[Federal Register Volume 65, Number 222 (Thursday, November 16, 2000)]
[Notices]
[Pages 69310-69313]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-29312]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 01011]


Improving Contact Investigations in Foreign-Born Populations; 
Notice of Availability of Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of Fiscal Year 2001 funds for a cooperative agreement for 
improving contact investigations in foreign-born populations. This 
program addresses the ``Healthy People 2010,'' focus areas of 
Immunization and Infectious Diseases. For the conference copy of 
``Healthy People 2010,'' visit the internet site http://www.health.gov/healthypeople.
    The purpose of this cooperative agreement is to (1) improve contact 
identification for foreign-born (FB) TB cases; (2) improve completeness 
and timeliness of screening for identified contacts to FB TB cases; (3) 
improve the interpretation of screening results for contacts to FB TB 
cases in [a] the context of screening results for U.S.-born contacts to 
the same cases and [b] using serum immunologic profile (IFN-gamma and 
TNF-alpha) and results of skin test screening with non-tuberculous 
mycobacterial antigens to aid interpretation of screening results for 
FB contacts; and (4) improve completion of treatment for latent TB

[[Page 69311]]

infection for foreign-born contacts to pulmonary TB cases. These funds 
will be used to provide information for public health officials and 
policy makers to better understand methods for conducting contact 
investigations in FB populations and will provide improved completeness 
and timeliness of screening, interpretation of screening results, and 
treatment for latent TB infection for FB contacts to pulmonary TB 
cases.
    This cooperative agreement will provide funds to build capacity at 
state and local health departments to conduct and implement protocol-
driven epidemiologic and operational research. Such actions are 
consistent with recommendations issued by the Advisory Council for the 
Elimination of Tuberculosis (ACET) calling for decisive actions to: (1) 
Better understand the changing epidemiology of TB to rebuild the public 
health infrastructure; (2) identify challenges and opportunities for TB 
control in an era of changes in health care organizations and delivery; 
(3) recognize the interdependence of global TB and TB in the United 
States; and (4) develop and evaluate new tools for TB diagnosis, 
treatment and prevention.

B. Eligible Applicants

    Assistance will be provided only to official public health agencies 
of States and territories, or their bona-fide agents that are (1) 
current recipients of the Tuberculosis Cooperative Awards announced in 
PA 00001 and (2) reported 200 or more TB cases in 1999, of which at 
least 100 must be among foreign-born persons. Eligible applicants are 
the states of Arizona, California, Florida, Georgia, Illinois, 
Maryland, Massachusetts, Minnesota, New Jersey, New York, North 
Carolina, Pennsylvania, Texas, Virginia, and Washington and the cities 
of Chicago, New York, Houston, Los Angeles, and San Francisco.

C. Availability of Funds

    Approximately $625,000 is available in FY 2001 to fund up to 4 
awards for the initial 12-month budget period within a project period 
of 2 years. It is expected that the average award would be $200,000 per 
year, ranging from $175,000 to $235,000. Funding estimates may change.
    It is anticipated that awards will begin on or about February 15, 
2001. 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.

Direct Assistance

    Applicants may request Federal personnel as direct assistance in 
lieu of a portion of financial assistance.

Use of Funds

    Categorical funds are awarded for a specifically defined purpose 
and may not be used for any other purpose or program. Funds for 
contractual services may be requested; however, the grantee, as the 
direct and primary recipient of grant funds, must perform a substantive 
role in carrying out project activities and not merely serve as a 
conduit for an award to another party or provide funds to an ineligible 
party. Funds may be used to support personnel and to purchase 
equipment, supplies, and services directly related to project 
activities. Funds may not be used to supplant state or local health 
department funds or for inpatient care or construction of facilities. 
Funds may not be used to purchase drugs for treatment. In addition, 
recipients must maintain clear accounting records to demonstrate that 
the funding awarded under this cooperative agreement is used toward the 
activities under this announcement and remains separate from any 
funding the recipient may be awarded under other mechanisms.

