LLPR_Amendment_2.pdf

AMENDMENT TO NICHD SOLICITATION

LIMB LOSS AND PRESERVATION REGISTRY

Solicitation Number: NIH-NICHD-NCMRR-2018-16 Amendment Number: 2 Amendment Issue Date: April 18, 2018 Proposal Due Date: May 30, 2018

DATE, TIME, Local Time UNCHANGED

Issued By: Gilberto Pérez Contracting Officer

NICHD

Office of Acquisitions 6710B Rockledge Drive, Room 1123B, MSC 7000 Bethesda, Maryland 20892

Point of Contact: Gilberto Pérez, Contracting Officer E-Mail: Gilberto.Perez-Rosa@nih.gov

This amendment is issued to all potential Offerors.

The above numbered solicitation is amended as set forth below. The hour and date specified for receipt of proposals (HAS NOT) been extended. Offerors must acknowledge receipt of this amendment by identifying this amendment number and date on each copy of the offer submitted. Failure to receive your acknowledgement may result in the rejection of your offer.

If by virtue of this amendment you desire to change an offer already submitted, such change may be made by e-mail, provided each e-mail makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

Except as provided herein, all terms and conditions of the RFP remain unchanged and in full force and effect. THE PURPOSE OF THIS AMENDMENT is to issue clarification questions received and to address updates to the RFP.

1. Question: Article H.4 states "NIH-funded investigators shall submit to the NIH National Library of Medicine's (NLM) PubMed Central (PMC) an electronic version of the author's final manuscript, upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. "; however there is no listed contract deliverable for a manuscript. Is a manuscript a deliverable under either the IDIQ or the Task Order?

Response: Journal publications are not required by the contract; however, publications arising from use of these funds would be subject to this policy. Journal publications are a potential example of “communications” to be addressed by the project plan (IDIQ SOW.B.ii and Task 1 Technical Requirements, C.2).

mailto:Gilberto.Perez-Rosa@nih.gov

2. Question: Can we assume since the data collected exists is other established systems, that the developed prototype will not be considered the System of Record for this data?

Response: We cannot advise the offeror in this matter.

3. Question: Is it required that the prototype system be cloud based?

Response: No, the prototype does not have to be cloud based but should be remotely accessible.

4. Question: SOW Section III-Technical Requirements for the IDIQ, item "B" which reads "B. Plan, design and develop a Limb Loss and Preservation Registry by building and maintaining an information technology platform that will: securely and efficiently collect data from electronic health record systems of multiple clinical settings, securely and efficiently collect patient reported outcome data, and integrate data into a standardized data system, with a well-defined data integration plan. The registry shall include a graphical user interface for functions such as data entry, data visualization, and data analysis.". Can NIH tell us the specific standardized data system? Also in sub-bullet #2 "2. The study plan shall also include other elements such as a plan for accessing Electronic Health Records", does NIH have specific EHRs that should be planned for interface to the registry?

Response: In answer to the first part of the question: No. The offeror must define the standardized data system.

Response: In answer to the second part of the question: No, NIH does not require specific EHRs to be interfaced as part of this registry.

5. Question: Attachment 3, page 2: The current RFP states that ‘The proposed registry will not interface with or collect data from Department of Defense (DoD) or U.S. Department of Veterans Affairs (VA) health systems’. This seems to differ from the previous request. Please explain how the thinking has evolved.

Response: For purposes of this solicitation, the registry will not interface with EHR systems or collect data from the Department of Defense or the Department of Veterans Affairs.

6. Question: Please explain how the partnership between NIH and DOD will work in regards to each organization’s contributions to the program.

Response: The NIH and DOD have entered into a partnership due to overlapping goals for scientific discovery. NIH and DOD representatives will each contribute to a Government Oversight Committee that receives deliverables, reviews progress and makes recommendations to the COR.

7. Question: For the Limb Loss Registry, in addition to the civilian EHR systems, please provide a list of possible military health systems?

Response: This contract will not provide for an interface with military health systems. Proposing to interface with a military health system will not benefit in the review or award of this contract.

8. Question: Should the two (at least) limb loss and preservation care facilities for Task Order 1 registry prototype development cover both civilian and military sectors?

Response: No. The facilities should both be civilian. The military sector should not be covered.

9. Question: We anticipate that the Limb Loss and Preservation Registry Project Plan will specify the scope of registry data elements and timeline for the staged development approach. However, please advise as to whether it is expected that all the data element development under Task Order 1 should be completed within the first 18 months.

Response: It is expected that all research and development necessary to complete Task Order 1 will be completed within 18 months.

10. Question: Should the offerors include international partners and/or sites/centers?

Response: This project is a national registry.

11. Question: What is the estimated number of sites/centers for the registry that should be used for assumptions?

Response: The estimated number of sites/centers will be provided by the offeror, with appropriate scientific justification.

