Support Services for Radiation and Cancer Risk

*Updated 5/16/14* Please find Amendment 2 attached. *Updated 5/7/14* Please find Amendment 1 attached. *Updated 4/24/14* Please find solicitation attached. THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION WILL BE ISSUED ON A LATER DATE. 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. 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. 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. This work is currently being conducted under contract HHSN261200900017C held by Research Triangle Institute. The services will be acquired through full and open competitive procedures under NAICS 541990. It is anticipated that one IDIQ contract may be awarded beginning on or about August 20, 2014. The RFP will be available electronically at a later date and may be accessed through FedBizOpps at www.fbo.gov. All responsible sources may submit a proposal which will be considered by the agency. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile or email transmissions will be accepted. IT IS THE OFFEROR'S RESPONSIBILITY TO MONITOR THE ABOVE MENTIONED SITE FOR THE RELEASE OF THE SOLICITATION AND ANY AMENDMENTS.