Responses_to_Questions_RFP_75D301-18-R-67962.xlsx

XLSX spreadsheet 13 KB Posted Sep 3, 2018

Attached to: Certified Reference Material Kits Federal contract opportunity
Solicitation number: 75D301-18-R-67962
Issued by: Department of Health and Human Services Centers for Disease Control and Prevention Office of Acquisition Services

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75D301-18-R-67962.pdf	PDF	Aug 27, 2018

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Sheet1

	REQUEST FOR PROPOSAL (RFP)
	75D301-18-R-67962
	Date:	9/3/18
	Contractor:	Combined
#	RFP Page

Reference

(if applicable)	Question	CDC Response
	1		We would need cooperation of DEA to get fentanyl on our license and assign quotas of at least 4 grams of each of the analogs (3.8 grams will be required to make 3200 ampules of each analog) in a timely manner. Is cooperation with DEA guarantied?	No, the vendor should have licenses in place with the DEA prior to contract award.
	2		Would CDC take all material not distributed after the 12 month contract period?	CDC will designate where to send remaining kits at the end of the contract performance period.
	3		Our NMR’s are located in the UK and Germany. Could material be sent there for characterization?	No, all material should be produced and distributed within the United States.
	4		List may change by up to five analogs throughout the contract period if need arises. Again, Would there be cooperation with DEA to expedite license modification?	No, the vendor should have licenses in place with the DEA that would cover most opioids prior to contract award.
	5		Are there any financial penalties for not hitting the timeline targets? The RFP was not clear on that.	No, but delays may be reflected in the contract evaluation (CPARS government database) and affect potential future contracts.
	6		What is the time line for award of the contract?	Award is intended to be made no later than September 30, 2018.
	7		Is there the possibility of two companies working together on this contract?	Offerors may subcontract or create teaming arrangements/joint-ventures. The government will make award to one company. The contractual relationship will exist between the government and only one entity.
	8		Would it be beneficial to the CDC to receive technical and pricing information on 1 mg/ml and 100 µg/ml for the C13 labelled standard (or the parent compounds)? Internal standards are often offered at 100 µg/ml so I wanted to double check if these were of interest.	Vendors should make the best offer they can in the proposal they submit. The CDC has requested 1 mg/mL quantities throughout the kits.
	9		Due to the nature of the manufacturing process with these products, especially C13 labelled materials, a timeline of 4 months to deliver the 10 pilot kits may not be possible. If after review this timeline is unfeasible, is it acceptable to propose a timeline that we are confident that we can meet in the technical proposal (likely around 6 months)?	Yes, please include a risk mitigation plan in the proposal.
	10		Do the 3,200 ampules for each analyte in each kit need to come from the same batch, different batches or is there no preference?	Ideally, materials would be of the same batch to avoid initial variation.
	11		For the representative ampules to be delivered in A.3, is there a breakdown of the number of labelled versus parent compounds that would be required?	There should be 40 ampoules per kit, requiring individual packaging of both labeled and native compounds.
	12		In B.1, it states that we need to deliver instructions for materials dilution. Would it be possible to provide specifics on what would be required? We provide general/recommended instructions for use statements on our certificate of analyses but we would need to know if more detailed instructions were required	A dilution protocol would list known solvents suitable for dilution and one example so that the process could be easily repeated the same between laboratories.
	13		For B.8, I don’t think that there will be enough progression week by week for weekly calls most of the project. Is it possible to have bi-weekly phone calls through the first 6 months of the project? I understand if this were to be decided through the process if a contract was to be awarded	Due to the visibility of this work in addressing a national epidemic, weekly calls will be conducted so that regular updates can be provided to internal federal program offices.
	14	Page 12, A.8	Shipment of kits to customer with 2 weeks is agreeable but contingent upon receiving correct DEA 222 Forms from customer. Incorrect forms will result in delays in order processing as corrections will be necessary. Our regulatory team would create an instructional template for the customers to follow when placing orders to minimize errors. Is this agreeable to the CDC?	A risk mitigation plan for all foreseeable delays should accompany the vendors' proposals.
	15	Page 12, B.2	Will the CDC provide the dilution instructions to be included with each order? Are the dilution instructions, SDS, and Certificates of Analyses okay to deliver as electronic documents or do they need to be in paper form, boxed with the material?	The vendor is responsible for dilution instructions and solvent compatibility protocols. If both electronic and hard copy materials for documents are not available, vendors should submit their best proposal.
	16	Page 12, B.4 & B.5	Does 24-hour timeframe equate to 1 business day?	The CDC has requested a 24-hour timeframe, and vendors should submit their best proposal to meet this request.
	17	Page 14, IV	Representative Certified Reference Materials- There are differences in concentrations between catalog representative products and the proposed concentrations by the CDC within this project. Is this agreeable?	CDC has requested 1 mg/mL, and vendors should submit their best proposal to meeting this amount.
	18	Page 19, VIII	Period of Performance: Is the timeframe 12 months upon contract award date or after confirmation of kits (18 months from award date)?	Contract award date
	19	Page 21, Section E	Section A: Technical Approach, point "e": Is the NMR and MS data on COA sufficient or would an electronic spectral database be required? We are equipped for both. Please specify which is preferred.	An electronic platform is preferred so that there is a consistent source of the information.
	20	Page 22, Section D	Similar/Corporate Experience: Can these be high-level summaries as this is confidential information for any projects outside of our past work with CDC?	Yes
	21	Page 23, #7, e.	Requesting clarification on "price per pound". Is price per product and/or kit acceptable?	CDC is interested in the price per kit.
	22	Page 23, #7	Question regarding invoicing: Would the CDC prefer invoicing at the completion of each stage of work (per analyte) or delineated as one price per kit?	Vendors may propose an invoicing schedule with their proposal, but the format should be included as a price per kit.

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