
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; reissuance.
SUMMARY: The Food and Drug
Administration (FDA) is reissuing the
notice announcing an opportunity to
request a hearing on the agency’s
proposal to withdraw approval of 13
new drug applications (NDAs) from
multiple sponsors. The basis for the
proposal is that the sponsors have
repeatedly failed to file required annual
reports for these applications. In the
Federal Register of January 28, 2005 (70
PO 00000
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FR 4134), FDA published a notice
announcing an opportunity for a hearing
on the agency’s proposal to withdraw
approval of 13 NDAs from multiple
sponsors. That notice published with an
inadvertent error; in a document
published elsewhere in this issue of the
Federal Register, the agency is
withdrawing that notice.
DATES: Submit written requests for a
hearing by May 31, 2005; submit data
and information in support of the
hearing request by June 27, 2005.
ADDRESSES: Requests for a hearing,
supporting data, and other comments
are to be identified with Docket No.
2005N–0143 to be submitted to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Florine P. Purdie Center for Drug
Evaluation and Research (HFD–7), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857,301–594–
2041.
FDA is
reissuing the notice announcing an
opportunity to request a hearing on the
agency’s proposal to withdraw approval
of 13 new drug applications (NDAs)
from multiple sponsors. The basis for
the proposal is that the sponsors have
repeatedly failed to file required annual
reports for these applications. In the
Federal Register of January 28, 2005 (70
FR 4134), FDA published a notice
announcing an opportunity for a hearing
on the agency’s proposal to withdraw
approval of 13 NDAs from multiple
sponsors. That notice published with an
inadvertent error; in a document
published elsewhere in this issue of the
Federal Register, the agency is
withdrawing that notice.
The holders of approved applications
to market new drugs for human use are
required to submit annual reports to
FDA concerning each of their approved
applications in accordance with
§ 314.81 (21 CFR 314.81). The holders of
the approved applications listed in the
following table have failed to submit the
required annual reports and have not
responded to the agency’s request by
certified mail for submission of the
reports.
SUPPLEMENTARY INFORMATION:
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Agencies
[Federal Register Volume 70, Number 81 (Thursday, April 28, 2005)]
[Notices]
[Pages 22051-22052]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-8497]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
National Center for Environmental Health/Agency for Toxic
Substances and Disease Registry
The Board of Scientific Counselors (BSC), Centers for Disease
Control and Prevention (CDC), National Center for Environmental Health/
Agency for Toxic Substances and Disease Registry (NCEH/ATSDR).
In accordance with section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463), the Centers for Disease Control and
Prevention (CDC) and the National Center for Environmental Health/
Agency for Toxic Substances Disease Registry (ATSDR) announce the
following committee meeting:
Name: Board of Scientific Counselors, National Center for
Environmental Health/Agency for Toxic Substances and Disease Registry.
Times and Dates: 8:30 a.m.-5 p.m., May 19, 2005. 8 a.m.-12:15 p.m.,
May 20, 2005.
Place: CDC facility, 1825 Century Boulevard, Atlanta, GA 30345.
Status: Open to the public for observation, limited only by the
space available. The meeting room
[[Page 22052]]
accommodates approximately 100 people.
Purpose: The Secretary, and by delegation, the Director of the
Centers for Disease Control and Prevention and the Administrator of the
National Center for Environmental Health/Agency for Toxic Substances
and Disease Registry, are authorized under section 301(42 U.S.C. 241)
and section 311 (42 U.S.C. 243) of the Public Health Service Act, as
amended, to (1) conduct, encourage, cooperate with, and assist other
appropriate public authorities, scientific institutions, and scientists
in the conduct of research, investigations, experiments,
demonstrations, and studies relating to the causes, diagnosis,
treatment, control, and prevention of physical and mental diseases and
other impairments; (2) assist states and their political subdivisions
in the prevention of infectious diseases and other preventable
conditions and in the promotion of health and well being; and (3) train
state and local personnel in health work. The Board of Scientific
Counselors, NCEH/ATSDR provides advice and guidance to the Secretary,
HHS; the Director, CDC and Administrator, ATSDR; 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 that
will assist NCEH/ATSDR in ensuring scientific quality, timeliness,
utility, and dissemination of results. The Board also provides guidance
to help NCEH/ATSDR work more efficiently and effectively with its
various constituents and to fulfill its mission in protecting America's
health.
Matters to be Discussed: The agenda items for the meeting on May
19-20, 2004, will include but are not limited to an update on future
initiatives for Environmental Health and Injury Prevention;
presentation on Places Goals and Research Agenda; an update on the
state of NCEH/ATSDR; review of the ATSDR Draft Dioxin Soil Policy
Guideline; presentation on asbestos; discussion on the criteria for
``De-Listing'' chemicals from the CDC's National Report on Human
Exposure to Environmental Chemicals; a discussion on the 3rd National
Report on Human Exposure to Environmental Chemicals and upates by the
subcommittees and workgroup.
Agenda items are tentative and subject to change.
Contact Person for More Information: Individuals interested in
attending the meeting, please contact Sandra Malcom, Committee
Management Specialist, NCEH/ATSDR, 1600 Clifton Road, Mail Stop E-28,
Atlanta, GA 30303; telephone (404) 498-0003, Fax (404) 498-0059; e-
mail: smalcom@cdc.gov. The deadline for notification of attendance is
May 13, 2005.
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: April 21, 2005.
B. Kathy Skipper,
Acting Director, Management Analysis and Services Office, Centers for
Disease Control and Prevention.
[FR Doc. 05-8497 Filed 4-27-05; 8:45 am]
BILLING CODE 4163-18-P