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93.943 EPIDEMIOLOGIC RESEARCH STUDIES OF ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS) AND HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN SELECTED POPULATION GROUPS

(Epidemiologic Research Studies of AIDS and HIV)

FEDERAL AGENCY
CENTERS FOR DISEASE CONTROL AND PREVENTION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

AUTHORIZATION
Public Health Service Act, Section 301, 42 U.S.C. 241, Section 311, 42 U.S.C. 243, as amended.

OBJECTIVES
To support research of important HIV-related epidemiologic issues concerning risks of transmission, the natural history and transmission of the disease in certain populations and development and evaluation of behavioral recommendations for reducing AIDS and HIV infection. Of special interest are programs that examine these research issues as they affect minority populations (defined as one of the four federally-recognized groups: African-Americans; Asian/Pacific Islanders; Latinos/Hispanics; and Native Americans).

TYPES OF ASSISTANCE
Project Grants.

USES AND USE RESTRICTIONS
Assistance is provided to support cooperative agreements that examine important epidemiologic research issues concerning AIDS and HIV infection. The research should contribute to the health services knowledge base from which empirically based information can be derived by policy makers, both immediately and over the coming decades. Grants include funds for direct costs (such as personnel, travel, equipment, or supplies) necessary to carry out an approved project as well as funds for the reimbursement of applicable indirect costs. Unallowable costs, as well as those for which prior written approval is required, are indicated in the PHS Grants Policy Statement.

Applicant Eligibility
Eligible applicants include States, political subdivisions of States or their agents or instrumentalities, private research organizations, including American Indian/Alaska Native tribal governments or tribal organizations located wholly or in part within their boundaries, other public and private nonprofit organizations, and for-profit organizations.

Beneficiary Eligibility
State and local health agencies; private research organizations, public and private nonprofit organizations, for profit organizations; minority groups; including American Indian/Alaska Native tribal governments or tribal organizations located wholly or in part within their boundaries, and persons physically afflicted with AIDS/HIV infection.

Credentials/Documentation
Costs will be determined by HHS Regulations 45 CFR Part 74, Subpart Q for nonprofit organizations and in accordance with OMB Circular No. A-87, "Cost Principles for State and Local Governments."

Preapplication Coordination
None. This program is excluded from coverage under E.O. 12372.

Application Procedure
A signed original and five copies of the application Form 398 must be sent to the Centers for Disease Control and Prevention (CDC). State and local governments may use Form 5161. An original and two copies must be submitted. This program is subject to the provisions of 45 CFR 92 for State and Local Governments and 45 CFR 74 for nonprofit organizations, as appropriate.

Award Procedure
After review and approval, a notice of award is prepared and processed, along with appropriate notification to the public, initial award provides funds for first budget period (usually 12 months) and Notice of Award indicates support recommended for the remainder of project period, allocation of Federal funds by budget categories, and special conditions, if any. However, applicants are encouraged to call CDC for programmatic technical assistance prior to the development and submission of their assistance application.

Deadlines
Contact the Headquarters Office listed below for application deadlines.

Range of Approval/Disapproval Time
About 120 days from receipt of application.

Appeals
None.

Renewals
If additional support is desired to continue a research project beyond the approved project period, an application for competing continuation must be submitted for review in the same manner as a new application.

Formula and Matching Requirements
There are no statutory formula or matching requirements.

Length and Time Phasing of Assistance
Assistance is available for a 12-month budget period within project periods ranging from one to three years. After awards are issued, funds are released in accordance with the payment procedure established by the grantee institution with DHHS, which may be an Electronic Transfer System or a Monthly Cost Request System.

Reports
Financial status and progress reports are required annually. Upon completion of the project, final financial status and performance reports are required.

Audits
In accordance with the provisions of OMB Circular No. A-133 (Revised, June 24, 1997), "Audits of States, Local Governments, and Nonprofit Organizations," nonfederal entities that expend financial assistance of $300,000 or more in Federal awards will have a single or a program-specific audit conducted for that year. Nonfederal entities that expend less than $300,000 a year in Federal awards are exempt from Federal audit requirements for that year, except as noted in Circular No. A-133. In addition, grants and cooperative agreements are subject to inspection and audits by DHHS and other Federal government officials.

Records
Financial records, supporting documents, statistical records, and all other records pertinent to the project must be kept readily available for review by personnel authorized to examine PHS grant accounts. Records must be maintained for a minimum of 3 years after the end of a budget period. If questions still remain, such as those raised as a result of an audit, records must be retained until completion or resolution of any audit in process or pending resolution. Property records must be retained in accordance with PHS Grants Policy Statement requirements.

Account Identification
75-0943-0-1-550.

Obligations
(Cooperative Agreements) FY 07 $4,415,183; FY 08 $4,483,640; and FY 09 est $4,483,640.

Range and Average of Financial Assistance
$49,585 to $757,500; $237,840.

PROGRAM ACCOMPLISHMENTS
It is anticipated that in FY 07 approximately 13 awards will be funded.

REGULATIONS, GUIDELINES, AND LITERATURE
Regulations governing this program are published in the application kit. PHS Grants Policy Statement No. 94-50,000 (Revised) April l, 1994.

Regional or Local Office
None.

Headquarters Office
Grants Management Contact: Cheryl Maddux, Grants Management Officer, Grants Management Branch, Procurement and Grants Office, Centers for Disease Control and Prevention, 2920 Brandywine Road, Room 3000, Atlanta, GA 30341. Telephone: (770) 498-1911.

Web Site Address
http://www.cdc.gov

RELATED PROGRAMS
93.118, Acquired Immunodeficiency Syndrome (AIDS) Activity.

EXAMPLES OF FUNDED PROJECTS
Assistance has been provided to support epidemiologic research studies of: the natural history of HIV infection in men who have sex with men, women and infants, injecting drug users, and adolescents; the transmission of HIV infection in populations of women, children, blood recipients, drug users, heterosexuals, prisoners and specific groups of minorities; and social, psychological and behavioral studies of HIV infection in selected population groups.

CRITERIA FOR SELECTING PROPOSALS
Applications will be reviewed and evaluated based on the evidence submitted which specifically describes the applicant's abilities to meet the following criteria: (1) the plans to develop and implement the study describing how study participants will be identified, enrolled, tested and followed; (2) the ability to enroll and follow an adequate number of eligible study participants to assure proper conduct of the study. This includes both demonstration of the availability of HIV-infected potential study participants and the experience of the investigator in enrolling and following such persons; (3) the applicant's current activities in AIDS and HIV research and how they will be applied to achieving the objectives of the study; letters of support from cooperating organizations that demonstrate that nature and extent of such cooperation should be included; (4) the applicant's understanding of the research study objectives and, their ability, willingness and/or need to collaborate with CDC and researchers from other study sites in study design and analysis, including use of common forms, and sharing of specimens and data; (5) the plan to protect the rights and confidentiality of all participants and ensure adequate participation; (6) the size, qualifications and time allocation of the proposed staff and the availability of facilities to be used during the research study; (7) how the project will be administered to assure the proper management of the daily activities of the program; (8) the proposed schedule for accomplishing the activities of the research; including time frames; and (9) the quality of an evaluation plan which specifies methods and instruments to be used to evaluate the progress made in attaining research objectives.


General Services Administration
Office of Chief Acquisition Officer
Regulatory and Federal Assistance Division (VIR)