Amendment_3_18Q0138.pdf

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90 Day Dermal Toxicity Testing of Sodium Nitrite (per EPA OPPTS 870. 3250)
Solicitation number
12639518Q0138
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Attachmnt_2_SF_30_18Q0138.pdf PDF
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AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE PAGE OF PAGES

2. AMENDMENT/MODIFICATION NO

3. EFFECTIVE DATE

07/11/20188

4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicable)

6. ISSUED BY CODE 7. ADMINISTERED BY (If other than Item 6) CODE

USDA APHIS MRPBS AAMD

Ft. Collins CO 80526

USDA APHIS MRPBS AAMD

Carol Dingess 970-494-7360 Fax 970-472-1897 Email : Carol.Dingess@aphis.usda.gov

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code) (X) 9A. AMENDMENT OF SOLICITATION

NO.

12639518Q0138

9B. DATED (SEE ITEM 11)

06/04/2018

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

CODE FACILITY CODE

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended, is not extended.

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing items 8 and 15, and returning copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment your desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO.

IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

Solicitation Amendment IAW FAR 13.307 (C )(3)

The following additions have been made to the Statement of Work - 2 bullets that contain specific information regarding the required work for the 90-day dermal toxicity study:

• The appropriate doses of the test substance for the 3 treatment groups will be determined in consultation with the study sponsor (USDA). No range finding study is required.

• The test substance will be administered 5 days a week for a period of 90 days. Application on a 5-day per week schedule is acceptable based on EPA guidance OPPTS 870.3250.

***See changes in Red Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print) 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

16C. DATE SIGNED

NSN 7540-01-152-8070

Previous edition unusable

STANDARD FORM 30 (REV. 10-83)

Prescribed by GSA FAR (48 CFR) 53.243

X X

This solicitation is hereby extended to 4:PM 07/19/2018

CAROL DINGESS - CONTRACTING OFFFICER

Name of company:________________________________________________________________

Phone#:_____________________________ Fax#: ______________________________

Point of contact Name:______________________________________________________________

DUNS#:___________________________________

EMAIL ADDRESS: ________________________________________________

TOTAL DOLLAR AMOUNT ON QUOTE $__________________________

The U.S. Department of Agriculture, Wildlife Services Program in Ft. Collins, CO is in immediate need of purchasing the following for a firm fixed price.

Description Quantity Total $ Firm Fixed Priced Purchase Order for 90 Day Dermal Toxicity Testing of Sodium Nitrite (per EPA

OPPTS 870.3250) 1

** Pricing shall include all costs necessary to accomplish the services in the statement of work (including but not limited to: overhead, general and administrative, profit, insurance, transportation, labor hours, equipment and supplies).

The U.S. Department of Agriculture is a tax exempt agency. (Exempt from state and Federal tax) Tax ID Number : 41-0696271. Tax Exempt # 471640000

STATEMENT OF WORK

TITLE OF CONTRACT

90-Day Dermal Toxicity Testing of Sodium Nitrite

BACKGROUND

90-Day Dermal Toxicity testing is required (40 CFR Subpart F) to support a future pesticide registration application to EPA for a sodium nitrite toxicant for feral swine.

OBJECTIVES

The study characterizes the toxicity for sodium nitrite under conditions of chronic exposure in accordance with EPA OPPTS study guidelines (870 series) and EPA FIFRA regulatory requirements for Good Laboratory Practices (GLPs).

SCOPE

The scope of this contract will include laboratory testing, data analysis and report writing, and quality assurance review phases of this sodium nitrite study in accordance with EPA OPPTS guidelines and EPA FIFRA regulatory requirements for Good Laboratory Practices (GLPs).

TASKS OR REQUIREMENTS

The tasks are to complete the following chronic toxicity studies (see table) in accordance with EPA OPPTS study guideline (870 series) and EPA FIFRA regulatory requirements for Good Laboratory Practices (GLPs).

Toxicology Data Requirement – Sodium Nitrite

OPPTS Guideline # Study Title

870.3250 90-day dermal toxicity

1) The appropriate doses of the test substance for the 3 treatment groups will be determined in consultation with the study sponsor (USDA). No range finding study is required.

2) The test substance will be administered 5 days a week for a period of 90 days. Application on a 5-day per week schedule is acceptable based on EPA guidance OPPTS 870.3250.

PERFORMANCE/DELIVERABLE REQUIREMENTS

Documentation:

The Contractor shall provide:

1) A study protocol, any amendments (as applicable)

2) A draft final report for review, and the completed final report

3) All documentation will be completed in accordance with EPA FIFRA GLPs

Delivery:

The Contractor shall complete the order within 365 calendar days of this contract.

Specific locations will be provided prior to contract finalization. The Contractor shall assist with providing the documentation listed above.

PLACE OF PERFORMANCE

The order shall be conducted within the Contractor’s research facilities.

PERIOD OF PERFORMANCE

The study shall be completed 365 calendar days of this contract.

INVOICING

The contractor shall provide invoices detailing description of work/tasks performed and processed through the Invoice Processing Platform (IPP).

Contacts:

Technical Contact:

Jeanette O’Hare Registration Manager USDA/APHIS/WS/National Wildlife Research Center 4101 LaPorte Avenue Fort Collins, CO 80521 970-266-6156 Jeanette.r.ohare@aphis.usda.gov mailto:Jeanette.r.ohare@aphis.usda.gov

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