[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]
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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
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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
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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
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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