[Federal Register Volume 63, Number 72 (Wednesday, April 15, 1998)]
[Notices]
[Pages 18427-18430]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-9909]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[Announcement 98023]


Human Immunodeficiency Virus (HIV), Sexually Transmitted Diseases 
(STDs), and Tuberculosis (TB) Related Applied Research Projects

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of funds beginning in fiscal year (FY) 1998 for 
cooperative agreements to conduct human immunodeficiency virus (HIV), 
sexually transmitted diseases (STDs), and tuberculosis (TB) related 
applied research into the control and prevention of HIV, STDs and TB. 
The purpose of this program is to encourage new and innovative methods 
to further the prevention of HIV, STDs and TB infection. Projects that 
will be considered for funding are applied research into the control 
and prevention of HIV, STDs, or TB. This program addresses the 
``Healthy People 2000'' priority area(s) HIV Infection, Sexually 
Transmitted Diseases, and Immunization and Infectious Diseases.

National Program Goals

    CDC's national strategic goals for the programs supported by the 
National Center for HIV, STDs and TB Prevention are:
    1. Increase public understanding of, involvement in, and support 
for HIV, STDs, and TB prevention.
    2. Ensure completion of therapy for persons identified with active 
TB or TB infection.
    3. Prevent or reduce behaviors or practices that place persons at 
risk for HIV and STDs infection or, if already infected, place others 
at risk.
    4. Increase individual knowledge of HIV serostatus and improve 
referral systems to appropriate prevention and treatment services.
    5. Assist in building and maintaining the necessary State, local, 
and community infrastructure and technical capacity to carry out 
necessary prevention programs.
    6. Strengthen the current systems and develop new systems to 
accurately monitor HIV, STDs, and TB, as a basis for assessing and 
directing prevention programs.

B. Eligible Applicants

    Eligible applicants will include universities, colleges, research 
institutions, hospitals, public and

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private non-profit organizations, community-based, national, and 
regional organizations, State and local governments or their bona fide 
agents or instrumentalities, federally recognized Indian Tribal 
governments, Indian tribes or organizations, and small, minority-and/or 
women owned non-profit businesses.

    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.

C. Availability of Funds

    Approximately $500,000 is available in FY 1998 to fund 
approximately four awards. It is expected that the average award will 
be $150,000, ranging from $100,000--$300,000. Funding estimates are 
subject to change. It is expected that awards will begin in September, 
1998 and will be made for a 12 month budget period within a project 
period of up to three years. Funding will be available during the 
fiscal year for applications submitted that are consistent with the 
National Center for HIV, STD, and TB Prevention (NCHSTP) National 
Program Goals. Funding estimates are subject to change. Continued 
support in future years will be based on the availability of funds and 
success in demonstrating progress toward achievement of objectives.

Program Priority Areas

    1. The impact of managed care on TB control activities.
    2. The impact of behavioral intervention in correctional settings 
on the community at large or the impact of corrections, public health, 
and substance abuse collaborations on the health of the community.
    3. The impact of peer and community education programs on health 
seeking behaviors of high risk populations, women, youth, and substance 
abusers.
    4. Correctional health care, especially the impact of managed care 
or privatized care providers, and its impact on health care utilization 
in the community.
    5. The relationship between drug and alcohol use and sexual 
behavior and high risk sexual behavior among IDUs, sexual partners of 
IDUs, women, adolescents, and men who have sex with men.
    6. The evaluation of non-abstinence based strategies for drug users 
who cannot or are unwilling to stop drug use.
    7. The development, piloting, evaluation, or technology transfer of 
innovative behavioral interventions designed to reduce the transmission 
or acquisition of HIV among vulnerable populations.
    8. The development of new methods for estimating HIV incidence, 
assessment of HIV incidence in selected, high-risk populations or 
social networks in geographically-defined communities where HIV 
incidence is known or expected to be high, or use of HIV incidence data 
for evaluating prevention interventions.
    9. The development, evaluation, or improvement of HIV prevention 
interventions.
    10. Develop a knowledge base to improve access to care of HIV-
infected persons and to reduce HIV-associated morbidity and mortality 
among persons in care.
    11. Among HIV-infected persons in care, prevent development of 
opportunistic infections and prevent/delay progression to AIDS and 
death.
    CDC may announce additional priority areas through both the Federal 
Register and the Internet.

D. Program Requirements

    1. Recipient activities to achieve the purposes of this program 
will vary by project. CDC will be responsible for the activities under 
CDC Activities.

