[Federal Register Volume 60, Number 123 (Tuesday, June 27, 1995)]
[Notices]
[Pages 33219-33221]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-15660]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Announcement No. 563]


Cooperative Agreements for Investigational Consortium for 
Research in Laboratory Medicine

Introduction

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 1995 funds for the establishment of an 
Investigational Consortium for Research in Laboratory Medicine to 
pursue new and evolving frontiers in laboratory quality research.
    The Public Health Service (PHS) is committed to achieving the 
health promotion and disease prevention objectives of ``Healthy People 
2000,'' a PHS-led national activity to reduce morbidity and mortality, 
and to improve quality of life. This announcement is related to the 
priority area of Surveillance and Data Systems. In December 1991, an 
institute was convened by CDC and the Association of State and 
Territorial Public Health Laboratory Directors (ASTPHLD) entitled 
``Laboratory Initiatives for the Year 2000 (LIFT 2000)'' to develop 
consensus on laboratory components which are essential to achieving the 
``Healthy People 2000'' national health objectives. (For ordering a 
copy of ``Healthy People 2000'' and ``LIFT 2000,'' see the section 
Where to Obtain Additional Information.)

Authority

    This program is authorized under section 317(k)(2) [42 U.S.C., 
247(k)(2)] of the Public Health Service Act, as amended.

Smoke-Free Workplace

    PHS strongly encourages all grant recipients to provide a smoke-
free workplace and to promote the nonuse of all tobacco products, and 
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in 
certain facilities that receive Federal funds in which education, 
library, day care, health care, and early childhood development 
services are provided to children.

Eligible Applicants

    Applications may be submitted by public and private nonprofit 
organizations and government and their agencies. Thus, universities, 
colleges, research institutions, hospitals, other public and private 
organizations, State and local governments or their bona fide agents, 
federally recognized Indian tribal organizations, and small, minority- 
and/or women-owned businesses are eligible to apply.

Availability of Funds

    Approximately $600,000 is available in FY 1995 to fund up to three 
cooperative agreements. It is expected that the award will begin on or 
about September 29, 1995, and will be made for a 12-month budget period 
within a project period of up to two years. Funding estimates may vary 
and are subject to change. Continuation awards within the project 
period will be made on the basis of satisfactory progress and the 
availability of funds.

Purpose

    The principal purposes of these cooperative agreements are a) to 
provide assistance in developing an Investigative Consortium for 
Research in Laboratory Medicine, and b) to increase the capability of 
laboratorians and clinicians interested in laboratory medicine to 
engage in outcome-based laboratory research. The results of the 
research conducted by such a laboratory-based consortium will include 
increased knowledge of:

1. Improved methods for measuring patient outcome and performance of 
laboratory services.
2. The relationship between performance of laboratory services and 
patient outcome.
3. More comprehensive and improved assessment of the impact that 
changes in analytical technologies and test site locations have on 
patient outcome and laboratory practice.
4. Improved methods for defining required and desirable analytical 
goals that would have medical relevance for patient care.

    Applications should explore new or evolving areas of critical 
research about quality measurements and components influencing quality 
in laboratory medicine. Also sought are applications from professional 
organizations interested in conducting outcome-based research in 
laboratory medicine. Applications dealing with clinical utility of 
specific tests are not sought unless they show direct relevance to 
specific areas of laboratory quality, and especially those enumerated 
above.

Benefits of the Cooperative Agreement

    Individual participants in this investigational consortium are 
expected to benefit from the collaboration, communication and 
information exchange among themselves, the recipients of these 
cooperative agreements, and CDC. The recipients of these cooperative 
agreements are [[Page 33220]] expected to benefit by initiating 
research programs that may lead to future research efforts and similar 
consortia on their own. The public will benefit from CDC-established 
additional linkages to frontier research efforts dealing with quality 
of laboratory services impacting patient outcome and the increased 
knowledge gained in evaluating and improving the critical components of 
laboratory testing that impact public health.

Program Requirements

    In conducting activities to achieve the purpose of this program, 
the recipient will be responsible for the activities under A. 
(Recipient Activities), and CDC will be responsible for the activities 
under B. (CDC Activities).

A. Recipient Activities

    1. Either alone or through their constituents, carry out the 
research projects that were developed as stated in the application for 
assistance and as evaluated and prioritized by both CDC and the 
recipient.
    2. Provide leadership in the design and implementation of research 
methodologies and protocols used to assess quality of laboratory 
testing and patient outcome.
    3. Provide leadership in optimal data collection and analysis using 
the best epidemiological, statistical, and mathematical approaches 
available. Participant identification information may be omitted from 
these data if the consortium manager or research director is able to 
respond to questions concerning the validity of the data without 
providing participant information.
    4. Use a mechanism for the sharing of the raw and analyzed data 
both within the consortium and with CDC.
    5. Prepare manuscripts, along with the principal investigators of 
the individual projects if appropriate, for peer-reviewed publications 
that describe the results of some or all of the activities listed 
above. Manuscripts should benefit the public; the papers must also note 
the source of the funding for the project.

B. CDC Activities

    1. Assist in the selection of projects that have the greatest 
public health concerns and in the evaluation of the detailed projects 
after their solicitation.
    2. Provide technical input in the refinement of research protocol 
and methodologies proposed by the recipients and individual researchers 
including data collection, statistical analyses, and epidemiological 
approaches.
    3. Collaborate in the development of a mutually defined data set 
standard for transmission of raw data, analyzed data, and reports 
within the consortium and with CDC.
    4. Provide technical input and participate in the presentation of 
data at professional forums, meetings, and conferences as needed.
    5. Provide technical assistance and input in the preparation of 
manuscripts related to the activities of the funded projects.

