SOURCES SOUGHT
R -- Follow up of the Alpha-Tocopherol- Beta-Carotene Cancer Prevent (ATBC) Study Cohort
- Notice Date
- 10/21/2014
- Notice Type
- Sources Sought
- 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-SS-ETSB-1008-55
- Archive Date
- 11/15/2014
- Point of Contact
- Randall Tiqui, Phone: 2402765428, Jill Johnson, Phone: 240-276-5395
- E-Mail Address
-
randall.tiqui@nih.gov, jill.johnson2@nih.gov
(randall.tiqui@nih.gov, jill.johnson2@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Type of Notice: This is a Support Services Sources Sought notice. 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 to perform a potential Support Services requirement. Background: The mission of the Nutritional Epidemiology Branch (NEB), National Cancer Institute (NCI), is to define the causal relationships between diet/nutritional status, energy balance, metabolism, lifestyle factors, and cancer. NEB's research encompasses diet, energy balance/obesity/physical activity, specific nutrients and supplements, diet-related additives, contaminants, metabolites, and intermediate biologic markers. In support of this mission, the Finnish National Institute of Health and Welfare ("NIHW") has and continues to collect health-related data for a large cancer cohort study, the Alpha-Tocopherol, Beta-Carotene Cancer Prevention (ATBC) Study, originally conducted in southwestern Finland. The study population includes all participants (n=29,133 male smokers) from the ATBC Study conducted between 1985 and 1993, originally as a cancer prevention trial testing supplementation with the vitamins beta-carotene and vitamin E. The ATBC Study has been an integral cohort and scientific resource for the 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 cells, and toenail samples. Half of the biospecimens are stored by Finnish NIHW 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, with the National Public Health Institute, and most recently, the National Institute of Health and Welfare. The latter institution solely retains personal identifiers, used for all of the cohort's data linkages and medical record access. The ATBC Study cohort is a valuable biomedical resource for NCI because it: 1) is a relatively large study population; 2) has up to 30 years of follow-up; 3) has complete national registry endpoint and other linkages (having ascertained ~11,000 cancers to date); 4) has stored fasting serum and DNA; and, 5) has high-quality information for other health behavior characteristics such as diet, body weight, smoking, physical activity, and other illnesses such as cardiovascular disease and diabetes. The cohort resources continue to be used by the Division of Cancer Epidemiology and Gentics (DCEG)/NCI and other investigators, and the project has been the basis of several hundred high-quality research studies relating to cancer etiology, survival, prevention, and early detection. The cohort project has also been used to research other health outcomes including cardiovascular disease, chronic obstructive pulmonary disease, diabetes, Alzheimer's disease, Parkinson's disease, and amyotrophic lateral sclerosis. Purpose and Objectives: The primary purpose of this acquisition is to provide for the continued health outcome surveillance of the Alpha-Tocopherol, Beta-Carotene Cancer Prevention (ATBC) Study cohort in Finland. Access of NCI to cancer patient medical records and blood and tumor tissue biospecimens from the study that are stored in Finland are the other key elements of the acquisition. Project Requirements: Major tasks of the Contractor include the following: A. 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 Contracting Officer's Representative (COR) 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 a. 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. As requested by the COR, link the ATBC Study population with the Finnish Hospital Discharge Registry to identify requested diagnoses during hospitalizations up to semi-annually. b. As requested by the COR, link the ATBC Study population with the Finnish prescription medication registers to identify type, dosage, calendar years and duration of medication use up to semi-annually. B. 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. 2. As requested by the COR, and based on ATBC Study participants whose NCI-Frederick serum or whole blood biospecimen samples have been depleted (e.g., case-control sets), package and ship (frozen) to NCI serum or whole blood samples. 3. As requested by the COR, 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. C. 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. D. Quality Control and Project Coordination 1. Develop and implement quality control plans to assure high quality in: a.Collection, preparation, review and transfer to NCI of registry data and medical records collected under this Contract. b.Retrieval, preparation, and shipment of biospecimens collected under this Contract to the NCI. c.Storage of all ATBC Study biological specimens maintained in Helsinki by the Contractor. Anticipated Period of Performance: The anticipated period of performance for this requirement is one year, with four one-year options. Other Important Considerations: Only the Finnish National Institute for Health and Welfare (NIHW) holds the personal identifiers for the ATBC Study participants that are required for all the registry data linkages that NCI requires. Additionaly, only the NIHW: 1) can access the required cancer case medical records from Finnish hospitals and clinics, as well as Finnish death certificates, and, 2) currently stores ATBC Study biospecimens that NCI requires for its research programs. Capability Statement/Information Sought: We encourage all responsible sources, particularly small businesses, to submit a capability statement which will be considered by the agency. Organizations that submit capability statements in response to this notice will be evaluated against the following criteria: 1. Documented access to this unique cohort population consisting of male Finnish smokers. This includes holding the personal identifiers for the ATBC Study participants that are required for all the registry data linkages that NCI requires. 2. Documented ability to obtain the necessary IRB approvals for the studies related to the ATBC cohort. 3. Documented infrastructure and training to ascertain cancer cases among members of the ATBC cohort. 4. Documented ability and experience in conducting nation-wide cancer and mortality follow-up through linkage with Finnish national registries and access to medical records from Finnish hospitals and clinics. Interested qualified organizations should submit a tailored capability statement for this requirement, not to exceed 20 single-sided pages (including all attachments, resumes, charts, etc.) presented in single-space 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 concern's name, point of contact, address and DUNS number. All capability statements sent in response to this SOURCES SOUGHT notice must be submitted electronically (via email) to Randall Tiqui, Contract Specialist, at randall.tiqui@nih.gov in MS Word or Adobe Portable Document Format (PDF), by October 31, 2014, 4:30PM, EST. All responses must be received by the specified due date and time in order to 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. 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-SS-ETSB-1008-55/listing.html)
- Place of Performance
- Address: Helsinki, Finland
- Record
- SN03555030-W 20141023/141021234433-04217b1a085ea8c95a11ad549f5af396 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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