RFP 08 09_12SEP2008
1 MB Posted
- Attached to
- Building Domestic Cell-Based Influenza Vaccine Manufacturing Facilities Federal contract opportunity
- Solicitation number
- RFP-HHS-BARDA-08-09
About this file
This is the powerpoint slide presentation from the pre-proposal conference held Friday September 12 2008.
Text of this file
Pre-proposal Conference
RFP-HHS-BARDA-08-09
Building Domestic Cell-based Influenza Vaccine Manufacturing Facilities
Paquetta Myrick-Hancock (CO) Mike Angelastro (COTR)
HHS/ASPR/BARDA
September 12, 2008
ASPR
Pre-proposal Conference Agenda
RFP-HHS-BARDA-08-09
Introduction – Dr. Mike Perdue Responses to Questions – Mike Angelastro Break – 15 Minutes Add’l Question from Attendees – Open Closing Remarks – Dr. Mike Perdue
Please Note: This meeting is being recorded and a transcript will be posted on FedBizOpps by Sept 19, 2008.
Responses to Pre-submitted Questions
QUESTION 1
Are costs associated with deliverables that are part of earlier awarded contracts to be included in the overall proposal costs?
ANSWER 1
| Costs that support the technical elements of this RFP but are currently funded with other US Government contracts should be identified as such in the business proposal. Those costs should not be included in the final estimate. | |
| * |
Responses to Pre-submitted Questions
QUESTION 2
What should be the basis for projected pandemic vaccine strain yields?
ANSWER 2
| The US Government will accept an averaged yield based on the performance of influenza strains manufactured as part of contracts administered under other BARDA contracts. | |
| Yes, the offerors may assume that facility design and capacity calculations can be based on yield data of seasonal influenza strains on the Offeror's cell substrate. | |
| * |
Responses to Pre-submitted Questions
QUESTION 3
Can DHHS clarify its position on indemnification if the pandemic vaccine requested to be made by DHHS under this RFP is not an already licensed vaccine?
ANSWER 3
| The Government has taken the foregoing comments under consideration and is weighing a number of options about how to best address contractor concerns in this area. A more definitive response to the question will be provided as part of any amended RFP. | |
| * |
Responses to Pre-submitted Questions
QUESTION 4
Can DHHS clarify the status of the USG position on this issue and whether or not a formal waiver to this potentially restrictive criteria would be afforded by DHHS? Does DHHS have an agreement(s) in place that allows other parties to use this technology in conjunction with DHHS affiliated warm based manufacturing contracts or in the event of a pandemic?
ANSWER 4
| The Government has taken the foregoing comments under consideration and is weighing a number of options about how to best address contractor concerns in this area. A more definitive response to the question will be provided as part of any amended RFP. | |
| * |
Responses to Pre-submitted Questions
QUESTION 5
Does DHHS anticipate amending the referenced September 29th proposal submission date of the RFP to a later date to allow offerors to compile a proposal that better meets the requirements of DHHS?
ANSWER 5
| No, proposal submission is due by 3:00PM on Monday, September 29, 2008. | |
| * |
Timeline to Award RFP-HHS-BARDA-08-09 Key Dates Aug 13th – Synopsis Published (COMPLETE) Aug 28th – RFP Issued (ON TARGET) Sept 12th – Pre-proposal Conference (TODAY) Sept 29th – Offerors’ Proposals Due to CO @ 3PM Oct 28th – Competitive Range Determination Complete Nov 28th – Final Proposals Due Dec 5th – Award Recommendation to HHS Leadership Dec 15th – Contract Award
Responses to Pre-submitted Questions
QUESTION 6
To what extent does DHHS anticipate having materials stockpiled to enable fill and finish of vaccine if such a shortage of non-offeror materials should occur?
ANSWER 6
| Materials for finishing doses will be the subject of another RFP issued by BARDA. | |
| * |
Responses to Pre-submitted Questions
QUESTION 7
Assuming that an offeror does not currently have funding from DHHS for all required clinical trials for licensure of a pandemic vaccine, will the clinical bridging studies to be funded by DHHS through this mechanism include conducting clinical trials required by FDA for licensure of a pandemic vaccine?
ANSWER 7
| Clinical bridging studies will be funded; however, studies that are required by FDA/CBER to achieve licensure will not be funded. | |
| * |
Responses to Pre-submitted Questions
QUESTION 8
Is HHS willing to modify or remove the mandatory requirement for successful completion of Phase I clinical trials for a mammalian, cell-based influenza vaccine candidate as a prerequisite to proposal submission? For example, can egg based seasonal or pandemic influenza vaccine clinical data be submitted? Can seasonal mammalian, cell-based influenza vaccine clinical data be submitted?
