FDA-RFP-1195133_Amend_1_QA.doc

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Engineering Analysis Laboratory Services Federal contract opportunity
Solicitation number
FDA-RFP-1195133
Issued by
Department of Health and Human Services Food and Drug Administration

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FDA-RFP-1195133 Amendment 1 Q&A

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FDA-RFP-1194857

Dissolution of Smokeless Tobacco Products

Document Type:
Amendment 1 - Questions & Answers
Solicitation Number:
FDA-RFP-1195133
Subject:
Engineering Analysis Laboratory Services for ENDS and other Newly Deemed Tobacco Products
Posted Date:
10 July 2018
Questions Date:
24 July 2018
Response Date:
3 August 2018
NAICS Code:
541380 Testing Laboratories, Small Size Standard is $15M dollars.

QUESTION:

I noticed that the RFP indicated the Mandatory requirement of AAALAC Certification. However, the RFP specifically stated there will be no animal studies. As we are simply a tobacco analysis lab, we do not have this type of certification; nor would we require it for any of our studies. Can you please clarify if this would be required as we would like to submit a response?

“The Offeror must meet the following mandatory criteria, Current AAALAC certification, before their proposal can be further evaluated. Those Offerors not meeting the mandatory criteria will not have their proposals further evaluated”

These projects will be limited to physical design parameter and engineering analysis and physical and chemical characterization of e-liquid and aerosol and as such will not include any in vitro, animal toxicological, or human clinical studies.

ANSWER:

Current AAALAC certification in NOT required, is no longer a Mandatory Criteria, and is struck from the Evaluation Criteria. Paragraph A in Volume 1 – Technical Proposal is deleted in its entirety.

Volume 1 – Technical Proposal

A. MANDATORY CRITERIA – deleted in its entirety.

All other terms and conditions of FDA-RFP-1195133 remain the same including the deadline for questions (24 July 2018) and the response date (3 August 2018).

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