MODIFICATION
R -- Support for Thyroid Cancer and Other Thyroid Diseases in Belarus
- Notice Date
- 7/13/2017
- Notice Type
- Modification/Amendment
- NAICS
- 541990
— All Other Professional, Scientific, and Technical 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
- HHS-NIH-NCI-SBSS-ETSB-71024-72
- Archive Date
- 8/12/2017
- Point of Contact
- Jame Chang, Phone: 240-276-5424
- E-Mail Address
-
jame.chang@nih.gov
(jame.chang@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Type of Notice: This is a Small Business Sources Sought (SBSS) notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small business; HUBZone small businesses; service-disabled, veteran-owned small businesses, 8(a) small businesses; veteran-owned small businesses; women-owned small businesses; or small disadvantaged business; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your response to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This requirement is assigned a NAICS code of 541990 and the small business size standard for such requirements is $15 Million per annum. The Division of Cancer Epidemiology and Genetics (DCEG), National Cancer Institute (NCI) is seeking capability statements from all eligible Small Businesses as stated above. THERE IS NO SOLICITATION AVAILABLE. THIS IS STRICTLY FOR MARKET RESEARCH. Background: The accident at the Chernobyl nuclear power plant in 1986 resulted in massive releases of radioactive materials into the atmosphere and contamination of large areas with significant levels of radioiodines (up to two months after the accident), radiocesiums and other radionuclides. Among the population groups affected by the accident a larger number of individuals who were exposed to radioiodines as fetuses, children or adolescents present a special concern, as the young thyroids are known to be especially susceptible to the carcinogenic effect of radiation exposure. The Belarus-American Study of Thyroid Cancer and Other Thyroid Diseases Following the Chernobyl Accident (BelAm) is a part of NCI's Chernobyl research program. It was designed to be parallel to a similar project in Ukraine. Ukraine and Belarus were chosen as study sites because they are the areas considered to be most contaminated by radioiodine fallout from the Chernobyl accident. The original BelAm cohort population consisted of about 12,000 persons - similar in size and nature to the corresponding Ukrainian cohort - who were children or adolescents (aged 18 or younger) at the time of the accident, who had thyroid activity measurements made within a short time following the accident on April 26, 1986, and who lived in specified affected areas (main cohort). Because of special concern for cancer and other health risks associated with exposure to radiation during the prenatal period (in-utero), NCI setup a cohort of about 2,600 persons in Ukraine, though not in Belarus, who were in-utero at the time of the accident. The study design for the main BelAm cohort originally focused on clinical screenings of the thyroid glands of cohort members at least every two years to collect data on clinical parameters for diagnosis of malignant and benign thyroid disorders. A questionnaire was also administered, like the one in Ukraine, primarily for capturing additional information important for dose estimation. Active screening ended in 2006, but cohort follow up has continued using record linkage with the National Belarus Cancer Registry and Chernobyl State Registry for ascertainment of cancer (thyroid and other) and non-cancer diseases. This program has resulted in the publication of several scientific papers, including dosimetry and reliability of questionnaire-based dose estimates; thyroid cancer prevalence risk at first screening in relation to radioactive iodine exposure, urinary iodine and goiter prevalence; benign thyroid tumor; non-cancer thyroid diseases, thyroglobulin, and study description. Several papers in preparation include thyroid cancer incidence data accumulated from repeated screenings and thyroid cancer pathology. In 2011, NCI began collaboration with Belarusian investigators to construct a cohort of persons exposed in utero and early life to Chernobyl fallout in Belarus. The cohort construction was completed in early 2017, with a target size of approximately 2,800 persons. Individual pre- and postnatal radiation exposure doses due to internal irradiation from incorporated radioisotopes of iodine-131 (131I) and cesium isotopes (134Cs and 137Cs) and due to external irradiation from mixture of radionuclides have been reconstructed for each cohort member. This unique cohort of persons exposed in utero with available radiation doses estimated for each cohort subject provides a scientific environment to assess the health effects in in-utero exposed persons. Because of the significant radiation exposure to the thyroid gland from 131I, clinical screening in this cohort will focus on thyroid cancer and other thyroid diseases. The UkrAm in utero cohort data suggested an increase in radiogenic risk of thyroid carcinoma 20 years after the accident; the estimated excess odds ratio per gray was very high but associated with statistical uncertainty due to the small number of cases involved. Data from the proposed BelAm screening study will provide an independent assessment of the risk associate with in utero (131I) exposure. In addition to thyroid cancer, thyroid screening will enable NCI to ascertain a wide spectrum of benign neoplastic as well as non-neoplastic lesions, including benign tumors, nodules, functional changes (hyper- or hypothyroidism, thyroiditis, etc.). Some of the non-malignant lesions, especially follicular adenoma, non-neoplastic nodules and subclinical hypothyroidism have been linked to radiation exposure in childhood and adolescence, but