[Federal Register Volume 69, Number 103 (Thursday, May 27, 2004)]
[Notices]
[Pages 30300-30312]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-11999]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Tuberculosis Elimination and Laboratory Cooperative Agreements

    Program Announcement Type: New.
    Program Announcement Number: 05003.
    Catalog of Federal Domestic Assistance Number: 93.116.
    Application Deadline: July 26, 2004.

I. Funding Opportunity Description

I.1. Authority

    This program is authorized under section 317 E of the Public Health 
Service Act, (42 U.S.C. 247, b-6), as amended.

I.2. Purpose

A. TB Prevention and Control
    The purpose of the Tuberculosis (TB) Elimination Cooperative 
Agreement Program is to assist the current efforts of State and local 
TB programs to prevent, control, and eventually eliminate TB in the 
United States. Financial assistance is provided to TB programs to 
ensure that program needs for the core TB prevention and control 
activities are met. This program addresses the ``Healthy People 2010'' 
focus area of Immunization and Infectious Diseases in conjunction with 
the Government Performance and Results Act of 1993 (GPRA).
    Funds are available for recipients to address the core TB 
prevention and control activities (i.e., completion of therapy, contact 
investigation, TB surveillance, TB public health laboratory, human 
resource development, and program evaluation).
    Measurable outcomes of program progress will be in alignment with 
all of the following performance goal(s) for the National Center for 
HIV,STD, and TB Prevention (NCHSTP):
    (1) Increase the percentage of TB patients who complete a course of 
curative TB treatment within 12 months of initiation of treatment (some 
patients require more than 12 months).
    (2) Increase the percentage of TB patients with initial positive 
cultures who also are tested for and receive drug susceptibility 
results.
    (3) Increase the percentage of infected contacts of infectious 
cases that are placed on treatment for latent TB infection (LTBI) and 
complete a treatment regimen.
    (4) Increase the percentage of other high-risk infected persons who 
are placed on treatment for LTBI and complete a treatment regimen.
    (5) Increase the percentage of immigrants and refugees designated 
as Class A, B1, or B2 who are appropriately evaluated and treated. 
Refer to the following Web link, pages 2-6, for classification 
descriptions. http://www.cdc.gov/ncidod/dq/pdf/ds-forms-instructions.pdf.
    (6) For jurisdictions with greater than 50 reported cases of TB 
occurring annually in U.S.-born African Americans, decrease the case 
rate.
    (7) Increase the proportion of adults with TB who have been tested 
for HIV.
    The highest priority TB prevention and control activities are the 
following activities: Finding all cases of active TB and ensuring, 
through appropriate case management, completion of therapy; finding and 
evaluating persons who have had contact with infectious TB patients, 
identifying those with TB and LTBI, and completing treatment of TB 
disease and LTBI; conducting program evaluation; ensuring human 
resource development through internal project training and education; 
and conducting TB surveillance and TB public health laboratory 
activities that are essential to addressing these priorities. Each of 
these activities is essential to effective TB prevention and control, 
and they are mutually reinforcing. Thus, they constitute a ``package'' 
of core activities. These activities should be carried out by all TB 
prevention and control programs, taking precedence over lower priority 
activities. Lower priority activities are those such as targeted 
testing and treatment of LTBI in high risk populations.
    State TB programs differ in the level of services and resources 
they provide to local programs and the amount of authority they have 
over local program activities. Regardless of these differences, state 
programs should work closely with their local TB programs to ensure 
that program activities are carried out appropriately and program 
objectives are met. States should provide leadership and technical 
assistance to the local programs in assessing program needs, setting 
local objectives, measuring performance, identifying problems, and 
designing interventions. In addition, State TB programs should 
facilitate resolution of inter-jurisdictional challenges (such as 
ensuring continuity of case management and treatment of persons with 
active TB who move between jurisdictions).
    Directly funded cities should work closely with the state TB 
program to facilitate consistency on statewide issues, minimize 
duplication of efforts, and share all reports that are sent to Centers 
for Disease Control and Prevention (CDC) with the State TB program.
B. Regional TB Training and Medical Consultation Centers (RTMCCs)
    Additional funds are available for the establishment of 
geographically distributed regional training and medical consultation 
centers.
    The first major activity of the Regional TB Training and Medical 
Consultation Centers (RTMCC) is to increase human resource development 
for the prevention and control of TB through education and training 
activities. RTMCCs will serve as centers of excellence within their 
assigned regions by providing innovative and quality human resource 
approaches in two areas:
    (1) Training courses and technical assistance to others developing 
and providing TB courses.
    (2) Educational and training material product development.
    Human resource development activities at RTMCCs should include:
     Developing and enhancing relationships with State and 
local public health agencies for TB control, as well as other partners 
(see below for a list of potential partners).
     Expanding capacities to provide professional education and 
training in tuberculosis to State and local health agencies and other 
partners.
     Working with State and local public health agencies to 
identify training needs of public health workers and private providers.
     Working with State and local public health agencies to 
assess and monitor specific training needs in TB.
     Developing competency-based education and training 
courses.
     Collaborating with State and local health agencies to 
develop methods for evaluating the effectiveness of the training 
activities.
     Identifying and sharing best practices, models, and 
innovative approaches to TB practices through the development of 
courses and materials.
     Assuring accountability through frequent monitoring and 
evaluation of RTMCC activities and materials.
    The RTMCCs should work closely with local, State, and regional 
representatives from TB programs as

[[Page 30301]]

well as with other partners that include, but are not limited to, the 
following:
     Tuberculosis Education and Training Network (TB ETN) 
members.
     TB education and training focal points of other grantees 
funded under this announcement.
     Additional partners (should include, but are not limited 
to the following organizations, agencies and groups within the 
geographic catchment area: Health Resources and Services Administration 
(HRSA) primary care centers; AIDS education and training centers; STD 
training centers; private providers; medical, nursing, and public 
health schools and associations; regional TB controller associations; 
and TB advisory councils).
    The second major activity of the RTMCCs is to increase the capacity 
for appropriate medical evaluation and management of persons with TB 
disease and infection in their assigned region. RTMCCs will:
     Develop and implement a medical consultation service for 
their assigned region.
     Develop and implement a plan to maintain and increase the 
capacity of the region to appropriately evaluate and medically manage 
persons with TB disease and infection.
C. TB Public Health Laboratory
    Effective treatment and control of TB require that timely and 
reliable TB laboratory services be available to clinicians and TB 
controllers. Delays in the laboratory confirmation of TB and reporting 
of drug-susceptibility results lead to delays in initiation of therapy, 
prolonged infectiousness, inappropriate therapy, and missed 
opportunities to prevent transmission. As part of the Centers for 
Disease Control and Prevention's (CDC) response to the threat of 
multidrug-resistant tuberculosis (MDR-TB), (National Action Plan to 
Combat MDR-TB), cooperative agreement funds were provided to strengthen 
public health laboratories and an increased emphasis was placed on 
providing laboratory results in a timely manner. During the past 
decade, laboratories made tremendous strides in improving test 
performance. These improvements contributed to the resumption in the 
decline of the incidence of TB and the decrease in MDR-TB cases 
nationwide.
    To reach the goal of eliminating TB in the U.S., the recent 
improvements in laboratory testing must be translated into improvements 
in TB treatment, prevention, and control. The critical next step will 
be to develop an integrated system that ensures timely laboratory 
testing and timely flow of information among laboratorians, clinicians, 
and TB controllers. Public health laboratories must take a leadership 
role to develop such a system and improve communication among 
laboratorians, clinicians, and TB controllers. Keys to providing 
timely, reliable laboratory services include (1) understanding the 
structure, performance, and cost of the current network of service 
providers and users, (2) developing a referral and information network 
to ensure reliable testing and the timely flow of specimens and 
information, and (3) using quality improvement principles to evaluate 
and improve the performance of the laboratory service network.
    In recognition of this critical need, the primary purpose of the 
FY05-FY09 Laboratory Upgrade Component of the TB Elimination 
Cooperative Agreements will be to build on past improvements to 
facilitate development of a system to provide timely and reliable 
laboratory testing for TB treatment and control efforts. To assist 
laboratories in this endeavor, Laboratory Upgrade funds will be awarded 
based on plans for, and progress toward, (1) meeting CDC recommended 
turnaround times (Tenover, et al. 1993. J. Clin. Microbiol. 31:767-770 
and Styrt, et al. 1997. J. Clin. Microbiol. 35:1401), (2) accomplishing 
the Healthy People 2010 TB Laboratory goal (laboratory confirmation of 
a case of tuberculosis within 48 hours of specimen receipt for 75 
percent of cases that are ultimately culture-confirmed), and (3) 
developing a system that ensures optimal use of laboratory services and 
effective reporting of information.
    To accomplish this goal and sustain past improvements, Laboratory 
Upgrade Program funds will be awarded in FY05 to eligible applicants, 
with one-third of these funds going toward accomplishing each of the 
three laboratory component objectives listed below.

