[Federal Register Volume 68, Number 131 (Wednesday, July 9, 2003)]
[Notices]
[Pages 40959-40961]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-17305]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 03117]


Initiative To Integrate Clinical Laboratories in Public Health 
Laboratory Testing; Notice of Availability of Funds

    Application Deadline: August 8, 2003.

A. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under section 317(k)(2) of the Public 
Health Service Act, 42 U.S.C. 247b(k)(2), as amended. The Catalog of 
Federal Domestic Assistance number is 93.283.

B. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 2003 funds for a cooperative agreement 
program regarding an Initiative to Integrate Clinical Laboratories in 
Public Health Testing. This program addresses the ``Healthy People 
2010'' focus areas of Access to Quality Health Services, and Public 
Health Infrastructure.
    The purpose of the program is to demonstrate the potential ways in 
which clinical laboratories may be better prepared to conduct public 
health related testing and participate in the public health system. 
Activities must revolve around national priorities for public health 
testing, such as those related to antimicrobial susceptibility, 
hepatitis C virus, HIV/AIDS, rapid HIV testing, foodborne diseases, 
sexually transmitted diseases, West Nile Virus, and other diseases of 
public health significance. Specifically, activities should center on 
investigating shortcomings in the delivery of medical and public health 
laboratory services, creating and demonstrating new approaches to 
create and implement voluntary laboratory practice standards, assessing 
the factors that impact why voluntary standards are or are not followed 
by clinical laboratories, training clinical laboratorians to better 
understand and adhere to voluntary national guidelines for testing and, 
as applicable, reporting results to public health authorities in the 
areas listed above. To the extent possible, the investigator(s) should 
demonstrate the possibilities for conducting some of the above 
activities in regional (inter-state) settings, and possibly in 
collaboration with Indian Health Service (IHS) clinical laboratories.
    Measurable outcomes of the program will be in alignment with one or 
more of the following performance goals for the Public Health Practice 
Program Office: Increase the number of frontline public health workers 
at the state, tribal and local level that are competent to respond to 
bioterrorism, other infectious disease outbreaks, and other public 
health threats and emergencies, and prepare frontline state and local 
health departments and laboratories to respond to current and emerging 
public health threats.

C. Eligible Applicants

    Applications may be submitted by:
    [sbull] Public nonprofit organizations
    [sbull] Private nonprofit organizations
    [sbull] Universities
    [sbull] Research institutions
    [sbull] Faith-based organizations
    [sbull] State, tribal, and local governments or their bona fide 
agents (this includes the District of Columbia, the Commonwealth of 
Puerto Rico, the Virgin Islands, the Commonwealth of the Northern 
Marianna Islands, American Samoa, Guam, the Federated States of 
Micronesia, the Republic of the Marshall Islands, and the Republic of 
Palau)
    Consideration will be given to those entities that are expected to 
have sufficient resources in terms of expertise in public health 
laboratory testing and medical microbiology to investigate and 
determine the influence on the delivery of public health laboratory 
testing. Important resources include standing advisory organizations 
composed of public health and private laboratorians, access to local 
and national subject matter experts, and demonstrated credibility in 
building laboratory partnerships.

    Note: Title 2 of the United States Code section 1611 states that 
an organization described in section 501(c)(4) of the Internal 
Revenue Code that engages in lobbying activities is not eligible to 
receive Federal funds constituting an award, grant or loan.

D. Funding

    Availability of Funds: Approximately $200,000 is available in FY 
2003 to fund approximately one award. It is expected that the average 
award will be $200,000, ranging from $180,000 to $220,000. It is 
expected that the award will begin on or about September 15, 2003 and 
will be made for a 12-month budget period within a project period of up 
to three budget years. Funding estimates may change.
    Continuation awards within an approved project period will be made 
on the basis of satisfactory progress as evidenced by required reports 
and the availability of funds.
    Recipient Financial Participation: Matching funds are not required 
for this program.
    Funding Preferences: Funding preferences will be given to those 
entities that have demonstrated significant expertise in microbiology 
and public health testing and that have available resources that can be 
leveraged. Important resources include standing advisory organizations 
composed of public health and private laboratorians, access to local 
and national subject matter experts, and demonstrated credibility in 
building laboratory partnerships.

