NOTICE OF INTENT TO AWARD SOLE SOURCE Purchase of FIFRA GLP preliminary (5-batch) analysis study for sodium nitrite Announcement No.: 12639524Q0241 USDA-APHIS-WS-NWRC request the following be acquired using a noncompetitive procurement in support of program mission requirements (i.e. conducting wildlife damage management research). USDA-APHIS-WS-NWRC requires a Preliminary (5-batch) Analysis regulatory study (following EPA OPPTS 830.1700) to be completed on five independent manufacturing batches from the manufacturing source of the technical grade pesticide active ingredient (sodium nitrite) in accordance with Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Good Laboratory Practices (GLPs). The resulting final report must also meet the FIFRA GLP requirements and EPA's data submission format requirements (EPA PRN 2011-3: Standard Format for Data Submitted Under FIFRA and Certain Provisions of FFDCA) in order to support a future pesticide registration application to the Environmental Protection Agency (EPA). This study must be completed by the end of February 2025 for APHIS’s registration application to EPA to remain on track and to help meet APHIS’s feral swine damage management goals. Product Safety Labs has the expertise, staff, and capacity to complete this regulatory study in compliance with EPA’s GLP regulations and within the necessary time frame. CONTRACTOR PERFORMANCE REQUIREMENTS The period of performance for this effort will be a 1 base period. 1) Draft a study protocol, which will be approved by the study sponsor's representative (USDA Technical Contact) prior to initiation of any laboratory testing of the five batches of the test substance. Any amendments to the study protocol will also be approved by the sponsor's representative prior to implementation. 2) Purchase and characterize the two technical reference standards (sodium nitrite and sodium nitrate). These reference standards must be characterized using GLP-validated chemistry analytical methods. 3) Characterize the concentration of the active ingredient sodium nitrite, sodium nitrate, and water in the five independent manufacturing batches of technical sodium nitrite in accordance with EPA OPPTS 830.1700 and the EPA FIFRA GLPs. These five batches must be characterized using GLP-validated chemistry analytical methods. 4) Draft a final study report and obtain approval of the final report from the sponsor’s representative. Once approved, provide a final report that meets the FIFRA GLP requirements and EPA's data submission format requirements in EPA PRN 2011-3. 5) Dispose of the test substance and samples. Responses to this notice must demonstrate clear and convincing This procurement is being conducted in accordance with Federal Acquisition Regulation (FAR) 6.302-1The statutory authority is 41 U.S.C. 253(c )(1) The property or services needed by the executive agency are available from only one responsible source and no other type of property or services will satisfy the needs of the executive agency. And 6.302-1 (ii) Supplies may be deemed to be available only from the original source in the case of a follow-on contract for the continued development or production of a major system or highly specialized equipment, including major components thereof, when it is likely that award to any other source would result in- (A) Substantial duplication of cost to the Government that is not expected to be recovered through competition; or (B) Unacceptable delays in fulfilling the agency’s requirements. 41 U.S.C. 3304(b)(2).)g evidence that competition would be advantageous to the Government, would not be cost or time prohibitive, and would not hinder the mission objective of the national solid waste recycling measurement initiative. The determination not to compete this proposed contract action is solely within the discretion of the Government. Information received will normally be considered for the purposes of determining whether to conduct a competitive procurement. The Government will not be responsible for any costs incurred by responding to this notice. This is NOT a request for quotes or proposals. Questions or comments to this Notice of Intent should be directed to Contracting Officer, Latisha Hollman, at
[email protected] via e-mail only (no phone calls/voice mail messages regarding questions will not be accepted and will not receive a response). Please indicate in the subject of your email: Notice of Intent Question Submission – 12639524Q0241 by 07/23/2024.