96-10629. HIV-Related Tuberculosis Preventive Therapy Regimen Demonstration Cooperative Agreements  

  • [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]
    
    
    
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    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: 
    MYL5@opspgo1.em.cdc.gov.
        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
    
    

Document Information

Published:
04/30/1996
Department:
Health and Human Services Department
Entry Type:
Notice
Document Number:
96-10629
Pages:
19073-19075 (3 pages)
Docket Numbers:
Announcement 619
PDF File:
96-10629.pdf