RFP-NIH-NHLBI-HB-99-10

"Refinement of New Assays for Direct Detection of Viral Nucleic Acids in Donated Organs"

Request for Proposals No.: NIH-NHLBI-HB-99-10
Issue Date: December 28, 1998
Issued By: Lynda A. Bindseil, Contracting Officer
National Heart, Lung, and Blood Institute
Contracts Operations Branch, DEA
Rockledge 2, Room 6134
6701 ROCKLEDGE DR MSC 7902
BETHESDA MD 20892-7902
Purchase Authority: Public Law 95-83, as amended
Small Business Set-Aside: No; SIC Code 8731
Proposal Due Date: February 10, 1999, 4:00 P.M. (Local Time)
Ladies and Gentlemen:

The National Heart, Lung, and Blood Institute is soliciting contract proposals to refine nucleic acid-based assays to identify infection of organ/tissue donors by blood-borne viruses, most notably human immunodeficiency virus (HIV) and hepatitis C virus (HCV). The major objectives of this program are: 1) to refine for use in clinical laboratories, one or more nucleic-acid based techniques that will be feasible for the direct detection of blood-borne viruses in donors of organs for transplantation to reduce the antibody-negative window period between infectivity and detection to the shortest possible time and, when possible, obviate the need for indirect antibody tests; and 2) to file for investigational new drug exemption (INDs) with the Food and Drug Administration (FDA), and submit and obtain approval for product license applications (PLAs). This Streamlined Technical Request for Proposal (RFP) consists of the combined solicitation form and cover letter and the Solicitation, Offer and Award form SF 33 with attachments.

Our method of posting this RFP on the Web is different from the normal, previous practice!

The text of this RFP as posted is available for viewing, printing, and downloading (saving) in Adobe Acrobat's portable document file (PDF) format. You will need to have the Acrobat Reader on your computer and configured to work on your browser to access the file. When viewed or printed in the Acrobat Reader, the document appears as it does in the hard copy version. If you do not have the Acrobat Reader, you may download a free copy from Adobe at:
http://www.adobe.com/prodindex/acrobat/readstep.html.

This cover letter and the attached Solicitation (SF 33) contain the technical information required for the submission of a proposal for this acquisition. Section L - Instructions, Conditions, and Notices to Offerors also contains specific RFP Instructions and Provisions, Applicable RFP References, and Project Information. The proposal intent response form is found on page 10 and the address for delivery of your proposal is found on page 11. The section entitled "Applicable RFP References" lists those items in STREAMLINED RFP REFERENCES directory that apply to this RFP, including forms for submission of the proposal.

RFP NHLBI-HB-99-10 in PDF Format

For more information and references, the NIH Request For Proposals Directory, contains a number of documents in a section entitled "STREAMLINED RFP REFERENCES," following the list of NIH Institutes. Although these documents contain sufficient information for you or your organization to submit a proposal, if you intend to submit a proposal in response to this RFP, it is essential that you immediately notify Lynda A. Bindseil, Contracting Officer, at the following internet address:

bindseil@nih.gov

If you do not notify the contracting office of your intent to submit a proposal, you will not receive an individual notice of any amendments to the RFP, if any are issued. However, all amendments will be posted on the NIH web site.

The original and fifteen (15) copies of your technical proposal and the original and six (6) copies of your business proposal must be received by the Contracting Officer no later than February 10, 1999, at 4:00 p.m. Local Time at the address listed in the item entitled "Packaging and Delivery of Proposal" on page 11. Also, please complete the form entitled "Proposal Intent Response Sheet" on page 10 and send it to the address indicated therein on or before January 11, 1999. This will allow us to expedite preparations for the technical review of proposals. Finally, your proposal must be organized and submitted in accordance with the "Technical Proposal Table of Contents." All three of these items are found under the "Specific RFP Instructions and Provisions" portion of this RFP in Section L starting on page 9.

You are reminded that the "Technical Proposal Cover Sheet" must be completed in full detail and used as the cover sheet for each copy of your technical proposal. (This form is contained in this NIH WEB site under the FORMS, FORMATS, AND ATTACHMENTS file found in the STREAMLINED RFP REFERENCES.) This information will be used to ensure that there will be no conflict of interest when selecting review committee members.

NOTE: If your proposal is not received by the Contracting Officer or designee at the place and time specified, then it will be considered late and handled in accordance with the PHS Clause 352.215-10 entitled, "LATE PROPOSALS, MODIFICATIONS OF PROPOSALS, AND WITHDRAWALS OF PROPOSALS." The full text is in the Optional RFP Instructions and Provisions file of the Streamlined RFP References Directory. Submission of proposals using facsimile or electronic mail is not authorized.

If you have any additional questions regarding this RFP, please contact Ms. Bindseil through the Internet using the electronic mail address listed above or phone (301) 435-0355, fax (301) 480-3432. Collect calls will not be accepted.

NOTE: DIRECTIONS FOR ACCESSING THE "STREAMLINED RFP REFERENCES" REFERRED TO THROUGHOUT THIS RFP ARE AS FOLLOWS:

"STANDARD RFP INSTRUCTIONS AND PROVISIONS" for proposal preparation instructions and other standard provisions,
"OPTIONAL RFP INSTRUCTIONS AND PROVISIONS" for the special provisions identified in this specific RFP,
"FORMS, FORMATS, AND ATTACHMENTS" to download the forms listed in this specific RFP that you will need to submit a proposal,
"SAMPLE CONTRACT FORMAT--GENERAL" to view some of the clauses that are typical for inclusion in a Research and Development type contract issued by NIH.,
BUSINESS PROPOSAL COST INFORMATION (includes EXCEL cost proposal spreadsheet)
Sincerely,
/s/
Lynda A. Bindseil
Contracting Officer



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