A1_-_RFP_Cover_Letter_081924_signed.pdf

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

National Institutes of Health National Institute on Drug Abuse Bethesda, Maryland 20892

NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

REQUEST FOR PROPOSAL (RFP) NUMBER: 75N95024R00086

PROJECT TITLE: Phase I Clinical Trials for Development of Small Molecule and Biologics Therapeutics

ISSUED BY:

Evan Feely Contract Specialist NINDS Section Contracts Management Branch, Red Office of Acquisition, NIDA

Email: evan.feely@nih.gov Phone: (301) 827-5301

Rieka Plugge Supervisory Contracting Officer Branch Chief Contracts Management Branch, Red Office of Acquisition, NIDA

Email: rieka.plugge@nih.gov Phone: (301) 827-7515

DATE ISSUED: August 19, 2024

PROPOSAL DUE: October 03, 2024, 5:00 P.M. (Eastern Time)

The National Institute of Neurological Disorders and Stroke (NINDS) invites you to submit a proposal responding to the requirements of RFP No. 75N95024R00086 - “Phase I Clinical Trials for Development of Small Molecule and Biologics Therapeutics.”

This Request for Proposal is released under FULL AND OPEN Competition Procedures.

NINDS prepared this Request for Proposal (RFP) in accordance with the Uniform Contract Format prescribed for Government Wide application by the Federal Acquisition Regulation (FAR). The Uniform Contract Format is both a Request for Proposal and a contract award document. The resulting contract will consist of Parts I, II, and III of the Uniform Contract Format.

All offerors must be REGISTERED and have an ACTIVE System for Award Management (www.sam.gov) account at the time an offer/proposal is submitted to the Government. All offerors registered in the System for Award Management (www.sam.gov) must be in full compliance with FAR 52.204-13 System for Award Management Maintenance to be eligible to submit a proposal. The Government will not accept proposals from offerors who do not meet the SAM requirement.

NINDS anticipates that multiple-award indefinite Delivery, indefinite Quantity (IDIQ), contracts will be awarded. NINDS may issue either firm-fixed-price or completion type cost reimbursement task orders under these contracts.

NINDS anticipates these contracts will have an ten-year ordering period that commences on the date of award or shortly thereafter and that the ordering period will be from April 01, 2025 through March 31, 2035. All contracts will contain a guaranteed minimum of $10,000.00 and a maximum ordering value of $233,227,446.00.

It is anticipated that individual task orders will include option quantities. If option quantities are utilized for an individual task order, they will be clearly defined in the Task Order Request for Proposal (TORFP) and will be evaluated at the time of task order solicitation and award. All funding will be made through the issuance of task orders and will be dependent on program needs and availability of funds.

Offerors shall respond with separate technical and cost/price proposals based on the assumptions provided in RFP Sections C and L. Please include separate pricing for the sample task orders.

General Part IV of the RFP contains instructions, provisions, and evaluation factors for the submission and review of proposals. Attachment 3 is a "Proposal Intent Response Form." Please complete this form and return it to the below address on or before 5:00 P.M. Eastern Time, on September 09, 2024. The balance of Parts I, II, and III contain provisions, clauses, and special requirements which will be made a part of any resultant award. Please review these sections and consider their impact on performance, capability, technical, and cost factors as you develop your proposal. Do not fill in blanks or otherwise complete portions of Parts I, II, and III which appear to require additional information. The Government will complete these items prior to contract award and, if negotiations are conducted, will tailor those items through final negotiations.

Offeror Questions Requests for clarification, additional information, or correction must be made in writing to the Contracting Officer. Offeror questions must be submitted on or before 5:00 P.M., on September 09, 2024. Offeror questions may be submitted by e-mail to evan.feely@nih.gov with the subject line:

“RFI – RFP 75N95024R00086”

NOTE: Site visits may be requested.

The Technical Proposal It is important that Offerors list all professional personnel and organizations named in the proposal that have any role in the proposed work. This includes staff, subcontractors, collaborating organizations, and consultants. Show organization affiliation(s) for every person named. Offerors may use extra sheets, as needed. NINDS will use this information to ensure that no conflicts of interest exist with the selected review committee members. Technical Proposal Instructions are detailed in Section L of this RFP.

