National Advisory Council on Migrant Health; Notice of Meeting, 48698-48699 [2010-19751]
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48698
Federal Register / Vol. 75, No. 154 / Wednesday, August 11, 2010 / Notices
date of this Federal Register notice to
seek either CLIA inspection by the State
Agency where the laboratory is located
or accreditation with another
accrediting organization that is
currently CMS-approved for the
specialty of Pathology.
This notice only addresses COLA’s
accreditation for the specialty of
Pathology. As discussed below, COLA’s
accreditation status in the other
specialties is not affected by this notice.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–2363–N]
Medicare, Medicaid and CLIA
Programs; COLA (Formerly the
Commission on Office Laboratory
Accreditation) Voluntary Withdrawal
From the Specialty of Pathology
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
This notice announces
COLA’s voluntary withdrawal from the
specialty of Pathology. COLA is an
accreditation organization for clinical
laboratories under the Clinical
Laboratory Improvement Amendments
(CLIA) program.
DATES: Effective Date: This notice is
effective on August 27, 2010.
FOR FURTHER INFORMATION CONTACT:
Raelene Perfetto, (410) 786–6876.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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I. Background
In a Federal Register notice published
on February 23, 2007(72 FR 8171), we
granted COLA approval as an
accreditation organization under 42 CFR
part 493 subpart E. The approval was
effective from February 23, 2007 until
February 25, 2013. During this time,
COLA was allowed to accredit
laboratories for purposes of establishing
their compliance with CLIA
requirements in the following specialty
and subspecialty areas:
• Microbiology, including
Bacteriology, Mycobacteriology,
Mycology, Parasitology, Virology.
• Diagnostic Immunology, including
Syphilis Serology, General Immunology.
• Chemistry, including Routine
Chemistry, Urinalysis, Endocrinology,
Toxicology.
• Hematology.
• Immunohematology, Including
ABO Group and Rh Group, Antibody
Detection, Antibody Identification,
Compatibility Testing.
• Pathology, including
Histopathology, Oral Pathology,
Cytology.
In a letter dated June 15, 2010, COLA
provided official notice of its intent to
voluntarily withdraw from accreditation
in the specialty of Pathology. This
withdrawal was effective June 30, 2010.
All laboratories accredited by COLA in
the specialty of Pathology (to include
Histopathology, Oral Pathology or
Cytology) will have 60 days from the
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II. Provisions of the Notice
This notice announces COLA’s
withdrawal as an accreditation
organization from the specialty of
Pathology. COLA retains deeming
authority as an accreditation
organization under 42 CFR part 493
subpart E in a number of specialties. It
may continue to accredit laboratories for
purposes of establishing their
compliance with CLIA requirements in
the following specialty and subspecialty
areas:
• Microbiology, including
Bacteriology, Mycobacteriology,
Mycology, Parasitology, Virology.
• Diagnostic Immunology, including
Syphilis Serology, General Immunology.
• Chemistry, including Routine
Chemistry, Urinalysis, Endocrinology,
Toxicology.
• Hematology.
• Immunohematology, including
ABO Group and Rh Group, Antibody
Detection, Antibody Identification,
Compatibility Testing.
A. Options for Laboratories Testing in
Both Pathology and Other Specialties
and Subspecialties
Laboratories currently accredited by
COLA and performing testing in both
the specialty of Pathology (to include
Histopathology, Oral Pathology, or
Cytology) and the other specialties and
subspecialties for which COLA retains
deeming authority may choose one of
the following courses of action:
• Remain with COLA for purposes of
the accreditation of non-Pathology
specialties and subspecialties only and
seek accreditation services for Pathology
from another CMS-approved accrediting
organization. The Certificate of
Accreditation (CoA) will remain.
• Seek certification for all applicable
specialties and subspecialties from the
State Agency where the laboratory is
located. A laboratory may not combine
accreditation from a CMS-approved
accrediting organization with a
certification from the State Agency
where the laboratory is located.
Laboratories must seek a single path,
either accreditation through one or more
accreditation organizations with the
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appropriate deeming authorities, or
certification through the appropriate
State Agency.
