Capacity Building Assistance for Global HIV/AIDS Laboratory Guidelines and Standards Development and Enhancing Laboratory Quality Improvement Skills Through Quality Systems Approach; Notice of Intent To Fund Single Eligibility Award, 36388-36389 [05-12411]
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36388
Federal Register / Vol. 70, No. 120 / Thursday, June 23, 2005 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Request for Application (RFA) AA014]
Supporting Laboratory Training and
Quality Improvement for Diagnosis and
Laboratory Monitoring of HIV/AIDS
Patients in Resource Limited Countries
Through Collaboration With the
American Society for Clinical
Pathology (ASCP); Notice of Intent To
Fund Single Eligibility Award
A. Purpose
The Centers for Disease Control and
Prevention (CDC) announces the intent
to award fiscal year (FY) 2005 funds for
a cooperative agreement program to
support laboratory training and quality
improvement for diagnosis and
laboratory monitoring of HIV/AIDS
patients in resource-limited countries
that are part of the President’s
Emergency Plan for AIDS Relief
(PEPFAR). Ultimately, this program will
serve to enhance laboratory testing
practices, and enhance the quality of
laboratory testing services, in order to
improve the effectiveness of HIV
diagnostic, care, and treatment services
and interventions. The Catalog of
Federal Domestic Assistance number for
this program is 93.067.
B. Eligible Applicant
Assistance will be provided only to
the American Society for Clinical
Pathology (ASCP) for this project. No
other applications are solicited or will
be accepted. ASCP is a not-for-profit
organization that has the largest and
most unique data base of certified
medical laboratory testing personnel.
ASCP will be the only eligible applicant
for the following reasons:
1. ASCP is the largest and most
influential leader in the certification of
Medical Technologists (MTs) and
Medical Laboratory Technicians (MLTs)
in the world.
2. ASCP is the world’s largest
organization representing the entire
laboratory team of pathologists, clinical
scientists, MTs and MLTs.
3. The Board of Registry (BOR) at
ASCP has issued more than 340,000
certificates to date, since ASCP began in
the late 1920’s, and their unique data
base of certified laboratorians comprise
the largest majority of the medical
laboratory work force in the U.S.
4. The ASCP BOR prepares
appropriate standards and develops
procedures to assure the competence of
laboratory personnel.
VerDate jul<14>2003
18:40 Jun 22, 2005
Jkt 205001
5. The ASCP BOR certifies MTs and
other medical laboratory personnel who
meet specific academic and clinical
prerequisites and who can attain
acceptable performance levels through
examination (e.g., MT ASCP
certification).
6. Additionally, ASCP has developed
and maintains the largest continuing
education activity in the world by
offering courses targeted for pathologists
and laboratory personnel to assure
competency.
7. ASCP provides extensive venues
for continuing education for
pathologists and laboratory personnel,
including web-based programs,
teleconferences, on-site education
programs, and regional and national
settings.
PEPFAR activities focus on
responding to an emergency situation
while building long-term in-country
capacity. Because of the complexity of
the laboratory needs in each of the
countries targeted, the number of
countries (25) and regional programs (3)
involved, the organization chosen to
provide support should have both the
technical competence and capacity to
provide high quality simultaneous
support to multiple countries. Selecting
ASCP as the only eligible applicant is
justified because of their vast
membership and outstanding technical
competence. Market research, through
internet searches and interviews with
leaders of laboratory service providers
in international settings, indicates that
ASCP is the only organization that is in
a position to provide the required
services to multiple countries
simultaneously at the greatest value-forservice to the United States
Government.
C. Funding
Approximately $2,000,000 is available
in FY 2005 to fund this award. It is
expected that the award will begin on or
before August 31, 2005, and will be
made for a 12-month budget period
within a project period of up to four
years. Funding estimates may change.
D. Where to Obtain Additional
Information
For general comments or questions
about this announcement, contact:
Technical Information Management,
CDC Procurement and Grants Office,
2920 Brandywine Road, Atlanta, GA
30341–4146, Telephone: 770–488–2700.
For program technical assistance,
contact: Elyse Hill, Project Officer, CDC/
NCHSTP/GAP, 1600 Clifton Road, NE
(MS–E30), Atlanta, GA 30333,
Telephone: 404–639–8181, E-mail:
elh8@cdc.gov.
PO 00000
Frm 00022
Fmt 4703
Sfmt 4703
For financial, grants management, or
budget assistance, contact: Diane
Flournoy, Contract Specialist, CDC
Procurement and Grants Office, 2920
Brandywine Road, Atlanta, GA 30341,
Telephone: 770–488–2072, E-mail:
dmf6@cdc.gov.