little or no data are available about the risk of these conditions due to in utero exposure. Another important aspect of the study is evaluating uncertainty of questionnaire-based doses due to memory recall. An NCI previous study shows that if dose-related measurements are available for study subjects, the quality of individual behavior and dietary data has, in general, a small influence on the results of the retrospective dose assessment. However, direct thyroid measurements are available only for around 15% of mothers of in utero cohort subjects, evaluation of uncertainty in doses due to possibly poor memory recall is important for this study. The incumbent, GU RNPTS RMIECH, Republican Research Center of Radiation Medicine and Human Ecology (RRCRM&HE), has provided support for this study via contract since 2004. Purpose and Objectives: This contract is for the continuation of the "Study of Thyroid Cancer and Other Thyroid Diseases in Belarus", 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 about 2,800 persons who were exposed to Chernobyl fallout radiation in-utero and early post-natal life. The main emphasis of this procurement is to conduct medical screening for thyroid cancer and diseases in the recently established in-utero cohort. The main cohort, after having undergone three cycles of thyroid screening, transitioned to linkage-based passive follow-up. The specific objectives are: for the in-utero cohort, (1) to conduct medical screening for thyroid cancer and thyroid non-cancer disease; (2) to evaluate the reliability of questionnaire-based doses previously reconstructed; and, for both the main and in-utero cohorts; (3) to maintain passive follow-up to update occurrences of thyroid cancer, other cancer and thyroid non-cancer disease, through linkage with the Chernobyl State Registry and the National Belarusian Cancer Registry; and (4) to provide support for the study of genome characterization of thyroid cancer conducted by NCI in Belarus. Project Requirements: Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, materials, equipment, and facilities, not otherwise provided by the Government, as needed to support this study. The Contractor shall perform some or all the following support activities, as may be specified by the NCI COR, in support of the study. The scientific design of studies, supervision of ongoing data collection, data analysis and publication-related activities are the responsibility of NIH/NCI scientific staff. 1. Update vital status and last known address of in-utero subjects and their mothers. 2. Conduct medical screening using fixed and mobile teams for in utero subjects. Project staff will travel to the subject's residence or other locations for conducting the medical screening. 3. Develop and establish a master database for 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, and report on adverse medical event, growth and physical development form (head circumference, height and weight measurements). 4. Locate and contact mothers of in-utero subjects and conduct second personal interviews with mothers who were interviewed during in-utero cohort construction in 2011- 2017. Project staff will travel to the cohort subject's mothers' residence or other locations for contacting and interviewing. 5. Reconstruct individual doses for the in-utero cohort with mothers who were interviewed a second time and provide a completed Microsoft Access database of individual calculated (a) pre- and postnatal thyroid doses due to 131I intakes 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. 6. 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. 7. Trace, locate, contact and invite the subjects identified by NCI for the study of genome characterization of thyroid cancer to the Center and obtain from them consent for study participation and one whole tube of blood (5 mL). Transfer signed consent form and one whole tube of blood frozen under -80ºC properly labeled with subject's ID to Minsk Municipal Clinical Hospital for Oncology. Anticipated Period of Performance: The anticipated period of performance for this requirement is a one-year base period and three 12-month options. Capability Statement/Information Sought: We encourage small businesses to submit a capability statement which will be considered by the agency. Small businesses possessing experience and demonstrated capability to accomplish the requirements and level of effort are to supply pertinent information in sufficient detail to demonstrate their ability to perform the required services. Information furnished must not exceed 5 pages (12-point font minimum), including all attachments, résumés, and charts; and should include an outline of previous or similar projects performed. All responses must include an indication of current certified small business status, clearly marked on the first page of the capability statement, as well as the eligible small business concern's name, point of contact, address, and DUNS number. Information Submission Instructions: All capability statements sent in response to this Small Businesses Sources Sought notice must be sent electronically (via email) to Jame Chang, Contracting Officer at jame.chang@nih.gov in either MS Word or Adobe Portable Document Format (PDF) by July 28, 2017 at 3:00 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. 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 Sources Sought 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. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. 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.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/RCB/HHS-NIH-NCI-SBSS-ETSB-71024-72/listing.html)
- Record
- SN04578259-W 20170715/170713235245-8519819333ef8706b62b10efdf9a908d (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |