Evaluation of the Impact of the 1993 AIDS Case Definition

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Announcement 447]

Evaluation of the Impact of the 1993 AIDS Case Definition

Introduction

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

availability of fiscal year (FY) 1994 funds for a competitive

cooperative agreement program to study the quality of AIDS surveillance

using the 1993 AIDS case definition and reporting system to determine

methods that increase the efficiency of AIDS surveillance activities.

The Public Health Service (PHS) is committed to achieving the

health promotion and disease prevention objectives of ``Healthy People

2000,'' a PHS-led national activity to reduce morbidity and mortality

and improve the quality of life. This announcement is related to the

priority area of HIV Infection. (To order a copy of ``Healthy People

2000,'' see the section Where To Obtain Additional Information.)

Authority: These cooperative agreements are authorized under

Sections 301(a) and 311 of the Public Health Service Act [42 U.S.C.

241(a) and 243], as amended. Applicable program regulations are

found in 42 CFR Part 52, Grants for Research Projects.

Smoke-Free Workplace

The Public Health Service strongly encourages all grant recipients

to provide a smoke-free workplace and promote the non-use of all

tobacco products. This is consistent with the PHS mission to protect

and advance the physical and mental health of the American people.

Eligible Applicants

Assistance will be provided only to official public health agencies

of States and their bona fide agents or instrumentalities. This

includes the District of Columbia, American Samoa, the Commonwealth of

Puerto Rico, the Virgin Islands, the Federated States of Micronesia,

the Northern Mariana Islands, the Republic of the Marshall Islands, the

Republic of Palau, and the following cities and county only: the cities

of Chicago, Houston, Philadelphia, New York, San Francisco, and the

County of Los Angeles.

Availability of Funds

Approximately $1,200,000 is available in FY 1994 to fund four to

six awards. It is expected that the average award will be $250,000,

ranging from $200,000 to $300,000. It is expected that the awards will

begin on or about September 30, 1994, and will be for a 12-month budget

period within a project period of up to 3 years. Funding estimates may

vary and are subject to change. Continuation awards within a project

period will be based on satisfactory progress and the availability of

funds.

Purpose

The purpose of these awards is to assist State and local health

departments in: (1) Determining the sensitivity, timeliness, and

validity of the AIDS surveillance system; (2) Improving the efficiency

of AIDS surveillance by evaluating a variety of case ascertainment

methods; and (3) Identifying the information collected as part of AIDS

surveillance that is most useful for planning and evaluating HIV-

related treatment and preventive services.

All activities should be implemented under various reporting

alternatives (provider-based vs. lab-initiated reporting) through a

population-based retrospective study.

Program Requirements

In conducting activities to achieve the purpose of this program,

the recipient shall be responsible for activities under A., below, and

CDC will be responsible for conducting activities under B., below:

A. Recipient Activities

1. Conduct a retrospective evaluation of medical and laboratory

records to obtain histories of CD4+ and HIV testing, the occurrence of

opportunistic infections (OIs) among persons reported to AIDS

surveillance, and the number and type of sites that provide care for

HIV-infected persons to determine the sensitivity, validity, and

timeliness of AIDS surveillance and the ability to effectively monitor

the epidemic using the 1993 AIDS surveillance definition and reporting

system. As needed, conduct personal interviews with all, or a sample

of, persons who are reported with AIDS to retrospectively collect data

on dates and results of all prior CD4+ and HIV tests, OIs, receipt of

treatment and prophylaxis, and degree of access to the health care

system. If the cases being investigated received treatment in multiple

health facilities, as many records as possible should be pursued.

2. Propose alternative surveillance methods to increase the cost

effectiveness, quality, and efficiency of case-finding. For example,

areas with provider-based surveillance can pilot a laboratory-initiated

reporting system and compare this activity to existing surveillance

methods. For areas with both provider and laboratory-initiated case-

finding methods, evaluative methods may include comparing data from

these sources to alternative data bases. The alternative data bases

used for evaluation should not currently be linked to case-finding

activities, and may vary by State (e.g., death certificates are used

for case-finding in most areas, and are therefore not useful for

evaluation activities). Other methods to increase efficiency may be

explored in comparison to existing case-finding methods, including:

sampling for risk information; reporting only from laboratory and

alternative data bases, such as death registries; and conducting active

surveillance for preventable opportunistic infections only.