Funding Preference

    Funding preference will be applied to ensure a balance of sites 
with exclusively urban populations, exclusively rural populations, and 
both urban and rural populations.

D. Program Requirements

    In conducting activities to achieve the purpose of this program, 
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

    a. Access patients with tuberculosis, latent tuberculosis 
infection, or recent exposure to persons with active tuberculosis 
(``contacts'') in the implementation of protocols for epidemiologic and 
operational research.
    b. Conduct site-specific epidemiologic and operational research 
activities in TB which rely upon the implementation of common, agreed-
upon study protocols.
    c. Within 3 months of award, attend an investigator meeting at CDC 
with the CDC Project Officer to develop a study protocol, 
questionnaires, and data abstraction forms.
    d. Promptly obtain all necessary human subjects protections 
assurances from the Office for Human Research Protections (OHRP). 
Submit protocol to local IRB and work with CDC to finalize protocol 
with appropriate approvals from the local IRB and CDC IRB. Ensure that 
the study is conducted according to the IRB-approved protocol, 
including that all policies to provide data security and protect 
confidentiality are implemented.
    e. Complete retrospective review of contact investigations done in 
the 12 months before this project according to protocol. This will 
include reviews of existing health department records of TB cases, 
their contacts, and the contact investigations.
    f. Complete survey of recent TB cases, their contacts, and 
community leaders to identify social networks and major contact sites, 
and to refine questions for the structured interview format to be used 
in case and contact interviews in the prospective phase of the study.
    g. Attend an investigator meeting at CDC with the CDC Project 
Officer to develop a prospective study protocol. Input from an 
ethnographer, results of the retrospective foreign-born study, results 
of the social networking survey, and preliminary results from the 
prospective US-born contact investigation study already ongoing at CDC 
will be considered in developing this protocol.
    h. Conduct prospective study of all foreign-born culture-positive 
pulmonary TB cases age >15 years of age reported during a specified 12-
month period and all their contacts. TB cases within each project area 
will be selected according to the protocol and their medical records 
will be reviewed. Cases will be interviewed in a structured format 
according to the study protocol. It is anticipated that there may be 
multiple interviews of the source case to obtain detailed information. 
Patients whose HIV status is not known will be encouraged to undergo 
HIV testing as per CDC recommendations. An example of the anticipated 
protocol activities is summarized in Attachment 1.
    i. Interview contacts. Review medical records of contacts using a 
standard data abstraction form. It is anticipated that multiple 
interviews with contacts may be needed to obtain detailed information. 
Contacts whose HIV status is unknown will be offered HIV testing. All 
contacts without evidence of prior Mycobacterium tuberculosis infection 
or disease will receive a tuberculin skin test when first identified as 
a contact and at 12 weeks after their last contact with the case while 
the case was infectious. Those with positive tuberculin skin tests will 
be evaluated for preventive or curative therapy as indicated.

[[Page 69312]]

    j. Test contacts with a panel of non-tuberculous mycobacterial 
antigens to determine whether supplementing tuberculin skin test 
screening with these antigens results in improved identification of 
persons recently infected with M. tuberculosis.
    k. Obtain serum from close contacts and test for a number of 
cytokines known to be associated with the immune response to M. 
tuberculosis infection. This information will be used to determine 
whether cytokine profiles are a useful supplement to tuberculin skin 
test screening for determining whether recent M. tuberculosis 
transmission has occurred.
    l. Conduct targeted tuberculin skin test screening in locations 
where the TB case spent time according to procedures and criteria 
specified in the study protocol.
    m. Monitor contacts with latent TB infection to determine rates of 
treatment for latent TB infection recommendation, initiation, and 
completion. Reason for not recommending, initiating, or completing 
therapy will be delineated.
    n. If secondary cases are identified, send M. tuberculosis isolates 
from the cases and their source case to the designated regional 
laboratory for DNA fingerprints.
    o. Ensure that all data collected are maintained in confidential 
and secured files.
    p. Send questionnaires and data abstraction forms for study 
participants to the CDC in accordance with the frequency specified in 
the protocol.