12. Question: What is the total estimated number of participants and number of participants at each site as well as the anticipated length of follow-up that should be used for assumptions?

Response: The estimated number of participants will be provided by the offeror, with appropriate scientific justification. The estimated number of participants per site will be provided by the offeror, with appropriate scientific justification. The one exception to this, is that centers participating in the prototype must have a minimum number of patients per year as described in the Task Order 1 SOW. The length of follow-up will be provided by the offeror along with an appropriate scientific justification.

13. Question: For the imaging data and files, please confirm that the registry needs to provide view and analysis capabilities.

Response: This is the purview of the offeror.

14. Question: Would the Government consider mental health professionals an active part of the limb loss care team such that they could serve as offeror personnel, a member of the Scientific Advisory Committee, and/or a provider in the prototype registry?

Response: Yes, if the offeror provides sufficient scientific justification.

15. Question: On page 19, it is mentioned that research involving human subjects shall not be conducted under this contract. However, on page 112, the offerors are requested to submit enrollment reports. Could you please clarify whether human subjects are allowed or not?

Response: The work proposed within this contract will include human subjects research. Article H.1. will be corrected via this amendment (see below) to state that human subjects will be involved in this Acquisition.

In Task Order 1 “Registry enrollment report” will be required monthly as detailed in Attachment 4, Article F – Deliveries found on page 120 of the electronic RFP. Enrollment reports will include the PHS Inclusions Enrollment Report, or a comparable report, as determined during the negotiation stage of this acquisition. A blank PHS Inclusions Enrollment Report can be found at the following URL:

https://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general/resources/images/compiled%20images/g.500_phs_inclusion_enrollment_report.pdf

ARTICLE H.1. of the RFP is being modified to reflect the following:

ARTICLE H.1. PROTECTION OF HUMAN SUBJECTS, HHSAR 352.270-4(b) (December 2015)

a. The Contractor agrees that the rights and welfare of human subjects involved in research under this contract shall be protected in accordance with 45 CFR part 46 and with the Contractor's current Federal-wide Assurance (FWA) on file with the Office for Human Research Protections (OHRP), Department of Health and Human Services. The Contractor further agrees to provide certification at least annually that the Institutional Review Board has reviewed and approved the procedures, which involve human subjects in accordance with 45 CFR part 46 and the Assurance of Compliance.

b. The Contractor shall bear full responsibility for the performance of all work and services involving the use of human subjects under this contract and shall ensure that work is conducted in a proper manner and as safely as is feasible. The parties hereto agree that the Contractor retains the right to control and direct the performance of all work under this contract. Nothing in this contract shall create an agency or employee relationship between the Government and the Contractor, or any subcontractor, agent or employee of the Contractor, or any other person, organization, institution, or group of any kind whatsoever. The Contractor agrees that it has entered into this contract and will discharge its obligations, duties, and undertakings and the work pursuant thereto, whether requiring professional judgment or otherwise, as an independent Contractor without creating liability on the part of the Government for the acts of the Contractor or its employees.

c. Contractors involving other agencies or institutions in activities considered to be engaged in research involving human subjects must ensure that such other agencies or institutions obtain their own FWA if they are routinely engaged in research involving human subjects or ensure that such agencies or institutions are covered by the Contractors' FWA via designation as agents of the institution or via individual investigator agreements (see OHRP Website at:

http://www.hhs.gov/ohrp/policy/guidanceonalternativetofwa.pdf).

d. If at any time during the performance of this contract the Contractor is not in compliance with any of the requirements and or standards stated in paragraphs (a) and (b) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. The Contracting Officer may communicate the notice of suspension by telephone with confirmation in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer's written notice of suspension, the Contracting Officer may, after consultation with OHRP, terminate this contract in whole or in part.

e. (End of clause) https://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general/resources/images/compiled%20images/g.500_phs_inclusion_enrollment_report.pdf https://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general/resources/images/compiled%20images/g.500_phs_inclusion_enrollment_report.pdf http://www.hhs.gov/ohrp/policy/guidanceonalternativetofwa.pdf

16. Question: Should we specifically address Task Order 1 in our proposal?

Response: Yes.

17. Question: Reference RFP # NIH-NICHD-NCMRR-2018-16: Would it be possible for the government to please provide the total number of lives to be managed in the subject registry?

Response: No. This information is provided by the offeror in the research plan, with appropriate scientific justification

18. Question: Reference RFP # NIH-NICHD-NCMRR-2018-16: Would it be possible for the government to please provide the number of data sources being ingested to populate the subject registry?

Response: No. This information is to be provided by the offeror in the research plan, with appropriate scientific justification.

19. Question: 508 Annual Report is not included in Attachment 4 as a Deliverable. Should it be included?

Response: Section 508 Annual Report is covered in ARTICLE C.2. REPORTING REQUIREMENTS, page 7 of the RFP.

20. Question: Page 28, item E of the solicitation discusses background checks however it does not refer to a timeframe as to by when they would need to be completed. Please provide the timeframe.

Response: The winning offeror of this Contract will be advised on how to handle this matter.

21. Question: Please clarify why the current solicitation (RFP No. NIH-NICHD-NCMRR-2018-16) was issued under full and open competition, while the previous cancelled solicitation (RFP No. NIH-NICHD- NCMRR-2017-11) was issued as a small business set-aside.

Response: We received capabilities statements in response to the Small Biz Sources Sought notice that were determined not be technically acceptable. The Acquisition Strategy was reviewed and approved by the Small Business Specialist and the SBA PCR (Procurement Center Representative) in support of a Full and Open competition.

22. Question: Reference RFP #NIH-NICHD-NCMRR-2018-16; Section I.4.a.4.b – Maximum Order states that “The Contractor is not obligated to honor 1. Any order for a single item in excess of $5,000,000; 2. Any order for a combination of items in excess of $5,000,000; or 3. A series of orders from the same ordering office within 30 days that together call for quantities exceeding the limitation in subparagraph (1) or (2) above.” Also, paragraph a. of Article B.2 Prices/Costs of the same RFP states that “…The Contractor shall be reimbursed by the Government in an amount not less than a total of $10,000 (minimum) nor more than a total of $5,000,000 (maximum) for successful performance of this contract.”

a. Given the two statements referenced above, it is implied that one (1) task order will be awarded under this contract, not to exceed $5,000,000 in value. Can the government please address whether the overall ceiling for the IDIQ contract is $5,000,000 or if it applies to individual task orders only?

b. If the $5,000,000 ceiling applies to individual task orders only, can the government please provide the ceiling/value of the IDIQ contract?

c. If more than one task order will be awarded as a result of a multiple award of the resultant IDIQ contract, does the implied $5,000,000 ceiling still apply?

Response:

a. The overall ceiling for the IDIQ contract is $5,000,000.

b. As stated in part (a) of the response, the overall ceiling for the IDIQ contract is $5,000,000.

c. This Acquisition is for a Single Award IDIQ contract.

23. Question: Who does the NICHD consider a Cloud Service Provider for FedRAMP certification? Is it limited to just the major vendors – AWS GovCloud, Azure GovCon, CISCO?

Response: FedRAMP compliant Cloud Service Providers can be found at the link below:

https://marketplace.fedramp.gov/#/products?sort=productName

Response: Anyone can apply to be FedRAMP compliant.

24. Question: General sense of how the registry would work compare to other databases within the model system (spinal cord)?

Response: Limb Loss and Preservation Registry will be funded by a different federal agency, using a different funding mechanism and with a different goal than that of the NIDILRR model systems program.

25. Question: The formation of the scientific advisory board appears to be within the scope, the criteria; a draft membership of that scientific advisory board as part of the proposal… What is the timeline for forming that board?

Response: For the proposal, provide a draft membership that will be evaluated and, the timeline for the delivery of the final membership is provided in the RFP in Task Order 1, in the deliverables section.

26. Question: Could the following question be explained a little more detail; Should the offerors include international partners and/or sites/centers?

Response: 1) This project is a national registry and should recruit and retain facilities, providers and patients in the United States. 2) This is a Full and Open competition therefore; all responsible sources are permitted to compete for the award. Potential Offerors can submit a proposal that has foreign subcontractor(s) and/or consultant(s).

https://marketplace.fedramp.gov/#/products?sort=productName

27. Question: Can multiple institutes share a single award?

Response: This Acquisition will be for a Single award IDIQ contract. Offerors can submit a proposal that include; subcontract(s), consultant(s) or, any other similar approach that they understand can help them accomplish the requirements outlined in the RFP.

28. Question: Is the announcement intending to fund a project that captures data broadly about limb loss from inception or would a project that methodically scales up enrollment as infrastructure and data collection methodologies are established be considered responsive to the announcement? For example, the evidence base for particular sub-populations of the limb loss community (e.g. traumatic amputations) is more robust others (e.g., congenital anomalies or pediatric acquired limb loss). Methodologically, it could be difficult to develop a representative subsample of those populations for which little prevalence and incidence data is known without some additional exploratory work to establish this evidence base. As such, it may be more scientifically rigorous to design a multi-tiered data capture system that on the one hand self-enrolls participants through various community-level events in a manner similar to a patient powered research network while scaling up the hospital-based data capture system starting with subpopulations that have more evidence to better create a representative, geographically diverse sample initially and then adding additional subpopulations once evidence about these populations becomes more settled. But, it is unclear if such a strategy would be considered responsive to the announcement as written. Any clarification would be helpful.

Response: The offeror must determine their own method for performing the research and development necessary for the Limb Loss and Preservation Registry, provide a rigorous and appropriate scientific justification for that method, while also responding to the Evaluation Criteria in the RFP.

END OF AMENDMENT #2 TO RFP (NIH-NICHD-NCMRR-2018-16)