Inactive
Notice ID:75N91020C00008
Type of Notice: This is a Non-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 ...
Type of Notice: This is a Non-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 Non-R&D requirement. Background: The Radiation Epidemiology Branch (REB), Division of Cancer Epidemiology and Genetics (DCEG), National Cancer Institute (NCI), sponsors joint U.S.-Ukraine studies of the health effects of the Chernobyl accident at the Chernobyl Nuclear Power Station on April 26, 1986 in Ukraine. Introduction The contract, “Administrative Support for Chernobyl Projects in Ukraine”, Contract number 75N91020C00008 with Science and Technology Center in Ukraine (STCU) supports the Ukrainian research institutes in Kyiv, Ukraine conducting two projects: 1) the “Clinical Cohort of Ukrainian Cleanup Workers” project and 2) the “Ukrainian Thyroid/Breast Cancer Project”. These institutions collaborate with NCI, who financially supports and directs the projects. The “Clinical Cohort of Ukrainian Cleanup Workers” project is a collaboration between NCI and the National Research Center for Radiation Medicine (NRCRM), Kiev. Following the Chernobyl Nuclear Power Plant accident on April 26, 1986, approximately 150,000 cleanup workers (primarily men) living in Ukraine participated in various recovery activities. Since the accident, these individuals were invited for clinical examinations every two (2) years at the NRCRM in Kiev, Ukraine. Although a population of Ukrainian cleanup workers has been established for many years, there is no cancer cohort with reliable doses estimated for a range of organs. The “Ukrainian Thyroid Cohort/Breast Cancer Project” is a collaboration between NCI and the Institute of Endocrinology and Metabolism (IEM), Kiev. The objectives of this study are: (a) to monitor changes in the thyroid glands in a 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; and (b) to create the cohort of women lactating during exposure to Iodine-131 from Chernobyl fallout. 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 in Ukraine. NCI is collaborating with IEM to conduct a study of thyroid and breast cancer in Ukraine following the Chernobyl accident. The study includes subjects who were exposed to fallout in utero or as children and women with children born between April 1, 1985 and May 1, 1986 (up to a year before and shortly after the accident). All subjects are followed for cancer morbidity and mortality through linkage of cohort data with the Ukrainian Cancer Registry. This contract was awarded on a competitive basis for a one (1)-year base period (May 1, 2020- April 30, 2021) and one (1) one-year option (“Option Period 1”) for a total potential performance through April 30, 2022. This contract has since been modified to exercise Option Period 1 and incorporate additional work. The total current value of the contract, inclusive of Options is $748,447 NCI has identified a need to extend the period of performance and incorporate an additional one (1) year option period, Option Period 2 (May 1, 2022- April 30, 2023), for the current work and incorporate one additional task for each project, “Clinical Cohort of Ukrainian Cleanup Workers” and “Ukrainian Thyroid Cohort/Breast Cancer Project.” Additionally, each project will include Optional Task areas that may be exercised during Option Period 2. 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. The “Clinical Cohort of Ukrainian Cleanup Workers” project requires that the Contractor provides administrative oversight and support to the National Research Center for Radiation Medicine (NRCRM) in order to provide the following to NCI: Option Period 2 - Base Task 7A: Cohort Maintenance for Clinical and Epidemiology Registry (CER) - May 1, 2022 – April 30, 2023 Update demographic information for at least 2,000 cleanup workers (cumulative 8,000, including 6,000 cleanup workers for whom demographic information has been updated during the first 2 years of this contract) registered in the CER (name/address/telephone number/email, close relative’s name/address/telephone number/email). Link the information of study subjects (where possible) to the Ukrainian Cancer Registry and Chernobyl State Registry to ascertain cases of cancer; compare incidence rate among the study subjects with corresponding indicators for the entire Ukrainian population. 