N02CP85030-45A_-_SOW.docx

STATEMENT OF WORK

1. PROJECT TITLE:

Administrative Support for Chernobyl Projects: Transgenerational Effects in Ukrainian Clean-Up Workers (Trio) and Ukrainian Thyroid Cohort

2. BACKGROUND

The Radiation Epidemiology Branch (REB), Division of Cancer Epidemiology and Genetics (DCEG), National Cancer Institute (NCI), conducts studies of health effects of the Chernobyl accident in Ukraine. One study is the Cleanup Worker Project, which aims to assess the risks of leukemia and other hematological diseases, thyroid cancer and transgenerational effects related to radiation exposure among Chernobyl clean-up workers in Ukraine. Another study is the UkrAm Thyroid Project, which aims to monitor changes in the thyroid glands and evaluate risk of thyroid cancer and other thyroid diseases in Ukrainian thyroid cohort of about 16,000 persons exposed at young ages or in utero to radiation from radioactive releases from the Chernobyl nuclear power plant accident. These projects have been administered as part of three-way agreements, Partnership Project Agreements. These agreements are signed by (1) NCI who financially supports and direct these projects, (2) the NCI Contractor who provides financial administration support, and (3) Ukrainian research institutes (“the NCI collaborating institutions”) who provide field support and conduct these projects. The NCI collaborating institutions for these projects are the Research Center for Radiation Medicine (RCRM), Kiev, and the Institute of Endocrinology and Metabolism (IEM), Kiev. The studies are conducted in accordance with approved protocols; outlines of the tasks for RCRM and IEM are given in Appendix A and Appendix B, respectively. The U.S.-Ukrainian projects require approval by the Government of Ukraine.

3. SCOPE/OBJECTIVE

The objective of this procurement is to provide administrative and financial management oversight to assure timely progress in field work, data collection, data/sample transfer and analyses as required by NCI for several key components of the two NCI supported projects: Cleanup Worker Project and the UkrAm Thyroid Project.

4. CONTRACT REQUIREMENTS

The Contractor shall perform administrative duties to support collaboration among the study personnel at NCI and the NCI collaborating institutions as specified in the study protocols for two NCI supported projects: Cleanup Workers (Appendix A) and Thyroid Cohort (Appendix B) as stated below:

· Assisting the NCI with maintaining Project Partnership Aagreements with NCI collaborating institutions.

· Providing financial and administrative oversight of the studies conducted by NCI collaborating institutions. This will include evaluation and verification of the progress of project activities, materials, supplies, personnel and services, auditing the costs, if deemed necessary.

· Reporting to the NCI COR if there are any significant managerial issues or problems, and provide advice in resolving them.

· Providing support in procuring materials and supplies, and compensation to study subjects as needed by RCRM and IEM in performance of the tasks outlined in Appendices A & B and approved by the NCI COR.

· Providing support in procuring equipment including customs clearance assistance to obtain duty-free as needed in performance of the tasks outlined in Appendices A & B and approved by the NCI COR. The ultrasound device for thyroid scan, specifically Terason uSmart3300 NextGen system is required for tasks under Appendix B.

5. TYPE OR ORDER

This is a firm fixed price purchase order.

6. PERIOD OF PERFORMANCE

Services provided for all projects during the period of September 17, 2018 – April 30, 2019, with an additional one-year option period and option tasks.

1. Base Period: September 17, 2018 – April 30, 2019 (Appendix A: TRIO and Dosimetry in Clean-up workers; Appendix B: Nodular Screening, Cohort Maintenance, Thyroid Dosimetry, and Breast Cancer Feasibility)

2. Option Period 1: May 1, 2019 – April 30, 2020 (Appendix B: Nodule Screening, Cohort Maintenance)

· Option Task 1: Appendix A: TRIO: August 1, 2019 – April 30, 2020

· Option Task 2: Appendix A: Dosimetry for Cohort of Clean-up Workers: August 1, 2019 – April 30, 2020

· Option Task 3: Appendix B: Breast Cancer Feasibility: August 1, 2019 – April 30, 2020

7. PLACE OF PERFORMANCE

Kiev, Ukraine

8. REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE

The NCI COR will be responsible for reviewing the work done by the Contractor, making sure that it is consistent with the terms of the Contract, and approving the reports/deliverables provided by the contractor.

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance. The Government may unilaterally change its COR designation.

