[Federal Register Volume 61, Number 106 (Friday, May 31, 1996)]
[Notices]
[Pages 27356-27360]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-13675]



-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Announcement 660]


Tuberculin Skin Testing Demonstration Projects; and Evaluation of 
Counseling and Testing of Tuberculosis Patients for Human 
Immunodeficiency Virus Infection and Reporting of Test Results

Introduction

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 1996 funds for a cooperative agreement 
program for two projects: (1) Tuberculin Skin Testing (TST) 
Demonstration Projects; and (2) Evaluation of Counseling and Testing of 
Tuberculosis (TB) Patients for Human Immunodeficiency Virus (HIV) 
Infection and Reporting of Test Results.
    CDC is committed to achieving the health promotion and disease 
prevention objectives of ``Healthy People 2000,'' a national activity 
to reduce morbidity and mortality and improve the quality of life. This 
announcement is related to the priority areas of HIV Infection and 
Immunization and Infectious Diseases. (To order a copy of ``Healthy 
People 2000,'' see the section ``WHERE TO OBTAIN ADDITIONAL 
INFORMATION.'')

Authority

    This program is authorized under Section 317E of the Public Health 
Service Act [42 U.S.C. 247b-6], as amended.

Smoke-Free Workplace

    CDC strongly encourages all grant recipients to provide a smoke-
free workplace and to promote the non-use of all tobacco products, and 
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in 
certain facilities that receive Federal funds in which education, 
library, day care, health care, and early childhood development 
services are provided to children.

Eligible Applicants

    Eligible applicants are the official public health agencies of 
States and local governments or their bona fide agents. This includes 
the District of Columbia, American Samoa, the Commonwealth of Puerto 
Rico, the Virgin Islands, the Federated States of Micronesia, Guam, the 
Northern Mariana Islands, the Republic of the Marshall Islands, the 
Republic of Palau, and federally recognized Indian tribal governments.

[[Page 27357]]

Availability of Funds

Tuberculin Skin Testing Demonstration Projects

    Approximately $750,000 is available in FY 1996 to fund 
approximately 8-10 awards. It is expected that the average award will 
be $75,000, ranging from $50,000-$200,000. Funding estimates are 
subject to change. It is expected that awards will begin on or about 
September 1, 1996, and will be made for a 12-month budget period within 
a project period of up to 2 years. Funding estimates may vary and are 
subject to change.
    Continuation awards within the project period will be made on the 
basis of satisfactory progress and the availability of funds.

Evaluation of Counseling and Testing of TB Patients for HIV Infection 
and Reporting of Test Results

    Approximately $750,000 per year is available in FY 1996 to fund 
approximately 4-6 awards. It is expected that the average award will be 
$125,000, ranging from $100,000-$200,000. Funding estimates are subject 
to change. It is expected that awards will begin on or about September 
1, 1996, and will be made for a 12-month budget period within a project 
period of up to 2 years. Funding estimates may vary and are subject to 
change.
    Continuation awards within the project period will be made on the 
basis of satisfactory progress and the availability of funds.

Purpose

    The purpose of the TST Demonstration Projects is: (1) Develop model 
TST programs in health departments and health care facilities; (2) 
track and monitor TST 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.
    The purpose of the Evaluation of Counseling and Testing of TB 
Patients for HIV Infection and Reporting of Test Results is: (1) To 
assess current HIV counseling and testing practices for TB patients; 
(2) to evaluate the extent to which TB patients are receiving 
counseling and testing; (3) to characterize TB patients who are not 
being tested and barriers to testing; (4) to evaluate the extent to 
which HIV results on TB patients known to be coinfected are reported to 
the State or local health department TB program; and (5) to 
characterize patients who were tested but are not being reported to the 
State or local health department TB program, and barriers to reporting 
HIV test results.
    This project is intended to assist State and local TB control and 
AIDS programs to: (1) identify barriers to HIV counseling and testing 
of TB patients and to sharing data between TB and AIDS programs; and 
(2) develop guidelines and initiate programs that will overcome these 
barriers within the health department and the provider community.

