MODIFICATION
B -- Experimental Study on the Subjective, Physiological and Puff Topography Measures of Little Cigars
- Notice Date
- 5/30/2012
- 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
- SSNDecember212011
- Point of Contact
- Vivian E Lucas, Phone: (301) 827-7117, Vivian E Lucas, Phone: (301) 827-7117
- E-Mail Address
-
vivian.lucas@fda.hhs.gov, vivian.lucas@fda.hhs.gov
(vivian.lucas@fda.hhs.gov, vivian.lucas@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Amendment 0003 The purpose of this amendment is to extend the proposal due date and to provide answers to contractor questions. The due date and time for proposals is hereby extended from June 15, 2012 at 2:00 PM Eastern Time to June 22, 2012 at 2:00 PM Eastern Time. Additionally, this amendment hereby transmits questions received from contractors and associated answers. Question 1: Is the Contractor or the Contracting Officer Representative (COR) responsible for obtaining Human Subjects Approval? Government Response: The contractor can help the COR get the package ready for IRB Human Subjects Approval but the COR is responsible for getting it through the approval process. Question 2: "Prices/Costs Contract Type: The RFP on page 2 states the contractor shall provide a firm-fixed price per labor category proposal based on an estimated quantity labor mix for the eighteen month period of performance of this contract. The loaded hourly rate for each labor category shall be fully burdened to include wages, indirect costs (including local travel), fringe benefits, overhead, general and administrative, and profit. For other direct (non labor) costs proposed, i.e. subject incentives, material, etc, can the contractor propose these as separate line cost items? " Government Response: Yes, the contractor may propose these as separate line cost items. Question 3: Is it acceptable to bid additional labor categories beyond those listed on page 2 that are needed to perform the contract? Government Response: Yes, the contractor may bid additional labor categories beyond those listed on page 2. Question 4: The RFP did not state whether an email only proposal submittal is acceptable or if the proposal needs to be submitted in hard copy. Would FDA please clarify the required format for the proposal response and the proposal delivery instructions? Government Response: An email submission is acceptable to the FDA, however, large proposals should be followed up with a hard copy. Question 5: 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: FORM FDA 3398 is sufficient. Question 6: Section 2.1.4.1 bullet two indicates a final report for publication on the FDA webpage and bullet three indicates that analyses and reports of analyses may be posted to the FDA CTP website. Are these deliverables (and if any other, please detail) intended for use by government employees such that all are required to be 508 compliant and delivered as web appropriate (508 compliant pdf) documents? Government Response: Documents do not need to be 508 compliant. Question 7: The ‘Deliverables and Reports' table in Section 3, Reports and Deliverables on page 6 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. Should the schedule be adjusted to account for these items? Government Response: The schedule can be amended to accommodate the OMB/RIHSC approval process. Question 8: Please clarify the ‘Preliminary Analysis' deliverable on the ‘Deliverables and Reports' table in Section 3, Reports and Deliverables. As written, the task associated with this deliverable calls for analysis of data and provision of preliminary results. However, this deliverable occurs very early in the project schedule and before the start of the Collection of Research Data - the deliverable just following the Preliminary Analysis deliverable in question. Government Response: For the preliminary analysis, the contractor shall provide a brief memo describing the data analysis plan. Question 9: 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: Yes. This amendment extends the proposal due date from June 15, 2012 to June 22, 2012. Question 10: Please confirm that the absence of #4 in the Statement of Work is typographical only and the RFP is not missing pertinent content (e.g., the SOW goes from Section 3 - Reports and Deliverables to Section 5 - Site Visit - Section 4 is missing.) Government Response: The information for this section should have read as follows: 4. Period of Performance Work under this contract shall be completed within 18 months of the award. Question 11: Please confirm whether CVs in the appendix need to adhere to the font size and margin requirements of the technical proposal. Government Response: It is not necessary for the CV's to conform to any particular font or margin size. Question 12: 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: Either format is acceptable. Question 13: Can an extension on the due date for the proposals be granted. Government Response: This amendment extends the proposal due date from June 15, 2012 to June 22, 2012.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/SSNDecember212011/listing.html)
- Record
- SN02760801-W 20120601/120530235134-6bd0c2cd902a75a3b1deae7015ae9491 (fbodaily.com)
- Source
-
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