[Federal Register Volume 62, Number 92 (Tuesday, May 13, 1997)]
[Notices]
[Pages 26315-26319]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-12455]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[Announcement Number 776]


Cooperative Agreements for Studies To Evaluate Primary Prevention 
of Childhood Lead Poisoning Notice of Availability of Funds for Fiscal 
Year 1997

Introduction

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 1997 funds for a cooperative agreement 
program to conduct studies to evaluate the costs and effectiveness of 
primary prevention of childhood lead poisoning.
    CDC is committed to achieving the health promotion and disease 
prevention objectives of Healthy People 2000, a 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

[[Page 26316]]

section WHERE TO OBTAIN ADDITIONAL INFORMATION.)

Authority

    This program is authorized under sections 301(a), 317A and 317B of 
the Public Health Service Act [42 U.S.C. 241(a), 247b-1 and 247b-3] as 
amended. Program regulations are set forth in 42 CFR Part 51b.

Smoke-Free Workplace

    CDC strongly encourages all cooperative agreement recipients to 
provide a smoke-free workplace and promote the non-use 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 governments and their agencies. Thus, universities, 
colleges, research institutions, hospitals, other public and private 
non-profit organizations, State and local governments or their bona 
fide agents, including small, minority-and/or women-owned non-profit 
businesses are eligible to apply.
    An organization described in section 501(c)(4) of the Internal 
Revenue Code of 1986 which engages in lobbying activities shall not be 
eligible to receive Federal funds constituting an award, grant, loan, 
or any other form.
    Applications will be considered for funding to conduct studies in 
one or more programmatic interest areas. The programmatic interest 
area(s) should be clearly indicated for each study on a cover letter 
submitted with the application.

Availibility of Funds

    Approximately $500,000 is available in FY 1997 to fund up to two 
cooperative agreements. It is expected that the average award will be 
$250,000 (direct and indirect cost). It is expected that the awards 
will begin on or about September 30, 1997. The awards will be made for 
12-month budget periods within a project period up to 4 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.

Use of Funds

    Grant funds may not be expended for medical care and treatment or 
for environmental remediation of lead sources.
    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.

Restrictions on Lobbying

    Applicants should be aware of restrictions on the use of HHS funds 
for lobbying of Federal or State legislative bodies. Under the 
provisions of 31 U.S.C. Section 1352 (which has been in effect since 
December 23, 1989), recipients (and their subtier contractors) are 
prohibited from using appropriated Federal funds (other than profits 
from a Federal contract) for lobbying Congress or any Federal agency in 
connection with the award of a particular contract, grant, cooperative 
agreement, or loan. This includes grants/cooperative agreements that, 
in whole or in part, involve conferences for which Federal funds cannot 
be used directly or indirectly to encourage participants to lobby or to 
instruct participants on how to lobby.
    In addition, the FY 1997 HHS Appropriations Act, which became 
effective October 1, 1996, expressly prohibits the use of 1997 
appropriated funds for indirect or ``grass roots'' lobbying efforts 
that are designed to support or defeat legislation pending before State 
legislatures. This new law, Section 503 of Pub. L. 104-208, provides as 
follows:
    Sec. 503(a). No part of any appropriation contained in this Act 
shall be used, other than for normal and recognized executive-
legislative relationships, for publicity or propaganda purposes, for 
the preparation, distribution, or use of any kit, pamphlet, booklet, 
publication, radio, television, or video presentation designed to 
support or defeat legislation pending before the Congress,  * * * 
except in presentation to the Congress or any State legislative body 
itself.
    (b) No part of any appropriation contained in this Act shall be 
used to pay the salary or expenses of any grant or contract recipient, 
or agent acting for such recipient, related to any activity designed to 
influence legislation or appropriations pending before the Congress or 
any State legislature.
    Department of Labor, Health and Human Services, and Education, and 
Related Agencies Appropriations Act, 1997, as enacted by the Omnibus 
Consolidated Appropriations Act, 1997, Division A, Title I, Section 
101(e), Pub. L. 104-208 (September 30, 1996).

