[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