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 study datasets. Maintain Microsoft Access electronic datasets with updated demographic information and deliver it to NCI. No personally identifiable information shall be sent (e.g., no names, birth year/month only). Option Tasks Within Option Period 2: Option Task 8A: Clinical Cohort of Cleanup Workers: Questionnaire Enroll participants in the study according to selection criterion for 200 cleanup workers. Administer detailed study questionnaires to these 200 cleanup workers using procedures approved by NCI. Ensure cohort members enrolled in the study receive a nominal compensation for their time spent filling out the mailed questionnaire or telephone interview. Create and maintain a dataset with demographic and epidemiological data obtained for 200 study subjects during mail survey or telephone interview conducted in bullet #1 and from other sources. Deliver to NCI an accurate, complete, error-free and up-to-date Microsoft Access dataset with demographic, epidemiological and dosimetry data created by means of double entry. Enroll participants in the study according to selection criterion for 700 cleanup workers and administrate dosimetry questionnaire under Option Task 9A. Ensure cohort members enrolled in the study receive a nominal compensation for their time spent filling out the mailed questionnaire or telephone interview. Option Task 9A: Clinical Cohort of Cleanup Workers: Dosimetry Administer dosimetry study questionnaire to 700 cleanup workers enrolled under Option Task 8A using procedures approved by NCI. Create and maintain a dataset with demographic and dosimetry data obtained for 700 study subjects during mail survey or telephone interview. Deliver to NCI an accurate, complete, error-free and up-to-date Microsoft Access dataset with demographic and dosimetry data created by means of double entry. Calculate individual doses for organs to be specified by NCI for 700 cleanup workers with completed study dosimetry questionnaire using the Dosimetry Operations Manual approved by NCI. Deliver to NCI a completed Microsoft Access dataset of individual organ doses for 700 interviewed subjects in the clinical cohort. No personally identifiable information shall be sent (e.g., no names, birth year/month only). Option Task 10A: Collection, Storage and Shipment of Biospecimens Collect and store blood and buccal cells samples from 200 subjects 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. Maintain tracking of sample collection and enter all necessary information per Operations Manual approved by NCI. Provide collected blood and buccal cells samples properly coded along with the sample information dataset to the NCI. It is critical to maintain blood sample temperature (-80ºC) during the shipping process. The “Ukrainian Thyroid Cohort/Breast Cancer Project” requires that the Contractor provides administrative oversight and support to the Institute of Endocrinology and Metabolism (IEM) in order to provide the following to NCI: Option Period 2 - Base Task 10B: Maintenance and Cancer Linkage of Ukrainian Thyroid Cohort - May 1, 2022 – April 30, 2023 Conduct mail survey of at least 2,000 (cumulative 6,000, including subjects for whom mail survey has been conducted during 1st and 2nd year of the current contract) 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 datasets with demographic (phenotype), epidemiological and dosimetry data; provide the computer programming support necessary to implement and maintain these error-free and up-to-date datasets. Option Tasks Within Option Period 2: Option Task 11B: Breast Cancer Tracing, Eligibility, and Linkage Trace at least 1,200 mothers whose children were born between April 1, 1985 – June 30, 1986 in radioactively contaminated areas of Ukraine around the date of the Chernobyl accident on April 26, 1986. Prepare MS Access datasets with mothers information including full name, date of birth, place of residence and children (date of birth, gender). Include short survey to determine eligibility for breast cancer study: alive, current address and contact information, breastfeeding at time of potential exposure (April 26, 1986 – June 30, 1986), willing to answer dosimetry and risk factor questionnaires. Each woman shall be nominally compensated for her time spent filling out the short questionnaire. Prepare MS Access datasets with mothers information including full name, date of birth, place of residence and children (date of birth, gender). Conduct linkage of the datasets of 1,200 mothers 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 datasets of results of linkage to the NCI. No identifying information shall be sent (e.g., no names, birth year/month only). Option Task 12B: Breast Cancer Enrollment Enroll at least 200 mothers in the study and administer risk factor questionnaires. Project staff shall use mail/telephone or travel to the mothers’ residence or other locations for contacting and collecting demographic and epidemiological data. Each woman shall be nominally compensated for her time spent filling out the short questionnaire. Maintain study datasets with demographic and epidemiological data obtained for the study subjects and from other sources. Provide the