[Federal Register Volume 70, Number 120 (Thursday, June 23, 2005)]
[Notices]
[Pages 36388-36389]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-12411]


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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

[[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: [email protected].
    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: [email protected].

    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