The Business Proposal Offerors must have an authorized organizational official sign the Business Proposal costs and provide a separate proposed budget for each sample task order. Offerors must propose a firm-fixed-price for Sample Task Order 1. Offerors may propose for Sample Task Orders 2 and 3 as firm-fixed-price, cost-plus-fixed-fee, or a combination of the two contract types. Offerors may propose alternative fixed-price and cost-reimbursement budgets for Sample Task Order 2 and/or

3. If proposing for any sample task order on a cost-reimbursement basis, Offerors must provide a detailed breakdown of each cost category/element, an explanation of the basis for all costs, and documentation to support these costs. NINDS directs special attention to Breakdown of Proposed Estimated Costs (plus fixed fee) w/Excel Spreadsheet contained in the Business Proposal Cost Information, Attachment 14. Please submit all proposed budgets for cost-reimbursement type sample task orders in this format. Use of the above format will hasten review and award. A PDF copy of the spreadsheet must be included in the Business Proposal. Do not send encrypted files.

A completed Form NIH-2043, “Proposal Summary and Data Record” (see Attachment 4) must be included with the Business Proposal. Include the e-mail addresses of both the Principal Investigator and the responsible business representative on the form. Note that in addition to telephone numbers, you should include the e-mail addresses of both the Principal Investigator and the responsible business representative on the form.

The Offeror must submit its Travel Policy, Total Compensation Plan and Annual Report with the initial Business Proposal. See Section L of this RFP for additional detail.

In addition, offerors are advised that a “Determination of Exceptional Circumstances” to incorporate HHSAR Clauses 352.227-11 and HHSAR 352.227-14 as part of any resultant contract awarded under this RFP has been approved for use by the NINDS for this acquisition.

The edited HHSAR Clauses at 352.227-11, Patent Rights-Exceptional Circumstances and 352.227-14, Rights in Data – Exceptional Circumstances, are included in full text in Section I of this RFP. Any prospective offeror must certify and agree that to be considered and if selected for award of a contract that they do accept and will abide by the terms and conditions of these clauses. To evidence this agreement, each Offeror is required to complete, sign and include the “DEC Acknowledgement” (see Attachment 18) as part of their Business Proposal. Submission of this form with your proposal is a Mandatory Qualification criteria under Section M.

Prospective Offerors are cautioned that failure to provide this form with your Business proposal may render the proposal unacceptable and may result in rejection of the proposal without further consideration.

Submitting a Proposal Proposals must be submitted via the electronic Contract Proposal Submission (eCPS) website (https://ecps.nih.gov) no later than October 03, 2024, 5:00 P.M., Eastern Time. Proposals submitted by facsimile, e-mail, or hard copy will not be accepted. An official authorized to bind your organization must sign the proposal.

Offerors are solely responsible for submitting proposals in a timely manner. Please note that creating an account to submit may take up to three (3) business days. Please plan accordingly.

Additional instructions on submitting a proposal via eCPS can be found at https://ecps.nih.gov/HowToSubmit and in Attachment 2.

All notices related to this solicitation will be posted on SAM (https://www.sam.gov). If you would like to receive e-mail notifications of updates to this solicitation, please register with

SAM.

In accordance with FAR 15.306(a)(3) and FAR 52.215-1, the Government intends to evaluate proposals and award a contract without discussions. Therefore, your initial proposal should contain the best terms from cost or price and technical standpoints. The Government does, however, reserve the right to conduct discussions if the Contracting Officer determines them to be necessary.

Disclaimers This RFP does not commit the Government to pay the costs for the preparation and submission of a proposal. The Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds in connection with this acquisition.

Any contract award for this requirement is contingent on the availability of funds (see FAR 52.232-18, Availability of Funds – April 1984).

The RFP shall take precedence if any of the content in this letter is contradictory.

The NINDS appreciates your interest in this RFP and looks forward to receipt of your proposal.

Requests for any information concerning this RFP should be directed to the undersigned or Evan Feely at evan.feely@nih.gov or (301) 827-5301. Discussions with any other individuals should not occur.

Sincerely, Rieka Plugge Supervisory Contracting Officer Branch Chief Contracts Management Branch, Red Office of Acquisition, NIDA

Email: rieka.plugge@nih.gov Phone: (301) 827-7515

Rieka N.

Plugge -S

Digitally signed by Rieka N. Plugge -S