Support for Thyroid Cancer and Other Thyroid Diseases in Belarus

Notice Type: Presolicitation Notice Classification Code: R -- Professional, administrative, and management support services NAICS Code: 541 -- Professional, Scientific, and Technical Services/541990 -- All Other Professional, Scientific, and Technical Services Place of Performance: Belarus Background: The Chernobyl Research Program (CRP), Radiation Epidemiology Branch (REB), National Cancer Institute (NCI) is seeking to extend the period of performance to the - Study of Thyroid Cancer and Other Thyroid Diseases in Belarus contract which supports a large-scale epidemiological study detecting thyroid and other pathology in persons who have been exposed to radiation as released by the accident at the Chernobyl Nuclear Power Station on April 26, 1986. This contract was awarded to GU RNPTS RMIECH on a sole source basis for a six-month base (August 15, 2018 - February 14, 2019) and three one-year options for a total potential performance through February 14, 2022. In February 2022, additional work was added extending the contract to February 14, 2023. The total current value of the contract, inclusive of Options is $993,251 The study involves two cohorts: (1) the - main cohort that was established in the late 1990s and consists of about 12,000 subjects who were age 18 or under at the time of the accident, had their dose to the thyroid gland measured, and lived in the Chernobyl affected areas in Belarus; and (2) the - in-utero cohort that was established in 2017 and consists of 3,000 people who were exposed to Chernobyl fallout radiation in-utero and early post-natal life. The Belarusian government has designated the contractor to be the head organization on rendering studies on the aftereffects of the Chernobyl catastrophe. The Belarusian Government mandated that all research related to the medical consequences of the Chernobyl catastrophe are to be performed in close cooperation with this contractor. As such, the contractor is the sole institution in Belarus with access to the study population. Description: Successful completion of this contract includes: (1) passive follow-up of the Belarusian main and in-utero cohorts; (2) medical screening of the Belarusian in-utero cohort; (3) evaluation of reliability of dose reconstruction for in-utero cohort; (4) updating demographic, clinical and epidemiologic data through a mail survey; and (5) breast Cancer tracing. In order to achieve this, additional work will need to be added to the current contract HHSN261201800015C. NCI intends to modify contract number HHSN261201800015C, with GU RNPTS RMIECH to extend the period of performance for 12 months to provide the following: (1) Medical Screening, (2) Dosimetry, (3) Belarus in utero risk factor survey, (4) Mail survey, (5) Breast cancer tracing, (6) Breast cancer enrollment and interviews, (7) Breast cancer study samples. The proposed contract action is for services for which the Government intends to solicit and negotiate with only one source, GU RNPTS RMIECH., under the authority of FAR 6.302-1. Statutory authority: 41 U.S.C. 253(c)(1), as set forth in FAR 6.302-1, only one responsible source and no other supplies or services will satisfy agency requirements. GU RNPTS RMIECH is the only responsible source, and no other supplies or services will satisfy agency requirements. GU RNPTS RMIECH has the unique capabilities as the only source to provide the services that mee NCI's needs. The Contractor has the necessary IRB approvals for this study from the Belarusian government and for data linkage with the National Cancer Registry and State Chernobyl Registry in Belarus in place. Another source, if applicable, would require substantial time and resources in obtaining new approvals. Since 2004, the Contractor established all infrastructure and accumulated extensive expertise for high performance of this project. The contractor has successfully established and maintained the main cohort of 11,732 subjects and has recently assembled the new in-utero cohort of 2,965 subjects. The contractor is the sole source of the data collected on the two important cohorts exposed early in life (such as fetuses, children or adolescents) who experienced fallout from Chernobyl. The contractor has accumulated a substantial amount of data on health effects in populations exposed to the Chernobyl accident since 2004. Only through an active collaboration with the contractor can NCI gain access to different sources of information (Belarusian State Register of Persons Exposed to Radiation due to the Chernobyl Accident, database of SI - RRCRM&HE, database of main BelAm and Belarusian in utero cohorts, databases of local polyclinics of studied regions, village councils, office of labor, emergency departments and records of secondary schools) to be used to establish cohort of lactating women. There is no other reasonable alternative to contracting directly with this contractor. As the designated institution of all Chernobyl related research by the Belarusian government, the contractor is also the only source for conducting a feasibility study on the construction of a cohort of lactating women. The proposed contract action is for