SOLICITATION NOTICE
66 -- Deepwater Horizon Oil Spill - FDA 2
- Notice Date
- 8/5/2010
- Notice Type
- Justification and Approval (J&A)
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- 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
- Archive Date
- 8/20/2010
- Point of Contact
- Sandra Bellinger, Phone: 301-827-7159, Priscella Sullivan, Phone: 214-253-5274
- E-Mail Address
-
sandra.bellinger@fda.hhs.gov,
(sandra.bellinger@fda.hhs.gov, /div)
- Small Business Set-Aside
- N/A
- Award Number
- HHSF2232010XXXXXX-Several
- Award Date
- 7/14/2010
- Description
- 1. Agency: Food and Drug Administration (FDA), Department of Health and Human Services • a. Program Office/Center/Mail Code: Office of Regulatory Affairs/Division Of Field Science/Scientific Compliance and Regulatory Review Branch • b. Project Officer/Address/Telephone Number: 5600 Fishers Lane-Rockville, MD • c. Contracting Activity: OAGS 2. Nature of Action Being Proposed for Approval: Deepwater Horizon oil spill assessment of food safety - new awards associated with Phase II laboratory readiness. 3. Title and Description of Supplies or Services and Estimated Value: • a. Project Title: Deepwater Horizon Oil Spill Assessment • b. Contract/Order No.: Numerous • c. Description of supplies or services: acquisition of instrumentation to assist in the assessment of food safety • d. Estimated Dollar Value: Collectively NTE $2,448,472 (see attached list of required instrumentation) - $535,298 for the initial base units and up to $1,913,174 for additional optional units...as required. 4. Statutory Authority: 41 U.S.C. 252 ( c ) (2) - Unusual and compelling urgency 5. Contractor's Unique Qualifications to Provide the Services or Supplies and/or Why The Nature of the Acquisition Requires Use of the Authority Cited. This is a combined justification to acquire equipment and/or instruments to equip additional laboratories to assist in the assessment of the Deepwater Horizon oil spill on the safety of seafood in the Gulf of Mexico. Through its Office of Regulatory Affairs (ORA), FDA, in concert with the National Oceanic and Atmospheric Administration (NOAA), has begun assessing the affect(s) of the Deepwater Horizon oil spill. ORA laboratories will be used to assess the affects of the oil spill and FDA began equipping those laboratories the first part of June. Equipment and/or instruments for the first phase of laboratory readiness included an unusual and compelling justification to support the compatibility needs for the approved NOAA protocol referenced below. The second phase of laboratory readiness began with this second justification. As before, contractors providing equipment and/or instruments vary; and the equipment list was developed using in a joint protocol between the FDA and the NOAA to re-open closed waters to harvesting. NOAA will be responsible for environmental assessment and FDA will be responsible for assessment of seafood safety. Due to sensitivities associated with this oil spill, i.e., its breath and depth and the affects they each have to the seafood industry in the Gulf, FDA's development of the list to address this urgency comes in part from NOAA's Office of Response and Restoration (OR&R) publication entitled Managing Seafood Safety after an Oil Spill (Yender et al. 2002). NOAA and the FDA are working with other federal and state agencies to protect consumers from adulterated and unsafe seafood while minimizing undue economic burden on recreational and commercial fishing seafood industries. Once oil or chemical contaminants are visually observed on the surface, it is recommended that the fishery be closed until testing is completed to confirm that the seafood are palatable, safe and present a negligible risk to human health. After the initial fishery closure, the best approach for determining safety and acceptability from oil-contaminated areas is one that combines organoleptic analysis of product with results from chemical analysis. Oil contamination presents two kinds of risks: the presence of polycyclic aromatic hydrocarbons (PAHs) that are chemical hazards, and the presence of petroleum taint that render seafood unfit for human consumption. Oil contaminated seafood is adulterated if chemical analysis verifies that the level of PAHs in it exceeds FDA's opening criteria levels or if the oil contamination (taint) is perceivable by olfaction. Consequently, after an oil spill, seafood suspected of oil contamination can only be brought into interstate commerce when it passes both the chemical-analytical test for PAHs and the organoleptic test for petroleum taint. Equipment and/or instruments selected for this immediate need are specified in the NOAA method NMFS-NWFSC-59 2004 which the BDA labs have undertaken to implement. The NOAA protocol entitled "Extraction, Cleanup, and Gas Chromatography/Mass Spectrometry Analysis of Sediments and Tissues for Organic Contaminants" is the official method FDA has committed to in the analysis of re-opening samples FDA expects to receive from affected Gulf Coast States. FDA labs do not