computer programming support necessary to implement and maintain these error-free and up-to-date datasets. Provide MS Access datasets with epidemiological and demographic data to the NCI. No personally identifiable information shall be sent (e.g., no names, birth year/month only). Option Task 13B: Dosimetry of Breast Cancer Study Conduct personal interviews with 200 mothers using the dosimetry questionnaire and interview manual approved by NCI. Project staff shall use mail/telephone or travel to the mothers’ residence or other locations for interviewing. Each woman enrolled in the study shall be nominally compensated for her time spent for the interview and travel costs. Prepare and provide an error-free, complete and up-to-date dataset of personal dosimetry interviews created by means of double entry. Scan the personal dosimetry interviews and create an electronic Microsoft Access dataset of scanned images of paper interview. Deliver an accurate, complete and up-to- date electronic dataset of scanned images. Update and maintain a 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). Calculate radiation doses to female breast for 200 mothers enrolled in the study using of Dosimetry Operations Manual approved by NCI. Verify calculated doses using results of direct thyroid measurements (for 131I) and whole-body counter measurements (for cesium isotopes) for the mothers with available instrumental measurements. Provide computer code for calculating doses, datasets of personal dosimetry interviews, input files to calculate doses and results of calculations to the NCI. No personally identifiable information shall be sent (e.g., no names, birth year/month only). Option Task 14B: Thyroid Genome Control Collection Identify, trace, and locate 500 subjects of UkrAm cohort selected by NCI based on year of birth (+/- 2 years), sex, and dose without papillary thyroid carcinoma at time of case diagnosis based on information provided by the Institute of Endocrinology and Metabolism and the U.S. National Cancer Institute. Collect one cheek swab from each of 500 subjects. Provide nominal compensation to the subjects to reimburse for time and travel costs. Provide administrative support for delivery of properly labeled samples with subject’s ID from IEM (Kiev) to the USA to NCI designated Lab. Option Task 15B: Breast Cancer: Collection, Storage and Shipment of Biospecimens Collect and store blood and buccal cells samples from 200 subjects enrolled in the study by Tasks 12B/13B 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. Maintain tracking of sample collection and enter all necessary information per Operations Manual approved by NCI. Provide collected blood and buccal cells samples properly coded along with the sample information dataset to the NCI. It is critical to maintain blood sample temperature (-80ºC) during the shipping process. Option Task 16B: The Chernobyl Tissue Bank (CTB) Maintenance Collect, document, and store consented specimens (including fresh frozen tumor, normal tissue, and metastatic tissue samples; formalin-fixed paraffin embedded diagnostic materials; and serum and/or whole blood) and the clinical-pathological data on each patient. Option Task 17B: CTB Collection, Storage and Shipment of Biospecimens Maintain tracking of sample collection and enter all necessary information per Operations Manual approved by NCI. Provide dataset with sample information to the NCI. Provide administrative support for delivery of samples properly labeled with subject IDs from IEM (Kiev) to the USA to an NCI designated laboratory. Option Task 18B: CTB Dosimetry Calculate radiation absorbed doses to the thyroid due to 131I intake and characterize associated uncertainties in doses for 1,300 subjects from CTB, including those who will be selected by NCI for the study of full genomic characterization of thyroid cancer, using Dosimetry Operations Manual approved by NCI. Prepare an edited and documented MS Access electronic file of thyroid doses for CTB subjects as requested by the NCI. Provide dosimetry results to the NCI. Anticipated Period of Performance: The anticipated period of performance for this requirement is one (1) year. It is anticipated to be applied as Option Period 2 beginning on May 1, 2022 and ending on April 30, 2023. 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’ a. Technical approach to recruit the specified population b. Staff expertise, including their availability, experience, and formal or other training c. Current in-house capability and capacity to perform the work d. 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 Nikki McKay, Contract Specialist (nikki.mckay@nih.gov) in either MS Word or Adobe Portable Document Format (PDF) by February 28, 2022 at 4:00 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.
