[Federal Register Volume 59, Number 102 (Friday, May 27, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-13006]


[[Page Unknown]]

[Federal Register: May 27, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Announcement Number 433]
RIN 0905-ZA37

 

FY 1994 Epidemiologic Research Studies of Acquired 
Immunodeficiency Syndrome (AIDS) and Human Immunodeficiency Virus (HIV) 
Infection

Introduction

    The Centers for Disease Control and Prevention (CDC) announces a 
program for competitive fiscal year (FY) 1994 cooperative agreement 
applications to conduct epidemiologic research studies of AIDS and HIV 
infection. These studies will evaluate the impact of existing program 
services on the psychological adjustment and transition to new living 
situations among children whose mothers are in the terminal stage of 
AIDS or have died of AIDS. The study of this research issue as it 
pertains to minority populations (defined as one of the four federally-
recognized groups: Black, Hispanic, Asian and Pacific Islander, and 
Native American) is encouraged because minorities constitute over 49 
percent of all reported cases of AIDS and approximately 75 percent of 
all women and children with AIDS.
    Research has suggested that by the end of the decade more than 
80,000 children and adolescents will be motherless due to AIDS. Not 
since the influenza epidemic of 1918 has this country been faced with 
this large a number of motherless children. Cities expected to be the 
most affected include Los Angeles, Miami, Newark, New York City, 
Washington, DC, and San Juan, P.R. However, the problem extends far 
beyond these pediatric HIV epicenters. More than 40 percent of the 
motherless children are anticipated in other cities as well as suburban 
and rural areas. In 1992 nearly 7,000 children were born to HIV-
infected women; 3,000 of these were born in the southeastern United 
States.
    It is currently expected that all children born to HIV-infected 
mothers will be left motherless. To place the magnitude of this problem 
in context, cancer kills the mothers of 4,200 children and 8,700 
adolescents each year. Motor vehicle accidents annually kill the 
mothers of 3,200 children and 1,900 adolescents. In 1994 AIDS will 
leave 3,900 children and 3,400 adolescents motherless.
    The impact of these deaths will be experienced on both the 
institutional and personal levels. Programs for children of HIV-
infected mothers will require large social welfare expenditures in the 
coming decades. And yet, little research has been completed to 
demonstrate the essential and effective social-service components that 
will be required, particularly for families with HIV-infected members. 
It is anticipated that programs for children and their caregivers 
should include mental health and bereavement counseling, programs that 
bridge the transition from AIDS-specific entitlement and services to 
general programs, housing support in the larger cities, and school/
community programs to help reduce high-risk behaviors in coming 
generations. In the face of the problems of exponential growth and 
diminishing funds, research should be conducted which determines the 
critical elements of a successful program.
    On the personal level, recently initiated behavioral studies have 
begun to highlight the impact of HIV infection on mothers and their 
children. Studies have emphasized both the stigma associated with HIV 
infection and the important role children play in decisions made by 
infected mothers. Evidence has suggested that mothers fear disclosing 
their HIV infection to their children, and because of this, often delay 
seeking much needed health care for themselves. Because of anticipated 
stigma, families may withdraw socially, attempting to cope without help 
from outside the family. Mothers also delay making plans for the care 
of their children after their death so that children may be placed in 
temporary foster care for many months during a period of considerable 
emotional stress to the child and family. Finally, there is preliminary 
evidence that teenaged children of HIV-infected mothers may engage in 
HIV-related sexual and drug-using behaviors in the period following the 
mother's death, behaviors attributed in part to the emotional trauma 
experienced by the adolescents during the transition period. 
Transitional social service programs for younger children at the time 
of their mother's death may in effect serve as primary prevention 
programs by helping children more effectively adjust to a new living 
situation and cope with the loss of their mother.
    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 improve the quality of life. This announcement is related to the 
priority area of HIV infection. (To order 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)(3) of 
the Public Health Service Act [42 U.S.C. 241(a) and 247b(k)(3)], as 
amended. Applicable program regulations are set forth in 42 CFR part 
52, entitled Grants for Research Projects.

Smoke-Free Workplace

    The Public Health Service strongly encourages all cooperative 
agreement recipients to provide a smoke-free workplace and promote the 
non-use of all tobacco products. This is consistent with the PHS 
mission to protect and advance the physical and mental health of the 
American people.

Eligible Applicants

    Eligible applicants include all nonprofit and for-profit 
organizations. Thus, universities, colleges, research institutes, 
hospitals, and other public and private organizations, including State 
and local health departments, are eligible for these cooperative 
agreements.

