[Federal Register Volume 59, Number 117 (Monday, June 20, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-14908]
[[Page Unknown]]
[Federal Register: June 20, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Program Announcement 472]
Study on Hospitalization of Tuberculosis (TB) Patients and
Tuberculin Skin Testing Demonstration Projects (Supplement to TB
Elimination Cooperative Agreements)
Introduction
The Centers for Disease Control and Prevention (CDC) announces the
availability of fiscal year (FY) 1994 funds to provide support for a:
(1) Study on Hospitalization of TB Patients, and (2) Tuberculin Skin
Testing Demonstration Projects. Applicants who meet the stated
eligibility criteria may apply for one or both of the projects
described in this program announcement. (For more information, see the
section ``Eligible Applicants''.)
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 and Immunization and Infectious
Diseases. (For ordering a copy of ``Healthy People 2000,'' see the
section ``Where to Obtain Additional Information''.)
Authority
This program is authorized under sections 301(a) and 317(k) of the
Public Health Service Act, [42 U.S.C 241(a) and 247b(k)], as amended.
Applicable program regulations are found in 42 CFR 51b, subpart A,
which contains general provisions relating to this program.
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
1. Study on Hospitalization of TB Patients. Eligible applicants are
the State and local health departments who are the current cooperative
agreement recipients under Announcement 211 ``Tuberculosis Elimination
Cooperative Agreements'', that reported 200 or more TB cases in 1993.
Tuberculosis control programs that have a caseload of at least 200 new
TB cases per year will assure an adequate proportion of
hospitalizations, cases with HIV infection, or cases of multidrug-
resistant (MDR) TB among patients enrolled in the study. Applicants may
either choose the entire project area or a selected area thereof from
which to enroll patients; however, the selected area must have access
to at least 200 cases per year.
2. Tuberculin Skin Testing Demonstration Projects. Eligible
applicants are the State and local health departments who are the
current cooperative agreement recipients under Announcement 211
``Tuberculosis Elimination Cooperative Agreements'', that reported 100
or more TB cases in 1993. Applicants may either choose the entire
project area or a selected area from it to include as part of the
study; however, the selected area must have access to at least 100
cases per year.
Applicants who meet the above stated eligibility criteria may apply
for one or both of the projects referenced in this program
announcement.
Availability of Funds
The total amount of funds expected to be available to supplement TB
elimination cooperative agreements is $1,250,000. It is expected that
awards will begin on or about August 1, 1994, and will be made a part
of the remaining FY 1994 budget period ending January 31, 1995. Funding
estimates may vary and are subject to change.
1. Study on Hospitalization of TB Patients. Approximately $350,000
is available to fund 7-10 projects. Awards are expected to range from
$35,000 to $50,000. Projects are expected to be completed within 36
months.
2. Tuberculin Skin Testing Demonstration Projects. Approximately
$900,000 is available to fund 4-5 projects. Awards are expected to
range from $150,000 to $200,000. Projects are expected to be completed
within 24 months.
Use Of Funds
Funds may be used to support personnel and to purchase equipment,
supplies, and services directly related to project activities. Funds
may not be used to supplant State or local health department funds
available for TB control, provide inpatient care, purchase drugs, or to
support construction or renovation of facilities.
Purpose
1. Study on Hospitalization of TB Patients. The purpose of this
project is to determine: (1) the rate of hospitalizations for persons
with active TB, including hospitalizations connected with the initial
diagnosis of TB, (2) indications for, and the costs of, these
hospitalizations, (3) the length of stay for these hospitalizations,
(4) the impact of HIV infection on hospitalization and hospitalization
costs of TB patients, and (5) the impact of MDR-TB on hospitalization
and hospitalization costs of TB patients.
2. Tuberculin Skin Testing Demonstration Projects. The purpose of
this project is to: (1) develop model tuberculin skin testing programs
in health departments and health care facilities, (2) track and monitor
tuberculin skin test data and TB infections among health care workers,
and (3) pilot a microcomputer software system developed by CDC to
assist in the collection, tracking, management, and analysis of
occupational TB exposures and infections.
