SOLICITATION NOTICE
B -- Follow-up of the Alpha-Tocopherol, Beta-Carotene Cancer Prevention (ATBC) Study Cohort
- Notice Date
- 1/23/2015
- Notice Type
- Presolicitation
- NAICS
- 541711
— Research and Development in Biotechnology
- 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
- N02CO57011-13
- Archive Date
- 2/24/2015
- Point of Contact
- Mary E. Loesch, Phone: 240-276-5215, Jill Johnson, Phone: 240-276-5395
- E-Mail Address
-
loeschme@mail.nih.gov, jill.johnson2@nih.gov
(loeschme@mail.nih.gov, jill.johnson2@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Division of Cancer Epidemiology and Genetics (DCEG) of the National Cancer Institute (NCI) is planning to negotiate a contract with the National Institute for Health and Welfare in Finland for the follow-up of the Alpha-Tocopherol, Beta-Carotene Cancer Prevention (ATBC) Study Cohort. The objectives of this contract and project are to provide ongoing support of NCI in the form of 1) population-based data linkages (cancer registry, causes of death, prescription medications, and hospital discharge diagnoses) of this unique, well-characterized cohort that has extensive risk factor data in conjunction with prospectively collected biologic samples, 2) abstracting and review of selected cancer case medical records, 3) replacement serum and whole blood samples from the Finnish Helsinki repository and continued access to toenail samples, and, 4) optional Formaldehyde Fixed-Paraffin Embedded (FFPE) tumor tissue collection (based on NCI PI requests and funding). Preservation of the ongoing passive follow-up and related support activities will maintain the value of the original investments in the ATBC Study of Finnish smokers and will continue to facilitate a wide range of cancer etiology, survival, early detection, and prevention studies throughout NCI (and the Division of Cancer Epidemiology and Genetics, in particular). The Contractor shall perform tasks in the following areas: Identification and Review of Endpoints and Related Data 1. CANCERS a. Incident cancers At least annually, identify all incident cancer cases among the ATBC Study participants through linkage with the Finnish Cancer Registry (some may be identified only through Statistics Finland mortality linkage, below). b. Cancer case medical record retrieval Collect, store, and abstract copies of all necessary and relevant medical records from hospitals, clinics, etc. pertaining to a sample of approximately 150 cancer cases identified for targeted cancer sites as selected annually by the NCI based on timely research priorities. This will include, but not be limited to, discharge summaries, progress notes, surgical and pathology reports, death certificates, reports from clinical examinations and procedures, and relevant laboratory tests. Provide for review and verification by an oncologist the cancer diagnoses, stage/grade, treatments, and other relevant information for these cases. 2. DEATHS At least annually, identify all deaths, including dates and the underlying and contributory causes of death, among members of the ATBC Study cohort through linkage with Statistics Finland and other relevant sources. 3. OTHER DISEASES AND DATA a. At the request of NCI, link the ATBC Study population with the Finnish Hospital Discharge Registry to identify requested diagnoses during hospitalizations in the second and fourth contract years. b. At the request of NCI, link the ATBC Study population with the Finnish Social Security prescription medication registers to identify type, dosage, calendar years and duration of medication use in the second and fourth contract years. c. At the request of NCI, develop and implement a short cancer risk factor questionnaire for use as a telephone survey of ATBC Study survivors. Current smoking behaviors will be key among information to be queried. Biological Specimens 1. Maintain a system of controlled inventory and storage for the existing baseline toenail samples (room temperature) and the third trial year serum (-70oC to -80oC) from the ATBC Study cohort that were retained only by Contractor and its predecessor. 2. At the request of NCI, and based on ATBC Study participants whose NCI-Frederick serum or whole blood biospecimen samples have been depleted, package and ship (frozen) to NCI serum or whole blood samples. Also package and ship selected toenail samples at the request of NCI. 3. At the request of NCI, and based on specific NCI principal investigator needs, collect archived formalin-fixed, paraffin embedded tumor tissue slides for samples of cancer cases annually based on slide specifications to be provided. Data Management 1. Code, key and verify all ATBC Study data acquired under this Contract onto secure computer files maintained at the National Institute for Health and Welfare, Helsinki, Finland. 2. Ensure that computerization of these data is conducted in a timely, secure and high-quality manner. 3. Transmit all these data in secure, computerized formats to the ATBC Study data management center of DCEG, NCI (currently Information Management Services (IMS), Inc., Silver Spring, MD). 4. Respond in a timely manner to NCI questions regarding all new data and biospecimens. Quality Control and Project Coordination Develop, including in the Technical Proposal, and implement quality control plans to assure high quality in: 1. Collection, preparation, review and transfer to NCI of registry data and medical records collected under this Contract. 2. Retrieval, preparation, and shipment of biospecimens collected under this Contract to NCI. 3. Storage of all ATBC Study biological specimens maintained in Helsinki by the Contractor. 4. Take part in periodic conference calls with NCI for data and biospecimen coordination. 5. Prepare for up to two Contract Officer Representative (COR) site visits of the Contractor. The National Institute for Health and Welfare in Finland is the only responsible source and no other supplies or services will satisfy agency requirements. The National Institute for Health and Welfare is uniquely qualified by virtue of its ownership of the study cohort. The proposed acquisition is for a 5-year follow-on contract of the National Cancer Institute (NCI) Alpha-Tocopherol, Beta-Carotene Cancer Prevention (ATBC) Study cohort follow-up based in Finland. The study population includes all participants (n=29,133 male smokers) from the ATBC Study that was conducted in southwestern Finland between 1985 and 1993, originally as a cancer prevention trial testing supplementation with the micronutrients beta-carotene and vitamin E. The ATBC Study has been an integral cohort and scientific resource for NCI for over two decades. The originally conducted controlled primary cancer prevention trial of vitamin supplementation collected medical, serial chest x-ray, anthropometric, dietary, smoking, and occupational data, along with highly valuable biospecimens including fasting serum, whole blood, red blood cell, and toenail samples. Half of the biospecimens are stored by Finland in Helsinki. Post-trial cancer and mortality surveillance of the cohort with essentially complete ascertainment has been maintained through contracts with Finnish government institutions: first the National Public Health Institute, and most recently, the National Institute of Health and Welfare. The latter institution solely retains personal identifiers, including the Finnish social security numbers used for all of the cohort's data linkages and medical record access. This acquisition is a recompete of contract no. HHSN261201000006C. The proposed contract action is for supplies or services for which the Government intends to solicit and negotiate with only one source, the National Institute for Health and Welfare in Finland under the authority of FAR 6.302. Interested persons may identify their interest and capability to respond to the requirement. This notice of intent is not a request for competitive proposals. However, all proposals received will be considered by the Government. A determination by the Government not to continue with this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive acquisition.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/RCB/N02CO57011-13/listing.html)
- Place of Performance
- Address: National Institute for Health and Welfare, Mannerheimintie 166, Helskink, FI-00271, Finland
- Record
- SN03623293-W 20150125/150123234545-788f56518cd5fe782237506c1f2ba034 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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