[Federal Register Volume 61, Number 112 (Monday, June 10, 1996)]
[Notices]
[Pages 29393-29396]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-14553]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Announcement 626]


Follow-up or Secondary Analysis of HIV Behavioral Intervention 
Research Studies

Introduction

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 1996 funds for a grant program for 
conducting follow-up or secondary analysis of data from HIV behavioral 
intervention research studies. This announcement provides funds for two 
types of activities:
    Activity 1  Follow-up or secondary analysis of outcome, process, or 
economic data from existing HIV behavioral intervention data sets, and;
    Activity 2  Secondary analysis of existing behavioral intervention 
data with methodological implications for how to conduct, analyze, or 
interpret research findings from behavioral intervention studies.
    The CDC is committed to achieving the health promotion and disease 
prevention objectives of ``Healthy People 2000,'' a national activity 
to reduce morbidity and mortality and improve the quality of life. This 
announcement is related to the priority area of Human Immunodeficiency 
Virus (HIV) Infection. (For ordering a copy of ``Healthy People 2000,'' 
see the section ``WHERE TO OBTAIN ADDITIONAL INFORMATION.'')

Authority

    This program is authorized under sections 301 and 317(k), of the 
Public Health Service Act [42 U.S.C. 241 and 247b], as amended.

Smoke-Free Workplace

    CDC strongly encourages all recipients to provide a smoke-free 
workplace and to promote the nonuse of all tobacco products, and Public 
Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain 
facilities that receive Federal funds in which education, library, day 
care, health care, and early childhood development services are 
provided to children.

Eligible Applicants

    Applications may be submitted by public and private, nonprofit and 
for-profit organizations and governments and their agencies. Thus, 
universities, colleges, research institutes, hospitals, other public 
and private organizations, State and local health departments or their 
bona fide agents or instrumentalities, federally recognized Indian 
tribal governments, Indian tribes or Indian tribal organizations, and 
small, minority- and/or women-owned businesses are eligible to apply.
    Eligible applicants must have access to data sets of outcome, 
process, or economic data collected during efficacy or effectiveness 
studies of HIV behavioral interventions in the United States.
    Applicants may submit applications for both Activity 1 (follow-up 
or secondary analysis) and Activity 2 (analysis with methodological 
implications) but must submit them as separate applications. 
Applications must state the activity type of the proposal in the 
application's title.

    Note: Organizations described in section 501(c)(4) of the 
Internal Revenue Code of 1986 that engage in lobbying are not 
eligible to receive Federal grant/cooperative agreement funds.

Availability of Funds

    Approximately $600,000 is available in FY 1996 to fund a total of 
approximately six awards under Activities 1 and 2. It is expected that 
the average award will range from $80,000 to $120,000, depending on the 
number of analyses proposed. Awards are expected to begin on or about 
September 30, 1996, and will be made for a 12-month budget period 
within a project period of one year. Funding estimates may vary and are 
subject to change based on availability of funds. Grant funds are to be 
applied to analyses of existing behavioral intervention data and cannot 
be used for the collection of new or supplemental data, secondary 
analyses of behavioral survey data, data entry, purchase of furniture, 
software, computers, rental of facilities, equipment or support of 
interventions.

Purpose

    These awards will expand the knowledge of HIV behavioral risk 
prevention by conducting further analyses of data sets from completed 
research on HIV behavioral interventions. Proposals are sought for the 
following activities:
    Activity 1  Follow-up or secondary analysis of existing data sets 
collected during efficacy or effectiveness trials of theory-based HIV 
behavioral interventions.
    Activity 2  Secondary analysis of existing behavioral intervention 
data with methodological implications for how to conduct, analyze, or 
interpret research findings from behavioral intervention studies. 
Examples of analyses include methods to assess the reliability or 
validity of behavioral measures, implementation and evaluation of 
intervention methods, the relationship between behavioral and 
biological outcome measures (including STD and HIV transmission), 
comparisons of data collection or sampling methods, methods to identify 
social networks, methods to determine cost-benefit or cost-
effectiveness, and the use of behavioral intervention data to model 
transmission trends.
    These awards also have the goal of obtaining information on diverse 
populations, on populations for whom there is little information on 
intervention effectiveness, on interventions conducted in geographic 
areas or venue types on which there is little intervention information, 
and on

[[Page 29394]]

the creativity and appropriateness of the intervention for the targeted 
population.

