ATTACHMENT_3__Additional_Proposal_Information_and_Instructions.pdf

ATTACHMENT 3, Additional Proposal Information and Instructions

RFP 75N94025R00008, “Contract Research Organization for the NIAAA Medications Development Clinical Trials Network”

ADDITIONAL PROPOSAL INFORMATION AND INSTRUCTIONS

In addition to the format and other requirements for the Technical and Business Proposals that are contained in Sections J and L of this solicitation (List of Attachments [with links] and Proposal Instructions), the information presented here intends to provide additional guidance, uniform cost assumptions and clarifications to assist in the preparation of your proposal.

GENERAL:

The Base indefinite delivery/indefinite quantity (IDIQ) Statement of Work and List of Possible Deliverables (ATTACHMENTS 4 and 5) contain all the possible work requirements that can be ordered via individual task orders under the resultant IDIQ contract.

For proposal preparation and evaluation purposes, two task order requirements are included with this Request for Proposals and offeror should prepare separate Excel budget proposals for each of the below two task order requirements using the provided Excel Budget Template (See link provided in Section J of the RFP – Attachment entitled “Breakdown of Proposed Estimated Costs (plus fee) w/Excel Spreadsheet”):

1) Core and Study Development Support for the NIAAA Medications Development Clinical Trials Network task order. This task order will be a cost plus fixed fee type task order with a base period of 12 months and will also contain six successive twelve month term options. Funding of the term options will be at the time of option exercise. This task order will be awarded at the same time as the base indefinite delivery/indefinite quantity contract and will fulfill the guaranteed minimum ordering amount under the indefinite delivery/indefinite quantity contract.

2) Sample Task Order #1 – Phase 2 Proof of Concept Medication Clinical Trial – Contract Research Organization Study and Data Management task order. This “sample” task order is for technical and overall proposal evaluation purposes only (inclusive of cost realism analysis) and will NOT be awarded as an actual task order. The budget shall be prepared on the basis of a cost plus fixed fee completion-type task order.

The Technical Proposal Document should be submitted as a single document with separate sections for each of the two task order requirements contained in the RFP.

COST/EFFORT ASSUMPTIONS (applicable to both the Technical and Business Proposals):

1) Core and Study Development Support for the NIAAA Medications Development Clinical Trials Network task order. Assume a cost plus fixed fee type task order with a base period of 12 months with six (6) successive term options for a total potential period of performance of seven years.

Period of performance:

Base Period: 11/15/2026 – 11/14/2027 Option Period 1: 11/15/2027 – 11/14/2028 Option Period 2: 11/15/2028 – 11/14/2029 Option Period 3: 11/15/2029 – 11/14/2030 Option Period 4: 11/15/2030 – 11/14/2031 Option Period 5: 11/15/2031 – 11/14/2032 Option Period 6: 11/15/2032 – 11/14/2033

As actual activity will vary from year to year (and some activities may not be performed at all in any given year), the Government’s estimated annual effort need for this task order is as follows:

Project Director: 2% annual effort Medical Writer: 1% annual effort Biostatistician: 1% annual effort

Other costs: Though no travel costs are assumed for this task order, the Governments estimates a need for ten teleconferenced per year and costs for 1 FDA electronic submission per year.

Indirect costs/rates should be in accordance with your organization’s most current indirect rate agreement with the cognizant Federal Government agency for your organization (typically the Federal Agency your organization has the largest dollar value of contracts with).

Annual cost escalation/inflation: The most recent Congressional Budget Office projections for the Consumer Price Index – All Urban Consumers (CPI-U) indicate an average annual inflation rate of 2.4% for the seven year period of performance.

These estimates are not prescriptive and are for general guidance purposes only. Offerors should budget in accordance with their own unique technical approach.

2) Sample Task Order #1 – Phase 2 Proof of Concept Medication Clinical Trial – Contract Research Organization Study and Data Management task order. Assume a cost plus fixed fee, completion type task order with the following assumptions [also contained on page 2 of the sample task order]:

Assumptions:

Number of Sites – 5 clinical sites - 3 on the east coast, 1 on the west coast and 1 in Colorado Number of Participants – 200 (100 per arm)- 40 per clinical site Study Parameters

• Double – blind, placebo-controlled.

