Cooperative Agreement for International Emerging Infections Program Surveillance in Thailand; Notice of Availability of Funds

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Federal RegisterJun 24, 2002
67 Fed. Reg. 42567 (Jun. 24, 2002)

A. Purpose

The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2002 funds for a cooperative agreement program for International Emerging Infections Surveillance in Thailand.

The purpose of the program is to provide assistance to the Thailand Ministry of Public Health to conduct population-based surveillance for emerging infections in Thailand in collaboration with the International Emerging Infections Program (IEIP).

The objectives of this program are to (1) establish an active, populations-based surveillance network that uses standardized data collection instruments, operational definitions, and laboratory diagnostic tests to enhance surveillance for severe pneumonia in Sa Kaeo Province; (2) use the experience gained from the first six months of surveillance in Sa Kaeo to expand the surveillance system to include one additional province and two additional syndromes; (3)improve local laboratory diagnostic capabilities by supporting and enhancing those local laboratories that participate in IEIP surveillance; (4) develop educational and training opportunities for local public health practitioners as part of broader efforts to improve public health infrastructure in the region; and (5) improve communications and data exchange between public health officials by electronically linking IEIP surveillance sites, laboratories, and provincial and national epidemiologists.

Measurable outcomes of the program will be in alignment with one or more of the following performance goals for the National Center for Infectious Diseases: (1) Apply scientific findings to prevent and control infectious diseases and (2) Strengthen epidemiologic and laboratory capacity to recognize, respond to, and monitor infectious diseases.

B. Authority and Catalog of Federal Domestic Assistance Number

This program is authorized under section 301 and 307 of the Public Health Service Act [42 U.S.C. 241 and 242l], as amended. The Catalog of Federal Domestic Assistance number is 93.283.

A. Eligible Applicants

Assistance will be provided only to the Ministry of Public Health, Thailand. No other applications are solicited.

The Thai Ministry of Public Health is the only qualified agency to conduct the activities specified under this cooperative agreement because:

1. The Ministry of Public Health is the governmental agency in Thailand legally responsible for disease surveillance activities and provides norms for provincial health department and local jurisdiction surveillance and disease investigation.

2. Within the Thai Ministry of Public Health are the Department of Communicable Disease Control (Thai CDC), the Department of Medical Sciences (including the Thai National Institute of Health), and the office of the Permanent Secretary (including the Division of Epidemiology), organizations responsible for national epidemiologic surveillance and national public health reference laboratory testing and training.

3. The IEIP Thailand has established a working group which includes representatives of the Thai CDC, the Thai NIH, and the Division of Epidemiology. This working group reports to a Steering Committee, which derives its authority from the Executive Committee for the Thai MOPH-US CDC Collaboration (TUC). The IEIP working group will be the principal collaborative mechanism for directing the surveillance system.

D. Availability of Funds

Approximately $200,000 is available in FY 2002 to fund one award. It is expected that the award will begin on or about September 30, 2002, and will be made for a 12-month budget period within a project period of up to five years. The funding estimate may change.

Continuation awards within an approved project period will be made on the basis of satisfactory progress as evidenced by required reports and the availability of funds.

Use of Funds

1. All requests for funds, including the budget contained in the application, shall be stated in U.S. dollars. Once an award is made, the Department of Health and Human Services (DHHS) will not compensate foreign grantees for currency exchange fluctuations through the issuance of supplemental awards.

2. Funds may be spent for reasonable program purposes, including personnel, travel, supplies, and services. Equipment may be purchased if deemed necessary to accomplish program objectives, however, the IEIP working group must be notified in advance of such purchases.

3. The costs that are generally allowable in grants to domestic organizations are likewise allowable to foreign institutions and international organizations, with the following exceptions:

Indirect Costs: With the exception of the American University, Beirut, the Gorgas Memorial Institute, and the World Health Organization, indirect costs will not be paid (either directly or through a sub-award) to organizations located outside the territorial limits of the United States or to international organizations regardless of their location, major alteration and renovation, customs and import duties, and, with limited exception, patient care.

4. The majority of funds are expected to directly support costs associated with strengthening the quality of the IEIP program, epidemiologist and laboratory staff salaries. Remaining funds are expected to support a coordinated approach to monitoring and evaluation, and integration of IEIP into the national surveillance program.

E. Program Requirements

In conducting activities to achieve the purpose of this program, the recipient will be responsible for the activities under 1. Recipient Activities, and CDC will be responsible for the activities listed under 2. CDC Activities.

1. Recipient Activities

a. Identify staff at the national level to work on an active, population-based surveillance system in collaboration with IEIP U.S. staff.

(1) The Division of Epidemiology will identify an epidemiologist to act as the National Epidemiology Coordinator for the active, population-based surveillance system. This person will work closely with the Chief of Epidemiology, IEIP.

(2) The Division of Epidemiology will support one Foreign Epidemiology Training Program (FETP) fellow whose primary role will be to assist with the active, population-based surveillance system.

b. In collaboration with Sa Kaeo Province, expand active, population-based surveillance for radiologically-confirmed pneumonia to include surveillance for two additional syndromes.