Component 1: Meeting Recommended Turnaround Times

    Many recipient laboratories have already met the recommendations 
for activities and turnaround times. Continued support is needed to 
sustain the improvements and to enable all laboratories to meet all 
recommendations. Because the cost of accomplishing this component 
depends on the number of tests performed, funds for this component will 
be distributed on a ``per patient reported basis''.

Component 2: Accomplishing the Healthy People 2010 Goal

    On the surface, this goal appears to be a daunting challenge for 
the public health laboratory both on the technical level and budgetary 
level. However, technologies are readily available on the market that 
could accomplish this goal and the cost of incorporating such 
technologies may not be as high as many fear. Much of the anticipated 
cost comes from the idea that any new test would inevitably be a test 
that must be added to whatever testing the laboratory is currently 
doing. To counter this, laboratories should consider novel testing 
algorithms that might enable cost-effective incorporation of new tests 
into their testing algorithm and workflow. Laboratories considering a 
new testing algorithm should consult with clinicians and TB controllers 
as to the acceptability of a new testing algorithm and should collect 
data to allow the performance and cost of the new testing algorithm to 
be compared to the current testing algorithm. Because the cost of 
accomplishing this component depends on the number of tests performed, 
funds for this component will be distributed on a ``per patient 
reported basis''.

Component 3: Developing an Integrated System That Ensures Timely 
Laboratory Testing and Timely Flow of Information

    To provide guidance for accomplishing this goal, the Association of 
Public Health Laboratories (APHL) and CDC commissioned a Task Force on 
the Future of TB Laboratory Services. The Task Force included 
representatives from APHL, CDC, public health laboratories, hospital 
and commercial laboratories, and the National TB Controllers 
Association (NTCA). Its charge was to define and address issues 
critical to those who perform TB testing and those who use the test 
results and to develop recommendations for improving TB treatment and 
control through optimal use of laboratory services and effective 
reporting and tracking of information. The report of this task force 
will be made available to applicants. It provides guidance on specific 
action items and performance measures necessary to develop and 
implement an integrated system for providing laboratory services. 
Because the cost of accomplishing this component should be about the 
same for each program, funds for this component will be distributed on 
a ``per program'' basis (i.e., an equal amount to each recipient).

I.3. Awardee Activities

    Awardee activities for this program are as follows:

[[Page 30302]]

A. TB Prevention and Control
(1) Treatment and Case Management of Persons With Active TB
     Ensure case management and treatment of persons with 
active TB through the use of adherence-promoting measures such as 
cohort analysis, outreach staff, extensive application of directly 
observed therapy, incentives, and enablers.
     Assess reasons for non-adherence with TB treatment, both 
for patients not completing therapy and for patients with delayed 
completion of therapy. Devise individual and programmatic interventions 
to increase completion of therapy and improve timely completion of 
therapy.
     Assess adequacy and appropriateness of therapy for each 
patient by reviewing initial regimen, susceptibility results, 
adherence, and response to therapy. Therapy should be consistent with 
American Thoracic Society/Infectious Disease Society of America/Centers 
for Disease Control and Prevention guidelines. Refer to the following 
Web link for more information. http://www.cdc.gov/nchstp/tb/.
     Collaborate with HIV/AIDS programs to ensure that all 
newly diagnosed TB cases are counseled and tested for HIV and referred 
for HIV services if found to be HIV positive.
     Collaborate with substance abuse and homeless programs to 
ensure all newly diagnosed TB cases are evaluated and treated for TB.
     Ensure that immigrants and refugees classified as A, B1, 
or B2 are located promptly and evaluated and treated appropriately. 
Refer to ``Medical Examination of Aliens and Technical Instructions'', 
page six, at the following Web link. http://www.cdc.gov/ncidod/dq/panel.htm.
     Develop and implement the appropriate use of the 
Binational TB Card and appropriate referral systems for patients who 
may receive care along the U.S.-Mexico border or who may cross the 
border while under treatment for TB.
     Ensure that effective interventions are implemented to 
identify foreign-born and U.S. minorities at highest risk for 
developing TB and that they are evaluated and treated for TB or TB 
infection.
     Establish a systematic process to routinely evaluate case 
management activities to ensure optimal program performance.
(2) Contact Investigation
     Ensure that contact investigation activities are initiated 
and completed promptly, including interviewing TB cases to identify 
contacts, evaluating contacts for latent TB infection and disease, and 
ensuring infected contacts begin and complete an appropriate course of 
treatment for latent TB infection.
     Assess reasons for cases with no contacts identified or a 
low number (e.g., less than three) of contacts identified, delays in 
interviewing cases or evaluating contacts, and low completion of 
preventive therapy rates, and devise strategies for improvement. 
Combine epidemiologic data with TB genotyping results, where 
appropriate, to confirm or identify previously unidentified 
transmission links between TB cases and use genotyping results to 
evaluate the completeness of contact investigations.
     Cooperative agreement recipients will submit data from 
contact investigations in the Aggregate Reports for Tuberculosis 
Program Evaluation (ARPE): Follow-up and Treatment of Contacts to 
Tuberculosis Cases, in accordance with the schedule in Attachment 2 (or 
via such reports that will supercede ARPEs as developed and agreed 
between CDC and the National Tuberculosis Controllers Association.)
(3) TB Surveillance/Reporting
     Enhance identification, reporting, and follow-up of TB 
cases and suspects by establishing liaisons with appropriate reporting 
sources such as hospitals, clinics (e.g., TB and HIV/AIDS clinics), 
laboratories performing tests for mycobacteria, selected physicians 
(e.g., pulmonary and infectious disease sub-specialists), correctional 
facilities, community and migrant health centers, pharmacies, and other 
public and private facilities providing care to populations with or at 
risk for TB. States should provide periodic feedback to reporting 
sources, and at least annually provide a written report summarizing TB 
surveillance data.
     Develop and implement active surveillance activities to 
ensure complete and timely reporting of TB cases and suspects. At 
minimum, ongoing active laboratory surveillance should be conducted in 
all areas to ensure complete reporting of all TB cases and suspects 
with positive acid-fast bacilli (AFB) smears and cultures for M. 
tuberculosis complex.
     Maintain a registry of TB cases that the jurisdiction will 
include in its morbidity total that contains at a minimum the elements 
to produce data for the national TB case report, Report of Verified 
Case of Tuberculosis (RVCT). All local jurisdictions should also have 
at least a log, if not a registry, that contains key demographic and 
clinical information on each reported TB suspect. It is also 
recommended that TB cases receiving diagnostic, treatment, or contact 
investigation services in the local jurisdiction, although not included 
in the annual morbidity total, be included in the TB registry.
     Incorporate quality assurance policies and procedures into 
the maintenance operations of the TB registry to ensure complete and 
reliable data.
     Routinely analyze (e.g., quarterly) TB surveillance data 
to monitor trends, detect potential outbreaks, and define high-risk 
groups, and produce and disseminate at least an annual report 
summarizing current data and trends.
     Routinely (e.g., annually) evaluate programmatic 
performance by using TB surveillance data to assist in compiling 
supporting evidence to determine the extent to which program objectives 
are being met and also to assist in developing strategies for 
improvement.
     Ensure that TB surveillance data are kept confidential and 
that all data files are secure. Policies and procedures must be in 
place to protect the confidentiality of all surveillance case reports 
and files. Policies and procedures to protect HIV test results must 
conform to the confidentiality requirements of the state and local HIV/
AIDS programs.
     Report all TB cases to be included in the annual morbidity 
total to the CDC according to a schedule agreed upon each year, 
generally monthly, and at least annually. TB case data will be reported 
to CDC using the RVCT form via an electronic format that conforms to 
Public Health Information Network (PHIN) and/or National Electronic 
Disease Surveillance System (NEDSS) messaging standards, or prior to 
the complete transition to NEDSS for national TB reporting, using the 
CDC provided software, the Tuberculosis Information Management System 
(TIMS).
     Periodically (e.g., at least every two years) evaluate the 
completeness of reporting of TB cases to the surveillance system by 
identifying and investigating at least one population-based secondary 
data source (e.g., statewide laboratory record review, pharmacy review, 
hospital discharge data review) to find potentially unreported TB 
cases. Potential TB cases identified during the evaluation must be 
verified through review of medical records, physician interviews, or 
patient interviews. Reasons for non-reporting of TB cases should be 
determined and a plan for

