[Federal Register Volume 66, Number 140 (Friday, July 20, 2001)]
[Notices]
[Pages 37969-37971]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-18048]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 01188]


Human Immunodeficiency Virus (HIV) Prevention Intervention 
Research Studies--Social and Environmental Interventions to Prevent 
HIV; Notice of Availability of Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 2001 funds for a cooperative agreement 
program for social and environmental interventions to prevent HIV. This 
program addresses the ``Healthy People 2010'' focus area of Human 
Immunodeficiency Virus (HIV).
    The purpose of the program is to design and implement social and 
environmental interventions to reduce the risk of HIV transmission.

B. Eligible Applicants

    Applications may be submitted by public and private nonprofit and 
for-profit organizations and by governments and their agencies; that 
is, universities, colleges, research institutions, hospitals, other 
public and private nonprofit and for-profit organizations, State and 
local governments or their bona fide agents, including the District of 
Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the 
Commonwealth of Northern Mariana Islands, American Samoa, Guam, the 
Federated States of Micronesia, the Republic of the Marshall Islands, 
and the Republic of Palau, and federally recognized Indian tribal 
governments, Indian tribes, or Indian tribal organizations, small, 
minority, women-owned businesses.


    Note: Title 2 of the United States Code, chapter 26, section 
1611 states that an organization described in section 501(c)(4) of 
the Internal Revenue Code of 1986 that engages in lobbying 
activities is not eligible to receive Federal funds constituting an 
award, grant, cooperative agreement, contract, loan, or any other 
form.

C. Availability of Funds

    Approximately $400,000 is available in FY 2001 to fund 
approximately two awards. It is expected that the average award will be 
$200,000, ranging from $150,000 to $250,000.
    It is expected that the awards will begin on or about September 30, 
2001, and will be made for a 12-month budget period within a project 
period of up to two years. Funding estimates may change.
    Continuation awards within an approved project period will be made 
on the basis of satisfactory progress as evidenced by required reports 
and the availability of funds.

Use of Funds

    Funds are awarded for a specifically defined purpose and may not be 
used for any other purpose or program. Funds may be used to support 
personnel and to purchase equipment, supplies, and services directly 
related to project activities. Funds may not be used to supplant State 
or local funds available for HIV Prevention. Funds may not be used to 
provide direct medical care or prevention case management.

D. Program Requirements

    In conducting activities to achieve the purpose of this program, 
the recipient will be responsible for the activities under 1. 
(Recipient Activities), and CDC will be responsible for the activities 
listed under 2.(CDC Activities).

1. Recipient Activities

    a. Develop a research protocol and plans for conducting this 
research with appropriate participation of State and local health 
departments; professional associations, community groups and 
organizations, especially those with a racial and ethnic minority 
membership and focus; HIV/AIDS service organizations; and organizations 
that serve persons increased risk of HIV/AIDS.
    b. Promote the development and evaluation of social and 
environmental interventions for HIV prevention by providing data and 
ongoing assistance to community planning groups; by disseminating data 
through publications and presentations; by participating in project 
planning and implementation meetings; and by reporting ways in which 
the data have been used to promote public health.
    c. Establish procedures to maintain the rights and confidentiality 
of all study participants. Prior to implementation, this study must be 
submitted to the local and CDC Institutional Review Boards (IRBs) for 
review and approval or deferral.
    d. Review existing information, research study protocols, and data 
collection forms.
    e. In collaboration with the community, identify opportunities and 
needs for interventions; assess the acceptability and feasibility of 
identified interventions; estimate the potential effectiveness of the 
interventions in preventing infection and disease.
    f. Implement the intervention and assess process outcomes.
    g. Identify, recruit, obtain informed consent (when appropriate), 
enroll, and follow an adequate number of study participants as 
determined by study protocol and the program requirements.
    h. Perform data analysis as determined in the study protocol.

2. CDC Activities

    a. Provide technical assistance, as needed, in the design and 
conduct of the research.
    b. The CDC IRB will review and approve the protocol initially and 
on at least an annual basis until the research project is completed.
    c. As needed, assist in designing a data management system.

E. Application Content

    Use the information in the Program Requirements, Other 
Requirements, and Evaluation Criteria sections to follow them in laying 
out your program plan. The narrative should be no more than 25 pages 
double-spaced, printed on one side, with one inch margins, and 
unreduced font.
    The narrative should consist of, at a minimum, a Plan, Objectives, 
Methods, Evaluation and Budget.

F. Submission and Deadline

    Submit the original and five copies of PHS-398 (OMB 0925-0001) 
(adhere to the instructions on the Errata Instruction Sheet for PHS 
398). Forms are available in the application kit and at the following 
Internet address: www.cdc.gov/od/pgo/forminfo.htm.
    On or before August 30, 2001, submit the application to the Grants 
Management Specialist identified in the ``Where to Obtain Additional 
Information'' section of this announcement.
    Deadline: Applications shall be considered as meeting the deadline 
if they are either:
    1. Received on or before the deadline date;
    2. Sent on or before the deadline date and received in time for 
submission to the Special Emphasis Panel. (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.)

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    Late: Applications which do not meet the criteria in 1. or 2. above 
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 and Objectives (10 points)

    The extent to which the application includes a detailed review of 
the scientific literature pertinent to the study being proposed, with 
evidence for the relationship of social and environmental factors to 
the incidence of HIV. This literature review and a review of conditions 
in the study community should suggest specific research questions that 
will guide the research. The extent to which the goals and objectives 
for the research are clearly stated along with how the intervention 
would impact one of the underlying factors determining HIV incidence in 
the community.

