Amendment 4 to RFP NIH-NICHD-NIAAA-2020-01 - Addnl Q and As.pdf

AMENDMENT 4

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: Four (4)

Amendment Issue Date: July 21, 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 3 on July 9, 2020.

RFP Questions and Answers (for questions received after July 9, 2020):

For questions/answers received prior to July 9, 2020 (question numbers 1-10), please refer to Solicitation Amendment 3.

11. In preparing the separate sections in the Technical Proposal for each of the three Task Orders (Task Order 0001, Sample Clinical Trial Task Order B-1 and Sample Clinical Trial Task Order B-2), since the two Sample Clinical Trial Task Order requirements appear to be “general”, in reading the Technical Proposal Instructions on pages 102-103 of the RFP are we meant to propose a study for each of the two Sample Clinical Trial Task Orders [B-1 and B-2] for the purpose of mailto:jason.williams2@nih.gov proposal evaluation as it pertains to the study proposed or should we respond to the sample Clinical Trial Task Orders (B-1 and B-2) more generally (e.g. “our objectives are to meet the goals outlined in the Task Order, which are…”)?

The purpose of the two “sample” clinical trial Task Orders (B-1 and B-2) is to evaluate, in a general sense, an offeror’s capabilities to perform these general types of studies.

As such, you would not actually “invent” a study but rather provide your organization’s general abilities to provide the services required by the Task Order SOW (separate sections for Sample Task Orders B-1 and B-2), in the general sense, for these types of studies (staff/labor mix would typically utilize for these types of studies and staff qualifications, types/quantities of materials would typically utilize for these types of studies, general recruitment strategy for these types of studies etc.).

Please reference Section M of the RFP for the Technical Evaluation Criteria that will be utilized for the Peer Review (starts of page 148 of RFP).

Please utilize the Draft Protocol Synopsis and Study Time Line/Events information at the end of the sample clinical trial Task Order SOWs to assist in developing the sample Task Order budgets (budgets are also used for evaluation purposes only as the sample clinical trial task orders are not going to be awarded).

Again, the intent of the “sample” clinical trial Task Orders is to obtain enough information to have a meaningful Peer Review of an offerors qualifications/abilities to perform these types of studies, so the information provided will be more “general” than would be typical for a Task Order that would actually be awarded (which would have a very detailed, specific work requirement).

In practice, after parent IDIQ contracts are awarded, when an actual clinical trial need is identified we will provide much more specific information (and request a more detailed task order proposal to correspond to a specific identified need).

The Peer Review of proposals received in response to this RFP will “pre-qualify” a network of research sites for the entire seven-year ordering period of the awarded IDIQ contracts for future [actual] clinical trial Task Orders and will alleviate the need to conduct separate Peer Reviews for each clinical trial Task Order need that arises over the next seven years.

12. Do we use the sample clinical trial Task Orders B-1 and B-2 for the proposal or create our own proposal? If we use the samples, do we use both or pick one (B-1 or B-2)?

Please utilize sample Clinical Trial Task Orders B-1 and B-2 for your proposal. Separate sections for Task Order 0001 “Site-Specific Core Function Activities”, Sample Clinical Trial Task Order B-1 and Sample Clinical Trial Task Order B-2 should be provided in your Technical Proposal, following the Technical Proposal Instructions beginning on page 102 of the RFP and the supplemental information contained in Attachments 1 (“Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission [eCPS] Website”, page 151 of RFP .pdf document) and Attachment 6 (“Additional Proposal Information and Instructions”, page 231 of RFP .pdf document).

It is recommended you review and refer back to the Technical Evaluation Criteria contained in Section M when preparing your Task Order proposals as this is the evaluation criteria the Peer Review Team will utilize when reviewing/scoring your Technical Proposal (page 148 of RFP).

Additionally, separate budgets for each of the three Task Orders (Task Order 0001, Sample Clinical Trial Task Order B-1 and Sample Clinical Trial Task Order B-2 should be made part of the Business Proposal.)

