[Federal Register Volume 66, Number 145 (Friday, July 27, 2001)]
[Notices]
[Pages 39172-39174]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-18756]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention (CDC)

[Program Announcement 01194]


Antiretroviral Drug Sentinel Surveillance To Examine Trends in 
Prevalence of Drug Resistant Strains of HIV; Notice of Availability of 
Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 2001 funds for a cooperative agreement 
program to establish sentinel surveillance methods to examine trends in 
the prevalence of drug resistant strains of HIV in persons recently 
infected or recently diagnosed with HIV. This program addresses the 
``Healthy People 2010'' focus area of HIV.
    The purpose of the program is to estimate trends in the prevalence 
of drug resistant strains of HIV in adults by testing HIV positive sera 
submitted to state or metropolitan area public health laboratories for 
HIV testing.
    Although the tested population is not representative of the 
population as a whole, state and local public health laboratories 
generally conduct diagnostic HIV testing on sera from a section of the 
population that is broadly similar from year to year. Performing 
antiretroviral drug resistance (ARVDR) testing on the sera that tested 
HIV positive should allow an estimate of trends in resistance in 
persons newly diagnosed with HIV in the geographic area. In addition, 
Serologic Testing Algorithm for Recent HIV Seroconversion (STARHS) 
testing will be performed on all HIV positive sera and results will be 
used to describe drug resistance in persons newly infected with HIV. 
Participants will explore methods to obtain specimens and data that 
will allow more precise estimates of trends.
    Minimal demographic, risk group, and clinical information collected 
by the HIV/AIDS reporting system will be linked to ARVDR and STARHS 
results locally without jeopardizing confidentiality.
    ARVDR results will be made available to health care providers of 
the persons whose sera were tested, if the persons tested agree. In 
future years, participating sites may evaluate the utility of providing 
baseline (initial pretreatment) antiretroviral resistance test results 
to clinicians.
    The use of sera for antiretroviral resistance testing is still 
uncommon; however, a satisfactory success rate is thought to be 
achievable if sera are handled and stored appropriately. This sentinel 
surveillance network will also provide means to examine the feasibility 
of routine use of sera for antiretroviral resistance testing. Health 
departments will be required to establish a quality assurance program 
for antiretroviral drug resistance testing.

B. Eligible Applicants

    Assistance will be provided only to the health departments of 
States, or their bona fide agents, including the District of Columbia, 
the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth 
of the Northern Mariana Islands, American Samoa, Guam, the Federated 
States of Micronesia, the Republic of the Marshall Islands, the 
Republic of Palau, and federally recognized Indian tribal governments. 
In consultation with States, assistance may be provided to political 
subdivisions of States.
    Eligible applicants include health departments meeting these 
criteria:
    1. Having HIV case reporting as of October 1, 2001, and
    2. Reporting at least 300 cases of HIV infection in the 12 months 
ending mid-year 2000, or 300 cases of AIDS (HIV/AIDS Surveillance 
Report, Dec. 2000, Vol. 12, No. 1).
    Funding will be awarded to applicants not currently participating 
in CDC-supported projects to estimate the prevalence of antiretroviral 
drug resistance among persons newly infected with HIV. This limitation 
is imposed to ensure that the gathering of the same or similar data is 
not already being supported by CDC
    Eligibility is limited to applicants reporting this minimum number 
of cases of HIV infection yearly (or AIDS cases, if HIV reporting was 
recently introduced), to insure testing of sufficient numbers of 
samples to allow a meaningful estimate of the proportion of 
antiretroviral drug resistant cases. Eligibility is limited to health 
departments because of the greater likelihood that HIV testing of 
members of the same subpopulations will take place year after year in 
health departments, allowing calculation of trends.
    Note: Title 2 of the United States Code, section 1611 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 $1,000,000 is available in FY 2001 to fund 
approximately three awards. It is expected that the average award will 
be $330,000, ranging from $200,000 to $600,000. It is expected that the 
awards will begin on or about September 30, 2001 and will be made for a 
12-month budget period within a project period of up to five (5) 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.