2. Site Selection (15 points)

    The extent to which the application includes a description of the 
size and characteristics of the communities proposed for study. The 
extent to which the application describes the prevalence and estimated 
incidence of HIV infection in the study community. Includes age, 
gender, race/ethnicity, and HIV-risks of persons with HIV in the 
community where the intervention will be implemented; describes the 
likely acceptability of the intervention by persons in the community. 
Letters of support from cooperating organizations should be included 
which detail the nature and extent of such cooperation.

3. Methods (45 points)

    Appropriateness of methods for implementing and evaluating the 
social and environmental interventions to reduce HIV incidence and 
assessing the potential impact of the intervention within a community 
or geographic area.
    The extent to which the application describes the social-
environmental issue that the recipient wants to address, how the 
potential intervention will influence the issue, and how the 
intervention might impact on HIV incidence in the study area.
    The extent to which the application specifies potential barriers to 
implementing the intervention and how barriers will be overcome. The 
potential impact on HIV reduction should be clear. The intervention 
should be new and sustainable in the future without ongoing CDC 
funding.
    In addition, applications will be evaluated on the degree to which 
the applicant has met the CDC Policy requirements regarding the 
inclusion of women, ethnic, and racial groups in the proposed research. 
This includes:
    a. The proposed plan for the inclusion of both sexes and racial and 
ethnic minority populations for appropriate representation.
    b. The proposed justification when representation is limited or 
absent.
    c. A statement as to whether the design of the study is adequate to 
measure differences when warranted.
    d. A statement as to whether the plans for recruitment and outreach 
for study participants include the process of establishing partnerships 
with communities and recognition of mutual benefits.

4. Research Capacity (20 points)

    The extent to which the application describes the capacity and 
experience of the research team and includes curriculum vitaes and 
position descriptions for key staff and project participants. The 
percentage-time commitments, duties, and responsibilities of project 
personnel should be sufficient to operationalize the proposed 
methodology.

5. Evaluation Plan (10 points)

    The extent to which the application includes time-phased and 
measurable objectives. The proposed report of research findings should 
document the process of identifying and implementing the intervention 
and the acceptability and estimated impact within the community.

6. Budget (not scored)

    The extent to which the budget is reasonable, clearly justified, 
and consistent with the intent of the announcement.

7. Human Subjects (not scored)

    The extent to which the application adequately addresses the 
requirements of 45 CFR part 46 for the protection of human subjects. 
(Not scored; however, an application can be disapproved if the research 
risks are sufficiently serious and protection against risks is so 
inadequate as to make the entire application unacceptable.)

H. Other Requirements

Technical Reporting Requirements

    Provide CDC with the original and two copies of:
    1. Annual progress reports to be submitted with subsequent 
continuation applications;
    2. Financial status report, no more than 90 days after the end of 
the budget period;
    3. Final financial report and performance report, no more than 90 
days after the end of the project period.
    Send all reports to the Grants Management Specialist identified in 
the ``Where to Obtain Additional Information'' section of this 
announcement.
    Projects that involve the collection of information from 10 or more 
individuals and funded by cooperative agreement will be subject to 
review and approval by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act.
    The following additional requirements are applicable to this 
program. For a complete description of each, see Attachment I of the 
announcement.

AR-1  Human Subjects Requirements
AR-2  Requirements for Inclusion of Women and Racial and Ethnic 
Minorities in Research
AR-4  HIV/AIDS Confidentiality Provisions
AR-5  HIV Program Review Panel Requirements
AR-7  Executive Order 12372 Review
AR-9  Paperwork Reduction Act Requirements
AR-10  Smoke-Free Workplace Requirements
AR-11  Healthy People 2010
AR-12  Lobbying Restrictions
AR-22  Research Integrity

I. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under the Public Health Service Act 
sections 317 (42 U.S.C. 241(a) and 247b); 301 (42 U.S.C. 241); and 311 
(42 U.S.C. 243), as amended. The Catalog of Federal Domestic Assistance 
number is 93.941.

J. Where To Obtain Additional Information

    This and other CDC announcements can be found on the CDC home page 
Internet address http://www.cdc.gov Click on ``Funding' then ``Grants 
and Cooperative Agreements.''
    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.
    If you have questions after reviewing the contents of all the 
documentation, business management technical

[[Page 37971]]

assistance may be obtained from:James Masone, Grants Management 
Specialist, Grants Management Branch, Procurement and Grants Office, 
Centers for Disease Control and Prevention (CDC), 2920 Brandywine Road, 
Room 3000, Mailstop E-15, Atlanta, GA 30341-4146, Telephone: (770) 488-
2736, Email address: [email protected]
    For program technical assistance, contact: Cassandra Walker, MPH, 
Acting Deputy Chief, Prevention Services Research Branch, Division of 
HIV/AIDS Prevention, Surveillance & Epidemiology, National Center for 
HIV, STD, TB Prevention Centers for Disease Control and Prevention, 
1600 Clifton Road, Mailstop E-46 Atlanta, GA 30333 Telephone Number: 
(404) 639-6191Email address: [email protected]

    Dated: July 13, 2001.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 01-18048 Filed 7-19-01; 8:45 am]
BILLING CODE 4163-18-P