[Federal Register Volume 64, Number 108 (Monday, June 7, 1999)]
[Notices]
[Pages 30335-30339]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-14281]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Program Announcement 99098]
Strengthening HIV/AIDS and STD Prevention Through Use of
Behavioral Data in Programmatic Decision Making; Notice of Availability
of Funds
A. Purpose
The Centers for Disease Control and Prevention (CDC) announces the
availability of fiscal year (FY) 1999 funds for competitive cooperative
agreement awards to (1) Better understand state and local decision-
making processes that involve the use of HIV- and STD-related
behavioral data, and (2) enhance the availability and utilization of
high-quality HIV/STD behavioral data for meeting the needs of HIV/AIDS
and STD prevention program planners. Use of scientifically credible
behavioral data is expected to strengthen HIV/AIDS/STD prevention by
enhancing decision makers' ability to target priority populations,
precisely design programs that address local HIV risk factors, and
respond quickly to changing prevention needs within their
jurisdictions. This Program Announcement addresses the Healthy People
2000 priority areas of (18) HIV infection, (19) Sexually Transmitted
Diseases, and (22) Surveillance and Data Systems.
Effective HIV/AIDS and STD prevention programs include the
development, implementation, and evaluation of HIV behavioral risk-
reduction interventions that address the specific needs of at-risk
populations within their communities. To help achieve these objectives,
public health decision makers need accurate, timely, and relevant data
about HIV/STD risk behaviors and their determinants for groups within
their jurisdictions. However, in some jurisdictions, HIV/STD behavioral
risk data may be incomplete, unavailable, of poor quality, or out of
date. In other areas, useful data are available but may not be
effectively used in HIV and STD prevention program planning.
This process is intended to support research to answer several
overarching questions: (1) How are HIV/AIDS/STD prevention decisions
made? (2) How do behavioral data currently inform these decisions? (3)
What gaps currently exist with respect to the match between available
behavioral data and current decision-making needs? (4) What data and
analyses can address key program decisions for setting community HIV/
STD prevention priorities? (5) How can decision makers make better use
of existing data? (6) In what measurable ways can HIV/STD prevention
programs be improved by enhancements in the capacity of local decision
makers to use behavioral data?
B. Eligible Applicants
Assistance will be provided only to the health departments of
States or their bona fide agents, including the District of Columbia,
the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth
of the Northern Mariana Islands, American Samoa, Guam, federally
recognized Indian tribal governments, the Federated States of
Micronesia, the Republic of the Marshall Islands, and the Republic of
Palau. In consultation with States, assistance may be provided to
political subdivisions of States.
C. Availability of Funds
Approximately $600,000 is available in FY 1999 to make up to 3
awards. CDC anticipates that the average award amount will range from
$180,000 to $220,000 for the first year of the project. An application
requesting more than $220,000 (including indirect costs) will not be
considered for review and will be returned to the applicant. Awards are
expected to begin on or about September 30, 1999. Initial awards will
be made for a 12-month budget period, with support anticipated for a
project period of up to 4 years. Limited funds are anticipated to be
available for the fourth year to support dissemination. These estimates
may vary and are subject to change. Continuation awards within the
project period will be made on the basis of satisfactory progress as
evidenced by required reports and the availability of funds.
Use of Funds
Funds may not be used to support laboratory testing; salary for
medical personnel to perform clinical services; pharmaceuticals; or
facility rental.
D. Program Requirements
In conducting activities to achieve the purpose of this Program
Announcement, recipients will be responsible for activities under
``Recipient Activities,'' and CDC will be responsible for the
activities under ``CDC Activities'' listed below.
1. Recipient Activities
a. Phase I: Baseline Study Phase: Design and conduct a baseline
study that systematically describes current HIV and STD prevention
program decision-making processes in your jurisdiction, with specific
attention to behavioral data. Focus should be on decision making by
health departments and associated community planning groups and on the
data used to support these purposes. Include evaluation of the data for
decision making purposes in terms of its availability, scientific
quality, and utility. Note gaps in data quality, availability, or
interpretability that constrain decision making.
b. Meetings and Collaboration: Meet and collaborate with other
recipients and CDC staff in the design, revision, and implementation of
all aspects of the
[[Page 30336]]
project. Meetings will occur twice yearly.