(1) Coordinate with provincial staff to assure that appropriate staff are hired as surveillance officers.

(2) Coordinate with provincial staff to assure that appropriate laboratory equipment is purchased.

c. Expand the active, population-based surveillance system to a second province. Collaborate via the IEIP working group to confirm site selection.

(1) Provide transportation costs for site visits during the selection process.

(2) Coordinate with provincial staff to assure that appropriate equipment is purchased (e.g., computers and laboratory equipment).

(3) Coordinate with provincial staff to assure that appropriate staff are hired to coordinate and run the surveillance system.

(4) Coordinate with provincial staff to assure that appropriate office space and support is available for surveillance personnel.

(5) Coordinate with provincial staff to provide transportation of personnel and clinical specimens when necessary.

d. Provide administrative support to assure that the personnel employed to work on the surveillance system are paid promptly according to a standard pay schedule.

e. Provide in-kind support for the following activities:

(1) Travel within Thailand of the national coordinator and the provincial staff to assist with surveillance activities.

(2) Perform and support the cost of reference diagnostic testing for specimens from the surveillance system.

(3) Office space and telephones for the national coordinator and the provincial surveillance officers.

f. Collaborate with all organizations in the context of the surveillance activities to broaden the exchange of infectious disease epidemiologic data between the United States and Thailand to improve the global prevention and control of infectious diseases.

g. Collaborate with all organizations in the context of the surveillance activities to foster binational collaboration in the investigation of disease outbreaks which affect communities in the provinces under surveillance. Such collaboration may involve binational teams working according to agreed-upon protocols.

2. CDC Activities

a. Provide assistance and technical consultation on all aspects of program planning, implementation, and evaluation methods, as needed.

b. Provide scientific support and training, and participate in study protocol development, epidemiological and laboratory studies, data management and analysis, writing, and dissemination of information by relevant means.

c. Provide scientific support, as needed, in the development and support of a research agenda.

d. Provide special reagents or other materials, as needed to conduct surveillance and research.

e. Assist in the development of a research protocol for Institutional Review Board (IRB) review by all cooperating institutions participating in the research project. The CDC IRB will review and approve the protocol initially and on at least an annual basis until the research project is completed.

F. Content

The Program Announcement title and number must appear in the application. Use the information in the Program Requirements, Other Requirements, and Evaluation Criteria sections to develop the application content. Your application will be evaluated on the criteria listed, so it is important to follow them in laying out your program plan. The narrative should be no more than twenty pages, double-spaced, printed on one side, with one-inch margins, and unreduced font.

The narrative should consist of:

1. Plan

2. Documented Results

3. Capacity

4. Proposed Program Plan

(a) Goals

(b) Objectives

(c) Operational Plan

(d) Evaluation Plan

(e) Collaborations

5. Budget, with Staffing Breakdown and Justification Provide a line-item budget and narrative justification for all requested costs, and separate line-item budgets for each research area. Budgets should be consistent with the purpose, objectives and research activities and include:

a. Line-item breakdown and justification for all personnel, i.e., name, position title, annual salary, percentage of time and effort, and amount requested.

b. For each contract: (1) Name of proposed contractor; (2) breakdown and justification for estimated costs; (3) description and scope of activities to be performed by contractor; (4) period of performance; (5) method of contractor selection (e.g., sole-source of competitive solicitation); and (6) methods of accountability.

Activities for all priority research areas should be clearly identified in a distinct portion of the Operational Plan. Although the activities proposed may address distinct issues and needs, they may be implemented in an integrated manner such that staff members work on more than one activity, or supplies and equipment are shared.

G. Submission and Deadline

Submit the original and two copies of PHS-398 (OMB Number 0925-0001) (adhere to the instructions on the Errata Instruction Sheet for PHS 398). Forms are available in the application kit and at the following Internet address: http://www.cdc.gov/od/pgo/forminfo.htm

Application forms must be submitted in the following order:

Cover Letter

Table of Contents

Application

Budget Information Form

Budget Justification

Checklist

Assurances

Certifications

Disclosure Form

HIV Assurance Form (if applicable)

Human Subjects Certification (if applicable)

Narrative

The application must be received on or before 5 p.m. Eastern Time August 1, 2002. Submit the application to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement.

Deadline: Letters of intent and applications shall be considered as meeting the deadline if they are received before 5 p.m. Eastern Time on the deadline date. Applicants sending applications by commercial delivery services must ensure that the carrier will be able to guarantee delivery of the application by the closing date and time. If an application is received 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, CDC will upon receipt of proper documentation, consider the application as having been received by the deadline.

An application which does not meet the above criteria will not be eligible for competition and will be discarded. Applicant will be notified of their failure to meet the submission requirements.

H. Evaluation Criteria

The applicant is 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 as stated in section “A. Purpose” of this announcement. Measures must be objective and quantitative and must measure the intended outcome. These Measures of effectiveness shall be submitted with the application and shall be an element of evaluation.