The Contractor shall provide the following reports:

1. A technical progress report, which is obtained from the NCI collaborating institutions, providing descriptions of tasks and activities accomplished, significant results obtained, and issues and problems, with suggested solutions, identified in each project shall be delivered electronically to the COR. The first technical progress report will be due one and a half months after the award date of the order. The next reports shall be submitted every three months thereafter. Final reports shall be submitted at one week before the award end date.

Any analytical data files noted on Appendices A & B shall be submitted directly to the NCI COR at one week before the end of the award end date.

2. A financial progress report, which is obtained from the Contractor, providing the expenditures for each project shall be delivered electronically to the COR. The first financial report will be due one and a half months after the award date of the order. The next reports shall be delivered every three months thereafter. Final financial reports shall be submitted at one week before the award end date.

After receipt of invoices the COR has 7 days to review and accept based on the completeness and adequacy of the issues addressed.

9. CLEARANCES

IRB: The data and samples are collected at the NCI collaborating institutions under IRB approved protocols, which have also been approved by the NCI IRB.

1. OH95CN020 “Scientific Protocol for the study of Thyroid Cancer and Other Thyroid Diseases in Ukraine Following the Chernobyl Accident”

2. 15CN199 “Parental Irradiation of Ukrainian Cleanup Workers and Evacuees and Germline Mutations in their Offspring (Trio Study)”

3. OH96CN030 “Scientific Protocol for the Study of Leukemia and Other Hematologic Diseases among /Clean-up Workers in Ukraine Following the Chernobyl Accident”

4. 11CN049 “Thyroid Cancer among Chernobyl Cleanup Workers in Ukraine”

The NCI collaborating institutions will not provide collected data or samples to the Contractor. The Contractor will not have access to these project data or samples. The NCI collaborating institutions will share collected data and samples with the NCI directly.

OMB: Clinical Exemption CE-99-10-02

10. PAYMENT

Payment shall be made upon acceptance of reports delivered as noted above. Payment authorization requires submission and approval of invoices to the COR and NIH OFM, in accordance with the attached payment provisions listed below:

The following clause is applicable to all Purchase Orders, Task or Delivery Orders, and Blanket Purchase Agreement (BPA) Calls: PROMPT PAYMENT (JUL 2017) FAR 52.232-25. Highlights of this clause and NIH implementation requirements follow:

1. INVOICE REQUIREMENTS

A. An invoice is the Contractor's bill or written request for payment under the contract for supplies delivered or services performed. A proper invoice is an "Original" which must include the items listed in subdivisions 1 through 12, below, in addition to the requirements of FAR 32.9. If the invoice does not comply with these requirements, the Contractor will be notified of the defect within 7 days after the date the designated billing office received the invoice (3 days for meat, meat food products, or fish, and 5 days for perishable agricultural commodities, dairy products, edible fats or oils) with a statement of the reasons why it is not a proper invoice. (See exceptions under II., below.) Untimely notification will be taken into account in the computation of any interest penalty owed the Contractor.

1. Vendor/Contractor: Name, Address, Point of Contact for the invoice (Name, title, telephone number, e-mail and mailing address of point of contact).

2. Remit-to address (Name and complete mailing address to send payment).

3. Remittance name must match exactly with name on original order/contract. If the Remittance name differs from the Legal Business Name, then both names must appear on the invoice.

4. Invoice date.

5. Unique invoice #s for all invoices per vendor regardless of site.

6. NBS document number formats must be included for awards created in the NBS: Contract Number; Purchase Order Number; Task or Delivery Order Number and Source Award Number (e.g., Indefinite Delivery Contract number; General Services Administration number); or, BPA Call Number and BPA Parent Award Number.

7. Data Universal Numbering System (DUNS) or DUNS + 4 as registered in the Central Contractor Registration (CCR).

8. Federal Taxpayer Identification Number (TIN). In those exceptional cases where a contractor does not have a DUNS number or TIN, a Vendor Identification Number (VIN) must be referenced on the invoice. The VIN is the number that appears after the contractor’s name on the face page of the award document.

9. Identify that payment is to be made using a three-way match.

10. Description of supplies/services that match the description on the award, by line billed.*

11. Freight or delivery charge must be billed as shown on the award. If it is included in the item price do not bill it separately. If identified in the award as a separate line item, it must be billed separately.