supplies or services for which the Government intends to continue with one source, GU RNPTS RMIECH, under authority FAR 6.302-1. Interested persons may identify their interest and capability to respond to the requirement. This notice is not a request for competitive proposals. However, all proposals received will be considered by the Government. A determination by the Government not to continue with this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive acquisition. Respondents should submit a tailored Capability Statement demonstrating the offerors qualifications, facilities, and experience. Capability statements must include the respondents DUNS number, organization name, address, and point of contact; and small business type(s). Sources are expected to have the necessary skills and tools to meet the requirements of this project. Interested qualified small business organizations should submit a tailored capability statement for this requirement, not to exceed 10 single-sided pages (including all attachments, resumes, charts, etc.) presented in single-space and using a 12-point font size minimum, that clearly details the ability to perform the aspects of the notice described above. All capability statements sent in response to this pre-solicitation notice must be submitted electronically (via email) to Kari Peterson, Contracting Officer, at kari.peterson@nih.gov in MS Word or Adobe Portable Document Format (PDF) by November 17, 2022 at 12:00 PM, EST. All responses must be received by the specified due date and time in order to be considered. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. No collect calls or facsimile transmissions will be accepted. Project Requirements: The Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities not otherwise provided by the U.S. Government as needed to perform the Statement of Work below. Option Period 5 - Passive follow-up of the Belarusian main and in-utero cohorts - February 15, 2023 - February 14, 2024 1. Acquire updated contact and medical diagnostic information, including diagnostic data on thyroid cancer, other cancers, and thyroid non-cancer diseases for the main and in-utero cohort subjects through linkage with the Chernobyl State Registry and obtain information from other sources, if needed for medical follow-up. 2. Link the main and in-utero cohort with the National Belarusian Cancer Registry for each specific cancer site reported to the Registry from 1987 through the latest calendar year for which complete incidence data are available and perform statistical analyses and tabulations for calculating observed and expected cancer cases and standardized incidence ratios for various cancer sites. 3. Create and maintain a master database of the main and in-utero cohort that links to computerized databases of questionnaires, vital status, tracing history, and other study data, which are to be entered. Provide the computer programming support necessary to implement and maintain these databases. 4. Update the database for the main and in-utero cohort with information obtained as a result of record linkage to the State Chernobyl Registry and National Belarusian Cancer Registry, and ongoing cleaning procedures. Deliver an accurate, complete and up-to-date electronic database, including cancer registry variables, as specified by NCI. No personally identifiable information should be sent (e.g., no names, birth year/month only). 5. With input and guidance from NCI, develop and implement procedures needed to assure the quality of data collected, entered and managed. Provide written documentation of the quality control procedures used along with error or problem rates. Maintain comprehensive documentation for the main and in-utero study databases. Use applicable and common security practices for protecting data collected under the contract. 6. Respond to data requests and questions concerning the main and in-utero cohorts and provide support to NCI investigators in their preparation of scientific papers. Option 22A - Medical screening of the Belarusian in-utero cohort - Six Months 1. Update and verify vital status and last known address of in-utero subjects and their mothers and contact them according to the procedures described in the study protocol and Operations Manual approved by NCI. 2. Using the study protocol and Operations Manual approved by NCI, conduct medical screening using fixed and mobile teams and screen a target of 200 (cumulative 1,800) in utero subjects. Project staff may also travel to the subject's residence or other locations for conducting the medical screening. Each individual enrolled in the screening shall be nominally compensated for his or her time spent for the screening and travel costs. 3. Update the master database with data from the medical screening, including data recorded on the study and data forms including but not limited to laboratory and clinical information, blood collection and processing form, ultrasound examination form, thyroid palpation form, prior medical history form, laboratory blood examination form, endocrine summary and recommendation form, fine needle aspiration form, hospitalization form, pathological examination form, report on adverse medical event, growth and physical development form (head circumference, height and weight measurements). Option 22B - Medical screening of the Belarusian in-utero cohort - Six Months 1. Update and verify vital status and last known address of in-utero subjects and their mothers and contact them according to the procedures described in the study protocol and Operations Manual approved by NCI. 2. Using the study protocol and Operations Manual approved by NCI, conduct medical screening using fixed and mobile teams and screen a target of 200 (cumulative 2,000) in utero subjects. Project staff may also travel to the subject's residence or other locations for conducting the medical screening. Each individual enrolled in the screening shall be nominally compensated for his or her time spent for the screening and travel costs. 3. Update the master database with data from the medical screening, including data recorded on the study and data forms including but not limited to laboratory and clinical information, blood collection and processing form, ultrasound examination form, thyroid palpation form, prior medical history form, laboratory blood examination form, endocrine summary and recommendation form, fine needle aspiration form, hospitalization form, pathological examination form, report on adverse medical event, growth and physical development form (head circumference, height and weight measurements). Option 23A - Evaluation of reliability of dose reconstruction for in-utero cohort - Six Months 1. Locate and contact mothers of in-utero subjects and conduct second personal interviews with a target of 150 (cumulative 1,200) mothers who shall be selected from mothers who were first interviewed in 2016-2017 using the dosimetry questionnaire and interview manual approved by NCI. Project staff may also travel to the cohort subject's mothers residence or other locations for contacting and interviewing. Each mother enrolled in the interview shall be nominally compensated for his or her time spent for the interview and travel costs. 2. Prepare and provide an accurate, complete and up-to-date Microsoft Access database of personal dosimetry interviews created by means of double entry. No personally identifiable information should be sent (e.g., no names, birth year/month only). 3. Scan the personal dosimetry interviews and create an electronic Microsoft Access database of scanned images of paper interviews. 4. Reconstruct individual doses for 150 (cumulative 1,200) subjects of in-utero cohort with re-interviewed mothers using the Dosimetry Operations Manual approved by NCI and provide a completed Microsoft Access database of individual calculated (a) pre- and postnatal thyroid doses for subjects, associated input data file and VBA macros used for calculations; and (b) pre- and postnatal doses to the thyroid and whole body from external irradiation and ingestion of Cs radioisotopes, associated input data file and VBA macros used for calculations. No personally identifiable information should be sent (e.g., no names, birth year/month only). Option 23B - Evaluation of reliability of dose reconstruction for in-utero cohort - Six Months 1. Locate and contact mothers of in-utero subjects and conduct second personal interviews with a target of 150 (cumulative 1,350) mothers who shall be selected from mothers who were first interviewed in 2016-2017 using the dosimetry questionnaire and interview manual approved by NCI. Project staff may also travel to the cohort subject's mothers residence or other locations for contacting and interviewing. Each mother enrolled in the interview shall be nominally compensated for his or her time spent for the interview and travel costs. 2. Prepare and provide an accurate, complete and up-to-date Microsoft Access database of personal dosimetry interviews created by means of double entry. No personally identifiable information should be sent (e.g., no names, birth year/month only). 3. Scan the personal dosimetry interviews and create an electronic Microsoft Access database of scanned images of paper interviews. 4. Reconstruct individual doses for 150 (cumulative 1,350) subjects of in-utero cohort with re-interviewed mothers using the Dosimetry Operations Manual approved by NCI and provide a completed Microsoft Access database of individual calculated (a) pre- and postnatal thyroid doses for subjects, associated input data file and VBA macros used for calculations; and (b) pre- and postnatal doses to the thyroid and whole body from external irradiation and ingestion of Cs radioisotopes, associated input data file and VBA macros used for calculations. No personally identifiable information should be sent (e.g., no names, birth year/month only). Option 24A - Update demographic, clinical and epidemiologic data through a mail survey Six Months 1. Update vital status and last known address through a mail survey of a target of 1,200 (cumulative 10,600) subjects of the main cohort and contact them as described in the study protocol and Operations Manual approved by NCI. 2. Create and maintain a database of the main and in-utero cohorts and mothers that links to computerized databases of questionnaires used to collect information, vital status, tracing history, and other study data, which are to be entered. Provide the computer programming support necessary to implement and maintain these databases. Option 24B - Update demographic, clinical and epidemiologic data through a mail survey Six Months 1. Update vital status and last known address through a mail survey of a target of 1,200 (cumulative 11,800) subjects of the main cohort and contact them as described in the study protocol and Operations Manual approved by NCI. 2. Finalize preparation of a database of the main and in-utero cohorts that links to computerized databases of questionnaires used to collect information, vital status, tracing history, and other study data, which are to be entered. Provide the computer programming support necessary to implement and maintain these databases. Deliver an accurate, complete and up-to-date electronic database on update information and collected data as specified by NCI. No personally identifiable information should be sent (e.g., no names, birth year/month only). 3. Respond to data requests and questions concerning the main and in-utero cohorts and provide support to NCI investigators in their preparation of scientific papers to be published to peer-reviewed Western journals. Option 25A: Breast Cancer - Tracing (six months) 1. Among mothers identified in earlier option, trace, locate and contact as described in the study protocol and Operations Manual approved by NCI at least 600 (cumulative 3,400 including mothers for whom information was collected during Tasks 14A, 14B, 19A and 19B) mothers whose children were born between January 1, 1985 and June 30, 1986 in Gomel and Mogilev Oblast of Belarus radioactively contaminated after the Chernobyl accident, with preference to those born in 1986. Multiple data sources may be used to gather this information, such as, Belarusian State Register of Persons Exposed to Radiation due to the Chernobyl Accident, database of SI - RRCRM&HE, database of main BelAm project, databases of local of local medical facilities of studied regions. Use additional resources, such as, village councils, office of labor, emergency departments and secondary schools, to collect and verify information about mothers and their children. Update vital status, last known address, demographic and other information for mothers through a mail survey for a target of 600 (cumulative 3,400 including mothers for whom information was collected during Tasks 14A, 14B, 19A and 19B) mothers as described in the study protocol and Operations Manual approved by NCI. 2. Create and maintain a master database of the cohort of lactating women and their children born after January 1, 1985 (including mothers from in utero and main cohort) that links to computerized databases of mail survey questionnaires, vital status, tracing history, and other study data as specified by NCI, which are to be entered. Provide computer programming support necessary to implement and maintain these databases. Option 25B: Breast Cancer -Tracing (six months) 1. Among mothers identified in earlier option, trace, locate and contact as described in the study protocol and Operations Manual approved by NCI at least 600 (cumulative 4,000 including mothers for whom information was collected during Tasks 14A, 14B, 19A, 19B and 25A) mothers whose children were born between January 1, 1985 and June 30, 1986 in Gomel and Mogilev Oblast of Belarus radioactively contaminated after the Chernobyl accident, with preference to those born in 1986. Multiple data sources may be used to gather this information, such as, Belarusian State Register of Persons Exposed to Radiation due to the Chernobyl Accident, database of SI - RRCRM&HE, database of main BelAm project, databases of local of local medical facilities of studied regions. Use additional resources, such as, village councils, office of labor, emergency departments and secondary schools, to collect and verify information about mothers and their children. Update vital status, last known address, demographic and other information for mothers through a mail survey for a target of 600 (cumulative 4,000 including mothers for whom information was collected during Tasks 14A, 14B, 19A, 19B and 25A) mothers as described in the study protocol and Operations Manual approved by NCI. 2. Create and maintain a master database of the cohort of lactating women and their children born after January 1, 1985 (including mothers from in utero and main cohort) that links to computerized databases of mail survey questionnaires, vital status, tracing history, and other study data as specified by NCI, which are to be entered. Provide computer programming support necessary to implement and maintain these databases. 3. Link database of the cohort of lactating women and their children born after January 1, 1985 (cumulative 2,800 mothers) with the National Belarusian Cancer Registry for each specific cancer site reported to the Registry from 1987 through the latest calendar year for which complete incidence data are available and perform statistical analyses and tabulations for calculating observed and expected cancer cases for various cancer sites. Primary Point of Contact: Kari Peterson, Contract Specialist Kari.peterson@nih.gov Phone: 240-276-7480