Amendment 01 to FDA-RFQ-75F40121Q00006 .pdf

Date: November 18, 2020

Subject: Amendment 01 to FDA-RFQ- 75F40121Q00006 FDA Safety Program Assessment Services

I. Description:

The purpose of this Amendment 01 is to do the following:

1. To provide final responses to the questions as attachment below labelled “Attachment 1:

Responses to Questions for FDA-RFQ- 75F40121Q00006”

2. To revise RFQ Section 14) Provisions and clauses to add the following provision:

Organizational Conflict of Interest

a. Determination. The Government has determined that this effort may result in an actual or potential conflict of interest, or may provide one or more offerors with the potential to attain an unfair competitive advantage specific to the nature of the conflict of interest and the limitation on future contracting.

b. If any such conflict of interest is found to exist, the Contracting Officer may (1) disqualify the offeror, or (2) determine that it is otherwise in the best interest of the United States to contract with the offeror and include the appropriate provisions to avoid, neutralize, mitigate, or waive such conflict in the contract awarded. After discussion with the offeror, the Contracting Officer may determine that the actual conflict cannot be avoided, neutralized, mitigated or otherwise resolved to the satisfaction of the Government, and the offeror may be found ineligible for award.

c. Disclosure: The offeror hereby represents, to the best of its knowledge that:

___ (1) It is not aware of any facts which create any actual or potential organizational conflicts of interest relating to the award of this contract, or

___ (2) It has included information in its proposal, providing all current information bearing on the existence of any actual or potential organizational conflicts of interest, and has included a mitigation plan in accordance with paragraph (d) of this provision.

d. Mitigation. If an offeror with a potential or actual conflict of interest or unfair competitive advantage believes the conflict can be avoided, neutralized, or mitigated, the offeror shall submit a mitigation plan to the Government for review. Award of a contract where an actual or potential conflict of interest exists shall not occur before Government approval of the mitigation plan. If a mitigation plan is approved, the restrictions of this provision do not apply to the extent defined in the mitigation plan.

e. Other Relevant Information: In addition to the mitigation plan, the Contracting Officer may require further relevant information from the offeror. The Contracting Officer will use all information submitted by the offeror, and any other relevant information known to FDA, to determine whether an award to the offeror may take place, and whether the mitigation plan adequately neutralizes or mitigates the conflict.

f. Corporation Change. The successful offeror shall inform the Contracting Officer within thirty (30) calendar days of the effective date of any Corporate mergers, acquisitions, and/or divestures that may affect this provision.

g. Flow-down. The contractor shall insert the substance of this clause in each first tier subcontract that exceeds the simplified acquisition threshold.

All other terms and conditions outlined in the RFQ remain unchanged. No further questions will be accepted/answered.

Attachment 1: Responses to Questions for FDA-RFQ- 75F40121Q00006

II. Questions and Responses:

1. Could you please tell me if the Combined Synopsis/Solicitation posted as solicitation number FDARFQ75F40121Q00006 will be a follow-on requirement to any work performed currently or in the past, or will this be a new requirement?

If possible, can you please provide the most recent contract or task order number?

FDA Response: This is a first time buy/procurement.

2. I wanted to know if there’s a past awarded amount?

FDA Response: This is a first time buy, therefore no awarded amount.

3. We respectfully request the Government disclose the company name of the incumbent, and if they are satisfied with the current incumbent and can the incumbent re-bid?

Additionally, if applicable which set-aside was the contract previously awarded. Thank you in advance for your response.

FDA Response: This is a first time buy/procurement, therefore there is no current incumbent for this requirement under this solicitation.