Amendment 5 to RFP NIH-NICHD-NIAAA-2020-01 - Addnl Q and As.pdf

AMENDMENT 5

Request for Proposal (RFP) NIH-NICHD-NIAAA-2020-04 entitled, “Clinical Research Sites for the NIAAA Medications Development Clinical Investigations Network for the Treatment of Alcohol Use Disorder”

Amendment Number: Five (5)

Amendment Issue Date: August 11, 2020

Proposal Due Date: August 31, 2020 (unchanged)

Issued By: Jason Williams Contracting Officer

DHHS, NIH, NICHD

Office of Acquisitions

NIAAA CMB

Point of Contact: Jason Williams Contact Email: jason.williams2@nih.gov

THIS AMENDMENT IS ISSUED TO ALL POTENTIAL OFFERORS:

The above numbered solicitation is amended as set forth below. 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.

Except as provided herein, all terms and conditions of the RFP remain unchanged and in full force and effect.

PURPOSE OF AMENDMENT:

To provide a list of additional questions and answers in response to the written questions received since the posting of solicitation Amendment 4 on July 21, 2020.

RFP Questions and Answers (for questions received after July 21, 2020):

For questions/answers received prior to July 21, 2020 (question numbers 1-13), please refer to Solicitation Amendment 3 (questions 1 through 10) and Solicitation Amendment 4 (questions 11 through 13).

14. The proposal instructions indicate “resumes” should be submitted for Key Personnel. Are NIH Biosketches or CV’s acceptable for this requirement?

Yes, NIH Biosketches or CV’s are acceptable.

mailto:jason.williams2@nih.gov

15. On page 112 of the RFP there is an instruction to address recruitment of women and minorities. This would appear to apply only to the Sample Clinical Trial Task Orders B-1 and B-2. Am I correct in assuming that my technical proposal for TO 0001 does not need this?

Yes, that is correct as Task Order 0001 does not involve human subjects.

16. For the Business Proposal, how do we separate the 5-month start up activity budget from the 1.5-year budget for the Study Implementation Activities on the “Breakdown of Proposed Estimated Costs Excel Spreadsheet”? For example, do we use period 1 for the 5-month budget costs and period 2 for the 1.5 year-budget costs? Do we use specific dates?

Yes, for purposes of the budget/spreadsheet you can use “Period 1” and “Period 2” with dates corresponding to 5 months and 1.5 years, respectively (or any other method as long as there is a clearly marked separation – the idea behind the separate Start Up and Study Implementation periods is that overall labor effort would typically be lower for the start-up period versus the implementation period).

As far as the dates, even though the two “Sample Clinical Trial” Task Orders B-1 and B-2 will not actually be awarded, please assume the anticipated start date of the parent IDIQ contract for the start date of all three Task Orders (December 18, 2020 [from solicitation Article F.1, “Period of Performance” on page 14 of the RFP]).

17. On page 234 of the RFP I see instructions for task order B1 to budget for 5 months to complete startup activities, and 1.5 years for study implementation activities. My read of this is that the total period is 23 months (5+18). It is possible to read this as 18 months and the first five of those are for startup, but I don't think that was the intent. Can you please confirm that the total budget period for task order B-2 is targeted to be 23 months?

Your interpretation is correct (5 + 18 = 23 months total). The idea behind a segregated budget for the Start-Up period is that labor effort and associated costs would typically be lower for the initial start-up activities versus labor effort and other costs for study implementation.

18. At some places in the RFP, there is an indication that there will be a need for a .1 or .2 FTE information technology staff person at the site. We presume this is to ensure that the interface between the site and the NIH or CRO systems are secure and that appropriate reports are submitted to the CRO and/or NIH. More guidance on this would be useful as we plan our submission. For example, as a clinical research site based in a hospital system, are we expected to create any data systems, or simply to interface with NIH or CRO systems? Are the documents needed by NIAAA for this contract existing policies, procedures and specifications of our existing systems and how they are protected as they interface with any NIAAA or CRO data systems, or will we be creating new ones? More guidance on exactly what kind of IT support is needed and what the reporting looks like would be very helpful.

With regard to the IT component, your presumption is correct. It is the interface with NIH and the data collection system used/provided by our CRO/Coordinating Center (Fast Track Drugs and Biologics, LLC) for secure submission of data and reports. The IT component is primarily associated with the secure storage and transmission of the data and its interface with existing systems (you would not be creating new systems). The associated reporting is the standard IT security reporting for all NIH contracts that involve the secure storage and transmission of data, as described in the RFP on pages 35-46 (Article H.27/ Information Security – this is the language that would actually go into the contract). If your organization uses Cloud storage, there is some additional guidance starting on page 47 of the RFP.

For purposes of budgeting for Task Order 0001, please assume that Information System Security Reporting will be required at the start of Task Order 0001 (even though we will not be awarding a Clinical Trial Task Order at the time of Task Order 0001 award).

19. One of the proposal review criteria is to have "an accredited outpatient research facility or equivalent." Can you point us to an organization that accredits outpatient research facilities? We believe we have the equivalent, as our hospital system, pharmacy, scanning facility, and training programs are all accredited by various oversight bodies, and our staff have all of the required research training, but would like to see the criteria for an "outpatient human research facility " in order to be sure that we have the equivalent.

We are basically looking for something similar to https://www.aahrpp.org/. If your facility/hospital has another process, then can simply state what is utilized for your organization. In general, please provide evidence of the accreditation that your organization feels is most appropriate for the work to be performed and best satisfies the requirements (the intent is to confirm that the Outpatient Clinical Research Facility is indeed accredited by an appropriate accreditation board for the conduct of clinical trials).

20. For the Task Order 0001 technical requirements, do we provide specific SOPs as part of the application, list in general terms what our SOPs include, the process by which we develop SOPs or something else altogether? We are not sure what is needed here.

As the Site-Specific Project Management Plan and SOPs would not be due until two-months after the start of the Task Order, we are basically looking for your technical approach and https://www.aahrpp.org/ demonstrated ability to provide such SOPs, so it is more process-oriented information/list in general terms of what your SOPs include. For proposal purposes we will be assessing approach/methods/resources/capabilities in performing the Task Order requirements.

21. For the Human Subjects section of the Technical Proposal should we include three separate human subjects’ forms (each with their own planned enrollment report and data and safety monitoring plan)?

As Sample Clinical Trial Task Orders B-1 and B-2 are two distinct requirements, any information that would differ between the two studies should be addressed separately (such as a separate Planned Enrollment Report [Attachment 7] for each). For other items where the requested information would be the same for both, such as providing evidence of education in the protection of human research participants, Protection of Human Subjects Assurance Identification/FWA number [Attachment 10], and potentially the Data and Safety Monitoring Plan [if would not differ for Sample Task Order B-1 and Sample Task Order B-2] can simply state something to the effect “applicable to both Sample Task Order B-1 and Sample Task Order B-2”.

(Task Order 0001, “Site-Specific Core Function Activities”, does not involve human subjects, so do not need to worry about that one).

22. Our IRB contact requires a study protocol in order to complete the "Protection of Human Subjects Form", however, there is no specific study protocol for this submission so this cannot be done. Does this submission need this exact template completed, or simply documentation that states that we follow all NIH guidelines for human subject protection?

Regarding the "Protection of Human Subjects Form" [attachment 10, link provided on page 79], our scientific staff indicated that they believed that the checkbox option listed under item 7. that states:

[ ] "This activity contains multiple projects, some of which have not been reviewed.

The IRB has granted approval on condition that all projects covered by the Common Rule will be reviewed and approved before they are initiated and that appropriate further certification will be submitted" would cover this situation as no specific fully developed study protocols are provided at this time. Basically, the intent of this form is to show us if your institution has an active FWA that would cover clinical trials to be performed [at some future date] under the overall project.

23. On the HHS Section 508 Voluntary Product Assessment Template, we'd like a more thorough understanding of what the scope of the evaluation is supposed to be, of what specific thing or things we would need to document the accessibility compliance: 1) The VPAT seems to be written to evaluate a specific product or service for accessibility compliance. In this scenario, where you’ve been given an example grant to come up with a budget/proposal for, it is unclear what we should be evaluating? Is it just our general infrastructure (web presence, equipment/software a subject might use to take an assessment, staff work environment, etc)? or something more specific; 2) Should it be approached from the standpoint of accessibility for the subjects participating in the study, or staff running the study, or both?; and 3) the WCAG section seems to break things down into Web, Electronic Docs, Software, and Authoring Tool. Similar to the previous question, is that just what a subject would interact with, or would it cover tools used by staff?

Regarding the Section 508 Assessment Template(s), these are basically for equipment and/or web services supplied by your organization that would be utilized by your staff in performance of the project (primarily computers/laptops). (VPAT 2.4Rev 508 form is used for equipment; VPAT 2.4Rev WCAG form is used for web services, as applicable to your organization). These are somewhat lengthy forms due the instructions, but the parts you would actually complete come toward the end of the documents (for the VPAT 2.4Rev508 form for equipment, page 21, beginning with "Functional Performance Criteria"). For the items listed you would respond with "Supports", "Partially Supports", "Does Not Support" or "Not Applicable". (And if anything is identified as "Does Not Support", would typically include a short statement to the effect of "will be provided on as as-needed basis" [e.g. in the event someone with visual impairment or hearing impairment etc. may need different equipment or an upgrade to utilize the equipment and perform their duties for the project]).