[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]
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