Breast Cancer Feasibility for Belarus Chernobyl Study

Type of Notice: This is a Research and Development (R&D) notice to find capable vendors. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources including small and small disadvantaged businesses to perform a potential R&D requirement. Background: The Chernobyl Research Program (CRP), Radiation Epidemiology Branch (REB), National Cancer Institute (NCI) isresponsible for a research program in radiation effects on cancer and other diseases. CRP develops, administers, and evaluates a contract-supported applied research program. Introduction The contract, - Support for Thyroid Cancer and Other Thyroid Diseases in Belarus, Contract number HHSN261201800015C with GU RNPTS RMIECH 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 in April 26, 1986. 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. This contract was awarded 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. The total potential value of the contract, inclusive of Options is $555,413. NCI has identified a need for the following: (1) to collect information about mothers and their children who were born between January 1, 1985 and June 30, 1986 in the study area; (2) to trace, locate and contact mothers whose children were born between January 1, 1985 and June 30, 1986; (3) to develop and test dosimetry questionnaire and dosimetry model to calculate radiation doses to the female breast; and (4) to collect, process and store blood and buccal cells samples from women enrolled. This information is for planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the NCI. 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. A. Breast Cancer Feasibility - Six Months 1. Collect information about mothers (name, date of birth, vital status, address) and their children (name, date of birth, address) who were born between January 1, 1985 and June 30, 1986 in Gomel and Mogilev Oblast of Belarus radioactively contaminated after the Chernobyl accident. Multiple data sources will be used to gather this information, such as, the 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 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. 2. Create and maintain a database with information collected for at least 3,000 mothers and their children born between January 1, 1985 and June 30, 1986. Provide the computer programming support necessary to implement and maintain these databases. 3. With input and guidance from NCI, develop methods to calculate radiation doses to female breast of lactating and non-lactating women from intake of 131I (during April - June 1986) and 134 and 137Cs (during entire period after the Chernobyl accident) and external irradiation (during entire period after the Chernobyl accident). B - Breast Cancer Feasibility - Six Months 1. Collect information about mothers (name, date of birth, vital status, address) and their children (name, date of birth, address) who were born between January 1, 1985 and June 30, 1986 in Gomel and Mogilev Oblast of Belarus radioactively contaminated after the Chernobyl accident. Multiple data sources will 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. 2. Create and maintain a database with information collected for at least 3,000 additional women (cumulative 6,000, including mothers for whom information was collected during Task A) and their children born between January 1, 1985 and June 30, 1986. Provide the computer programming support necessary to implement and maintain these databases. Deliver to the NCI an accurate, complete and up-to-date electronic master database on demographic and other relevant information as specified by NCI. No personally identifiable information should be sent (e.g., no names, birth year/month only). 3. Develop the study dosimetry questionnaire to collect individual behavior, consumptions, breastfeeding and other information (e.g., direct thyroid measurements, whole-body counter measurements) required for the estimation of radiation doses to female breast of lactating and non-lactating women. C - Breast Cancer Feasibility - Six Months 1. Trace, locate and contact as described in the study protocol and Operations Manual approved by NCI, at least 800 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. Update vital status, last known address, demographic and other information for mothers and all their children born after January 1, 1985, with preference for those born in 1986, through a mail survey for a target of 800 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. Deliver to the NCI an accurate, complete and up-to-date electronic master database on demographic and other relevant information as specified by NCI. No personally identifiable information should be sent (e.g., no names, birth year/month only). 3. Test the study dosimetry questionnaire to collect individual behavior, consumptions, breastfeeding and other information required for the estimation of radiation doses to female breast of lactating and non-lactating women. Interview 20 women for testing of dosimetry questionnaire, provide nominal compensation for time spent for the interview and travel costs. 4. Prepare a draft of Dosimetry Operations Manual for the estimation of radiation doses to female breast of lactating and non-lactating women from intake of 131I (during April - June 1986) and 134, 137Cs (during entire period after the Chernobyl accident) and external irradiation (during entire period after the Chernobyl accident). D - Breast Cancer Feasibility - Six Months 1. Trace, locate and contact as described in the study protocol and Operations Manual approved by NCI at least 800 (cumulative 1,600, including mother for whom information was collected during Task C) 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. Update vital status, last known address, demographic and other information for mothers through a mail survey for a target of 800 (cumulative 1,600, including mothers for whom information was collected during Task C) 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. Test questionnaires in 100 subjects according to the procedures described in the study protocol and Operations Manual approved by NCI. Conduct personal interviews with 100 women using the dosimetry questionnaire and interview manual approved by NCI. Project staff will travel to the mothers residence or other locations for contacting and interviewing. Each woman enrolled in the study shall be nominally compensated for her time spent for the interview and travel costs. 4. Collect, process and store blood and buccal cells samples from 100 subjects using RNA PAxgene tubes, BD Vac EDTA tubes and Oragene OG500 saliva kits. Blood samples should be processed and stored at a specified temperature per Operations Manual approved by NCI. 5. Maintain MS Access database to track sample collection and enter all necessary information per Operations Manual approved by NCI. Provide MS Access database with sample data to the NCI. No personally identifiable information should be sent (e.g., no names, birth year/month only). 6. Prepare and provide an error-free, complete and up-to-date 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). 7. Scan personal dosimetry interviews and create an electronic Microsoft Access database of scanned images of paper interview. Deliver an accurate, complete and up-to-date electronic database of scanned images. 8. Build and provide computer code to calculate individual breast doses due to intake of 131I (during April - June 1986) and 134, 137Cs (during entire period after the Chernobyl accident) and external irradiation (during entire period after the Chernobyl accident). Anticipated Period of Performance: The anticipated period of performance for this requirement is four 6-month options. It is anticipated to be applied starting Option Period 2 (February 15, 2020) to the end of the contract (February 14, 2022). Capability Statement/Information Sought: Tailored Capability Statements submitted as a result of this announcement should demonstrate the offerors Technical Approach to recruit the specified population and experience. Sources are expected to have the necessary skills and tools to meet the requirements of this project. Capability statements must include the following: 1. Respondents DUNS number, organization name, address, and point of contact. 2. Respondents opinions about the difficulty and/or feasibility of the potential proposed acquisition, possible solutions and approaches that may currently exist in the marketplace, and information regarding innovation ideas or concepts. 3. Information regarding respondents Staff expertise, including their availability, experience, and formal or other training Current in-house capability and capacity to perform the work Prior completed projects of similar nature 4. Any other information that may be helpful in developing or finalizing the acquisition requirements. Information Submission Instructions: Interested qualified organizations should submit a tailored capability statement for this requirement, not to exceed 5 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 notice must be received electronically (via email) by Gary Debes, Contract Specialist at gary.debes@nih.gov in either MS Word or Adobe Portable Document Format (PDF) by January 22, 2020 at 4:30 PM, Eastern Time. All responses must be received by the specified due date and time in order to be considered. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response to this notice. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation.