A. Objectives
1. To collect and establish baseline data on the incidence and
prevalence of (multi-)drug resistant tuberculosis in the
territory of the authorities represented by the Coordination
Council for North American Affairs (CCNAA), since renamed the
Taipei Economic and Cultural Representative Office in the
United States (TECRO) and evaluate the treatment procedure of
treatment.
2. To evaluate the burden, cost-benefit, effectiveness, and
impact on measures undertaken for the Directly Observed
Therapy Short-course (DOTS) program in the territory of the
authorities represented by TECRO.
3. To evaluate and assess the tuberculosis (TE) infection
prevention interventions in the territory of the authorities
represented by TECRO, including new technical skills.

The activities described in this Implementing Arrangement should
be carried out under the general terms and conditions
established between the American Institute in Taiwan (AIT) and
the CCNAA, in the Guidelines for a Cooperative Program in Public
Health and Preventive Medicine, hereinafter referred to as the
Guidelines.

The AIT designated topic coordinator for the activities
described in this Implementing Arrangement is:

Kenneth G. Castro, M.D.
Director, Division of Tuberculosis Elimination
National Center for HIV, Viral Hepatitis, STD, and TB
Prevention
Centers for Disease Control and Prevention
U.S. Department of Health and Human Services

The TECRO designated topic coordinator for the
activities described in this
Implementing Arrangement is:
Steve Hsu-Sung Kuo M.D., MPH, Ph.D.
Director, Center for Disease Control
Taiwan


B. Services
AIT, through its designated representative the Centers for
Disease Control and Prevention (CDC) within the United States
Department of Health and Human Services (BI-IS), intends to
provide the following services:
1. To provide technical assistance in preparing study protocol
and data collection forms, supervision of data collection,
data analysis, and manuscript preparation.
2. To share the experiences of TB treatment, especially on
(multi-) drug-resistant tuberculosis ((M) DR-TB).
3. To provide training programs for staff sent by TECRO's
designated representative the Center for Disease Control of
Taiwan (Taiwan. CDC) including in policymaking, outbreak
investigation, internal and external evaluation DOTS, and
other related public health or medical fields.
4. To provide training programs for staff sent by TECRO's
designated representative Taiwan CDC including in laboratory
diagnosis of TB and internal and external evaluation of
quality control,
5. To provide technical assistance in assessing current TB
infection control practices and making recommendations for
possible improvements through administrative, engineering,
and personal protective controls,
6. To provide expertise and assistance in planning and
implementing the training.
TECRO, through its designated representative Taiwan CDC, intends
to provide the following services:
1. Facilitating the international cooperative study of
management of chronic and drug resistant cases.
2. Analyzing indicator data of pre-DOTS and post-DOTS era for
internal and external evaluation of DOTS.
3. Facilitating the international cooperative study of
laboratory molecular diagnosis and drug susceptibility of
chronic and drug resistant cases,
4. Sharing the data of TB strains/ or other related
epidemiological information in the territory of the
authorities represented by TECRO.


