[Federal Register Volume 59, Number 102 (Friday, May 27, 1994)]
[Unknown Section]
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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