[[Page 30303]]

improvement developed and implemented.
     Collaborate with the HIV/AIDS program to conduct at least 
annual TB and AIDS registry matches to ensure completeness of reporting 
of HIV and TB co-infected patients to both surveillance systems. 
Investigate and verify all TB cases reported to the HIV/AIDS program 
and not reported to the TB program. Update the TB registry as 
indicated.
     Periodically (e.g., annually) assess reasons for 
incomplete HIV results on the RVCT for each verified case of TB. 
Determine if patients were not tested for HIV or were tested but 
results not reported to the TB program. Develop and implement plans for 
improvement.
     Periodically (e.g., annually), evaluate the validity of 
RVCT data, focusing particularly on drug susceptibility test results 
and other laboratory data, by comparing TB registry data to original 
data sources. Develop and implement plans for improvement.
     Establish a systematic process to routinely evaluate 
activities related to surveillance and reporting to ensure optimal 
program performance.
(4) Human Resource Development
    States and big city TB programs receiving funding should assign 
someone to serve as a focal point for training within the TB program. 
This person should be (or become) an active participant in the 
Tuberculosis Education and Training Network (TB ETN) in order to 
increase and develop knowledge and skills, increase awareness of 
resources available, and actively participate in determining needs and 
developing high priority resources for TB control and elimination. 
States and big cities receiving funding should develop a Training/Human 
Resource Strategy Plan to:
     Establish and improve existing in-service TB training and 
human resource development.
     Establish evaluation strategies to improve existing 
systems and to identify ongoing training and human resource needs.
     Establish and improve patient education and communications 
capacity within the program.
     Coordinate training related to TB control with training 
for other disease control interventions such as HIV/AIDS and STD.
     Target other health care providers or organizations 
serving high-risk populations.
    Technical assistance on developing a state or local Training and 
Human Resource Strategy Plan will be provided via the TB ETN and/or the 
RTMCCs after award of funds. Utilization of funds for training external 
to the TB program (e.g., National Jewish Clinical Course, or a RTMCC 
Course) should be limited to courses that cannot be delivered by the TB 
program as determined by course content and job responsibilities of the 
participant; this external training need must be specified in the 
Training/Human Resource Strategy Plan.
    For identified high priority needs, such as an outbreak or 
identified case in a high-risk setting, additional funding and 
assistance may be provided as needed via the DTBE Outbreak Response 
Plan. Organizations, programs such as state TB control programs with 
training capacity, or one of the RTMCCs could be utilized via a 
contract method to deliver training and human resource development in 
this low incidence area to address identified outbreak response needs.
(5) Program Evaluation Activities
    All grantees should actively engage in self-evaluation to ensure 
that their findings guide the program in making necessary changes to 
more effectively carry out their mission of TB prevention and control.
     By Fall of 2005, all grantees will be required to submit 
to CDC an evaluation plan that explains their process for program 
assessment, defines the methods used for program self-evaluation, and 
how they plan to provide technical assistance to local programs that 
grantees should actively engage in self-evaluation and use findings to 
guide the program in making necessary changes to more effectively carry 
out their mission of TB prevention and control. Findings should also be 
used to evaluate the effectiveness of their own TB efforts. The 
evaluation plan should be based on a systematic approach, such as that 
provided in the CDC's Framework for Program Evaluation in Public Health 
[MMWR 1999:48 (No. RR11)]. Refer to Web link: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr4811a1.htm.
     All evaluation efforts should ensure that the diverse 
perspectives of relevant stakeholders (e.g., TB program staff and 
managers, other service providers, patients and community 
representatives) are represented throughout the process. Grantees 
should also cultivate partnerships to expand their evaluation capacity.
     All grantees will use core performance measurements to 
assess program performance.
     As part of their evaluation plan, all grantees should 
select the performance measurements to evaluate their program's 
performance and provide baseline program data for selected indicators. 
The selected performance measurements must include, but are not limited 
to:
     TB Cases: the proportion that complete treatment within 12 
months (among those with rifampin-sensitive TB).
     Contacts: the proportion of eligible contacts that start 
treatment, and of those who start treatment, the proportion that 
complete treatment.
     Immigrants and Refugees: the estimated proportion of 
immigrants and refugees classified as A, B1, or B2 eligible for 
treatment who start treatment, and of those who start treatment, the 
proportion that complete treatment.
     Case rates of African Americans (U.S.-born black non-
Hispanic).
     Surveillance: the percentage of TB case reports in which 
90 percent of the core data items are complete.
     In consultation with the CDC program consultants, grantees 
will set benchmarks and timelines for each selected measurement. In 
addition, as part of the grantees' evaluation plan, local and state 
indicators should be selected from a library of program indicators (or 
use locally tailored indicators of program performance) that reflect 
the demographic features of the TB in their jurisdiction, the resources 
available, and the capacity of the program to implement changes. 
Findings from the evaluation should be used to guide program 
development.
     Annually thereafter, grantees will submit, as part of the 
cooperative agreement continuation application, progress report data 
supporting progress toward meeting their goal for each program 
indicator. Where a goal has not been met, the grantee should provide an 
analysis of the factors leading to non-achievement of their objective 
and a plan and timeline for making progress toward achieving the 
objective. Monitoring progress toward meeting the self-designated goals 
for the program indicators will be the responsibility of the grantee in 
conjunction with the CDC program consultant.
     Project areas are accountable for achieving the target 
levels of performance established in their plans. If a project area 
fails to achieve their target, the project will need to submit as part 
of subsequent year funding applications, a plan to improve performance 
and achieve objectives.

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B. RTMCCs
(1) Training and Technical Assistance
     Spend approximately 50 percent of their total effort and 
resources on training courses and training technical assistance, with 
primary emphasis on state and big city TB programs in their assigned 
geographic region. Each RTMCC, although part of the national network, 
will primarily serve a specific geographic region.
     Provide core courses based on a standardized curriculum 
developed in collaboration with the CDC and other RTMCCs. These courses 
should include, but are not limited to, program management training, 
supervisor training, outbreak response planning, case management, and 
program evaluation.
     Develop specialty courses, in addition to the core 
courses, that are unique to the needs of the region served or the area 
of expertise of the RTMCC.
     Both core and specialty course development should occur in 
consultation with CDC and be derived from recommendations and needs 
assessments from multiple sources, including: (1) CDC identified needs 
and priorities; (2) local and regional needs assessments; (3) the 
National Strategic Plan for Education and Training; and (4) new and 
existing national guidelines.
     Provide at least 400 hours of training each year. Training 
can take place at the RTMCC, but at least 30 percent of the training 
should take place in other settings, preferably in other states and in 
conjunction with regional TB controllers' association meetings.
     The RTMCCs should strive to develop the training capacity 
of local and state TB programs. In this activity, the RTMCCs will 
provide technical assistance, but will not be the principal organizer 
of training activities. As such, the RTMCCs will be responsible for the 
development of facilitator-led training materials for use by these 
programs, as well as the provision of technical assistance on how to 
utilize and fully implement these materials to build capacity within 
the TB programs.
     Conduct on-going evaluation of all courses and document 
the results of their evaluations in annual reports. Evaluation should 
include measuring appropriate process indicators (e.g., trainee 
demographics, quality of training), immediate training outcomes (e.g., 
changes in knowledge, attitudes, and skills) and where possible, long-
range impact (e.g., changes in provider practice behavior, changes in 
service delivery).
     Each RTMCC must demonstrate the capacity and plans to host 
Mini-Fellowship trainings each year. The purpose of the Mini-Fellowship 
is to provide participants with first hand knowledge and experience 
about the role of public health agencies in carrying out TB control 
activities.
     RTMCCs should provide education and training consultation 
and technical assistance on an ongoing basis to all partners. This 
technical assistance can be provided via telephone, e-mail, or written 
consultation. Technical assistance can also be provided on site for 
less experienced training coordinators or where greater needs and fewer 
resources are available.
     The RTMCCs will be expected to work collaboratively with 
each other and CDC by participating in monthly conference calls, annual 
meetings, and ongoing consultations.
(2) Educational and Training Material Product Development
     Spend approximately 30 percent of their resources on 
educational and training material development, including materials used 
in training courses sponsored by the RTMCC. Submit to CDC proposals for 
development of materials that can be used regionally and nationally. 
Develop proposals based on previously discussed criteria.
     Emphasis of product development should be to increase the 
capacity of local and state TB program personnel, TB training focal 
points, and TB ETN members to deliver high quality, competency based 
training and education. Facilitator led training materials should be a 
special focus of product development.
     Submit to CDC proposals for development of materials that 
can be used regionally and nationally. Develop proposals based on 
previously discussed criteria and collaboration and input from CDC and 
other RTMCCs.
     Utilize distance learning strategies in course or product 
development. Create materials in multiple formats (e.g., print and 
electronic formats) to meet the varied needs of the intended target 
audiences.
     RTMCCs will be responsible for initial production and 
distribution of products. For products that are needed in large 
quantities, RTMCCs can submit these products through the CDC/Division 
of Tuberculosis Elimination (DTBE) clearance process. If approved, DTBE 
will be responsible for printing and distribution of these materials.
     Develop and maintain a Web site containing, at minimum, a 
list of courses and materials offered by the RTMCC, as well as ordering 
information. In addition, electronic versions (HTML and PDF) of 
products developed by the RTMCC should also be posted on the Web site.