Program Requirements
In conducting activities to achieve the purpose of this program,
the recipient shall be responsible for the activities under A.
(Recipient Activities), and CDC will be responsible for the activities
listed under B. (CDC Activities).
1. Study on Hospitalization of TB Patients
A. Recipient Activities
1. Implement a research protocol jointly developed with CDC for the
study of hospitalization for TB. This study will be a prospective study
of hospitalization of TB patients. The subjects will be all the
incident cases of TB entered in the TB case register during a period of
six consecutive months, or the first 200 cases entered in the register
from the beginning of the study period, whichever comes first. The
grantee will be responsible for appointing someone with public health
experience, (e.g., public health advisor, nurse, medical student) to
enroll the patients in the study and gather the following information:
(1) determine if and when the hospitalization took place, (2) establish
contact with hospital clerks to facilitate abstraction of hospital
records, (3) obtain informed consent and/or release of record
information forms, if applicable, and (4) complete a data extraction
form for each patient. CDC will provide training on uniform data
collection procedures to be employed in the protocol.
A minimum of 80% of the patients enrolled in the study should be
followed for a period of 1 year after their enrollment or until
completion of treatment, whichever comes first. All of the patient's
hospitalizations during that period should be documented. Data to be
collected on enrollment include: (a) age, (b) sex, (c) race/ethnicity,
(d) country of origin, (e) history of substance abuse, (f) anatomic
site of TB disease, (g) HIV serostatus, (h) income, and (i) housing
status. Data to be collected for each hospitalization include: (a)
admission date, (b) admission diagnoses, (c) indications for
hospitalization, (d) type of hospital, (e) days in acid-fast bacillus
(AFB) isolation, (f) discharge date, (g) discharge diagnoses, (h)
reasons for extended length of stay (if applicable), (i) patient
disposition upon discharge, (j) hospital charges, (k) charges per
service, including isolation, and (l) third party payer.
2. Develop procedures to adequately monitor patient enrollment and
follow-up, data collection, and data management.
3. Develop and implement a quality assurance plan to monitor the
effectiveness of protocol implementation.
B. CDC Activities
1. Jointly develop a research protocol for the study of
hospitalization for TB.
2. Train health department employees in protocol study procedures
and data collection forms.
3. Develop a plan for data management, specifically, the methods
for data transfer. Develop a timeline for data transfer and submission
of quarterly reports.
4. Review site performance and ensure compliance with the study
protocol.
5. Conduct data analysis and summarize and present findings.
2. Tuberculin Skin Testing Demonstration Projects
A. Recipient Activities
1. Conduct a tuberculin skin test (TST) program for health
department personnel with direct patient contact or contract with a
hospital to perform tuberculin skin testing of hospital employees. If
contracting with a hospital, the hospital should have reported at least
50 cases of TB within the preceding year.
In conducting the program the applicant will perform skin testing
at one or more health department facilities or hospitals where health
care workers (HCWs) are potentially exposed to TB. Where employees have
been exposed, the applicant will:
a. Perform contact investigations of HCWs exposed to an infectious
TB patient who was not recognized and appropriately isolated.
b. Collect information on the circumstances surrounding these HCW
exposures.
c. Initiate appropriate TST for exposed HCWs, including baseline
and follow-up testing.
d. Clinically evaluate all employees with a TST conversion.
The applicant in performing the TST program for employees on a
routine basis will be required to:
(1) Use a two-step Mantoux test for all initial tests to minimize
the likelihood of interpreting a boosted reaction as a true conversion
due to recent infection.
(2) Place and read a TB skin test on all HCWs. This will include
measures or incentives likely to enhance workers' compliance with such
testing;
(3) Perform subsequent Mantoux testing annually (or more frequently
if appropriate for the level of risk in the occupational group or
facility) of all employees whose initial skin tests were negative.
