[Federal Register Volume 64, Number 100 (Tuesday, May 25, 1999)]
[Notices]
[Pages 28200-28203]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-13140]


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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

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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

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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