    Note: Materials developed by the RTMCCs must be in the public 
domain and cannot be copyrighted. Furthermore, CDC reserves the 
right to make additional changes to materials or products produced 
by the RTMCCs that will be distributed nationally.


     RTMCCs should acquire or make provisions to award 
continuing education credits, including Continuing Medical Education 
(CME), Continuing Nursing Education (CNE), Continuing Education Units 
(CEU), and Continuing Health Education Credits (CHES) when possible and 
appropriate for training and educational products.
(3) Medical Consultation
     Spend approximately 20 percent of their time and resources 
on activities related to medical consultation, including the activities 
listed below.
     Provide real-time medical consultation, in the region 
assigned by CDC, to physicians and other providers of medical care on 
the diagnosis and treatment of TB disease, including MDR-TB. 
Consultation should also be provided on the diagnosis and treatment of 
LTBI, including persons presumed to be infected with drug resistant 
strains of M. tuberculosis.
     Develop a strategy to appropriately promote this medical 
consultation service to healthcare providers in the assigned region.
     Evaluate the effectiveness of medical consultation service 
and document the results of the evaluation in the annual reports.
     Conduct a needs assessment in the assigned region for 
current and future needs for consultation related to the medical 
evaluation and management of persons with TB disease and LTBI. (Year 1 
of the funding period.)
     Develop a regional plan, in consultation with regional TB 
control programs, CDC, and other interested parties to address current 
and future regional needs for consultation related to the medical 
evaluation and management of TB disease and infection in the assigned 
region. (Years 1 and 2 of the funding period.)
     Implement relevant sections of regional plan in 
consultation with regional TB control programs and CDC. (Years 3-5 of 
funding period.)
C. TB Public Health Laboratory
    (1) Develop and implement plans to ensure availability of reliable, 
timely TB laboratory services and to meet or make progress towards 
meeting CDC recommended turnaround times

[[Page 30305]]

(Tenover, et al. 1993. J. Clin. Microbiol. 31:767-770 and Styrt, et al. 
1997. J. Clin. Microbiol. 35:1401). Use recommended methods for the 
isolation, identification, and susceptibility testing for M. 
tuberculosis complex appropriate to the individual laboratory's 
workload and experience. Ensure rapid reporting of results (smear, 
culture, susceptibility results) to the TB control program and to the 
submitting health care provider.
    (2) Develop and implement plans to meet, or make progress towards 
meeting, the Healthy People 2010 TB Laboratory goal. The goal is 
laboratory confirmation of a case of tuberculosis within 48 hours of 
specimen receipt for 75 percent of cases that are ultimately culture-
confirmed.
    (3) Develop and implement plans to create a system to provide 
timely and reliable laboratory testing for TB treatment and control 
efforts. Key steps will include to (a) assess the structure, 
performance, and cost of the current network of laboratory service 
providers and users, (b) develop a referral and information network to 
ensure reliable testing and the timely flow of specimens and 
information, and (c) use quality improvement principles to continually 
evaluate and improve the performance of the laboratory service network.

I.4. CDC Activities

    In a cooperative agreement, CDC staff is substantially involved in 
the program activities, above and beyond routine grant monitoring.
    CDC activities for this program are as follows:
A. TB Prevention and Control
     Provide consultation and technical assistance in setting 
priorities, establishing partnerships, and planning, conducting, and 
evaluating TB prevention and control activities.
     Provide up-to-date information on the recommendations and 
guidelines for diagnosis, treatment, follow-up, surveillance, and 
prevention of TB.
     Provide assistance to improve systems that monitor 
surveillance, prevention and control activities.
     Facilitate the technological and methodological transfer 
of successful prevention and intervention models among project areas, 
e.g., workshops, conferences, written communications.
     Assist recipients in monitoring program evaluation/
performance, setting and meeting objectives, implementing methods, and 
complying with cooperative agreement requirements and other funding 
issues, through various methods including telephone consultation, site 
visits (and expanded site visits when appropriate), and site visit 
reports.
     Provide consultation and technical assistance for 
tuberculosis outbreaks, including on-site support of investigations 
when requested by the state health department.
     Provide technical assistance in assessing and prioritizing 
training and education needs and in planning, implementing and 
evaluating training and education activities.
     Coordinate cross-program collaborative approaches to HIV, 
STD and TB prevention and intervention when indicated and appropriate.
     Support individual recipients by providing technical 
assistance in the development and evaluation of new or innovative 
approaches to TB control, including behavioral or health systems 
interventions.
     Establish and maintain effective working relationships 
with a TB elimination advisory committee for the purpose of formulating 
and implementing a plan for the elimination and interruption of 
transmission of TB.
     Provide tools, educational materials, and technical 
assistance to help implement the national program evaluation 
initiative.
B. RTMCCs
     Within three months of funding (notice of grant award), 
CDC will convene a meeting of all funded RTMCCs to outline a 
comprehensive plan for collaboration between the RTMCCs and CDC.
     Provide consultation and technical assistance in setting 
priorities, establishing partnerships, and planning, conducting, and 
evaluating training and medical consultation activities and education 
and training materials.
     Conduct annual site visits to review training capabilities 
and products, advise on instructional design and curriculum and product 
content, provide technical assistance, and review resource allocations 
and budgets.
     Participate in regularly scheduled telephone conference 
calls.
     Monitor program implementation, project management, and 
evaluation activities.
     Provide up-to-date information on the CDC/ATS 
recommendations and guidelines for diagnosis, treatment, surveillance, 
and prevention of TB.
     Facilitate the technological and methodological transfer 
of successful training and medical consultation models among the 
project areas.
     Facilitate collaboration between the RTMCCs and TB control 
programs in their designated geographic region.
     Serve as a liaison with the clearance process and the 
Management Analysis Services Office (MASO) for printing and 
distribution of educational products to be printed and distributed by 
CDC.
C. TB Public Health Laboratory
     Provide consultation and technical assistance in setting 
priorities, establishing partnerships, and planning, conducting, and 
evaluating TB laboratory activities.
     Provide up-to-date information on the recommendations and 
guidelines for diagnostic mycobacteriology and TB Laboratory services.
     Provide assistance to improve systems or networks that 
provide TB laboratory services.
     Facilitate the technological and methodological transfer 
of successful laboratory service models among project areas, e.g., 
workshops, conferences, written communications.
     Assist recipients in monitoring program evaluation and 
performance, setting and meeting objectives, implementing methods, and 
complying with cooperative agreement requirements and other funding 
issues, through various methods including telephone consultation, site 
visits (and expanded site visits when appropriate), and site visit 
reports.
     Provide technical assistance for participation in the 
program for DNA genotyping of M. tuberculosis isolates.
     Provide consultation and technical assistance for 
laboratory aspects of tuberculosis outbreaks and for laboratory 
investigations, including on-site support of investigations when 
requested by the state health department.
     Support individual recipients by providing technical 
assistance in the development and evaluation of new or innovative 
approaches to providing TB Laboratory services.
     Establish and maintain effective working relationships 
with laboratory advisory committees including the Association of Public 
Health Laboratories for the purpose of formulating and implementing a 
plan for the provision of reliable tuberculosis laboratory services.

II. Award Information

    Type of Award: Cooperative agreement. (CDC involvement in this 
program is listed in section ``I.4. CDC Activities'' above.)
    Fiscal Year Funds: FY 2005.

A. TB Prevention and Control

    Approximate Total Funding: $85.0 million. Approximately $83 million 
will be available in FY2005 for core TB prevention and control 
activities (completion of therapy, contact

[[Page 30306]]

investigation, and TB surveillance). Approximately $2 million in 
additional funds are expected to be available in FY2005 for training, 
education, and human resource development.
    Approximate Number of Awards: 68.
    Approximate Average Award: $1,200,000. (This amount is for the 
first 12-month period, and includes both direct and indirect costs.) 
Programs reporting 50 or fewer TB cases annually will receive $20,000 
in supplemental funding for TB training and education. Programs 
reporting 51-500 TB cases annually will receive $30,000 in supplemental 
funding for TB training and education. Programs reporting greater than 
500 cases annually will receive $50,000 in supplemental funding for TB 
training and education.
    Floor of Award Range: $50,000.
    Ceiling of Award Range: $15,000,000.
    Anticipated Award Date: January 1, 2005.
    Budget Period: 12 months.
    Project Period Length: Five Years.

B. RTMCCs

    Approximate Total Funding: $7.5 million.
    Approximate Number of Awards: 3-5.
    Approximate Average Award: $1,500,000. (This amount is for the 
first 12-month period, and includes both direct and indirect costs.)
    Floor of Award Range: $1,500,000.
    Ceiling of Award Range: $2,500,000.
    Anticipated Award Date: January 1, 2005.
    Budget Period: 12 months.
    Project Period Length: Five years.