2. CDC Activities

    a. Assist in the development of a research protocol for IRB review 
by all cooperating institutions participating in the research project. 
Assist in development of a study protocol for retrospective, social 
networking survey, and prospective portions of the study.
    b. The CDC IRB will review and approve the protocol initially and 
on at least an annual basis until the research project is completed.
    c. Organize and host a meeting at CDC with all the principal 
investigators within 3 months of awards being granted.
    d. Assist in development of questionnaires and data abstraction 
forms for collecting and reporting results.
    e. Collaborate as necessary in training the persons interviewing 
cases and contacts and doing the data abstraction from medical records.
    f. Assist as needed and review the results of data analysis done 
locally.
    g. Prepare study report and disseminate findings.

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 15 double-spaced on 8\1/2\ 
by 11" pages (excluding budget justification), printed on one side, 
with one inch margins, and unreduced font. Applications must be 
developed in accordance with CDC Form 0.1246(E). Pages must be clearly 
numbered, and a complete index to the application and its appendices 
must be included. The original and each copy of the application must be 
submitted unstapled and unbound. Materials which should be part of the 
basic plan should not be in the appendices. For the budget section, 
submit a Form 424A (included in the Application Package) and detailed 
line-item justification for this focus area project. Applicants should 
follow the outline below in preparing the narrative.
    1. Abstract (not to exceed 1 page): Applicants should provide a 
summary of their proposal and rational plan to carry out the project 
activities.
    2. Understanding the Project: Applicants should describe their 
knowledge of current research conducted in this area, past studies and 
existing literature. Applicants should state clear study objectives for 
the current proposed study. Applicants should describe experience with 
conducting thorough, timely, and comprehensive contact investigations 
for foreign-born TB cases and their contacts, and the related public 
health impact.
    3. Methodology and Approach: Applicants should describe a rational 
plan to carry out the project activities, including timely methods for 
the identification of newly diagnosed TB cases and their contacts; 
methods for medical record review and source case and contact 
interviews; ability to integrate serologic and non-tuberculous antigen 
testing portions of the study into existing contact investigation 
procedures; and ability to conduct targeted location based screening in 
immigrant communities. Recognition of and plans for overcoming 
difficulties that may be encountered during the study should be 
described.
    4. Program Management and Staff experience: Describe the personnel 
who will be involved in this project, including information about who 
will be responsible for general oversight and management of this 
project. Include descriptions of the experience required for each 
proposed staff member to conduct their assigned duties in the proposed 
project and the projected time commitment from each.
    5. Data Management: Provide a brief outline of data flow for the 
proposed project. Provide a description how data abstraction forms will 
be handled and maintained. Provide a plan for updating data abstraction 
forms as additional information becomes available over time. Provide a 
plan for including quality assurance steps that will be used in 
managing the data.
    6. Budget: Provide an itemized budget and supporting justification 
for the first 12 months of the anticipated 2-year project.

F. Submission and Deadline

    Submit the original and 2 copies of the application including the 
CDC Form 0.1246(E). Forms are available at the following Internet 
address: http://www.cdc.gov/od/pgo/forminfo.htm or in the application 
kit. On or before January 5, 2001, submit your 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:
    (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 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: Applications which do not meet the criteria in 
(a) or (b) above are considered late applications, will not be 
considered, and will be returned to the applicant.

G. Evaluation Criteria

    Your application will be evaluated individually against the 
following criteria by an independent review group appointed by CDC.

1. Understanding of the Project (20 Points)

    The extent to which the applicant demonstrates a clear 
understanding of the public health impact of conducting thorough, 
timely, and comprehensive contact investigations for foreign-born TB 
cases and their contacts as demonstrated through experience, a

[[Page 69313]]

knowledge of current research conducted in this area, past studies, 
existing literature, and the clarity of the proposed study objectives.