Program Requirements

    In conducting activities to achieve the purpose of this program, 
the recipient will be responsible for the following activities:
    1. Secure access to the data set. The recipient will secure access 
to the completed outcome, process, and/or economic data set from the 
current manager of the data set with sufficient time to complete the 
proposed analysis.
    2. Prepare the data set. The recipient will finish cleaning the 
data and debugging computer programs, if relevant.
    3. Ensure completion of the project by sustaining analytic 
capability. Throughout the course of the project, the recipient has the 
responsibility to sustain and continue the level of analytic capability 
which was presented in their application, particularly:
    a. The skills to analyze the data and to design, oversee, and 
evaluate the results of the follow-up or secondary analyses;
    b. Adequate and appropriate technical and support services for the 
proposed project;
    c. Adequate computer and data management systems for the proposed 
analyses; and
    d. Plan and capacity for storing the data securely and 
confidentially.
    4. Conduct the proposed analyses. The recipient will:
    a. Conduct the:
    (1) Follow-up or secondary analysis of outcome, process, or 
economic data from the data set (Activity 1); or
    (2) Analysis of the data set for methodological implications 
(Activity 2);
    b. Apply appropriate statistical methods; and
    c. Adhere to the proposed timeline for completion.
    5. Disseminate results. The recipient is expected to publish the 
results of the funded analyses in a peer-reviewed journal and to 
prepare a report on the implication of those results for improving HIV 
prevention programs or future behavioral research.

Evaluation Criteria

    Applications for Activities 1 and 2 will be reviewed and evaluated 
according to the following criteria:
    1. Description of the Behavioral Intervention (15 points).
    Thoroughness of the description of the intervention that generated 
the proposed data set, including completion and evaluation. Clarity of 
the goal of the intervention. Quality of the intervention design, 
components, and methods. Appropriateness of the theoretical basis for 
the target population and intervention method. Appropriateness of the 
intervention methods for the target population.
    2. Quality of the Proposed Data Set (20 points).
    Detailed description of the proposed data set, including contents, 
quality, size, integrity, and format. Statement whether the data are 
process, outcome, or economic. Description of previous analyses on the 
data set. Presence of required reprints. Demonstrated possession of or 
access to the data set.
    3. Quality of the Research Question(s) (20 points).
    Appropriateness of the research question(s) for the data set and 
the data collection design. Contribution toward improving HIV 
prevention programs and HIV behavioral intervention research and its 
effectiveness. Uniqueness of the research question(s) and proposed 
analysis for the data set. Adequacy of justification for the proposed 
analysis and for additional funding if more than one analysis is 
proposed.
    4. Adequacy of the Analysis Plan (20 points).
    Thoroughness of analysis plan. Reasonableness and appropriateness 
to the data set, including demonstration that the data set is large 
enough to have the statistical power for the proposed analyses. 
Statistical rigor and complexity. Adequacy of time line.
    5. Analytic Capability (25 points).
    Overall ability of the applicant to perform the proposed analysis 
as reflected in staff qualifications, experience, demonstrated 
familiarity with HIV behavioral interventions, and statistical 
expertise. Clarity of the described duties and responsibilities of 
project personnel. The extent to which staff time commitments for the 
conduct of the analysis are realistic and sufficient. Quality of 
applicant's previous statistical and methodologic work. Adequacy of the 
facilities, equipment, and plans for the administration of the project. 
Quality of data processing and analysis capacity. Appropriate data 
management, software, and statistical packages for the proposed 
analysis. Adequacy of systems for the management of data security. 
Presence of required documentation.
    6. Budget (not scored).
    Extent to which the budget is reasonable, itemized, clearly 
justified, and consistent with the intended use of the funds.