C. TB Public Health Laboratory

    Approximate Total Funding: $7.9 million.
    Approximate Number of Awards: 62.
    Approximate Average Award: $130,000. (This amount is for the first 
12-month period, and includes both direct and indirect costs.) 
Laboratory Upgrade Program funds will be awarded in FY05 as follows: 80 
percent of FY05 funds will be awarded based on FY04 funding level 
(i.e., each recipient will receive 80 percent of their FY04 base funds) 
and the remaining 20 percent of FY05 funds will be distributed to 
recipients on a ``per patient reported to the TB control program'' or a 
``per program'' basis with one-third of these funds going toward 
accomplishing each of the three laboratory component objectives.
    Floor of Award Range: $5,000.
    Ceiling of Award Range: $960,000.
    Anticipated Award Date: January 1, 2005.
    Budget Period: 12 months.
    Project Period Length: Five years.
    Throughout the project period, CDC's commitment to continuation of 
awards will be conditioned on the availability of funds, evidence of 
satisfactory progress by the recipient (as documented in required 
reports), and the determination that continued funding is in the best 
interest of the Federal government.

III. Eligibility Information

III.1. Eligible Applicants

A. TB Prevention and Control
    Applications may be submitted by health departments of States or 
their bona fide agents, including the District of Columbia; the 
Commonwealths of Puerto Rico, Virgin Islands, and Northern Mariana 
Islands; American Samoa, Guam, the Federated States of Micronesia, the 
Republic of the Marshall Islands, the Republic of Palau; and the cities 
of Baltimore, Chicago, Detroit, Houston, Los Angeles, New York, 
Philadelphia, San Diego, and San Francisco. The nine cities were the 
only original sites funded by CDC TB Cooperative Agreement dollars. 
When CDC expanded TB funding to State and territorial TB programs, the 
agency continued to fund the cities as separate project areas with the 
concurrence of the States in which they are located.
    A bona fide agent is an agency/organization identified by the State 
as eligible to submit an application under the State eligibility in 
lieu of a State application. If you are applying as a bona fide agent 
of a State or local government, you must provide a letter from the 
State as documentation of your status. Place this documentation behind 
the first page of your application form.
B. RTMCCs
    See III.1.A. above.
C. TB Public Health Laboratory
    See III.1.A. above.

III.2. Cost Sharing or Matching

    Matching funds are not required for this program.

III.3. Other

    If your application is incomplete or non-responsive to the 
requirements listed in this section, it will not be entered into the 
review process. You will be notified that your application did not meet 
submission requirements.
    If you request a funding amount greater than the ceiling of the 
award range, your application will be considered non-responsive, and 
will not be entered into the review process. You will be notified that 
your application did not meet the submission requirements.


    Note: Title 2 of the United States Code 1611 states that an 
organization described in section 501(c)(4) of the Internal Revenue 
code that engages in lobbying activities is not eligible to receive 
Federal funds constituting an award, grant, or loan.


IV. Application and Submission Information

IV.1. Address To Request Application Package

    To apply for this funding opportunity, use application form CDC 
1246. Application forms and instructions are available on the CDC Web 
site, at the following Internet address: http://www.cdc.gov/od/pgo/forminfo.htm.
    If you do not have access to the Internet, or if you have 
difficulty accessing the forms on-line, you may contact the CDC 
Procurement and Grants Office Technical Information Management Section 
(PGO-TIM) staff at: 770-488-2700. Application forms can be mailed to 
you.

IV.2. Content and Form of Submission

Application
    You must submit a project narrative with your application forms. 
The narrative must be submitted in the following format:
     Maximum number of pages: There is a maximum of 30 pages 
for TB Prevention and Control Activities, 30 pages for the Regional TB 
Training and Medical Consultation Centers, and 10 pages for the TB 
Public Health Laboratory. If your narrative exceeds the page limit, 
only the pages which are within the page limit will be reviewed. Budget 
justifications will not be counted in the stated page limits.
     Number all pages sequentially.
     Include a table of contents.
     Font size: 12 point unreduced.
     Single spaced.
     Paper size: 8.5 by 11 inches.
     Page margin size: One inch.
     Header on each page: Program name, grant number.
     Printed only on one side of page.
     Held together only by rubber bands or metal clips; not 
bound in any other way.
    Your narrative should address activities to be conducted over the 
entire project period. Use the information in the Awardee Activities 
(section I.3.) and Application Review Criteria (section V.1.) sections 
to develop the application content, and you must include the following 
items in the order listed.

[[Page 30307]]

A. TB Prevention and Control Activities
     Program need.
     Objectives.
     Methods.
     Evaluation.
     Budget Justification (not included in narrative page 
limit).
B. RTMCCs
     Introduction/Program Description.
     Methods: Training, Technical Assistance and Educational/
Training Product Development.
     Methods: Medical Consultation.
     Evaluation.
     Objectives.
     Budget Justification (not included in narrative page 
limit).
C. TB Public Health Laboratory
    The President's Management Initiative requires that programs that 
receive Federal funds include in their proposals clearly stated goals 
and objectives for which the program will be held accountable and 
performance measures by which progress toward accomplishment of goals 
can be assessed. For the Laboratory Upgrade Program, applicants are 
requested to describe realistic achievable goals for each of the key 
components of the program. Although the ultimate goals for each 
component of the Laboratory Upgrade Program are described in this 
announcement, it is not anticipated that all programs will be able to 
accomplish all goals in the first year of the cooperative agreement, or 
perhaps, even during the 5-year project period. Therefore, programs are 
encouraged to set time-phased, realistic, achievable goals and describe 
appropriate milestones toward achieving the ultimate goals. Performance 
measures should be described that will allow assessment of progress 
towards each of the goals and/or milestones set by the program.
    Provide a report describing the number of confirmed TB cases for 
which the laboratory provided any test result to the TB control program 
that was used to complete the RVCT form during each of the three 
calendar years preceding the application and the current (partial) 
year. For the FY05 application, report the numbers for the full 
calendar years of 2001, 2002, and 2003, and any available data for 
2004. For a case to be counted, the laboratory must have reported to 
the TB control program at least one of the following pieces of 
information: isolation of M. tuberculosis from a patient specimen; 
identification of M. tuberculosis from a specimen, culture, or referred 
isolate; or drug susceptibility results from a culture or referred 
isolate.
    Include a description of the current laboratory activities and 
performance, which should include the following:
    (1) A brief description of the methods used in the laboratory, and 
include work load and work flow in the laboratory and any written 
policies to eliminate redundant or unnecessary testing. The description 
of the laboratory work load in 2003 and 2004 (to date) should include 
the following (this can be in a tabular form):
    (a) Number of patients for whom the laboratory confirmed an initial 
diagnosis of TB by culturing M. tuberculosis from a primary patient 
specimen (e.g., sputum, CSF, biopsy, etc,).
    (b) Number of patient specimens processed and cultured.
    (c) Number of patients for whom cultures were processed for 
mycobacterial identification testing, and/or whose isolates were 
referred to other laboratories for identification testing.
    (d) Number of patients whose specimens produced cultures containing 
any species of Mycobacterium.
    (e) Number of patients whose specimens produced cultures containing 
M. tuberculosis.
    (f) Number of patients for whom M. tuberculosis drug susceptibility 
tests were performed and/or whose isolates were referred to other 
laboratories for susceptibility testing.
    (g) Number of patients for whom nucleic acid amplification tests 
confirmed the presence of M. tuberculosis in a primary patient 
specimen.
    (2) A brief description of progress towards meeting CDC 
recommendations as described in Tenover, et al. and Styrt, et al. Each 
of the following recommendations should be addressed in the narrative, 
including laboratory methods used and current turnaround times (TAT) 
for initial diagnostic specimens described in the narrative or in a 
tabular form:
    (a) Promote rapid delivery of specimens to the laboratory (goal TAT 
is 24 hours from collection of specimen).
    (b) Use fluorescent acid-fast staining and promptly transmit 
results by phone, FAX, or electronically. (goal TAT is 24 hours from 
receipt of specimen).
    (c) Inoculate a liquid medium as one of the primary cultures.
    (d) Identify growth as acid-fast and use rapid methods to identify 
isolates as M. tuberculosis as soon as possible (goal TAT is 14-21 days 
from receipt of specimen).
    (e) Determine the susceptibilities of initial M. tuberculosis 
isolates to primary drugs in a rapid culture system (goal TAT is 21-28 
days from receipt of specimen).
    (f) Report the results of drug susceptibility testing to the 
clinician as soon as they are available by phone, FAX, or 
electronically.
    (3) Describe baseline activities and any progress on accomplishing 
the Healthy People 2010 goal of the laboratory confirmation of TB 
within 48 hours of specimen receipt for 75 percent of TB cases that are 
ultimately culture-confirmed.
    (a) Number and percent of specimens received by the laboratory 
within 24 hours of collection.
    (b) Number of patient specimens tested using rapid detection and 
identification tests (e.g., MTD tests or nucleic acid amplification 
tests).
    (c) Number of patients for whom laboratory confirmation of TB was 
provided within 48 hours.
    (d) Number of patients for whom the laboratory confirmed TB by 
isolation of M. tuberculosis from a patient specimen.
    (4) An update on TB public health laboratory recipient activities 
to include a description of any modifications to Laboratory goals and 
objectives, any obstacles encountered and/or reasons for failing to 
meet established objectives, future plans and objectives, and other 
pertinent information, such as laboratory facility or staffing changes, 
high costs for performance of objectives, plans to minimize costs, etc.