C. Implementation Plans
In Year one, the services described in section B. above are to
be implemented through the following plans:
1. To collect epidemiology and laboratory data of TB strains and
(M) DR-TB for establishing baseline data on the incidence and
prevalence of (M) DR-TB in the territory of the authorities
represented by TECRO.
2. To collect the data for analysis and evaluation of the DOTS
program.
3. One to two experts from AIT's designated representative
HHS/CDC and other institutions of the territory of the
authorities represented by AIT are expected to visit the
territory of the authorities represented by TECRO once to
twice a year, to assist with study design in external
evaluation of policy which includes DOTS programs.
4. To select one to two staff from TECRO’s designated
representative Taiwan CDC or affiliated institutes to visit
AIT’s designated representative HHS/CDC and designated
institutions once or twice a year, on trips that should take
one to three months, to collect information on policy making,
outbreak investigation, and the DOTS program.
5. To select one to two staff from TECRO's designated
representative Taiwan CDC to visit AIT's designated
representative HHS/CDC's laboratory and designated institutes
once or twice a year, on trips that should take one to three
months, to collect information on laboratory diagnosis of TB
and internal and external evaluation of quality control.
6. One to two laboratory and treatment experts from AIT's
designated representative HHS/CDC and other institutions of
the territory of the authorities represented by AIT to visit
the territory of the authorities represented by TECRO to
share experiences and update knowledge of clinical and
laboratory work.
In Year two, the services described in section B. above are
expected to be implemented through the following plans. In-the
meantime, the international cooperative study of management of
chronic and multiple drug resistant cases or laboratory
molecular diagnosis and drug susceptibility of chronic and
multiple drug resistant cases should be started at least with
the commencement of data collection.
1. To collect and analyze epidemiological and laboratory data of
TB strains and (M)DR-TB.
2. To analyze and monitor the progress of the DOTS programs.
3. To select one to two staff from TECRO's designated
representative Taiwan CDC or affiliated hospitals to visit
AITs designated representative HHS/CDC and designated
institutes once or twice a year, on trips that should take
one to three months, to collect the information mentioned
above in section B, including how to conduct the
international cooperative study of management of chronic and
multiple drug-resistant cases.
4. To select one to two staff from TECRO's designated
representative Taiwan CDC to visit AIT’s designated
representative HHS/CDC' laboratory and designated institutes
once or twice a year, on trips that should take one to three
months, to collect the information mentioned above in section
B including laboratory molecular diagnosis and drug
susceptibility of chronic and multiple drug resistant cases..
5. To select one to two hospitals or medical centers of
excellence in the territory of the authorities represented by
TECRO, to which patients of chronic and multiple drug
resistant TB are referred for treatment, to conduct the study
on management of chronic and multiple drug resistant cases,
laboratory molecular diagnosis and drug susceptibility of
chronic and multiple drug resistant cases.
6. One to two experts from AIT’s designated representative
HHS/CDC may visit the territory of the authorities
represented by TECRO once or twice a year, on trips that are
each expected to take a week, to assist in implementing the
study.
In Years three, four and five, the services described in B.
above are expected to be implemented through the following plans:
Based on the staff training and communication between the
designated representatives of AIT and TECRO in the first 2 years
of program, the study is expected to be conducted according to
the study protocol established in year 2.


D. Financial Arrangements
1. All costs for implementation of the program components
conducted in the territory of the authorities represented by
TECRO are expected to be born by TECRO's designated
representative, Taiwan CDC. AIT and TECRO intend that the
cost for the activity described in the Implementation Plans
for Year One of this Implementing Arrangement is not to
exceed N.T. $6,000,000 (approx. U.S. $200,000). Costs for
Years 2-5 are expected to be approved by TECRO's designated
representative the Department of Health, Taiwan, depending on
the evaluation of cost-effective analyses, reports, and data
from the first year. Funds should be granted to the principal
investigator / program coordinator in the territory of the
authorities represented by TECRO by TECRO's designated
representative Taiwan CDC.
2. TECRO's designated representative Taiwan CDC is expected to
bear the fares of international travel and associated local
costs for visits of its staff to the territory of the
authorities represented by AIT and also for the visiting
experts from the territory of the authorities represented by
AIT.
3. Should the designated representatives of AIT and TECRO,
HHS/CDC and Taiwan CDC respectively, hold any conference or
symposium on a related subject and invite mutual scholar(s)
to attend, costs for the trip are to be shared as follows:
the sending party should bear the international travel fares
of its staffs. The receiving party should provide the local
costs of the visit.
4. AIT and its designated representative HHS/CDC's Division of
Tuberculosis Elimination do not commit any funds through this
Implementing Arrangement.


E. Intellectual Property Considerations
No intellectual property rights (IPR) are expected to arise in
conjunction with activities described in this Implementing
Arrangement. TECRO and its designated representative, Taiwan
CDC, are requesting AIT's designated representative HHS/CDC's
expertise and knowledge to assess the risk of M. tuberculosis,
including (M)DR-TB transmission. The objective of the
cooperative activities is to strengthen tuberculosis infection
control activities in the territory of the authorities
represented by TECRO. Reference reagents may be provided. None
of these activities are to be patented.
Data/Results from the annual program are not to be distributed
to other parties until they have been approved in final form by
AIT's designated representative HHS/CDC Division of Tuberculosis
Elimination, and TECRO's designated representative Taiwan CDC.


F. Effective Date
This Implementation Arrangement is to become effective on the
date of the last signature hereafter.


G. Amendment and Termination
This Implementing Arrangement may be modified by mutual consent
of AIT and TECRO or terminated at the discretion of either AIT
or TECRO.


IN WITNESS WHEREOF, the undersigned, being duly authorized have
signed this Implementing Arrangement.

DONE at Washington, in duplicate, in the English language.



FOR THE TAIPEI FOR THE AMERICAN
ECONOMIC INSTITUTE IN TAIWAN
AND CULTURAL
REPRESENTATIVE
OFFICE IN THE UNITED
STATES
Huang Wei-Feng Barbara J. Schrage
Deputy Representative Managing Director
Date: 6/18/2008 Date: 4/16/2008