[Federal Register Volume 60, Number 68 (Monday, April 10, 1995)]
[Notices]
[Pages 18134-18136]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-8717]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Announcement 525]


Continuation of the Development of Technology for the Measurement 
of Lead in Blood; Notice of Availability of Funds for Fiscal Year 1995

Introduction

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 1995 funds for a grant program for the 
continuation of the development of new and innovative technology, or 
significant improvement of existing technology, for the measurement of 
lead in blood. CDC has supported such development efforts under a grant 
program since FY 1992 and under Cooperative Research and Development 
Agreements (CRADAs) since 1991. State, community and physician office-
based childhood lead poisoning prevention programs have a need for 
reasonably priced, accurate, precise, portable, rugged, and easy-to-
operate instruments or analytical techniques to measure the 
concentration of lead in blood. Such programs screen large numbers of 
infants and young children and identify those with lead poisoning.
    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 improve the quality of life. This announcement is related to the 
priority area of Environmental Health. (For ordering a copy of 
``Healthy People 2000,'' see the section Where To Obtain Additional 
Information.)

Authority

    This program is authorized under sections 301(a) [42 U.S.C. 241(a)] 
and 317B(b) [42 U.S.C. 247b-3(b)] 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

    Eligible applicants are limited to those organizations which are 
currently developing innovative technology for the measurement of lead 
in blood, funded under CDC grant Announcement 269 (included in the 
application package), or organizations which have a current CDC 
Cooperative Research and Development Agreement (CRADA) dealing with 
blood lead measurement technology. However, if funded, the CDC CRADA 
dealing with blood lead will be terminated.


    Note: Eligible applicants are encouraged to enter into 
contracts, including consortia agreements, as necessary to meet the 
requirements of the program and strengthen the overall application.

Availability of Funds

    Approximately $800,000 is available in FY 1995 to fund up to three 
grants. It is expected that the average award will be $250,000, ranging 
from $100,000 to $500,000. It is expected that the awards will begin on 
or about June 30, 1995, and will be made for a 12-month budget period 
within a project period of up to one year. Funding estimates may vary 
and are subject to change.

Purpose

    State and community health agencies are the principal delivery 
points for childhood lead screening and related medical and 
environmental management activities. Universal screening of children is 
recommended in ``Preventing Lead Poisoning in Young Children--a 
Statement by the Centers for Disease Control,'' (October 1991); 
however, the lack of analytical systems (methods plus instrumentation) 
which are easy-to-operate, rugged, and suitable for field use in 
screening programs have made it difficult and costly for agencies to 
develop programs for the elimination of this totally preventable 
disease. This program will provide financial support for the 
continuation and possible completion of the development and validation 
of new and innovative technology leading to better blood lead 
measurement systems.

Program Requirements

    The following are essential requirements of the Grantee:
    1. Provide a principal investigator with the authority, 
responsibility, and research experience to carry out the objectives of 
the grant.
    2. Provide qualified staff, laboratory and/or production 
facilities, equipment, and other resources necessary to carry out the 
objectives of the grant.
    3. Conduct a scientifically sound, goal-oriented research and 
development program which will yield all or portions of practical 
analytical systems which measure one or more chemicals in complex 
solutions. Understand and address the difficult analytical problem 
presented by a blood sample matrix.
    4. Publish the results of the research effort in the peer-reviewed 
scientific literature, or otherwise make the research findings 
available for objective evaluation and use.
    5. Provide evidence of significant progress under the previous 
grant or CRADA for blood lead measurement technology consistent with 
the goals and objectives of the original grant or CRADA, and clearly 
show that successful completion could be reasonably expected within the 
one year project period.

Evaluation Criteria

    The applications will be reviewed and evaluated according to the 
following criteria:

1. Understanding of the Problem (30%)

    By progress under previous grant or CRADA agreement, the Applicant 
has [[Page 18135]] demonstrated understanding of whole blood matrix 
effects, interferences, and contamination issues. Applicant's prototype 
instrument(s) and/or experimental data address CDC criteria of 
accuracy, precision, compactness, ruggedness and ease of use, as 
described in grant Announcement 269 and/or CRADA agreement.

2. Technical Progress and Approach to Remaining Problems (30%)

    Sound technical approach, as demonstrated by analytical performance 
of applicant's prototype instruments or experimental data. Performance 
should meet CDC criteria, or show evidence of adequate performance 
attainable under this announcement.

