CISA questions 6_11_12.docx
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- Clinical Immunization Safety Assessment (CISA) Federal contract opportunity
- Solicitation number
- 2012-N-14296
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Solicitation 2012-N-14296 – Response to Questions – CISA Requirement
1. How long (years) does the budget have to be for each Task Order?
Response
Offerors shall provide the following information as part of their business proposals for each of the Sample Task Orders:
Sample Task Order 1: a five year period of performance. This must cover the base period and the four 1- year options periods.
Sample Task Order 2: a five year period of performance. This must cover the base period and the four 1- year options periods.
Sample Task Order 3: a one year period of performance.
Sample Task Order 4: a two year period of performance. This must cover the base period and one 1-year option period.
2. Are the monetary caps for Task Order No. 1 and 2 (as they are with Task Order No. 3 and 4)?
The cost estimate range for Sample Task Orders 1 and 2 are the following:
Sample Task Order 1: the year 1 cost estimate range is $442,000 to $663,500 Sample Task Order 2: the year 1 cost estimate range is $37,000 to $55,500
Offerors shall use the Year-1 cost estimate range to develop the multi-year budgets as specified in question 1
3. Does the Cryptographic Module Validation referenced in Section H.2.(b) need to be performed and provided at the proposal stage or after award notice?
Offerors shall state if their encryption meets the Federal Information Processing Standard (FIPS) 140-2 requirement during the proposal stage in their Draft Security Information Plan. See section L.12 for information on how to submit the Draft Security Information Plan
4. H.15 Information Security Plan – Is this due at the time of proposal, or after notice of award?
Offerors must submit a Draft Security Information Plan, as described in Section L.12, as part of their proposal.
5. Are certified cost and/or pricing data, or an exemption for such, required? Section L.1 discusses certification of cost and/or pricing data, however, in Section L.9.(d) it states that Offerors are not required to submit cost or pricing data. Please clarify.
Offerors are not required to submit certified cost or pricing information in accordance L. 9 (d). If after receipt of proposals it is determined that adequate price competition does not exist, cost and pricing information will be required.
6. In L.11, Technical Proposal Instructions, it states “resumes detailing relevant experience and training for proposed key personnel…” are requested. Is a full CV required, or will the NIH biosketch format be sufficient for this requirement?
A NIH Biographical Sketch is preferred, however other formats such as a CV are also acceptable. However, either format must address the section L.11 evaluation criteria, including the Volume 1 mandatory criteria, in other to be considered eligible for evaluation. Please refer to http://grants.nih.gov/grants/funding/phs398/phs398.html for a copy of the NIH Biographical Sketch form.
7. Are copies of medical licenses and board certifications needed for the PI of each Task Order, or just the overall proposal PI?
Offerors should supply copies of the medical licenses and board certification, and the other information as stated in the Section L.11 Volume 1 Mandatory Criteria, for the Principal Investigator for the Overall Project and Sample Task Order 1, in order to make the response eligible for review.
The Offeror may supply the medical licensure and board certification information for the PI for Sample Task Order 2, in order to demonstrate experience, though this is not a requirement.
However, the PI(s) for Sample Task Orders 3 and 4 are not required to have a medical license. Other qualifications such as a PhD and relative expertise are acceptable.
8. For the Business Proposal, what format would you like the budget to be completed in. Would you like it on the PHS 398, the SF 424, or some other format?
PHS 398 and SF 424 are for grants – this is a contract. See FAR Part 15.4, 15.404-3 and Table 15-2 for guidance on the submission of the business proposal.
9. Our understanding is that CDC will be making multiple awards. Therefore, we assume that some sites might be able to apply as contributing contractors only. Is this correct?
CDC intends on making multiple awards for the basic indefinite delivery, indefinite quantity (IDIQ) contract and reserves the right to make single or multiple awards for the sample task orders. Reference Section L – Instructions, Conditions, and Notices to Offerors which includes all requirements for the submission of a proposal. All Offerors that are submitting a proposal to CDC as a prime contractor must address all requirements defined in Section L which includes a response to the Mandatory Criteria and all four (4) sample task orders.
