[Federal Register Volume 68, Number 131 (Wednesday, July 9, 2003)]
[Notices]
[Pages 40956-40958]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-17307]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 03119]


Enhancing Testing Practices in the Clinical Laboratory by 
Developing Specific Training Activities for Medical Technologists, 
Medical Laboratory Technicians, and Pathologists; 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 for Enhancing Testing Practices in the Clinical Laboratory by 
Developing Specific Training Activities for Medical Technologists (MT), 
Medical Laboratory Technicians (MLT), and Pathologists. 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 enhance laboratory testing 
practices and the quality of laboratory testing in the United States. 
These enhancements in testing practices and the quality of laboratory 
testing will be related to areas of public health significance such as, 
antimicrobial susceptibility testing, human immunodeficiency virus 
(HIV) rapid testing, testing for genetic disorders, chemical terrorism 
events, other diseases of public health importance, and the 
regulations, (i.e., Clinical Laboratory Improvement Amendments of 1988 
(CLIA)) governing laboratory testing. In addition to enhancing the 
quality of laboratory testing, the cooperative agreement will also 
evaluate the training received by laboratory MTs, MLTs, and 
pathologists to ensure appropriate training efforts are being developed 
and targeted effectively to the work force of laboratorians located in 
clinical laboratories across the United States.
    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 and local level that are competent and prepared 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] Faith-based organizations.
    Applications from the above referenced entities are being solicited 
because they represent organizations that have sufficient background, 
experience, and current knowledge of testing in the nation's clinical 
laboratories, already have in place an established training system for 
laboratorians that will reach laboratorians across the nation, have an 
established network of laboratories that provide unique opportunities 
for continued learning to constituents in all 50 states, have an 
established training system to enhance laboratory infrastructure with 
regard to testing, identifying, and reporting potential disease 
threats, and have a broad outreach to the medical laboratory 
professionals. These organizations are being solicited because they 
have a variety of established methods for delivery of laboratory 
training even in remote areas.

    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 $150,000 is available in FY 2003 to fund 
approximately one award. It is expected that the award will be 
$150,000, ranging from $125,000 to $175,000. 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

    Preference may be given to organizations having established medical 
laboratory training systems that offer a variety of methods to conduct 
training related to a large variety of subject matter, consistent with 
those disease threats of public health significance, and that would 
have a broad outreach to the medical laboratory community that would 
provide an end result of enhancing laboratory infrastructure.

E. Program Requirements

    In conducting activities to achieve the purpose of this program, 
the recipient

[[Page 40957]]

will be responsible for the activities listed in 1. Recipient 
Activities, and CDC will be responsible for the activities listed in 2. 
CDC Activities.
1. Recipient Activities
    a. Provide leadership in evaluating the knowledge of clinical 
laboratory professionals regarding antimicrobial susceptibility 
testing.
    b. Develop an evaluation protocol to determine gaps in knowledge 
associated with susceptibility testing.
    c. Determine if laboratory professionals understand why 
susceptibility testing is necessary and the implications associated 
with not performing this type of testing. Develop training and 
education programs and related materials based on up-to-date laboratory 
procedures.
    d. Implement training and education programs to resolve the 
knowledge gaps and apply evaluation model to ensure laboratory 
professionals have received appropriate training, knowledge gaps are 
resolved, and that knowledge is retained over a specific time period.
    e. Provide leadership in developing, implementing, and evaluating 
training and education programs associated with HIV Rapid Testing.
    f. Determine if laboratory professionals know how to perform HIV 
rapid testing, what algorithm should be applied to results obtained 
from rapid testing, i.e., how does HIV Rapid Testing affect the current 
testing algorithm in the United States, as well as, how rapid testing 
performed in the international laboratory may affect rapid testing in 
the United States.
    g. Provide leadership in developing, implementing, and evaluating 
training and education programs associated with performing tests to 
detect chemical terrorism events. Recipient would determine among the 
clinical laboratory professionals, how many professionals are 
knowledgeable in detecting chemical terrorism agents and, even if 
knowledgeable, does their laboratory have the capacity to perform 
testing.
    h. Evaluate the knowledge of laboratory professionals concerning 
their understanding of DNA testing and the relationship to 
identification of genetic disorders.
    i. Develop and implement training programs for laboratory 
professionals to increase the awareness of genetics testing in their 
laboratory and how the testing results assist the clinician in the 
diagnosis of genetic disorders in their patient, i.e., inherited or 
mutated disorders.
    j. Provide leadership in developing, implementing, and evaluating 
training and education programs related to CLIA. Ensure that laboratory 
professionals have received adequate information and are aware of the 
impact of CLIA regulations on the day-to-day operation of their 
laboratory.
    k. Access information obtained from the CDC sponsored Quality 
Institute Conference to develop strategies that can be used to improve 
quality assurance activities, use of quality control materials, 
recognition of where most testing errors may be occurring, and issues 
related to point of care testing. It may be necessary for the recipient 
to form focus groups of experts to discuss the information from the 
conference associated with these issues to determine possible future 
recommendations. This may include developing a set of indicators for 
quality laboratory testing and testing services against which changes 
in the safety, effectiveness, timeliness, and adequacy of service can 
be measured.
2. CDC Activities
    a. If requested, senior staff will provide consultation and 
technical assistance in the planning, implementation, and evaluation, 
of program activities.
    b. Senior staff will provide the most up to date scientific 
information related to antimicrobial susceptibility testing that would 
assist grantee in developing the appropriate training and education 
programs.
    c. Senior staff will provide consultation and technical assistance 
related to HIV Rapid Testing and any published reports or other 
scientific information related to rapid testing that would assist 
grantee in understanding the possible impact of rapid testing in the 
United States, and how rapid testing has been performed in 
international laboratories.
    d. Senior staff in the division would provide any up to date 
genetics testing information, use of genetics quality assurance 
materials, or other information grantee would find useful in developing 
training and education programs related to genetics testing.
    e. Senior divisional staff would assist the grantee in 
collaborating with other organizations, other CDC staff, and obtaining 
useful information regarding testing for chemical terrorism agents that 
could be useful in developing, implementing, and evaluating training 
and education programs for chemical terrorism agent testing.
    f. Provide current information and experienced senior staff that 
could assist grantee in preparing training and education programs 
concerning CLIA regulations and the impact on laboratory testing.
    g. Provide information from the CDC sponsored Quality Institute 
Conference. Senior staff would assist grantee in establishing any 
expert focus groups from whom strategies and recommendations could be 
developed, e.g., assistance might be related to helping establish 
collaborations with world expert scientists who may participate on 
focus group panels.

