Amendment_1.pdf

PDF 59 KB Posted

Attached to
Counterfeit Detection Device Development Project Federal contract opportunity
Solicitation number
16-223-SOL-1159742
Issued by
Department of Health and Human Services Food and Drug Administration

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Questions and Responses

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Other files for this federal contract opportunity

Other files attached to Counterfeit Detection Device Development Project, newest first.
File Type Posted
Attachment_4_Form_FDA_3398.pdf PDF
16-223-SOL-1159742.pdf PDF
Attachment_2_Industry_Video.mp4 MP4 file
Attachment_1_Data_Documents.doc DOC document
Attachment_3_Testing_Method.docx DOCX document

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Amendment 1 - Questions and Responses to 16-223-SOL-1159742 - FDA Counterfeit Detection Device

Question 1:

Will we need to present and identify our manufacturing capability in Phase II of this program?

Response 1:

Yes, manufacturing capabilities must be identified with in the Phase II final submission.

Question 2:

Will the FDA allow for overseas (OCONUS) production of the units in Phase III?

Response 2:

Due to the sensitive nature of the device we would prefer the devices be manufactured in the States.

Question 3:

What is the total possible number of units to be manufactured over the life of the Phase III IDIQ contract?

Response 3:

The solicitation stated an approximation of 450 devices. That is the best estimate we can give at this time.

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