[Federal Register Volume 61, Number 118 (Tuesday, June 18, 1996)]
[Notices]
[Pages 30906-30909]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-15382]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Announcement 630]


Formative Behavioral Intervention Research on the Prevention of 
Sexual Transmission of HIV by HIV-Seropositive Men

Introduction

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 1996 funds for a cooperative agreement 
program for the prevention of the sexual transmission of HIV by men who 
have tested positive for HIV infection.
    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)(2), of the 
Public Health Service Act (42 U.S.C. 241 and 247b(k)(2)) 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.

[[Page 30907]]

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 or women-owned businesses are eligible to apply.

Availability of Funds

    Approximately $750,000 is available in FY 1996 to fund 
approximately three awards. It is expected that the average award will 
be $250,000, ranging from $225,000 to $275,000. 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 up to two years. Funding 
estimates may vary and are subject to change.
    Continuation awards within the project period will be made on the 
basis of satisfactory progress and the availability of funds.

Purpose

    The purpose of this announcement is to stimulate formative research 
on behavioral intervention strategies to further reduce HIV 
transmission by men who know that they are HIV-seropositive. Funding 
under this cooperative agreement will support the collection of 
qualitative and quantitative data in the development and evaluation of 
pilot behavioral intervention programs for HIV-seropositive men. These 
intervention activities should be designed to motivate and support HIV-
seropositive men in sustaining sexual practices that reduce the risk 
and prevent HIV transmission to seronegative partners.
    It is expected that cooperative agreement recipients will conduct 
the formative research according to a common protocol that will be 
developed collaboratively with other cooperative agreement recipients 
including CDC. The intervention, or its core elements, will be piloted 
and evaluated on a limited basis during the award period. The ultimate 
goal of this formative research is the identification of potential 
intervention strategies for HIV-seropositive men that are appropriate 
for implementation in community settings (e.g., local health 
departments, community-based organizations, health maintenance 
organizations) and that merit further evaluation to determine their 
effectiveness in sustaining reduced-risk sexual practices.

Program Requirements

    In conducting activities to achieve the purpose of this program the 
recipient will be responsible for the activities under A. (Recipient 
Activities), and CDC will be responsible for the activities listed 
under B. (CDC Activities).

A. Recipient Activities

    1. Collaborate with other recipients to refine research and 
intervention protocols and data collection instruments.
    2. Establish procedures to maintain the rights and confidentiality 
of all study participants, including review of research activities by 
applicant's and CDC's Internal Review Board (IRB).
    3. Identify, recruit, obtain informed consent, and enroll an 
adequate number of research participants according to procedures 
specified in the study protocol.
    4. Conduct interviews and other assessments according to the 
research protocol.
    5. Summarize data and conduct analyses for the recipient's own 
site.
    6. Establish a standardized format for data entry to facilitate 
cross-site analyses.
    7. Collaborate with other recipients in the preparation and 
dissemination of research findings in peer-reviewed journals and at 
professional meetings.

B. CDC Activities

    1. Host a meeting(s) of the award recipients to plan key aspects of 
the research program. CDC will convene additional meetings as needed.
    2. Act as mediator on the recipients' collaborative design of this 
research, including data collection protocols and instruments, and 
intervention protocols.
    3. Monitor, coordinate, and evaluate scientific and operational 
conduct and accomplishments of this research project in order to keep 
all recipients on track with the common protocols and their timelines.
    4. Coordinate cross-site data aggregation and the analysis of 
aggregate data.
    5. Participate in the preparation of study findings for publication 
and presentation.
    6. Conduct site visits to assess program progress and mutually 
solve problems, as needed.

Evaluation Criteria

    Applications that meet the eligibility requirements will be 
reviewed and evaluated according to the following criteria:
    1. Familiarity with and access to HIV-seropositive men (20 points).
    a. Extent of applicant's knowledge of issues faced by HIV-
seropositive men and experience in working with this population;
    b. Existence of linkages to facilitate recruitment from and 
referral to programs providing services for HIV-seropositive men and;
    c. Feasibility of plans to involve HIV positive men, their 
advocates, or service providers in the development of research and 
intervention activities.
    (1) 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 
will be documented.
    (2) The proposed plan for the inclusion of racial and ethnic 
minority populations for appropriate representation.
    (3) The proposed justification when representation is limited or 
absent.
    2. Formative research plan (25 points).
    a. Quality of the proposed formative research plan, including 
research questions, methodology, sampling strategies, data summary 
methods, and procedures for obtaining subjects' consent and protecting 
their confidentiality and;
    b. Thoroughness of description of proposed study group(s).
    3. Intervention research plan (20 points).
    a. Quality, feasibility, and theoretical bases of the suggested 
behavioral intervention;
    b. Appropriateness of the suggested research design, including 
recruitment and randomization of subjects, process and outcome 
measures, schedule for data collection;
    c. Adequacy of methods for obtaining informed consent, maintaining 
participant confidentiality, and addressing any potential ethical 
issues associated with the suggested research strategy and;
    d. A statement as to whether the design of the study is adequate to 
measure racial and ethnic differences when warranted.
    4. Research and intervention capability (25 points).
    a. Ability of the applicant to perform the technical aspects of the 
project as reflected in the training, research, and behavioral 
intervention experience of the applicant's staff;
    b. Applicant's expertise in the application of qualitative and 
quantitative data collection methods used in behavioral science and;