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 goals and objectives, methods and 
technical approach, project management and staffing, evaluation plan, 
and proposed budget for carrying out the recipient activities 
consistent with the criteria listed in the evaluation criteria section 
of this announcement.
    The plan and methods should address activities to be conducted over 
the entire three-year project period. Narrative should include a 
detailed plan for the first year and a brief plan 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--
PA03119, CDC Procurement and Grants Office, 2920 Brandywine 
Road, Atlanta, GA 30341-4146.
    Applications may not be submitted electronically.

[[Page 40958]]

CDC Acknowledgement of Application Receipt

    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 and Technical Approach (30 Points)
    a. The extent to which the applicant's proposal describes the 
approach taken in the planning and implementation of the proposed 
cooperative agreement.
    b. The extent to which the applicant describes the methods to be 
used to carry out the responsibilities of the proposed cooperative 
agreement.
2. Project Management and Staffing (30 Points)
    a. The extent to which the applicant describes their ability to 
provide staff, knowledge, expertise, and other resources required to 
perform the responsibilities associated with the project.
    b. The extent to which the applicant describes their 
qualifications, time allocations of key personnel to be assigned to 
this project, facilities and equipment, and other resources available 
for performance of this project.
3. Goals and Objectives (20 Points)
    a. The extent to which the applicant describes their understanding 
of the objectives of the project and the relevance of their proposal to 
the stated objectives, including specific outcomes.
    b. The extent to which the applicant describes objectives that are 
specific, measurable, and achievable, including a reasonable schedule 
for implementation.
4. Evaluation Plan (20 Points)
    The extent to which the applicant describes a schedule for 
accomplishing the activities related to this project and a plan for 
evaluating their accomplishments.
5. Budget (Reviewed, But Not Scored)
    The extent to which the budget is appropriate, reasonable, 
justified, and consistent in relation to the activities proposed.
6. Performance Measures (Reviewed, But Not Scored)
    The extent to which the proposed activities relate to the PHPPO 
performance goals listed in the purpose section of this announcement.
    7. 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 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:

AR9 Paperwork Reduction Act Requirements
AR10 Smoke Free Workplace Requirements
AR11 Health People 2010
AR12 Lobbying Restrictions
AR15 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: William O. Schalla, 
M.S., Associate Director for Program and Finance, Division of 
Laboratory Systems, Public Health Practice Program Office, 4770 Buford 
Hwy., NE., Atlanta, GA 30341-3717, Telephone: (770) 488-8098, E-mail: 
[email protected].

    Dated: July 1, 2003.
Edward Schultz,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 03-17307 Filed 7-8-03; 8:45 am]
BILLING CODE 4163-18-P