[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
