[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