[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

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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