Component 1: Accomplishment of CDC Recommended Laboratory Activities 
and Turnaround Times

     Program need.
     Objectives.
     Methods.
     Evaluation.
     Budget Justification. (See below for additional guidance.)

Component 2: Accomplishment of the Healthy People 2010 TB Laboratory 
Goal

     Program need.
     Objectives.
     Methods.
     Evaluation.
     Budget Justification. (See below for additional guidance.)

Component 3: Development of a System To Provide Timely and Reliable 
Laboratory Testing in Support of TB Treatment and Control Efforts

     Program need.
     Objectives.
     Methods.
     Evaluation.
     Budget Justification. (See below for additional guidance.)
    For the Public Health Laboratory portion, two budget proposals are

[[Page 30308]]

requested: (1) Budget reflecting true needs: a combined budget should 
be provided that includes all projected costs associated with 
conducting all components of the Laboratory Upgrade Component. A 
combined budget is requested because some activities support more than 
one component. (2) Budget reflecting anticipated funding level. A 
combined budget reflecting the anticipated funding level should be 
provided. Applicants should assume that they will receive 80 percent of 
their base award for the FY04 TB Cooperative Agreement plus $50 per 
patient reported for Component 1 (recommended activities and turnaround 
times) plus $50 per patient reported for Component 2 (Healthy People 
2010 goal) plus $6000 for Component 3 (laboratory system development). 
Please note that the amounts for Components 1 and 2 will be awarded 
based on the average yearly number (3-year average) of confirmed TB 
cases for which the laboratory provided any test result to the TB 
control program that was used to complete the RVCT form. The precise 
``per patient reported'' amount is not yet known and will depend on the 
total number of cases reported on by all recipient laboratories in the 
U.S. If one assumes that the public health laboratories report 
information on all culture-positive cases within their TB programs, 
funds for Components 1 and 2 would be awarded at $50 per patient 
reported. Funds available for Component 3 will depend on the number of 
technically acceptable applications received. The $6,000 assumes that 
all laboratories will submit acceptable proposals.
    In addition to the information provided in the sample guideline, 
please include the following specific for the Laboratory Upgrade 
program:
Salaries and Wages
    For each TB lab position for which full or partial funding is 
requested, indicate whether the position is ``continuation funding'' or 
``new request for funding''. If the position is a ``new request for 
funding'', state whether the position is new to this program or a 
continuation position previously funded by another source (describe 
source), and provide complete justification for the need to establish a 
new position based on specific program objectives.
Equipment
    Laboratory equipment should be listed in priority order, with the 
first item being of highest priority. Provide a justification of the 
need for the equipment. Items of equipment are considered one-time 
expenditures separate from the base budget; therefore, funding 
decisions will be based primarily on the availability of funds and the 
priority of needs based on the justifications provided.
Supplies
    When requesting TB lab upgrade supplies, consolidate them by 
relevant item groups (e.g., (a) Microscopy, (b) Liquid Culture, (c) 
Identification, (d) Drug Testing, etc.) with the dollar amounts for 
each group. Do not use item groups such as Miscellaneous Lab Supplies 
or General Office Supplies. These type of items are not appropriate for 
funding under this program. Provide justification for each item and 
relate to specific laboratory activities.
Travel
    Dollars requested for travel for TB lab staff should be justified 
for reasons pertaining to specific program objectives (e.g., training 
in TB Lab Upgrade recommended activities, site visits to develop a 
laboratory network). Please provide details about the training 
course(s) in the justification. Meeting and conference attendance are 
not considered training under this lab upgrade program.

For All Activities

Indirect Costs
    Provide the date of the most recent indirect cost rate agreement, 
the rate or percentage, and the cost on which the rate is computed. 
Please attach a copy of the most recent and/or current indirect cost 
rate agreement. Indirect costs cannot be requested at a percentage 
greater than the approved rate, but can be requested at a percentage 
less than the approved rate.
Direct Assistance
    You may request Federal personnel as direct assistance (DA), based 
on an identified need and pending the availability of funds. DA funding 
will be administered separately and will not be a part of your base 
award. To request a Federal assignee for new position, provide 
sufficient information for CDC to develop and grade a position 
description.
    To request new direct-assistance assignees, include:
    a. Number of assignees requested.
    b. Description of the position, proposed duties, and supervisory 
responsibilities.
    c. Ability or inability to hire locally with financial assistance.
    d. Justification for request.
    e. Organizational chart and name of intended supervisor;
    f. Opportunities for training, education, and work experiences for 
assignees.
    g. Description of assignee's access to computer equipment for 
communication with CDC (e.g., personal computer at home, personal 
computer at workstation, shared computer at workstation on site, shared 
computer at a central office).
    h. A signed Agreement to Detail form.
State and Local Contributions
    As part of the application process, the grantee will be required to 
provide the amounts of State and local contributions for TB prevention, 
control, and elimination by budget category. Refer to Attachment 5.
    Additional information may be included in the application 
appendices. The appendices will not be counted toward the narrative 
page limit. This additional information should be limited to the 
following:
     Letters of Support.
     Organizational Charts.
    Any additional materials will not be reviewed.
    You are required to have a Dun and Bradstreet Data Universal 
Numbering System (DUNS) number to apply for a grant or cooperative 
agreement from the Federal government. The DUNS number is a nine-digit 
identification number, which uniquely identifies business entities. 
Obtaining a DUNS number is easy and there is no charge. To obtain a 
DUNS number, access http://www.dunandbradstreet.com or call 1-866-705-
5711. For more information, see the CDC Web site at: http://www.cdc.gov/od/pgo/funding/pubcommt.htm. If your application does not 
have a DUNS number field, please write your DUNS number at the top of 
the first page of your application, and/or include your DUNS number in 
your application cover letter.
    Additional requirements that may necessitate you to submit 
additional documentation with your application are listed in section 
``VI.2. Administrative and National policy Requirements.''

IV.3. Submission Dates and Times

    Application Deadline Date: July 26, 2004.
    Explanation of Deadlines: Applications must be received in the CDC 
Procurement and Grants Office by 4 p.m. eastern time on the deadline 
date. If you send your application by the United States Postal Service 
or commercial delivery service, you must ensure that the carrier will 
be able to guarantee delivery of the application by the closing date 
and time. If CDC

[[Page 30309]]

receives your application after closing due to: (1) carrier error, when 
the carrier accepted the package with a guarantee for delivery by the 
closing date and time, or (2) significant weather delays or natural 
disasters, you will be given the opportunity to submit documentation of 
the carrier's guarantee. If the documentation verifies a carrier 
problem, CDC will consider the application as having been received by 
the deadline.
    This program announcement is the definitive guide on application 
format, content, and deadlines. It supercedes information provided in 
the application instructions. If there are discrepancies between the 
application form instructions and the program announcement, adhere to 
the guidance in the program announcement.

IV.4. Intergovernmental Review of Applications

    Your application is subject to Intergovernmental Review of Federal 
Programs, as governed by Executive Order (EO) 12372. This order sets up 
a system for state and local governmental review of proposed federal 
assistance applications. You should contact your state single point of 
contact (SPOC) as early as possible to alert the SPOC to prospective 
applications, and to receive instructions on your state's process. 
Click on the following link to get the current SPOC list: http://www.whitehouse.gov/omb/grants/spoc.html.

IV.5. Funding Restrictions

    Restrictions that must be taken into account while writing your 
budget are as follows:
    Categorical funds are awarded for a specifically defined purpose 
and may not be used for any other purpose or program. Emphasis must be 
given to directing the majority of funds to first-line TB control 
activities. 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.
    If you are requesting indirect costs in your budget, you must 
include a copy of your indirect cost rate agreement. If your indirect 
cost rate is a provisional rate, the agreement should be less than 12 
months of age.
    Awards will not allow reimbursement of pre-award costs. Guidance 
for completing your budget can be found in attachment 2 of this 
announcement as posted on the CDC Web site.

IV.6. Other Submission Requirements

    Application Submission Address: submit the original and two hard 
copies of your application by mail or express delivery service to: 
Technical Information Management-PA 05003, CDC Procurement and 
Grants Office, 2920 Brandywine Road, Atlanta, GA 30341.
    Applications may not be submitted electronically at this time.

