[Federal Register Volume 64, Number 103 (Friday, May 28, 1999)]
[Notices]
[Pages 29036-29039]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-13605]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Program Announcement 99106]
Social and Environmental Interventions To Reduce HIV Incidence;
Availability of Funds
A. Purpose
The Centers for Disease Control and Prevention (CDC) announces the
availability of fiscal year (FY) 1999 funds for a cooperative agreement
program to identify social and environmental interventions to reduce
HIV incidence. This program addresses
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the ``Healthy People 2000'' priority areas of Educational and
Community-Based Programs (Objective: Increase years of healthy life to
at least 65 years) and HIV Infection (Objective: Confine annual
incidence of diagnosed AIDS cases to no more than 43 per 100,000).
Prevention research has identified effective methods to help
individuals change behavior to reduce their risk of acquiring or
transmitting HIV. This research has contributed to significant
decreases in risk and has saved many lives. However, an estimated
40,000 persons per year acquire HIV in the United States, so currently
available methods are not sufficient and additional prevention
approaches are needed. This announcement seeks research proposals to
identify interventions in the social environment that could further
reduce HIV incidence.
In 1988 the Institute of Medicine defined the mission of public
health as ``ensuring the conditions in which people can be healthy.''
Since then, many studies have identified societal characteristics that
are associated with a variety of illnesses, but few studies have
identified social or environmental interventions and evaluated their
effectiveness. Early in the AIDS epidemic, members of affected
communities reported that the social environment contributed to the
incidence of disease. The contribution of the social environment can
clearly be seen in countries where women's rights have not been
protected, facilitating international trafficking in women for
commercial sex. Stigma surrounding AIDS impedes many HIV prevention
interventions. Environmental or structural conditions in the United
States may also contribute to the incidence of HIV. Laws against
carrying needles and syringes may encourage needle sharing by drug
users. Laws that preclude recognition of same-sex partnerships may
discourage long-term monogamous relationships among gay men or
intimidate gay men so they cannot be reached with prevention
interventions. A high concentration of liquor stores may foster
environments where HIV and other sexually transmitted diseases
flourish. Areas with low levels of community cohesion tend to have high
rates of many different diseases.
This announcement seeks research applications to identify social
and environmental interventions that could further reduce HIV
incidence. Social and environmental factors that might be addressed
include, but are not limited to: housing, legal issues, stigma,
employment, physical environments of communities, and family and peer
support systems. The purpose of this research is not simply to add to
the list of social and environmental conditions that may facilitate HIV
transmission, but to also systematically examine the acceptability and
feasibility of interventions to change the conditions, and to estimate
the impact that the interventions might have on HIV incidence.
These research studies will: (1) Determine who is acquiring HIV in
the community (use of relevant existing data is encouraged); (2)
identify and document evidence of social and environmental factors that
contribute to HIV incidence (using primary and secondary data
analyses); (3) determine which social and environmental factors are
amenable to specific interventions; and (4) assess the acceptability
and feasibility of the identified interventions, and estimate the
impact of the interventions on HIV incidence in a defined study
population or geographic area. An important aspect of the study will be
the participation of the affected community to identify their
assessments of associations between social conditions and HIV
infection, and of the acceptability and feasibility of proposed
interventions. Study teams should be multi-disciplinary and include
experts in sociology, epidemiology, human rights, and community
organization and development. The goal of this announcement is to
identify and develop social and environmental interventions to reduce
HIV incidence and assess the acceptability, feasibility, and potential
impact of those interventions. It is not anticipated that long-term
interventions would be accomplished by this announcement. However,
documenting the process of identifying and prioritizing interventions
could facilitate implementation of interventions in the study community
and other communities.
Jonathan Mann and others proposed a health and human rights
framework for public health as a way to moving beyond the
``paralyzing'' effects of simply viewing poverty as the root cause of
ill health. While not a requirement for these proposals, applicants
might consider a human rights framework in their approach to
identifying possible areas for intervention.
B. Eligible Applicants
Applications may be submitted by public and private nonprofit and
for-profit organizations and by governments and their agencies; that
is, universities, colleges, research institutions, hospitals, other
public and private nonprofit and for-profit organizations, State and
local governments or their bona fide agents, and federally recognized
Indian tribal governments, Indian tribes, or Indian tribal
organizations. Small and minority owned businesses are encouraged to
apply.
Note: Public Law 104-65 states that an organization described in
section 501(c)(4) of the Internal Revenue Code of 1986 that engages
in lobbying activities is not eligible to receive Federal funds
constituting an award, grant, cooperative agreement, contract, loan,
or any other form.
C. Availability of Funds
Approximately $500,000 is available in FY99 to fund approximately
2-3 awards. It is expected that the average award will be $200,000,
ranging from $150,000 to $250,000, for a 12 month budget period within
a two year project period. It is expected that awards will be made
September 1, 1999. Funding estimates may change.
Continuation awards within an approved project period will be made
on the basis of satisfactory progress as evidenced by required reports
and the availability of funds.