Availability of Funds

    Approximately $250,000 will be available in FY 1994 to fund 
approximately two awards. It is expected that the average award will be 
approximately $125,000. Awards will begin on or about September 1, 
1994, and will be made for 12-month budget periods within a project 
period of up to 3 years. Funding estimates may vary and are subject to 
change. Continuation awards within the project period will be made on 
the basis of satisfactory programmatic progress and the availability of 
funds.

Purpose

    The purpose of these awards is to help support researchers in the 
study of important HIV-related epidemiologic issues and specifically to 
evaluate the impact of HIV program services on the psychological 
adjustment and transition to new living situations among children (ages 
5-12) whose mothers are in the terminal stage of AIDS or have died of 
AIDS. Programs which examine this research issue as it affects minority 
populations are of special interest.

Program Requirements

Research Issues

    One research issue of programmatic interest to the health care 
community and to CDC for FY 1994 is described below and is considered 
to be of significant importance in gaining a greater understanding of 
the epidemiology of AIDS and HIV infection. However, applications 
submitted by organizations that examine other important HIV-related 
epidemiologic research issues will also be accepted and considered for 
funding.
    Study proposals are solicited that address issues related to the 
impact of the terminal illness and death of the HIV-infected mother 
upon the child by evaluating services available to families before, 
during, and after the mother's death. Specifically, proposals are 
sought which will describe methods to identify and evaluate those 
interventions which are necessary and effective in promoting the 
child's healthy, psychological adjustment as well as transition to 
their new living situation. The transition period of specific interest 
includes the periods immediately prior to and after the mother's death. 
The evaluation component must include both process and outcome 
evaluations and descriptions of how the researchers will access 
children with HIV-infected mothers and follow them after the mother's 
death. Preference will be given to proposals that evaluate two or more 
existing transitional programs sponsored by State or local governmental 
agencies or community-based organizations and include a minimum of 125 
children (ages 5-12) per program. Applicants are also encouraged to 
submit proposals that compare different types of transitional programs.
    Examples of worthwhile proposals include: Limited, longitudinal 
studies of children enrolled in foster care or other transitional 
programs specifically for families of HIV-infected mothers. Research 
strategies may include, but need not be limited to, record reviews to 
document numbers and types of foster or other caretaking arrangements 
of the child, placement of siblings, quantitative interviews with 
caretakers, and psychological measures including measures of 
bereavement, anxiety and depression, etc. Applicants must document 
specific behavioral research and evaluation expertise among the 
proposed staff. Applicants must also be willing to participate 
collaboratively with CDC and other researchers in the development, 
implementation, and analysis of data from the proposed study.

Cooperative Agreements

    A cooperative agreement indicates that CDC will assist the 
collaborator in conducting the epidemiologic research of AIDS and HIV 
infection described in the PURPOSE section of this announcement. The 
application should be presented in a manner that demonstrates the 
applicant's ability to address the research problem in a collaborative 
manner with CDC.
    In conducting activities to achieve the purpose of this program, 
the recipient shall be responsible for the activities under A., below, 
and CDC shall be responsible for conducting activities under B., below:

A. Recipient Activities

1. Develop the research study protocol and the interview instrument;
2. Identify, recruit, obtain informed consent, and enroll an adequate 
number of study participants as determined by the study protocol;
3. Continue to follow study participants as determined by the study 
protocol;
4. Establish procedures to maintain the rights and confidentiality of 
all study participants;
5. Perform laboratory tests (when appropriate) and data analysis as 
determined in the study protocol;
6. Collaborate and share data and specimens (when appropriate) with CDC 
and other collaborators to answer specific research questions; and
7. Conduct data analysis with CDC and other collaborators as well as 
present research findings.

B. CDC Activities

1. Provide technical assistance in the design and conduct of the 
research;
2. Provide technical guidance in the development of study protocols, 
consent forms and questionnaires;
3. Assist in designing a data management system;
4. Perform selected laboratory tests;
5. Coordinate research activities among the different sites; and
6. Participate in the analysis of research information and the 
presentation of research findings.