ANSWER 8
| No, the mandatory requirement for successful completion of Phase I clinical trials for a mammalian, cell-based influenza vaccine candidate as a prerequisite to proposal submission will not be removed. | |
| No, egg based seasonal or pandemic influenza vaccine clinical data may not be submitted to satisfy the mandatory criteria. | |
| However, clinical trial data for inter-pandemic or seasonal mammalian cell-based influenza vaccine candidates will satisfy this element of the mandatory criteria. | |
| * |
Responses to Pre-submitted Questions
QUESTION 9
Will contractors be reimbursed for their actual costs plus a fixed fee subject to the limitation of costs, or will their cost recovery be limited to their estimated cost plus fixed fee (unless actual costs are less than estimated costs: then it would be actual costs plus fixed fee) as suggested in the language of the RFP regardless of whether actual costs exceed estimates?
ANSWER 9
| The total CPFF that has been obligated at contract award cannot be exceeded without approval, in writing, from the Contracting Officer. Actual costs, however, that are billed against the current obligated amount will be reimbursed up to the obligated amount as long as they are reasonable, allocable, and allowable in accordance with the Federal Acquisition Regulations (FAR). Once the contractor reaches 75% of the obligated amount, the Contracting Officer must be notified, in writing, in accordance with the Limitation of Cost clause (FAR 52.232-20). At that time, BARDA will determine whether or not additional funds will be obligated to fund the anticipated cost overrun under the contract. A determination to fund the cost overrun as identified in the revised estimate submitted by the Contractor does not affect the fixed fee (which remains unchanged in a cost overrun situation). Contractors who exceed the total CPFF on the contract without notification, in writing, from the Contracting Officer do so at their own risk. | |
| * |
Responses to Pre-submitted Questions
QUESTION 10
…would the Government consider amending the RFP in some way to lessen the burden on potential contractors? Alternatively will HHS consider allowing the contractors to negotiate in good faith new terms or to terminate the option period if circumstances in the influenza market deteriorate due to technology changes or if other non-viable market conditions prevail?
ANSWER 10
| As stated in the RFP, it is the commitment of the offeror to maintain a facility in a manner that will allow for the production of pandemic influenza vaccine throughout the duration of this contract. | |
| The contractor has the opportunity to propose contract modifications that support influenza vaccine technology advancements. | |
| Please note that this contract does not support the advance development of an influenza vaccine. | |
| * |
Responses to Pre-submitted Questions
QUESTION 11
The facility, fully licensed for the manufacture of an influenza vaccine candidate, must remain in a state of readiness commensurate with the terms of the contract.
ANSWER 11
| The purpose of this RFP is to support eligible contractors in the design, construction and licensure of a domestic facility to manufacture seasonal influenza vaccines. In order to remain in a state of readiness commensurate with the terms of the contract, the contractor must not compromise their ability to manufacture licensed seasonal influenza in the facility. | |
| However, if the facility is utilized to manufacture other biologics, and the contractor is able to maintain their license to manufacture seasonal influenza, then the US Government would not object. | |
| * |
Responses to Pre-submitted Questions
QUESTION 12
May contractors utilize equipment purchased under the RFP in conjunction with non-contract related activities at the facility so long as such activities do not interfere with contract performance?
ANSWER 12
| Title and use rights in and to any equipment purchased under the RFP will be subject to the provisions of Part II, Section I.2 of the RFP, and the provisions of FAR Part 45, including but not limited to FAR 45.301(f). | |
| * |
Responses to Pre-submitted Questions
QUESTION 13
Past Performance Questionnaire is included as Attachment 13. Please provide further instruction as to number of questionnaires to submit.
ANSWER 13
| The solicitation instructs the offeror to submit information concerning their last 3 contracts completed during the last three years or information for the last three contracts currently in process. It does not require that the offeror submit the questionnaire as a part of their proposal or forward the questionnaire to their past performance references. Please ensure that you furnish accurate, complete contact information for references specified in your proposal to expedite the past performance evaluation. | |
| * |
Responses to Pre-submitted Questions
QUESTION 14
Please clarify the definition of the term "Vaccine Candidate" used throughout the RFP. Is the term in reference to a pre-pandemic vaccine, seasonal vaccine or both?
ANSWER 14
| Yes, the term ‘Vaccine Candidate’ refers to an offeror’s seasonal and/or pre-pandemic influenza vaccine. | |
| * |
Additional Questions from Attendees
Closing Remarks
Other files for this federal contract opportunity
| File | Type | Posted |
|---|---|---|
| 0912DHHS | — | |
| Handout_12SEP2008.pdf | ||
| RFP-HHS-BARDA-08-09-final.pdf |
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