Funding Priorities

    It is the intention of this announcement to solicit proposals to 
fund further analyses of data sets from completed HIV behavioral 
intervention research. For Activity 1, priority will be given to 
proposals requesting funds to conduct quantitative analysis of outcome, 
process, or economic data collected during HIV intervention studies. 
Outcome (dependent) variables may include both behavioral and 
biological markers. Analysis of qualitative data or analysis of 
behavioral determinants may also be included if such data were 
collected during the implementation phase of intervention studies and 
are relevant to understanding the impact of a specific intervention. 
For Activity 2, priority will be given to proposals to conduct 
secondary analysis of existing behavioral intervention data with 
methodological implications for how to conduct, analyze, or interpret 
research findings from behavioral intervention studies.
    Interested persons are invited to comment on the proposed funding 
priorities. All comments received on or before July 15, 1996, will be 
considered before the final funding priority is established. If the 
funding priorities should change as a result of any comments received, 
revised applications will be accepted prior to the final selection of 
awards.
    Written comments should be addressed to: Van Malone, Grants 
Management Officer, Grants Management Branch, Procurement and Grants 
Office, Centers for Disease Control and Prevention (CDC), 255 East 
Paces Ferry Road, NE., Room 300, Mailstop E15, Atlanta, GA 30305.

Executive Order 12372 Review

    Applications are subject to Intergovernmental Review of Federal 
Programs as governed by Executive Order (E.O.) 12372. E.O. 12372 sets 
up a system for State and local government review of proposed Federal 
assistance applications. Applicants (other than federally recognized 
Indian tribal governments) should contact their State Single Point of 
Contact (SPOC) as early as possible to alert them to the prospective 
applications and receive any necessary instructions on the State 
process. For proposed projects serving more than one State, the 
applicant is advised to contact the SPOC for each affected State. A 
current list of SPOCs is included in the application kit. If SPOCs have 
any State process recommendations on applications submitted to CDC, 
they should send

[[Page 29395]]

them to Van Malone, Grants Management Officer, Grants Management 
Branch, Procurement and Grants Office, Centers for Disease Control and 
Prevention (CDC), 255 East Paces Ferry Road, NE., Room 300, Mailstop 
E15, Atlanta, GA 30305, no later than 30 days after the application 
deadline. (The appropriation for this financial assistance program was 
received late in the fiscal year and would not allow for an application 
receipt date which would accommodate the 60-day State recommendation 
process period.) The granting agency does not guarantee to 
``accommodate or explain'' for State process recommendations it 
receives after that date.
    Indian tribes are strongly encouraged to request tribal government 
review of the proposed application. If tribal governments have any 
tribal process recommendations on applications submitted to the CDC, 
they should forward them to Van Malone, Grants Management Officer, 
Grants Management Branch, Procurement and Grants Office, Centers for 
Disease Control and Prevention (CDC), 255 East Paces Ferry Road, NE., 
Room 300, Mailstop E15, Atlanta, GA 30305. This should be done no later 
than 30 days after the application deadline date. The granting agency 
does not guarantee to ``accommodate or explain'' for tribal process 
recommendations it receives after that date.

Public Health System Reporting Requirements

    This program is subject to the Public Health System Reporting 
Requirements. Under these requirements, all community-based 
nongovernmental applicants must prepare and submit the items identified 
below to the head of the appropriate State and/or local health 
agency(s) in the program area(s) that may be impacted by the proposed 
project no later than the receipt date of the Federal application. The 
appropriate State and/or local health agency is determined by the 
applicant. The following information must be provided:
    A. A copy of the face page of the application (SF 424).
    B. A summary of the project that should be titled ``Public Health 
System Impact Statement'' (PHSIS), not exceed one page, and include the 
following:
    1. A description of the population to be served;
    2. A summary of the services to be provided; and
    3. A description of the coordination plans with the appropriate 
state and/or local health agencies.
    If the State and/or local health official should desire a copy of 
the entire application, it may be obtained from the Single Point of 
Contact (SPOC) or directly from the applicant.

Catalog of Federal Domestic Assistance Number

    Catalog of Federal Domestic Assistance number is 93.941.

Other Requirements

HIV/AIDS Requirements

    Recipients must comply with the document entitled Content of AIDS-
Related Written Materials, Pictorials, Audiovisuals, Questionnaires, 
Survey Instruments, and Educational Sessions (June 1992) (a copy is in 
the application kit). To meet the requirements for a program review 
panel, recipients are encouraged to use an existing program review 
panel, such as the one created by the State health department's HIV/
AIDS prevention program. If the recipient forms its own program review 
panel, at least one member must be an employee (or designated 
representative) of a State or local health department. The names of the 
review panel members must be listed on the Assurance of Compliance for 
CDC 0.1113, which is also included in the application kit. The 
recipient must submit the program review panel's report that indicates 
all materials have been reviewed and approved.