B. Options for Laboratories Testing Only
in Pathology
Laboratories currently accredited by
COLA and performing testing in only
the specialty of Pathology (to include
Histopathology, Oral Pathology or
Cytology) have the following options:
• Seek CLIA accreditation with
another CMS-approved accrediting
organization that currently possesses
deeming authority in the specialty of
Pathology.
• Seek certification with the State
Agency where the laboratory is located.
III. Collection of Information
Requirements
This document does not impose
information collection and
recordkeeping requirements.
Consequently, it need not be reviewed
by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995.
Authority: Section 353 of the Public
Health Service Act (42 U.S.C. 263a).
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance Program; No. 93.774, Medicare—
Supplementary Medical Insurance Program;
and No. 93.778, Medical Assistance
Program.)
Dated: July 27, 2010.
Donald M. Berwick,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2010–19675 Filed 8–10–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Advisory Council on Migrant
Health; Notice of Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
of the following meeting:
Name: National Advisory Council on
Migrant Health.
Dates and Times: October 19, 2010, 8:30
a.m. to 5 p.m. October 20, 2010, 8:30 a.m. to
5 p.m.
Place: Charleston Marriott Hotel, 170
Lockwood Boulevard, Charleston, South
Carolina 29403, Telephone: 800–968–3569,
Fax: 843–723–0276.
Status: The meeting will be open to the
public.
Purpose: The purpose of the meeting is to
discuss services and issues related to the
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Federal Register / Vol. 75, No. 154 / Wednesday, August 11, 2010 / Notices
health of migrant and seasonal farmworkers
and their families and to formulate
recommendations for the Secretary of Health
and Human Services.
Agenda: The agenda includes an overview
of the Council’s general business activities.
The Council will also hear presentations
from experts on farmworker issues, including
the status of farmworker health at the local
and national levels.
The Council meeting is being held in
conjunction with the East Coast Migrant
Stream Forum sponsored by the North
Carolina Community Health Center
Association, which is being held in
Charleston, South Carolina, October 21–23,
2010.
Agenda items are subject to change as
priorities indicate.
For Further Information Contact: Marcia
Gomez, M.D., Office of Minority and Special
Populations, Bureau of Primary Health Care,
Health Resources and Services
Administration, 5600 Fishers Lane, Maryland
20857; telephone (301) 594–4897.
Dated: August 5, 2010.
Wendy Ponton,
Director, Office of Management.
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Cancer Institute; Notice of
Closed Meeting
sroberts on DSKD5P82C1PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Cancer
Institute Initial Review Group, Subcommittee
I—Career Development, NCI–I Career
Development.
Date: September 21, 2010.
Time: 8 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Alexandria Old Town, 1767
King Street, Alexandria, VA 22314.
Contact Person: Sergei Radaev, PhD,
Scientific Review Officer, Resources and
Training Review Branch, Division of
Extramural Activities, National Cancer
Institute, NIH, 6116 Executive Blvd, Rm
16:52 Aug 10, 2010
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Dated: August 4, 2010.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2010–19787 Filed 8–10–10; 8:45 am]
[FR Doc. 2010–19783 Filed 8–10–10; 8:45 am]
BILLING CODE 4140–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Food and Drug Administration
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the CDC announces
the following meeting of
aforementioned subcommittee:
National Institutes of Health
the meeting should contact Mark Byers,
Telephone: (770) 488–8619, E-mail:
mbyers@cdc.gov. The deadline for
notification of attendance is August 13, 2010.
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: August 5, 2010.
Anna Snouffer,
Deputy Director, Office of Federal Advisory
Committee Policy.
Advisory Committee to the Director
(ACD), Centers for Disease Control and
Prevention (CDC)—National
Biosurveillance Advisory
Subcommittee (NBAS)
[FR Doc. 2010–19751 Filed 8–10–10; 8:45 am]
VerDate Mar<15>2010
8113, Bethesda, Md 20892, 301–435–5655,
sradaev@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
48699
Time and Date: 8 a.m.–3:30 p.m., August
24, 2010.
