[Federal Register Volume 65, Number 132 (Monday, July 10, 2000)]
[Notices]
[Pages 42379-42382]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-17294]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 00006]


Intervention Epidemiologic Research Study of HIV/AIDS; Notice of 
Availability of Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 2000 funds for a cooperative agreement 
program to support a prospective study to develop and evaluate the role 
of different levels of assistance with and observation of the 
administration of antiretroviral (ARV) therapy for the treatment of 
HIV-1 infection. This program addresses the ``Healthy People 2010'' 
focus area of HIV.
    The purpose of the program is to investigate whether different 
levels of support have an impact on: improving virologic, immunologic, 
and clinical outcomes of HIV disease; on the development of HIV-1 ARV 
drug resistance; and on therapeutic plasma drug concentrations. 
Innovative applications are invited that assess the impact of three 
different levels of administration and oversight of antiretroviral 
treatment: (1) Directly observed antiretroviral therapy (DART), the 
relative ``gold standard'' of what is achievable with maximum adherence 
support--any setting or system in which antiretroviral medications are 
routinely dispensed by dose and per-dose medication record is kept. 
Possible examples of such settings include but

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are not limited to residential treatment facilities, prisons, and 
methadone clinics; (2) Standard of care: provision of the level of 
support typically available through comprehensive HIV care clinics, and 
may include measures such as individual counseling, group counseling, 
and use of ancillary aids; (3) Intensive adherence support: any setting 
or system for support in which the HIV-infected person has at least 
weekly, and ideally more frequent, contact with the adherence support 
model. Possible settings include but are not limited to day health 
centers, methadone clinics, or visiting/home services. This arm could 
allow for the development or refinement of creative adherence support 
systems that may be integrated into ongoing care and services.

B. Eligible Applicants

    Applications may be submitted by public and private nonprofit 
organizations and by governments and their agencies; that is, 
universities, colleges, research institutions, hospitals, other public 
and private nonprofit organizations, State and local governments or 
their bona fide agents, and federally recognized Indian tribal 
governments, Indian tribes, or Indian tribal organizations.

    Note: Public Law 104-65 states that an organization described in 
section 501(c)(4) of the Internal Revenue Code of 1986 that engages 
in lobbying activities is not eligible to receive Federal funds 
constituting an award, grant, cooperative agreement, contract, loan, 
or any other form.

C. Availability of Funds

    Approximately $400,000 is available in FY 2000 to fund 
approximately 2 awards. It is expected that the average award will be 
approximately $200,000. It is expected that the awards will begin on or 
about September 30, 2000, and will be made for a 12-month budget 
period, within a project period of up to four years. Funding estimates 
may change.
    Continuation awards within an approved project period will be made 
on the basis of satisfactory progress as evidenced by required reports 
and the availability of funds.

D. Program Requirements

    In conducting activities to achieve the purpose of these programs, 
the recipient will be responsible for the activities listed under 1. 
Recipient Activities, and CDC will be responsible for conducting 
activities listed under 2. CDC Activities.

1. Recipient Activities

    Successful applicants addressing the same research issue should be 
willing to jointly develop the study protocol in collaboration with 
other CDC-sponsored researchers. This will include developing and using 
common data collection instruments, specimen collection protocols, and 
data management procedures, as determined in post-award grantee 
planning conferences. Recipients will be encouraged to work 
collaboratively as a study group to:
    a. Develop the research study protocols and standardized data 
collection forms, specimen collection, and laboratory testing across 
sites. This includes transfer of certain specimens to a central 
repository and transfer of other specimens to designated laboratories 
for specific laboratory studies.
    b. Identify, recruit, obtain informed consent from, and enroll an 
adequate number of study participants as determined by the study 
protocols and the program requirements.
    c. Continue to follow study participants as determined by the study 
protocols.
    d. Establish procedures to maintain the rights and confidentiality 
of all study participants.
    e. Contribute blood specimens of study participants as determined 
by the protocol requirements for shipment and storage at a centralized 
repository system.
    f. Conduct data analysis with all collaborators as well as present 
and publish research findings.

2. CDC Activities

    a. Provide technical assistance in the design and conduct of the 
research.
    b. Assist in the development of a research protocol for 
Institutional Review Board (IRB) review by all cooperating institutions 
participating in the research project. The CDC IRB will review and 
approve the protocol initially and on at least an annual basis until 
the research project is completed.
    c. Assist in designing a data management system.
    d. Assist in performance of selected laboratory tests.
    e. Work collaboratively with investigators to help facilitate 
research activities across sites involved in the same research project.
    f. Assist in the analysis of research information and the 
presentation and publication of research findings.

