[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:
mdd2@opspgo1.em.cdc.gov.
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:
sns9@phpdls1.em.cdc.gov.
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