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

1. Objectives and Technical Approach (50 points total):

a. Extent to which applicant describes specific objectives of the proposed program that are consistent with the purpose and goals of this announcement and which are measurable and time-phased. (10 points)

b. Extent to which the applicant identifies appropriate populations for study, with an adequate size to perform the proposed studies. (10 points)

c. Extent to which applicant presents a detailed operational plan for initiating and conducting the program, which clearly and appropriately addresses all recipient activities. Extent to which applicant clearly identifies specific assigned responsibilities for all key professional personnel. Extent to which the plan clearly describes applicant's technical approach/methods for developing and conducting the proposed program and evaluation and extent to which the plan is adequate to accomplish the study objectives. If research involving human subjects is proposed, the degree to which the applicant has met the CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research. This includes: (1) The proposed plan for the inclusion of both sexes and racial and ethnic minority populations for appropriate representation; (2) the proposed justification when representation is limited or absent; (3) a statement as to whether the design of proposed studies is adequate to measure differences when warranted; and (4) a statement as to whether the plans for recruitment and outreach for study participants include the process of establishing partnerships with community/ies and recognition of mutual benefits. The extent to which applicant describes the existence of or plans to establish partnerships. (10 points)

d. Extent to which applicant describes adequate and appropriate collaborations with other health agencies during various phases of the project. (10 points)

e. Extent to which applicant provides a detailed and adequate plan for evaluating program results. This includes plans for evaluating specific projects as well as plans for evaluating other aspects of the collaboration (e.g., training). (10 points)

2. Capacity (35 points total):

a. Extent to which applicant describes adequate resources and facilities (both technical and administrative) for conducting the project. This includes the capacity to conduct quality laboratory measurements. (20 points)

b. Extent to which applicant documents that professional personnel involved in the project are qualified and have past experience and achievements in research and programs related to the program as evidenced by curriculum vitae, publications, etc. (15 points)

3. Background and Need (10 points):

Extent to which applicant's discussion of the background for the proposed project demonstrates a clear understanding of the purpose and objectives of this cooperative agreement program. Extent to which applicant illustrates and justifies the need for the proposed project that is consistent with the purpose and objectives of this program.

4. Measures of Effectiveness (5 points):

The extent to which the applicant provides Measures of Effectiveness that will demonstrate the accomplishment of the various identified objectives of the grant. The degree to which the measures are objective/quantitative and adequately measure the intended outcome.

5. Budget and Justification (not scored): Extent to which the proposed budget is reasonable, clearly justifiable, and consistent with the intended use of cooperative agreement funds.

6. Protection of Human Subjects (Not scored) The extent to which the application adequately addresses the requirements of Title 45 CFR Part 46 for the protection of human subjects. (Not 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.)

VII. Other Requirements

Technical Reporting Requirements Provide CDC with original plus two copies of:

1. Semi-annual progress reports. The progress report will include a data requirement that demonstrates measures of effectiveness.

2. Financial status report, no more than 90 days after the end of the budget period.

3. Final financial and performance reports, no more than 90 days after the end of the project period.

Awardee is required to obtain an annual audit of these CDC funds (program specific audit) by a U.S. based audit firm with international branches and current license/authority in-country, and in accordance with International Accounting Standards or equivalent.

A fiscal Recipient Capability Assessment may be required, pre or post award, with the potential Awardee in order to review their business management and fiscal capabilities regarding the handling of U.S. Federal funds.

Send all reports to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement.

The following additional requirements are applicable to this program. For a complete description of each, see Attachment I of the application kit.

AR-1 Human Subjects Requirements

AR-2 Requirements for Inclusion of Women and Racial and Ethnic Minorities in Research

AR-9 Paperwork Reduction Act Requirements

AR-10 Smoke-Free Workplace Requirements

AR-14 Accounting Systems Requirement

AR-22 Research Integrity

J. Where To Obtain Additional Information

This and other CDC announcements, the necessary applications, and associated forms can be found on the CDC home page Internet address— http://www.cdc.gov. Click on “Funding” then “Grants and Cooperative Agreements.”

For business management assistance, contact: Cynthia Collins, Grants Management Specialist, International and Territories Acquisition and Assistance Branch, Procurement and Grants Office, Centers for Disease Control and Prevention, 2920 Brandywine Road, Room 3000, Atlanta, GA 30341-4146, Telephone number: 770-488-2757, E-mail address: coc9@cdc.gov

For program technical assistance, contact: Sonja Olsen, Ph.D., Epidemiology Section Chief, International Emerging Infections Program, National Center for Infectious Diseases, Centers for Disease Control and Prevention (CDC), DMS building 6, Ministry of Public Health, Thanon Tivanon, Nonthaburi, Thailand, Telephone number: +66-2-591-8358, E-mail address: sco2@cdc.gov

Dated: June 18, 2002.

Edward Schultz,

Acting Director, Procurement and Grants Office Centers for Disease Control and Prevention.

[FR Doc. 02-15829 Filed 6-21-02; 8:45 am]

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