Place: Emory Conference Center Hotel,
1615 Clifton Road, N.E., Atlanta, GA 30329.
Status: Open to the public, limited only by
the space available. The meeting room
accommodates approximately 75 people. The
public is welcome to participate during the
public comment periods. The public
comment periods are tentatively scheduled
for 10 a.m.–10:05 a.m. and 3:25 p.m.–
3:30 p.m.
Purpose: As a subcommittee to the CDC’s
ACD, the NBAS will provide counsel to the
CDC and the Federal government through the
ACD regarding a broad range of human
health surveillance issues arising from the
development and implementation of a
roadmap for the human health component of
a national biosurveillance system.
Matters to be Discussed: Agenda items will
include establishing task force action plans
for developing recommendations and
guidance in order to expand and strengthen
the national portfolio of activities in
biosurveillance practice and scientific
assessment.
The agenda is subject to change as
priorities dictate.
Contact Person for More Information:
Pamela Diaz, M.D., Designated Federal
Officer, ACD,CDC—NBAS, 1600 Clifton
Road, NE., M/S E–33, Atlanta, GA 30333.
Telephone: (770) 488–8806. E-mail:
pdiaz@cdc.gov. For security reasons,
members of the public interested in attending
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[Docket No. FDA–2010–N–0004]
[FDA 225–10–0010]
Memorandum of Understanding
Between United States Food and Drug
Administration and the Centers for
Medicare and Medicaid Services
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is providing
notice of a memorandum of
understanding (MOU) between FDA and
the Centers for Medicare and Medicaid
Services (CMS), both part of the U.S.
Department of Health and Human
Services. The purpose of the MOU is to
promote collaboration and enhance
knowledge of efficiency by providing for
the sharing of information and expertise
between the Federal partners. The goals
of the collaboration are to explore ways
to further enhance information sharing
efforts through more efficient and robust
inter-agency activities; promote efficient
utilization of tools and expertise for
product analysis, validation, and risk
identification; and build infrastructure
and processes that meet the common
needs for evaluating the safety, efficacy,
utilization, coverage, payment, and
clinical benefit of drugs, biologics, and
medical devices.
DATES: The agreement became effective
June 25, 2010.
FOR FURTHER INFORMATION CONTACT:
David H. Dorsey, Office of Policy,
Planning and Budget, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, rm. 4222, Silver Spring,
MD 20993, 301–796–4800.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 20.108(c),
SUMMARY:
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Agencies
[Federal Register Volume 75, Number 154 (Wednesday, August 11, 2010)]
[Notices]
[Pages 48698-48699]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-19751]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
National Advisory Council on Migrant Health; Notice of Meeting
In accordance with section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463), notice is hereby given of the following
meeting:
Name: National Advisory Council on Migrant Health.
Dates and Times: October 19, 2010, 8:30 a.m. to 5 p.m. October
20, 2010, 8:30 a.m. to 5 p.m.
Place: Charleston Marriott Hotel, 170 Lockwood Boulevard,
Charleston, South Carolina 29403, Telephone: 800-968-3569, Fax: 843-
723-0276.
Status: The meeting will be open to the public.
Purpose: The purpose of the meeting is to discuss services and
issues related to the
[[Page 48699]]
health of migrant and seasonal farmworkers and their families and to
formulate recommendations for the Secretary of Health and Human
Services.
Agenda: The agenda includes an overview of the Council's general
business activities. The Council will also hear presentations from
experts on farmworker issues, including the status of farmworker
health at the local and national levels.
The Council meeting is being held in conjunction with the East
Coast Migrant Stream Forum sponsored by the North Carolina Community
Health Center Association, which is being held in Charleston, South
Carolina, October 21-23, 2010.
Agenda items are subject to change as priorities indicate.
For Further Information Contact: Marcia Gomez, M.D., Office of
Minority and Special Populations, Bureau of Primary Health Care,
Health Resources and Services Administration, 5600 Fishers Lane,
Maryland 20857; telephone (301) 594-4897.
Dated: August 5, 2010.
Wendy Ponton,
Director, Office of Management.
[FR Doc. 2010-19751 Filed 8-10-10; 8:45 am]
BILLING CODE 4165-15-P