E. Program Requirements

    In conducting activities to achieve the purpose of this program, 
the recipient will be responsible for the activities listed in 1. 
Recipient Activities, and 2. Optional Recipient Activities, and CDC 
will be responsible for the activities listed in 3. CDC Activities.
    1. Required Recipient Activities:
    (a) Collaborate with CDC, including subject matter experts, to 
determine specific programs (STDs, antimicrobial susceptibility 
testing, etc.) that could be selected as the best models for 
demonstrating the local and regional benefits of improved integration 
of clinical laboratories into the delivery of testing that has public 
health implications.
    (b) Identify training needs and work with laboratory training 
experts, including the American Society for Clinical Pathology (ASCP) 
and the National Laboratory Training Network (NLTN), and conduct 
training to improve laboratory practices in areas of national priority, 
as mentioned in the purpose section of this announcement. To the extent 
possible, all training should be evaluated for its impact on knowledge 
and practices.
    2. Optional Recipient Activities:
    (a) Select ways to link clinical laboratories into the public 
health system using communication and promotion, which may include 
newsletters, e-mails, websites, teleconferences, site visits, etc.
    (b) Determine factors that affect adherence to voluntary 
guidelines, such as the National Committee for Clinical Laboratory 
Standards (NCCLS) guidelines for antimicrobial susceptibility testing, 
or CDC Morbidity and Mortality Weekly Reports (MMWR) Recommendations 
and Reports, or locally derived laboratory practice standards.
    (c) Work with local and national stakeholders to identify the need 
for

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additional laboratory practice guidelines and then, through a consensus 
process, draft and implement needed guidelines.
    (d) Determine the factors that influence the delivery of medical 
and public health laboratory testing services. This may involve 
providers (laboratorians) and/or users (physicians and medical staff) 
of these testing services.
    3. CDC Activities:
    (a) Provide assistance as requested, especially subject matter 
expertise on specific public health programs that depend upon 
laboratory testing.
    (b) Provide, if requested, access to and technical support for the 
National Laboratory Database, a searchable index of clinical and public 
health laboratories, which provides testing capabilities and contact 
information.
    (c) If requested, assist with survey design, validation and 
statistical analysis.
    (d) Provide graphic art support, as requested.
    (e) Make available consultation on performance of outcomes 
assessments, including training and any other systematic interventions.
    (f) Collaborate to leverage findings through partnerships with the 
NLTN, Association of Public Health Laboratories, the ASCP, and others.
    (g) Assist, if requested, in the development of a study protocol 
for review by all cooperating partnership institutions participating in 
the project.

F. Content

Applications

    The Program Announcement title and number must appear in the 
application. Use the information in the Program Requirements, Other 
Requirements, and Evaluation Criteria sections to develop the 
application content. Your application will be evaluated on the criteria 
listed, so it is important to follow them in laying out your program 
plan. The narrative should be no more than 50 pages, double-spaced, 
printed on one side, with one inch margins, and unreduced 12-point 
font.
    The narrative should consist of Background (including relevant 
activities by the recipient), Plan, Objectives, Methods, Evaluation and 
Budget.
    The plan should address activities to be conducted over the entire 
three year project period. The plan for year one should be detailed, 
while the plan can be brief for years two through three.

G. Submission and Deadline

    Application Forms: Submit the signed original and two copies of PHS 
5161-1 (OMB Number 0920-0428). Forms are available at the following 
Internet address: http://www.cdc.gov/od/pgo/forminfo.htm.
    If you do not have access to the Internet, or if you have 
difficulty accessing the forms on-line, you may contact the CDC 
Procurement and Grants Office Technical Information Management Section 
(PGO-TIM) at: 770-488-2700. Application forms can be mailed to you.
    Submission Date, Time, and Address: The application must be 
received by 4 p.m. Eastern Time, August 8, 2003. Submit the application 
to: Technical Information Management--PA03117, CDC Procurement 
and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341-4146.
    Applications may not be submitted electronically.
    A postcard will be mailed by PGO-TIM, notifying you that CDC has 
received your application.
    Deadline: Applications shall be considered as meeting the deadline 
if they are received before 4 p.m. Eastern Time on the deadline date. 
Any applicant who sends their application by the United States Postal 
Service or commercial delivery services must ensure that the carrier 
will be able to guarantee delivery of the application by the closing 
date and time. If an application is received after closing due to (1) 
carrier error, when the carrier accepted the package with a guarantee 
for delivery by the closing date and time, or (2) significant weather 
delays or natural disasters, CDC will upon receipt of proper 
documentation, consider the application as having been received by the 
deadline. Any application that does not meet the above criteria will 
not be eligible for competition, and will be discarded. The applicant 
will be notified of their failure to meet the submission requirements.