Dated: June 17, 2005.
William P. Nichols,
Director, Procurement and Grants Office,
Centers for Disease Control and Prevention.
[FR Doc. 05–12412 Filed 6–22–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Request for Application (RFA) AA013]
Capacity Building Assistance for
Global HIV/AIDS Laboratory Guidelines
and Standards Development and
Enhancing Laboratory Quality
Improvement Skills Through Quality
Systems Approach; Notice of Intent To
Fund Single Eligibility Award
A. Purpose
The Centers for Disease Control and
Prevention (CDC) announces the intent
to award fiscal year (FY) 2005 funds for
a cooperative agreement program to
support capacity building assistance for
global HIV/AIDS laboratory guidelines
and standards development and
enhancing laboratory quality
improvement skills through quality
systems approach. The purpose of the
program is to provide support for the
development and application of easy-touse guidelines and standards for
laboratory testing and quality systems
development, and to foster development
of in-country leaders to implement
laboratory activities in Global AIDS
Program (GAP) and Presidents
Emergency Program for AIDS Relief
(PEPFAR) countries based on
internationally acceptable standards.
The Catalog of Federal Domestic
Assistance number for this program is
93.067.
B. Eligible Applicant
Assistance will be provided only to
the CLSI. No other applications are
solicited or will be accepted. This
announcement and application will be
sent to the CLSI.
The CLSI is the appropriate and only
qualified institution to provide the
services specified under this
cooperative agreement because:
1. CLSI is the only officially
established and accredited United States
E:\FR\FM\23JNN1.SGM
23JNN1
Federal Register / Vol. 70, No. 120 / Thursday, June 23, 2005 / Notices
(U.S.) organization for developing
consensus standards for clinical and
laboratory testing. CLSI members,
approximately 2,000, are organizations
(not individuals) representing the three
major sectors contributing to assuring
the quality of laboratory testing in the
health field. They are the professional
sector, the government sector, and
industry. The professional sector is
comprised of: (a) Clinical and medical
science health services delivery
organizations such as hospitals, health
clinics, public health laboratories; and
(b) clinical and laboratory science
professional organizations. The
government sector is represented by
agencies such as the Centers for Disease
Control and Prevention (a founding
member), the Food and Drug
Administration, the National Institute
for Standards and Technology, and the
Department of Veteran Affairs. The
industry sector is represented by
laboratory device and reagent
manufacturers, the pharmaceutical
industry, and the informatics industry.
2. CLSI is a global, nonprofit,
standards-developing organization that
promotes the development and use of
voluntary consensus standards and
guidelines within the healthcare
community. CLSI is recognized
worldwide for the application of its
unique consensus process. CLSI is based
on the principle that consensus is an
efficient and cost-effective way to
improve patient testing and services.
3. CLSI is a global leader in the
development of medical laboratory
standards.
a. One-fourth of CLSI members are
located outside the U.S.
b. CLSI is the Executive Secretariat for
the International Organization for
Standardization (IOS) Technical
Working Group. The IOS group
develops internationally applicable
medical laboratory testing standards.
c. CLSI is designated the World
Health Organization (WHO)
Collaborating Center for Clinical
Laboratory Standards and Accreditation
d. Standards developed by CLSI are
recognized and used throughout the
world.
4. CLSI portfolio of more than 200
standards is recognized worldwide and
provides a core for modification and
expansion to better meet the needs in
resource limited settings.
5. CLSI volunteers who develop
laboratory standards represent CLSI
member organizations. The volunteers
are recognized as experts and world
leaders. The accredited consensus
process assures that all views are
accounted for and adequately
addressed. Consequently, standards
VerDate jul<14>2003
18:40 Jun 22, 2005
Jkt 205001
developed by CLSI are considered
authoritative and recognized among
federal agencies, large segments of the
health industry, and the professional
sector.
6. CLSI staff and volunteers are
actively engaged in numerous HIV
activities to improve the quality of
testing for diagnosing infection, staging
disease in those infected, monitoring
therapy, and detecting opportunistic
infections. Venues for these interactions
include CLSI workgroups developing
standards in related technical areas,
CLSI’s Limited Resource Laboratories
Working Group, and interaction with
the Forum for Collaborative HIV
Research.
7. CLSI Quality Systems Standards are
a key building block for work that has
already been done by the U.S.
