Cooperative Agreements for Studies to Evaluate the Effectiveness of Interventions to Prevent or Reduce Childhood Lead Poisoning, Notice of Availability of Funds for Fiscal Year 1994

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Announcement Number 437]

RIN 0905-ZA27

Cooperative Agreements for Studies to Evaluate the Effectiveness

of Interventions to Prevent or Reduce Childhood Lead Poisoning, Notice

of Availability of Funds for Fiscal Year 1994

Introduction

The Centers for Disease Control and Prevention (CDC) announces the

availability of fiscal year (FY) 1994 funds for a cooperative agreement

program to conduct studies to evaluate the effectiveness of

interventions to prevent or reduce childhood 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 317A (42 U.S.C. 247b-1) of the Public Health Service Act, as

amended. Program regulations are set forth in 42 CFR part 51b.

Smoke-Free Workplace

The Public Health Service strongly encourages all cooperative

agreement recipients to provide a smoke-free workplace and promote the

non-use of all tobacco products. This is consistent with the PHS

mission to protect and advance the physical and mental health of the

American people.

Eligible Applicants

Applications may be submitted by public and private, nonprofit and

for-profit organizations and governments and their agencies. Thus,

universities, colleges, research institutions, hospitals, other public

and private organizations, State and local health departments or their

bona fide agents, and small, minority and/or women-owned businesses are

eligible for these cooperative agreements.

Applications will be considered for funding to conduct studies in

one or more programmatic interest areas. Applicants interested in

conducting more than one study must submit a separate application for

each. If a single study addresses more than one programmatic interest

area, only one should be identified as the primary interest area. The

programmatic interest area should be clearly indicated for each study.

Availability of Funds

Approximately $600,000 is available in FY 1994 to fund

approximately three cooperative agreements. It is expected that the

average award will be $200,000 (direct and indirect cost), ranging from

$100,000 to $350,000. It is expected that the awards will begin on or

about September 30, 1994. The awards will be made for 12-month budget

periods within a project period up to 3 years. Funding estimates may

vary and are subject to change based on the availability of funds.

Continuation awards within the project period will be made on the

basis of satisfactory progress and the availability of funds.

Purpose

The purpose of these awards is to study important epidemiologic

questions critical to the implementation, operation, and expansion of

childhood lead poisoning prevention programs, and to support the

development of guidelines and policies. These awards are to study:

1. The effectiveness of environmental interventions for primary

prevention of childhood lead poisoning;

2. The effectiveness of nutritional strategies in preventing and/or

reducing childhood lead poisoning; and

3. The effectiveness of education strategies in preventing and/or

reducing childhood lead poisoning.

Program Requirements

To fulfill the objectives of this cooperative agreement, an

applicant must meet the following requirements:

1. A director who has specific authority and responsibility to

carry out the requirements of the project.

2. Demonstrated ability to collect and analyze data needed to

fulfill the study objectives.

3. Demonstrated experience in conducting relevant epidemiologic

studies.

4. Demonstrated effective and well-defined working relationships

within the performing organization and with outside entities which will

insure implementation of the proposed study.

5. Demonstrated access to a laboratory with demonstrated

proficiency in performing blood lead (and other laboratory measurements

as indicated in the applicant's study protocol).

6. Demonstrated ability to insure that children identified with

elevated blood levels receive appropriate medical and environmental

management through an ongoing childhood lead poisoning prevention

program (which need not be applicant's organization).

7. For applicants proposing to ``evaluate the effectiveness of

environmental lead hazard reduction interventions,'' the following

additional requirements apply:

Applicant has responsibility for ongoing lead hazard

inspection and reduction activities or must document a close working

relationship with the agency or organization responsible for ongoing

lead hazard inspection and reduction activities. If the applicant does

not have direct responsibility for such activities, a letter of support

from the organization with that responsibility is required. Ongoing

activities should include the inspection of residences of children

identified with elevated blood lead levels for lead hazards and provide

for or insure the reduction of identified lead hazards.

The lead hazard identification and reduction program

should be based on written guidelines, statutes, or regulations that

specify methods used to inspect dwellings, and identify and reduce lead

hazards. Lead hazard reduction standards should include: acceptable

methods of controlling lead-based paint hazards (including dust);

requirements for containment and clean-up of dust and debris generated

by the lead hazard control process; and inspection of dwellings to

ensure compliance with applicable lead hazard control standards.

Note: Eligible applicants may enter into contracts, including

consortia agreements, as necessary to meet the requirements of the

program and strengthen the overall application; however, applicants

must perform a substantial portion of the activities for which funds

are requested.

Programmatic Interest Areas

The studies must be in one of these following areas:

1. Prospective studies to evaluate the effectiveness of

environmental lead hazard reduction interventions in primary prevention

of childhood lead poisoning (e.g., preventing blood lead levels from

increasing). Preferably, these studies should be done collaboratively

with health, housing, and environmental government agencies, and

community-based organizations.

