MODIFICATION
B -- Research and Analysis of Clinical Pharmacology of Tobacco Products
- Notice Date
- 5/23/2012
- 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
- The purpose of this amendment is to provide the following responses to vendor questions: Amendment No. 0002 The following responses are provided to vendor questions received: 1) Question: In addition to the products outlined on page 2 of the solicitation (dissolvable tobacco products, cigarillos, e-cigarettes), what additional products will be characterized during the duration of this IDIQ? Government Response: The current IDIQ focuses on the identified products. Currently, products of interest are limited to orally dissolvable or inhaled products If another product is identified as of interest, FDA would work with the Contractor to ensure a good fit for that particular task order and the IDIQ contract would be appropriately modified. 2) Question: What are the primary technologies of the modified risk tobacco products (i.e., buccal spray, nasal spray, sublingual, heated tobacco, chewing gum, vaporizers, etc.) that will be studied under this IDIQ? Government Response: The products identified under the current solicitation include a multiple of routes of exposure, including buccal and inhalation. 3) Question: Do you anticipate the utilization of a comparator (i.e., a cigarette or other nicotine replacement) in some or all of these studies? Government Response: Yes. 4) Question: Can you share with us your vision for the full set of PD assessments? Government Response: As stated in the RFP, it is anticipated that all assessments will typically include measurement of tobacco-related compounds in saliva, blood and/or plasma. What is measured, and using what matrix, will depend on the product being tested which cannot be fully identified at this time. 5) Question: Is there a comprehensive list of exactly what compounds and metabolites need to be assayed and in what specific matrix (urine, saliva, plasma) they are to be analyzed? Government Response No. As with the specific matrix, details will depend on the product being tested. FDA will work with the Contractor and provide additional information in specific task orders. 6) Are there documents specifying the methodology to be used for each assay with required LLOQ's, concentration ranges, etc.? FDA will work with the Contractor on methodologies as appropriate for individual task orders. 7) Question: Under which regulatory requirements do these assays need to be performed (CLIA, GMP, GLP)? Government Response: CLIA Amendment No. 0003 The purpose of this amendment is to provide responses to vendor questions: 1. Question: Will proposing clinical trial study designs, or biospecimen collection, processing or analysis methodologies, in response to the opportunity, prohibit the offeror from: a) proposing the same or similar designs and/or methodologies in response to Federal Government sponsored grant opportunities, and b) receiving similar levels of peer and administrative review, whether or not some or all of the designs and/or methodologies are later incorporated into Task Orders funded by this contract? Government Response: No If the answer to the first question is no, we have the following follow-up question. 2) Question: Will clinical data, biospecimens, associated data and analysis results funded by this opportunity and generated by the contractor, using funding provided by the Federal Government, be available to the contractor for tobacco research grant opportunities sponsored by the Federal Government? Government Response: No. 3. Question: FDA's answer to question 7 (May 14, 2012) states that CLIA requirements will apply to the assays required by the RFP. Is it sufficient for the analytical laboratory that performs the analyses for tobacco-related analytes in biological media to follow CLIA requirements, or must the laboratory be CLIA certified? We offer this observation: although the analytical work described in this RFP will be performed on specimens of human origin, this work appears to be research-related rather than "... testing on specimens derived from humans to give information for the diagnosis, prevention, treatment of disease, or impairment of, or assessment of health." It would appear that CLIA regulations should not apply to the analyses described in the RFP. Government Response: The study description includes "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 and CLIA certification. Additionally, this amendment changes the contract specialist from Dawn Rabunsky to Ms. Kathleen Marsden. Any questions should be directed to Ms. Marsden at kathleen.marsden@fda.hhs.gov telephone number 301-827-9361.
- 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
- SN02756855-W 20120525/120524000741-c45d34c22b89c87bc556ae600fe1efb0 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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