NINDS_RFP_15-01_Cover_Letter.pdf

REQUEST FOR PROPOSALS (RFP) No. NIH-NINDS-15-01

Project Title: “Phase 1 Clinical Trials for Development of Neurotherapeutics”

ISSUE DATE: July 6, 2015

DATE DUE: September 4, 2015

Ladies and Gentlemen:

The National Institute of Neurological Disorders and Stroke (NINDS), NIH, invites you to submit a proposal in response to the requirements of the enclosed RFP No. NIH-

NINDS-15-01.

The NINDS seeks to award IDIQ contracts to organizations with the requisite qualifications and capabilities to provide a full service, turn-key Phase I Clinical Trials Facility in support of the development of novel neurotherapeutic agents. This full service facility will be required to perform a full range of services from protocol development through submission of clinical study reports to be used by the NINDS, sponsored Investigators or Contributors in support of Investigative New Drug (IND) applications. The primary emphasis of this Phase I Clinical Trials Facility will be to perform Single Ascending Dose (SAD) and possibly Multiple Ascending Dose (MAD) Phase I clinical trials utilizing NINDS-supplied novel agents developed by NINDS, sponsored Investigators or Contributors with an emphasis on first in human testing to determine the tolerated dose range, the dosing regimen, the safety profile and pharmacokinetic (PK) parameters.

THIS ACQUISITION IS ISSUED ON A FULL AND OPEN COMPETITVIE BASIS. The North American Industry Classification System (NAICS) code that best describes this requirement is 541712. The small business size standard is 500 employees.

Your attention is particularly directed to Part IV, which contains instructions, provisions, and evaluation factors for the submission and review of proposals. Your attention is further directed to Attachment 2, "Proposal Intent Response Sheet.” If you intend to submit a proposal in response to this solicitation, we ask that you mail a copy of the Proposal Intent Response Sheet to the address provided, or e-mail it to cartera@mail.nih.gov.

It is your responsibility to monitor the web page at http://www.FedBizOpps.gov/ for any amendments that might be issued under this RFP. A separate notice of RFP amendments, if any, to individual sources, will not be made.

An original and five (5) hard copies of the technical proposal and an original and three

(3) hard copies of the business proposal must be received by the Contracting Officer, no later than 4:30 P.M. (Eastern Standard Time) on September 4, 2015, at the addresses indicated below. The original hard copy of the technical and business proposals shall be mailto:cartera@mail.nih.gov http://www.fedbizopps.gov/ signed by an official authorized to bind your organization.

In addition to the number of hard copy versions mentioned above, offerors must deliver ten (10) CD copies of the complete technical proposal and five (5) CD copies of the complete business proposal. It is preferred that the CD proposals, including any and all attachments to the proposals, be submitted in either a Microsoft or a searchable PDF format, except for the budget spreadsheets which must be submitted in Microsoft Excel© format. Do not send encrypted files.

If your proposal is hand-delivered or sent via an overnight delivery service, e.g., Federal Express, DHL, etc, your proposal must be delivered to the following address:

Contracting Officer Office of Acquisitions, Neurosciences

NINDS R&D CMB, NIDA, NIH

6001 Executive Boulevard, Suite 3287 Rockville, Maryland 20852

If mailing your proposal through the U.S. Postal Service your proposal must be sent to the following address:

Contracting Officer Office of Acquisitions, Neurosciences

NINDS R&D CMB, NIDA, NIH

6001 Executive Boulevard, Suite 3287 Bethesda, Maryland 20892-9531

If you deliver your proposal in person, you will be required to provide photo identification and provide a name and telephone number of the individual being visited, (in this case, Annette Carter at (301) 496-1813), at our buildings’ guard station. You will then need to personally bring the boxes to Room 3287. Proposals must NOT be left with the guard.

Your attention is directed to the RFP provision entitled “LATE PROPOSALS AND REVISIONS” set forth in Section L, paragraph 1, (k) of this RFP, implemented by HHSAR 352.215-70. Please review these provisions so that you will be fully aware of the time requirements for submitting your proposal. It is your responsibility to ensure that your proposal is delivered by the due date and time, and at the specific location (Room 3287) as required in the RFP.

Your proposal must be prepared in the format prescribed in the RFP. Please be sure that all documents which you are required to complete and sign, e.g., Representations and Certifications, NIH Form 2043, etc… are submitted with your proposal. All attachments are provided under Section J. Offerors are advised to pay particular attention to Section L entitled “Instructions, Conditions, and Notices to Offerors” and Section C entitled “Description/Specification/Work Statement.” Proposals will be evaluated pursuant to Section M entitled “Evaluation Factors for Award.”

Your proposal must provide a contact name and telephone number, your company name and complete mailing address. Furthermore, FAR Provision 52.204-7, System for Award Management (SAM), which is applicable to this solicitation, requires that a prospective awardee be registered in the SAM database prior to award, during performance, and through final payment of any contract resulting from this solicitation. In addition, your organization’s Tax Identification Number (TIN) and Dun & Bradstreet Number must be provided. Additionally, please note that FAR Provision 52.204-6, Data Universal Numbering System (DUNS) Number, requires you to submit a DUNS number for your company along with your offer. Contact information for Dun and Bradstreet is provided in the FAR provision at 52.204-6. Please include this information on the first page of your business proposal.

The award of any contract resulting from this solicitation is contingent upon the availability of appropriated funds from which payment for contract purposes can be made.

The RFP does not commit the Government to pay the costs for the preparation and submission of a proposal.

It also is brought to your attention that the Contracting Officer is the only individual who legally can commit the Government to the expenditure of public funds in connection with this acquisition. No legal liability on the part of the Government for any payment may arise until funds are made available to the Contracting Officer for this contract and until the Contractor receives notice of such availability, to be confirmed in writing by the Contracting Officer.

Any and all questions concerning this RFP should be directed to Annette Carter, Contracting Officer, NINDS R&D CMB, NIDA, in writing to cartera@mail.nih.gov. In Mrs. Carter’s absence inquires/questions, etc… can be directed to Mr. Kirkland Davis, Chief, NINDS R&D CMB, NIDA, NIH at kd17c@nih.gov or at 301 496-1813.

Sincerely yours, /S/

Annette Carter Office of Acquisition, Neurosciences NINDS R&D Contracts Management Branch, NIDA, NIH mailto:cartera@mail.nih.gov mailto:kd17c@nih.gov