3. Collect data in the treatment and services referral section of

the adult HIV/AIDS confidential case report form on all or a

representative sample of persons reported to AIDS surveillance,

describe the data sources, the collection methods, and determine

resources needed to obtain these data. Develop measures to assess the

usefulness of these data for the planning of prevention activities by

the local health department and community planning bodies.

4. Participate in meetings to plan and develop standardized

evaluation protocols and to discuss progress and methodologic issues.

If travel is needed it will be supported through specific funds awarded

in this cooperative agreement.

5. Ensure confidentiality of information collected from persons

with AIDS and persons with confirmed or suspected HIV infection.

6. Maintain responsibility for analysis and presentation of data

collected for local purposes.

7. Demonstrate coordination with existing HIV/AIDS surveillance

activities.

8. Identify and select appropriate staff.

B. CDC Activities

1. Provide oversight and technical assistance as the project

progresses.

2. Assist the participant in planning and implementing the

evaluation, including providing technical guidance in the development

of data collection instruments, outcome measures, reporting protocols,

training, and pretesting methods. Coordinate activities among project

participants to promote information sharing and ensure comparability of

data collection.

3. Compile, analyze, and report results of aggregate data in

collaboration with participating sites.

Evaluation Criteria

Applications will be reviewed and evaluated according to the

following criteria:

1. The quality of the plan to evaluate the 1993 surveillance case

definition and the impact of the case definition on AIDS surveillance.

(10 points)

2. Descriptions of the alternative data bases that will be used and

how they will be used. (10 points)

3. The applicant's current activities in the surveillance of AIDS

and HIV infection and past or ongoing research projects to evaluate

sensitivity, representativeness, and validity of reporting. (10 points)

4. The number and distribution of recent AIDS cases collected by

the health department and their representativeness of minority

populations, women, heterosexual transmission cases, and geographic

areas with the largest increases in the number of cases reported. (25

points)

5. The applicant's willingness to cooperate in the project with CDC

and other participants. (5 points)

6. The applicant's ability to obtain data from charts or interviews

with patients directly or in association with personnel not currently

responsible for the reporting of AIDS cases, and the ability to manage,

analyze, and use surveillance data. (10 points)

7. Description of methods for evaluating project activities and for

modifying activities based on evaluation findings. (5 points)

8. The extent to which the proposal describes how the project will

be administered, including the size, qualifications, commitment, and

time allocation of the proposed staff; the availability of facilities

to be used during the project and a schedule for accomplishing

activities. (10 points)

9. The applicant's ability to mobilize resources effectively to

ensure the quality and quantity of data needed to implement this

evaluation. (5 points)

10. A plan to protect the confidentiality of all surveillance data

and a description of the applicant's authority to collect data from

patients, alternate sources, and medical records. (10 points)

11. The extent to which the budget is reasonable, clearly

justified, and consistent with the intended use of funds. (Not

Weighted)

Funding Priorities

Cooperative agreement recipients reporting at least 4,500

cumulative cases of AIDS to CDC through December 31, 1993 (as

provisionally reported in the draft CDC HIV/AIDS Surveillance Report,

1993 Year-End Edition, released in March 1994), will be given priority

for funding. In addition, the final selection of applications for this

project must include at least one of each group of States representing

these categories: (1) Laboratory-initiated HIV or CD4 reporting

implemented by January 1, 1994, by law or regulation, and (2) provider-

initiated reporting only. This approach is justified since the

objective of the project is to evaluate the attributes of surveillance

systems under various reporting alternatives.

Interested persons are invited to comment on the proposed funding

priority. All comments received on or before August 11, 1994, will be

considered before the final funding priority should change as a result

of any comments received, a revised Announcement will be published in

the Federal Register prior to the final selection of awards.

Written comments should be addressed to Edwin L. Dixon, Grants

Management Officer, Grants Management Branch, Procurement and Grants

Office, Centers for Disease Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 314, Mailstop E-18, Atlanta, Georgia 30305.