V. Application Review Information

V.1. Criteria

    You are required to provide measures of effectiveness that will 
demonstrate the accomplishment of the various identified objectives of 
the cooperative agreement. Measures of effectiveness must relate to the 
performance goals stated in the ``Purpose'' section of this 
announcement. Measures must be objective and quantitative, and must 
measure the intended outcome. These measures of effectiveness must be 
submitted with the application and will be an element of evaluation.
    Each activity category will be reviewed and scored separately. 
Specific criteria for each activity category are as follows:
A. TB Prevention and Control Activities
    All technically acceptable applications will be funded for TB 
prevention and control activities. The following criteria will be used 
to evaluate applications for their technical acceptability.
    (1) Objectives: (30 percent) The proposed program objectives are 
measurable, specific, time-phased, and related to the recipient 
activities, program purpose, and program need, and the proposed 
progress toward the applicable national TB objectives is appropriate 
and feasible.
    (2) Methods: (30 percent) The proposed strategies and activities 
are appropriate and feasible to achieve the stated program and 
applicable national objectives.
    (3) Program need: (20 percent) The applicant demonstrates program 
need for TB prevention and control activities in terms of annual number 
of reported TB cases (and case rates), TB suspects (patients started on 
TB treatment but later determined not to be a TB case) per verified 
case, and Class A, B1, and B2 notifications. In addition, the program 
demonstrates the contribution of factors, such as HIV prevalence, drug 
resistance and multidrug resistance rates, TB in U.S.-born minorities, 
foreign-born persons, the homeless, and substance abusers, and the 
presence of barriers to achieving the applicable national TB program 
objectives.
    (4) Evaluation: (20 percent) The evaluation plan is appropriate for 
measuring progress toward project and national TB objectives and 
identifying contributing factors when objectives are not met.
    (5) Budget: (reviewed, not scored) The budget is reasonable, 
clearly justified, consistent with the demonstrated need and proposed 
activities, and likely to lead to program success.
B. Regional TB Training and Medical Consultation Centers
    These projects will be evaluated individually against the following 
criteria by an independent review group appointed by CDC. Funding 
preference will be given to applicants that ensure geographic 
distribution of centers.
    (1) Methods: Training, Technical Assistance, and Educational/
Training Product Development (40 percent). The extent to which the 
applicant provides: (a) A description of planned activities to 
determine the training and education needs of state and local health 
department staff, health care providers, and prevention specialists 
involved in TB control and elimination activities, including a 
description of the proposed process to update the training needs of 
target audiences in their coverage area; (b) a plan for acquiring CME, 
CEU, CNE, and CHES appropriate for trainees; (c) a description of 
available facilities and equipment for training and education; (d) a 
plan to produce course materials and for providing resources to 
trainees; (e) the proposed approach to developing the training plan 
based on the center's capability and the needs assessment, that will 
provide at least 400 hours of instruction per year; (f) a description 
of their ability to provide courses using distance learning technology; 
(g) a description of plans for providing technical assistance to 
training focal points, TB ETN members, and other trainers; and (h) a 
plan for the development of high priority educational and training 
materials, including the subject matter of the material, target 
audience, format, development process, and marketing and distribution.
    (2) Methods: Medical Consultation (20 percent). The extent to which 
the applicant provides: (a) A description of the plan to determine the 
current and future needs for medical consultation in the jurisdictions 
in their assigned region in regard to appropriate medical evaluation 
and treatment of persons with active TB disease and latent TB

[[Page 30310]]

infection; (b) a description of and the appropriateness and quality of 
the plans to provide needed medical consultation; (c) a description of 
the plan to have physicians with appropriate expertise available to 
provide to consults; (d) a description of the infrastructure available 
to support medical consultation activities; and (e) a description of 
the plan to market their medical consultation services.
    (3) Evaluation: (15 percent). The extent to which the applicant 
provides: (a) a plan for utilizing program evaluation data to provide 
continuous quality improvement of training activities and material 
development processes; (b) a plan for conducting evaluation activities 
that determine the impact, outcomes, and utilization of training 
activities and educational materials; and (c) a plan to evaluate the 
effectiveness and impact of medical consultation services.
    (4) Introduction/Program Description: (15 percent). The extent to 
which the applicant provides: (a) a history of training experience and 
provision of technical assistance in training and education, and 
experience in product development; (b) a history of experience in 
providing TB medical consultation; (c) position descriptions for 
proposed RTMCC staff, including credentials and appropriate experience; 
(d) a proposed protocol for collaborating with regional, State, and 
local TB control programs, other RTMCCs, CDC, and TB-ETN members; and 
(e) a letter of endorsement from each university/college or health 
department partner stating their intent to participate in the RTMCC.
    (5) Objectives: (10 percent) The extent to which the applicant 
provides specific, measurable, time-phased, realistic objectives.
    (6) Budget: (reviewed, not scored): The extent to which the budget 
is reasonable, clearly justified, and consistent with the proposed 
plan.
C. TB Public Health Laboratory
    All technically acceptable applications will be funded for TB 
Public Health Laboratory activities. The following criteria will be 
used to evaluate applications for their technical acceptability.
    Component 1: Accomplishment of CDC recommended laboratory 
activities and turnaround times.
    (1) Objectives (30 percent): Measurable, specific, time-phased, 
relevant, realistic objectives for attaining or maintaining CDC 
recommended laboratory activities and turnaround times are described 
and related to the recipient activities, program purpose, and program 
need. The timeline for the proposed progress toward the laboratory 
objectives is appropriate and feasible.
    (2) Evaluation (30 percent): Specific performance measures and 
milestones are clearly described. The evaluation plan is appropriate 
for measuring progress toward objectives and identifying contributing 
factors when objectives are not met.
    (3) Program need (20 percent): The applicant demonstrates a need 
for upgrading laboratory activities in terms of the current performance 
of the laboratory with respect to recommended activities and turnaround 
times and the annual number of confirmed TB cases for which the 
laboratory provided any test result that was used to complete the RVCT 
form. The recommendations are described above and in Tenover, et al. 
1993. J. Clin. Microbiol. 31:767-770 and Styrt, et al. 1997. J. Clin. 
Microbiol. 35:1401.
    (4) Methods (20 percent): The proposed strategies and activities 
are appropriate and feasible to achieve the stated objectives.
    (5) Budget (not scored): The budget is reasonable, clearly 
justified, consistent with the demonstrated need and proposed 
activities, and likely to lead to success.
    Component 2: Accomplishment of the Healthy People 2010 TB 
Laboratory goal.
    (1) Objectives (30 percent): Measurable, specific, time-phased, 
relevant, realistic objectives for attaining or maintaining the Healthy 
People 2010 TB Laboratory goal are described and related to the 
recipient activities, program purpose, and program need. The timeline 
for the proposed progress toward the laboratory objectives is 
appropriate and feasible. Short term goals may include efforts to 
promote rapid delivery of specimens to the laboratory or rapid testing 
for a subset of patients or specimens; and long term goals may include 
accomplishment of the Healthy People 2010 TB Laboratory goal.
    (2) Evaluation (30 percent): Specific performance measures and 
milestones are clearly described. The evaluation plan is appropriate 
for measuring progress toward objectives and identifying contributing 
factors when objectives are not met.
    (3) Program need (20 percent): The applicant demonstrates a need 
for attaining or maintaining the Healthy People 2010 TB Laboratory goal 
in terms of the current performance of the laboratory and annual number 
of patients for whom the program laboratory confirmed an initial 
diagnosis of tuberculosis by culturing M. tuberculosis from a primary 
patient specimen. The goal is laboratory confirmation of a case of 
tuberculosis within 48 hours of specimen receipt for 75 percent of 
cases that are ultimately culture-confirmed.
    (4) Methods (20 percent): The proposed strategies and activities 
are appropriate and feasible to achieve the stated laboratory 
objectives.
    (5) Budget (not scored): The budget is reasonable, clearly 
justified, consistent with the demonstrated need and proposed 
activities, and likely to lead to success.
    Component 3. Development of a system to provide timely and reliable 
laboratory testing in support of TB treatment and control efforts.
    (1) Objectives (30 percent): Measurable, specific, timephased, 
relevant, realistic objectives for developing a system to provide 
timely and reliable laboratory testing in support of TB treatment and 
control efforts are described and related to the recipient activities, 
program purpose, and program need. The timeline for the proposed 
progress toward the laboratory objectives is appropriate and feasible. 
Short term objectives may include assessing the structure, performance, 
and cost of the current network of laboratory service providers and 
users; medium term goals may include developing a referral and 
information network to ensure reliable testing and the timely flow of 
specimens and information; and long term goals may include using 
quality improvement principles to continually evaluate and improve the 
performance of the laboratory service network.
    (2) Evaluation (30 percent): Specific performance measures and 
milestones are clearly described. The evaluation plan is appropriate 
for measuring progress toward objectives and identifying contributing 
factors when objectives are not met.
    (3) Program need (20 percent): The applicant demonstrates a need 
for developing a system to provide timely and reliable laboratory 
testing in support of TB treatment and control efforts.
    (4) Methods (20 percent): The proposed strategies and activities 
are appropriate and feasible to achieve the stated laboratory 
objectives.
    (5) Budget (not scored): The budget is reasonable, clearly 
justified, consistent with the demonstrated need and proposed 
activities, and likely to lead to success.
    Protection of Human Subjects from Research Risks: Does the 
application adequately address the requirements of title 45 CFR part 46 
for the protection

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of human subjects? This will not be scored; however, 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.