[[Page 30908]]

    c. Quality and outcomes of applicant's previous HIV intervention 
and research efforts.
    5. Staffing, facilities, and time line (10 points).
    a. Availability of qualified and experienced personnel with 
sufficient time dedicated to the proposed project. Presence of 
behavioral scientists in key leadership positions on the project;
    b. Clarity of the described duties and responsibilities of project 
personnel;
    c. Stated agreement to work collaboratively with CDC and other 
cooperative agreement recipients in developing common research, 
intervention, and evaluation protocols and to disseminate study 
findings;
    d. Adequacy of the facilities, equipment, data management 
resources, and systems for ensuring data security and;
    e. Specificity and reasonableness of time line.
    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

    This announcement is for formative research proposals that lead to 
the development of innovative pilot programs for reducing HIV 
transmission by men who know they are HIV positive. Priority will be 
given to projects that focus on reducing the sexual risk of HIV 
transmission by HIV-seropositive men who are (1) men who have sex with 
men (regardless of sexual identity) or (2) male injecting drug users. 
Involvement of HIV-seropositive men, their advocates, or service 
providers in the design of research and intervention activities is 
required. Based upon available funding, applications will be accepted 
for behavioral intervention studies targeting other high-risk 
populations that have not been adequately addressed.
    Interested persons are invited to comment on the proposed funding 
priorities. All comments received on or before July 24, 1996, will be 
considered before the final funding priority is established. If the 
funding priorities should change as a result of any comments received, 
a revised Announcement will be published in the Federal Register 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 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 
department 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 State Single Point 
of Contact (SPOC) or directly from the applicant.

Catalog of Federal Domestic Assistance Number

    The Catalog of Federal Domestic Assistance number is 93.941.

Other Requirements

Paperwork Reduction Act

    Projects that involve the collection of information from 10 or more 
individuals and funded by the cooperative agreement will be subject to 
review by the Office of Management and Budget (OMB) under the Paperwork 
Reduction Act.

Human Subjects

    If the proposed project involves research on human subjects, the 
applicant must comply with the Department of Health and Human Services 
Regulations, 45 CFR Part 46, regarding the protection of human 
subjects. Assurance must be provided to demonstrate that the project 
will be subject to initial and continuing review by an appropriate 
institutional review committees. In addition to other applicable 
committees, Indian Health Service (IHS) institutional review committees 
also must review the project if any component of IHS will be involved 
or will support the research. If any American Indian community is 
involved, its tribal government must also approve that portion of the 
project applicable to it. The applicant will be responsible for 
providing assurance in accordance with the appropriate

[[Page 30909]]

guidelines and form provided in the application kit.

Racial and Ethnic Minorities

    It is the policy of the Centers for Disease Control and Prevention 
(CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR) 
to ensure that individuals of the various racial and ethnic groups will 
be included in CDC/ATSDR-supported research projects involving human 
subjects, whenever feasible and appropriate. Racial and ethnic groups 
are those defined in OMB Directive No. 15 and include American Indian, 
Alaskan Native, Asian, Pacific Islander, Black and Hispanic. Applicants 
shall ensure that racial and ethnic minority populations are 
appropriately represented in applications for research involving human 
subjects. Where clear and compelling rationale exist that inclusion is 
inappropriate or not feasible, this situation must be explained as part 
of the application. This policy does not apply to research studies when 
the investigator cannot control the race, ethnicity and/or sex of 
subjects. Further guidance to this policy is contained in the Federal 
Register, Vol. 60, No. 179, pages 47947-47951, dated Friday, September 
15, 1995.

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 of 
which is included in the application kit. At least one member of the 
program review panel must be an employee (or designated representative) 
of the health department consistent with the Content guidelines. 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, as an attachment to the quarterly 
summaries, the program review panel's report that all material 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 24, 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 19, 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 written information call (404) 332-4561. You 
will be asked to leave your name, address, and telephone number and 
will need to refer to Announcment 630. 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: 
<[email protected]>. 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: <[email protected]>.
    Please refer to Announcement 630 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.

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 using Internet, following all instructions in this 
announcement and leaving messages on the contact person's voice mail 
for more timely responses to any questions.

    Dated: June 11, 1996.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for 
Disease Control and Prevention (CDC).
[FR Doc. 96-15382 Filed 6-17-96; 8:45 am]
BILLING CODE 4163-18-P