Rapid HIV Point-of-Care Diagnostic Device for Resource-Limited Settings

This amendment provides answers to questions regarding the solicitation from prospective offerors. The hour and date specified for receipt of proposals HAS NOT been extended.

Offerors must acknowledge receipt of this Amendment by identifying this amendment number and date of the amendment on each copy of the offer submitted. Failure to receive your acknowledgement may result in the rejection of your offer. Except as provided herein, all terms and conditions of the solicitation remain unchanged and in full force and effect.

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This amendment does not designate a suggested cut off date for the submittal of questions regarding this BAA. However, if questions are received one week prior to the due date for the submission of proposals, we cannot guarantee a response. In addition, the proposal submission due date will not be extended.



Questions and Answers (numbering continued from Amendment #1)



24. Page 8, PART I, THE SCHEDULE, SECTION C, ARTICLE C.2., Reporting Requirements, paragraph a.5., requires that the source code be delivered at the completion of the project. Some of the work that has gone into the development of the platform we propose to use was developed at our own expense. Is it absolutely necessary that source code be delivered at the completion of the contract?



Response: The BAA incorrectly specified that source code be delivered at the completion of the contract. Therefore, SECTION C, ARTICLE C.2., Reporting Requirements, paragraph a.5., is deleted in its entirety. Please note, however, that contractors must be willing to share the necessary documentation with the Government in order to prepare a pre-Investigation Device Exemption (IDE) and a Pre-market Approval (PMA) package for regulatory approval of the HIV POC diagnostic device.



25. ATTACHMENT 5, RESEARCH AND TECHNICAL OBJECTIVES, Table 1, would alternate power sources compatible with a resource limited setting be acceptable?



Response: Yes, but the device must function as a POC diagnostic device in a resource limited setting.



26. ATTACHMENT 5, RESEARCH AND TECHNICAL OBJECTIVES, page 2, Table 1, issue: Cost. We would propose an HIV test that will concurrently assess multiple independent gene targets. The specification indicated a $12 - $20 range per result. As our platform would provide multiple results concurrently is the cost per result ($12 -$20) or is it simply $12- $20 for all results.



Response: We are focused on diagnosing HIV and therefore are unwilling to pay for the cost of unrelated tests.



27. ATTACHMENT 5, RESEARCH AND TECHNICAL OBJECTIVES, page 2, Table 1, issue: Full Set of Specifications. If we cannot hit all specifications listed in Attachment 5, Research and Technical Objectives, Table 1, is it worth our continued interest in responding to the RFP?



Response: The specifications listed in Table 1 are estimates provided to offerors to assist with proposal preparation. They are not meant to be restrictive. Therefore, Attachment 5, page 2, the paragraph preceding Table 1, Key Specifications and Ranges for a Rapid, HIV POC Diagnostic Device, is hereby revised to read as follows:



The specifications required for the diagnostic device to be successfully implemented in the field are summarized in Table 1. These specifications are estimates provided to offerors to assist with proposal preparation and are not meant to be restrictive.



28. Amendment 1, responses to questions 7 and 16, refer to a NIAID sponsored workshop entitled "Novel Technologies in Rapid HIV-1 Viral Detection" at NIH on July 12-13, 2007. Is a transcript of the meeting available?



Response: A Summary Report of the meeting is attached. Also, links to videocast of the two day meeting can be accessed via the following websites:



Novel Technologies in Rapid HIV-1 Viral Detection (Day 1):

http://videocast.nih.gov/Summary.asp?File=13930



Novel Technologies in Rapid HIV-1 Viral Detection (Day 2):

http://videocast.nih.gov/Summary.asp?File=13932



29. Page 16, SECTION H SPECIAL CONTRACT REQUIREMENTS, ARTICLE H.3. HUMAN

MATERIALS (ASSURANCE OF OHRP COMPLIANCE) speaks to a question about the exclusion of human subjects from this contract. It was presumed that obtaining blood samples from HIV infected and non-infected individuals be permitted under this contract.....to your knowledge, is that correct?



Response: The resulting contract is expected to obtain, receive, collect, store, modify or otherwise utilize human materials. A properly completed Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption, Optional Form OMB No. 0990-0263 (or a self-designated form) certifying IRB review and approval of the protocol from which the human materials were obtained must be received from the contractor/subcontractor before research or collection involving human materials may be conducted under the contract.



30. Page 4, SECTION B SUPPLIES OR SERVICES AND PRICES/COST, ARTICLE B.1. BRIEF

DESCRIPTION OF SUPPLIES OR SERVICES, addresses NIAIDs intended target location for this device. In other words, the question was posed as to whether this device is planned to be used more domestically or more in developing countries?



