[Federal Register Volume 60, Number 130 (Friday, July 7, 1995)]
[Notices]
[Pages 35405-35408]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-16688]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[Announcement Number 529]
RIN 0905-ZA95


FY 1995 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) 1995 grant or cooperative 
agreement applications to conduct epidemiologic and behavioral research 
studies of AIDS and HIV infection. These include studies to evaluate 
the implementation and effectiveness of policies to reduce mother-to-
child HIV transmission, to examine factors related to mother-to-child 
HIV transmission, and to evaluate factors associated with healthy, 
long-term HIV- seropositive persons. The study of these research areas 
as they pertain to minority populations (defined as Black, Hispanic, 
Asian and Pacific Islander, and American Indian), is encouraged because 
minorities constitute over 50 percent of all reported cases of AIDS and 
approximately 76 percent of all women and children with AIDS.
    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)(2) of 
the Public Health Service Act [42 U.S.C. 241(a) and 247b(k)(2)], 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 grant recipients 
to provide a smoke-free workplace and promote the non-use of all 
tobacco products. Public Law 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. This is consistent with 
the PHS mission to protect and advance the physical and mental health 
of American people.

Eligible Applicants

    Eligible applicants include all public and private, nonprofit and 
for-profit organizations and governments and their agencies. Thus, 
universities, colleges, research institutions, hospitals, and other 
public and private organizations, State and local governments or their 
bonafide 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 $3,900,000 will be available in FY 1995 to fund 
approximately eight awards. It is expected that the average award will 
be approximately $375,000, ranging from $350,000 to $400,000. It is 
expected that about 5 new and 3 competing renewal awards will be made 
and that awards will begin on or about September 30, 1995. Awards will 
be funded for a 12-month budget period 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 conduct epidemiologic and 
behavioral research studies of AIDS and HIV infection. These include 
studies to evaluate the implementation and effectiveness of policies to 
reduce mother-to-child HIV transmission, to examine factors related to 
mother-to-child HIV transmission, and to evaluate factors associated 
with healthy long-term HIV- seropositive persons. The study of these 
research areas as they pertain to minority populations (defined as 
Black, Hispanic, Asian and Pacific Islander, and American Indian), is 
encouraged because minorities constitute over 50 percent of all 
reported cases of AIDS and 

[[Page 35406]]
approximately 76 percent of all women and children with AIDS.
Program Requirements

    In conducting activities to achieve the purpose of this program, 
the applicant should follow the procedures set forth below.

Research Issues

    Three research issues of programmatic interest to the health care 
community and to CDC for FY 1995 are listed below and are 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 additional important HIV-related 
epidemiologic research issues will also be accepted and considered for 
funding.

A. Evaluating the Implementation of Policies to Reduce Mother-to-Child 
Transmission

    Studies should be designed to evaluate the implementation and 
effectiveness of guidelines for universal counseling and voluntary HIV 
testing of pregnant women, for offering zidovudine (ZDV) to HIV-
infected pregnant women to reduce mother-to-child HIV transmission, and 
for providing needed health and social services for HIV-infected women 
and their children. Specifically, proposals are sought which will 
address the following objectives:
    1. To describe the extent to which current prenatal HIV counseling, 
testing, and intervention practices reflect full implementation of 
local and/or national guidelines (i.e., the United States PHS 
Recommendations for HIV Counseling and Testing for Pregnant Women) in a 
well-defined population.
    2. To identify and quantify determinants of success or failure to 
implement guidelines for offering HIV counseling and testing among 
pregnant women and to identify and quantify determinants of accepting 
HIV testing by pregnant women.
    3. To identify and quantify determinants of the acceptance of and 
adherence to preventive ZDV therapy, and the receipt of needed HIV-
related services by HIV-infected pregnant women and their children.
    4. To identify and quantify social and psychological effects of 
being diagnosed with HIV, in particular potential adverse social and 
psychological consequences of HIV testing of pregnant women including 
discrimination, domestic violence, and loss of social and family 
supports. Preference will be given to applicants who address two or 
more of the above objectives and are able to document their ability to 
enroll an adequate number of pregnant women and HIV-infected pregnant 
women. Applicants must be willing to participate collaboratively with 
CDC and other researchers in the development, implementation, and 
analysis of data from the proposed study.

B. Mother-to-Child HIV Transmission Studies

    Studies should be designed to identify HIV-infected women during 
pregnancy or at delivery and enroll the women and their infants in a 
prospective follow-up study to examine factors related to mother-to-
child HIV transmission, early diagnosis of infant infection, and 
disease progression, particularly in infants. Studies designed to 
examine the effect of interventions to prevent mother-to-child HIV 
transmission are of particular interest. Preference will be given to 
studies in which mother-infant pairs are already being systematically 
identified and followed, and which have the ability to perform 
virologic and immunologic assays. Applicants must demonstrate that they 
can provide adequate rates of follow-up of both mothers and infants, 
including collection of laboratory specimens at periodic intervals 
(particularly within the first 48 hours of birth and during the first 6 
months of life), and long-term follow-up of infants, including those 
placed in foster care. Applicants must be willing to participate in 
collaborative studies with other CDC-sponsored mother-to-child HIV 
transmission projects, including use of common data collection 
instruments and study design where warranted. Applicants must 
demonstrate cost-efficient data management and statistical capability 
or provide explicit plans for data management by CDC or an outside 
group. Applicants must demonstrate the ability to enroll and follow at 
least 30 HIV-positive mother-infant pairs per year at each study site.