Government efforts to assure laboratory
capacity to meet the needs of HIV
prevention, care and treatment,
surveillance, prevention of mother-tochild-transmission (PMTCT), voluntary
counseling and testing (VCT), and blood
safety programs. Quality systems
training using CLSI standards has
already been initiated in Africa and
Southeast Asia countries. Laboratory
leaders in these countries recognize
CLSI as the world leader in developing
these standards and would value and
consider authoritative and credible
additional contributions by CLSI.
C. Funding
Approximately $6,000,000 is available
in FY 2005 to fund this award. It is
expected that the award will begin on or
before August 31, 2005, and will be
made for a 12-month budget period
within a project period of up to three
years. Funding estimates may change.
D. Where To Obtain Additional
Information
For general comments or questions
about this announcement, contact:
Technical Information Management,
CDC Procurement and Grants Office,
2920 Brandywine Road, Atlanta, GA
30341–4146; Telephone: 770–488–2700.
For program technical assistance,
contact: Elyse Hill, Project Officer, CDC/
NCHSTP/GAP, 1600 Clifton Road, NE.
(MS–E30), Atlanta, GA 30333,
Telephone: 404–639–8181; E-mail:
elh8@cdc.gov.
For financial, grants management, or
budget assistance, contact: Diane
Flournoy, Grants Management
Specialist, CDC Procurement and Grants
Office, 2920 Brandywine Road, Atlanta,
GA 30341, Telephone: 770–488–2072;
E-mail: dmf6@cdc.gov.
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
36389
Dated: June 17, 2005.
William P. Nichols,
Director, Procurement and Grants Office,
Centers for Disease Control and Prevention.
[FR Doc. 05–12411 Filed 6–22–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
STD Surveillance Network (SSuN)
Announcement Type: New.
Funding Opportunity Number:
AA055.
Catalog of Federal Domestic
Assistance Number: 93.977.
Key Dates:
Letter of Intent Deadline: July 8, 2005.
Application Deadline: July 25, 2005.
I. Funding Opportunity Description
Authority: Sections 317(k)(2) and 318
of the Public Health Service Act [42
U.S.C. Sections 247b(k)(2) and 247c], as
amended.
Background: A dynamic STD
surveillance network, comprised of
local enhanced STD surveillance
systems following common protocols,
has the potential to fill several
important gaps in the existing national
STD surveillance system. National STD
surveillance data, reported through the
National Electronic Telecommunication
Surveillance System (NETSS), currently
involves a limited number of
demographic data elements collected
from all states for a limited number of
sexually transmitted diseases
(chancroid, chlamydia, gonorrhea, and
syphilis). Weekly reporting through
NETSS is insufficient for rapid
identification of many trends in disease,
and does not support the collection and
reporting of data on many relevant STD
risk behaviors. Furthermore, even if
trends in disease or risk behaviors are
identified, the national STD morbidity
surveillance infrastructure comprised of
NETSS reporting from all states has
limited capacity to be easily and rapidly
modified. Even though the transition to
the National Electronic Disease
Surveillance System (NEDSS) is
intended to improve the timeliness and
flexibility of national STD surveillance,
the flexibility of national morbidity
reporting will always be restricted by
the scale of the system.
CDC has traditionally relied on
supplemental activities such as
prevalence monitoring projects and
special studies to enhance STD
surveillance at a national level. While
these types of activities focus on
E:\FR\FM\23JNN1.SGM
23JNN1
Agencies
[Federal Register Volume 70, Number 120 (Thursday, June 23, 2005)]
[Notices]
[Pages 36388-36389]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-12411]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Request for Application (RFA) AA013]
Capacity Building Assistance for Global HIV/AIDS Laboratory
Guidelines and Standards Development and Enhancing Laboratory Quality
Improvement Skills Through Quality Systems Approach; Notice of Intent
To Fund Single Eligibility Award
A. Purpose
The Centers for Disease Control and Prevention (CDC) announces the
intent to award fiscal year (FY) 2005 funds for a cooperative agreement
program to support capacity building assistance for global HIV/AIDS
laboratory guidelines and standards development and enhancing
laboratory quality improvement skills through quality systems approach.
The purpose of the program is to provide support for the development
and application of easy-to-use guidelines and standards for laboratory
testing and quality systems development, and to foster development of
in-country leaders to implement laboratory activities in Global AIDS
Program (GAP) and Presidents Emergency Program for AIDS Relief (PEPFAR)
countries based on internationally acceptable standards. The Catalog of
Federal Domestic Assistance number for this program is 93.067.