Evaluation Criteria

    Applications will be reviewed and evaluated according to the 
following criteria:
    1. Responsiveness of the overall application and its constituent 
projects to the objectives of the cooperative agreement including: a) 
applicant's understanding of the objectives of the proposed cooperative 
agreement and each proposed project; b) relevance of the projects to 
the stated objectives; c) public health benefits of the proposed 
research projects; and d) relationship to previous studies if 
applicable. (25 points)
    2. Ability to provide staff, knowledge, and other resources 
required to provide oversight of the investigators responsibilities in 
the individual projects. Of paramount importance are the assessed 
quality of the individual projects and ability of the individual 
investigators to carry out the functions as stated in their projects. 
The qualifications and time allocations of key personnel to be assigned 
to the cooperative agreement as well as the facilities, equipment, and 
other resources available to provide oversight of the constituent 
projects. (30 points)
    3. The methods to be used in carrying out the responsibilities of 
the cooperative agreement and the projects contained therein and the 
steps to be taken in the planning and implementation of the projects. 
Scope of the studies in addition to the statistical and epidemiological 
methods to be used if applicable. (35 points)
    4. Schedule for the activities of the cooperative agreement and the 
individual projects therein and methods for evaluating the 
accomplishments including detailed research plan to meet the objectives 
of the projects. (10 points)
    5. In addition, consideration will be given to the extent to which 
the budget is reasonable, clearly justified, and consistent with the 
intended use of the funds. (Not scored)

Executive Order 12372 Review

    This program is not subject to the Executive Order 12372 review.

Public Health Reporting Requirements

    This program is not subject to the Public Health System Reporting 
Requirements.

Catalog of Federal Domestic Assistance Number

    The Catalog of Federal Domestic Assistance number is 93.283.

Other Requirements

Paperwork Reduction Act

    Projects that involve the collection of information from ten or 
more individuals and funded by the cooperative agreement will be 
subject to review and approval by the Office of Management and Budget 
(OMB) under the Paperwork Reduction Act.

Human Subjects

    If any of the proposed projects involves research on human 
subjects, the applicant must comply with the Department of Health and 
Human Services Regulations, 45 CFR part 46, regarding the protection of 
human subjects. Assurance must be provided to demonstrate that the 
project will be subject to initial and continuing review by an 
appropriate institutional review committee. The applicant will be 
responsible for providing assurance in accordance with the appropriate 
guidelines and form provided in the application kit. In addition to 
other applicable committees, Indian Health Service (IHS) institutional 
review committees also must review the project if any component of IHS 
will be involved or will support the research. If any Native American 
community is involved, its tribal government must also approve that 
portion of the project applicable to it.

Application Submission and Deadline

    The original and two copies of the application Form PHS 5161-1 (OMB 
Control Number 0937-0189) must be submitted to Henry S. Cassell III, 
Acting Chief, Grants Management Branch, Procurement and Grants Office, 
Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry 
Road, NE., Room 300, Atlanta, Georgia 30305, Attention: Marsha D. 
Driggans, Grants Management Specialist, Mailstop E16, on or before 
August 7, 1995.
    1. Deadline: Applications shall be considered as meeting the 
deadline if they are either: (a) Received on or before the deadline 
date; or (b) Sent on or before the deadline date and received in time 
for submission to the objective review group. (Applicants must request 
a legibly dated U.S. Postal Service postmark or obtain a legibly dated 
receipt from a commercial carrier or [[Page 33221]] U.S. Postal 
Service. Private metered postmarks shall not be acceptable as proof of 
timely mailing.)
    2. Late Application: Applications which do not meet the criteria in 
1.(a) or 1.(b) above are considered late applications. Late 
applications will not be considered and will be returned to the 
applicant.
Where to Obtain Additional Information

    A complete program description, information on application 
procedures, application package and business management technical 
assistance may be obtained from Marsha D. Driggans, Grants Management 
Specialist, Grants Management Branch, Procurement and Grants Office, 
Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry 
Road, NE., Room 305, Mailstop E16, Atlanta, Georgia 30305, telephone 
(404) 842-6523, facsimile (404) 842-6513, or via Internet: 
[email protected].
    Programmatic technical assistance may be obtained from Dr. Shahram 
Shahangian, Supervisory Health Scientist, Division of Laboratory 
Systems, Centers for Disease Control and Prevention (CDC), 4770 Buford 
Highway, NE., Mailstop G23, Atlanta, Georgia 30341, telephone (404) 
488-7680, facsimile (404) 488-7693, or via Internet: 
[email protected].
    Please refer to Announcement Number 563 when requesting information 
and submitting an application.
    Potential applicants may obtain a copy of ``Healthy People 2000'' 
(Full Report, Stock No. 017-001-00474-0) or ``Healthy People 2000'' 
(Summary Report, Stock No. 017-001-00473-1) referenced in the 
INTRODUCTION through the Superintendent of Documents, Government 
Printing Office, Washington, DC 20402-9325, telephone (202) 512-1800. A 
copy of ``Laboratory Initiatives for the Year 2000'' may be obtained 
through Division of Laboratory Systems, CDC, Mailstop G25, Atlanta, 
Georgia 30341-3724, telephone (404) 488-7660.

    Dated: June 21, 1995.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for 
Disease Control and Prevention (CDC).
[FR Doc. 95-15660 Filed 6-26-95; 8:45 am]
BILLING CODE 4163-18-P