[Federal Register Volume 59, Number 66 (Wednesday, April 6, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-8247]


[[Page Unknown]]

[Federal Register: April 6, 1994]


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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