routinely perform analyses or poly-cyclic aromatic hydrocarbons in seafood. The NOAA protocol calls for specific equipment which the FDA labs need to procure in order to implement the methods in their labs and qualify it in a speedy manner. FDA and NOAA labs will simultaneously analyzing seafood samples from state and federal waters, respectively, therefore, the two agencies need to follow the agreed upon protocol using the same type of equipment in order to produce directly comparable results. Procuring equipment specified in the method also ensures FDA will be able to attain the QA/QC targets described in the protocol. FDA laboratories will need to acquire the equipment listed in this justification by June 18, 2010, in order to start, in some cases and continue in others, processing surveillance, baseline and re-opening samples in a timely manner. 6. Description of Efforts Made to Ensure Offers Are Solicited from As Many Potential Sources As Practicable. Market Research revealed that the National Oceanic and Atmospheric Administration's Office of Response and Restoration published in 2002, Managing Seafood Safety after an Oil Spill. The FDA and NOAA used this guidance in developing a protocol entitled "Protocol for Interpretation and use of Organoleptic and Analytical Chemistry Results for Re-Opening Oil-Impacted Areas Closed to Seafood Harvesting" designed to address the Gulf oil spill. The protocol is specific to how the results of the organoleptic and chemical analyses will be used in re-opening seafood closure areas. Oil contamination presents two kinds of risks: the presence of hydrocarbons that are chemical hazards, and the presence of petroleum taint that render seafood unfit for human consumption. Most petrochemical products such as diesel oil and crude oil contain aromatic components: mono-, bi-. And polycyclic aromatic hydrocarbons (PAHs). Well established liquid chromatography (LC)/fluorescence detection (D) and gas chromatography (GC)/mass spectrometry (MS) methods are used to separate and quantify these contaminants in seafood. The suggested equipment list associated with this Deepwater action was compiled using data from the NOAA/OR&R publication, web searches, professional association data and current laboratory instrumentation/equipment. In addition, competition from as many sources as is practical is anticipated using the list of suggested sources for responses. 7. Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable. The contracting officer will use a combination of competition from as many sources as is practical and/or past acquisitions along with GSA schedules to establish price reasonableness. 8. Description of the Market Survey Conducted and the Results, or Statement of the Reasons a Market Survey was not conducted. Please refer to Items 5 and 6 above. Due to the urgency associated with acquiring the equipment/instruments to mitigate the potential environmental impact, market research was limited to current practice and available literature along with competition from as many sources as is practical for the items required. 9. Other Relevant Facts Supporting the Proposed Noncompetitive Acquisition. The following list of items are supported by this JOFOC: Gilson GPC Automated Sample Preparation Instrument (1076005) Phenomenex GPC Columns (1075999) Agilent Cool-On Column Injector Kits (1075847) Accelerated Solvent Extractor + supporting equipment (1075960) Robot Coup Blixer Units (TBD) Turbo Vap Evaporation Systems (1076407) Ovens (TBD) Muffle furnaces (TBD) NIST standard mussle tissue (TBD) Identified equipment/instruments are identified using (i) salient characteristics; (ii) performance specifications; and/or (iii) brand or make/model numbers. Identified items may be acquired via GSA schedule while others will require open market competition from as many sources as is practical. All items are considered commercially available. 10. Sources that have Expressed Interest in the Acquisition in Writing. Due to the urgency associated with this action, expressions of interest in writing to each item identified in Item 9 above will be limited to responses to competition. 11. Statement of Actions, if any, to Remove or Overcome Barrier to Competition Before any Subsequent Acquisition for the Supplies or Services. Under normal circumstances competition would follow the normal acquisition route; however, due to the urgency of potential environmental impact associated with this spill, it became urgent and compelling to acquire equipment and/or instruments necessary to assess the safety of seafood in the area. 12. Provide a statement that indicates that the use of the Justification for procuring this supply or service is not a result of a lack of planning or the expiration of funds. This JOFOC is necessitated by the major oil spill resulting from the Deepwater Horizon oil spill and the urgency associated with equipping laboratories to assess the impact on the seafood safety and what will be required for the re-opening of the industry.
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