c. Phase II: Intervention Activities: Design and implement
activities to address the quality, availability, interpretation, or
application of behavioral data with respect to the jurisdiction's HIV/
STD prevention needs. Activities should address data gaps or barriers
to data utilization identified in the baseline study.
d. Evaluation: Evaluate the effects of intervention activities on
jurisdictional HIV/STD program decision making and associated outcomes,
including changes in policy, service delivery, resource allocation, or
risk behavior monitoring.
e. Dissemination of Findings: Disseminate findings of the baseline
and intervention studies in peer-reviewed scientific journals and at
professional and community meetings.
f. Obtain Permissions and Consent: Obtain all needed permissions,
consent, and reviews for carrying out project activities, including
Institutional Review Board (IRB) clearances at the local level and
provide documentation and materials necessary for review and approval
by CDC IRB.
2. CDC Activities
a. Assist recipients in the design, revision, and implementation of
all project protocols:
(1) Host an initial meeting to review and coordinate proposals and
conduct subsequent follow up meetings.
(2) Conduct site visits, as needed, for each recipient. Monitor
site activities and progress toward meeting project objectives.
(3) Work with recipient staff, as needed, to resolve research and
implementation issues related to project protocols. This includes the
provision of technical assistance during the baseline study and the
intervention phase.
b. Provide general project oversight:
(1) Review and assist with or provide guidance on behavioral
surveys, sampling, questionnaire design, rapid assessment
methodologies, data analysis techniques, and ethnographic
methodologies, as well as other elements of protocol design or methods.
(2) Participate in analysis of data gathered from program
activities; assist in reporting and disseminating results.
(3) Conduct site visits, as needed, to assess program progress and
evaluate progress reports to ensure that objectives are being
accomplished and terms and conditions of the award are being met.
(4) Assist in development of research protocols resulting from this
project that are subject to Institutional Review Board (IRB) review by
all cooperating institutions participating in the research project. The
CDC IRB will review and approve the protocol initially and on an annual
basis until the research project is completed.
E. Application Content
Submit a proposal that includes plans for addressing all activities
outlined in the program requirements section. The application may not
exceed 30 double-spaced pages, excluding table of contents, abstract,
and appendices (appendices are the appropriate location for references,
publications, resumes, MOA, sample reports, and other supportive
documents). Print all materials double-spaced, in a 12 point or larger
font size, on one side of 8\1/2\'' by 11'' paper with at least 1''
margins. Number each page. Submit your application unbound and
unstapled. Applications that exceed the 30-page limit, excluding
attachments, will not be reviewed and will be returned to the
applicant.
Achieving the main objectives of this project will require
participation from HIV community planning groups and may benefit from
the participation of academic researchers, particularly in areas such
as decision making models, development of new data systems, and
specialized data management or analysis functions. Therefore,
applicants should demonstrate evidence of strong collaborative
partnerships among these parties. Memoranda of agreement (MOA) showing
existence of, or intent to collaborate with the applicant must
accompany the proposal for funding. MOA should delineate the specific
roles and activities to be performed by the collaborating partners.
Use the following outline to organize their proposals:
1. Title and Abstract: The title and abstract should be a clear 1-
page summary of the applicant's proposal.
2. Background: Describe the HIV/AIDS epidemic in your jurisdiction,
recent STD epidemiology, and the programmatic responses, i.e., funding
priorities and prevention efforts. Whenever possible, cite specific
data and sources referenced, e.g., epidemiologic characteristics,
behavioral risk factors, or documented community conditions that place
groups at elevated HIV/STD risk within the jurisdiction. Note changes
in HIV/STD prevalence and incidence rates, with special attention to
populations that have recently emerged as a major focus of programmatic
intervention. Finally, describe the characteristics of HIV and STD
prevention programs developed over the past 5 to 10 years within the
jurisdiction.
3. Assessment of Existing Data: Describe current content, utility,
adequacy, and scientific merit (e.g., reliability, validity, sampling
methodology) of behavioral data available to the applicant. Also
describe uses of these data in HIV program decision making. Provide
similar descriptions for relevant sources of biomedical or other
epidemiological data for use in local HIV and STD prevention decision
making. Relevant CDC-sponsored data sources, as well as data from
academic sources, vital statistics registries, census data, or case
data from other public agencies should be included, as appropriate.
