SOURCES SOUGHT
B -- Prevention Assessment for Tobacco and Health (PATH) Analyte Study - RFI Doc
- Notice Date
- 11/19/2013
- Notice Type
- Sources Sought
- NAICS
- 541380
— Testing Laboratories
- 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
- FDA-1127453
- Archive Date
- 12/17/2013
- Point of Contact
- Narissa Charles, Phone: 3018276803
- E-Mail Address
-
narissa.charles@fda.hhs.gov
(narissa.charles@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- RFI Doc In accordance with FAR Part 10, this Request for Information (RFI)/Sources Sought is for information, planning and market research purposes only and shall not be construed as either a solicitation or obligation on the part of the Food and Drug Administration or its Centers. The purpose of this RFI is to help the FDA understand industry best practices and the technical solutions capable of fulfilling FDA's requirements as described in this RFI. This market research information will be used to assess the market's capacity and support the FDA in reaching a decision support solution. FDA welcomes responses from all interested parties. This Request for Information (RFI) is for information and planning purposes only, and shall not be construed as a solicitation or as an obligation on the part of FDA. FDA does not intend to make a selection decision or award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted or FDA's use of such information. Acknowledgment of receipt of responses will not be made, nor will respondents be notified of the outcome of the FDA's review of the information received. Additionally, the FDA does not intend to hold discussions concerning this RFI with any interested parties. However, should such a requirement materialize, no basis for claims against the Government shall arise as a result of a response to this RFI or the Government's use of such information as either part of the evaluation process or for the development of specifications of a subsequent requirement. FDA reserves the right to contact vendors if additional information is required. PURPOSE The Food and Drug Administration (FDA), Center for Tobacco Products (CTP) is seeking to identify providers of laboratory services to support the Population Assessment of Tobacco and Health (PATH) study. The Government seeks to better understand the market place of providers who possesses the technical expertise, performance capabilities, laboratory facilities (or access to), proven performance record and other information not limited to labor, material and general operating costs of responsible business concerns who have the potential to successfully perform the identified services. BACKGROUND On June 22, 2009, the Family Smoking Prevention and Tobacco Control Act (FSPTCA) was signed into law. This act gives broad authority to the Food and Drug Administration (FDA) to enact or facilitate tobacco product regulations, with the overall goals to (1) prevent Americans, particularly youth from initiating tobacco use; (2) encourage current users to quit; and (3) decrease the harms of tobacco product use. In support of these mandates, the FDA's Center for Tobacco Products (CTP) is partnering with the National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA), on a large scale research collaboration, the "Population Assessment of Tobacco and Health" or PATH Study. This landmark effort is aimed at enhancing the evidence base available to FDA to inform the development and implementation of near- and long-term tobacco product regulations. The PATH Study is a longitudinal, nationally representative study of tobacco use and health in the U.S. population. A cohort of approximately 59,000 adults and youth ages 12 years and older will be followed annually for three years to assess use of existing and emerging tobacco products; attitudes and perceptions related to the use of different tobacco products; and near- and longer-term health outcomes associated with tobacco product use. The study includes the collection of biospecimens among adults 18 years of age and older to examine markers of exposure and tobacco-related disease processes. Urine and whole blood will be collected and shipped to the PATH Study Repository for processing, aliquoting and long-term storage. GOALS AND OBJECTIVES OF ANALYZING BIOSPECIMENS FOR THE PATH STUDY The Government anticipates that if this requirement is formally solicited, the following are the minimum tasks which may be required: 1) measurement of specific analytes in participant biospecimen samples collected annually over a three year data collection period; and 2) characterization of quality control (QC) pools associated with each analyte. SPECIFIC INFORMATION REQUESTED Table 1. Summary of Analytes Biomarker Assay Sample Matrix Preferred Test Methodology Human Fibrinogen Antigen Serum ELISA Human Fibrinogen Activity Plasma Clauss Human IL-6 Plasma ELISA Human sICAM Plasma ELISA F2-Isoprostane (8-epi-PGF2a) Urine ELISA or HPLC A total of five analytes will be measured in participants' samples collected throughout the study. The analytes to be assayed and preferred methodologies are summarized