1. Use of Funds

    Funds may not be used to provide direct medical care or prevention 
case management. Funds may not be used to develop a new HIV infection 
reporting system for the purpose of this ARVDR project.

2. Funding Preference

    Will be given to health departments that report 300 or more newly 
diagnosed

[[Page 39173]]

persons per year and where health department laboratories provide 
testing for 30% or more of the geographic areas' HIV reports.

D. Program Requirements

    In conducting activities to achieve the purpose of this program, 
recipient shall be responsible for the activities under 1., (Recipient 
Activities), and CDC shall be responsible for conducting activities 
under 2., (CDC Activities):

1. Recipient Activities

    a. Develop and administer a suitable consent form for tested 
individuals and a method for reporting ARVDR results to clinicians of 
consenting individuals.
    b. Collect and appropriately handle serum samples submitted for HIV 
diagnosis at the public health laboratory. Store and transport samples 
for STARHS and ARVDR testing to the appropriate laboratory for 
processing. Report sample collection, handling and storage methods, 
including the type of anti-coagulant used and the time after blood 
collection that the serum was separated.
    c. If possible, develop a method to identify sera from individuals 
previously reported as HIV positive to the health department to remove 
them before they are STARHS tested.
    d. Arrange for STARHS testing and genotypic and phenotypic ARVDR 
testing in the public health laboratory, CDC contract laboratory, or 
other suitable laboratory. Assure participation in the quality 
assurance program supported by this activity, including quarterly 
testing of panels of specimens, if appropriate.
    e. Provide results to clinicians of persons whose sera were tested.
    f. Capture selected variables from HIV reports for inclusion in the 
project database.
    g. Provide results and share data with other participants, other 
collaborators in the field, and with CDC.
    h. Attend an annual meeting to discuss project activities and 
methods for data and specimen collection to facilitate more precise 
estimation of trends.
    i. Evaluate the success of the program in providing results to 
estimate trends in ARVDR in persons newly infected or newly diagnosed 
with HIV including a plan for the extension of the project in future 
years, if the program is successful and if funds are available.
    j. Develop a research protocol and plans for conducting this 
research in collaboration with CDC.

2. CDC Activities

    1. Assist as needed in the development of a research protocol for 
IRB review at 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.
    2. Provide assistance as needed in the design and conduct of the 
research and statistical analysis.
    3. Provide assistance in training, if requested.
    4. Assist as needed in the analysis of the data and the 
presentation and publication of results.
    5. If requested, CDC may provide antiretroviral drug susceptibility 
testing at a reference laboratory.
    6. Provide STARHS testing services at collaborating regional public 
health laboratories.

E. Application Content

    Use the information in the Program Requirements, Other 
Requirements, and Evaluation Criteria sections to develop the 
application content. Your application will be evaluated on the criteria 
listed, so it is important to follow them in laying out your program 
plan. The narrative should be no more than 10 double-spaced pages, 
printed on one side, with one-inch margins, and unreduced 12 pt. font. 
All pages should be numbered and indexed. The narrative should consist 
of, at a minimum, a Plan, Objectives, Methods, Evaluation and Budget.

