[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] ----------------------------------------------------------------------- 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