Application Submission and Deadlines

1. Preapplication Letter of Intent

    A non-binding letter of intent-to-apply is required from potential 
applicants. An original and two copies of the letter should be 
submitted to the Grants Management Branch, CDC (see ``Applications'' 
for the address). It should be postmarked no later than July 15, 1996. 
The letter should identify the announcement number, name of principal 
investigator, and specify the activity(ies) to be addressed by the 
proposed project. The letter of intent does not influence review or 
funding decisions, but it will enable CDC to plan the review more 
efficiently, and will ensure that each applicant receives timely and 
relevant information prior to application submission.

2. Applications

    An original and two copies of the application PHS Form 5161-1, OMB 
Number 0937-0189) must be submitted to Van Malone, Grants Management 
Officer, Grants Management Branch, Procurement and Grants Office, 
Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry 
Road, NE., Room 300, Mailstop E-15, Atlanta, GA 30305, on or before 
August 15, 1996.

3. Deadlines

    A. Applications shall be considered as meeting the deadline if they 
are either:
    (1) Received on or before the deadline date; or
    (2) Sent on or before the deadline date and received in time for 
submission to the objective review group. (Applicants must request a 
legibly dated U.S. Postal Service postmark or obtain a legibly dated 
receipt from a commercial carrier or the U.S. Postal Service. Private 
metered postmarks shall not be acceptable as proof of timely mailing.)
    B. Applications that do not meet the criteria in 3.A.(1) or 3.A.(2) 
above are considered late applications. Late applications will not be 
considered in the current competition and will be returned to the 
applicant.

Where to Obtain Additional Information

    To receive additional information call (404) 332-4561. You will be 
asked to leave your name, address, and phone number and will need to 
refer to Announcement 626. You will receive a complete program 
description, information on application procedures, and application 
forms.
    If you have questions after reviewing the contents of all the 
documents, business management technical assistance may be obtained 
from Adrienne Brown, Grants Management Specialist, Grants Management 
Branch, Procurement and Grants Office, Centers for Disease Control and 
Prevention (CDC), 255 East Paces Ferry Road, NE., Room 300, Mailstop E-
15, Atlanta, GA 30305, telephone (404) 842-6634, email: 
<<a href="/cdn-cgi/l/email-protection#badbc9d78bfad5cac9caddd58b94dfd794d9ded994ddd5cc"><span class="__cf_email__" data-cfemail="7d1c0e104c3d120d0e0d1a124c531810531e191e531a120b">[email protected]</span></a>>. Programmatic technical assistance may be 
obtained from Robert Kohmescher, Division of HIV/AIDS Prevention, 
National Center for HIV/STD/TB Prevention, Centers for Disease Control 
and Prevention (CDC), 1600 Clifton Road, NE., Mailstop E-44, Atlanta, 
GA 30333, telephone (404) 639-8302, email: <<a href="/cdn-cgi/l/email-protection#4735292c7607242e232f2e317569222a6924232469202831"><span class="__cf_email__" data-cfemail="6c1e02075d2c0f050804051a5e420901420f080f420b031a">[email protected]</span></a>>.
    Please refer to Announcement 626 when requesting information and 
submitting an application.
    Potential applicants may obtain a copy of ``Healthy People 2000,'' 
(Full Report, Stock No. 017-001-00474-0) or ``Healthy People 2000,'' 
(Summary Report, Stock No. 017-001-00473-1) referenced in the 
``INTRODUCTION,'' through the Superintendent of Documents, Government 
Printing Office, Washington, DC 20402-9325, telephone (202) 512-1800.

[[Page 29396]]

Internet Home Page

    The announcement will be available on one of two Internet sites on 
the publication date: CDC's home page at <http://www.cdc.gov>, or at 
the Government Printing Office home page (including free access to the 
Federal Register) at <http://www.access.gpo.gov>.
    There may be delays in mail delivery and difficulty in reaching the 
CDC Atlanta offices during the 1996 Summer Olympics. Therefore, CDC 
suggests applicants use Internet, follow all instructions in this 
announcement, and leave messages on the contact person's voice mail for 
more timely responses to any questions.

    Dated: June 4, 1996.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for 
Disease Control and Prevention (CDC).
[FR Doc. 96-14553 Filed 6-7-96; 8:45 am]
BILLING CODE 4163-18-P

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