This CISA contract is an IDIQ contract. The government intends to make multiple awards for the overall CISA IDIQ contract. If a prime contractor receives an IDIQ award for the overall contract, the government intends to award Sample Task Orders 1,2,3 or 4 to the contractor that represents the best value to CDC. A contractor could receive a basic IDIQ contract award, but not rate high enough to receive a Sample Task Order. .
The Government reserves the right not to fund any or all of the current Sample Task Orders.
However, if CDC decides to fund some of the Sample Task Orders listed in this solicitation, then:
CDC intends to award Sample Task Order 1 to one prime contractor. This contractor is known as the Lead Contractor for the CISA Clinical Vaccine Safety Evaluation function.
CDC may award Sample Task Order 2 to multiple prime contractors. These contractor(s) are known as Contributing Contractor(s) for the Clinical Vaccine Safety Evaluation function.
CDC intends to award Sample Task Order 3 to one prime contractor.
CDC intends to award Sample Task Order 4 to one prime contractor.
The prime contractors may choose to subcontract to address the solicitation requirements.
The same prime contractor may also receive one or more of these Sample Task Order awards. However, the same prime contractor will not receive an award for both Sample Task Orders 1 and 2, due to the nature of the work.
Please see the amended diagram for the CISA Project Organization for Sample Tasks that was previously in Figure 1 on page 86 of the solicitation. This diagram is amended to reflect the possible CISA Project Organization for Sample Tasks as described in the text of the Solicitation and Sample Task Orders documents. Please note that Task Order 2 is not awarded by a subcontract under the prime contractor from Task Order 1; CDC intends to award Task Order 2 directly to a prime contractor.
After contract award, future Task Orders will be competed among the CISA IDIQ prime contract awardees for the ten year contract period of performance.
10. We understand that each respondent must reply to all components of the project, including all of the Task Orders. Please clarify that each respondent must include all of the responsibilities of the lead contractor.
Response An Offeror that submits a proposal to CDC is responsible for addressing all requirements defined in Section L which includes a response to the Mandatory Criteria and all four (4) Sample Task Orders. Only prime contractors can submit proposals to CDC. Prime contractors may address the requirements in Section L by subcontracting with other contractors. If the prime contractor that submitted a proposal to CDC receives an award, CDC’s engagement will only be with the prime contractor, who is responsible is management of their subcontractors.
Although an Offeror may not receive an award for both Sample Task Order 1 and 2 due to the nature of the work, their proposal must include a response to both of these Sample Task Orders in order to be eligible for evaluation and award.
11. Can a single site applicant respond as both the lead contractor and a contributing contractor? If we can respond as both, but CDC determines that some other applicant would be the lead contractor, we assume there would be the opportunity to adjust our budget to be the contributing contractor only. Is this correct?
See the CDC’s response to question 10. Only prime contractors can submit proposals directly to the CDC . Prime contractors may choose to subcontract with other contractors to address the requirements. All subcontracting must be through a prime contractor.
12. Task Orders 1 and 2 both include descriptions of working groups 1 and 2. In our response we intend to describe our approach to working group 1 under Task Order 1 and working group 2 under Task Order 2. Is this acceptable, or do we need to repeat our approach to both working groups under a response to Task Orders 1 and 2?
Offerors should describe their approach to both working groups 1 and 2 under a response to Sample Task Order 1 and under another separate response to Sample Task Order 2.
Each Sample Task Order response is evaluated separately, so therefore they should be considered as stand-alone documents although there could be similar responses to both Sample Task Orders.
Offerors must respond separately to all four Sample Task Orders.
13. If tasks orders are awarded, the funding will be coming to the prime or directly to the contributing sites?
CDC’s contractual relationship is with the prime contractor only. The Task Order award and associated funding is awarded to the prime contractor. The prime contractor is responsible for managing their subcontractors which includes payment for any services rendered. CDC will not have a direct contractual relationship with any subcontractors.
14. For budget purposes, Core budget is for a period of 10 years (1 base + 9 optional periods), How about Task Orders? Should we budget for 1, 5 or 10 years?
Response
The business proposal requirements for the basic IDIQ contract are defined in Section L.9(c).
The periods of performance are detailed in the response to question 1. Offerors must submit a business proposal for all periods in the Sample Task Orders.
15. Is the solicitation written broadly enough to permit a US 501(c)3 public charity to apply?
Is it allowed for such a legal entity to engage non-US citizens to contribute to a product such a standardized case definitions or guidelines or protocols which are then used in CISA case assessments.
Response This solicitation has no restrictions to United States 501(c)(3) public charities on applying for this solicitation.
As described in Section L.11 in the Volume 1 Mandatory Criteria (p 81), the Offeror shall demonstrate that their organization is located within the United States (50 states or District of Columbia). The place of performance for work conducted under this Contract is specific in individual Task Orders. For each of the 4 Sample Task Orders in this solicitation services will be performed at the vendor’s specified site in the United States (4. Place of Performance) (see Amendment 00001)
16. Will CDC be making one award to the lead contractor who will then distribute the funds to the contributing contractors, or will CDC be making multiple awards to multiple sites?
See the response to question 9, 10, and 13. CDC intends on making multiple awards for the basic IDIQ contract.
17. Significant redundancy exists within the Task Orders, particularly in Task Orders 1 and 2, regarding staff and management plan. Is it necessary to answer for each Task Order completely or can we refer back to other Task Orders for details?
See CDC’s response to question 12.
18. Task Order #1 and #2 – do these budgets need to be for just one year or all the years listed (five in total – base plus option 1-4)? Do we need to include all 10 years?
See CDC’s response to question 14.
19. In the business plan should we include only federal contracts, or should we also include co-operative agreements and grants? If yes, what if co-operative agreements and grants do not have formal evaluations?
See Section L.10(b). Offerors may include both federal and non-federal contracts only.
20. Is there a specific budget format?
See CDC’s response to question 8.
21. What exactly do you need for the direct labor spreadsheet (L.9 Business Proposal Instructions (c))? Can you elaborate on what is needed for this item?
Section L.9(c) defines the requirements.
22. FISMA-compliance appears to be necessary for some elements of the response, most notably any databases that are created, such as that listed in TO#1. However, is it expected that the entire web-presence of TO#1 (ie, the CISA website that would coordinate calls, etc.) be FISMA compliant as well? Our assumption is that this element would be FISMA-exempt, and only upon reaching sections of the website that involve the database of clinical case reviews or clinical trials databases, would FISMA be an issue.”
Response In the Sample Task Orders in the current CISA solicitation, the Federal Information Security Management Act (FISMA) is applicable to Sample Task Order 1: CISA Clinical Vaccine Safety Evaluation – Lead Contractor Functions. Specifically, FISMA applies to the database in Sample Task Order 1 that the Contractor would use to track vaccine safety inquiries on behalf of CDC.
FISMA is NOT applicable to the Sample Task Order 1 internal secure password-protected web site for coordination activities. This coordination website shall not contain links to databases where FISMA applies or to databases with personally identifiable data on patients or subjects. This site may contain sensitive but unclassified information, as defined in the CDC document available at http://www.cdc.gov/hiv/testing/resources/guidelines/qas/pdf/25-SensitiveButUnclInfoCDC.pdf FISMA also does NOT apply to databases maintained by the Contractor in the research Sample Task Orders 3 and 4. For these research tasks, CDC is purchasing the finished product of data without personal identifiers from the Contractor. The Contractor would not be collecting data on behalf of CDC.
There is also no FISMA requirement for Sample Task Order 2.
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