Program Requirements

    In conducting activities to achieve the purpose of the TST 
Demonstration Projects, the recipient shall be responsible for the 
activities listed under A. (Recipient Activities), and CDC will be 
responsible for the activities under B. (CDC Activities):

A. Recipient Activities

    1. Conduct a program for health department personnel with direct 
patient contact or contract with a hospital to perform TST of hospital 
employees. 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:
    a. 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.
    b. Place and read a TB skin test on all HCWs. This will include 
measures or incentives likely to enhance workers' compliance with such 
testing.
    c. 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.
    d. 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.
    e. Confidentially assess potential pertinent demographic factors, 
(such as, gender, 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. Use CDC-developed software to assist in the collection, 
tracking, management, and analysis of data from TST programs.
    3. Follow CDC guidelines for TST. 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 TST 
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, TST 
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 versions 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.
    In conducting activities to achieve the purpose of the Evaluation 
of Counseling and Testing of TB Patients for HIV Infection and 
Reporting of Test Results, the recipient shall be responsible for the 
activities listed under A. (Recipient Activities), and CDC will be 
responsible for the activities under B. (CDC Activities):

A. Recipient Activities

    1. Provide a joint training session to personnel from TB and AIDS 
programs in local and State health departments. Training will include 
the latest CDC recommendations for TB prevention and control, the 
reasons for collaboration between the two groups, surveillance 
mechanisms and definitions, the importance of and methods for

[[Page 27358]]

maintaining confidentiality and availability of services for 
counseling, testing, and treating HIV-infected TB patients.
    2. Assess current practices and policies of TB care providers who 
have reported cases to the health department in the past year, 
including policies and practices for HIV counseling and testing of TB 
patients, availability of services for coinfected patients, referral 
for services, reporting of coinfected patients, and perceived barriers 
to testing and reporting.
    3. Implement a study protocol, developed jointly with CDC, to 
determine by medical record review whether TB patients, age 25-44 
years, were offered HIV counseling and testing, the results of such 
testing, whether patients were questioned about HIV risk factors, 
missed opportunities for counseling and testing, and whether HIV-
positive patients were referred for HIV-related services. If HIV status 
was known to the TB care provider, document the effect of this 
knowledge on TB care and on contact investigations. Other possible 
sources of documentation of HIV counseling and testing may include 
matching with the AIDS registry and the HIV reporting registry, HIV 
counseling and testing records, sexually transmitted disease registries 
and other public health records depending on availability and local 
confidentiality requirements. For patients whose HIV test results were 
already reported to the TB program, the medical record review will 
ascertain their mechanism through which the HIV results was reported 
and their subsequent HIV service referrals.
    4. Evaluate the completeness of the TB surveillance system by 
matching the AIDS and TB registries.
    5. Ensure that all data are kept confidential and in secured files.
    6. Based on the results of above evaluations, describe barriers to 
providing HIV counseling and testing to TB patients and to reporting 
HIV results to the TB program. Make recommendations and initiate 
programs to overcome identified barriers and to improve coverage of HIV 
counseling and testing, reporting of HIV test results and provision of 
services (or referral for services) for coinfected patients.
    7. Participate in two meetings to be held in Atlanta, GA, each one 
day in length, one each year of the project, with other study 
participants and staff from the Division of TB Elimination and the 
Division of HIV/AIDS Prevention, CDC.

B. CDC Activities

    1. Provide assistance in developing a protocol for conducting the 
Recipient Activities described above.
    2. Plan and organize the annual meetings for recipient 
representatives and staff from the Division of TB Elimination and the 
Division of HIV/AIDS Prevention, CDC .
    3. Provide technical consultation as needed for training, 
implementing the protocol, and interpreting and using the results of 
the project.
    4. Review site performance and ensure compliance with the study 
protocol.
    5. Assist with data management.

