Amendment 3 to RFP NIH-NICHD-NIAAA-2020-01 - Q and As.pdf

AMENDMENT 3

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: Three (3)

Amendment Issue Date: July 9, 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 written questions received to date and answers to the questions received to assist potential offerors in preparation of their proposals.

Additionally, a separate fillable .pdf of Attachment 4, Representations and Certifications, requested to be submitted as part of the Business Proposal is also provided with this solicitation amendment for convenience (Attachment 4 is also contained within the overall RFP document).

RFP Questions and Answers:

1. It appears that this requirement would cover clinical trials up through Phase II, along with Human Lab Paradigm studies. Are there plans to issue a separate solicitation to cover Phase III clinical trials?

mailto:jason.williams2@nih.gov

It is indeed correct that the current solicitation only covers clinical trials up through Phase II (along with Human Lab Paradigm studies), so Phase III trials would indeed require a separate solicitation. There are no plans at this time to issue a solicitation/award contracts for Phase III trials. It is always a possibility this may occur at a future date, but this is not currently being considered (and it would not occur any time soon).

2. It appears this requirement in addition to establishing a network of clinical sites for Phase I and Phase II clinical trials would also cover studies currently being performed under the NIAAA Human Labs Paradigm contracts. Is this correct?

Yes, this is correct. The last day to place new Task Orders under the current active NIAAA Human Labs Paradigm sites contracts, which were awarded in 2015, is September 21, 2020. As such, in addition to covering future Phase I and Phase II clinical trials, this requirement will also serve as the follow-on re-competition for the current active NIAAA Human Labs Paradigm sites contracts (you will notice that Sample Clinical Trial Task Order B-2 within the RFP is for a theoretical Human Lab study).

3. In reviewing Attachment 1, “Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website”, it was not clear to us if it was possible for more than one person at our institution to register and have an account in order to submit proposals.

Could you please let us know if more than one person at an institution can have an account for this proposal submission system?

Yes, multiple system accounts are possible for an institution [more than one person at your institution/university can register and have an account in the NIH eCPS system]. However, each individual proposal submission should be associated with one registered account.

4. Is there a limit on direct costs / total costs per year?

No, there is no limit on direct costs / total costs per year. Proposed costs should be reasonable and realistic and appropriately align with the technical approach proposed.

5. How should we organize the technical proposal to show all three task orders? I was thinking we use the information in the Task Order Statements of Work at the end of the solicitation but follow the order on pages 102-103. We’re not sure how it should logically be written or how to address each task order. Is there a template we should follow?

For the Technical proposal, there should be separate sections in the proposal for each of the three Task Orders addressing the technical approach to the Task Order Statement of Work for each (following the order/guidance on pages 102-103 for each, exactly as you were thinking) and also, following the three Task Order sections, sections for human subjects and clinical imaging [if interested in Task Orders that would involve clinical imaging]. (And for the Business

Proposal, separate budgets should be submitted for each Task Order as they are separate and distinct requirements). Please reference Attachment 6, “Additional Proposal Information and Instructions”, [pages 231-236 of the .pdf solicitation plus attachments document] for additional guidance.

6. Should the proposal be submitted through the PI’s account or the institutional official? Or it doesn’t matter?

The proposal should be submitted by someone with the authority to bind the organization contractually (typically an official in the business office). The proposal also needs to be submitted through the NIH electronic Proposal Receipt System (please see Attachment 1 to the RFP for full details on submitting the proposal).

7. Do we send the proposal intent response form (Attachment 2) to you via email directly?

Yes, the Proposal Intent Response form can be sent directly to the Contracting Officer’s attention via e-mail (Jason.Williams2@nih.gov).

8. Regarding the Section 508 accessibility forms (Attachment 11). I see they’re to be included in the proposal, but the title also says “Voluntary”. Are they required forms? If so, based on your experience, who usually completes them? I’m not exactly sure what it is asking for.

These forms are typically completed by an IT person (and despite the word “Voluntary” in the title of the form, we do request offerors complete this as compliance with Section 508 accessibility standards will be a requirement of any awarded contract [and this particular form will be an annual report/deliverable]).

Section 508 accessibility standards are equipment-based and list equipment requirements by need of someone with a disability (e.g. can someone who has a disability [sight, motion etc.] utilize equipment at their institution to allow them to access needed information to perform their assigned duties on the project).

The form has been updated since this solicitation was developed, so under the link for Attachment 11 the instructions should now read “use form VPAT 2.4Rev508 (Feb 2020) for non web-based products/services and form VPAT 2.4Rev WCAG (Feb 2020) for web-based services.

Supplemental instructions for completing the form for the proposal [typically completed by IT staff]:

The applicable standards for this project are as follows: (from contract clause on page 56 of solicitation)

• Standard 300 – Functional Performance Requirements mailto:Jason.Williams2@nih.gov

• Standard 400 – Hardware Standards General

• Standard 500 – Software Standards General

• Standard 600 – Support Services & Documentation Standards

For form VPAT 2.4Rev 508 (Feb 2020), the Report that would be submitted with the proposal [and as an annual report for each year of an awarded contract] begins on page

10. For each of the applicable categories (“Functional Performance Requirements”, “Hardware Standards General”, “Software Standards General” and “Support Services & Documentation Standards”), under the column “Conformance Level” for each listed criterion, IT staff would simply insert one of terms listed on page 11 (“Supports”, “Partially Supports”, “Not Applicable [to the project]” etc.). If current equipment that would be used for this project is identified as “Does Not Support [an applicable criterion/standard]”, then would write in the remarks column something to the effect “conforming equipment will be obtained and provided on an as-needed basis”. [The time burden for completing the form is intended to be minimal].

The intent of the accessibility requirements is the ensure anyone working on the project that may have a disability will be provided equipment by their institution that will allow them to perform needed duties on the project (and this is a general requirement for Federal contracts). Page 56 of the solicitation contains the associated contract clause that would be included in any awarded contract (“Electronic & Information Technology Accessibility Notice, HHSAR 352.239-74).

At first glance this is admittedly very confusing, but IT staff should be able to complete the form for the proposal submission fairly quickly. The equipment being evaluated would only be for electronic/IT equipment anticipated to be used for this project (computers/phones etc.).

9. On a separate business proposal I worked on, we found 3-5 different vendors to support why we chose a particular vendor on the “Materials” tab. Should we provide different vendors for tasks orders 1, B-1 and B-2 in this proposal as well or can we use prior invoices/receipts and/or a single vendor to show that support?

For budget preparation purposes (separate budget for each Task Order), please use the most realistic estimate (if you plan on utilizing one vendor, then only need to cite that vendor’s costs;

if would use multiple materials vendors, please list the associated unit cost/quantity for each item listed). In terms of price documentation/substantiation prior invoices/receipts are fine (and can also state pricing based on competitive quotes if multiple vendors were considered – this would satisfy a price reasonableness determination).

Given the Small Business Subcontracting goals for NIH contracts, please consider small business sources for materials/supplies wherever possible.

10. ADDITIONAL GUIDANCE REGARDING PREPARATION OF THE INDIVIDUAL SMALL BUSINESS

SUBCONTRACTING PLAN:

In preparing the Individual Small Business Subcontracting Plan (see pages 132-135 of the RFP), there is just one single overall plan for the full seven year order period of the IDIQ that would cover all possible Task Orders. (No “options”, just a single overall period of performance that covers all seven years, tentatively Dec 18, 2020 through Dec 17, 2027).

For IDIQ-type contracts, the HHS Small Business Office requires we utilize the maximum possible amount of the overall IDIQ for the dollar value associated with the 7-year ordering period (in this case $48,000,000) for these Individual Small Business Subcontracting Plans and apply the HHS subcontracting percentage goals to that maximum amount [the HHS subcontracting percentage goals by small business category can be found on the top of page 135 of the RFP].

(In practice, when periodically evaluating “good faith effort” toward compliance with the small business subcontracting goals contained in the Individual Small Business Subcontracting Plan, we utilize the percentage goals [mathematically applied toward the actual dollar amount awarded to date], rather than the dollar goals cited in the plan [based on $48 Million]).

For purposes of developing the Individual Small Business Subcontracting Plan, it would be helpful to identify all possible small business vendors that might be utilized over the seven-year ordering period for any possible future Task Orders (which may be a more expansive list than the sources contained in the proposal budgets for the three Task Orders contained in the RFP).