Executive Order 12372 Review

Applications are subject to Intergovernmental Review of Federal

Programs as governed by Executive Order (E.O.) 12372. E.O. 12372 sets

up a system for State and local government review of proposed Federal

assistance applications. Applicants should contact their State Single

Point of Contact (SPOC) as early as possible to alert them to the

prospective applications and receive any necessary instructions on the

State process. For proposed projects serving more than one State, the

applicant is advised to contact the SPOC of each affected State. A

current list of SPOCs is included in the application kit. If SPOCs have

any State process recommendations on applications submitted to CDC,

they should send them to Edwin L. Dixon, Grants Management Officer,

Grants Management Branch, Procurement and Grants Office, Centers for

Disease Control and Prevention (CDC), 255 East Paces Ferry Road, NE.,

Room 314, Mailstop E-18, Atlanta, Georgia 30305, no later than 60 days

after the application deadline date. The Program Announcement Number

and Program Title should be referenced on the document. The granting

agency does not guarantee to ``accommodate or explain'' State process

recommendations it receives after that date.

Public Health System Reporting Requirement

This program is not subject to the Public Health System Reporting

Requirements.

Catalog of Federal Domestic Assistance Number

The Catalog of Federal Domestic Assistance number assigned to this

program is 94.944.

Other Requirements

Paperwork Reduction Act

Projects that involve the collection of information from 10 or more

individuals and funded by cooperative agreement will be subject to

review by the Office of Management and Budget (OMB) under the Paperwork

Reduction Act.

Human Subjects

If the proposed project involves research on human subjects, the

applicant must comply with the Department of Health and Human Services

Regulations (45 CFR Part 46) regarding the protection of human

subjects. Assurance must be provided to demonstrate that the project

will be subject to initial and continuing review by an appropriate

institutional review committee. The applicant will be responsible for

providing assurance in accordance with the appropriate guidelines and

form provided in the application kit.

HIV/AIDS Requirements

Recipients must comply with the document entitled ``Content of HIV/

AIDS-related Written Materials, Pictorials, Audiovisuals,

Questionnaires, Survey Instruments, and Educational Sessions,'' (June

1992), a copy of which is included in the application kit. To meet the

requirements for a program review panel, recipients are encouraged to

use an existing program review panel, such as the one created by the

State health department's HIV/AIDS prevention program. If the recipient

forms its own program review panel, at least one member must be an

employee (or a designated representative) of a State or local health

department. The names of the review panel members must be listed on the

Assurance of Compliance Form CDC 0.1113, which is also included in the

application kit. The recipient must submit the program review panel's

report that indicates all materials have been reviewed and approved.

Application Submission and Deadline

The program announcement and application kit were sent to all

eligible applicants in June 1994.

Where To Obtain Additional Information

A complete program description, information on application

procedures, an application package and business management technical

assistant may be obtained from Nealean K. Austin, Grants Management

Specialist, Grants Management Branch, Procurement and Grants Office,

Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry

Road, NE., Room 314, Mailstop E-18, Atlanta, Georgia 30305, telephone

(404) 842-6508. Programmatic technical assistance may be obtained from

R. Monina Klevens, D.D.S., M.P.H., Division of HIV/AIDS, National

Center for Infectious Diseases, Centers for Disease Control and

Prevention (CDC), 1600 Clifton Road, NE., Mailstop E-47, Atlanta,

Georgia 30333, telephone (404) 639-2050.

Please refer to Announcement Number 447 when requesting information

and submitting an application.

Potential applicants may obtain a copy of ``Healthy People 2000''

(Full Report, Stock No. 017-001-00474-0) or ``Healthy People 2000''

(Summary Report, Stock No. 017-001-00473-1) referenced in the

Introduction through the Superintendent of Documents, Government

Printing Office, Washington, DC 20402-9325, telephone (202) 783-3238.

Dated: July 6, 1994.

Martha Katz,

Acting Associate Director for Management and Operations, Centers for

Disease Control and Prevention (CDC).

[FR Doc. 94-16805 Filed 7-11-94; 8:45 am]

BILLING CODE 4163-18-P