Evaluation Criteria

    Applications will be reviewed and evaluated based on the evidence 
submitted which specifically describes the applicants' abilities to 
meet the following criteria:
    1. The inclusion of a detailed review of the scientific literature 
pertinent to the study being proposed and specific research questions 
and/or hypotheses that will guide the research. (25 points)
    2. The originality and need for the proposed research and the 
extent to which it does not replicate past or present research efforts. 
(25 points)
    3. The plans to develop and implement the study describing how 
study participants will be identified, enrolled, tested and followed. 
(25 points)
    4. The ability to enroll and follow an adequate number of eligible 
study participants to assure proper conduct of the study. This includes 
both demonstration of the availability of HIV-infected potential study 
participants and the experience of the investigator in enrolling and 
following such persons. (25 points)
    5. The applicant's current activities in AIDS and HIV or related 
research and how they will be applied to achieving the objectives of 
the study. Letters of support from cooperating organizations which 
demonstrate the nature and extent of such cooperation should be 
included. (20 points)
    6. The applicant's understanding of the research objectives and 
their ability, willingness and/or need to collaborate with CDC and 
researchers from other study sites in study design and analysis, 
including use of common forms, and sharing of specimens (when 
appropriate) and data. (25 points)
    7. The plan to protect the rights and confidentiality of all 
participants. (25 points)
    8. The size, qualifications and time allocation of the proposed 
staff and the availability of facilities to be used during the research 
study. How the project will be administered to assure the proper 
management of the daily activities of the program should be described. 
(10 points)
    9. The proposed schedule for accomplishing the activities of the 
research, including time-frames. (10 points)
    10. A detailed evaluation plan which specifies methods and 
instruments to be used to evaluate the progress made in attaining 
research objectives. (10 points)

(A maximum of 200 points can be awarded.)

    The budget will be reviewed to determine the extent to which it is 
reasonable, clearly justified, and consistent with the intended use of 
funds. Budget information should be specific to the purpose of each 
budget item and all budget categories should be itemized.

Executive Order 12372 Review

    Applications are not subject to review under Executive Order 12372, 
Intergovernmental Review of Federal Programs.

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 93.943, 
Epidemiologic Research Studies of Acquired Immunodeficiency Syndrome 
(AIDS) and Human Immunodeficiency Virus (HIV) Infection in Selected 
Population Groups.

Other Requirements

1. Paperwork Reduction Act

    Projects that involve the collection of information from 10 or more 
individuals and funded by cooperative agreement will be subject to 
review by the Office of Management and Budget (OMB) under the Paperwork 
Reduction Act.

2. Human Subjects

    This program involves research on human subjects. Therefore, all 
applicants must comply with Public Law 93-148 regarding the protection 
of human subjects. Assurances must be provided which demonstrate that 
the project or activity 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 forms provided in the 
application kit.

3. HIV Program Review Panel

    Recipients must comply with the document entitled Content of AIDS-
Related Written Materials, Pictorials, Audiovisuals, Questionnaires, 
Survey Instruments, and Educational Sessions (June 1992) (a copy is in 
the application kit). To meet the requirements for a program review 
panel, recipients are encouraged to use an existing program review 
panel, such as the one created by the State health department's HIV/
AIDS prevention program. If the recipient forms its own program review 
panel, at least one member must be an employee (or a designated 
representative) of a State or local health department. The names of the 
review panel members must be listed on the Assurance of Compliance Form 
CDC 0.1113, which is also included in the application kit. The 
recipient must submit the program review panel's report that indicates 
all materials have been reviewed and approved.

4. Patient Care

    Applicants should provide assurance that all HIV-infected patients 
enrolled in their studies will be linked to an appropriate local HIV 
care system that can address their specific needs such as medical care, 
counseling, social services and therapy. Details of the HIV care system 
should be provided, describing how patients will be linked to the 
system. Funds will not be made available to support the provision of 
direct care for study participants.

Application Submission and Deadline

    The original and five copies of the completed application Form PHS-
398 (Rev. 9/91) must be submitted to Edwin L. Dixon, 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, Mail Stop E-18, Atlanta, Georgia 30305, on or 
before July 1, 1994. States and local governments may use Form PHS-
5161-1 (Rev.7/92); however, Form PHS-398 is preferred. If using Form 
PHS-5161-1, submit an original and two copies to the address stated 
above.

1. Deadline

    Applications shall be considered as meeting the deadline if they 
are either:
    (a) Received on or before the stated deadline date; or
    (b) Sent on or before the deadline date and received in time for 
submission to the independent review group. (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 accepted 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 in the current competition and will be returned to the 
applicant.

Where to Obtain Additional Information

    A complete program description, information on application 
procedures, an application package and 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 314, Mail Stop E-18, Atlanta, Georgia 30305, telephone 
(404) 842-6508.
    Programmatic technical assistance may be obtained from John 
Narkunas, Division of HIV/AIDS, National Center for Infectious 
Diseases, Centers for Disease Control and Prevention (CDC), Mail Stop 
E-45, Atlanta, Georgia 30333, telephone (404) 639-6130. Eligible 
applicants are encouraged to call prior to the development and 
submission of their application. 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 the Superintendent of Documents, Government 
Printing Office, Washington, DC 20402-9325, telephone (202) 783-3238.


    Dated: May 20, 1994.
Ladene H. Newton,
Acting Associate Director for Management and Operations, Centers for 
Disease Control and Prevention (CDC).
[FR Doc. 94-13006 Filed 5-26-94; 8:45 am]
BILLING CODE 4163-18-P