4. Phase I: Baseline Study Phase: Describe:
a. The proposed baseline study to examine HIV and STD prevention
program decision making, with particular attention given to the current
use of behavioral data, as well as other data types. For the purposes
of this study, ``decision making'' is defined as those activities that
involve program planning, development, monitoring, and evaluation, as
well as allocation of financial, personnel, and material resources.
Similarly, ``decision makers'' include those individuals or groups
within the jurisdiction who have authority for determining how these
actions are carried out in HIV and STD prevention programs. Describe
who the key decision makers are in the locality and provide a summary
of their responsibilities within their respective groups or
organizations.
b. Key decision making factors and how they will be measured.
c. The overall research design to be used for the baseline study.
d. Approaches for identifying the role behavioral data currently
have in decision making, as well as ways to identify potential gaps or
needs related to behavioral data and HIV prevention in the
jurisdiction. If formal or theoretical models of decision making are
proposed, describe them and cite appropriate literature in the list of
references.
e. Evaluate existing sources of data, particularly behavioral data,
in terms of availability, scientific quality, timeliness, ease of
analysis and interpretation, as well as utility for prevention program
decision making.
f. Plans for using baseline study results to develop a descriptive
or empirical decision-making model for the jurisdiction that
incorporates better utilization of behavioral data.
g. All data collection methods and instruments to be used.
[[Page 30337]]
h. Anticipated approaches to data management, specific analysis
techniques, and software tools.
5. Phase II: Intervention Phase: Describe:
a. The anticipated study design for addressing potential gaps or
needs identified during the baseline study, e.g., pre and post-
intervention comparison, quasi-experimental, experimental.
b. The anticipated features of the intervention activities, i.e.,
what steps are anticipated for enhancing the availability, quality, or
use of behavioral data in decision making.
c. How intervention activities are to be carried out.
d. Key decision makers.
e. Anticipated barriers and facilitators of data use.
f. All assessment or evaluation methods and instruments to be used
to assess the effects of these intervention activities on HIV and STD
prevention program decision making, e.g., sampling, procedures for
review of archival documents, key informant interviews, ethnographic
observation, surveys, or other methods.
g. How changes in key-decision making variables will be measured in
relation to anticipated changes in the quality, availability, or use of
behavioral data.
h. Plans for data management, specific analysis techniques, and
software tools.
i. How the methods, variables, and instruments used during the
intervention (including evaluation) will provide comparability with
methods, variables, and instruments used in the baseline study.
6. Staffing Plan and Organizational Commitment: The application
should:
a. Explain the proposed staffing plan and organizational commitment
for the baseline and the intervention phases, including the percentage
of time each staff member will commit to the project.
b. Provide evidence that the proposed staff have the capacity and
experience to conduct all the proposed activities.
c. Include copies of curriculum vitae for the staff in the appendix
of the proposal.
d. Include copies of previous staff publications in the appendix,
if relevant.
e. Provide evidence of strong collaborative partnerships between
HIV prevention program decision makers, community planning groups, and
academic researchers. Describe collaborations in detail, and provide
signed and dated copies of MOA and letters of support between
participating partners.
7. Dissemination Plan: Describe plans for disseminating findings
from the baseline study and the intervention through peer-reviewed
scientific journals and presentation to appropriate professional and
community audiences. Meetings such as the CDC-sponsored HIV Prevention
Summit, as well as more academic meetings, should be considered.
8. Time Line: Provide a detailed time line for completion of all
the proposed activities, including anticipated meetings with other
recipients and CDC staff. It is expected that the baseline study will
require 9-12 months, while implementation, evaluation, and
dissemination of the intervention activities and associated findings
will require the remainder of the 4-year project period.
9. Permissions and Human Subjects: Describe plans for obtaining all
formal permissions and reviews needed for carrying out project
activities, including human subjects protection (Institutional Review
Board) plans, as well as procedures for safeguarding data collected
during the project. Application adequately addresses the requirements
of 45 CFR part 46 for the protection of human subjects. Policy
requirements regarding the inclusion of women, ethnic, and racial
groups in the proposed research are met. Documentation of study design
adequacy measure group differences is present. Documentation of
recruitment and outreach plans for study participants includes the
process of establishing partnerships with community(ies) and
recognition of mutual benefits.
