FDA-15-SOL-1146775_Responses_to_Questions.pdf

RFP No. FDA-15-SOL-1146775 Third Party Recall Audit Checks

Responses to Questions August 10, 2015

Q.1. Would you please confirm that the Recall Audit Checks requested by the FDA are for Food, and not Drugs?

A1. Recall Audit Checks are for all FDA Regulated Products (refer to 2. Objectives, Product

Types on page 3 of the solicitation. However, FDA intends to issue primarily Food audits at retail locations. Once food recall audit checks are successfully completed, audit checks for other commodities.

Q.2. Section 3 B2.(page 3 of 25) indicates the timeframe for a RAC assignment will range between 1-

10 work days, with the majority of assignments expected to last between 2-3 work days. For pricing clarity, please advise if 1 RAC = 1 assignment, or if there will be multiple RACs included in 1 assignment. In other words, how many days/hours is estimated for each RAC?

A2. A request for a RAC is equivalent to one RAC assignment. A RAC assignment will be specific to one recall event and may specify more than one (1) recalled product. A RAC assignment will require no less than five (5) RACs at multiple locations. Each RAC performed at each individual location is billable as one RAC.

FDA expects the Contractor to begin the recall audit check process and assign staff/auditors within 24 to 48 hours. Thereafter, the Contractor’s staff/auditors shall begin and complete within 24 hrs.

Q.3. Section I. A/B (page 14 of 25) - is there a page limit for the technical volume response?

A.3. Section I. A/B was not found in this solicitation. There is no page limitation for Volume 1 –

Technical Proposal.

Q.4. General - Is this a new requirement or recompete? If recompete,please provide the name of incumbent, contract term and award value.

A.4. This is a not a recompete and there is no incumbent. However, the previous contract for recall audit checks was awarded to Information Systems & Networks, Corp. for the period of performance 05/01/2014 - 11/28/2014 for $21,183.

Q.5. Who is the incumbent contractor?

A.5. Refer to A. 4 above.

Q.6 What is the value of the current contract?

A.6 Refer to A.4 above.

Q.7. Will the government consider an extension to the due date of at least one week?

A.7. No, proposals submitted in response to this solicitation are due

Q.8. Page 1, Section 2.2, Pricing: Are the quantities identified in the pricing table the expected units or are they inserted for pricing comparison?

A.8. The quantities identified in the pricing table are the estimated units that will be ordered. These quantities are estimates only and there is no obligation on the Government to order the total quantities. This section or an identical format should be completed for price evaluation.

Q.9. Page 1, Section 2.2, Pricing: Will the government consider regionally based unit pricing to accommodate the differences in travel time across different geographical areas?

A.9. The Government expects that the Contractor will have staff disbursed throughout the United

States to accommodate different geographical areas, and that there will be one unit price which will remain the same throughout the performance period.

Q.10. Page 3, Section 2.0, Objectives: Please confirm that it is not anticipated that all of a period’s

(Base Year or Option Year) Recall Audit Checks (RAC) will be consumed by one RAC assignment.

A.10. It is not likely that 1,000 or 1,200 RACs would be issued in one assignment. However, if all of the estimated number of RACs for one performance period were consumed by one assignment, timeframes and quantities may be adjusted due to the volume requested in one assignment.

Q11. For Contractor purposes, should it be expected that over the course of a contract period, the

Contractor will receive multiple assignments that total approximately 1,000 RAC’s?

A.11. Routinely, assignments are based on emerging needs and are made throughout the year.

However, in the event of an outbreak, a large amount of audits may be requested in one or multiple assignments during a short period of time.

Q.12. Additionally, please confirm whether or not it will be within the government’s purview to expand the quantity of RAC’s assigned in a period over and above the optional amount (200), should that be necessary.

A.12. Refer to A.10 above.

Q.13. Please provide historical volume of RAC assignments by month for the previous 24 month period. Please include the location and duration in days associated with each RAC assignment for that period.

A.13. The volume of RAC assignments in a month will be inconsistent from month to month, depending on need. Over the last 24 month period, the highest volume in one month was 1373 and the lowest volume was 10 RACs.

Q.14. Section 2.2 Pricing of the RFP enumerates CLINS for 1,000 and 200 respective RACs per year.

Section 3.B.2 mentions that “The Contractor must be capable of conducting 1,000 RACs in a 5-work day assignment, if required.” Should the Contractor be required to perform this surge, would the volume of 1,000 and 200 normal and optional RACs per year be affected in any way?

A.14. Refer to A.10 above.

Q.15. If the surge performance of 1,000 RACs in 5 work days is enacted and does affect the normal

CLINs volumes, how would the proposed volumes of RACs change in that contract year.

A.15. Refer to A.10 above.