13. It appears that Section L of the RFP purports to be the proposal instructions, but these instructions read as a mix of actual required information for the proposal and then general post award information. Additionally, it is not clear how the Attachments contained in Section J of the RFP interface overall with the proposal instructions and the requested format of the proposal. Could you please clarify in list form, or through a sample proposal Table of Contents, what should be provided in the Technical and Business Proposals so we do not miss anything?

The standard RFP format required for the issuance of Federal contract solicitations can admittedly be confusing as there is some “cross-referencing” required. Generally speaking, Section L of the RFP provides the general “boilerplate” instructions (regulatory/legally-vetted solicitation language required for all RFPs, selected from a template, in accordance to the type of requirement). Additional clarifying and supplemental project-specific proposal instructions are provided via Attachments (in this case, Attachment 1 (“Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission [eCPS] Website”, page 151 of RFP .pdf document) and Attachment 6 (“Additional Proposal Information and Instructions”, page 231 of RFP .pdf document).

Technical Proposal

In preparing your Technical Proposal, it is recommended you review and refer back to the Technical Evaluation Criteria contained in Section M as these are the evaluation criteria that will be utilized by the Special Emphasis Panel (Peer Review) Team in evaluating and scoring proposals.

Following the Section L Technical Proposal Instructions the begin on page 102 and the supplemental information provided in Attachment 6 (“Additional Proposal Information and Instructions”), separate sections for each of the three Task Orders (Task Order 0001, Sample Clinical Trial Task Order B-1 and Sample Clinical Trial Task Order B-2) shall address the “Technical Discussions (a. SOW Objectives/Approach/Methods/Schedule; b. Personnel” and “Other Considerations” contained in Section L pages 102-105 separately for each of the three Task Orders. (If some of the information is repetitive from one Task Order to the next, can simply refer back to a previous Task Order, e.g. “see proposal for Task Order X, page X”). These three segregated Task Order sections will address the following Technical Evaluation Criteria in Section M: “Understanding the Requirement and Technical Approach”, “Personnel” and “Organizational Capabilities and Resources” (see RFP pages 148-149).

Following the segregated Task Order sections, a separate file/section of the Technical Proposal shall be prepared addressing Human Subjects following the guidance contained in Section L pages 105-127 (which also refer back to Attachments 7 and 10 on pages 78-79 of the RFP for links to forms to complete). This section will address the following Technical Evaluation Criteria in Section M: “Human Subject Evaluation” (see RFP pages 142-147).

A separately titled section of the Technical Proposal should address Clinical Imaging Capability (if your site is interested in Task Orders that may involve Clinical Imaging). See Attachment 6, “Additional Proposal Information and Instructions” item 3, page 232 of the RFP .pdf document).

This section will address the following Technical Evaluation Criteria in Section M: “Clinical Imaging Capability” (see RFP page 149).

A separately titled section of the Technical Proposal should address Accreditation of Outpatient Clinical Research Facility in accordance with the Technical Evaluation Criteria in Section M:

“Accreditation of Outpatient Clinical Research Facility” (see RFP page 149).

A separate section of the Technical Proposal should address a Data Sharing Plan. Please reference Section L, pages 126-127. This section will address the following Evaluation Factor for Award in Section M: “Evaluation of Data Sharing Plan” (see RFP page 147).

If your organization has experience with Federal Information System Security requirements as described in the solicitation, you may wish to provide a short section in your Technical Proposal describing such experience and/or familiarity with FISMA/Federal Information System security requirements or a statement to the effect your organization has reviewed and agrees to comply with the Information Security requirements contained in the solicitation if awarded a contract.

Finally, the following Attachments (in addition to the Human Subjects-related attachments referenced earlier) should be completed and submitted as part of your Technical Proposal:

Attachment 8 [Technical Proposal Cost Summary], Attachment 9 [Summary of Related Activities] and Attachment 11 [HHS Section 508 Template] (see Section J, pages 78-79, for links to the attachments). The Human Subjects-related attachments mentioned previously should be incorporated into the Human Subjects section/file of the Technical Proposal. The non-Human Subjects related attachments can be submitted as appendices.

NOTE: A corrected link was provided for Attachment 8 in solicitation Amendment 1:

ATTACHMENT 8: Technical Proposal Cost Summary http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/Tech-Prop-Cost-Summ.pdf

Please provide a separate Attachment 8 for each of the three Task Orders.

For additional guidance on completion on Attachment 11 [HHS Section 508 template], which is typically completed by IT staff, please refer to Solicitation Amendment 3, Question 8.

http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/Tech-Prop-Cost-Summ.pdf

BUSINESS PROPOSAL (the business proposal is NOT viewed/reviewed by the Special Emphasis Peer Review Panel and its contents will only be available to NIH staff)

Following the Section L Business Proposal Instructions the begin on page 127 and the supplemental information provided in Attachment 6 (“Additional Proposal Information and Instructions”), please provide separate sections and related budgets for each of the three Task Orders (Task Order 0001, Sample Clinical Trial Task Order B-1 and Sample Clinical Trial Task Order B-2). Please utilize the Excel spreadsheet links provided as Attachment 14, “Breakdown of Proposed Estimated Costs (plus fee) w/ Excel Spreadsheet” (RFP page 79). Please also provide supporting cost documentation/narrative for each of the three Task Orders following the guidance provided on pages 128-130. Please reference page 132 for the current HHS reimbursable salary rate limitation. This section of the Business Proposal will address the following Evaluation Factor for Award in Section M: “Cost/Price Evaluation” (see RFP page 142).

In accordance with the Business Proposal Instructions, if your organization has a negotiated indirect rate agreement with the Federal Government, please provide a copy of your organization’s most recent F&A indirect rate agreement with the Department of Health and Human Services or other cognizant Federal Government auditing office as applicable to your organization.

Please provide a separate section addressing Past Performance Information utilizing the “Summary of General Experience, Organizational Experience Related to this RFP, Performance History and Pertinent Contracts” guidance on RFP page 140. (Please also reference the Past Performance section in the General Instructions on page 99 for assistance in how to “list” the pertinent contracts [paragraph d. of the guidance on page 140]. This section of the Business Proposal will address the following Evaluation Factor for Award in Section M: “Past Performance Factor (see RFP page 150).

Following the Business Proposal Instructions on pages 137-139, please provide separately labeled sections in your Business Proposal addressing Electronic Funds Transfer Information, Financial Capacity and Adequate Accounting System (required for a cost-reimbursement type contract). If applicable to your organization, please also provide separately labeled sections for Government Furnished Property and/or Facilities Capital Cost of Money.

Following the Business Proposal Instructions on page 141, please provide separate sections in your Business Proposal addressing Subcontractors, Annual Financial Report, and Travel Policy as applicable to your organization.

If your organization is not a small business concern, please provide as an appendix to your Business Proposal an “Individual Small Business Subcontracting Plan” utilizing Attachment 13 on page 79 of the RFP. Please reference the instructions on pages 132-135 of the RFP and the additional guidance provided in response to Question 10 of solicitation Amendment 3 posted to beta.SAM.gov contract opportunities. (An Individual Small Business Subcontracting Plan is not required if your organization is a small business concern).

Finally, please complete Attachments 4 [Representations and Certifications of Offeror – provided as a separate fillable .pdf attachment with solicitation Amendment 3 posted to beta.SAM.gov contract opportunities], Attachment 12 [Proposal Summary and Data Record], Attachment 15 [Offeror’s Points of Contact] and Attachment 16 [Disclosure of Lobbying Activities]. All Attachments provided in Section J of the RFP (beginning on page 79).

Questions/Answers from Solicitation Amendment 3 referenced in the responses above:

Technical Proposal Attachment 11

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

• 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.).

Business Proposal Attachment 13

10. ADDITIONAL GUIDANCE REGARDING PREPARATION OF THE INDIVIDUAL SMALL BUSINESS

SUBCONTRACTING PLAN (ATTACHMENT 13):

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).