10. Budget: Provide a detailed, line-item budget for carrying out
all proposed activities, including travel expenses for meetings with
other recipients and CDC staff and a budget narrative that justifies
each line item.
F. Submission and Deadline
Submit the original and two copies of the complete application
along with Form PHS 5161-1 (OMB Number 0937-0189). On or before July
20, 1999, submit the application to: Brenda Hayes, Grants Management
Specialist, Grants Management Branch, Procurement and Grants Office,
Centers for Disease Control and Prevention, 2920 Brandywine Road, Room
3000, Mail Stop E-15, Atlanta, GA 30341-4146.
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 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 acceptable as proof of timely mailing.) Applications that
do not meet these criteria are considered to be late, 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 review group appointed by CDC.
1. Background (10 Points)
a. Quality, completeness, and specificity of the description of
HIV/AIDS and STD epidemiology within the applicant's jurisdiction.
b. Quality, completeness, and specificity of the description of
programmatic response to prevention needs over the past 5 to 10 years.
c. Adequacy of appropriate supporting data and reference citations.
2. Assessment of Existing Data (10 Points)
Quality, completeness, and specificity of the description of the
content, utility, and adequacy of existing behavioral data for the
applicant's jurisdiction, along with known uses of these data in
current HIV program decision making. Similar descriptions of other
data, such as biomedical or epidemiological information used in HIV and
STD program decision making. Appropriate sources should be cited in the
references.
3. Phase I: Baseline Study Plans (25 Points)
a. Clarity, completeness, and scientific quality of the plans to
conduct a baseline study on how behavioral and other types of data are
used in local HIV and STD prevention program decision making.
b. Clarity, scientific credibility, and feasibility of plans for
all baseline study components including overall research design;
sampling plan; methods and data collection protocols and instruments;
description and measurement of key variables related to decision
making, as well as potential barriers and facilitators that may
contribute to the quality, availability, and use of data in HIV and STD
prevention programs; data management and analysis plans; and
appropriate software tools.
c. Quality of the explanation of how results will be used to
develop a model of decision making for the jurisdiction; the model will
delineate the role of behavioral data relative to other factors
[[Page 30338]]
that might influence HIV and STD program decision making.
d. Quality of plans to identify specific needs and gaps related to
behavioral data important for HIV and STD program decision making,
including the extent to which needs and gaps related to women and
racial and ethnic minority populations are addressed.
4. Phase II: Intervention Plans (30 Points)
a. Clarity, completeness, and scientific quality of the plans to
conduct and evaluate an intervention to address the gaps identified in
the baseline study. Intervention activities should focus on enhancing
data quality, availability, or utilization as they relate to HIV and
STD prevention decision making.
b. Clarity, scientific credibility, and feasibility of plans for
all intervention components, including overall intervention design;
anticipated types of intervention activities; methods and data
collection protocols, variables, and instruments needed for evaluating
the intervention; sampling, data management and analysis plans; and
appropriate software tools.
c. Comparability of evaluation methods and data used during
intervention phase with those used during the baseline study.
d. Likelihood that the intervention will improve the quality and
availability of behavioral data, promote their use in decision-making
and improve the overall quality and effectiveness of the local HIV
prevention programs.
e. Likelihood that the evaluation plans and methods can accurately
document these improvements in a scientifically credible manner.
5. Staffing Plan and Organizational Commitment (10 Points)
Clarity of proposed staffing plan. Participating staff and
organizations are qualified, committed, and available for carrying out
the proposed activities. Strong evidence is provided that documents
relevant staff experience and capabilities. Copies of curriculum vitae
or resumes are included in an appendix. Roles of participating
individuals and organizations are clearly described and are adequate
for completing the proposed work. Detailed and dated memoranda of
agreement or letters of support, written on appropriate institutional
letterhead, are provided in an appendix. Evidence is included of past
collaboration between the participating organizations or individual
staff. Applicant describes a strong commitment to collaborate with
other recipients and CDC staff involved with the project.
6. Dissemination Plans (5 Points)
Quality, completeness, and specificity of plans for disseminating
findings from the baseline and intervention phases of the project.
Include plans for written publications in peer-reviewed scientific
journals and presentation to appropriate professional and community
audiences.