3. Management Plan (20%)

    Applicant should describe a plan to finalize the development of 
their instrument as a manufacturable, marketable, commercial product. 
Key points include appropriate business resources or collaborations, 
market research, field testing, regulatory compliance, distribution and 
support, or plans to sell the technology to a third party for final 
production and marketing.

4. Program Personnel (10%)

    The extent to which the proposal has described (a) the 
qualifications and commitment of the applicant including training and 
experience in chemistry, biochemistry, biomedical engineering or other 
relevant scientific disciplines, (b) detailed allocations of time and 
effort of staff devoted to the project.

5. Collaboration (5%)

    While collaboration is not required, it is encouraged if necessary 
to accomplish the research objectives in a timely manner. If 
applicable, the applicant should have demonstrated the ability to 
collaborate with other research centers, manufacturers, or commercial 
interests to conduct the described research and development plan. 
Evidence of collaborative relationships include jointly developed plans 
for developing separate components of the analytical system and written 
commitments of support from other program-related entities that 
describe the collaborative activities or serious negotiation or 
agreements with companies experienced in the development, marketing and 
support of clinical instruments.

6. Publication of the Research Effort (5%)

    The purpose of this grant is to encourage the rapid development and 
deployment of measurement systems for blood lead which will be useful 
in lead poisoning prevention screening programs. Therefore, an 
explanation of how the grantee plans to encourage the publication of 
the research findings or otherwise make the information available to 
the public is required. Research which results only in findings of 
academic interest with no practical application to the objectives of 
the grant is not acceptable.

7. Budget Justification (Not Scored)

    The budget will be evaluated for the extent to which it is 
reasonable, clearly justified, and consistent with the intended use of 
grant funds. The adequacy of existing and proposed facilities to 
support program activities also will be evaluated.

8. Human Subjects Review (Not Scored)

    The applicant must clearly indicate whether or not human subjects 
will be involved in their research.

Executive Order 12372 Review

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

Public Health System 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 93.197.

Other Requirements

Human Subjects

    If the proposed project 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 
forms provided in the application kit.

Paperwork Reduction Act

    Projects that involve the collection of information from 10 or more 
individuals and funded by this grant will be subject to review by the 
Office of Management and Budget (OMB) under the Paperwork Reduction 
Act.

Application Submission and Deadline

    The original and five copies of the application form PHS 398 (OMB 
Number 0925-0001) must be submitted to Henry S. Cassell, III, Grants 
Management Officer, Grants Management Branch, Procurement and Grants 
Office, Centers for Disease Control and Prevention (CDC), 255 East 
Paces Ferry Road, NE., Room 300, Mailstop E-13, Atlanta, GA 30305, on 
or before May 31, 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 the U.S. Postal Service. Private 
metered postmarks shall not be acceptable as proof of timely mailing.)
    2. Late Applications: Applications which do not meet the criteria 
in 1.a. or 1.b. above are considered late applications. Late 
applications will not be considered in the current competition and will 
be returned to the applicant.

Where to Obtain Additional Information

    A complete program description, information on application 
procedures, an application package, and business management technical 
assistance may be obtained from Adrienne Brown, Grants Management 
Specialist, Grants Management Branch, Procurement and Grants Office, 
Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry 
Road, NE., Room 300, Mailstop E-13, Atlanta, GA 30305, telephone (404) 
842-6630. Programmatic technical assistance may be obtained from Dayton 
T. Miller, Ph.D. or Robert L. Jones, Ph.D., Nutritional Biochemistry 
Branch, Division of Environmental Health Laboratory Sciences, National 
Center for Environmental Health, Centers for Disease Control and 
Prevention (CDC), 4770 Buford Highway NE., Mailstop F-18, Atlanta, GA 
30341-3724, telephone (404) 488-4452.
    Please refer to Announcement 525 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'' [[Page 18136]] through the Superintendent of 
Documents, Government Printing Office, Washington, DC 20402-9325, 
telephone (202) 512-1800.
    A copy of ``Preventing Lead Poisoning in Young Children--a 
Statement by the Centers for Disease Control,'' (October 1991) may be 
obtained from the Lead Poisoning Prevention Branch, Division of 
Environmental Hazards and Health Effects, National Center for 
Environmental Health, Centers for Disease Control and Prevention (CDC), 
4770 Buford Highway, NE., Mailstop F-28, Atlanta, GA 30333, telephone 
(404) 488-7330.


    Dated: April 3, 1995.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for 
Disease Control and Prevention (CDC).
[FR Doc. 95-8717 Filed 4-7-95; 8:45 am]
BILLING CODE 4163-18-P