Response: The diagnostic technology must demonstrate feasibility for use in resource-limited settings and In POC clinics without the use of supporting laboratory equipment such as centrifuges, vortexes or pipettes.



31. One of our primary questions is related to the current state of completion that will be considered by the reviewers. In short, will the reviewers prefer to select an existing technology that is currently in use in other market areas or is the preference for a new technology that addresses the specific needs of the solicitation, even though the new technology is not currently available for use? To put it even more simply, is the purpose of the solicitation to fund promising new technology to bring it to a state that can be commercialized or is the solicitation targeted for existing technology that can be modified to suit the requirements?



Response: ATTACHMENT 5 TABLE 1, RESEARCH AND TECHNICAL OBJECTIVES, addresses how your response to the solicitation can be targeted at either new or a modification of existing technology providing it meets the POC device specifications. The product development activities should include your plan to submit an IDE and subsequently a PMA package to FDA as listed in Attachment 5. Your selection of a platform should plan on getting this accomplished in a 5 year time frame.



32. Article I.2(c) Authorized Substitution of Clauses on page 25 states that FAR Clause 52.227-14, Rights in Data-General (December 2007) is deleted in its entirety. However, Article I.3 (a) (8)-(10)

Additional Contract Clauses on page 26 states that FAR Clause 52.227-14, Rights in Data General (December 2007) as well as Alternate IV and Alternate V are incorporate[d] . . . by reference into the contract. Can you clarify whether FAR Clause 52.227-14 is incorporated in the contract?



Response: FAR Clause 52.227-14 is incorporated in the contract, as well as Alternate IV (JUN 1987) and Alternate V (JUN 1987).



33. Article C.3 on page 3 makes reference to FAR Clause 52.227-11, Patent- Rights-Ownership by the Contractor. This clause is also referenced in Article F.1 (pg.11) and on page 5 of Attachment 6. However, Article I..3(a)(7) on page 26 states that FAR Clause 52.227-13, Patent Rights-Ownership by the Government is incorporate[d] . by reference into the contract. These two clauses are mutually exclusive, or at least in tension with one another. Which clause do you intend to include? The multiple references to 52.227-11 make it appear that this clause is the intended one, and it would also be our preference.



Response: The Government is not interested in retaining possession of an invention, therefore FAR clause 52.227-13, Patent Rights-Ownership by the Government is not applicable and is hereby deleted from the Broad Agency Announcement. However, FAR clause 52.227-11 is applicable with respect to any subject invention in which the Contractor has acquired title, the Federal agency has the right to a nonexclusive, nontransferable, irrevocable, paid-up license to practice or have practiced each subject invention throughout the world by or on behalf of the United States (including any Government agency).



34. Page 8, issue: Source code. If the source code for the contractors instrument is proprietary and was developed at the organizations expense, the contractor would not be willing to share this with the goverrment. If a contractor is unwilling to share source is it worth their effort to respond to the RFP?



Response: A stated in the response to question no. 24, Article C.2 (a) (5) on page 8 is deleted in its entirety. Also, on page 4 of ATTACHMENT 6, REPORTING REQUIREMENTS AND OTHER DELIVERABLES, the paragraph titled Source Code and Object Code is deleted in its entirety.



35. Is there a page limit?



Response: The page limit for the technical proposal is 150 pages. The specific details are found in Section J of the RFP, again in Attachment 1, page 2.



36. Would NIH vaccine center provide clinical samples to test for vaccine efficacy testing by this POC test? We have developed a prototype for sensitive ultra rapid test for HIV detection, which can be modified for testing vaccine efficacy. Question is how do we test these devices for their usefulness of vaccine efficacy?



Response: A mechanism for requesting archived specimens from previous vaccine trials is available at http://www.HVTN.org. This information is stated in Attachment 5, Research and Technical Objectives, bottom of page 1. The offeror should attempt to establish this collaboration and if this proposal is successful, the NIAID Program Staff will ensure that specimens are available through NIAID-sponsored network clinical trials.



37. It is unclear to me how it is possible to develop a human in vitro diagnostic test/device without performing Human Subject research? Naturally all required FWA, IRB and other oversight would be obtained for all Institutions involved both domestic and international. Must the project really not include Human Subjects? It would be impossible to develop a test without a component of the assessment involving human subjects. Could you clarify this?



Response: We anticipate that you will obtain or request archived human specimens from previous or ongoing human clinical trials to evaluate the diagnostic devise. This solicitation does not have funds for the purpose of conducting a new clinical trial. Is there a reasons that the proof-of concept, validation, and test-of-concept studies cannot be done with achieved specimens? Because we anticipate that Offeror's will use existing specimens which are not individually identifiable from the original source, this research is not classified as human subjects research.



END OF AMENDMENT #2 to RFP-NIAID-DAIDS-NIHAI2008027