SOURCES SOUGHT
B -- Animal Vaccine Analysis using Near Infrared Spectroscopy
- Notice Date
- 11/13/2009
- Notice Type
- Sources Sought
- NAICS
- 325414
— Biological Product (except Diagnostic) Manufacturing
- Contracting Office
- Department of Agriculture, Animal and Plant Health Inspection Service, Administrative Services Division/Contracting, 100 North 6TH Street, Butler Square 5TH Floor, Minneapolis, Minnesota, 55403
- ZIP Code
- 55403
- Solicitation Number
- AG-6395-S-10-0021
- Point of Contact
- Nathan Johnson,
- E-Mail Address
-
nathan.d.johnson@aphis.usda.gov
(nathan.d.johnson@aphis.usda.gov)
- Small Business Set-Aside
- N/A
- Description
- Project Summary : 1) Contract Near Infrared Spectroscopy Method Validation in Compliance with EPA Pesticide Test Guideline OPPTS 830.1800 - Enforcement Analytical Method 2) Contract Analysis of an Animal Vaccine in Compliance with EPA Pesticide Test Guideline OPPTS 830.1700 - Preliminary Analysis Statement of Work : The United States Department of Agriculture, Animal and Plant Health Inspection Service, Wildlife Services (WS) is seeking interested parties with the intention of negotiating a contract for the following services: 1) In compliance with the US Environmental Protection Agency (EPA) conventional pesticide registration data requirements (http://www.epa.gov/opptsfrs/publications/Test_Guidelines/series830.htm), WS is seeking development of a validated near infrared (NIR) spectroscopy method to confirm identity and concentration of a short-chain peptide formulated in a high viscosity water-oil emulsion animal vaccine under EPA guideline OPPTS 830.1800 - Enforcement Analytical Method. Due to the low concentration of the peptide (< 0.1%), it is anticipated that the method will require a NIR transflectance spectroscopy approach. NIR is a novel technique to analyze pesticide products registered with the EPA, and as such, does not entirely align with the OPPTS 830.1800 guidance. WS provided preliminary data to EPA demonstrating proof of concept. EPA has concurred with the approach and is requiring submission of a validated method to analyze the active ingredient in the vaccine. The project will result in a final written method in compliance with EPA PR Notice 86-5 "Standard Format for Data Submitted under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Certain Provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA)" (http://www.epa.gov/PR_Notices/pr86-5.html) due prior to September 15, 2010 for submission to EPA. 2) In addition to the validated enforcement analytical method, WS is also seeking a contractor to perform successful analysis of five batches of vaccine using the validated NIR method in compliance with EPA Pesticide Test Guideline OPPTS 830.1700 - Preliminary Analysis. A final written report of the results in compliance with EPA PR Notice 86-5 is due prior to September 15, 2010 for submission to EPA. 3) Based upon the responses to this notice the Government will decide to compete full and open, set-aside the requirement for small businesses, enter into a cooperative agreement, or conduct the work internally. Interested parties should submit via email to Nathan Johnson the following information: 1 - Evidence of access to NIR instrumentation 2 - Scientific staffing with expertise in NIR method development and use (use resumes or c.v. of key personnel, past performance references, copies of papers, articles, etc) 3 - Demonstrate a history of GLP standards compliance or manufacturing under Good Manufacturing Practices. Familiarity with Good Laboratory Practices (GLP) is preferred (40 CFR Part 160). However, the contractor may work in cooperation with WS National Wildlife Research Center (NWRC), to ensure a successful GLP method validation. This announcement does not commit the Government to award of a contract. A determination by the Government not to open the requirement to competition based upon the response to this notice is solely within the discretion of the Government. Responses must be received within 30 days of publication of this notice. For further information please contact Nathan Johnson at (612) 336-3404 Nathan.d.johnson@aphis.usda.gov
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USDA/APHIS/Contracting/AG-6395-S-10-0021/listing.html)
- Record
- SN02003920-W 20091115/091114000530-48a9994a06c2c23e038ad5b63cf04e65 (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 |