C. Prospective Evaluation of Healthy, Long-Term HIV-Seropositive 
Persons

    Studies should be designed to assess virologic and host factors in 
which the HIV-infected persons remain disease- free or asymptomatic for 
prolonged periods (usually, for 10 or more years after HIV infection). 
Preference will be given to studies in which cohorts of long-term 
healthy HIV-seropositive persons with characterized dates of 
seroconversion and high CD4+ lymphocyte counts (e.g., >500 cells/
mm3) have been established. Studies should be designed to try to 
identify virologic and immunologic factors that may modulate the 
clinical course of HIV infection. Applicants should demonstrate a 
willingness to collaborate, or have a proven collaborative 
relationship, with virologic and immunologic laboratories, CDC, and 
providers of care to HIV-infected persons.
Research Project Grants

    A research project grant is one in which substantial programmatic 
involvement by CDC is not anticipated by the recipient during the 
project period. Applicants for grants must demonstrate an ability to 
conduct the proposed research with minimal assistance, other than 
financial support, from CDC. This would include possessing sufficient 
resources for clinical, laboratory and data management services, and a 
level of scientific expertise to achieve the objectives described in 
their research proposal without substantial technical assistance from 
CDC.

Cooperative Agreements

    A cooperative agreement implies 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 
in collaboration with CDC;
    2. Identify, recruit, obtain informed consent, and enroll an 
adequate number of study participants as determined by the study 
protocol and the program requirements, where applicable;
    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 

[[Page 35407]]

    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.

Determination of Which Instrument to Use

    Applicants must specify the type of award for which they are 
applying, either project grant or cooperative agreement. CDC will 
review the applications in accordance with the evaluation criteria. 
Before issuing awards, CDC will determine whether a grant or 
cooperative agreement is the appropriate instrument based upon the need 
for substantial Federal involvement in the project.

Evaluation Criteria

    Applications will be reviewed and evaluated based on the evidence 
submitted, which specifically describes the applicants' abilities to 
meet the following criteria:
    A. 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)
    B. The originality and need for the proposed research and the 
extent to which it does not replicate past or present research efforts. 
(25 points)
    C. The plans to develop and implement the study describing how 
study participants (including racial/ethnic minority populations) will 
be identified, enrolled, tested and followed. (25 points)
    D. 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 in a culturally and linguistically appropriate 
manner. (25 points)
    E. 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)
    F. 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)
    G. The plan to protect the rights and confidentiality of all 
participants. (25 points)
    H. The size, qualifications and time allocation of the proposed 
staff and the availability of facilities to be used during the research 
study. Description of how the project will be administered to assure 
the proper management of the daily activities of the program. (10 
points)
    I. The proposed schedule for accomplishing the activities of the 
research, including time-frames. (10 points)
    J. 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 cumulative 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. All budget categories should be itemized.

Funding Priorities

    Priority will be given to competing continuation applications from 
satisfactorily performing projects over applications for projects not 
already receiving support under the program. Projects to evaluate the 
implementation of policies to reduce mother-to-child transmission will 
be awarded so that the composite of projects represents the geographic 
and demographic characteristics of HIV-infected childbearing women.
    Public comments are not being solicited regarding the funding 
priority because time does not permit solicitation and review prior to 
the funding date.

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

A. 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.

B. Human Subjects

    This program involves research on human subjects. Therefore, all 
applicants 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 or 
activity will be subject to initial and continuing review by an 
appropriate institutional review committee. The applicant will be 
responsible for providing 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 American Indian community is involved, its tribal government must 
also approve that portion of the project applicable to it.
C. 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 

[[Page 35408]]
review panel's report that indicates all materials have been reviewed 
and approved.

D. 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 (OMB No. 0925-0001) must be submitted to Clara 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 320, Mail Stop E-15, Atlanta, Georgia 
30305, on or before August 11, 1995. States and local governments may 
use Form PHS-5161-1 (OMB No. 0937-0189); 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 or financial management 
technical assistance may be obtained from Kevin G. Moore, Grants 
Management Specialist, Grants Management Branch, Procurement and Grants 
Office, Centers for Disease Control and Prevention (CDC), 255 East 
Paces Ferry Road, NE., Room 320, Mail Stop E-15, Atlanta, Georgia 
30305, telephone (404) 842-6550. The announcement is available through 
the CDC homepage on the Internet. The address for the CDC homepage is 
http://www.cdc.gov.
    Programmatic technical assistance may be obtained from Jeff Efird, 
Division of HIV/AIDS, National Center for Infectious Diseases, Centers 
for Disease Control and Prevention (CDC), 1600 Clifton Road, NE., 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. Please refer to Announcement Number 
529 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 from the Superintendent of Documents, Government Printing 
Office, Washington, DC 20402-9325, telephone (202) 512-1800.

    Dated: June 30, 1995.
Joseph R. Carter,
Acting Associate Director for Management,Management and Operations 
Centers for Disease Control and Prevention (CDC).
[FR Doc. 95-16688 Filed 7-6-95; 8:45 am]
BILLING CODE 4163-18-P