2. Prospective studies to determine the effectiveness of

nutritional supplements or dietary changes in preventing blood lead

levels from increasing and/or in reducing blood lead levels in young

children.

3. Prospective studies to determine the effectiveness of education

of care givers in preventing blood lead levels from increasing and/or

in reducing blood lead levels in young children. Educational activities

may include provision of cleaning or other supplies.

Cooperative Activities

In conducting activities to achieve the purpose of these

cooperative agreements, the recipient will be responsible for

conducting activities under A. (Recipient Activities), and CDC will be

responsible for conducting activities under B. (CDC Activities):

A. Recipient Activities

1. Conduct study activities, including: (1) Enrolling eligible

study subjects, after obtaining informed consent; (2) collecting data;

(3) ensuring appropriate medical and environmental management of study

subjects, and (4) conducting all other components required for

implementation of the study.

2. Enter and maintain data in a computerized database.

3. Analyze collected data and prepare a report of the study

findings.

B. CDC Activities

1. Collaborate with the recipient in refining the approved study

protocol and the data collection instrument(s), as appropriate.

2. Provide technical advice on data collection and management.

3. Assist in assessment of quality of laboratory measurements, if

needed.

Evaluation Criteria

Applications will be reviewed and evaluated according to the

following criteria:

1. Study Protocol (30%)--The protocol's scientific soundness,

quality, feasibility, consistency with the project goals, and soundness

of the evaluation plan.

2. Access to Study Subjects (20%)--Documented ability to identify,

access, enroll, and follow study subjects.

3. Laboratory Capacity (15%)--Documented availability to a

laboratory with demonstrated proficiency in performing lead

measurements (and other laboratory measurements as indicated in

applicant's proposed study).

4. Medical and Environmental Management (15%)--Documented ability

to ensure that children identified with elevated blood lead levels

receive appropriate medical and environmental management.

5. Project Personnel (10%)--The qualifications, experience,

(including experience in conducting relevant studies) and time

commitment of the staff needed to ensure implementation of the project.

6. Plan for Administration of Project (10%)--Schedule for

implementing, monitoring, and evaluating the project.

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 cooperative agreement funds.

Executive Order 12372 Review

Applications are not subject to the review requirements of

Executive Order 12372 entitled, Intergovernmental Review of Federal

Programs.

Public Health System Reporting Requirement

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 assigned to this

program is 93.283.

Other Requirements

Paperwork Reduction Act

Projects that involve the collection of information from ten or

more individuals and funded by this cooperative agreement will be

subject to review by the Office of Management and Budget (OMB) under

the Paperwork Reduction Act.

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

form provided in the application kit.

Application Submission and Deadline

A. Preapplication Letter of Intent

Although not a prerequisite of application, a non-binding letter of

intent-to-apply is requested from potential applicants. The letter

should be submitted to the Grants Management Officer (whose address is

reflected in section B, ``Applications''). It should be postmarked no

later than one month prior to the planned submission deadline (e.g.,

May 10 for June 10 submission). The letter should identify the

announcement number, the intended submission deadline, name the

principal investigator, and specify the study area addressed by the

proposed project.

The letter of intent does not influence review of funding

decisions, but it will enable CDC to plan the review more efficiently,

and will ensure that each applicant receives timely and relevant

information prior to application submission.

B. Applications

All applicants should use Form PHS-398 and adhere to the ERRATA

Instruction Sheet for form PHS-398. The original and five copies 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 321, Atlanta, GA 30305, on or before June 10, 1994.

C. Deadline

1. 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 for the review process. Applicants must request a legibly

dated U.S. Postal Service Postmark or obtain a legibly dated receipt

from a commercial carrier or 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

To receive additional written information call (404) 332-4561. You

will be asked to leave your name, address, and phone number and will

need to refer to Announcement 437. You will receive a complete program

description, information on application procedures, and application

forms.

If you have questions after reviewing the contents of all

documents, business management technical assistance may be obtained

from Lisa Tamaroff, Grants Management Specialist, Grants Management

Branch, Procurement and Grants Office, Centers for Disease Control and

Prevention (CDC), 255 East Paces Ferry Road, NE., room 321, Mailstop E-

13, Atlanta, GA 30305, telephone (404) 842-6796.

Please refer to Announcement Number 437 when requesting information

and submitting an application.

Programmatic technical assistance may be obtained from Lisa

Rosenblum, M.D., 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-42, Atlanta, GA 30341-3724,

telephone (404) 488-7330.

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) through the Superintendent

of Documents, Government Printing Office, Washington, DC 20402-9325,

telephone (202) 783-3238.

To receive a copy of the Strategic Plan for the Elimination of

Childhood Lead Poisoning, contact 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-42, Atlanta, GA 30341-3724,

telephone (404) 488-7330.

Dated: March 31, 1994.

Robert L. Foster,

Acting Associate Director for Management and Operations, Centers for

Disease Control and Prevention (CDC).

[FR Doc. 94-8247 Filed 4-5-94; 8:45 am]

BILLING CODE 4163-18-P