• Active and placebo investigational products are provided but Contractor is responsible for blister packaging (1 capsule per day), kitting, randomization schema, and site distribution/tracking.

• 14-week study with 12 weeks of maintenance (patient treatment) and 2-week follow-up visit.

• 20 monitoring visits – 18 during study, 1 site initiation visit and 1 site close out visit.

• 3 participants randomized per month per site.

• Period of performance is 6 months for start-up activities, 15 months for recruitment, 3 months for data lock, 2 months for analysis and close-out (2 years and 2 months total).

Assume start date of 12/1/2026.

Please propose effort and costs in accordance with your organization’s unique technical approach. (No additional information is provided for this task order in order to evaluate an offeror’s understanding of the performance requirements).

Annual cost escalation/inflation: The most recent Congressional Budget Office projections for the Consumer Price Index – All Urban Consumers (CPI-U) indicate an average annual inflation rate of 2.6% for the 26-month period of performance.

ADDITIONAL INSTRUCTIONS AND GUIDANCE:

1) Guidance on completing the VPAT template(s) for Section 508 Accessibility (Please provide as part of your Business Proposal document).

(See RFP Section J, List of Attachments)

VPAT - Information Technology Industry Council

The NIAAA Section 508 Coordinator has determined that the following Section 508 standards are applicable to this project:

300 – Functional Performance Requirements

400 – Hardware Standards General

500 – Software Standards General

600 – Support Services & Documentation Standards

WCAG Level A Requirements

WCAG Level AA Requirements

The VPAT 2.5Rev 508 (April 2025) form is used for equipment, as applicable to your organization for use on this project (Standards 300, 400, 500, 600 listed above).

https://www.itic.org/policy/accessibility/vpat

The VPAT 2.5Rev WCAG (April 2025) form is used for web services, as applicable to your organization for use on this project (Standards WCAG Level A and WCAG Level AA listed above).

These are somewhat lengthy forms due to the instructional pages, but the parts the offeror would actually complete come toward the end of the documents.

For Standards 300, 400, 500 and 600, the offeror would utilize the VPAT 2.5Rev508 (April 2025) form for equipment. Beginning on page 21, “Functional Performance Criteria", Chapter 3, which corresponds with Standard 300, 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]). Do the same for Standards 400 (Chapter 4), 500 (Chapter

5) and 600 (Chapter 6).

Similarly, for Standards WCAG Level A and WCAG Level AA (for web-based services) utilize form VPAT 2.5Rev WCAG (April 2025). Beginning on page 12, fill out Table 1 (corresponds with WCAG Level A) and Table 2 (corresponds with WCAG Level AA).

The intent of the accessibility requirements is to ensure anyone working on the project that may have a disability will be provided equipment/resources by their institution that will allow them to perform needed duties on the project (and this is a general requirement for Federal contracts).

2) IMPORTANT REMINDER: For acquisitions conducted under a 100% Small Business Set-Aside, per FAR 19.505(b)(1)(i), “Limitations on Subcontracting”, the concern [small business prime contractor] will not pay more than 50 percent of the amount paid by the Government for contract performance to subcontractors that are not similarly situated entities [e.g. also small businesses]. Any work that a similarly situated entity further subcontracts will count towards the concern's 50 percent subcontract amount that cannot be exceeded.

In other words, for acquisitions conducted under 100% small business set-asides, the small business prime contractor cannot function as a “pass-though” entity where the majority of the contract expenditures are going to “other than” small business concerns.

A small business “concern”, as defined by FAR 19.001, means any business entity organized for profit (even if its ownership is in the hands of a nonprofit entity) with a place of business located in the United States or its outlying areas and that makes a significant contribution to the U.S. economy through payment of taxes and/or use of American products, material and/or labor, etc. "Concern" includes but is not limited to an individual, partnership, corporation, joint venture, association, or cooperative. For more information, see 13 CFR 121.105.

The small business size standard for NAICS 541715 is 1,000 employees.

3) In order to mitigate performance risk, the prime contractor is expected to have the expertise and experience to manage all work performed by subcontractors as the Government does not have a direct contractual relationship with subcontractors.

4) Be sure to reference both Section J for the RFP (List of Attachments, inclusive of links to documents/Excel budget templates to complete and submit with your proposal) and Section L (Proposal Instructions) in addition to the information contained in this Attachment.