SOLICITATION NOTICE
B -- Russia MDR TB Project Coordinator
- Notice Date
- 5/31/2006
- Notice Type
- Solicitation Notice
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, Center for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, GA, 30341-4146
- ZIP Code
- 30341-4146
- Solicitation Number
- 200-2006-Q-32307
- Response Due
- 6/14/2006
- Archive Date
- 6/15/2006
- Description
- This notice is a combined synopsis/solicitation for professional, scientific, and technical services prepared in accordance with the FAR Subpart 12.6 and FAR Subpart 13.106. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. The procurement is being issued as a request for quotation. Submit offers on Solicitation Number: 2006-Q-32307. The solicitation is being issued as a request for quotation. he solicitation documents and incorporated provisions and clauses are those in effect through Federal Action Circular 2005-04, dated June 8, 2005. This acquisition will be processed under Simplified Acquisition Procedures and is not a Small Business Set-Aside. The North American Classification System (NAICS) code for this procurement is 541990. The Centers for Disease Control and Prevention (CDC) has a requirement for a vendor to measure the rate of, and risk factors for amplification of resistance to second-line drugs where amplification is defined as second-line drug resistance that develops during treatment. This will be determined by examining the drug susceptibility test (DST) results of a follow-up isolate compared to a baseline isolate. DNA fingerprinting will ensure that the same strain of TB is being observed. Standardized patient and laboratory data will be collected to examine factors that may affect amplification of resistance. MDR TB treatment outcomes will also be evaluated to determine the impact of amplification of resistance to 2nd-line drugs. I. BACKGROUND Russia is affected by high rates of multi-drug resistant (MDR) Tuberculosis (TB), which is an indication of poor TB control in the past. In the same way MDR TB develops from (mis)use of first-line drugs, expanded use of second-line drugs (SLDs) will result in the emergence of resistance to SLDs. Foreseeing this problem, the World Health Organization established the Green Light Committee (GLC) to provide access to low-cost, high-quality SLDs to TB control programs that will use them properly. To obtain these drugs, the TB program must demonstrate political commitment, adequate financial resources, solid basic TB services by international standards, laboratory and programmatic capacity for MDR TB, and a clinical protocol consistent with WHO guidelines for Directly Observed Therapy Short Course (DOTS)-Plus programs. The GLC evaluates, provides technical assistance, and monitors the project for adherence and outcomes. The experience of GLC-approved DOTS-Plus programs will provide evidence for strategies to combat MDR TB in Russia and worldwide. To assist the Russian Federation in addressing the problem of MDR TB, this project will evaluate the extent to which the GLC has achieved its goals of increasing access while preventing resistance to second-line anti-TB drugs. II. PURPOSE The project is a multinational, prospective, observational study of patients being treated with second-line drugs for MDR TB. The primary goal is to measure the rate of, and risk factors for amplification of resistance to second-line drugs where amplification is defined as second-line drug resistance that develops during treatment. This will be determined by examining the drug susceptibility test (DST) results of a follow-up isolate compared to a baseline isolate. DNA fingerprinting will ensure that the same strain of TB is being observed. Standardized patient and laboratory data will be collected to examine factors that may affect amplification of resistance. MDR TB treatment outcomes will also be evaluated to determine the impact of amplification of resistance to 2nd-line drugs. III. SCOPE OF WORK The contractor will assist CDC in developing and implementing this research project in Russia, by providing appropriate technical, operational, and administrative support. This will include obtaining to obtain official approval of the project protocol in the Russian Federation (RF) by the RF Ministry of Health and Social Development, Federal TB Research Institutes, and local authorities in Tomsk and Arkhangelsk oblasts. The contractor will coordinate the project activities in these two sites. Such activities will include but will not be limited to enrolling eligible patients, obtaining and validating patient and laboratory data as specified in the final study protocol, transmitting data, shipping isolates to CDC, training Russian participants, monitoring the implementation of the project, and analyzing data. IV. TASKS The contractor will provide services as follows: (1) Assist CDC with revision of the protocol according to the RF requirements and specifications, including facilitating input from Russian specialists who will be involved in the project and preparing Russian-language translation of the protocol; (2) Ensure the project receives formal written approval from the Ministry of Health and the Federal TB Research Institutions (TBRIs) (3) Supervise the two territories (Tomsk and Arkhangelsk) selected to participate in the project; (4) Obtain written approval by appropriate Russian authorities to ship isolates from participating territories to CDC in Atlanta (actual shipments will be carried out through a separate contract with World Courier or other specialized shipping agency). (5) Collaborate and coordinate efforts with the Global Coordinating Center at CDC, Atlanta to plan logistics of patient enrollment, follow-up, and collection and shipment of isolates; (6) In collaboration with staff at both of the participating project sites: a. Identify a study team; specify the roles and responsibilities of each member of the team. b. Plan logistics of patient recruitment, enrollment, monthly follow-up, and data collection; c. Plan logistics of baseline and monthly cultures and shipping