Support Services for Radiation and Cancer Risk Studies

This is a Small Business Sources Sought 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 businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses 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. THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. THIS IS STRICTLY FOR MARKET RESEARCH. Background The Radiation Epidemiology Branch (REB) in the Division of Cancer Epidemiology and Genetics (DCEG) of the National Cancer Institute (NCI) is re-competing a full and open contract for support services for several on going studies, feasibility studies, and future studies. Purpose and Objectives A major objective of DCEG is to identify and understand mechanisms of carcinogenesis. Studies within REB focus on cancer risk and other health outcomes associated with medical, occupational or environmental exposure to radiation as well as the etiology of certain cancers associated with radiation exposure (e.g. thyroid, breast, leukemia) and the radiation dosimetry to assess the cancer risks under investigation. To achieve its goals, REB's approach has been to conduct high-impact epidemiologic studies that integrate cancer risk factor information, carefully defined radiation exposure assessments, and sometimes biologic markers to provide new insights into radiation carcinogenesis. Molecular approaches play a critical and increasingly important role in REB research. REB is often called upon to address rapidly emerging issues in radiation exposure and cancer epidemiology through novel investigations and data sources. REB also assists in training the next generation of radiation epidemiologists, statisticians, and applied radiation dosimetrists. Approximately 12-30 studies in various phases will require support at any one time under the contract. Project Requirements This support services contract is essential for REB to conduct high-impact epidemiologic studies that integrate radiation exposure, cancer risk factor information, and at times biologic markers to provide new insights into cancer etiology and mechanisms of action. The NCI/DCEG/REB requires the assistance of an organization highly experienced in providing technical support for all phases of epidemiologic studies, including support for pilot and feasibility efforts to assess capabilities for launching multidisciplinary studies, development of precise methods of defining radiation dose for the purposes of identifying new causes of cancer and to adequately characterize the shape of the dose-response relationship, and to understand the interaction of genetic, radiation, and other risk factors related to cancer risk. Thus, the support services contract will need to provide staff with superb logistical skills, knowledge of and experience conducting epidemiological studies and collection of biological specimens. The contract will establish a mechanism to provide all the services required to conduct a wide variety of domestic and international (case-control, cohort, cross-sectional, and pilot) epidemiologic studies. The scientific design and oversight of the activities are the responsibility of the REB professional staff. Some of the major activities of the contractor include: 1) Obtain necessary information to determine effective study resources (e.g., capabilities of collaborating institutions, numbers of eligible study subjects, exposure information, etc.) and prepare, pretest, evaluate and produce data collection forms and specification manuals, including computer-assisted questionnaires; 2) Provide project management and assist in the coordination of multi-center studies and facilitate cooperation between NCI and its collaborators; 3) Prepare training programs and materials for abstractors, interviewers and other study personnel and procedure manuals; 4) Arrange for the collection, handling, processing, transport and storage of biologic samples or to send them to specific laboratories as directed; 5) Validate cancer incidence and cause of death by performing registry linkages (e.g., linkage with cancer registries), conducting NDI+ searches, and obtaining medical records, and have them coded by appropriate nosologists, pathologists or clinicians; 6) Collect, code, and key data from medical and radiation records; 7) Trace study subjects to locate them for interview or biologic specimen collection, to determine their vital status, and obtain other information necessary for the study with the understanding that some of the subjects were last contacted years ago; 8) Hire, train and supervise abstractors, interviewers, telephone screeners, coders, phlebotomists and others who will be involved with acquiring and assembling data; abstract, scan, photocopy or obtain records (clinical or office medical records, hospital charts, pathology reports, radiation treatment records etc.); 9) Interview subjects or surrogates using mail, telephone, computer-assisted or personal interviews; 10) Assist in evaluating the feasibility of integrating specific molecular components into planned epidemiologic studies; 11) Act as a liaison for collection of radiation exposure records and arrange for estimation of radiation doses as needed; 12) Arrange for laboratory evaluation of biologic material; 13) Enter coded information into electronic databases; 14) Design and maintain computer databases and associated reporting software and prepare edit programs, edit data, maintain quality control, and correct computer files where necessary; prepare analytical data files and maintain version control of files as requested by the REB staff; 15) Document each step of a study, including decision logs, and maintain in an orderly arrangement all relevant material so that any aspect of the study may be reviewed and evaluated by the REB staff at any point in time; 16) Develop and manage subcontracts for conducting epidemiologic and radiation dosimetry studies inside and outside the U.S., for specialized field procedures in the U.S., and for laboratory analyses of biologic samples. 17) Provide the support necessary to make dose measurements using soil, archived tissues, milk, teeth, blood, human-like phantoms, computerized treatment planning programs or specialized software, as appropriate, to reconstruct radiation doses to specific organs (or sites within organs) following natural, environmental, man-made, or therapeutic and diagnostic medical exposures for ongoing epidemiologic studies. Anticipated period of performance It is anticipated that the period of performance for this Indefinite Delivery/Indefinite Quantity (IDIQ) contract will be for 5-years with two 1-year options. Capability statement/Information sought To be deemed capable of providing the requirement, organizations shall submit a written capability statement demonstrating ability and experience in performing the requirements noted in this notice. Organizations must demonstrate experience, capabilities, qualified personnel, and expertise in (1) managing, planning and conducting multiple small and large epidemiologic projects in widespread geographic areas (including internationally), some of which involve molecular or international components; (2) collecting radiotherapy records and assisting the resolution of deficiencies and problems, and collecting and transporting biological and environmental samples; (3) training abstractors and interviewers in other aspects of field studies such as obtaining medical records and death certificates; (4) constructing analytic data files using SAS or other similar statistical programs for epidemiologic studies and manipulating large data sets; (5) providing adequate staffing to provide support on multiple studies, at different stages in the studies, worldwide; (6) quality control/quality assurance plans for epidemiologic and radiotherapy data, biospecimen, and environmental sample management and security of data; (7) assist in coordination of biologic or environmental specimen collection, handling and transport to a repository for storage; and (8) providing capable, suitable, adequate, and available facilities, equipment, and other resources necessary to carry out the requirements. Information Submission Instructions Interested qualified small business organizations should submit a tailored capability statement for this requirement, not to exceed 15 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. Statements should also include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement, as well as the eligible small business concerns name, point of contact, address and DUNS number. NCI does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information received. All capability statements sent in response to this sources sought notice must be submitted electronically (via email) to Ms. Jessica Chu, Contract Specialist, at Jessica.chu2@nih.gov in MS Word or Adobe Portable Document Format (PDF), by March 24, 2014 at 10:00 AM local time, Rockville, MD. 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 Note This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. 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(s).