Human Immunodeficiency Virus (HIV) Related Applied Research and Professional Education Projects; Notice of Availability of Funds

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 99100]

Human Immunodeficiency Virus (HIV) Related Applied Research and

Professional Education Projects; Notice of Availability of Funds

A. Purpose

The Centers for Disease Control and Prevention (CDC) announces the

availability of funds beginning in fiscal year (FY) 1999 for

cooperative agreements to conduct human immunodeficiency virus (HIV)

related applied research and professional education in the control and

prevention of HIV. The purpose of this program is to encourage new and

innovative methods to further the prevention of HIV infection. Projects

that will be considered for funding are applied research or

professional education for the control and prevention of HIV. This

program addresses the ``Healthy People 2000'' priority areas of 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 sero status 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 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.

Note: Pub. L. 104-65 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 $500,000 is available in FY 1999 to fund

approximately four awards. It is expected that the average award will

be $125,000, ranging from $100,000-$300,000. Funding estimates

[[Page 28201]]

are subject to change. It is expected that awards will begin in

September, 1999, and will be made for a 12 month budget period within a

project period of up to three years. 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

Funding Priorities

Interested persons are invited to comment on the proposed funding

priorities. All comments received within 30 days after publication in

the Federal Register will be considered before the final funding

priority is established. If the funding priority changes because of

comments received, a revised announcement will be published in the

Federal Register, and revised applications will be accepted before the

final selections are made. Address comments to the Grants Management

Specialist listed in the ``Where to Obtain Additional Information''

section of this announcement.

1. Among HIV-infected persons receiving medical care, prevent

development of opportunistic infections and prevent or delay

progression to AIDS and death.

2. Develop, pilot, evaluate, and transfer technology of HIV rapid

testing and counseling strategies.

3. Among national organizations representing health professionals

who provide prenatal or neonatal care, assist in the national

dissemination of perinatal HIV transmission information, resources, and

interventions to pediatricians, obstetricians, family practitioners,

nurse practitioners, and other health care providers.

4. The identification and characterization of recently HIV-infected

persons in specific populations or geographic areas; or the 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 to evaluate

prevention interventions.

5. Develop and implement methods to improve access to care of HIV-

infected person and to reduce HIV associated morbidity and mortality

among persons in medical care.

6. Pilot test, implement, and evaluate perinatal HIV transmission

prevention programs to domestic and global prevention partners, e.g.,

ministries of health, UNAIDS, UNICEF.

D. Program Requirements

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 (applied research).

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. Recipient Activities (professional education).

a. Develop and disseminate HIV prevention education and training

programs and materials.

b. Evaluate the materials and their dissemination.

c. Report and disseminate results and recommendations and relevant

HIV prevention and education and training information to appropriate

health-care providers, HIV/AIDS prevention and service organizations,

and the general public.

3. 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. As requested, provide technical assistance in planning and

evaluating strategies and protocols.

E. Application Content

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, and funding

priority which it addresses. 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, relationship to funding priorities, and the

availability of funds. LOI's may focus on more than one programmatic

priority area.

An invitation to submit a full application does not constitute a

commitment by CDC to fund the applicant.

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 submit the original and five copies of

PHS-398 (OMB Number 0925-0001) (adhere to the instructions on the

Errata Instruction Sheet for PHS 398). Forms are in the application

kit. The application narrative should consist of:

1. Abstract (Not to exceed 1 page): An executive summary of your

program covered under this announcement, specifying whether your

program is applied research or professional education.

2. 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.

3. Budget: Submit an itemized budget and supporting justification

that is consistent with your proposed program plan.

F. Submission and Deadlines

Letter of Intent (LOI)

One Original and Two Copies of the LOI must be postmarked on or

before June 21, 1999. (Facsimiles Are Not Acceptable.)

Application

Submit the original and five copies of the application on Form PHS

398 (OMB Number 0925-0001). Forms are available at the following

Internet address: HTTP://WWW.CDC.GOV/OD/PGO/FROMINFO.HTM or in the

application kit. On or before July 23, 1999, submit your application to

the Grants Management Specialist listed in

[[Page 28202]]

the ``Where to Obtain Additional Information'' section of this

announcement.

