[Federal Register Volume 66, Number 140 (Friday, July 20, 2001)]
[Notices]
[Pages 37966-37969]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-18047]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 01187]


Human Immunodeficiency Virus (HIV) Prevention Intervention 
Research Studies--Routinely Recommending HIV and Sexually Transmitted 
Disease (STD) Counseling and Testing in Ambulatory Care Clinics and 
Emergency Rooms; Notice of Availability of Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 2001

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funds for a cooperative agreement program to reduce HIV incidence 
through prevention intervention research studies that routinely 
recommend HIV and STD counseling and testing in ambulatory care clinics 
and emergency rooms. This program addresses the ``Healthy People 2010'' 
focus area of HIV.
    The purpose of this activity is to study the outcome of routinely 
recommending HIV counseling and testing and STD screening in ambulatory 
care clinics and emergency rooms.

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 $600,000 is available in FY 2001 to fund 
approximately two to three 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.

Funding Preference

    Funding preference may be given to achieve geographical diversity.

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. Review existing information, research study protocols, and data 
collection forms to build on existing knowledge and to establish the 
basis for the application.
    b. Develop a research protocol and plans for conducting this 
research, with appropriate participation of State and local health 
departments, hospitals and other public and private organizations; 
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 with HIV disease, STD, or AIDS.
    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. The IRB review at each cooperating 
institution will be done by an Office for Human Research Protections 
(OHRP)-approved IRB with either a single, multiple, or federal-wide 
project assurance.
    d. 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.
    e. Perform testing for chlamydia, gonorrhea and HIV.
    f. Perform data analysis as determined in the study protocol.
    g. Disseminate the findings.

2. CDC Activities

    a. Provide technical assistance, if requested, in the design and 
conduct of the research.
    b. The CDC IRB will review and approve each 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 and data 
analysis.

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; or
    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.)
    Late: Applications which do not meet the criteria in 1. or 2. above 
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):

    To the degree to which the applicant includes: (1) A detailed 
review of the scientific literature pertinent to testing in ambulatory 
care clinics and emergency rooms; (2) clearly stated goals and 
objectives for the research; and (3) a description of how the 
intervention would impact HIV and STD prevention in the community.

2. Site Selection (15 points)

    The extent to which the application includes a description of: (1) 
The

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current magnitude and characteristics of the HIV epidemic; (2) STD 
disease burden; (3) the number of persons served by the clinics; and 
(4) the expected number of newly-identified HIV infections that will be 
detected. Letters of support from cooperating organizations should be 
included which clearly describe the nature and extent of such 
cooperation.

3. Methods (30 points)

    To the extent the application describes the potential intervention 
and how it might impact on HIV and STD incidence in the study area. It 
should specify potential barriers to implementing the intervention and 
how they will be overcome. The methods for assessing the increase in 
number of persons tested, as well as the number of infected persons 
identified and successfully referred for treatment, should also be 
addressed. 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 which includes curriculum vitae and 
position descriptions for key staff. The percentage-time commitments, 
duties, and responsibilities of project personnel and involvement of 
state and local health department personnel should be sufficient to 
operationalize the proposed methodology. Letters of support from key 
collaborators, community groups, State and local health departments, 
should be included. The letters of support must include a brief 
description of the specific support to be provided, and should be 
limited to three pages each. The application should document that there 
is sufficient space available in the ambulatory care clinic or 
emergency room for the addition of the testing program. The application 
should also provide evidence that at least 500 persons per year visit 
the ambulatory care facility or emergency room, many of whom may be 
HIV-infected and who do not know they are HIV-infected. The application 
should demonstrate the applicant's ability to do testing for chlamydia, 
gonorrhea, and HIV, either in house or through contractual services.

5. Sustainability of the intervention (15 points)

    Strength of plans, time-lines, and objectives for how project will 
be sustained.

6. Evaluation Plan (10 points)

    Appropriateness and comprehensiveness of: (a) The schedule for 
accomplishing the activities of the research; (b) an evaluation plan 
that identifies methods and instruments for evaluating progress in 
implementing the research objectives; and (c) a proposal to complete 
and submit for publication, a report of research findings.

7. Budget (not scored)

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

8. Human Subjects (not scored)

    Does the application adequately address 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 are 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 and 
Attachment II 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 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, Mailstop E-15, 
Atlanta, GA 30341-4146, Telephone: (770) 488-2741, 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) 
639-6191, Email address: [email protected]


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    Dated: July 13, 2001.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 01-18047 Filed 7-19-01; 8:45 am]
BILLING CODE 4163-18-P