H. Evaluation Criteria

    Application: Applicants are required to provide measures of 
effectiveness that will demonstrate the accomplishment of the various 
identified objectives of the cooperative agreement. Measures of 
effectiveness must relate to the performance goals stated in the 
purpose section of this announcement. Measures must be objective and 
quantitative and must measure the intended outcome. These measures of 
effectiveness must be submitted with the application and will be an 
element of evaluation.
    An independent review group appointed by CDC will evaluate each 
application against the following criteria:
    1. Methods (30 points): The extent to which the applicant's 
proposal demonstrates the necessary approaches to be used in 
accomplishing the activities.
    2. Objectives (20 points):
    a. The applicant's proposal should describe program objectives that 
fit the activities in the application, including specific outcomes.
    b. The extent to which the applicant describes objectives that are 
specific, measurable, and feasible, including a reasonable schedule for 
implementation.
    3. Plan (20 points):
    a. The extent to which the proposed plan demonstrates the 
applicant's understanding of the issues.
    b. The extent to which the applicant describes a proposed plan for 
collaboration with CDC to accomplish the proposed activities.
    c. The extent to which the proposed activities are capable of 
achieving the intent of this program announcement.
    d. The plan should address activities to be conducted over the 
entire three-year project period.
    5. Evaluation (20 points): The quality of the applicant's plan for 
evaluating the proposed program activities.
    6. Background (10 points):
    a. The applicant's proposal should demonstrate an understanding of 
the need to better integrate activities between public health 
laboratories and private, clinical laboratories.
    b. The importance of the chosen public health problem(s) should be 
clearly elaborated and the relevance to CDC goals should be clarified.
    7. Budget (reviewed, but not scored): The extent to which the 
budget is appropriate, reasonable, justified, and consistent in 
relation to the activities proposed.
    8. Performance Goals (reviewed but not scored): The extent to which 
the application the performance goals listed in the purpose section of 
this announcement.
    9. Does the application adequately address the requirements of 
Title 45 CFR part 46 for the protection of human subjects? Not scored; 
however, an application can be disapproved if the research risks are 
sufficiently serious and protection against risks is so inadequate as 
to make the entire application unacceptable.

I. Other Requirements

    Technical Reporting Requirements: Provide CDC with original plus 
two copies of:
    1. Interim progress report, no less than 90 days before the end of 
the budget period. The progress report will

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serve as your non-competing continuation application, and must contain 
the following elements:
    a. Current Budget Period Activities Objectives.
    b. Current Budget Period Financial Progress.
    c. New Budget Period Program Proposed Activity Objectives.
    d. Detailed Line-Item Budget and Justification.
    e. Additional Requested Information.
    2. Financial status report, no more than 90 days after the end of 
the budget period.
    3. Final financial and performance reports, no more than 90 days 
after the end of the project period.
    Send all reports to the Grants Management Specialist identified in 
the ``Where to Obtain Additional Information'' section of this 
announcement.
    Additional Requirements: The following additional requirements are 
applicable to this program. For a complete description of each, see 
Attachment I of the program announcement, as posted on the CDC web 
site.

AR-10 Smoke-Free Workplace Requirements
AR-11 Healthy People 2010
AR-12 Lobbying Restrictions
AR-15 Proof of Non-Profit Status

    Executive Order 12372 does not apply to this program.

J. Where To Obtain Additional Information

    This and other CDC announcements, the necessary applications, and 
associated forms can be found on the CDC web site, Internet address: 
http://www.cdc.gov Click on ``Funding'' then ``Grants and Cooperative 
Agreements''.
    For general 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 business management and budget assistance, contact: Deborah 
Workman, Contract Specialist, CDC Procurement and Grants Office, 2920 
Brandywine Road, Atlanta, GA 30341-4146, Telephone: (770) 488-2085, E-
mail address: [email protected].
    For program technical assistance, contact: J. Rex Astles, Ph.D., 
Office of Laboratory Systems Development, Division of Laboratory 
Systems (Mail Stop G-25), CDC Public Health Practice Program Office, 
4770 Buford Hwy., NE., Atlanta, GA 30341-3717, Telephone: (770) 488-
8052, E-mail address: [email protected].

    Dated: July 1, 2003.
Edward Schultz,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 03-17305 Filed 7-8-03; 8:45 am]
BILLING CODE 4163-18-P