V.2. Review and Selection Process

    Applications will be reviewed for completeness by the Procurement 
and Grants Office (PGO) staff, and for responsiveness by NCHSTP/DTBE. 
Incomplete applications and applications that are non-responsive to the 
eligibility criteria will not advance through the review process. 
Applicants will be notified that their application did not meet 
submission requirements.
    An objective review panel will evaluate complete and responsive 
applications according to the criteria listed in the ``V.1. Criteria'' 
section above.

V.3. Anticipated Announcement and Award Dates

    Awardees will be notified on or before January 1, 2005.

VI. Award Administration Information

VI.1. Award Notices

    Successful applicants will receive a Notice of Grant Award (NGA) 
from the CDC Procurement and Grants Office. The NGA shall be the only 
binding, authorizing document between the recipient and CDC. The NGA 
will be signed by an authorized Grants Management Officer, and mailed 
to the recipient fiscal officer identified in the application.
    Unsuccessful applicants will receive notification of the results of 
the application review by mail.

VI.2. Administrative and National Policy Requirements

    45 CFR part 74 and part 92.
    For more information on the Code of Federal Regulations, see the 
National Archives and Records Administration at the following Internet 
address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html.
    The following additional requirements apply to this project:
     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.
    Additional information on these requirements can be found on the 
CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm.

VI.3. Reporting Requirements

A. TB Prevention and Control Activities
    You must provide CDC with an original and two hard copies of:
    (1) Annual Progress Report: The annual progress report summarizes 
the activities conducted during the previous budget period and 
documents the impact federally funded items have had in the achievement 
or progress of the goals and objectives of the project. This report is 
due 90 days after the end of the budget period (March 31). The annual 
progress report shall include:
    (a) Brief project description.
    (b) Overall program performance and progress of approved recipient 
activities as measured against the recipient activities outlined in the 
program's approved application and any subsequent amendments. Narrative 
describing major accomplishments in prevention and control activities 
in the project area. In addition, include a table with five years 
trends for all national objectives.
    (c) Measures of Effectiveness: The grantee shall provide objective 
and measurable indicators that demonstrate the accomplishment of the 
various identified objectives of the award agreement. When a project is 
not meeting the specified objectives, a written discussion shall be 
included concerning how the activities were evaluated, the obstacles 
identified, and the proposed strategies to address the identified 
problem(s). It is recommended that the following format be utilized to 
convey this information:
    Objective:
    Status: (Met, Ongoing, Unmet)
    Discussion:
    (d) Overall Program Budget Issues: Identify any issues that may 
have or have had an impact on successful program performance.
    (e) Financial Status Report due no more than 90 days after the end 
of the budget period.
    (2) Interim Progress Report/Non-Competing Continuation Application: 
The Interim Progress report details the programmatic and fiscal 
activities conducted during the current budget period and documents the 
proposed activities and objectives for the upcoming new budget period. 
Current budget period activities are considered those activities 
initiated since the beginning of the current budget period to the date 
of the interim progress report. New budget period proposed activities 
are those for the following year's budget period. Submission of the 
completed Interim Progress Report and information requested in the 
Solicitation of Non-Competing Continuation Notification letter (see 
Attachment 4) shall constitute the grantee's non-competing continuation 
application. This report is due 90 days prior to the end of the budget 
period (September 30). The principal investigator shall sign the 
Interim Progress report. The project director and business office 
official shall sign the accompanying detailed budget and budget 
justification. The Interim Progress Report shall include:
    (a) Current Budget Period Activities Objectives: For each 
objective, list the status, and provide a brief written discussion. 
Include in this discussion for each objective a description of lessons 
learned, barriers encountered, and how the barriers were addressed. 
Include a discussion of the reasons why goals were not met. Problems, 
delays, or adverse conditions, which materially impair the ability to 
meet the objectives of the award, shall be included in the discussion 
with a statement of action taken or contemplated and any assistance 
needed to resolve the situation. It is recommended that the following 
format be utilized:
    Objective:
    Status: (Met, Ongoing, or Unmet)
    Discussion:
    (b) Current Budget Period Financial Progress: Provide an estimate 
of the overall obligations for the current budget period.
    i. If unobligated funds are anticipated at the end of the current 
budget period based on the current rate of obligation, provide detailed 
actions to be taken to obligate the estimated unobligated amount before 
the end of the current budget period, including the identification of 
vacant positions or contracts that have not been executed. If it is 
anticipated that the estimated unobligated amount will not be obligated 
by the end of the current budget period, the grantee can request that 
these unobligated funds be carried over to the new budget period if 
those unobligated funds are still required to support the program.
    ii. If it is estimated that insufficient funding remains to support 
the project to the end of the current budget period, provide detailed 
justification of the

[[Page 30312]]

shortfall and the anticipated or taken actions to bring the obligations 
in line with the authorized funding level, or request supplemental 
funds.
    (c) New Budget Period Program Proposed Activity Objectives:
    List new proposed objectives for the upcoming budget period. These 
proposed objectives must support the intent of the original program 
announcement. Each objective shall be time-phased, measurable, and have 
a performance or outcome measure by which the success of the objectives 
can be assessed. For each objective, list proposed activities that will 
be implemented to accomplish the objective. Provide a timeline for 
objective accomplishment. If there is a redirection of activities, the 
grantee shall identify, justify and explain the methodology for the 
implementation of the redirection. The detailed line-item budget to 
support this proposed new budget period program activity, as requested 
in the Solicitation of Non-Competing Continuation Notification letter, 
shall be attached to the interim progress report.
    (3) Final Financial Status Report and Final Progress Report due no 
more than 90 days after the end of the project period.
    These reports must be mailed to the Grants Management or Contract 
Specialist listed in the ``Agency Contacts'' section of this 
announcement.
B. Regional TB Training and Medical Consultation Centers
    (1) Additional supporting documentation: As part of the annual TB 
Cooperative Agreement progress report (in a separate section), the 
grantee will be required to provide additional RTMCC supporting 
documentation in the following areas:
    (a) List of regional training courses and medical consultation 
provided during the year.
    (b) Evaluation data--Reports should include measuring appropriate 
process indicators (e.g., trainee demographics, quality of training, 
distribution of products, Web use), immediate training outcomes (e.g., 
changes in knowledge, attitudes, and skills) and where possible, long-
range impact (e.g., changes in provider practice behavior, changes in 
service delivery).
    (c) Resource allocation--amount of human resource time (percent) 
and dollar expenditure for training, education, and medical and 
technical consultation activity should be provided. In addition, 
resource allocation for printing, travel, consultation services, and 
supplies should be provided. Breakdown of each RTMCC employee's percent 
effort on varied RTMCC activities.
    (d) Summary of product distribution (including Web trends for Web-
based products) and other evaluation data.
    (e) Status of stated objectives.
    (f) Strategies for marketing training, educational materials, and 
medical consultation services.
    (g) Status of regional needs assessment for training and education 
and medical consultation including timelines for implementation of 
plans.
    (h) Results of evaluations conducted on center activities.
    (i) Listing of RTMCC activities not funded by CDC, and RTMCC 
employee efforts on such activities.
    (2) Annual Progress Report: Refer to the Annual Progress Report 
section above, for reporting requirements.
    (3) Interim Progress Report/Non-Competing Continuation Application: 
Refer to the Interim Progress Report/Non-Competing Continuation 
Application section above, for reporting requirements.
C. TB Public Health Laboratory
    (1) Annual Progress Report: Refer to the Annual Progress Report 
section above, for reporting requirements.
    (2) Interim Progress Report/Non-Competing Continuation Application: 
Refer to the Interim Progress Report/Non-Competing Continuation 
Application section above, for reporting requirements.

VII. Agency Contacts

    For general questions about this announcement, contact:
    Technical Information Management Section, CDC Procurement and 
Grants Office, 2920 Brandywine Road, Atlanta, GA 30341. Telephone: 770-
488-2700.
    For program technical assistance, contact: Zachary Taylor, MD, MS, 
Project Officer, Division of Tuberculosis Elimination, Centers for 
Disease Control and Prevention, 1600 Clifton Rd., NE., Atlanta, GA 
30333. Telephone: 404-639-8126, e-mail: [email protected].
    For financial, grants management, or budget assistance, contact: 
Jesse Robertson, Grants Management Specialist, CDC Procurement and 
Grants Office, 2920 Brandywine Road, Atlanta, GA 30341. Telephone: 770-
488-2747, e-mail: [email protected].

    Dated: May 21, 2004.
William P. Nichols,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 04-11999 Filed 5-26-04; 8:45 am]
BILLING CODE 4163-18-P