[Federal Register Volume 59, Number 132 (Tuesday, July 12, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-16805]


[[Page Unknown]]

[Federal Register: July 12, 1994]


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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