Evaluation Criteria

    Applications for the Tuberculin Skin Testing Demonstration Projects 
will be reviewed and evaluated according to the following criteria (100 
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 TST program 
exists in the facility proposed for the project. This includes the 
compliance rate with the TST 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. In addition, 
the degree to which the applicant has met the CDC Policy requirements 
regarding the inclusion of women, ethnic, and racial groups in the 
proposed research. Specifically the following items will be addressed:
    a. The proposed plan for the inclusion of both sexes and racial and 
ethnic minority populations for appropriate representation.
    b. The appropriateness of the proposed justification when 
representation is limited or absent.
    c. Whether the design of the study is adequate to measure 
differences when warranted.
    d. Whether the plans for recruitment and outreach for study 
participants include the process of establishing partnerships with 
community(ies) and recognition of mutual benefits is documented. (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)
    E. Other (Not Scored)

Budget

    Consideration will be given to the extent to which the budget is 
reasonable, clearly justifiable, and consistent with the intended use 
of funds.

Human Subjects

    Procedures adequate for the protection of human subjects must be 
documented: (1) Protections appear adequate and there are no comments 
to make or concerns to raise, (2) protections appear adequate, but 
there are comments regarding the protocol, (3) protections appear 
inadequate and the Objective Review Group (ORG) has concerns related to 
human subjects, or (4) disapproval of the application is recommended 
because the research risks are sufficiently serious and protection 
against the risks are inadequate resulting in unacceptability of the 
entire application.
    Applications for the Evaluation of Counseling and Testing of TB 
Patients for HIV Infection and Reporting of Test Results will be 
reviewed and evaluated according to the following criteria (100 points 
maximum):
    A. Understanding the problem (10 points).
    B. Plan for required activities. In addition, the degree to which 
the applicant has met the CDC Policy requirements regarding the 
inclusion of women, ethnic, and racial groups in the proposed research. 
Specifically the following items will be addressed:
    a. The proposed plan for the inclusion of both sexes and racial and 
ethnic minority populations for appropriate representation.
    b. The appropriateness of the proposed justification when 
representation is limited or absent.
    c. Whether the design of the study is adequate to measure 
differences when warranted.
    d. Whether the plans for recruitment and outreach for study 
participants include the process of establishing partnerships with 
community(ies) and recognition of mutual benefits is documented. (50 
points)
    C. Collaboration (10 points).
    D. Experience in related activities (10 points).
    E. Personnel and management plan (20 points).

[[Page 27359]]

    F. Other (Not Scored).

Budget

    Consideration will be given to the extent to which the budget is 
reasonable, clearly justifiable, and consistent with the intended use 
of funds.

Human Subjects

    Procedures adequate for the protection of human subjects must be 
documented: (1) Protections appear adequate and there are no comments 
to make or concerns to raise, (2) protections appear adequate, but 
there are comments regarding the protocol, (3) protections appear 
inadequate and the Objective Review Group (ORG) has concerns related to 
human subjects, or (4) disapproval of the application is recommended 
because the research risks are sufficiently serious and protection 
against the risks are inadequate resulting in unacceptability of the 
entire application.

Funding Priority

    Funding priority for the Tuberculin Skin Testing Demonstration 
Projects may be given to ensure geographic balance, urban and rural 
balance, high and low prevalence of HIV infection, and high and low TB 
morbidity areas.
    Funding Priority for the Evaluation of Counseling and Testing of TB 
Patients for HIV Infection and Reporting of Test Results will be given 
to applicants that demonstrate a need to improve HIV counseling and 
testing of TB patients and reporting of test results. Funding priority 
also may be given to ensure a geographic balance, urban and rural high 
and low prevalence of HIV infection and high and low TB morbidity.
    Interested persons are invited to comment on the proposed funding 
priority. All comments received on or before July 1, 1996, will be 
considered before 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 and revised 
applications will be accepted prior to the final selection of awards. 
Written comments should be addressed to: Van Malone, 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-15, 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 (other than federally recognized 
Indian tribal governments) 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 Van Malone, 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-15, Atlanta, GA 30305, not later than 60 days after the 
application deadline date. 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. Indian tribes are strongly encouraged to request 
tribal government review of the proposed application. If tribal 
governments have any tribal process recommendations on applications 
submitted to CDC, they should forward them to Van Malone, 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-15, Atlanta, GA 30305. This 
should be done no later than 60 days after the application deadline 
date. CDC does not guarantee to ``accommodate or explain `` for tribal 
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 93.947, TB 
Demonstration, Research, Public and Professional Education Projects.

