RFP_19-100-SOL-00008_Questions-Responses.docx

RFP 19-100-SOL-00008

Questions & Responses

Question 1:

Do you require that the product be serialized?

Answer 1:

Yes, FDA requirements will apply.

Question 2:

Product. This is a seasonal product, which may result in fluctuation of pricing, will there be an opportunity to address annually?

Answer 2:

No, there will not be an opportunity to address annually.

Question 3:

R-VMI Purchase, Storage and Return of Material. Are these services part of the $186 Million?

Answer 3:

Yes, any product and/or service proposed is included in the $186M.

Question 4:

Maximum Dollar Amount. Section B.3.3 states that “The total scope of the technical tasks for which orders may be issued is set forth in Section C – State of Work. The maximum dollar amount the Government may order under this contract is $186 Million dollars.” Is this for the technical part of the contract only or does this figure include product? Is this maximum per order, year or the entire length of the contract?

Answer 4:

This includes technical part and product. This is for the entire length of the contract. Please also refer to I.3. Additional Contract Clauses 52.216-19 Order Limitations.

Question 5:

NAICS Codes. Section K.2 of the Solicitation states that the applicable NAICS Code is 339112 Surgical and Medical Instrument Manufacturing. In addition, the fedbizopps.gov notice states that the applicable NAICS Code 446110, Pharmacies and Drug Stores. We believe the proper NAICS Code is 325412, Pharmaceutical Preparation Manufacturing. Please clarify which NAICS Code applies.

Answer 5:

The NAICS code is 325412, Pharmaceutical Preparation Manufacturing

Question 6:

Certified Cost or Pricing Data Related Clauses. Section L.1 and other provisions of the Solicitation indicate that this is a competitive procurement, in which case the certified cost or pricing data submission requirements of the Truthful Cost or Pricing Data should not apply. In addition, Section L.8(f) states that “cost and pricing data is not required with initial proposals.” However, the Solicitation includes numerous clauses that only apply in the event certified cost or pricing data IS required – e.g., FAR 52.215-10, Price Reduction for Defective Cost or Pricing Data, FAR 52.215-18, Reversion or Adjustment of Plans for Postretirement Benefits other than Pensions; FAR 52.230-2, Cost Accounting Standards; and FAR 52.230-6, Administration of Cost Accounting Standards. We assume that these clauses were included in the unlikely event that certified cost or pricing data is required. If it is not, will CDC omit these clauses from the contract?

Answer 6:

Yes.

Question 7:

Cost Reimbursement Clauses. Although Sections B and I.1 indicate that the contract will be a “fixed price supply” contract, Section I includes several clauses that only apply to cost reimbursement type contracts – e.g., FAR 52.215-2, Audit and Records-Negotiation; FAR 52.216-7, Allowable Cost and Payment; FAR 52.232-20, Limitation of Cost; FAR 52.242-3, Penalties for Unallowable Cost; and HHSAR 352.231-70, Salary Rate Limitation. We assume these clauses were included because Section B.3 states that there is a possibility that CDC may agree to offeror-proposed cost reimbursement based “distribution fees” for optional CLINs 1004, 2004, 3004, 4004 and 5005. If a successful offeror does not propose cost reimbursement-based distribution fees, will CDC omit these clauses from the contract?

Answer 7:

Yes.

Question 8:

Research and Development (“R&D”) Clauses. As noted, the Solicitation is for commercial items of supply. Section C, Statement of Objectives, does not include any requirement to perform R&D. However, the following R&D related clauses are included in the Solicitation: FAR 52.224-1, Privacy Act; FAR 52.232-2, Payments Under Fixed Price Research and Development Contracts; Alt V to FAR 52.243-1, Changes; FAR 52.249-9. Default (Fixed Price Research and Development); HHSAR 352.224-70, Privacy Act; HHSAR 352.270-5a, Notice re Compliance with PHS Policy on Care of Laboratory Animals; HHSAR 352.270-6, Restriction on Use of Human Subjects. Will CDC consider changing the Solicitation to remove these clauses?

Answer 8:

Yes, these clauses will be removed.

Question 9:

Services Clauses. Sections B and I.1 indicate that the contract will be a “fixed price supply” contract. However, the following service-related clauses are included in the Solicitation: FAR 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (Multiple Year and Option Contracts); FAR 52.222-49, Service Contract Labor Standards-Place of Performance Unknown; FAR 52.246-25, Limitation of Liability-Services; and FAR 52.217-8, Option to Extend Services. Will CDC consider changing the Solicitation to remove these clauses?

Answer 9:

Yes, these clauses will be removed.

Question 10:

FAR Part 12 versus FAR Part 15. Section M.1 includes FAR 52.212- 2 Evaluation—Commercial Items (Oct 2014), indicating that the procurement is for “commercial items” as defined in FAR 2.101. We agree that that the FDA approved antivirals required by the Solicitation qualify as commercial under FAR 2.101. Therefore, this procurement should be conducted under FAR Part 12, Acquisition of Commercial Items. However, the solicitation and contract clauses included in Section I do not reflect the streamlined clauses prescribed by FAR Part 12. Rather, Section I includes the typical multiplicity of clauses required by FAR Part 15, Contracting by Negotiations. Will CDC consider changing the Solicitation to include only the streamlined clauses required by FAR Part 12 – e.g., FAR 52.212-4, Contract Terms and Conditions – Commercial Items?

Answer 10:

FAR Part 12 is applicable.