isolates to CDC; (7) Train local project teams and participating personnel at each site on project protocol; (8) Coordinate shipment of isolates from site labs to CDC (through a separate contract with World Courier or alternative shipping agent ); (9) Visit participating sites at least quarterly to: a. Evaluate patient enrollment and data collection procedures; b. Ensure adherence to ethics requirements; c. Assess and ensure validity and completeness of patient and program data; d. Evaluate study-related lab procedures; e. Identify and resolve problems and/or advise CDC coordinating center; f. Provide additional support to sites as needed; (10) Provide CDC with monthly reports on study progress, problems, plans, and recommendations V. PERIOD OF PERFORMANCE The period of performance shall begin upon award for a six-month period VI. DELIVERABLES The contractor will provide the following deliverables to the Project Officer by dates shown below: (1) Revise Russian-language protocol and any amendments or modifications. - Reports to CDC on study progress, problems, plans, and recommendations. Due 30 days after date of award, and every 30 days thereafter on a monthly basis. (2) Obtain formal approval of the protocol by the Federal TB Research Institutions (TBRIs) supervising the territories selected to participate in the project Due 60 days after date of award (3) Supervise the two territories (Tomsk and Arkhangelsk) selected to participate in the project through biweekly telephone calls and frequent emails (as needed). Biweekly conference calls with CDC within 1 week after each supervisory contact. (4) Obtain formal approval by Russian authorities to ship isolates from two participating Russian sites (Tomsk and Arkhangelsk) to CDC in Atlanta through a separate contract with a world courier; Due 60 days after date of award (5) Plan logistics of patient enrollment, follow-up, and collection and shipment of isolates, and collaborate and coordinate efforts with the Global Coordinating Center at CDC, Atlanta Written plan due 60 days after date of award (6) In collaboration with local staff at each of the selected project sites: (a) identify a study team; specify the roles and responsibilities of each member of the team, (b) plan logistics of patient recruitment, enrollment, and monthly follow-up, (c) plan logistics of baseline and monthly cultures and shipping isolates to CDC. a. Report to CDC on study progress, problems, plans, and recommendations Due 90 days after date of award and within 30 days of substantial changes in team or work plans (7) Train teams from Tomsk and Arkhangelsk on the project protocol Training to be completed within 90 days after date of award; report of training within 30 days after training (8) Ensure shipment of isolates to arrive at CDC?s Division of TB Elimination, Mycobacteriology Lab no less than bimonthly Written confirmation of shipment with expected arrival date to be sent to CDC with 2 working days of shipment. (9) Visit participating sites to (a) evaluate patient enrollment and data collection procedures, (b) ensure adherence to ethics requirements, (c) assess and ensure validity and completeness of sociodemographic, clinical, epidemiological, and programmatic data, (d) evaluate study-related lab procedures and archive of isolates, (e) identify and resolve problems and/or advise CDC coordinating center, (f) provide additional support to sites as needed/possible, and (g) report status, plans, and recommendations to CDC; First visit within 30 days of award then no less than quarterly; Report to CDC on the monitoring visits, including details of (a) through (g), and study progress, problems, plans, and recommendations due within 14 days of each visit. VII. PAYMENT TERMS Payment will be made on a monthly basis in payments outlined above for the duration of the contract and in accordance with the line items established herein and in accordance with FAR 52.232-25, Prompt Payment, which states that the due date for making invoice payments shall be the 30th day after the designated billing office has received a proper invoice from the contractor or the 30th day after Government acceptance of the services performed by the contractor, whichever is later. MINIMUM VENDOR QUALIFICATIONS 1) Doctoral degree in medicine and epidemiology; 2) Experience of conducting clinical and public health research studies; 3) Fluency in the Russian language (oral and written); 4) High level of organizational and communication skills (oral and written); 5) Tact and diplomacy in cross-cultural and politically delicate situations; 6) Willing and able to travel domestically in Russia as well as internationally 7) Graduate of CDC?s Epidemic Intelligence Service Program Interested parties who feel that that they possess the capabilities to perform the services described herein, should provide a capabilities statement demonstrating their qualifications, experience, equipment and ability to perform the requirements. The vendors must meet the minimum qualifications. Please send your documentation to Ronnie Francis by e-mail to efi8@cdc.gov or by fax at (770) 488-2688. Any questions regarding the solicitation should be submitted within ten (10) days after the date of publication of this synopsis. Quotes and other documentation should be received within fifteen (15) days after the date of publication of this synopsis to be considered by CDC. This award will be made to the technically accepted lowest price offeror. NO TELEPHONIC RESPONSESTO THIS SOLICITATION WILL BE ACCEPTED. All vendors must be registered in the Central Contractor Registry (CCR) prior to an award of a federal contract. All questions concerning this RFQ must be in writing. A determination by the CDC not to compete this proposed contract based upon responses to this notice is solely within discretion on of the government.
- Place of Performance
- Address: Tomsk and Arkhangelsk Russia
- Country: Russia
- Country: Russia
- Record
- SN01059555-W 20060602/060531220346 (fbodaily.com)
- Source
-
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