[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]


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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risk data may be incomplete, unavailable, of poor quality, or out of 
date.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

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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.

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    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

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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

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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: [email protected].
    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: [email protected].
    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