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

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.

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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