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 and approval 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, 45 CFR Part 46, 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. The applicant 
will be responsible for providing assurance in accordance with the 
appropriate guidelines and forms provided in the application kit.
    In addition to other applicable committees, Indian Health Service 
(IHS) institutional review committees also must review the project if 
any component of the IHS will be involved or will support the research. 
If any American Indian community is involved, its tribal government 
must also approve that portion of the project applicable to it.
    Women, Racial and Ethnic Minorities: It is the policy of the CDC to 
ensure that women and racial and ethnic groups will be included in CDC-
supported research projects involving human subjects, whenever feasible 
and appropriate. Racial and ethnic groups are those defined in OMB 
Directive No. 15 and include American Indian, Alaska Native, Asian, 
Pacific Islander, Black and Hispanic. Applicants shall ensure that 
women, racial and ethnic minority populations are appropriately 
represented in applications for research involving human subjects. 
Where clear and compelling rationale exist that inclusion is 
inappropriate or not feasible, this situation must be explained as part 
of the application. This policy does not apply to research studies when 
the investigator cannot control the race, ethnicity and/or sex of 
subjects. Further guidance to this policy is contained in the Federal 
Register, Vol. 60, No. 179, Friday, September 15, 1995, pages 47947-
47951 (a copy is included in the application kit).
    Pre- and Post-test Counseling and Partner Notification: Recipients 
are required to provide HIV antibody testing to determine a person's 
HIV infection status; therefore, they must comply with State laws and 
regulations and CDC

[[Page 27360]]

guidelines regarding pre- and post-test counseling and partner 
notification of HIV-seropositive patients. A copy of the guidelines 
will be included in the application kit. Recipients must also comply 
with State and local health department requirements relating to 
specific reportable diseases or conditions. Recipients must provide 
referrals for HIV diagnosis and treatment.
    HIV/AIDS Requirements: Recipients must comply with the document 
entitled ``Content of AIDS-Related Written Materials, Pictorials, 
Audiovisuals, Questionnaires, Survey Instruments, and Educational 
Sessions'' (June 1992), a copy of which is included in the application 
kit. In complying with 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 
government health department consistent with the Content guidelines. 
The names of the review panel members must be listed on the Assurance 
of Compliance form (CDC 0.1113), which is included in the application 
kit.

Application Submission and Deadline

    The original and two copies of the application must be submitted 
to: Van Malone, 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-
15, Atlanta, GA 30305, on or before July 29, 1996.
    1. Deadline: Applications shall be considered as meeting the 
deadline if they are either:
    (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 objective review committee. (Applicants must request 
a legibly dated U.S. Postal Service postmark or obtain a legibly dated 
receipt from a commercial carrier or U.S. Postal Service. Private 
metered postmarks shall 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

    Business management technical assistance may be obtained from 
Juanita Dangerfield, Grants Management Specialist, at telephone (404) 
842-6577, fax: (404) 842-6513, or INTERNET address: 
<[email protected]>.
    Programmatic technical assistance may be obtained from Eugene 
McCray, M.D., Division of Tuberculosis Elimination, at telephone (404) 
639-8117.
    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) 512-1800.
    Atlanta, Georgia, will be the host of the 1996 Summer Olympics 
Games (July 19 through August 4, 1996). As a result of this event, it 
is likely that the Procurement and Grants Office (PGO) may experience 
delays in the receipt of both regular and overnight mail deliveries. 
Contacting PGO employees during this time frame may also be hindered 
due to the possible telephone disruptions.
    To the extent authorized, please consider the use of voice mail, e-
mail, and facsimile transmissions to the maximum extent practicable. 
Please do not fax lengthy documents or grant applications.
    This announcement will be available on one of two Internet sites on 
the publication date: CDC's home page at http://www.cdc.gov, or at the 
Government Printing Office home page (including free access to the 
Federal Register) at http://www.access.gpo.gov.


    Dated: May 24, 1996.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for 
Disease Control and Prevention (CDC).
[FR Doc. 96-13675 Filed 5-30-96; 8:45 am]
BILLING CODE 4163-18-P