B. Eligible Applicant
Assistance will be provided only to the CLSI. No other applications
are solicited or will be accepted. This announcement and application
will be sent to the CLSI.
The CLSI is the appropriate and only qualified institution to
provide the services specified under this cooperative agreement
because:
1. CLSI is the only officially established and accredited United
States
[[Page 36389]]
(U.S.) organization for developing consensus standards for clinical and
laboratory testing. CLSI members, approximately 2,000, are
organizations (not individuals) representing the three major sectors
contributing to assuring the quality of laboratory testing in the
health field. They are the professional sector, the government sector,
and industry. The professional sector is comprised of: (a) Clinical and
medical science health services delivery organizations such as
hospitals, health clinics, public health laboratories; and (b) clinical
and laboratory science professional organizations. The government
sector is represented by agencies such as the Centers for Disease
Control and Prevention (a founding member), the Food and Drug
Administration, the National Institute for Standards and Technology,
and the Department of Veteran Affairs. The industry sector is
represented by laboratory device and reagent manufacturers, the
pharmaceutical industry, and the informatics industry.
2. CLSI is a global, nonprofit, standards-developing organization
that promotes the development and use of voluntary consensus standards
and guidelines within the healthcare community. CLSI is recognized
worldwide for the application of its unique consensus process. CLSI is
based on the principle that consensus is an efficient and cost-
effective way to improve patient testing and services.
3. CLSI is a global leader in the development of medical laboratory
standards.
a. One-fourth of CLSI members are located outside the U.S.
b. CLSI is the Executive Secretariat for the International
Organization for Standardization (IOS) Technical Working Group. The IOS
group develops internationally applicable medical laboratory testing
standards.
c. CLSI is designated the World Health Organization (WHO)
Collaborating Center for Clinical Laboratory Standards and
Accreditation
d. Standards developed by CLSI are recognized and used throughout
the world.
4. CLSI portfolio of more than 200 standards is recognized
worldwide and provides a core for modification and expansion to better
meet the needs in resource limited settings.
5. CLSI volunteers who develop laboratory standards represent CLSI
member organizations. The volunteers are recognized as experts and
world leaders. The accredited consensus process assures that all views
are accounted for and adequately addressed. Consequently, standards
developed by CLSI are considered authoritative and recognized among
federal agencies, large segments of the health industry, and the
professional sector.
6. CLSI staff and volunteers are actively engaged in numerous HIV
activities to improve the quality of testing for diagnosing infection,
staging disease in those infected, monitoring therapy, and detecting
opportunistic infections. Venues for these interactions include CLSI
workgroups developing standards in related technical areas, CLSI's
Limited Resource Laboratories Working Group, and interaction with the
Forum for Collaborative HIV Research.
7. CLSI Quality Systems Standards are a key building block for work
that has already been done by the U.S. Government efforts to assure
laboratory capacity to meet the needs of HIV prevention, care and
treatment, surveillance, prevention of mother-to-child-transmission
(PMTCT), voluntary counseling and testing (VCT), and blood safety
programs. Quality systems training using CLSI standards has already
been initiated in Africa and Southeast Asia countries. Laboratory
leaders in these countries recognize CLSI as the world leader in
developing these standards and would value and consider authoritative
and credible additional contributions by CLSI.
C. Funding
Approximately $6,000,000 is available in FY 2005 to fund this
award. It is expected that the award will begin on or before August 31,
2005, and will be made for a 12-month budget period within a project
period of up to three years. Funding estimates may change.
D. Where To Obtain Additional Information
For general comments or questions about this announcement, contact:
Technical Information Management, CDC Procurement and Grants Office,
2920 Brandywine Road, Atlanta, GA 30341-4146; Telephone: 770-488-2700.
For program technical assistance, contact: Elyse Hill, Project
Officer, CDC/NCHSTP/GAP, 1600 Clifton Road, NE. (MS-E30), Atlanta, GA
30333, Telephone: 404-639-8181; E-mail: elh8@cdc.gov.
For financial, grants management, or budget assistance, contact:
Diane Flournoy, Grants Management Specialist, CDC Procurement and
Grants Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: 770-
488-2072; E-mail: dmf6@cdc.gov.
Dated: June 17, 2005.
William P. Nichols,
Director, Procurement and Grants Office, Centers for Disease Control
and Prevention.
[FR Doc. 05-12411 Filed 6-22-05; 8:45 am]
BILLING CODE 4163-18-P