in Table 1. Declarations of capabilities for individual or any combination of analytes are sought. For the analyte F2-Isoprostane, provide detailed explanation for the use of preferred method(s). The tasks to be supported include: Characterization of quality control (QC) pools Frozen specimen pool samples will be batch shipped from the PATH Repository to the Contractor for characterization. The analytes to be assayed and preferred methodology are summarized in Table 1. The measurements shall be made in duplicate (or triplicate depending on the assay) in 20 successive analytical runs to obtain maximum among - and within -run variation to calculate the mean, standard deviation, and coefficient of variation for precision and accuracy estimates for the quality control pools. This project will include 40 quality control samples shipped in advance of participant samples. Characterization of participant and blinded quality control samples The Contractor will analyze specimens collected from participants in the PATH Study. Frozen specimen pool samples will be batch shipped from the PATH Repository to the Contractor for characterization. Blind QC samples will be seeded into the study participant specimens as a method of internal quality assessment for the study operations. Each sample assay should be run in duplicate or triplicate, depending on the assay. Respondents are to discuss laboratory's expertise in performing specific or similar analyses of the tests listed in Table 1, the plan for characterization of the quality control pools and scenarios of analyzing batches of 2,500, 5,000 or 10,000 samples per year (over a 3 year project period*), including maximum capacity of samples per assay run and projected timeframe for completed batches; CLIA certification or equivalent certification; validation of current laboratory methods and/or the proposed validation plan for each assay; quality surveillance and monitoring plan; ability to report batch records of results in an electronic format ; management of samples including sample processing proposal and electronic tracking through the life cycle of the sample; management of equipment and facilities; any necessary information regarding specimen requirements; ability to process aliquots received in FluidX cryovial tubes stored at -80º C; ability to accept delivery of specimens on an agreed upon schedule; ability to furnish necessary personnel, materials, services and facilities required for the project and ability to retain samples for up to one month after receipt and return unused samples to the biorepository. In addition, discuss any information technology data exchange/return results including the capacity to read two-dimensional barcodes in order to track specimens and assay results. *Biospecimen collection in the PATH Study varies by year. Information on years 1 and 3 should include analyte analysis from both blood and urine. Year 2 information should include analytes measured in urine only. Disclaimer and Important Notes. **Respondents shall NOT include proprietary, classified, confidential, trade-secrets or sensitive information in their responses. The Government reserves the right to use any information provided by respondents in resultant solicitation(s). The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed. Information provided will be used to assess tradeoffs and available alternatives during the Government's requirements development process. General Information: 1. All respondents are asked to indicate the type and size of your business organization, e.g., Large Business, Small Business, Veteran-owned Small Business, Service-Disabled Veteran-Owned Small Business, Hubzone Small Business, Small Disadvantaged Business, Women-Owned Business, 8(a), Historically Black College or University/Minority Institution (HBCU/MI), educational institution, profit/non-profit hospital, or other nonprofit organization. 2. All respondents are to recommend an appropriate North American Industry Classification System (NAICS) code and provide rationale supporting the recommendation. 3. Please provide the following information about your business: a. Organization name b. DUNS number c. Organization's website d. Contact Name e. Contact Telephone f. Contact E-mail address g. Size designation h. Number of employees in your organization i. Your organization's current and past gross revenue 4. Provide information concerning contract vehicles available which may be used by the FDA in acquiring the products and services outlined above. Submission Response Instructions: Responses to this RFI shall not exceed 15 written pages (to include graphics). The paper shall be letter size (8.5"x11") and the font shall be at least 10 pt. All interested parties shall provide electronic responses by Monday, December 2nd 2013 by 2:00 PM EST to the attention of Narissa Charles, Contract Specialist at Narissa.Charles@fda.hhs.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-1127453/listing.html)
- Record
- SN03236636-W 20131121/131119234140-83a8c0d4a0716907dca80e01bfb717a3 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |