[Federal Register Volume 60, Number 129 (Thursday, July 6, 1995)]
[Notices]
[Pages 35210-35212]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-16518]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
[Announcement Number 570]
Cooperative Agreement Program to Assess the Impact of Emerging
Infectious Diseases on Health Outcomes of Children and Their Families
Related to Out-of-Home Child Care
Introduction
The Centers for Disease Control and Prevention (CDC) announces the
availability of fiscal year (FY) 1995 funds for a cooperative agreement
program for competitive applications to assess the impact of out-of-
home child care on health outcomes related to infectious diseases among
children and their families and to evaluate the impact of interventions
designed to improve those health outcomes. For purposes of this
cooperative agreement program, out-of-home child care is defined as
care provided to children outside the home for at least ten hours per
week in child care centers, family child care homes, family group
homes, or similar settings. The primary population of interest is
children five years of age and younger and their families; however,
children up to 13 years of age (and their families) attending ``after-
school''-type care programs may be included in the study population.
Because of the difficulty in obtaining high quality data on illness and
health status from child care providers and the need to compare
children who receive child care in different settings, the focus for
recruitment and data collection should be through providers of health
care services (e.g., health maintenance organizations, preferred
provider organizations, physician-hospital organizations, other
integrated and/or managed care-type health provider networks or
organizations).
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 to improve the quality of life. This announcement is related
primarily to the priority area of Immunization and Infectious Diseases.
(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) and 317(k)(2) of
the Public Health Service Act, as amended (42 U.S.C. 241(a) and
247b(k)(2)). Applicable program regulations are found in 42 CFR part
51b, Project Grants for Preventive Health Services.
Smoke-Free Workplace
PHS strongly encourages all grant recipients to provide a smoke-
free workplace and to promote the non-use of all tobacco products, and
Pub. L. 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 and
for-profit organizations and governments and their agencies. Thus,
universities, colleges, research institutions, hospitals, other public
and private organizations, State and local governments or their bona
fide agents, federally recognized Indian tribal governments, Indian
tribes or Indian tribal organizations, and small, minority- and/or
women-owned businesses are eligible to apply.
Availability of Funds
Approximately $300,000 is available in FY 1995 to fund two to three
projects. It is expected that awards will range from $75,000 to
$150,000 and will begin on or about September 30, 1995, for a 12-month
budget period within a project period of up to three years. Funding
estimates may vary and are subject to change. Continuation awards
within the project period will be made on the basis of satisfactory
progress and the availability of funds.
There are no matching or cost participation requirements; however,
the applicant's anticipated contribution to the overall program costs,
if any, should be provided on the application.
[[Page 35211]]
Funds awarded under this cooperative agreement should not be used to
supplant existing State government expenditures in this area.
Purpose
The purpose of this cooperative agreement program is to provide
assistance to quantitatively assess: Infectious disease morbidity (both
in the child and the child's family) associated with out-of-home child
care; associations between morbidity (e.g., days of illness, days of
restricted activity, physician's visits, etc.) and the type of health
care (i.e., health maintenance organizations, preferred provider
organizations, fee-for-service, physician-hospital organizations, other
integrated and/or managed care-type health provider networks or
organizations) utilized by children and other family members. Health
care provider-focused interventions that will have a measurable impact
on morbidity among children and their families should also be assessed.
Program Requirements
In conducting activities to achieve the purpose of this program,
the recipient will be responsible for the activities under A., below,
and CDC will be responsible for activities listed under B., below:
A. Recipient Activities
1. Assess the health outcomes and health status of a population
using specific health indicators (e.g., number of days of a specific
illness, days of restricted activity, colonization or infection with
antibiotic-resistant bacteria, other measures of health or wellness)
and health care process measures (e.g., utilization and cost of health
services, number of antibiotic prescriptions, immunization rate). Also
study how the types and forms of health care services to which the
study population has access may be mediating factors in both process
and outcome measures.
2. Establish and monitor achievement of a series of measurable sub-
objectives (e.g., recruitment of adequate sample size; development of
data collection instruments; identification of adequate systems for
data processing and analysis; establishment of evaluation mechanisms,
including validation of data, etc.) so that progress toward
accomplishing the defined objectives can be clearly assessed.
3. Enroll study subjects representing populations that
appropriately address study objectives. For example, rates of illness
can be compared among families with children in a variety of child care
settings (including family child care homes, family group homes, and
child care centers), families with children not in out-of-home child
care (as one comparison group), and families/persons without children
(as a second comparison group). Types of health care these populations
receive that could be considered in comparing practices and in
evaluating access include managed care (traditional HMO, point-of-
service HMO, physician hospital organization), fee-for-service care,
private insurance and government-supported health care (e.g.,
Medicaid). Study populations should include a reasonable demographic
diversity by racial/ethnic composition, socio-economic status, etc.
4. Monitor and adhere to project timelines to ensure completion of
data collection and analysis and reporting to the scientific community
within a three-year project period.
5. Initiate and complete one or more of the following:
a. Surveillance for infectious disease morbidity, including
information on antimicrobial drug use (e.g., pharmaceutical used,
duration, dosage, indication and prescribing physician). When
appropriate, assessment should include identification of risk factors
for illness, collection of nasopharyngeal swabs and stool specimens for
identification of respiratory and enteric pathogens, and evaluation of
direct and indirect costs of illness among study subjects.
b. Definition of the impact of common respiratory illnesses,
respiratory complications including otitis media and related antibiotic
use on morbidity among children, family members and child care
providers. When appropriate, studies should include assessment of the
effectiveness of influenza vaccination in reducing influenza- related
morbidity, and the costs and use of antibiotics among children in child
care, their family members, and child care providers.
c. Assessment of the effectiveness of health education and its
impact on antimicrobial use and antimicrobial resistance (e.g.,
education of parents regarding appropriate use of antimicrobial drugs
in respiratory tract infections to decrease patient demand, handwashing
for the prevention of enteric and respiratory infections).
B. CDC Activities
1. Provide technical assistance in the design and conduct of the
projects.
2. Provide assistance in the evaluation and dissemination of the
results of the projects.
Evaluation Criteria
Applications will be reviewed and evaluated based on the following
weighted criteria:
A. The applicant's understanding of the purpose of the proposed
activity and inclusion of appropriate background information
demonstrating knowledge and understanding of the subject and rationale
for the proposed objectives. (10 points)
B. The extent to which applicant's description of the methods to be
used to assess health outcomes/health status of the population under
study (including accurately defining and measuring health outcomes,
characterizing exposures to risk factors, and assessing the impact of
intervention strategies) is detailed and adequate to accomplish project
objectives. The extent to which the applicant's description of the
methods to be used to measure health care process activities such as
site of service delivery, type of provider, financial mechanism (e.g.,
reimbursement, capitation), services provided, and the impact of these
process measures on the outcomes under study is detailed and adequate
to accomplish project objectives. (35 points)
C. The extent to which background information and other data
demonstrate that the applicant has the appropriate organizational
structure, administrative support, and ability to access appropriate
target populations or study objects and that these target populations
and study objects will ensure an adequate sample size and
representativeness of the types of health care settings, of families
with children in various types of child care settings, and reasonable
demographic diversity. (20 points)
D. The extent to which applicant demonstrates capacity to achieve
collaboration and participation of key groups, organizations, and
agencies necessary for successful implementation of these projects. (10
points)
E. The degree to which the proposed objectives are specific,
achievable, measurable and time-phased. (10 points)
F. The extent to which the applicant documents that professional
personnel involved in the project are qualified and have experience and
achievements in related research as evidenced by curriculum vitae,
publications, etc., and to which the projected level of effort by all
project personnel is adequate to accomplish the proposed activities.