7. Time Line (5 Points)
A detailed, clear, complete, and feasible time line is provided.
Time line includes plans for participating in meetings with other
recipients and CDC staff, as described in the Recipient Activities
section of this Program Announcement.
8. Permissions and Human Subjects (5 Points)
Includes plans for human subject review (Institutional Review Board
[IRB]) as well as procedures for safeguarding data and other
information or records gathered during the project.
Clear and appropriate plans are provided for obtaining all formal
permissions and reviews needed for the project at all levels (i.e,
applicable local IRBs; provide necessary documentation for review by
CDC IRB).
Does the application adequately address the requirements of 45 CRF
part 46 for the protection of human subjects?
____ Yes ____No
Comments:--------------------------------------------------------------
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:
1. The proposed plan for the inclusion of both sexes and racial and
ethnic minority populations for appropriate representation.
2. The proposed justification when representation is limited or
absent.
3. A statement as to whether the design of the study is adequate to
measure differences when warranted.
4. A statement as to whether the plans for recruitment and outreach
for study participants include the process of establishing partnerships
with community(ies) and recognition of mutual benefits
9. Budget (Not Scored)
A detailed line item budget is provided. Budget expenditures are
well-justified and appropriate. Budget includes line-items for
attending project meetings described in the Recipient Activities
section of this Program Announcement. Travel for these meetings should
be budgeted with Atlanta as the destination for all meetings, although
the location may rotate among sites.
H. Other Requirements
1. Technical Reporting Requirements.
Provide CDC with original plus two copies of semiannual progress
reports, 30 days after the end of each reporting period. The progress
reports must include the following for each program, function, or
activity involved:
a. Progress in achieving stated goals.
b. Reasons that any goals were not met.
c. A description of steps taken to overcome barriers to
accomplishing the goals for the period.
2. Financial status report, no more than 90 days after the end of
the budget period.
3. Final financial status and performance reports, no more than 90
days after the end of the project period.
4. The following additional requirements are applicable to this
program. For a complete description of each, see Attachments.
AR98-1 Human Subjects Requirements
AR98-2 Requirements for Inclusion of Women and Racial and Ethnic
Minorities in Research
AR98-4 HIV/AIDS Confidentiality Provisions
AR98-5 HIV Program Review Panel Requirements
AR98-7 Executive Order 12372 Review
AR98-9 Paperwork Reduction Act Requirements
AR98-10 Smoke-Free Workplace Requirements
AR98-11 Healthy People 2000
AR98-12 Lobbying Restrictions
I. Authority and Catalog of Federal Domestic Assistance Number
This program is authorized under Section 301 and 317 (k) (2) of the
Public Health Service Act (42 U.S.C. 241 and 247b(k) (2) as amended.
The catalog of Federal Domestic Assistance Number is 93.941.
J. Where to Obtain Additional Information
To receive additional written information and to request an
application kit, call 1-888-GRANTS4 (1-888-472-6874). You will be asked
to leave your name and address and will be instructed to identify the
Announcement number of interest (99098). You may view or download this
and other CDC/ATSDR Program Announcements, and download application
forms, at the following web site: HTTP://WWW.CDC.GOV
If you have questions after reviewing the contents of all the
documents, business management technical
[[Page 30339]]
assistance may be obtained from: Brenda Hayes, Grants Management
Specialist, Grants Management Branch, Procurement and Grants Office,
Centers for Disease Control and Prevention (CDC), 2920 Brandywine Road,
Room 3000, Atlanta, Georgia 30341-4146, Telephone: (770) 488-2720,
Email: bkh4@cdc.gov.
Programmatic technical assistance can be obtained from: Robert
Kohmescher, Behavioral Intervention Research Branch, Division of HIV/
AIDS Prevention, Centers for Disease Control and Prevention (CDC), 1600
Clifton Road, NE, Mailstop E-37, Atlanta, GA 30333, Telephone: 404-639-
1900, Fax: 404-639-1950, Email: rnk1@cdc.gov.
See also the CDC home page on the Internet: HTTP://WWW.CDC.GOV.
Dated: June 1, 1999.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control
and Prevention (CDC).
[FR Doc. 99-14281 Filed 6-4-99; 8:45 am]
BILLING CODE 4163-18-P
