Los Alamos Historical Document Retrieval and Assessment (LAHDRA) Project, 72829 [2010-29778]
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Federal Register / Vol. 75, No. 227 / Friday, November 26, 2010 / Notices
The estimate of the time required for
record preparation and maintenance is
based on Agency communications with
industry. Other information needed to
calculate the total burden hours (i.e.,
manufacturing sites, number of type A
medicated articles being manufactured,
etc.) are derived from Agency records
and experience.
Dated: November 19, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–29687 Filed 11–24–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Los Alamos Historical Document
Retrieval and Assessment (LAHDRA)
Project
srobinson on DSKHWCL6B1PROD with NOTICES
The Centers for Disease Control and
Prevention (CDC) and the Agency for
Toxic Substances and Disease Registry
(ATSDR) announces the following
meeting.
Name: Public Meeting to release CDC’s
recommendations to the Department of
Energy resulting from the release of the Final
Report of the Los Alamos Historical
Document Retrieval and Assessment
(LAHDRA)Project.
Time and Date: 5 p.m.–7 p.m., (Mountain
Time), Wednesday, December 8, 2010 and 5
p.m.–7 p.m. Thursday, December 9, 2010.
Place: December 8, 2010, Santa Claran
Hotel & Casino in Espanola (25 miles north
of Santa Fe on US 84/285), 460 Riverside
Drive, Espanola, New Mexico 87532,
telephone 877–505–4949.
December 9, 2010, Tularosa Senior &
Community Center in Tularosa (14 miles
north of Alamogordo on US 70), 1050
Bookout Rd., Tularosa, New Mexico 88352,
telephone 575–585–4532.
Status: Open to the public, limited only by
the space available. The meeting room(s)
accommodates approximately 100 people.
Background: Under a Memorandum of
Understanding (MOU) signed in December
1990 with the Department of Energy (DOE)
and replaced by MOUs signed in 1996 and
2000, the Department of Health and Human
Services (HHS) was given the responsibility
and resources for conducting analytic
epidemiologic investigations of residents of
communities in the vicinity of DOE facilities,
workers at DOE facilities, and other persons
potentially exposed to radiation or to
potential hazards from non-nuclear energy
production use. HHS delegated program
responsibility to CDC.
In addition, a memo was signed in October
1990 and renewed in November 1992, 1996,
and in 2000, between the Agency for Toxic
Substances and Disease Registry (ATSDR)
and DOE. The MOU delineates the
responsibilities and procedures for ATSDR’s
VerDate Mar<15>2010
16:32 Nov 24, 2010
Jkt 223001
public health activities at DOE sites required
under sections 104, 105, 107, and 120 of the
Comprehensive Environmental Response,
Compensation, and Liability Act (CERCLA or
a Superfund). These activities include health
consultations and public health assessments
at DOE sites listed on, or proposed for, the
Superfund National Priorities List and at
sites that are the subject of petitions from the
public; and other health-related activities
such as epidemiologic studies, health
surveillance, exposure and disease registries,
health education, substance-specific applied
research, emergency response, and
preparation of toxicological profiles.
Purpose: This study group was charged
with locating, evaluating, cataloguing, and
copying documents that contain information
about historical chemical or radionuclide
releases from facilities at the Los Alamos
National Laboratory and Trinity Site since its
inception. The purpose of this meeting is to
release the CDC’s recommendations to the
Department of Energy as a result of the
release of the Final Report (https://
www.Lahdra.org).
Matters to Be Discussed: Agenda items for
the December 8th meeting include a
presentation from the National Center for
Environmental Health (NCEH) and poster
sessions on various report topics. There will
be time for the public to ask questions. At the
December 9th meeting, ChemRisk personnel
will present on the Final Report’s Trinity Site
chapter. All agenda items are subject to
change as priorities dictate.
Contact Person for Additional Information:
Phillip R. Green, Public Health Advisor,
Radiation Studies Branch, Division of
Environmental Hazards and Health Effects,
NCEH, CDC, 1600 Clifton Road, NE.,
(Mailstop F–58), Atlanta, Georgia 30333,
telephone 770/488–3748, fax 770/488–1539,
or e-mail address: prg1@cdc.gov.
Dated: November 19, 2010.
Tanja Popovic,
Deputy Associate Director for Science,
Centers for Disease Control and Prevention.
[FR Doc. 2010–29778 Filed 11–24–10; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2010–M–0402, FDA–
2010–M–0361, and FDA–2010–M–0519]
Medical Devices; Availability of Safety
and Effectiveness Summaries for
Premarket Approval Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of premarket approval applications
(PMAs) that have been approved. This
list is intended to inform the public of
the availability of safety and
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
72829
effectiveness summaries of approved
PMAs through the Internet and the
Agency’s Division of Dockets
Management.
ADDRESSES: Submit written requests for
copies of summaries of safety and
effectiveness data to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Please cite the appropriate docket
number as listed in table 1 of this
document when submitting a written
request. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the summaries of safety and
effectiveness.
