75N95021R00008_Cover Letter.pdf

DEPARTMENT OF HEALTH & HUMAN SERVICES

National Institutes of Health National Institute on Drug Abuse Office of Acquisitions c/o 3WFN MSC 6012 301 N Stonestreet Ave Bethesda, MD 20892

NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES

REQUEST FOR PROPOSALS (RFP) No. 75N95021R00008 PROJECT TITLE: CRO Support for NCATS Regulatory Affairs Support and Related Services

ISSUED BY:

Rieka Plugge Contracting Officer Section Head, NCATS Section NIDA Office of Acquisitions 301 N Stonestreet Ave Bethesda, MD 20892

Kimberly Espinosa Contract Specialist NCATS Section NIDA Office of Acquisitions 301 N Stonestreet Ave Bethesda, MD 20892

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

Email: kimberly.espinosa@nih.gov Phone: 301-827-3546

DATE ISSUED: August 4, 2021

DUE DATES:

PROPOSAL INTENT RESPONSE FORM: 12:00:00PM ET on August 16, 2021 PHASE I SUBMISSIONS: 12:00:00PM ET on August 30, 2021 PHASE II PROPOSALS: 12:00:00PM ET on October 14, 2021

The National Center for Advancing Translational Sciences (NCATS) invites you to submit a proposal responding to the requirements of this RFP No. 75N95021R00008 for CRO Support for NCATS Regulatory Affairs Support and Related Services. This RFP is released as a TOTAL

SMALL BUSINESS SET-ASIDE.

The NCATS 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.

The NCATS anticipates that up to three (3) Indefinite Delivery, Indefinite Quantity (IDIQ) type contracts will be awarded with an ordering period of five (5) years. Individual task orders may be awarded under this contract as firm fixed-price and/or labor hour. These individual task orders may include option periods and/or option quantities. If option periods or 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.

The contract will contain a guaranteed minimum of $1,000 and an estimated maximum quantity of $19,364,880.00 for the ordering period.

Offeror Questions Requests for clarification, additional information, or correction must be submitted to the Contracting Officer and Contract Specialist listed above. Offeror questions regarding Phase I must be submitted to the Contracting Officer and Contract Specialist listed above before 12:00:00PM on August 16, 2021. Offeror questions regarding Phase II must be submitted to the Contracting Officer and Contract Specialist listed above before 12:00:00PM on September 29, 2021.

All offeror questions and requests for clarification, additional information, or correction must be submitted via email with “RFP 75N95021R00008” in the subject line.

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

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. NCATS 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.2.b.

Business Proposal: Offerors must have an authorized organizational official sign the Business Proposal. The Business Proposal must contain a detailed breakdown of costs and prices for the sample task order. Please submit this breakdown of prices in the form of an Excel spreadsheet; 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 7) must be included with the Business Proposal. Include the e-mail address(es) of the responsible business representative(s) on the form.

The Offeror must submit its Travel Policy and most recent Annual Report with the initial Business Proposal. See Section L.2.c. for additional detail.

Submitting a Proposal The Government will conduct this acquisition using two phases:

Phase I: Offerors MUST complete and submit a Proposal Intent Response Form by the deadline listed on Page 1 of this cover letter. The Proposal Intent Response Form is provided as Attachment 1 to this RFP. Offerors will receive electronic delivery instructions for the Phase I submission after the Proposal Intent Response Form is received. Offerors that do not submit a Proposal Intent Response Form will not receive electronic delivery instructions for Phase I.

Phase I submissions that do not comply with the delivery instructions will not be accepted. Phase I submissions are due by the deadline listed on Page 1 of this cover letter.

Phase II: Proposals must be submitted via the electronic Contract Proposal Submission (eCPS) website (https://ecps.nih.gov) by the deadline listed on Page 1 of this cover letter. Instructions on using eCPS are provided as Attachment 2, Packaging and Delivery of Proposals. Proposals submitted by facsimile, e-mail, or hard copy will not be accepted. An official authorized to bind your organization must sign the proposal.

PLEASE NOTE: The Phase I and Phase II submissions requires registration in two different systems. Due to the variety in document type and size, the same system cannot be used for both phases. It may take up to three (3) business days to complete the registration process for each system. Therefore, offerors are encouraged to plan accordingly and allow sufficient time for system registrations before the submission deadlines.

All notices related to this solicitation will be posted in the Contract Opportunities section of the System for Award Management (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 contract(s) 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.

Additional Information 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.

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 NCATS appreciates your interest in this RFP and looks forward to receipt of your submission. Requests for any information concerning this RFP should be directed to the Contracting Officer and Contract Specialist listed on Page 1 of this cover letter. Communications with any other individuals should not occur.

Sincerely, Rieka Plugge Contracting Officer Section Head, NCATS Section NIDA Office of Acquisitions 301 N Stonestreet Ave Bethesda, MD 20892

Rieka N.

Plugge -S

Digitally signed by Rieka N.

Plugge -S Date: 2021.08.04 15:32:52 -04'00'