Background and Definitions

    The adverse health effects of lead on young children can be 
profound. Lower levels of lead, which rarely cause symptoms, can result 
in decreased intelligence, developmental disabilities, behavioral 
disturbances, and disorders of blood production. It is estimated that 
in the United States nearly one million children younger than 6 years 
old have blood levels high enough to cause adverse health effects. Lead 
poisoning affects children of all socioeconomic strata, racial/ethnic 
groups, and regions of the country; however, children who are 
minorities, are residents of central cities, live in older housing, or 
live in households with lower income are at higher risk for lead 
poisoning.
    In February 1991, HHS released the document, Strategic Plan for the 
Elimination of Childhood Lead Poisoning, which described the goals and 
objectives of CDC to eliminate this disease. The strategic plan focuses 
heavily on lead-based paint because of its key role in lead poisoning 
and because of the limited nature of previous efforts to reduce this 
source of lead. However, a national plan to eliminate childhood lead 
poisoning must focus on other sources and pathways of lead exposure 
that contribute significantly to children's blood lead levels. 
Continued efforts to identify and reduce these sources and pathways of 
lead exposure will result in lower average blood lead levels in the 
United States and will further diminish the likelihood of lead 
poisoning developing even in children exposed to a high-dose source.
    In general, blood lead levels of infants begin to correlate with 
the amount of lead contamination in their environments when the infants 
reach crawling age and their mobility puts them in contact with 
household dust, paint, and soil. By the time older infants and toddlers 
have been identified with elevated blood lead levels, often between 12 
and 24 months of age, they have already begun to accumulate high body 
burdens of lead and have had substantial periods of exposure to levels 
of lead potentially harmful to the developing nervous system. Thus, 
long periods of lead exposure prior to initiating an intervention may 
reduce the impact of the intervention on blood lead levels and 
neurobehavioral outcomes. For these reasons, it may be desirable to 
initiate interventions in

[[Page 26317]]

children at high risk for lead exposure at 6 months or younger.

Definitions

    Primary prevention refers to the prevention of lead exposure among 
children who have not yet developed elevated blood lead levels at the 
time of initiation of prevention measures.

Purpose

    The purposes of these awards are to (1) Study important 
epidemiologic questions critical to the implementation, operation, and 
expansion of childhood lead poisoning primary prevention programs; and 
(2) to support the development of guidelines and directives. 
Specifically, the purpose is to evaluate the feasibility, costs, and 
effectiveness (in terms of average blood levels and the proportion of 
children with elevated blood lead levels as measured in children 12 to 
24 months of age) of various strategies for primary prevention among 
young children (6 months of age or younger at study initiation) who are 
at high risk for lead exposure.

Programmatic Interest Areas

    Studies must be in one of the following areas:
    1. Evaluation of primary prevention through environmental 
intervention.
    2. Evaluation of primary prevention through educational 
intervention.
    3. Evaluation of primary prevention through nutritional 
intervention.
    Applicants are encouraged to work collaboratively with health, 
housing, and environmental government agencies and community-based 
organizations.

Application Content

    Please prepare your application following the instructions in the 
PHS-398. Please include the following:
    1. Identify a director who has specific authority and 
responsibility to carry out the requirements of the project.
    2. Demonstrate ability to collect and analyze data on cost and 
effectiveness needed to fulfill the study objectives.
    3. Demonstrate ability to describe in detail the materials, 
activities, and administrative arrangements that constitute the 
intervention and the way in which the program will be delivered.
    4. Demonstrate ability to evaluate the effectiveness of the program 
as measured by blood lead levels in children 12 to 24 months of age.
    5. Demonstrate ability to accurately assess the intervention costs 
and differentiate these costs from those of the research study.
    6. Demonstrate experience in conducting relevant epidemiologic 
studies, including publication of original research in peer-reviewed 
journals.
    7. Demonstrate effective and well-defined working relationships 
within the performing organization and with outside entities which will 
ensure implementation of the proposed study.
    8. Demonstrate access to a laboratory with demonstrated proficiency 
in performing blood lead (and other laboratory measurements as 
indicated in the applicant's study protocol).
    9. Demonstrate ability to ensure 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).
    10. Provide assurance that, when appropriate, referrals and other 
appropriate measures will be taken to ensure that children receive 
household environmental assessments and interventions that are 
consistent with applicable health and housing regulations and the 
community standard of care. If the applicant does not have direct 
responsibility for such activities, a letter of support from the 
organization with that responsibility is required.

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) collection, 
analysis, and interpretation of collected data; (3) ensuring 
appropriate medical and environmental management of study subjects; (4) 
evaluation of project during implementation of study and after 
completion of study; and (5) all other components required for 
implementation of the study.
    2. Enter and maintain data in a computerized database.
    3. Analyze collected data and prepare and publish 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.

Technical Reporting Requirements

    Annual progress reports in a CDC-approved format are required of 
all cooperative agreement recipients. Timelines for the annual reports 
will be established at the time of award. The narrative progress 
reports must include the following for each goal or activity involved 
in the study: (1) A comparison of actual accomplishments to the goals 
established for the period; (2) the reasons for slippage if established 
goals were not met; and (3) other pertinent information and data 
essential to evaluating progress and findings of the study.
    The Financial Status Report is required no later than 90 days after 
the end of the budget period. A final progress report and financial 
status report are required no later than 90 days after the end of the 
project period. Submit the original and two copies of the reports to 
the Grants Management Branch, CDC.