FOR FURTHER INFORMATION CONTACT:
Nicole Wolanski, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 1650, Silver Spring,
MD 20993–0002, 301–796–6570.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 30,
1998 (63 FR 4571), FDA published a
final rule that revised 21 CFR 814.44(d)
and 814.45(d) to discontinue individual
publication of PMA approvals and
denials in the Federal Register. Instead,
the Agency now posts this information
on the Internet on FDA’s home page at
https://www.fda.gov. FDA believes that
this procedure expedites public
notification of these actions because
announcements can be placed on the
Internet more quickly than they can be
published in the Federal Register, and
FDA believes that the Internet is
accessible to more people than the
Federal Register.
In accordance with section 515(d)(4)
and (e)(2) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C.
360e(d)(4) and (e)(2)), notification of an
order approving, denying, or
withdrawing approval of a PMA will
continue to include a notice of
opportunity to request review of the
order under section 515(g) of the FD&C
Act. The 30-day period for requesting
reconsideration of an FDA action under
§ 10.33(b) (21 CFR 10.33(b)) for notices
announcing approval of a PMA begins
on the day the notice is placed on the
Internet. Section 10.33(b) provides that
FDA may, for good cause, extend this
30-day period. Reconsideration of a
denial or withdrawal of approval of a
PMA may be sought only by the
applicant; in these cases, the 30-day
period will begin when the applicant is
notified by FDA in writing of its
decision.
The regulations provide that FDA
publish a quarterly list of available
E:\FR\FM\26NON1.SGM
26NON1
]]>Agencies
[Federal Register Volume 75, Number 227 (Friday, November 26, 2010)]
[Notices]
[Page 72829]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-29778]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Los Alamos Historical Document Retrieval and Assessment (LAHDRA)
Project
The Centers for Disease Control and Prevention (CDC) and the Agency
for Toxic Substances and Disease Registry (ATSDR) announces the
following meeting.
Name: Public Meeting to release CDC's recommendations to the
Department of Energy resulting from the release of the Final Report
of the Los Alamos Historical Document Retrieval and Assessment
(LAHDRA)Project.
Time and Date: 5 p.m.-7 p.m., (Mountain Time), Wednesday,
December 8, 2010 and 5 p.m.-7 p.m. Thursday, December 9, 2010.
Place: December 8, 2010, Santa Claran Hotel & Casino in Espanola
(25 miles north of Santa Fe on US 84/285), 460 Riverside Drive,
Espanola, New Mexico 87532, telephone 877-505-4949.
December 9, 2010, Tularosa Senior & Community Center in Tularosa
(14 miles north of Alamogordo on US 70), 1050 Bookout Rd., Tularosa,
New Mexico 88352, telephone 575-585-4532.
Status: Open to the public, limited only by the space available.
The meeting room(s) accommodates approximately 100 people.
Background: Under a Memorandum of Understanding (MOU) signed in
December 1990 with the Department of Energy (DOE) and replaced by
MOUs signed in 1996 and 2000, the Department of Health and Human
Services (HHS) was given the responsibility and resources for
conducting analytic epidemiologic investigations of residents of
communities in the vicinity of DOE facilities, workers at DOE
facilities, and other persons potentially exposed to radiation or to
potential hazards from non-nuclear energy production use. HHS
delegated program responsibility to CDC.
In addition, a memo was signed in October 1990 and renewed in
November 1992, 1996, and in 2000, between the Agency for Toxic
Substances and Disease Registry (ATSDR) and DOE. The MOU delineates
the responsibilities and procedures for ATSDR's public health
activities at DOE sites required under sections 104, 105, 107, and
120 of the Comprehensive Environmental Response, Compensation, and
Liability Act (CERCLA or a Superfund). These activities include
health consultations and public health assessments at DOE sites
listed on, or proposed for, the Superfund National Priorities List
and at sites that are the subject of petitions from the public; and
other health-related activities such as epidemiologic studies,
health surveillance, exposure and disease registries, health
education, substance-specific applied research, emergency response,
and preparation of toxicological profiles.
Purpose: This study group was charged with locating, evaluating,
cataloguing, and copying documents that contain information about
historical chemical or radionuclide releases from facilities at the
Los Alamos National Laboratory and Trinity Site since its inception.
The purpose of this meeting is to release the CDC's recommendations
to the Department of Energy as a result of the release of the Final
Report (https://www.Lahdra.org).
Matters to Be Discussed: Agenda items for the December 8th
meeting include a presentation from the National Center for
Environmental Health (NCEH) and poster sessions on various report
topics. There will be time for the public to ask questions. At the
December 9th meeting, ChemRisk personnel will present on the Final
Report's Trinity Site chapter. All agenda items are subject to
change as priorities dictate.
Contact Person for Additional Information: Phillip R. Green,
Public Health Advisor, Radiation Studies Branch, Division of
Environmental Hazards and Health Effects, NCEH, CDC, 1600 Clifton
Road, NE., (Mailstop F-58), Atlanta, Georgia 30333, telephone 770/
488-3748, fax 770/488-1539, or e-mail address: prg1@cdc.gov.
Dated: November 19, 2010.
Tanja Popovic,
Deputy Associate Director for Science, Centers for Disease Control and
Prevention.
[FR Doc. 2010-29778 Filed 11-24-10; 8:45 am]
BILLING CODE 4163-18-P