Deadline: Letters of Intent and Applications shall be considered as

meeting the deadline if they are either:

1. Received on or before the deadline date, or

2. 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.)

Applications that do not meet these criteria are considered late

applications and will be returned to the applicant without review.

G. Evaluation Criteria

Letters of Intent responding to this announcement will be evaluated

on the documented need for the proposed activities and the relationship

to the listed funding priorities.

Each application will be evaluated individually against the

following criteria by an independent review group appointed by CDC.

1. Applied Research

a. 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. (25 points)

b. 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:

(1) The proposed plan for the inclusion of both sexes and racial

and ethnic minority populations for appropriate representation.

(2) The proposed justification when representation is limited or

absent.

(3) A statement as to whether the design of the study is adequate

to measure differences when warranted.

(4) 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. (25

points)

c. Extent to which proposed activities, if well executed, support

attaining project objectives. (25 points).

d. Extent to which personnel involved in this project are

qualified, including evidence of past achievements appropriate to the

project, and realistic and sufficient time commitments. Evidence of

adequacy of facilities and other resources supported to carry out the

project. (25 points).

e. Other (not scored).

(1) 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.

(2) Human Subjects: Does the application adequately address the

requirements of Title 45 CFR part 46 for the protection of human

subjects?

2. Professional Education

a. Extent to which the applicant demonstrates the scientific

soundness of the technology to be transferred. (25 points)

b. The extent to which the applicant's description of the proposed

material relates to HIV prevention and education, responds to a

specific public health need, and can be expected to influence public

health practices. (25 points)

c. The adequacy and commitment of institutional resources to

administer the program. (25 points)

d. The degree to which the application demonstrates that all key

personnel have education and expertise relative to its objectives. (25

points)

e. 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.

Funding decisions on approved applications will depend on the area

of interest of the proposals, their relationship to NCHSTP National

Program Goals, 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 status 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.

The following additional requirements are applicable to this

program. For a complete description of each, see attachment 1 in the

application kit.

AR-1--Human Subjects Requirements (applied research only)

AR-2--Inclusion of Women and Racial and Ethnic Minorities in Research

Requirements (applied research only)

AR-4--HIV/AIDS Confidentiality Provisions

AR-5--HIV Program Review Panel Requirements

AR-6--Patient Care Prohibitions

AR-9--Paperwork Reduction Act Requirements

AR-10--Smoke-Free Workplace Requirements

AR-11--Healthy People 2000

AR-12--Lobbying Restrictions

I. Authority and Catalog of Federal Domestic Assistance Number

This program is authorized under the Public Health Service Act,

section 317(k)(2)(42 U.S.C. 247b(k)(2)), as amended. 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 Syndrome (AIDS) and Human

Immunodeficiency Virus (HIV) Infection in Selected Population Groups.

J. Where to Obtain Additional Information

To receive additional written information and to request an

application kit, call 1-888-472-6874. You will be asked to leave your

name and address and will be instructed to identify the announcement of

interest.

This and other CDC announcements are also available through the CDC

home page on the Internet. The address for the CDC home page is HTTP://

www.cdc.gov.

If you have questions after reviewing the contents of all

documents, business management technical assistance may be obtained

from: Sheryl Disler, Grants Management Specialist, Grants Management

Branch, Centers for Disease Control and Prevention (CDC), 2920

Brandywine Road, Mailstop E-15, Room 3000, Atlanta, GA 30341-4146,

telephone (770) 488-2756 or facsimile at (770) 488-2777, or INTERNET

address: HTTP://[email protected]

You may obtain programmatic technical assistance from: Peggy Bloom,

National Center for HIV, STD and TB Prevention, Centers for Disease

Control and Prevention (CDC), 1600 Clifton Road, NE, Atlanta, GA 30333,

Telephone (404) 639-0927, INTERNET

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address: HTTP://[email protected]

Dated: May 19, 1999.

John L. Williams,

Director, Procurement and Grants Office, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 99-13140 Filed 5-24-99; 8:45 am]

BILLING CODE 4163-18-P