1. Recipient Activities

    A. Complete the development of the research protocol.
    B. Carry out the activities according to the approved protocol.
    C. Ensure that appropriate approvals are secured for the protection 
of human subjects, Office of Management and Budget and Paperwork 
Reduction Act, privacy, confidentiality, and data security.
    D. Compile and disseminate findings.

2. CDC Activities

    A. Monitor and evaluate scientific and operational accomplishments 
of the project through periodic site visits, frequent telephone calls, 
and review of technical reports and interim data analysis.
    B. For recipients whose project involves collaboration with a State 
or local health department, CDC will assist in facilitating the 
planning and implementation of the necessary linkages with local or 
State health departments and assist with the developmental strategies 
for applied clinical or prevention oriented research programs.
    C. Facilitate the technological and methodological dissemination of 
successful prevention and intervention models among appropriate target 
groups, such as, State and local health departments, community based 
organizations, and other health professionals.
    D. Participate in planning, implementing, and evaluating strategies 
and protocols.

E. Application Content

1. Letter of Intent (LOI)

    Potential applicants must submit an original and two copies of a 
two-page typewritten Letter of Intent (LOI) that briefly describes the 
title of the project, purpose and need for the project as well as its 
relationship to the National Program Goals, the estimated total cost of 
the proposed project, and the dollar amount and percentage of the total 
cost being requested from CDC. Current recipients of CDC funding must 
provide the award number and title of the funded programs. No 
attachments, booklets, or other documents accompanying the LOI will be 
considered.
    LOI's will be reviewed by CDC program staff and an invitation to 
submit a full application will be made based on the documented need for 
the proposed project, contribution to the NCHSTP National Program 
Goals, and the availability of funds. LOI's may focus individually on 
HIV, STD, or TB, or may address more than one programmatic priority 
area.
    An invitation to submit a full application does not constitute a 
commitment by CDC to fund the applicant.

2. Application

    Applications may be submitted only after a Letter of Intent has 
been approved by CDC and a written invitation from CDC has been 
extended to the prospective applicant. Applicants who are invited to 
submit a full application must use Form PHS 398 (OMB Number 0925-0001), 
and submit an original and five copies. The application narrative 
should consist of:
    A. Abstract (Not to exceed 1 page): An executive summary of your 
program covered under this announcement.
    B. Program Plan (Not to exceed 10 pages): In developing the 
application under this announcement, please review the recipient 
activities and, in particular, evaluation criteria and respond 
concisely and completely.
    C. Budget: Submit an itemized budget and supporting justification 
that is consistent with your proposed program plan.

[[Page 18429]]

F. Submission Requirements and Deadlines

1. Letter of Intent (LOI)

    ONE ORIGINAL AND TWO COPIES of the LOI must be postmarked on or 
before May 18, 1998. (FACSIMILES ARE NOT ACCEPTABLE.)

2. Application

    ONE ORIGINAL AND FIVE COPIES of the invited applications must be 
submitted on Form PHS 398 (OMB Number 0925-0001) and must be postmarked 
on or before July 20, 1998.

3. Address for Submission of Letter of Intent and Invited Application

    Juanita Dangerfield, Grants Management Specialist, Grants 
Management Branch, Centers for Disease Control and Prevention (CDC), 
255 East Paces Ferry Road NE., Room 300, Mailstop E-15, Atlanta, 
Georgia 30305

4. Application Deadline

    Letters of Intent and Applications shall be considered as meeting 
the deadline if they are either:
    a. Received on or before the deadline date, or
    b. Postmarked on or before the deadline date and received in time 
for submission to the objective review committee. (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.)

5. Late Applications and Letters of Intent

    Applications that do not meet the criteria in 4a or 4b are 
considered late applications and will be returned to the applicant 
without review.