Evaluation Criteria

    Applications will be reviewed and evaluated according to the 
following criteria:

1. Study Protocol (35%)

    The protocol's scientific soundness (including adequate sample size 
with power calculations), quality, feasibility, consistency with the 
project goals, and soundness of the evaluation plan (which should 
provide sufficient detail regarding the way in which the program will 
be implemented to facilitate replication of the program).

2. Access to Study Subjects (20%)

    Documented ability to identify, access, enroll, and follow high-
risk study subjects. The degree to which the applicant has met the CDC 
policy requirements regarding the inclusion of women, ethnic, and 
racial groups in the proposed research. This includes: (a) The proposed 
plan for the inclusion of both sexes and racial and ethnic minority 
populations for appropriate representation; (b) the proposed 
justification when representation is limited or absent; (c) a statement 
as to whether the design of the study is adequate to measure 
differences when warranted; and (d) a statement as to whether the plans 
for recruitment and outreach for study participants include the process 
of establishing partnerships with community(ies) and recognition of 
mutual benefits.

[[Page 26318]]

3. Environmental, Educational, and Medical Intervention (15%)

    Ability to provide environmental and educational interventions 
before infants are exposed to potential lead hazards. Documented 
ability to ensure that children identified with elevated blood lead 
levels receive appropriate medical and environmental management.

4. Project Personnel (15%)

    The qualifications, experience, (including experience in conducting 
relevant studies) and time commitment of the staff needed to ensure 
implementation of the project.

5. Laboratory Capacity (10%)

    Documented availability to a laboratory with demonstrated 
proficiency in performing lead measurements (and other laboratory 
measurements as indicated in applicant's proposed study).

6. Performance Measurement (5%)

    Schedule for implementing and monitoring the project. The extent to 
which the application documents specific, attainable, and realistic 
goals and clearly indicates the performance measures that will be 
monitored, how they will be monitored, and with what frequency. This 
section should contain enough detail to determine at the end of each 
budget year, the extent to which the project is on target in completing 
the study process and outcome objectives.

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.

8. Human Subjects (not scored)

    The extent to which the applicant complies with the Department of 
Health and Human Services Regulations (45 CFR Part 46) regarding the 
protection of human subjects.

Executive Order 12372 Review

    Applications are not subject to the review requirements of 
Executive Order 12372.

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.

Women and Minority Inclusion Policy

    It is the policy of the CDC to ensure that women and racial and 
ethnic groups will be included in CDC supported research projects 
involving human subjects, whenever feasible and appropriate. Racial and 
ethnic groups are defined in OMB Directive No. 15 and include American 
Indian, Alaskan Native, Asian, Pacific Islander, Black and Hispanic. 
Applicants shall ensure that women, racial and ethnic minority 
populations are appropriately represented in applications for research 
involving human subjects. Where a clear and compelling rationale exists 
that inclusion is inappropriate or not feasible, this situation must be 
explained as part of the application.
    In conducting the review of applications for scientific merit, 
review groups will evaluate proposed plans for inclusion of minorities 
and both sexes as part of the scientific assessment and assigned score. 
This policy does not apply to research studies when the investigator 
cannot control the race, ethnicity and/or sex of subjects. Further 
guidance to this policy is contained in the Federal Register, Vol. 60, 
No. 179, Friday, September 15, 1995, pages 47947-47951.

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., 
June 16 for July 16 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

    Applicants should use Form PHS-398 (OMB No. 0925-0001 Revised 5/95) 
and adhere to the ERRATA Instruction Sheet for form PHS-398 contained 
in the grant application kit. Please submit an original and five copies 
on or before July 16, 1997, to 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, Atlanta, GA 30305, telephone (404) 842-6796.

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 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 telephone number and 
will need to refer to Announcement 776. 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

[[Page 26319]]

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, or Internet 
[email protected].
    Programmatic technical assistance may be obtained from Alan B. 
Bloch, M.D., M.P.H. , 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 (770) 488-7330, or Internet [email protected].
    Please refer to Announcement Number 776 when requesting information 
and submitting an application.
    This and other CDC announcements are also available through the CDC 
home page on the Internet. The address for the CDC home page is http://
www.cdc.gov.
    CDC will not send application kits by facsimile or express mail.
    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) 512-1800.
    To receive a free copy of the Strategic Plan for the Elimination of 
Childhood Lead Poisoning, call toll-free 1-888-232-6789 and leave name, 
address, and telephone number.

    Dated: May 7, 1997.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for 
Disease Control and Prevention (CDC).
[FR Doc. 97-12455 Filed 5-12-97; 8:45 am]
BILLING CODE 4163-18-P