[Federal Register Volume 61, Number 84 (Tuesday, April 30, 1996)]
[Notices]
[Pages 19073-19075]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-10629]



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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Announcement 619]


HIV-Related Tuberculosis Preventive Therapy Regimen Demonstration 
Cooperative Agreements

Introduction

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 1996 funds to continue the cooperative 
agreement program started in FY 1992 through announcement number 261 
entitled ``Human Immunodeficiency Virus (HIV) Related Tuberculosis (TB) 
Preventive Therapy Regimen (PTR) Demonstration Cooperative 
Agreements.'' Current recipients will compete to extend the project 
period for an additional three years to allow sufficient time to 
actively monitor and ensure compliance with drug therapy, assess 
toxicity, and appropriately evaluate patients for up to two years after 
completion of preventive therapy. All applicants, however, who meet the 
eligibility criteria will be considered. See the section entitled 
Eligible Applicants.
    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. (For ordering 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

    Applications may be submitted by public and private, nonprofit and 
for-profit organizations and governments and their agencies. Thus, 
universities, and colleges; and research institutions, hospitals, other 
public and private organizations, State and local governments or their 
bonafide agents, federally recognized Indian tribal governments, Indian 
tribes or Indian tribal organizations, and small, minority- and/or 
women-owned businesses are eligible to apply. Applicants must have the 
ability to (1) identify, obtain informed consent, and enroll a minimum 
of 25 dually-infected (TB/HIV-infected) persons and start them on one 
of two TB preventive regimens according to the randomization schedule 
provided by CDC and (2) conduct patient follow-up according to accepted 
clinical study practices. A copy of the prescribed regimens is included 
in the application kit. Applicants must be able to complete all phases 
of the project within the proposed three year project period.
    Preference will be given to competing continuation applications 
submitted by the current cooperative agreement recipients funded in FY 
1992 through competitive announcement number 261 entitled ``Human 
Immunodeficiency

[[Page 19074]]

Virus (HIV)-Related Tuberculosis (TB) Preventive Therapy Regimen (PTR) 
Demonstration Cooperative Agreements.'' Current recipients are: Beth 
Israel Medical Center, Cathedral Healthcare System, Inc., City of 
Chicago, Johns Hopkins University (Brazil), Johns Hopkins University 
(Haiti), Trustees of Health and Hospitals of Boston, and the University 
of New Jersey.

Availability of Funds

    Approximately $2,000,000 is available in FY 1996 to fund up to 
seven awards. It is expected that the average award will be $285,000, 
ranging from $232,000 to $508,000. Awards are expected to begin on or 
about September 30, 1996, for a 12-month budget period within a three-
year project period. 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 this program is to improve preventive treatment 
regimens for HIV-related TB through applied research. Applied research, 
as used in the context of this announcement, means the process of the 
development and evaluation of practical operational approaches and 
solutions to HIV-related TB problems and the evaluation of new 
technology (e.g., new drugs, new drug regimens, new methods of testing 
drug effectiveness, and applicability.)
    Specific objectives of this project are to:
    A. Determine the efficacy of a rifampin/pyrazinamide drug regimen 
(as prescribed by CDC) in preventing the development of TB in HIV-
infected persons at risk of developing TB.
    B. Describe the host factors that affect the efficacy of TB 
preventive therapy.
    C. Evaluate the toxicity and acceptability of the drug regimen in 
the prevention of TB.

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).
A. Recipient Activities
    1. Develop and implement strategies that are applicable to TB/HIV-
infected persons in the United States including: (a) methods and 
strategies to successfully identify, enroll, and administer appropriate 
preventive drug therapy to HIV- infected persons co-infected with M. 
tuberculosis; and (b) methods to actively monitor and ensure compliance 
with drug therapy, assess toxicity, and appropriately evaluate patients 
for up to two years after completion of preventive therapy.
    2. Identify and enroll a minimum of 25 dually-infected (TB/HIV-
infected) persons into one of two prescribed preventive therapy 
regimens. (A copy of the prescribed regimen is included in the 
application kit.)
    3. Implement specified follow-up procedures to monitor toxicity and 
efficacy in dually-infected persons receiving the prescribed preventive 
therapy.
    4. Develop and implement an evaluation plan that measures the 
effectiveness of the trial regimen employed.
    5. Compile and disseminate findings.
B. CDC Activities
    1. Provide consultation and technical assistance in planning, 
developing, implementing, and evaluating strategies.
    2. Provide up-to-date scientific information and coordinate the 
exchange of information among recipients.
    3. Assist in data management, analysis, and the evaluation of 
programmatic activities.
    4. Assist in the preparation and publication of findings.

Evaluation Criteria

    Applications will be reviewed and evaluated according to the 
following criteria. (100 total points maximum)
    1. The extent to which the applicant has demonstrated the ability 
to enroll at least 25 dually-infected (TB/HIV- infected) persons and 
start them on one of two TB preventive regimens according to the 
randomization schedule provided by CDC (a copy of the prescribed 
regimens is included in the application kit). 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 establishing partnerships with community(ies) and 
recognition of mutual benefits. (60 points)
    2. The ability of the applicant to perform active follow-up 
procedures on all participants who receive preventive therapy (defined 
as persons who are currently receiving drugs or those who have 
completed the drug therapy portion of their treatment) including 
methods to deal with noncompliant patients; and the extent to which 
qualified and experienced personnel are available to carry out the 
proposed follow-up activities. (20 points)
    3. The adequacy of the proposed plans to evaluate progress in 
implementing methods and achieving objectives. (20 points)
    4. Other (Not Scored).
Budget
    The budget must be 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 no comments or concerns 
are raised, or (2) protections appear adequate, but comments are made 
regarding the protocol, or (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.

Executive Order 12372 Review

    This program is not subject to the Executive Order 12372 review.

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 numbers are 93.947, 
Tuberculosis Demonstration, Research, Public and Professional 
Education; and 93.118, Acquired Immunodeficiency Syndrome (AIDS) 
activities.

Other Requirements

    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

[[Page 19075]]

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 form 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 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 PHS Form 5161-1 (OMB 
Number 0937-0189) 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 
1, 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

    Questions on application procedures and the 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, Mailstop E-
15, Atlanta, GA 30305, telephone (404) 842-6777, or Internet address: 
MYL[email protected].
    Programmatic technical assistance may be obtained from Veronica 
Greene, D.D.S., M.P.H., Division of Tuberculosis Elimination, National 
Center for STD, HIV, and TB Prevention, Centers for Disease Control and 
Prevention (CDC), 1600 Clifton Road, NE., Mailstop E-10, Atlanta, GA 
30333, telephone (404) 639-8123.
    Please refer to Announcement Number 619 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) 512-1800.


    Dated: April 24, 1996.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for 
Disease Control and Prevention (CDC).
[FR Doc. 96-10629 Filed 4-29-96; 8:45 am]
BILLING CODE 4163-18-P