E. Application Content

    Use the information in the Program Requirements, Other 
Requirements, and Evaluation Criteria sections to develop your 
application. Your application will be evaluated on the criteria listed, 
so it is important to follow them in laying out your program plan. 
Follow the directions for completing the application that are found in 
the Public Health Service (PHS) 398 form.

F. Submission and Deadline

    Submit the original and five copies of PHS-398 (OMB Number 0925-
0001) (adhere to the instructions on the Errata Instruction Sheet for 
PHS 398). Forms are in the application kit.
    On or before August 17, 2000, submit the application to the Grants 
Management Specialist identified in the ``Where to Obtain Additional 
Information'' section of this announcement.
    Deadline: Applications shall be considered as meeting the deadline 
if they are either:
    (1) Received on or before the deadline date; or
    (2) Sent on or before the deadline date and received in time for 
submission to the independent review group. (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 or timely mailing.
    Late Applications: Applications that do not meet the criteria in 
(1) and (2) above are considered late applications, will not be 
considered, and will be returned to the applicant.

G. Evaluation Criteria

    Each application will be evaluated individually against the 
following criteria by an independent review group appointed by CDC. 
Applicants will be ranked on a scale of 100 maximum points according to 
the research area identified. Applications must demonstrate the 
applicant's ability to address the research in a collaborative manner 
with other recipients. Applications will be reviewed and evaluated 
based on the evidence submitted, as they specifically describe the 
applicant's abilities to meet the following criteria:

1. Recruitment, Retention, and Adherence to Study Protocol (35 Points)

    a. Extent of applicant's experience in HIV infection epidemiologic 
research.
    b. Evidence of ability to successfully recruit and follow HIV-
infected persons in longitudinal research studies.
    c. Evidence of ability to provide at least two or preferably three 
types of adherence support: DART (each dose dispensed and per-dose 
medication record kept); intensive adherence support (at least weekly 
and ideally more frequent contact with care model);

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and standard of care (such as support provided at comprehensive HIV 
treatment clinics).
    d. Ability to recruit and retain at least 50 and ideally 100 HIV-
infected persons in each adherence model annually (150-300 persons 
total) fulfilling the objectives of the study. Multiple sites may be 
used to accomplish these goals.
    e. Evidence of availability of comparable populations among the 
three adherence models, especially with regards to stage of disease, 
quality of clinical care, and antiretroviral experience.
    f. Evidence of ability to collect complete data and to obtain 
regular blood samples and sufficiently large blood samples from HIV-
infected persons for testing as will be determined in the study 
protocol.
    g. Ability to oversee specimen collection for the timely 
processing, storage, and retrieval of laboratory specimens as needed 
for the study.
    h. Ability to measure costs associated with adherence interventions 
as well as those associated with HIV care provision.

2. Description and Justification of Research Plans (25 Points)

    a. Extent of familiarity and quality of experience pertinent to 
proposed research activities.
    b. Understanding of research objectives as evidence by the high 
quality and scientific rigor of the proposed plan for research and a 
study design that is appropriate to answer research questions.
    c. The inclusion of innovative approaches to provide intensive 
adherence support. These approaches may be existing or may be designed 
and implemented specifically for this study.
    d. As more than one applicant may be funded, extent to which the 
applicant demonstrates willingness to work with all successful 
applicants to develop a common core research protocol across funded 
sites.
    e. Feasibility of plans to follow study participants particularly 
treatment experienced patients. This includes demonstration of the 
experience of the investigator in following HIV-infected persons, and 
the comprehensiveness of the plan to protect the rights and 
confidentiality of all participants.
    f. Thoroughness of plans for data management, data analysis, and 
laboratory analysis; reasonableness of data collected; and statistical 
rigor.
    g. Extent to which the application demonstrates feasible plans for 
coordinating research activities of multiple local study sites, where 
appropriate, and with CDC. Letters of support from cooperating 
organizations that demonstrate the nature and extent of such 
cooperation should be included.
    h. 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. This includes: (1) The proposed plan for the 
inclusion of racial and ethnic minority populations for appropriate 
representation; (2) The proposed justification when representation is 
limited or absent; (3) A statement as to whether the design of the 
study is adequate to measure differences when warranted; (4) A 
statement as to whether the plans for recruitment and outreach for 
study participants include the process of establishing partnerships 
with communities and recognition of mutual benefits.