(4) Directly observe the reading of the TB skin test (in mm of
induration) by personnel trained in correct placement and reading of
Mantoux skin tests.
(5) Confidentially assess potential pertinent demographic factors,
(such as, sex, race/ethnicity, country of birth, and history of receipt
of Bacille Calmette-Guerin) and occupational factors, (such as,
occupation and worksite) which may place HCWs at risk for TB exposure.
2. Pilot CDC-developed software to assist in the collection,
tracking, management, and analysis of data from tuberculin skin testing
programs.
3. Follow CDC guidelines for tuberculin skin testing. A copy of the
guidelines will be included in the application kit.
4. Implement a research protocol jointly developed with CDC for the
TST demonstration project.
5. Use CDC-developed skin test software to enter all tuberculin
skin test information onto the software and send a diskette of the
database to CDC on a monthly basis.
6. Develop forms appropriate to their sites for the collection of
data including HCW's demographics, occupational information, tuberculin
skin test information, and results of follow-up clinical evaluations
for persons with reactive skin tests.
7. Ensure that all data are kept confidential and in secured files.
B. CDC Activities
1. Jointly develop a research protocol for the TST demonstration
project.
2. Provide technical assistance in implementation of the TST
program.
3. Provide one or more version of microcomputer software for use in
the project.
4. Train health department personnel in the use of the software.
5. Develop a plan for data management and for data transfer to CDC.
6. Review site performance and ensure compliance with the study
protocol.
7. Conduct data analysis and summarize and present findings.
Evaluation Criteria
1. Study on Hospitalization of TB Patients
Applications will be reviewed and evaluated according to the
following criteria. (100 total points maximum)
A. The extent of the problem of TB, HIV, and MDR-TB in the
applicant's area. (25 Points)
B. The extent to which the applicant's proposed staff and
description of duties meet project requirements; the extent to which
the applicant can demonstrate that institutional barriers will not
impede the initiation, implementation, and completion of the project.
(25 Points)
C. The ability of the applicant to manage local data and ensure the
quality of the data collected. The ability of the applicant to ensure
that the data will be received at CDC in a timely manner. (25 Points)
D. The extent to which the evaluation plan is appropriate to assess
the study objectives. (25 Points)
In addition, consideration will be given to the extent to which the
budget is reasonable, clearly justifiable, and consistent with the
intended use of funds.
2. Tuberculin Skin Testing Demonstration Projects
Applications will be reviewed and evaluated according to the
following criteria. (100 total points maximum)
A. The extent of the problem of TB, HIV, MDR TB, and TB/AIDS in the
applicant's area. (10 Points)
B. The extent to which an efficient and effective tuberculin skin
testing program exists in the facility proposed for the project. This
includes the compliance rate with the tuberculin skin testing program.
If compliance rates are sub-optimal, the extent to which the
applicant's plan for improving compliance during the project period is
likely to succeed. (30 Points)
C. Agreement by the applicant to pilot test CDC-developed software
and provide diskettes of the database to CDC on a monthly basis. The
extent to which the applicant's data management plan demonstrates an
ability to ensure the integrity of the data. (30 Points)
D. The extent to which the applicant describes how the study will
be administered, including the size, qualifications, duties and
responsibilities, and time allocation of the proposed staff; the
availability of the facilities to be used, and a schedule for
accomplishing the activities, including time frames. If a contract with
a hospital is proposed, a letter of support must be included. (30
Points)
In addition, consideration will be given to the extent to which the
budget is reasonable, clearly justifiable, and consistent with the
intended use of funds.
Funding Priority
Study on Hospitalization of TB Patients
Funding preference may be given to applicants with the highest
number of TB cases. Priority may also be given to ensure geographic
balance, urban and rural balance, high prevalence of HIV-infection, and
high prevalence of MDR-TB.
