[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