(10 points)
G. The degree to which appropriate staff are available, either
through direct participation or through assured
[[Page 35212]]
consultative services, to provide expertise in health services
research, biostatistics, and health economics. (5 points)
H. The extent to which the proposed budget is reasonable, clearly
justified, and consistent with the intended use of cooperative
agreement funds. (Not scored)
Executive Order 12372 Review
Applications are subject to Intergovernmental Review of Federal
Programs as governed by Executive Order 12372. E.O. 12372 sets up a
system for State and local government review of proposed Federal
assistance applications. Applicants (other than federally recognized
Indian tribal governments) should contact their State Single Point of
Contact (SPOC) as early as possible to alert them to the prospective
applications and receive any necessary instructions on the State
process. For proposed projects serving more than one State, the
applicant is advised to contact the SPOC for each affected State. A
current list of SPOCs is included in the application kit. Indian tribes
are strongly encouraged to request tribal government review of the
proposed application. If SPOCs or tribal governments have any process
recommendations on applications submitted to CDC, they should forward
them to Clara M. Jenkins, Grants Management Officer, Grants Management
Branch, Procurement and Grants Office, Centers for Disease Control and
Prevention (CDC), 255 East Paces Ferry Road, NE., Mailstop E18, Room
314, Atlanta, GA 30305. The due date for State process recommendations
is 30 days after the application deadline date for new and competing
continuation awards. (A waiver for the 60 day requirement has been
requested). The granting agency does not guarantee to ``accommodate or
explain'' for State process recommendations it receives after that
date.
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 93.283.
Other Requirements
Paperwork Reduction Act
Projects that involve collection of information from ten or more
individuals and funded by the 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 evidence of this assurance in accordance with the appropriate
guidelines and form provided in the application kit. In addition to
other applicable committees, Indian Health Service (IHS) institutional
review committees also must review the project if any component of IHS
will be involved or will support the research. If any Native American
community is involved, its tribal government must also approve that
portion of the project applicable to it.
Application Submission and Deadline
In order to assist CDC in planning for and executing the evaluation
of applications submitted under this announcement, all parties
intending to submit an application are requested to inform CDC of their
intention to do so at their earliest convenience prior to the
application due date. Notification should include name and address of
institution and name and telephone number of contact person.
Notification can be provided by telephone, facsimile, or postal mail to
Steve Solomon, M.D., Special Studies Activity, Hospital Infections
Program, National Center for Infectious Diseases, 1600 Clifton Road,
NE., Mailstop A07, Atlanta, GA 30333, telephone (404) 639-6475,
facsimile (404) 639-6483. The original and two copies of the
application Form PHS-5161-1 (Revised 7/92, OMB Number 0937-0189) must
be submitted to Clara M. Jenkins, Grants Management Officer, Grants
Management Branch, Procurement and Grants Office, Centers for Disease
Control and Prevention (CDC), 255 East Paces Ferry Road, NE., Room 314,
Mailstop E18, Atlanta, GA 30305, on or before August 15, 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 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 Number 570. You will receive a complete
program description, information on application procedures, and
application forms.
If you have questions after reviewing the contents of all the
documents, business management technical assistance may be obtained
from Gordon R. Clapp, 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-
18, Atlanta, GA 30305, telephone (404) 842-6508. Programmatic technical
assistance may be obtained from Steve Solomon, M.D., Special Studies
Activity, Hospital Infections Program, National Center for Infectious
Diseases, Centers for Disease Control and Prevention (CDC), 1600
Clifton Road, NE., Mailstop A07, Atlanta, GA 30333, telephone (404)
639-6475.
Please refer to Announcement Number 570 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
through Superintendent of Documents, Government Printing Office,
Washington, DC 20402-9325, telephone (202) 512-1800.
Dated: June 29, 1995.
Deborah L. Jones,
Deputy Director for Management and Operations, Centers for Disease
Control and Prevention (CDC).
[FR Doc. 95-16518 Filed 7-5-95; 8:45 am]
BILLING CODE 4163-18-P