G. Evaluation Criteria

    Applications responding to this announcement will be evaluated 
individually according to the following criteria.
    1. The inclusion of a brief review of the scientific literature 
pertinent to the study being proposed and specific research questions 
or hypotheses that will guide the research. The originality and need 
for the proposed research, the extent to which it does not replicate 
past or present research efforts, and how findings will be used to 
guide prevention and control efforts. (20 points)
    2. The quality of the plans to develop and implement the study, 
including 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 community(ies) and recognition of mutual benefits. (20 points)
    3. Extent to which proposed objectives will further the NCHSTP 
National Program Goals. (20 points)
    4. Extent to which proposed activities, if well executed, are 
capable of attaining project objectives. (20 points)
    5. Extent to which personnel involved in this project are 
qualified, including evidence of past achievements appropriate to the 
project and realistic and sufficient percentage-time commitments. 
Evidence of adequacy of facilities and other resources needed to carry 
out the project. (20 points)
    6. Other (not scored)
    a. Budget: Will be reviewed to determine the extent to which it is 
reasonable, clearly justified, consistent with the intended use of the 
funds, and allowable. All budget categories should be itemized.
    b. Human Subjects: Whether or not exempt from the Department of 
Health and Human Services regulations, are procedures adequate for the 
protection of human subjects? Recommendations on the adequacy of 
protections include the following:
    (1) Protections appear adequate and there are no comments to make 
or concerns to raise, (2) protections appear adequate, but there are 
comments regarding the protocol, (3) protections appear inadequate and 
the Objective Review Group (ORG) has concerns related to human 
subjects; or (4) disapproval of the application is recommended because 
the research risks are sufficiently serious and protection against the 
risks are inadequate as to make the entire application unacceptable.
    Funding decisions on approved applications will depend on the area 
of interest of the proposals, their relationship to NCHSTP National 
Program Goals, the specific research questions being proposed, and the 
quality of the application.

H. Other Requirements

Technical Reporting Requirements

    Provide CDC with original plus two copies of:
    1. An annual progress report,
    2. Financial status report, no more than 90 days after the end of 
the budget period, and
    3. Final financial report and performance report, no more than 90 
days after the end of the project period.
    Send all reports to Juanita Dangerfield, Grants Management 
Specialist, Grants Management Branch, Procurement and Grants Office, 
Announcement 98023, Centers for Disease Control and Prevention (CDC), 
255 East Paces Ferry Road, NE., Mail Stop E-15, Room 300, Atlanta, GA 
30305-2209.
    For descriptions of the following Other Requirements, see 
Attachment I:

1. AR98-1--Human Subjects Requirements
2. AR98-2--Inclusion of Women and Racial and Ethnic Minorities in 
Research Requirements
3. AR98-4--HIV/AIDS Confidentiality Provisions
4. AR98-5--HIV Program Review Panel Requirements
5. AR98-6--Patient Care Prohibitions
6. AR98-9--Paperwork Reduction Act Requirements
7. AR98-10--Smoke-Free Workplace Requirements
8. AR98-11--Healthy People 2000
9. AR98-12--Lobbying Restrictions

I. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under the Public Health Service Act, 
sections 317(k)(2) (42 U.S.C. 247b(k)(2)), 317E (42 U.S.C. 247b-6) and 
318 of the Public Health Service Act, (42 U.S.C. 247c), as amended. 
Regulations governing grants for STD research are codified in part 51b, 
subparts A and F of Title 42, Code of Federal Regulations. The Catalog 
of Federal Domestic Assistance numbers are 93.941, HIV Demonstration, 
Research, Public and Professional Education; 93.943, Epidemiologic 
Research Studies of Acquired Immunodeficiency Virus (AIDS) and Human 
Immunodeficiency Virus (HIV) Infection in Selected Population Groups; 
93.947, Tuberculosis Demonstration, Research, Public and Professional 
Educations; and 93.978, Prevention Health Services--Sexually 
Transmitted Diseases Research, Demonstrations, and Public Information 
and Education Grants.

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J. Where to Obtain Additional Information

    To receive additional written information, call 1-888-472-6874. You 
will be asked to leave your name, address, and phone number, and refer 
to Announcement Number 98023. You will receive a complete program 
announcement. CDC will not send application kits by facsimile or 
express mail unless the cost for the latter is paid by the addressee.
    This and other CDC announcements are also available through the CDC 
homepage on the Internet. The address for the CDC homepage is http://
www.cdc.gov.
    Business management technical assistance may be obtained from 
Juanita Dangerfield, Grants Management Specialist, Grants Management 
Branch, Centers for Disease Control and Prevention (CDC), Procurement 
and Grants Office, 255 East Paces Ferry Road NE., Room 300, Mailstop E-
15, Atlanta, GA 30305, telephone (404) 842-6577, or facsimile at (404) 
842-6513, or INTERNET address: [email protected].
    Programmatic technical assistance may be obtained from the National 
Center for HIV, STDs and TB Prevention, Centers for Disease Control and 
Prevention (CDC), Atlanta, GA 30303, for HIV, contact Carol Aloisio, 
telephone (404) 639-0902; for STD, contact Sevgi Aral, telephone (404) 
639-8259; for TB, contact Bess Miller, telephone (404) 639-8120.
    Please refer to Announcement 98023 when requesting information and 
submitting an application.

    Dated: April 9, 1998.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for 
Disease Control and Prevention (CDC).
[FR Doc. 98-9909 Filed 4-14-98; 8:45 am]
BILLING CODE 4163-18-P