12. Quantity, Unit of Measure, Unit Price, Extended Price of supplies delivered or services performed, as applicable, and that match the line items specified in the award.*

* NOTE: If your invoice must differ from the line items on the award, please contact the Contracting Officer before submitting the invoice. A modification to the order or contract may be needed before the invoice can be submitted and paid.

B. Shipping costs will be reimbursed only if authorized by the Contract/Purchase Order. If authorized, shipping costs must be itemized. Where shipping costs exceed $100, the invoice must be supported by a bill of lading or a paid carrier's receipt.

C. Mail an original and 1 copy of the itemized invoice to:

National Institutes of Health Office of Financial Management, Commercial Accounts 2115 East Jefferson Street, Room 4B-432, MSC 8500 Bethesda, MD 20892-8500

For inquiries regarding payment call: (301) 496-6088

In order to facilitate the prompt payment of invoices, it is recommended that the vendor submit a photocopy of the invoice to the “Consignee” designated for the acquisition in blocks 6A – 6E of the face page of the Order/Award document.

II. INVOICE PAYMENT

1. Except as indicated in paragraph B., below, the due date for making invoice payments by the designated payment office shall be the later of the following two events:

1. The 30th day after the designated billing office has received a proper invoice.

2. The 30th day after Government acceptance of supplies delivered or services performed.

B. The due date for making invoice payments for meat and meat food products, perishable agricultural commodities, dairy products, and edible fats or oils, shall be in accordance with the Prompt Payment Act, as amended.

III. INTEREST PENALTIES

A. An interest penalty shall be paid automatically, if payment is not made by the due date and the conditions listed below are met, if applicable.

1. A proper invoice was received by the designated billing office.

2. A receiving report or other Government documentation authorizing payment was processed and there was no disagreement over quantity, quality, or contractor compliance with a term or condition.

3. In the case of a final invoice for any balance of funds due the contractor for supplies delivered or services performed, the amount was not subject to further settlement actions between the Government and the Contractor.

1. Determination of interest and penalties due will be made in accordance with the provisions of the Prompt Payment Act, as amended, the Contract Disputes Act, and regulations issued by the Office of Management and Budget.

IV. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS

SUBCONTRACTORS, FAR 52.232-40 (DEC 2013)

1. Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.

1. The acceleration of payments under this clause does not provide any new rights under the prompt Payment Act.

Include the substance of this clause, include this paragraph c, in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items.

Appendix A. Tasks for the Research Center for Radiation Medicine (RCRM) [Cleanup Workers]

Data on transgenerational effects following nuclear accidents are important for understanding fully the consequences of parental exposure to ionizing radiation. To gather additional data on mutagenic effects, NCI is collaborating with RCRM to conduct a study of parent-child trios in which at least one parent was exposed to Chernobyl radiation as a clean-up worker and/or evacuee from a contaminated area. Data are being collected at RCRM for up to 450 trios of parents with preconceptional doses and their unexposed offspring. NCI is using state-of-the-art genomic technologies to test whether parents’ radiation exposure causes genetic mutations transmitted to the offspring, by examining de novo mutation rates, minisatellite mutations, copy number alterations, and variations in telomere length, using blood samples from complete father-mother-child trios. Doses to the gonads from the time of the accident to the time of conception are being reconstructed for all parents using existing records supplemented by interview data.

Qualifications: To perform the tasks the collaborating institute shall:

· Demonstrate the ability to trace, locate and enroll in the studies of health effects in populations exposed to ionizing radiation Ukrainian cleanup workers and members of their families through having access to Ukrainian Chernobyl State Registry, Polyclinical Registry at RCRM, and other medical facilities;

· Have access to the archives of the Dosimetry department at the Chernobyl Nuclear Power Plant;

· Have access to the epidemiological, demographic and dosimetry information and biological samples collected in the framework of the following: (i) the study of Paternal irradiation of Ukrainian clean-up workers and germline mutations in their offspring (TRIO study); (ii) the study of leukemia and other hematologic diseases among clean-up workers in Ukraine following the Chernobyl accident; (iii) the study of thyroid cancer among clean-up workers in Ukraine following the Chernobyl accident; and (iv) the study of human factor uncertainties in radiation doses to cleanup workers;

· Have detailed knowledge of the following: (i) the radiation measurements that were carried out at the Chernobyl power plant and in its vicinity; (ii) the type of work that was performed by various categories of clean-up workers; and (iii) the various methods that have been used to assess the doses received by the emergency and clean-up workers.