F. Submission and Deadline

    Submit the original and two copies of CDC 0.1246. Forms are 
available in the application kit and at the following Internet address: 
www.cdc.gov/od/pgo/forminfo.htm
    On or before August 31, 2001, 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 of timely mailing.)
    Late: Applications which do not meet the criteria in 1. or 2. above 
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.
    1. Plan (20 points): The quality of the plan to develop and 
implement the surveillance project. The extent to which the applicant 
demonstrates:
    a. The ability to capture selected variables from HIV reports for 
inclusion in the project database,
    b. The ability to identify, store and transport HIV-positive serum 
samples of at least half of the number of HIV reports or AIDS cases 
reported in the 12 months ending mid-year 2000.
    2. Objectives (20 points) The extent to which the applicant's 
proposed objectives are measurable, specific, time-phased, and related 
to required recipient activities and the program purpose.
    3. Methods (25 points) The extent to which the methods proposed are 
appropriate and feasible to achieve the stated program objectives. This 
application should describe:
    a. How sera will be identified, collected, processed and 
transported for Antiretroviral Drug Resistance (ARVDR) and Serologic 
Testing Algorithm for HIV Serconversion (STARHS) testing,
    b. The plan to conduct or contract for ARVDR testing the plan for 
collecting data, and
    c. The plan for confidentially linking laboratory tests to the HIV/
AIDS reporting system in order to identify persons who have been 
previously diagnosed and reported to the system.
    4. Research Capacity (20 points): The extent to which the applicant 
demonstrates the knowledge, ability, and experience necessary to 
facilitate the collection of sera and to provide oversight for data 
collection and laboratory operations. The application should describe:
    a. How the project will be administered,
    b. Duties, qualifications, curriculum vitae if available, and time 
allocation of the proposed staff,
    c. The availability of suitable facilities required to conduct this 
program,
    d. In addition, applications will be evaluated on 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: (10 points)
    1. The proposed plan for the inclusion of both sexes and racial and 
ethnic minority populations for appropriate representation.
    2. The proposed justification when representation is limited or 
absent.

[[Page 39174]]

    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.
    5. Evaluation (15 points): The applicant's ability to evaluate the 
usefulness of the surveillance program for epidemiologic monitoring and 
other public health purposes; the extent to which the evaluation plan 
is appropriate for measuring progress toward program objectives and 
includes plans to evaluate each aspect of the performance elements 
outlined in the Recipient Activities; and, the extent to which the 
applicant documents their willingness and ability to collaborate with 
CDC in evaluating the success of the pilot project.
    6. Budget (reviewed, but not scored): The extent to which the 
budget is reasonable, clearly justified, consistent with the intended 
use of funds, and allowable. All budget categories should be itemized.
    7. Human Subjects (reviewed, but not scored): The extent to which 
the application adequately addresses the requirements of 45 CFR part 46 
for the protection of human subjects. An application can be disapproved 
if the research risks are sufficiently serious and protection against 
risks is so inadequate as to make the entire application unacceptable.

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;
    3. Final financial report and performance report, 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 I of the 
announcement 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-7  Executive Order 12372 Review
AR-9  Paperwork Reduction Act Requirements
AR-10  Smoke-Free Workplace Requirements
AR-11  Healthy People 2010
AR-12  Lobbying Restrictions
AR-14  Accounting System Requirements
AR-22  Research Integrity

I. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under section 317 of the Public Health 
Service Act [42 U.S.C. 241(a) and 247(b)]; 301 (42 U.S.C. 241); 311 (42 
U.S.C. 243), as amended. The Catalog of Federal Domestic Assistance 
number is 93.944.

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 ``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.
    If you have questions after reviewing the contents of all the 
documents, business management technical assistance may be obtained 
from: Julia Valentine, Grants Management Officer, Grants Management 
Branch, Procurement and Grants Office, Centers for Disease Control and 
Prevention, 2920 Brandywine Road, Room 3000, Atlanta, GA 30341-4146, 
Telephone number (770) 488-2732, E-mail address: [email protected].
    For program technical assistance, contact: Kenneth A. Clark, M.D., 
Prevention Services Research Branch, Division of HIV/AIDS Prevention, 
Surveillance & Epidemiology National Center for HIV/STD/TB Prevention, 
Centers for Disease Control and Prevention, 1600 Clifton Road, Mail 
Stop E-46, Atlanta, Georgia 30333, Telephone: (404) 639-2042, E-mail 
address: [email protected].

    Dated: July 23, 2001.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention.
[FR Doc. 01-18756 Filed 7-26-01; 8:45 am]
BILLING CODE 4163-18-P