SOLICITATION NOTICE
R -- Administrative Support For Chernobyl Projects: Thyroid Screening Follow-up and Leukemia/Thyroid Cancer in Clean-up Workers in Ukraine
- Notice Date
- 3/16/2014
- Notice Type
- Presolicitation
- NAICS
- 541611
— Administrative Management and General Management Consulting Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Rockville, Maryland, 20852, United States
- ZIP Code
- 20852
- Solicitation Number
- N02CPP4509-85
- Archive Date
- 4/12/2014
- Point of Contact
- Terry Galloway, Phone: 240-276-5384, Seena Ninan, Phone: 240-276-5419
- E-Mail Address
-
gallowaytl@mail.nih.gov, ninans@mail.nih.gov
(gallowaytl@mail.nih.gov, ninans@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Contracting Office Address: Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive Room 1E136 Bethesda, MD 20892 This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority in FAR 13.106-1(b)(2) and 13.501-(a)(1) using simplified acquisition procedures for commercial acquisitions. The North American Industry Classification System code is 541611 and the business size standard is $14 Million. Only one (1) award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. The period of performance is twelve (12) months from date of award plus one - one year option period. It has been determined that there is no opportunity to acquire green products or services under this procurement. Description: The National Institute of Cancer (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Radiation Epidemiology Branch (REB), is anticipating awarding competitive contract to implement the continuation of the partner project agreements between the Research Center for Radiation Medicine (RCRM) of the Academy of Medical Sciences of Ukraine and the National Cancer Institute (NCI) of the United States and between the Institute of Endocrinology and Metabolism (IEM) of the Academy of Medical Sciences of Ukraine and the NCI to provide financial management oversight for three NCI supported projects in Ukraine: follow-up for thyroid cancer and related activities in individuals exposed to radioactive fallout from the Chernobyl accident; field work for the case-control study of thyroid cancer in Chernobyl clean-up workers; and data collection for the case-control study of leukemia. The Chernobyl Research Unit (CRU), DCEG REB sponsors joint U.S.-Ukraine studies of health effects of the Chernobyl Accident. Currently, there are two partnership agreements supporting three collaborative U.S.-Ukraine epidemiological projects in Ukraine. These projects are 1) "Thyroid Cancer and Other Thyroid Diseases in Ukraine Following the Chernobyl Accident" (P004) undertaken at the Institute of Endocrinology and Metabolism (IEM), Kiev; 2) "Leukemia and Other Hematologic Diseases Among Clean-up Workers in Ukraine Following the Chernobyl Accident" (P003) at the Research Center for Radiation Medicine (RCRM), Kiev; and 3) "Thyroid Cancer among Chernobyl Cleanup Workers in Ukraine" (P003A) undertaken as a variation of the project name, "Leukemia and Other Hematologic Diseases Among Clean-up Workers in Ukraine Following the Chernobyl Accident" (see below) also at RCRM. The partnership agreement for "Thyroid Cancer and Other Thyroid Diseases in Ukraine Following the Chernobyl Accident" (P004) involves thyroid screening and other related tasks in a cohort of about 13,000 people who were exposed to post-Chernobyl radioactive fallout under age 20 years. The aim of this project is to assess early and late morphologic and functional changes in the thyroid glands of persons exposed at young ages to radiation from radioactive materials released as a consequence of the Chernobyl nuclear power plant accident. The cohort members have been undergoing diagnostic thyroid examinations since 1998. Under a rigid protocol approved by NCI, IEM staff carries out the field work to maintain contact with the cohort members and invite them to diagnostic thyroid examinations, which may include palpation, ultrasound scanning, thyroid hormone and other laboratory tests. These examinations are done at IEM or by a mobile team. If deemed necessary by the protocol, cohort members are referred to an expert endocrinologist at IEM for a fine-needle aspiration biopsy for diagnostic confirmation. Interview information collected by IEM regarding residential, health, diet and lifestyle history has been used for estimating radiation doses by an international expert group involving NCI. Follow-up is also performed on all subjects for thyroid cancer morbidity and mortality through linkage with the national cancer registry in Ukraine. The IEM is responsible for the tracing of cohort subjects, recording medical and other data, data processing, and database management and organizing analytical data for NCI. IEM collects fresh and/or archived samples for study by NCI genetic and genomic investigations. IEM also provides data management and quality control, services needed for radiation dose reconstruction to be undertaken by NCI and other dosimetry experts, and assist data analysis and manuscript preparations for NCI. The partnership project agreement for "Leukemia and Other Hematologic Diseases among Clean-up Workers in Ukraine Following the Chernobyl Accident" (P003) involves a case-control study of leukemia among clean-up workers carried out by RCRM staff. The objective of this study is to assess the risk of leukemia and other hematological cancers related to radiation exposure that the clean-up workers received during the recovery and clean-up operations after the accident. Data collection undertaken by RCRM is nearly completed, and major study results showing a significant risk of leukemia associated with radiation exposure have been published. The RCRM continues to provide additional data and/or biological samples for analyses performed by NCI. Recently, an amendment