[Federal Register Volume 68, Number 131 (Wednesday, July 9, 2003)]
[Notices]
[Pages 40954-40956]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-17308]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 03118]


Cooperative Agreement for the Development and Evaluation of 
Medical Laboratory Quality Indicators and the Monitoring of Voluntary 
Practice Guidelines as a Model; 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 
for a program to develop and evaluate appropriate medical laboratory 
quality indicators and to evaluate the implementation of voluntary 
laboratory practice guidelines. This program addresses the ``Healthy 
People 2010'' focus area of Access to Quality Health Services.
    The purpose of the program is twofold:
    (1) Collaborate with a broad spectrum of laboratories (e.g., 
hospital, public health, doctor's office, and local clinic), care 
providers and payers, and public health to develop and evaluate 
appropriate laboratory quality indicators and to develop a plan for 
collection and monitoring of the indicators.
    (2) Recently collected data show that a significant number of 
laboratories do not follow professional practice guidelines in the 
areas of antimicrobial susceptibility testing and coagulation. The 
cooperative agreement recipient will further evaluate implementation of 
voluntary practice guidelines and assess the barriers to their 
implementation. This activity may be considered a subcomponent of the 
first activity and serve as a model for some of the quality indicators.
    Measurable outcomes of the program will be in alignment with the 
following performance goal 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.
    [sbull] State 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).
    Applications from the above entities are being solicited because 
they represent organizations that have sufficient background, 
experience, and current knowledge of laboratory testing. These entities 
include institutions or organizations with knowledge and experience in 
public health and medical laboratory testing who are also knowledgeable 
about current regulatory and voluntary laboratory standards, quality 
assurance, the use of quality indicators to measure performance and to 
identify areas in laboratory testing that are error-prone, and who can 
evaluate these findings in the broader context of the impact on patient 
health and safety. In addition, these entities will be able to 
collaborate and work with existing laboratory and health care networks, 
professional organizations, and others in the field of laboratory 
medicine to collect data and information on laboratory quality issues 
and implementation of laboratory standards.

    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 $125,000 is available in FY 
2003 to fund one award ranging from $100,000 to $150,000. It is 
expected that the award will begin on or about September 15, 2003 and 
the project period will consist of one 12-month budget period. Funding 
estimates may change.
    Recipient Financial Participation: No matching funds are required 
for this program.
    Funding Preferences: Preference may be given to a State health 
department clinical laboratory quality assurance or evaluation program 
or other organization with existing laboratory networks (data 
collection networks comprised of clinical and public health 
laboratories that periodically monitor and report on issues related to 
the delivery of laboratory medicine and quality assurance programs 
associated with them).

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 CDC will be responsible for the activities 
listed in 2. CDC Activities.
    1. Recipient Activities:
    a. Provide leadership in developing and evaluating laboratory 
quality indicators in collaboration with representatives from 
laboratories, care providers, payers, and public health.
    b. Provide leadership in the development of an implementation plan 
for the use of quality indicators to collect and monitor data from a 
broad spectrum of laboratories (e.g., hospitals, public health sites, 
doctors' offices and local clinics).
    c. Test the plan developed in (b) above by collecting indicator 
measurement data from laboratories.
    d. Evaluate the implementation of selected voluntary laboratory 
practice guidelines and identify and assess barriers to guideline 
implementation in various types of laboratories.
    e. Collect, enter, analyze, and summarize the data in a manner that 
is statistically valid and, whenever necessary, ensures participant 
confidentiality.
    f. Distribute reports to participants for self-evaluation and 
improvement, and make information available to other laboratories 
nationwide, as appropriate.
    g. Develop recommendations for potential mechanisms to overcome 
barriers and improve the implementation of quality indicators and 
voluntary laboratory practice guidelines.
    h. Prepare manuscripts for peer-review publications.
    2. CDC Activities:
    a. Assist in identifying quality indicators and voluntary 
laboratory practice guidelines for evaluation.
    b. Facilitate collaboration with external partners who volunteer to 
work

[[Page 40955]]

with the recipient and CDC in developing laboratory quality indicators 
and identifying practice guidelines.
    c. If requested, assist in the development of an implementation 
plan for the use of the quality indicators.
    d. If requested, provide technical assistance with the development 
of data collection instruments.
    e. Collaborate in analyzing the data and information collected and 
in preparing written summaries.
    f. Work with the recipient to identify barriers to using laboratory 
practice guidelines and to develop recommendations for potential 
mechanisms to overcome these barriers.
    g. Assist in the preparation of manuscripts for peer-reviewed 
publications.

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 20 pages, double-spaced, 
printed on one side, with one-inch margins and unreduced 12-point font, 
and on 8.5'' x 11'' paper.
    The narrative should consist of goals and objectives, a plan of 
operation, project management and staffing, an evaluation plan, and 
proposed budget for carrying out the recipient activities in light of 
the evaluation criteria as described below.

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-PA03118, CDC Procurement 
and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341-4146.
    Applications may not be submitted electronically.
    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. Plan of Operation (30 Points):
    a. The extent to which the applicant describes the steps to be 
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, including the ability to provide the representative 
participants in the laboratory groups with which they will collaborate.
    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 in this 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 its understanding of 
the objectives of this project, the relevance of its proposal to the 
stated objectives, and any unique characteristics of populations to be 
studied.
    b. The extent to which the applicant's goals and objectives are 
time-phased, measurable, specific, and achievable.
    4. Evaluation Plan (20 Points):
    The extent to which the applicant describes their schedule for 
accomplishing the activities to be carried out in this project and 
methods for evaluating the accomplishments.
    5. Proposed Budget (reviewed but not scored): The extent to which 
the proposed budget is reasonable, clearly justified, and consistent 
with the intended use of funds.
    6. Performance Goals (reviewed but not scored): The extent to which 
the application is consistent with the performance goals stated in the 
purpose section of this announcement.
    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. Semiannual progress reports, which 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.

[[Page 40956]]

    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: Devery Howerton, Ph.D., 
Chief, Laboratory Practice Evaluation and Genomics Branch, Division of 
Laboratory Systems, CDC Public Health Practice Program Office, 4770 
Buford Highway, NE., Mailstop G-23, Atlanta, GA 30341-3717, Telephone: 
(770) 488-8126, E-mail: [email protected].

    Dated: July 1, 2003.
Edward Schultz,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 03-17308 Filed 7-8-03; 8:45 am]
BILLING CODE 4163-18-P