MODIFICATION
B -- Research and Analysis of Clinical Pharmacology of Tobacco Products
- Notice Date
- 5/14/2012
- 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
- Dawn Rabunsky, Phone: 301-827-7062, Dawn Rabunsky, Phone: 301-827-7062
- E-Mail Address
-
Dawn.Rabunsky@fda.hhs.gov, Dawn.Rabunsky@fda.hhs.gov
(Dawn.Rabunsky@fda.hhs.gov, Dawn.Rabunsky@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
- 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
- SN02747645-W 20120516/120515000744-b8b360aff56cce38e1bcd3a71d06f8fd (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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