Amendment_01-HHS-NIH(AG)-RFP-17-028.pdf

Solicitation No. HHS-NIH-NIDA(AG)-RFP-17-028 Amendment No. 01

SPECIAL PROVISIONS

Question 1. Is this a new requirement?

Response 1. Yes, this is a new requirement.

Question 2. Unable to open Attachment 3 page 39: SOLICITATION ATTACHMENTS, Attachment 3: Statement of Work. An error message is displayed.

Response 2. All attachments can be found at the end of the solicitation.

Question 3. Is the 4,000 hours listed under the Estimate of Effort on page 46 of the RFP to cover the entire 5 year period of performance at 800 hours per year or is the 4,000 hours per year (of the 5 years) of the contract leading to a total of 20,000 hours for the project?

Response 3. Estimated of effort is 4,000 labor hours per year.

Question 4. Please confirm only an electronic submission is required via the eCPS website.

Response 4. The Government will be accepting only electronic submissions via eCPS website.

Question 5. Please clarify if this is a Cost Plus Fixed Fee contract or a Fixed Fee contract.

Response 5. As specified on page 46, paragraph c.2. of the Solicitation, it is anticipated that the award from this solicitation will be a multiple-year cost-reimbursement type completion contract with a Period of Performance of one (1) 12-month base period and four (4) 12-month option periods.

Question 6. Can the Source Code and Object Code requirement be removed from the contract given that the BSI system is hosted and owned by IMS?

Response 6. No, the Source Code and Object Code cannot be removed.

Question 7. Are there any specific qualifications the proposed key personnel must adhere other than those listed on Page 80 of the RFP?

Response 7. Proposed Offerors are expected to read the solicitation in its entirety for complete understanding of the requirement, expectations, and qualifications.

Question 8. Is the 4,000 labor hours per year to be assumed across all labor resources and tasks? Would it be possible to receive a breakdown of the 4,000 labor hours by role or task?

Response 8. As specified on page 46 of the Solicitation, the Estimate of Effort is approximately 4,000 labor hours. This information is furnished for the offeror’s information only and is not to be considered restrictive for proposal purposes. The 4,000 labor hours is estimated per year.

Question 9. The RFP states “Government considers the effort to be approximately 4,000 labor hours.”

a. Can the Government provide the basis for the LoE?

b. What roles are expected to be bid?

c. What is the current number of FTEs supporting this work?

Response 9 a-c. As specified on page 46 of the Solicitation, the Estimate of Effort is approximately 4,000 labor hours. This information is furnished for the offeror’s information only and is not to be considered restrictive for proposal purposes. The 4,000 labor hours is estimated per year.

Question 10. Would the Government consider a GOTs product?

Response 10. No, the Government will not consider a GOTs product.

Question 11. Where are the data to be hosted?

Response 11. It is expected that the data will be hosted at the Offeror’s/Contractor’s location.

Question 12. Will the Government consider hosting the data in a cloud environment?

Response 12. Yes, the Government will consider hosting the data in a cloud environment as a back-up.

Question 13. How will hosting for the public website and system application be managed?

(for example, under the NIA Central Biorepository Biological Specimens Storage contract? Or is that just physical samples and data?)

Response 13. Refer to Solicitation pages 5 through 8, Task Areas 4 and 5, Attachment No.3.

Question 14. Will the contractor be responsible for acquiring ATO for the system(s)?

Response 14. Yes, refer to Solicitation pages 21 through 27.

Question 15. Task Area 1: The RFP states "Migration or consolidation of inventories from NIA-funded studies under one inventory management system – BSI-II - shall be accomplished within 90 calendar days of the award of the contract." Is BSI-II the only solution to be considered for the effort? Or can the offeror propose a different solution?

Response 15. BSI-II is highly preferred. The Offeror is expected to have knowledge of available inventory systems for biorepositories and experience with migrating data from different systems.

Question 16. Does NIA have license agreement with BSI-II? If yes, what cost is expected from the contractor in order to migrate or consolidate current inventories into BSI-II?

Response 16. No. The Offeror should have experience with work/steps involved in migrating data from one system to another including associated costs.

Question 17. Is the developer of BSI precluded from bidding on this procurement?

Response 17. This requirement is being competed under full and open competition.

Question 18. Please provide a full list of the software programs and/or inventory systems to be migrated and consolidated.

Response 18. As stated on page 3 of Attachment No.3 – Statement of Work, BSI is used by some NIA studies including the large collection of biospecimens/data mentioned in the Solicitation.

Question 19. Please provide a high-level database design of the inventory systems to be migrated/consolidated and that of BSI-II. This will help us estimate the complexity of the migration and consolidation effort.

Response 19. The Offeror shall provide expertise with inventory systems and estipulate plans for migrating biorepository inventory.

Question 20. Task Area 2: The RFP states "Collections of datasets (e.g., disease-specific, biomarkers-specific, etc.) have been built by participating studies and may continue to be built and shall be maintained as finished databases by the Contractor. These datasets shall be kept as part of an inventory in a web-based database. The web-based database shall be searchable and expandable." Is there an existing web-based database at the NIA for this purpose, such that the offeror is responsible for maintaining and enhancing? Or does this web-based database need to be developed from scratch?

Response 20. No, there is no existing web-based database at the NIA.

Question 21. BSI-II appears to provide certain capabilities as RFP requested. What agreement does NIA have with BSI for enhancement per SOW requirement?

Response 21. There are no agreements in place between NIH/NIA and BSI.

Question 22. Task Area 3: The RFP states "Within 60 calendar days of the award of the contract, the Contractor shall provide the NIA COR with the specifications of the consent tracking system for approval by the NIA COR." What type of consent tracking system does the NIA expect from the offeror?

Response 22. Offeror can propose a tracking system, but consent tracking may not be absolutely necessary during the duration of the contract. However, its need will be determined on a case by case basis.

Question 23. Will the Government consider any COTS product?

Response 23. No, the Government will not consider any COTS product.

Question 24. Task Area 4: The RFP states “Specifications and sample pages from the Website shall be provided to the NIA COR for review and approval within 60 calendar days of award of the contract. The NIA COR will review and provide approval to the Contractor. The Website shall be established and be fully operational within 90 calendar days of contract award.” Is there a defined level of functionality expected for 90-day delivery the public-facing web site?

Response 24. As specified in Attachment No. 3 – Statement of Work, the public-facing web site should be fully operational within 90 days.

Question 25. Does NIA have any existing user data or research to inform initial development?

Response 25. No, the NIA does not have any existing user data or research information.

Question 26. What is the current state of the data to be displayed on the public site?

Response 26. Datasets are already in a format publicly available.

Question 27. Who is responsible for developing and managing the content for the public-facing website? By the offeror?

Response 27. The Offeror/Contractor will be responsible for developing and managing the content for the public facing website.

Question 28. Is the website required to be accessible via mobile devices such as phones and tablets?

Response 28. The website should be fully operational and accessible.

Question 29. Task Area 4: The RFP states “The Contractor shall ensure that a process to identify and catalog publications resulting from research…” What data is to be stored from the publication libraries in the data repository?

Response 29. A list of publications and potential links to PubMed.

Question 30. How is the linkage between a publication and the use of data in the repository to be identified?

Response 30. If Federal funds are involved, NIH policies including data sharing and publication requirements (notification of publication by investigators) will be enforced or followed as applicable.

Question 31. How many libraries are expected to be searched?

Response 31. PubMed.

Question 32. Does NIA have subscriptions to all the libraries to be searched?

Response 32. Yes.

Question 33. Task Area 5: The RFP states "The Contractor shall create or maintain a Web-based Data/Sample Request System to facilitate review of applications for access to databases/biospecimens from the NIA Central Biorepository, allowing distribution of materials to reviewers, recording of reviews and final decisions, and maintenance of relevant documentation.” Please clarify whether such request system needs to be created from scratch, or maintained and/or enhanced per SOW requirement.

Response 33. This is a new requirement, so new website is to be built from scratch.

Question 34. Task Area 5: RFP states “the Contractor shall have a system fully operational within 90 calendar days of contract award, to support examples of the following situations: (lists 4 request types).” Our assumption is the design and layout of systems outlined in Tasks 4 and Task 5 will use the same design system/user experience standards. Please confirm.

Response 34. This is a new requirement, new website and new repository. There is an opportunity to design and lay out a good system – following Federal guidelines, since this will be a Federal website.

Question 35. Please clarify whether the 90-day delivery window for a fully operational system include fulfillment of these requests.

Response 35. Yes.

Question 36. Task Area 5: RFP states “The Contractor shall be able to query the various databases to respond to inquiries from the NIA COR and from the scientific community about the data and biosamples in the NIA Central Biorepository. These queries will be limited to questions about the content of the databases.” Is there an SLA for responding to inquiries from NIA COR and scientific community?

Response 36. No, this is a new research resource to be established by NIA.

Question 37. Is there an estimated number of monthly requests contractor is required to support?

Response 37. Not at this time.

Question 38. Task Area 5: RFP states “When investigators are granted access by the NIA COR for the requested data, the Contractor shall transmit the requested data within 7 calendar days of the NIA COR approval.” How is the data to be transmitted to the requestor?

Response 38. Access to clinical datasets is anticipated through a web-based portal.

Question 39. Is there a defined file format for the data?

Response 39. Datasets are already publicly available in pre-established format that will be used/followed.

Question 40. The sample transfer has estimated ~1.8 M samples. Is there a corresponding number of patient numbers or unique patient records count?

Response 40. There is no direct relationship between number of biospecimens/data and number of study participants.

Question 41. Has a survey of unique sample management or records management platforms been performed? Can the results be shared?

Response 41. No, this is a new requirement.

Question 42. Is BSI-II the required platform?

Response 42. BSI-II is highly preferred. The Offeror is expected to have knowledge of available inventory systems for biorepositories and experience with migrating data from different systems.

Question 43. Will the planning and support of the Scientific Committee and Steering Committee meetings be the responsibility of the Data Coordination and Systems Management contractor or will that be done by the NIA? Will these two committees require any other type of support from the Data Coordination and Systems Management contractor?

Response 43. Refer to page 8 of Attachment No. 3 – Statement of Work. NIA will bear most of the responsibility of supportting Scientific and Steering Committees.

Question 44. How many data only studies will be included in the initial startup of the contract? How many studies with biospecimens?

Response 44. Studies have both data and biospecimens.

Question 45. How many data only studies per year will need to be prepared for distribution? How many studies with biospecimens?

Response 45. We cannot accurately provide an answer at this time.

Question 46. Will the Data Coordination and Systems Management contractor be responsible for providing the BSI-II system for specimen inventory, or will that be provided under the repository contract?

Response 46. Specimen inventory is the primary responsibility of the Offeror/Contractor awarded the contract for biospecimens storage and management. Refer to page 3, item B, Attachment No. 3 – Statement of Work.

Question 47. In Task 4B, the timeline for a fully functional website is set at 30 days after the initial specifications are delivered. Is this timeline correct?

Response 47. As specified in Attachment No. 3 – Statement of Work, page 6 item B, Task Area 4, the timeline is 90 days.

Question 48. In Task 5 F, “portions of data sets” are mentioned. Will customized subsets of data be built to fulfill requests?

Response 48. Yes, data subsets will be built upon request.

Question 49. Will the curation of datasets require the harmonization of variables beyond those used for classification of the study and the demographics of subjects?

Response 49. May or may not be needed, but any harmonization of variables is the focus of specific analyses.

Question 50. In Task 5 H, are the fees charged those that are incurred in the course of responding to data queries or in fulfilling biospecimen requests?

Response 50. Additional guidance will be available upon award of the contract.

Question 51. Did the Government vet systems other than BSI-II? If yes, how did the Government chose BSI-II?

Response 51. The Government has knowledge and experience with several available bioinventory systems.

Question 52. Would the Government consider systems other than BSI-II?

Response 52. BSI-II is highly preferred. The Offeror is expected to have knowledge of available inventory systems for biorepositories and experience with migrating data from different systems.

ALL OTHER CONTRACT TERMS AND CONDITIONS OF THIS SOLICITATION REMAIN UNCHANGED.