MODIFICATION
B -- Research and Analysis of Clinical Pharmacology of Tobacco Products
- Notice Date
- 6/12/2012
- Notice Type
- Modification/Amendment
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- SSN12201011
- Point of Contact
- Kathleen J. Marsden, Phone: 3018279361, Kathleen J. Marsden, Phone: 3018279361
- E-Mail Address
-
kathleen.marsden@fda.hhs.gov, kathleen.marsden@fda.hhs.gov
(kathleen.marsden@fda.hhs.gov, kathleen.marsden@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Amendment Number 004 (June 12, 2012). The purpose of this amendment is to provide the following responses to vendor questions: 1) QUESTION: P. 4 of the RFP states that the pricing schedules for the categories shall contain loaded hourly rates for each labor category and shall be fully burdened to include wages, indirect costs (including local travel), fringe benefits, overhead, general and administrative, and profit. P.2 Section 1.3. Overview of Pricing Schedules states that task orders may be Fixed Price, Time & Materials, or Labor Hour contract types. May the offeror provide separate category rate schedules for each contract type? GOVERNMENT RESPONSE: Yes; however, the Government may follow-up with clarifying questions, if necessary, after proposals are received. 2) QUESTION: The ID/IQ Pricing Tables on p. 3 of the RFP do not allow for Other Direct Costs (ODCs) such as non-local travel, purchased materials and services, subject incentives, subcontractors, etc. However, p. 42 states the offeror shall also provide pricing for any applicable ODCs as well as non local travel. Is it the intent of the Government for ODCs to be proposed on a task-by-task basis and not at the ID/IQ level? If we are to propose ODCs at the ID/IQ level, should they be proposed as a separate line item as shown on p. 42? GOVERNMENT RESPONSE: Please propose ODCs on a task-by-task basis 3) QUESTION: P. 41 Section 11.6.2 Pricing Approach states that the Offeror shall use the following pricing templates for the submission of their pricing proposals: FDA IDIQ Pricing.xls: The Offeror shall use Sample 1 below and this pricing template for the submission of their IDIQ pricing schedule. Would the government please provide the Excel pricing template? GOVERNMENT RESPONSE: There is no actual template - the sample is simply a sample. Offerors may use whatever format they feel is most informative. 4) QUESTION: The instructions under 11.6 Volume 3 - Business Proposal pp. 41-42 state that Table 1 should be used to for the submission of the ID/IQ pricing schedule. Table 1 has a column for Estimated Hours. Is that column to be completed for the ID/IQ level or only for Task Order -1? GOVERNMENT RESPONSE: Task Order One 5) QUESTION: "Alternative Line Items": The RFP on page 4 states that additional labor categories may be added through modifications. As the contractor shall provide a firm-fixed price per labor category proposal for the IDIQ period of performance of this contract, the RFP also states on page 41, the Offeror may also propose additional labor categories if deemed necessary and appropriate for the work to be performed on the IDIQ proposal, in addition to proposing additional labor categories on Task Order 1 as stated in 11.6.3, may the Offeror propose additional labor categories on the IDIQ pricing schedule? GOVERNMENT RESPONSE: Yes; however, the Government may follow-up with clarifying questions, if necessary, after proposals are received. 6) QUESTION: Section 7.9 requires a Confidentiality Agreement to be signed by each employee/subcontractor employee prior to accessing Government information. Would FDA please clarify that FORM FDA 3398 is sufficient for this purpose? GOVERNMENT RESPONSE: Yes, the FDA 3398 is sufficient for this purpose. 7) QUESTION: The ‘Reports and Deliverables' table in Section 5.2 on page 8 of the solicitation does not seem to accommodate for what can be a lengthy OMB approval process or FDA's Research Involving Human Subjects Committee (RIHSC) approval process in the timeline. Please clarify. GOVERNMENT RESPONSE: FDA understands that this can be a lengthy process. The timeline may be modified to accommodate OMB requirements. 8) QUESTION: Is the subject opportunity required to receive approval from FDA's Research Involving Human Subjects Committee (RIHSC)? GOVERNMENT RESPONSE: This is not the responsibility of the Contractor. 9) QUESTION: Please clarify whether one or separate business volumes are required for the ID/IQ and the Task Order. GOVERNMENT RESPONSE: Please submit separate business proposal volumes for the ID/IQ and the Task Order. 10) QUESTION: Please confirm whether CVs in the appendix need to adhere to the font size and margin requirements of the technical proposal. GOVERNMENT RESPONSE: CVs do not need to adhere to the font size and margin requirements; however, please limit them to 2 pages each. 11) Would FDA consider staggering the due date for this opportunity in consideration of the multiple FDA RFPs released with the exact same due date? GOVERNMENT RESPONSE: The proposal due date is extended to June 29, 2012. 12) QUESTION: Section 7.9 requires a Confidentiality Agreement to be signed by each employee/subcontractor employee prior to accessing Government information. Would FDA please clarify that FORM FDA 3398 is sufficient for this purpose? GOVERNMENT RESPONSE: Repeated question (please see #6 above). 13) QUESTION: Please confirm if deliverables must be in SAS or is a file that has been translated by another software program into a SAS transport (.xpt) format sufficient. GOVERNMENT RESPONSE: As long as the data can be manipulated/analyzed by FDA using SAS, the.xpt format is acceptable 14) QUESTION: Can the FDA please clarify if biospecimen samples can be shipped internationally for analysis purposes? GOVERNMENT RESPONSE: Yes, this is acceptable. 15) QUESTION: Section 12.8 Subcontracting Plan contains directions to include dollars and percentages for each socio-economic category. Under an IDIQ where the exact nature and dollar value of the tasks to be issued is unknown initially, the ability to express dollars is extremely challenging. Would FDA allow the offeror to express subcontracting goals in terms of percentages only in the subcontracting plan? GOVERNMENT RESPONSE: Yes 16) QUESTION: Because we are not diagnosing, treating or preventing any tobacco-related conditions, is a CLIA certified laboratory absolutely required for analysis of biological samples? GOVERNMENT RESPONSE: The RFP has the study description as a "human subjects study with multiple blood draws following controlled exposure to a TP with....measurement of physiological responses during exposure." This statement acknowledges that laboratory monitoring is necessary to ensure human safety against the potential for toxic exposures and adverse events. Therefore, clinical decision-making is exercised based on these laboratory results. CLIA certification is needed. 17) QUESTION: Can you please clarify if data collection for the Task Order needs to be conducted in a CLIA certified clinical site? GOVERNMENT RESPONSE: Yes, data collection needs to be conducted in a CLIA certified clinical site. Additionally, the proposal due date is hereby extended from Friday, June 15, 2012 to Friday, June 29, 2012, 1:00 pm ET.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/SSN12201011/listing.html)
- Place of Performance
- Address: [to be specified in each task order], United States
- Record
- SN02773276-W 20120614/120612235243-8f14b231bd9dc07ff01d108b0c5830d4 (fbodaily.com)
- Source
-
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