SOURCES SOUGHT
B -- The Establishment of a Centralized Institutional Review Board (CIRB) to Review Minimal Risk Registry Linkage Studies
- Notice Date
- 2/13/2017
- Notice Type
- Sources Sought
- NAICS
- 541690
— Other Scientific and Technical Consulting 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
- N02PC72520-24
- Archive Date
- 3/8/2017
- Point of Contact
- Kimesha Leake, Phone: 2402765669, Jolomi Omatete, Phone: 2402766561
- E-Mail Address
-
kimesha.leake@nih.gov, jolomi.omatete@nih.gov
(kimesha.leake@nih.gov, jolomi.omatete@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Issued By: National Cancer Institute (NCI), Office of Acquisitions (OA) http://www.nci.nih.gov or http://rcb.cancer.gov/rcb-internet/ Key Dates: Capability Statement Due Date: February 21, 2017 by 4:00 PM Eastern Time This Sources Sought Notice is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the National Cancer Institute (NCI). The purpose of this Sources Sought Notice is to identify businesses that are interested in and capable of performing the work described herein. The NCI does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information submitted. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. This requirement is assigned North American Industry Classification System (NAICS) code 541690 with a size standard of $15 million. As a result of this Sources Sought Notice, the NCI may issue a Request for Quotation (RFQ). THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NCI shall arise as a result of a response to this Sources Sought Notice or the NCI's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. The Surveillance, Epidemiology, and End Results (SEER) Program is one of the premier cancer surveillance programs in the world being currently composed of population-based cancer registries covering 30% of the total US population. SEER receives approximately 450,000 pathology reports/records annually, and the information collected on each and every cancer patient in SEER coverage areas includes demographics, a description of their cancer, treatment, and patient follow-up including cause of death for deceased patients. Periodic reports on various aspects of the cancer burden on the population including incidence, survival, treatment, and mortality using the SEER database are made available to the general research community and the public, and are routinely cited in the medical literature and the media. The SEER Program is managed by the Surveillance Research Program (SRP) within the Division of Cancer Control and Population Studies (DCCPS) at the National Cancer Institute (NCI). SRP contracts directly with 14 central registries within the U.S. responsible for the collection of pathology reports and records. Registry staff annotates the required elements into local systems that are then passed into the SEER Data Management System (SEER*DMS). In addition to the contracts directly with registries, SRP also works in a collaborative fashion with The North American Association of Central Cancer Registries (NAACCR) which is the professional organization that develops and promotes uniform data standards for cancer registration and promotes the use of cancer surveillance data and systems. The purpose of this requirement is to contract with a commercial IRB to serve as a Central IRB (CIRB) for the intake, processing and review of minimal risk registry linkage studies. This need exists in order to streamline the IRB application and review process which is a component of the Virtual Pooled Registry Cancer Linkage System (VPR-CLS) work flow. The contractor must provide evidence of IRB review and approval (or exemption) to initiate the VPR-CLS linkage request process. Contractor Requirements are: 1. Have a process in place for the expedited review, adjudication and communication of minimal risk studies. This will include: a. the submission of minimal risk protocols for central cancer registry linkages with cohort studies, clinical trials or other research applications, b. review processes and timelines, process for requesting changes to a reviewed minimal risk registry study, and c. the process and timelines for the re-review of modified minimal risk registry linkage studies. Submissions will be reviewed for completeness and the contractor shall work with the submitting party to resolve any issues around completeness. 2. Have a plan in place to accommodate an increase in the number of minimal risk studies submitted for CIRB review. It is possible that the number of studies can increase by at least 25% per year above the starting estimate of 50 studies. It is also possible that the volume of studies will fall below estimates and the contractor's plan should account for that as well. 3. Create and maintain a review board for the review of minimal risk registry linkage studies. This will include: a. identification of a Chair, b. listing of review board members, c. process steps and timeline for action by the review board for the initial review and, d. any subsequent re-review of minimal risk registry linkage studies. The contractor shall ensure that the review board membership has adequate expertise to review submitted studies. The contractor shall appropriately assign reviewers for each review to be conducted including initial review, amendment review, continuing review, etc. While this is not required to be a standing board, the CIRB shall ensure that appropriately qualified members are available without delaying the review. 4. Coordinate, prepare and distribute agendas for all meetings. 5. Coordinate, prepare and distribute meeting packets including agenda and related review materials to CIRB members (which may include members of the VPR-CLS and/or DCCPS leadership teams). This shall include but not be limited to: a. recording attendance, b. completion of reviewer assignments, c. review board members conflict of interest, recusal and meeting quorum per the CIRB SOPs. 6. Document all aspects of the review meetings and prepare minutes of review meetings. 7. Prepare all correspondence related to CIRB meeting review outcomes, including, but not limited to, drafting outcome letters and sending the drafted letters to the Chair for signature, distributing the letters to the appropriate Study personnel (Study Chair, PI, etc.), copying all relevant staff per request or CIRB SOPs. 8. Provide a secure system for the storage of submitted minimal risk registry linkage studies. The system shall restrict access to CIRB members based on role (to be identified by the CIRB). This includes all associated study documents but not limited to: a. the protocol, b. correspondence between stakeholders, and c. any supporting documentation required to render a review and decision. 9. Track CIRB activity related to minimal risk registry linkage studies and provide regular updates to the VPR-CLS leadership team or as requested. The contractor shall recommend tracking statistics it is capable of providing. The contractor shall provide such information with the understanding that the government or VPR-CLS leadership will use it when presenting on minimal risk registry linkage study activity to relevant stakeholders at public meetings. 10. Place-holder to determine if OMB clearance is required for any CIRB forms to be used. 11. Promote or otherwise post information regarding minimal risk registry linkage study activity on the CIRB's organizational web site. The contractor shall work with the COR to determine what information shall be presented on the web site. 12. Maintain and update annually the CIRB SOPs related to the review of minimal risk registry linkage studies. SOPs for new or revised processes may be drafted/updated more frequently as required. The contractor shall ensure that all applicable CIRB SOPs are in compliance with Federal laws and regulations. 13. Identify CIRB review board members, VPR-CLS/DCCPS leadership, or Study personnel educational needs related to the CIRB process as part of the processing of minimal risk registry linkage study work flow. The contractor shall appraise the government of such educational needs and work with the government to develop, implement, or otherwise share such educational material so as to enhance the effectiveness of the CIRB submission process. 14. Develop and implement a plan as part of the CIRB review process for addressing local context issues as applicable. 15. Maintain AAHRPP accreditation for the duration of this contract. OPTIONAL TASK 16. Within the first six months following contract award, the Contractor shall develop and submit a draft final transition plan which will describe the Contractor's strategy for transferring work form this contract to a successor contract, in the event a final transition would be required. The plan must include information on the transfer of policies and procedures; transfer of relevant files, records, materials and data; transition of all activities as appropriate. The draft final transition plan will be revised, if necessary, and the draft final transition plan will become the final transition plan upon approval of the COR. The approved final transition plan shall be followed to ensure and orderly, secure, efficient and expedited transition of all contract activities by the contract completion date. CONTRACT TYPE The anticipated award shall be an indefinite delivery, indefinite quantity (IDIQ) contract with firm fixed priced task orders. PERIOD OF PERFORMANCE The period of performance for this contract includes a 12-month base period and four 12-month option periods. The anticipated period of performance shall be 12 months from the date of award. PLACE OF PERFORMANCE All work shall be performed at the Contractor's facility. GOVERNMENT FURNISHED EQUIPMENT The CIRB shall provide all materials and supplies to conduct the work under this award. OTHER UNIQUE REQUIREMENTS OR CONSIDERATIONS The CIRB must have full AAHRPP accreditation and maintain it for the duration of the contract. INSPECTION AND ACCEPTANCE CRITERIA NCI will have one month in which to review and accept the specimens and final data. If no comments or request for revisions are provided within one month, the deliverables shall be considered acceptable. REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE The contractor will provide five deliverables during the course of this contract. The reports will be provided when work on a specific milestone is completed and vouchers will be submitted for the amount indicated: o Deliverable 1: Provide a written description of the expedited review process (SOPs) for the review of minimal risk registry linkage studies. This shall be provided in the RFP response and within 15 days of award. o Deliverable 2: Provide a list of potential reviewers that will participate on the review board for minimal risk registry linkage studies. This shall be provided in the RFP response and within 15 days of award. o Deliverable 3: Provide a written description of the various tracking statistics captured for assessing the performance of the CIRB for submitted studies. This shall be provided in the RFP response and within 15 days of award. o Deliverable 4: The contractor shall provide a report of the tracking statistics as well as other pertinent information, to be determined between the COR and the CIRB, representing CIRB activity related to submitted studies on a monthly basis or upon request to the COR. See below for specifics to be included in the monthly report. o Deliverable 5: Provide a written plan for the posting and promotion of VPR-CLS activities and review statistics on the CIRB's web site. This shall be provided in the RFP response and within 15 days of award. o Deliverable 6: Provide a written description of any changes anticipated to study review activities, processes, operations, etc. based on changes to HRPP rules. This shall be provided within 30 days of the release or posting of any draft changes to relevant rules. o Deliverable 7: Provide evidence of current AAHRPP accreditation. This shall be provided in the RFP response and at the time of award. The contractor shall also provide a written plan for the re-accreditation effort should the need for re-accreditation occur during the time this contract is in effect. This shall be provided once the CIRB has developed its reaccreditation plan. The contractor shall notify the COR immediately if there is any change in its AAHRPP accreditation status. o Final Report: The contractor shall provide a final report using the specified fields listed below and provide within 30 days of contract completion. Deliverable Name Deliverable Purpose Deliverable Submission Schedule CIRB SOPs SOPs to inform the government on CIRB operating procedures with respect to the review of minimal risk registry linkage studies. Within 15 days of award. Any modifications or new SOPs required to be submitted at the time it is completed. List of CIRB Review Board Members To identify reviewers that will participate in the review of minimal risk registry linkage studies including identification of board chair, along with relevant background or specialty information. Within 15 days of award or when the list of reviewers changes. Tracking statistics elements To identify how and what the CIRB will track related to minimal risk registry linkage study activity. Within 15 days of award of when the list of elements changes. Monthly report Includes tracking statistics activity and other pertinent information. By the 5th of each month. Web site plan The web site plan will inform the COR of how the contractor shall post and promote minimal risk registry linkage study activity on its web site. Within 15 days of award or whenever the plan needs to change. AAHRPP Accreditation Provide evidence of current accreditation status as well as plan for re-accreditation. At time of award for evidence of current accreditation status. Re-accreditation plan shall be submitted when the plan is developed. Transition Plan To identify and document contractor succession plan. Within six months of award. Final Plan To document findings, accomplishments, etc. at the conclusion of the contract. Within 30 days of contract completion. MONTHLY and FINAL REPORT REQUIREMENTS Monthly Status Report The Subcontractor shall document the efforts performed in the completion of each task in a detailed Monthly Status Report due within five business days after the start of each Month. It is expected that this report will include, but not be limited to: • Program status, to include objectives met, work completed and work outstanding • Notable achievements • Issues or obstacles impeding progress and recommended solutions • Status of deliverables/milestones • Reporting on tracking statistics and related activity • Issues and resolutions • Resource planning/status • Description of work completed and plans for next month including anticipated travel Final Report Subcontractor shall submit a Final Report within 30 days of subcontract completion and shall include the following: • Subcontractor Name and Address • Name of Person Submitting the Report • Subcontract Number • Report Date • Period Covered by the Report • A comprehensive Summary of Work performed during reporting period • Specifics of data quality audit plan How to Submit a Response: 1. Page Limitations: Interested qualified businesses/organizations should submit a tailored capability statement for this requirement not to exceed 10 single sided pages including all attachments, resumes, charts, etc. (single spaced, 12 point font minimum) that clearly details the ability to perform the requirements of the notice described above. All proprietary information should be marked as such. Responses should include a minimum of a one page resume of the individuals meeting the requirements, and up to two pages demonstrating experience over the past two years meeting the requirements of this notice. Responses will be reviewed only by NIH personnel and will be held in a confidential manner. Organizations shall demonstrate 1.) Demonstrated Experience and Capabilities of Essential Personnel 2.) Demonstrated Experience and Capabilities of Other Personnel 3.) Technical Approach 4.) Managerial Approach 5.) Facilities and Equipment 2. Due Date: Capability statements are due no later than February 21, 2017 by 4:00 pm Eastern Time 3. Delivery Point: All information furnished must be in writing and must contain sufficient detail to allow the NCI to determine if it can meet the unique specifications described herein. All questions must be in writing and emailed to Kimesha.leake@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. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. In order to receive an award, contractors must have valid registration and certification in the System for Award Management (SAM) through www.sam.gov. No collect calls will be accepted. Please reference number N02PC72520-24 on all correspondence. 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 RFQ may be published in Fed Biz Opps. However, responses to this notice will not be considered adequate responses to a solicitation(s). Point of Contact: Inquiries concerning this Notice may be direct to: Kimesha Leake at Kimesha.leake@nih.gov. 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.
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