SPECIAL NOTICE
B -- Request for Information (RFI): A new prospective U.S. cohort set within the health care system institutions
- Notice Date
- 2/5/2016
- Notice Type
- Special Notice
- 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-RFI-ETSB-0002-58
- Point of Contact
- Rosa M. Lopez, Phone: 2402765426, Jill Johnson, Phone: 240-276-5395
- E-Mail Address
-
rosa.lopez@nih.gov, jill.johnson2@nih.gov
(rosa.lopez@nih.gov, jill.johnson2@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Issued By: National Cancer Institute (NCI), Office of Acquisitions (OA) General Information: This Request for Information (RFI) is intended to provide source material to formulate a procurement strategy for a prospective cohort set within U.S. integrated health care system institutions. This RFI should not be construed as a solicitation or as an obligation on the part of the Federal Government, the National Institutes of Health (NIH), and the National Cancer Institute (NCI). The Government does not intend to award a contract on the basis of this solicitation or to otherwise pay for the information solicited except as an allowable cost under other contracts as provided in subsection 31.205-18, Bid and proposal costs, of the Federal Acquisition Regulation. Although "proposal" and "offeror" are used in this Request for Information, your response will be treated as information only. It shall not be used as a proposal. This solicitation is issued for the purpose of providing source material to assist in formulating a procurement strategy for a prospective cohort set within U.S. integrated health care system institutions. Purpose: The responses to this RFI may guide the NCI in awarding future contracts at an undetermined time. There is no solicitation available at this time; no basis for claims against NCI shall arise as a result of this RFI, responses thereto or the NCI’s use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. This notice is for market research only to make decisions regarding development of strategies for enrollment and follow-up of, biospecimen collection from, and providing access to electronic medical records from study participants enrolled through the integrated health care system institutions. NAICS Code and Size Standard : In the event a Request for Proposal (RFP) is issued, North American Industry Classification System (NAICS) code 541990- All Other Professional, Scientific and Technical Services with a size standard of $15M is being considered. Background: The Division of Cancer Epidemiology and Genetics (DCEG) plans to build a new prospective multi-center adult cohort study of at least 200,000 adult participants enrolled through integrated health care system institutions. Participants will provide an e-consent followed by an online “smart” questionnaire, collection of biological specimens including blood, urine, and others and possibly a physical exam. The new cohort will additionally have all of the desirable attributes of a contemporary study including serial samples, tumor tissue, comprehensive data from Electronic Medical Records on elements such as drug prescription, medical conditions and procedures, and repeated surveys combined with reliable passive and long-term follow-up strategies for outcome ascertainment. The cohort infrastructure will be designed to allow enhancements to be added in subsets of the participants at any phase to allow more detailed assessment of certain exposures, collection of additional specimens, and to facilitate patient-centered and health delivery research to improve patient care through evidence-based decisions. A separate Central Coordinating Center (CCC) will provide the infrastructure and extend support for the NCI and the individual health care system institutions that participate in recruitment, enrollment, and follow-up of women and men longitudinally. The CCC will work with NCI, recruitment sites, processing labs, central repository, various oversight committees, and researchers. The CCC will provide support for core study operations including provision of procedures and protocols, staff training (as required), and will host an informatics network for study and data management (e.g. online consent, identifying individuals eligible for reminders to complete their online questionnaire and/or donate blood, coordinate data linkages such as tumor registry submissions), data collection (e.g. online questionnaire and core electronic health record data), as well as data management, and eventual data sharing. Anticipated activities for the health care system institutions include: Obtain approvals and implement study protocols. These include activities necessary for preparing for participant recruitment and follow-up. Specifically, obtaining relevant study approvals (e.g. Institutional Review Board (IRB)), and customizing template protocols and procedures for site-specific requirements. Identify, Recruit, and Retain participants. These include activities necessary to develop and maintain the necessary infrastructure to identify, recruit, and retain eligible participants (using e.g. data programs, databases), and replenish recruitment as individuals leave the healthcare plan or are lost to follow-up. Also included are activities necessary to engage participants throughout all stages of the study (e.g. general study information, pre-enrolling questions, questionnaire issues, blood donation issues), such as by hosting a toll-free study telephone line to answer questions from individuals and participants. Collect and process biological specimens. These include activities necessary to collect biological specimens from participants according to standardized operating protocols (SOPs). Specimens shall be transferred to a central biorepository according to SOPs. Examples of biological specimen types include blood, urine, saliva, discard clinical tests (e.g. fecal immunochemical test), and tumor tissue. Provide Electronic Medical Record Data. These include activities to provide services as necessary to enable abstraction of data from electronic medical records, death certificates and other relevant materials, and expert review of clinical events by field centers. In addition, it would include the development and/or modification and validation of algorithms to abstract data from Electronic Medical Records (EMR) for delivery to the CCC. Perform regular routine updates of data as well as creating/modifying algorithms for ‘new’ data abstraction. Follow-up participants. These include activities necessary to f ollow participants for disease outcomes, with a primary focus on cancer. Information Requested: I. General Information – contact information, including name, institution / organization, telephone and fax numbers and e-mail address; website URL II. Contract Strategy To assist in formulating a contract strategy, the following Request for Information (RFI) questions are offered for your consideration. Complete the table below and identify any portion(s) of this procurement for which fixed-price contracting could be utilized and provide rationale and feasibility. Identify any portion(s) of this procurement for which fixed price contracting could not be utilized and provide rationale and an alternative strategy. ITEM INDICATOR YES NO 1 Obtain approvals and implement study protocols. 2 Identify, Recruit and Retain participants. 3 Collect biospecimens. 4 Provide Electronic Medical Record Data 5 Follow-up participants. Provide any other feedback on contract type along with rationale f or any of the characteristics identified in the Background section, and any other specific areas you believe are worthy of consideration by NCI. In particular, please suggest alternative fixed price strategies for the tasks referenced in the table above. For example, if a task could be priced on a fixed unit rate basis, please indicate that in your response. How to Submit a Response: Interested organizations should submit a response to this Request for Information, not to exceed 5 single sided pages including all attachments, charts, etc. (single space, 12 point font minimum) that clearly responds to the above questions. Brevity and structured format (such as bulleted items) are encouraged whenever applicable to aid in processing. All proprietary information should be marked as such. Responses will be held in a confidential manner. NCI will provide confirmation of response submission, but respondent will not receive individualized feedback. Due Date: Responses are due no later than 3PM Eastern Time on March 4, 2016. Number of Copies and Delivery Point: Please submit one (1) original and three (3) copies of your response as follows: If hand-delivered or delivery service: If using U.S. Postal Service Rosa Lopez, Contract Specialist Rosa Lopez, Contract Specialist National Institutes of Health National Institutes of Health National Cancer Institute, OA National Cancer Institute, OA 9609 Medical Center Drive 9609 Medical Center Drive Room 1E576, MSC 9705 Room 1E576, MSC 9705 Rockville, MD 20850 Bethesda, MD 20892 All information furnished must be in writing. All questions must be in writing and emailed to Rosa Lopez, Contract Specialist, at rosa.lopez@nih.gov. A determination by the Government not to compete this requirement based upon responses to this notice is solely within the discretion of the Government. Please reference number HHS-NIH-NCI-RFI-ETSB-0002-58 on all correspondence. Point of Contact: Inquiries concerning this Notice may be directed to: Rosa Lopez 9609 Medical Center Drive Bethesda, MD 20892 rosa.lopez@nih.gov
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