MODIFICATION
R -- Data Collection
- Notice Date
- 8/27/2009
- Notice Type
- Modification/Amendment
- NAICS
- 541711
— Research and Development in Biotechnology
- 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-09-1061161
- Point of Contact
- Karen R. Petty, Phone: 301-827-8774
- E-Mail Address
-
karen.petty@fda.hhs.gov
(karen.petty@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- **************************************The purpose of this modification is to change the location of the place of performance and extend the closing date. The place of performance is hereby changed to read: Contractors location. Contractor shall be required to attend a minimum of 3 site visits to the FDA offices in Maryland. The closing date is now extended to September 3, 2009 @4:30 pm, Eastern Standard Time. ******************************************This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6. This announcement constitutes the only solicitation and a written solicitation will not be issued. This synopsis, NAICS code 541711, is to notify contractors that the Food and Drug Administration (FDA) is seeking competition of this requirement in accordance with FAR Part 13.106 for the following statement of work, under the simplified acquisition procures. Under the simplified acquisition procedures and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-35. This synopsis is designated for 100% Small Business Set Aside competition for a firm fixed-price purchase order. Prospective offerors are responsible for monitoring the FedBizOpps website for the release of any amendments to this solicitation. Hard copies will be provided to individuals eligible under the Americans with Disabilities Act and Rehabilitation Act upon request. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary. The Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS), Division of Acquisition Operations (DAO) is seeking to obtain data collection services. Background In Fiscal Year 2001, the Center hired contractor to collect foreign aquaculture drug use information, develop a database to house the information and conduct food safety risk assessments using the available data. The purpose of the contract was so FDA could gain the knowledge needed to ensure the safety of imported aquaculture seafood products. Information was collected on the drugs and chemicals used worldwide. We gave the contractor a list of countries which we knew imported the most seafood products into the United States. The contractor was asked to gather data on the types, amounts, and use patterns of drugs and chemicals in aquaculture and provide the methods available to measure residues of the drugs and chemicals or their metabolites. The contractor was also asked to gather available human food safety data including, but not limited to, toxicity, metabolism, and pharmacokinetics about the drugs and chemicals. All of this information was entered into a database, AQRIS. Following the development of the database, the data was analyzed within a risk assessment framework to prioritize FDA concerns for exposures of U.S. consumers to unsafe residues in the edible tissue of imported aquaculture products. The contractor created a Risk Assessment Tool, AQRRT, using Microsoft Access, so that the Agency could look at the data in different ways to determine the risk of a compound. This tool provided flexibility when reviewing the data and the risk ranking of the individual data components. Initial project was completed in 2006 but the data was reviewed and obtained for 2001-2002 only. Since the data used for this project is now over seven years old it needs to be updated. The database needs to include new species that are being cultured in foreign countries such as bass, catfish, tilapia, and any other fish species that may be identified as being cultured, the drugs and chemicals used in the production of these species, and all the other data points that were reviewed for the original contract of foreign drug use information. Scope of Work/Deliverables include: The contractor shall provide the following: For each species listed in the database, the contractor shall provide, at a minimum, information on the types of drugs (including transgenics), chemicals, and conditions of use in each country as follows: odrug or chemical name/tradename ochemical structure of drug/chemical oCAS (Chemical Abstract Society) number odosage form(s) odosages, frequency, duration of treatment oconditions/indications for use for each species; including lifestages oany special conditions of use owithdrawal times [if any] ouse of drug according to country's guidelines (state if drug/chemical is approved or not) ocopy of label(s) oextent of use of drug or chemical Contractor shall attend a minimum of 3 site visits at the FDA offices in Maryland. EVALUATION AND AWARD: Award will be made to the party whose quote offers the best value to the Government, technical, price, and other factors considered. The Government may award this purchase order to other than the lowest price technically acceptable quote. The Government will evaluate information based on the following evaluation criteria: 1) Technical Capability factor "Meeting or Exceeding the Requirement," (2) Past performance and 3) Price. Technical Capability and past performance when combined are significantly more important than price. The FDA intends to make an award immediately after the response date of this notice. The award will be made in accordance with FAR Part 13, Simplified Acquisition Procedures. CCR: Vendors must be registered in the Central Contractor Register (CCR) prior to the award of a contract. You may register by going to www.ccr.gov. You will need your Dun & Bradstreet number and banking information. All responsible sources that can provide and meet the above requirements, shall submit written quotation by the response date. QUESTIONS DUE: All questions must be received by email to: karen.petty@fda.hhs.gov, no later than 4:30pm, EST on or before August 24, 2009. QUOTATIONS DUE: All quotations must be received by email to: karen.petty@fda.hhs.gov, no later than 4:30pm, EST on or before August 27, 2009. Telephone calls will not be accepted. PROVISIONS and CLAUSES: The provision at FAR 52.212-1, Instructions to Offerors Commercial Items applies to this solicitation. The following agenda has been attached to this provision: None. Offerors shall include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications Commercial Items. The clause at FAR 52.212-4, Contract Terms and Conditions, Commercial Items applies to this acquisition. The clause at FAR 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders, Commercial Items applies to this acquisition. The following FAR clauses cited are applicable: FAR 52.217-8, FAR 52.222-26, FAR 52.222-35, FAR 52.222-36, and FAR 52.232-33. Clauses and provisions are incorporated by reference and apply to this acquisition.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-09-1061161/listing.html)
- Place of Performance
- Address: Contractors location, United States
- Record
- SN01929765-W 20090829/090828082319-5a90f05880f53fa13f2de87dd1149e23 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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