RFP No. 75N95024R00050_Cover Letter.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: 75N95024R00050

PROJECT TITLE: Manufacturing and Nonclinical Studies Support for Development of

Therapeutic Biotechnology Products (Biologics) for Neurological-related Disorders

ISSUED BY:

Kimberly Espinosa Contracting Officer, SOS Section Contracts Management Branch, Blue Office of Acquisition, NIDA C/O NIH Mail Center, 3WFN, MSC 6012 16071 Industrial Dr. – Dock 11 Gaithersburg, MD 20877 Email: kimberly.espinosa@nih.gov Phone: (301) 827-3546

Primary Point of Contact: Secondary Point of Contact:

Kimberly Espinosa Valerie Whipple Contracting Officer, SOS Section Supervisory Contracting Officer, SOS Section Email: kimberly.espinosa@nih.gov Email: valerie.whipple@nih.gov Phone: (301) 827-3546 Phone: (301) 827-5218

DATE ISSUED: April 26, 2024

The National Institute of Neurological Disorders and Stroke (NINDS) invites you to submit a proposal responding to the requirements of RFP No. 75N95024R00050 – NINDS Manufacturing and Nonclinical Studies Support for Development of Therapeutic Biotechnology Products (Biologics) for Neurological-related Disorders.

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.

mailto:kimberly.espinosa@nih.gov mailto:kimberly.espinosa@nih.gov mailto:valerie.whipple@nih.gov

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 in accordance with FAR Provision 52.204-7, System for Award Management. 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 (MAC) indefinite-delivery, indefinite-quantity (IDIQ) contracts with cost reimbursement or fixed price type task orders, will be awarded.

NINDS anticipates these MACS will have an ordering period that commences on the date of award or shortly thereafter and is active through September 29, 2030. All contracts will contain a guaranteed minimum of $1,000 and a maximum value of $149,200,000 for the ordering period.

Offerors shall respond with separate technical and cost/price proposals based on the assumptions provided in Sections C and L.

General Part IV of the RFP contains instructions, provisions, and evaluation factors for the submission and review of proposals. 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 2:00pm Eastern Daylight Time on May 28, 2024. Offeror questions must be submitted by e-mail to Kimberly.espinosa@nih.gov with the subject line:

“RFP 75N95024R00050”

NOTE: Site visits may be requested.

Pre-Proposal Conference The Government anticipates, but does not guarantee, that it will hold a pre-proposal conference prior to the Offer Due Date. If a pre-proposal conference is held, information regarding the date, time, and how to attend will be published on SAM.gov.

http://www.sam.gov/ http://www.sam.gov/ mailto:Kimberly.espinosa@nih.gov

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.

The Business Proposal Offerors must have an authorized organizational official sign the Business Proposal, which must contain a detailed breakdown of costs for all sample task orders included in the Business Proposal Budget Template. For each cost category/element, provide an explanation of the basis for all costs, and provide documentation to support these costs. Please submit business proposals with a spreadsheet 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 9) 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 and fax 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 Small Business Subcontracting Plan, Travel Policy, Total Compensation Plan and Annual Report with the initial Business Proposal. See Section L.2.c. for additional detail.

Submitting a Proposal Proposals must be submitted via the electronic Contract Proposal Submission (eCPS) website (https://ecps.nih.gov) and received no later than the Offer Due Date listed on SAM.gov.

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 1.

All notices related to this solicitation will be posted on SAM (https://www.sam.gov).

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.

https://ecps.nih.gov/ https://ecps.nih.gov/howtosubmit https://www.sam.gov/

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 legally can 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.

Discussions with any other individuals should not occur.

Sincerely, Kimberly Espinosa Contracting Officer, SOS Section Contracts Management Branch, Blue Office of Acquisition, NIDA Email: kimberly.espinosa@nih.gov Phone: (301) 827-3546 mailto:kimberly.espinosa@nih.gov