Funding Preferences
In making awards, geographic and population risk group diversity
will be considered.
D. Program Requirements
In conducting activities to achieve the purpose of this program,
the recipient will be responsible for the activities listed under
Recipient Activities. Because this is a cooperative agreement, there
will be substantial federal involvement and CDC will be responsible for
conducting activities listed under CDC Activities:
1. Recipient activities:
a. Develop a research protocol and plans for conducting this
research in collaboration with CDC, and where appropriate, with the
participation of State and local professional associations; community
groups and organizations, especially those with a racial and ethnic
minority membership and focus; HIV/AIDS service organizations; and
organizations that serve persons at increased risk of HIV/AIDS.
b. Promote the development and evaluation of social and
environmental interventions for HIV prevention by providing data and
ongoing assistance to community planning groups; by disseminating data
through publications and presentations by participating in project
planning and implementation meetings; and by reporting ways in
[[Page 29038]]
which the data have been used to promote public health.
c. Establish procedures to maintain the rights and confidentiality
of all study participants. Prior to implementation, this study must be
submitted to the CDC Institutional Review Board (IRB) for review and
approval or deferral.
d. Develop the review of existing information, research study
protocol, and data collection forms.
e. In collaboration with the community, identify opportunities and
needs for social and environmental interventions; assess the
acceptability and feasibility of identified interventions; estimate the
effectiveness of the interventions in preventing infection and disease.
f. Review existing information to evaluate the contribution of the
social and environmental factors to the incidence of HIV, and potential
opportunities for intervention.
g. Identify, recruit, obtain informed consent (when appropriate),
enroll, and follow an adequate number of study participants as
determined by study protocol and the program requirements.
h. Perform data analysis as determined in the study protocol.
(1) Share data with other collaborators to answer specific research
questions.
(2) When appropriate, participate in multi-site data analysis and
presentation and publication of research findings with collaborators.
(3) Prepare and submit for publication, a report of research
findings describing the process of selecting and prioritizing
interventions based on the acceptability, feasibility, and potential
impact identified by this research.
2. CDC activities:
a. Provide technical assistance in the design and conduct of the
research.
b. Assist in the development of a research protocol for IRB review
by all cooperating institutions participating in the research project
by an OPRR-approved IRB with either a single or multiple project
assurance. The CDC IRB will review and approve the protocol initially
and on at least an annual basis until the research project is
completed.
c. As needed, assist in designing a data management system.
d. Coordinate research activities among the different sites, when
appropriate.
e. Assist in the analysis of research information and the
presentation and publication of research findings.
E. Application Content
Use the information in the Program Requirements, Other
Requirements, and Evaluation Criteria sections to develop the
application content. Your application will be evaluated on the criteria
listed, so it is important to follow the Evaluation Criteria in laying
out your program plan. The narrative should be no more than 25 double-
spaced pages, printed on one side, with one inch margins, and unreduced
font. Applications containing narratives that are longer than 25 pages
will not be reviewed.
F. Submission and Application Deadline
Submit the original and five copies of PHS-398 (OMB Number 0925-
0001) (adhere to the instructions on the Errata Instruction Sheet for
PHS 398). Forms are in the application kit. On or before August 1,
1999, submit the application to: Sheryl Disler, Grants Management
Specialist, Grants Management Branch, Procurement and Grants Office,
Announcement 99106, Centers for Disease Control and Prevention (CDC),
Brandywine Road, Mail Stop E15, Room 3000, Atlanta, Georgia 30341-4146.
Deadline: Applications shall be considered as meeting the deadline
if they are either received on or before the deadline date; or sent on
or before the deadline date and received in time for Peer Review.
(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 acceptable as
proof of timely mailing.) Applications that do not meet these criteria
are considered late applications, will not be considered, and will be
returned to the applicant.
G. Evaluation Criteria
Each application will be evaluated individually against the
following criteria by an independent peer reviewer group appointed by
CDC. Applications will be reviewed and evaluated only on the basis of
the evidence submitted.
1. Background and Objectives (15 points): Demonstrated scientific
significance of the proposed study in that it will publish data not
otherwise available concerning social and environmental interventions
to reduce HIV incidence.
The application should include a detailed review of the scientific
literature pertinent to the study being proposed, with evidence for the
relationship of social and environmental factors to the incidence of
HIV. This literature review should suggest specific research questions
that will guide the research. The goals and objectives for the research
should be clearly stated along with how findings from this study could
be used to implement social and environmental interventions.
2. Site Selection (20 points): Demonstration of a high prevalence
of HIV or AIDS in the study area. Demonstrated capacity to access the
relevant study community or communities.
The application should include a description of the size and
characteristics of the communities proposed for study. Describe the
prevalence and estimated incidence of HIV infection in the study
community. Include the age, gender, race/ethnicity, and HIV-risks of
persons with HIV in the community to be studied. Describe the potential
for community participation to identify interventions and participate
in the assessment of their acceptability, feasibility, and estimated
impact. Describe the experience of the investigators in working with
communities in a culturally and linguistically appropriate manner.