Tuberculin Skin Testing Demonstration Projects
Funding preference may be given to applicants that have established
tuberculin skin testing programs for employees and include TB clinics
and field workers in the project. Priority may also be given to ensure
geographic balance, urban and rural balance, high and low prevalence of
HIV infection.
Interested persons are invited to comment on the proposed funding
priority. All comments received on or before July 20, 1994, will be
considered before the final funding priority is established. If the
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: Elizabeth M. Taylor,
Grants Management Officer, Grants Management Branch, Procurement and
Grants Office, Centers for Disease Control and Prevention (CDC), 255
East Paces Ferry Road, NE., Room 300, Mailstop E-16, Atlanta, GA 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 for 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 Elizabeth M. Taylor, Grants Management
Officer, Grants Management Branch, Procurement and Grants Office,
Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry
Road, NE., Atlanta, GA 30305, not later than 60 days after due date for
receipt of applications. The Program Announcement Number and Program
Title should be referenced on the document. CDC does not guarantee to
``accommodate or explain'' State process recommendations it receives
after that date.
Public Health System Reporting Requirements
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 is 93.116.
Other Requirements
Paperwork Reduction Act
Projects that involve the collection of information from 10 or more
individuals and funded by the cooperative agreement will be subject to
review by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act.
Confidentiality
Applicants must have in place systems to ensure the confidentiality
of all patient records.
Human Subjects
The applicant must comply with the Department of Health and Human
Services Regulations regarding the protection of human subjects.
Assurances must be provided to demonstrate that the project will be
subject to initial and continuing review by an appropriate
institutional review committee.
Application Submission and Deadline
Each application must be complete as it will be evaluated without
reference to any other application. The original and two copies of each
application must be submitted to Elizabeth M. Taylor, Grants Management
Officer, Grants Management Branch, Procurement and Grants Office,
Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry
Road, NE., Room 300, Mailstop E-16, Atlanta, GA 30305, on or before
July 15, 1994.
1. Deadline: Applications shall be considered as meeting the
deadline if they are:
A. Received on or before the deadline date, or
B. Sent on or before the deadline date and received in time for
submission to the independent review committee. (Applicants must
request a legibly dated U.S. Postal Service postmark or obtain a
legibly dated receipt from a commercial carrier or the U.S. Postal
Service. Private metered postmarks will not be acceptable as proof of
timely mailing.)
2. Late Applications: Applications that do not meet the criteria in
1.A. or 1.B. are considered late applications. Late applications will
not be considered in the current competition and will be returned to
the applicant.
Where To Obtain Additional Information
A complete program description, information on application
procedures, an application package, and business management technical
assistance may be obtained from Manuel Lambrinos, Grants Management
Specialist, Grants Management Branch, Procurement and Grants Office,
Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry
Road, NE., Room 300, Atlanta, GA 30305, telephone (404) 842-6777.
Programmatic technical assistance for the Study on Hospitalization
of TB Patients may be obtained from Nilka M. Rios, Division of
Tuberculosis Elimination, National Center for Prevention Services,
Centers for Disease Control and Prevention (CDC), 1600 Clifton Road,
Mailstop E10, Atlanta, GA 30333, telephone (404) 639-8123.
Programmatic technical assistance for the Tuberculin Skin Testing
Demonstration projects may be obtained from Dale R. Burwen, M.D.,
Division of Tuberculosis Elimination, National Center for Prevention
Services, Centers for Disease Control and Prevention (CDC), 1600
Clifton Road, Mailstop E10, Atlanta, GA 30333, telephone (404) 639-
8117.
Please refer to Announcement 472 ``Study on Hospitalization of TB
Patients and Tuberculin Skin Testing Demonstration Projects'' when
requesting information or 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: June 14, 1994.
Ladene H. Newton,
Acting Associate Director for Management and Operations, Centers for
Disease Control and Prevention (CDC).
[FR Doc. 94-14908 Filed 6-17-94; 8:45 am]
BILLING CODE 4163-18-P