3. Research and Intervention Capability (20 Points)

    a. Applicant's ability to carry out the proposed research as 
demonstrated by the training and experience of the proposed research 
team and organizational setting, including demonstration of ability to 
collect, manage, and analyze accurate data in a timely manner.
    b. Demonstration of working relationships with the proposed 
investigators and extent to which services to be provided by external 
experts or consultants are documented by memoranda of agreement.
    c. Demonstration of epidemiologic, behavioral, clinical, 
administrative, laboratory, data management and statistical analysis 
expertise needed to conduct proposed research.
    d. Ability to sustain adherence support mechanisms at the cessation 
of study.

4. Staffing, Facilities, and Time line (20 Points)

    a. Availability of qualified and experienced personnel with 
sufficient time dedicated to the proposed project.
    b. Clarity of the described duties and responsibilities of project 
personnel.
    c. Adequacy of plans for project oversight to assure quality of 
data.
    d. Adequacy of facilities, equipment, data management resources, 
and systems for ensuring data security and patient confidentiality.
    e. Adequacy of time line for completion of project activities.

5. Other (Not Scored)

    a. Budget: the extent to which it is reasonable, clearly justified, 
consistent with the intended use of funds, and allowable. All budget 
categories should be itemized.
    b. Human Subjects: Does the application adequately address the 
requirements of Title 45 CFR Part 46 for the protection of human 
subjects?

H. Other Requirements

Technical Reporting Requirements

    Provide CDC with original plus two copies of:
    1. Annual progress reports;
    2. Financial status report, no more than 90 days after the end of 
the budget period; and
    3. Final financial status and performance reports, no more than 90 
days after the end of the project period.
    Send all reports to the Grants Management Specialist identified in 
the ``Where to Obtain Additional Information'' section of this 
announcement.
    The following additional requirements are applicable to this 
program. For a complete description of each, see Attachment 1 in the 
application kit.

AR-1  Human Subjects Requirements
AR-2  Requirements for Inclusion of Women and Racial and Ethnic 
Minorities in Research
AR-4  HIV/AIDS Confidentiality Provisions
AR-5  HIV Program Review Panel Requirements
AR-6  Patient Care
AR-9  Paperwork Reduction Act Requirements
AR-10  Smoke-Free Workplace Requirements
AR-11  Healthy People 2010
AR-12  Lobbying Restrictions

I. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under sections 301(a) and 317(k)(2) of 
the Public Health Service Act, [42 U.S.C. section 241(a) and 
247b(k)(2)], as amended. The Catalog of Federal Domestic Assistance 
number is 93.943.

J. Where To Obtain Additional Information

    This and other CDC announcements can be found on the CDC home page 
Internet address--http://www.cdc.gov Click on ``Funding'' then ``Grants 
and Cooperative Agreements.''
    To receive additional written information and to request an 
application kit, call 1-888-GRANTS4 (1-888 472-6874). You will be asked 
to leave your name and address and will be instructed to identify the 
Announcement number of interest.

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    If you have questions after reviewing the contents of all the 
documents, business management technical assistance may be obtained 
from: Brenda Hayes, Grants Management Specialist, Grants Management 
Branch, Procurement and Grants Office, Announcement 00006, Centers for 
Disease Control and Prevention (CDC), Grants Management Office Room 
3000, Attn: Colgate Building, 2920 Brandywine Rd., Mailstop E-15, 
Atlanta, GA 30341, telephone (770) 488-2741, Email address [email protected]
    For program technical assistance, contact: Jeff Efird, MPA, Deputy 
Chief, Epidemiology Branch, Division of HIV/AIDS Prevention, 
Surveillance & Epidemiology, National Center for HIV, STD, and TB 
Prevention, Centers for Disease Control and Prevention (CDC), 1600 
Clifton Road, NE., Mailstop E-45, Atlanta, Georgia 30333, Telephone 
(404) 639-6130, E-mail [email protected]

    Dated: July 3, 2000.
Ron Van Duyne,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention (CDC).
[FR Doc. 00-17294 Filed 7-7-00; 8:45 am]
BILLING CODE 4163-18-P