has been made to the above agreement with RCRM to add a case-control study of thyroid cancer in the same clean-up worker population, "Thyroid Cancer among Chernobyl Cleanup Workers in Ukraine" (P003A). Under the protocol approved by NCI, RCRM staff conducts field work to identify cases with thyroid cancer and non-cancer controls, interview them for radiation exposure information, and collect saliva samples for future genetic studies. In addition, under the protocol approved by NCI, RCRM acquire and store archival thyroid tumor tissues and other biological samples for NCI genetic research ("Tissue Archiving"). The RCRM also provides data management and quality control, services needed for radiation dose reconstruction to be undertaken by NCI and other dosimetry experts, and assist data analysis and manuscript preparations for NCI. In all three projects, NCI investigators are responsible for study design and methodologies while the contractor shall implement an un-interrupted continuation of these projects under the Partner Project Agreement, providing technical and financial management for the projects in Ukraine. As set forth in the agreement signed by the United States, Canada, Sweden and Ukraine, funds received by the Recipients (RCRM and IEM) in Ukraine from the NCI in connection with the contractors projects shall be excluded in determining the profits of the contractor for the purpose of tax liability and funds received by persons shall not be included in these persons taxable incomes. The allocation of intellectual property arising from the agreement and the responsibilities for protecting and exploiting such intellectual property have been negotiated between the Recipient and the Partner. Exploitation of results shall be limited to applications for peaceful purposes, and the Recipient and the NCI shall ensure that any results that could result in concerns over proliferations of weapons technology and transfer of sensitive technologies will be protected in accordance with Ukrainian laws and international agreements. Scope of Work: The Contractor shall perform the following in accordance with Partner Project Agreement: 1. Work with NCI, Institute of Endocrinology and Metabolism (IEM) and Research Center for Radiation Medicine (RCRM) to develop a draft agreement for each project (P003, P003A and P004) to become effective April 20, 2014 through April 19, 2015, if none of the Options are exercised, or April 19, 2016, if any of the Options are exercised, describing the scope of the project that includes the project objectives, work plan, personnel plan, budget lines, and reports and deliverables to be submitted to NCI. 2. Submit the draft agreement to NCI for approval; and after approval, formalize the agreement with IEM and RCRM. 3. Implement the projects under the Partner Project Agreement by managing the project as described in the agreement, including evaluation and verification of the progress of project activities, equipment, information, data systems, materials, supplies, personnel and services, auditing the costs, if deemed necessary. 4. Report to NCI if there are any significant managerial issues or problems, and provide advice in resolving them. 5. Assist NCI, IEM and/or RCRM to formalize an amended agreement, if needed. 6. Provide customs clearance assistance in purchasing duty-free equipment and materials as approved by NCI. Period of Performance Base (Thyroid screening; thyroid cancer in cleanup workers.): April 20, 2014-April 19, 2015 Optional Tasks 1a (Thyroid genomic): April 20, 2014-April 19, 2015 Optional Tasks 1b (Tissue archiving in clean-up workers): April 20, 2014-April 19, 2015 Optional Tasks 1c (Trio tissues): April 20, 2014-April 19, 2015 Optional Tasks 1d (Dosimetry): April 20, 2014-April 19, 2015 Option Period One: Option Period One (Thyroid screening/follow-up): April 20, 2015-April 19, 2016 Optional Tasks 2b (Thyroid genome): April 20, 2015-April 19, 2016 Optional Tasks 2c (Thyroid cancer in clean-up workers): April 20, 2015-April 19, 2016 Optional Tasks 2d (Tissue archiving in clean-up workers): April 20, 2015-April 19, 2016 Optional Tasks 2e (Trio tissues): April 20, 2015-April 19, 2016 Optional Tasks 2f (Dosimetry): April 20, 2015-April 19, 2016 Qualifications The contractor shall: 1. Be capable of establishing US-Ukrainian binational project agreement equivalent to the Partner Project Agreement for un-interrupted continuation of the three ongoing NCI support post-Chernobyl projects, described above, within 10 days after an award date; 2. Be capable of providing on-site managerial oversight to the three ongoing NCI support post-Chernobyl projects, described above; 3. Have close knowledge and on-site experience of all technical and financial aspects of the above three projects; 4. Have demonstrated experience in managing and administering projects funded by US government agencies; 5. Have multilingual staff who are capable of communicating in English, Ukrainian, and Russian; 6. Have demonstrated experience of successfully establishing research projects funded by US government agencies, as described in this procurement, negotiating with medical institutions, national and/or local governments in Ukraine; Potential offerors may request a copy of the solicitation from Terry Galloway, Contracting Officer via electronic mail at gallowaytl@mail.nih.gov on or before 11:00 AM EST on March 28, 2014. All questions must be in writing and can be emailed. In order to receive an award, contractors must have valid registration and certification in the Central Contractor Registration (CCR) and the Online Representations and Certifications Applications (ORCA) through SAM.gov. No collect calls or facsimile transmissions will be accepted. Please reference solicitation number N02CPP4509-85 on all correspondence.
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