Tasks for the collaborating institute are the following during the Base Period (September 17, 2018 – April 30, 2019):

1. Study of Paternal irradiation of Ukrainian clean-up workers and germline mutations in their offspring (TRIO study):

· Trace, locate and enroll to the study according to selection criterion 70 new families (trios) with exposed and non-exposed parents and their offspring born after the Chernobyl accident). Each family member enrolled in the study will be compensated with $20.00 (twenty) for his/ her time spent for the personal interview.

· Collect blood and buccal cells samples from each family member enrolled in the study using RNA PAxgene tubes, BD Vac EDTA tubes and Oragene OG500 saliva kits. Blood samples shall be tested for HBsAg, HBV and HCV before shipping to the NCI.

· Conduct personal interviews with enrolled study subjects using study questionnaires and procedures approved by NCI.

· Maintain study databases with demographic (phenotype), epidemiological and dosimetry data obtained for the study subjects during personal interviews and from other sources. Provide the computer programming support necessary to implement and maintain these error-free and up-to-date databases.

· Provide the collected samples blood and buccal cells samples properly coded to the NCI for genomic research to be conducted in collaboration with NCI. It is critical to maintain blood sample temperature (-80ºC) during the shipping process.

· Provide MS Access database with epidemiology and demographic data to the NCI.

2. Feasibility and dosimetry support of clinical cohort of Ukrainian cleanup workers:

· To characterize in detail the clinical data that is available from the Clinical and Epidemiological Registry.

· Prepare a detailed, written description of clinical data available in the CER including summary statistics of risk factors and outcomes.

· In collaboration with dosimetrists from NCI and other institutions to develop approaches and methodologies to estimate organ doses due to external and internal irradiation to Ukrainian cleanup workers and members of their families.

· Collect radiation and exposure dose data from different facilities as identified by the NCI investigators.

· Calculate radiation absorbed doses and characterize associated uncertainties in doses for the subjects of the epidemiological studies using computer code Rockville and Operations Manual approved by NCI.

· Prepare an edited and documented MS Access electronic database of organ doses the subjects on of the epidemiological studies as requested by the NCI.

· Prepare a detailed, written description of the final methodology that was employed in the estimation of organ doses and their associated sources of uncertainty.

· Provide MS Access database with dosimetry results to the NCI.

Tasks for the collaborating institute are the following during the Option Period 1 (May 1, 2019 – April 30, 2020):

Optional Task 1: August 1, 2019- April 30, 2020

3. Study of Paternal irradiation of Ukrainian clean-up workers and germline mutations in their offspring (TRIO study):

· Trace, locate and enroll to the study according to selection criterion 70 new families (trios) with exposed and non-exposed parents and their offspring born after the Chernobyl accident). Each family member enrolled in the study will be compensated with $20.00 (twenty) for his/ her time spent for the personal interview.

· Collect blood and buccal cells samples from each family member enrolled in the study using RNA PAxgene tubes, BD Vac EDTA tubes and Oragene OG500 saliva kits. Blood samples shall be tested for HBsAg, HBV and HCV before shipping to the NCI.

· Conduct personal interviews with enrolled study subjects using study questionnaires and procedures approved by NCI.

· Maintain study databases with demographic (phenotype), epidemiological and dosimetry data obtained for the study subjects during personal interviews and from other sources. Provide the computer programming support necessary to implement and maintain these error-free and up-to-date databases.

· Provide the collected samples blood and buccal cells samples properly coded to the NCI for genomic research to be conducted in collaboration with NCI. It is critical to maintain blood sample temperature (-80ºC) during the shipping process.

· Provide MS Access database with epidemiology and demographic data to the NCI.

Optional Task 2: August 1, 2019- April 30, 2020

4. Feasibility and dosimetry support of clinical cohort of Ukrainian cleanup workers

· In collaboration with dosimetrists from NCI and other institutions to develop approaches and methodologies to estimate organ doses due to external and internal irradiation to Ukrainian cleanup workers and members of their families.

· Collect radiation and exposure dose data from different facilities as identified by the NCI investigators.

· Calculate radiation absorbed doses and characterize associated uncertainties in doses for the subjects of the epidemiological studies using computer code Rockville and Operations Manual approved by NCI.

· Prepare an edited and documented MS Access electronic database of organ doses the subjects on of the epidemiological studies as requested by the NCI.

· Prepare a detailed, written description of the final methodology that was employed in the estimation of organ doses and their associated sources of uncertainty.

· Provide MS Access database with dosimetry results to the NCI.

3.

Appendix B. Tasks for the Institute of Endocrinology and Metabolism (IEM) [Thyroid Cohort]

The nuclear power plant accident at Chernobyl released large quantities of Iodine-131 and other radioisotopes of iodine into the atmosphere, contaminating thousands of square kilometers and exposing millions of people. NCI is collaborating with IEM to conduct a cohort study of thyroid cancer and other thyroid diseases in Ukraine following the Chernobyl accident. The Ukrainian-American (UkrAm) cohort includes approximately 16,000 persons who were children in 1986 or were born shortly after the accident. Under a rigid research protocol these subjects received diagnostic thyroid examinations, including palpation, ultrasound scanning, thyroid hormone and other laboratory tests. If indicated, they were referred for a fine-needle aspiration biopsy. Interview information regarding residential, health, diet and lifestyle history are also collected. Based on thyroid radiation measurements made in May-June 1986, and other information (reconstruction of deposition patterns and environmental pathways of the radioiodines, and of the location, dietary characteristics, and lifestyle of each person throughout the exposure period), each person's radiation dose to the thyroid are being estimated. All subjects were followed for cancer morbidity and mortality through linkage of cohort data with Ukrainian Cancer Registry.

Qualifications: To perform the tasks the collaborating institute shall:

· Demonstrate ability to trace, locate and enroll in the studies of health effects in population exposed to ionizing radiation residents of Ukraine and members of their families who were exposed to radiation following the Chernobyl accident through having access to Ukrainian Cancer Registry, Clinical data at IEM, and other medical facilities;

· Demonstrate ability and have appropriate facility and staffs to conduct medical screening of thyroid cancer, thyroid nodules and other thyroid diseases, including examinations by endocrinologist, ultra-sonographer, performing fine-needle aspiration biopsy, collection of blood and urine samples and conducting laboratory work as directed by NCI;

· Have access to the epidemiological, demographic and dosimetry information and biological samples collected in the framework of the Study of thyroid cancer and other thyroid diseases in Ukraine following the Chernobyl accident.

Tasks for the collaborating institute are the following during the Base Period (September 17, 2018 – April 30, 2019):

5. Nodular Screening in Ukrainian thyroid cohort:

· In collaboration with NCI, develop criteria for the inclusion of subjects with thyroid nodules detected during first through fifth screening cycles in expanded thyroid nodular study; modify the existing software for archive information collection and processing; revise clinical forms and Operation Manual, and train Project staff.

· Conduct a thyroid clinical examination of 900 study subjects with nodular thyroid pathology. Purchase of the Terason uSmart3300 NextGen system is required to perform this task. The specification for this equipment are: uSmart 3300 NexGen Ultrasound System - 2D Digital Imaging, Anatomical M-Mode, Color Doppler, Pulsed Wave Doppler, Power Doppler, Directional Power Doppler, CW Doppler, Tissue Doppler, Tissue Harmonic Imaging with SuperHarmonics™, Triplex, Dynamic Depth Resolution (DDR), exclusive Enhanced Needle Visualization (ENV), 2D Electronic Beam Steering, TeraVision™ II, OmniBeam™, TeraScape™, TeraZoom™, Split Screen, Full Screen, Post Processing, Auto-Optimization, Smart Resolution Imaging, USB, Ethernet, and HDMI ports, Wireless and Ethernet connection, image format in still frame or dynamic clip (BMP, JPEG, AVI, and DICOM), 1 TB solid state hard drive, application-specific presets, high-resolution LCD monitor, stereo speakers, camera, uConnect remote capabilities, Enhanced Needle Visualization (ENV), and 15L4A uSmart Linear Array Transducer with system.

The equipment with the above noted specifications is required to obtain data that is consistent and compatable with previously collected data under the protocol.

· Perform fine-needle aspiration biopsy and cytology study of thyroid biopsy and pathomorphology study of surgically removed thyroid tumors.

· Maintain study databases with demographic (phenotype), epidemiological and dosimetry data; provide the computer programming support necessary to implement and maintain these error-free and up-to-date databases.

6. Maintenance of Ukrainian thyroid cohort:

· Conduct mail survey of 3,000 study subjects with demographic questionnaires to update demographic and medical information.

· Conduct linkage of the information of study subjects and their mothers (where possible) to the Ukrainian Cancer Registry and ascertain cases of thyroid cancer and cancer of localizations other than thyroid; to compare incidence rate among the study subjects and their mothers with corresponding indicators for the entire Ukrainian population.

· Maintain study databases with demographic (phenotype), epidemiological and dosimetry data; provide the computer programming support necessary to implement and maintain these error-free and up-to-date databases.

· Prepare and transfer to NCI analytical MS Access databases with epidemiological and dosimetry information for all cycles (1, 2, 3, 4, 4.5, 5), including detailed information on thyroid nodular pathology for the study subjects as specify by NCI.

7. Thyroid Dosimetry:

· In collaboration with dosimetrists from NCI and other institutions to develop approaches and methodologies to estimate thyroid doses due to Iodine-131 (I-131) intake for individuals without direct thyroid measurements.

· Calculate radiation absorbed doses to the thyroid due to I-131 intake and characterize associated uncertainties in doses for 382 subjects without direct thyroid measurements of the study of full genomic characterization of thyroid cancer using Operations Manual approved by NCI.

· Calculate radiation absorbed doses to the thyroid due to I-131 intake for 1,862 subjects whom mothers did not have direct thyroid measurements of the Ukrainian in utero cohort using Operations Manual approved by NCI.

· Prepare an edited and documented MS Access electronic file of thyroid doses the subjects on of the epidemiological studies as requested by the NCI.

· Prepare a detailed, written description of the final methodology that was employed in the estimation of thyroid doses due to I-131 intake and their associated sources of uncertainty.

· Provide MS Access database with dosimetry results to the NCI.

8. Breast Cancer Feasibility:

· Prepare MS Access database of around 5,000 alive childbirth registered in radioactively contaminated areas of Ukraine around date of the Chernobyl accident (April 26, 1986) using textbooks from hospitals. Database should include information on mothers (full name, date of birth, place of residence) and children (date of birth, gender).

Tasks for the collaborating institute are the following during the Option Period (May 1, 2019-April 30, 2020):

9. Nodular screening in Ukrainian thyroid cohort:

· Conduct a thyroid clinical examination of 1,440 study subjects with nodular thyroid pathology.

· Perform fine-needle aspiration biopsy and cytology study of thyroid biopsy and pathomorphology study of surgically removed thyroid tumors.

· Maintain study databases with demographic (phenotype), epidemiological and dosimetry data; provide the computer programming support necessary to implement and maintain these error-free and up-to-date databases.

10. Maintenance of Ukrainian thyroid cohort:

· Conduct mail survey of 5,000 study subjects with demographic questionnaires to update demographic and medical information.

· Conduct linkage of the information of study subjects and their mothers (where possible) to the Ukrainian Cancer Registry and ascertain cases of thyroid cancer and cancer of localizations other than thyroid; to compare incidence rate among the study subjects and their mothers with corresponding indicators for the entire Ukrainian population.

· Maintain study databases with demographic (phenotype), epidemiological and dosimetry data; provide the computer programming support necessary to implement and maintain these error-free and up-to-date databases.

· Prepare and transfer to NCI analytical MS Access databases with epidemiological and dosimetry information for all cycles (1, 2, 3, 4, 4.5, 5), including detailed information on thyroid nodular pathology for the study subjects as specify by NCI.

Optional Task 3: August 1, 2019- April 30, 2020

11. Breast Cancer Feasibility, including dosimetry:

· Conduct linkage of the database of 5000 alive childbirth in Ukraine to the Ukrainian Cancer Registry and ascertain cases of breast cancer and thyroid cancer in mothers; to compare incidence rate among mothers with corresponding indicators for the entire Ukrainian population.

· Provide MS Access database of results of linkage to the NCI.

· In collaboration with dosimetrists from NCI and other institutions to develop model of I-131 and Caesium isotopes (Cs-134, Cs-137) kinetic in the body of lactating women with detailed description of parameters related to I-131, Cs-134 and Cs-137 concentration in breast milk.

· Prepare a detailed, written description of the kinetic model and associated sources of uncertainties in model parameters.

Summary of tasks by period

100 (new families) (Option Task 1)

1000 subjects (Option Task 2)

5000 (mothers and children) (Option Task 3)

N02CP85030-45 Page 8 of 12 Attachment 1 – Statement of Work