2. Methodology and Approach (45 Points)

    a. The extent to which the applicant describes a rational plan to 
carry out the project activities, including timely methods for the 
identification of newly diagnosed TB cases and their contacts; methods 
for medical record review and source case and contact interviews; 
ability to integrate serologic and non-tuberculous antigen testing 
portions of the study into existing contact investigation procedures; 
and ability to conduct targeted location based screening in immigrant 
communities. Recognition of and plans for overcoming difficulties that 
may be encountered during the study are described.
    b. 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 both sexes and 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 the 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 community(ies) and recognition of mutual benefits.
    (5) The proposed plan to address language needs during the course 
of the project.
    (6) Delineate the countries of origin from the major foreign-born 
populations in the projected area.
    (7) Describe the language capabilities of staff proposed for this 
study.

3. Program Management and Staff experience (20 Points)

    The proposal clearly describes the (1) qualifications, commitment, 
and epidemiologic skills and experience of the project director and 
his/her ability to devote adequate time and effort to provide effective 
leadership; (2) qualifications and experience of other staff involved 
in the project to accomplish the proposed activity, and their 
commitment and time they will devote; (3) successful experience the 
project director and staff have in managing, coordinating and 
conducting similar or related projects; (4) a study coordinator with 
epidemiologic training and experience who is able to devote at least 50 
percent of his or her time to this project; and (5) facilities, space, 
and equipment necessary for conducting the project.

4. Data Management (10 points)

    The proposal clearly describes how data management and data 
validation will be done.

5. The extent to which the applicant demonstrates continued achievement 
of the following National TB Program Objectives (5 Points):

    a. At least 90 percent of patients with newly diagnosed TB, for 
whom therapy for 1 year or less is indicated*, will complete therapy 
within 12 months (*please refer to the definitions in ``Reported 
Tuberculosis in the United States, 1997'' for more information). To 
obtain a copy of this report, you may order through the CDC Website 
http://www.cdc.gov/nchstp/tb/ and go to online ordering; or you may 
contact the Communication and Education Branch, Sherry Hussain, 404-
639-8135.
    b. At least 85 percent of infected contacts who are started on 
treatment for latent TB infection will complete therapy.
    c. Completeness of RVCT reporting on HIV status for at least 75 
percent of all newly reported TB cases age 25-44.

6. Other (Not Scored)

a. Budget
    Extent to which the budget is reasonable, clearly justified, and 
consistent with the intended use of the funds.
b. Human Subjects
    Does the application adequately address the requirements of 45 CFR 
46 for the protection of human subjects?

H. Other Requirements

Technical Reporting Requirements

    Provide CDC with an original plus two copies of:
    1. Annual progress report, no more than 90 days after the end of 
the budget period;
    2. Financial status report, no more than 90 days after the end of 
the budget period; and
    3. Final financial 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 
announcement.

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-7 Executive Order 12372 Review
AR-9 Paperwork Reduction
AR-10 Smoke-Free Workplace Requirements
AR-11 Healthy People 2010
AR-12 Lobbying

I. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under section 317E of the Public Health 
Service Act, 42 U.S.C. 247b-6, as amended. The Catalog of Federal 
Domestic Assistance number is 93.947.

J. Where To Obtain Additional Information

    This and other CDC Announcements can be found on the CDC homepage 
Internet address--http://www.cdc.gov. Click on ``Funding'' then 
``Grants and Cooperative Agreements.''
    To obtain additional information, contact: Carrie Palumbo, Grants 
Management Branch, Procurement and Grants Office, Centers for Disease 
Control and Prevention (CDC), 2920 Brandywine Road, Room 3000, Atlanta, 
GA 30341-2783. Telephone (770) 488-2783. Email address: [email protected].
    For program technical assistance, contact: Your program consultant 
at (404) 639-8125 and from Mary Reichler, Project Officer, Division of 
Tuberculosis Elimination, Centers for Disease Control and Prevention, 
National Center for HIV, STD, and TB Prevention, Division of TB 
Elimination, 1600 Clifton Road, Mailstop E-10, Atlanta, Georgia 30333. 
Telephone: (404) 639-8118. E-Mail Address: [email protected].

    Dated: November 9, 2000.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 00-29312 Filed 11-15-00; 8:45 am]
BILLING CODE 4163-18-P