[Federal Register: May 27, 2004 (Volume 69, Number 103)]
[Notices]
[Page 30300-30312]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27my04-62]
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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.
[[Page 30304]]
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://
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
[[Page 30311]]
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: ZTaylor@cdc.gov.
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: JRobertson@cdc.gov.
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