Letters of support from cooperating organizations should be included
which detail the nature and extent of such cooperation.
3. Methods (25 points): Appropriateness of methods for identifying
social and environmental interventions to reduce HIV incidence and
measuring the acceptability, feasibility and potential impact of the
interventions within a community or geographic area.
The application should describe the approach to gathering
information on the potential contribution of social and environmental
factors to HIV incidence in the study area, including anticipated
primary and secondary data collection. It should specify quantitative
and qualitative analytic techniques to be used to develop an
intervention and evaluate its acceptability, feasibility, and potential
impact. The application should also outline the methods and rationale
that will be used in the study to assess acceptability, feasibility,
and estimate impact of possible interventions, including the plan for
involving members of the affected community. The percentage-time
commitments, duties, and responsibilities of project personnel should
be sufficient to operationalize the proposed methodology.
4. Research Capacity (20 points): Experience in similar social
interventions, human rights evaluations, and HIV prevention research;
and availability of qualified and experienced personnel.
The application should describe the capacity and experience of the
research
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team and should include CVs and position descriptions for key staff and
project participants. Letters of support from key collaborators and
community groups should be included.
5. Evaluation Plan (15 points): Appropriateness and
comprehensiveness of: (a) the schedule for accomplishing the activities
of the research; (b) an evaluation plan that identifies methods and
instruments for evaluating progress in implementing the research
objectives; and (c) a proposal to complete and submit for publication,
a report of research findings.
The application should include time-phased and measurable
objectives. The proposed report of research findings should address a
plan for documenting the process of identifying and prioritizing
interventions based on acceptability, feasibility, and estimated impact
within a defined community or population.
6. Confidentiality (5 points): Appropriateness of the plan to
protect the rights and confidentiality of all participants, including
the degree to which the applicant has met the CDC Policy requirements
regarding the inclusion of women, ethnic, and racial groups in the
proposed research. This includes:
a. The proposed plan for the inclusion of both sexes and racial and
ethnic minority populations for appropriate representation.
b. The proposed justification when representation is limited or
absent.
c. A statement as to whether the design of the study is adequate to
measure differences when warranted.
d. A statement as to whether the plans for recruitment and outreach
for study participants include the process of establishing partnerships
with communities and recognition of mutual benefits.
7. Budget (not scored): The extent to which the budget is
reasonable, clearly justified, and consistent with the intent of the
announcement.
The 12 month budget should anticipate the organizational and
operational needs of the study. The budget should include staff,
supplies, and travel (including two trips per year for up to four
members of the study team to meet with CDC staff and other
investigators).
8. Human Subjects: Does the application adequately address the
requirements of Title 45 CFR Part 46 for the protection of human
subjects?
H. Other Requirements
Technical Reporting Requirements
Provide CDC with original plus two copies of:
1. Progress reports (semiannual);
2. Financial status report, no more than 90 days after the end of
the budget period; and
3. Final financial status and performance reports, no more than 90
days after the end of the project period.
Send all reports to: Sheryl Disler, Grants Management Specialist,
Grants Management Branch, Procurement and Grants Office, Centers for
Disease Control and Prevention (CDC), 2920 Brandywine Road, Room 3000,
Mail Stop E15, Atlanta, GA 30341-4146.
The following additional requirements are applicable to this
program. For a complete description of each, see Attachment I in the
application kit.
AR-1 Human Subjects Requirements
AR-2 Requirements for Inclusion of Women and Racial and Ethnic
Minorities in Research
AR-4 HIV/AIDS Confidentiality Provisions
AR-5 HIV Program Review Panel Requirements
AR-7 Executive Order 12372 Review
AR-8 Public Health System Reporting Requirements
AR-9 Paperwork Reduction Act Requirements
AR-10 Smoke-Free Workplace Requirements
AR-11 Healthy People 2000
AR-12 Lobbying Restrictions
I. Authority and Catalog of Federal Domestic Assistance Number
This program is authorized under the Public Health Service Act,
Section 301(a), 42 U.S.C. 241(a), as amended, and Section 317(a), 42
U.S.C. 247b(a), as amended. The Catalog of Federal Domestic Assistance
number is 93.941.
J. Where To Obtain Additional Information
Please refer to Program Announcement 99106 when you request
information. For a complete program description, information on
application procedures, an application package, and business management
technical assistance, contact: Sheryl Disler, Grants Management
Specialist, Grants Management Branch, Procurement and Grants Office,
Announcement 99106, Centers for Disease Control and Prevention (CDC),
2920 Brandywine Road, Room 3000, Mail Stop 15, Atlanta, GA 30341-4146,
Telephone (404) 842-488-2756; Email: [email protected].
See also the CDC home page on the Internet: HTTP://WWW.CDC.GOV.
For program technical assistance, contact Catherine Avery, Mailstop
E46, CDC, Atlanta, GA 30333. 404-639-6191, [email protected].
Dated: May 24, 1999.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control
and Prevention (CDC).
[FR Doc. 99-13605 Filed 5-27-99; 8:45 am]
BILLING CODE 4163-18-P