[Federal Register: June 23, 2005 (Volume 70, Number 120)]
[Notices]
[Page 36388-36389]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23jn05-52]
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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
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(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