FAR 13.5 Single Source or Brand Name Justification Exceeding SAT_12639523Q0205_Redacted.pdf

United States Department of Agriculture Sole Source (Including Brand Name) Justification under

Simplified Procedures for Certain Commercial Items (FAR 13.5)

1. Identification of the agency and the contracting activity.

Agency:

APHIS, VS, NVSL/CVB Laboratory 1920 Dayton Ave.

B20-2419 Ames, IA 50010

Contracting Activity:

USDA APHIS, AAMD

250 Marquette Ave, Suite 410 Minneapolis, MN 55401

2. The nature and/or description of the action being approved.

The USDA proposes to enter into a firm fixed-price contract with Envigo RMS LLC using the simplified procedures for certain commercial items under Federal Acquisition Regulation (FAR) Part 13.5)

3. A description of the supplies or services required to (including the estimated value).

Purchase of Envigo (formally Harlan Sprague Dawley) female CF-1 mice for use in the potency testing of inactivated rabies virus vaccines. Mice are used to evaluate the efficacy of inactivated rabies vaccine according to SAM 308: Supplemental Assay Method for Potency Testing of Inactivated Rabies Vaccine in Mice Using the National Institutes of Health (NIH) Test. The protocol defines the specifications of mice to be used for testing as female CF-1 mice within a weight range of 13-15 grams. Historically, the CVB rabies program has been developed over the past twenty years using Envigo, female mice from colony 206 Barrier 202B Strain Hsd:NSA(CF-1).

Since the NIH rabies potency test is highly variable, controlling as many influencing factors as possible is necessary for test success. Female CF-1 mice from colony 206 were selected based upon their genetic line and predictable response in the NIH rabies potency assay. Vaccine manufacturers use Colony 206 for rabies potency testing. The use of a constant mouse line of known genetics results in both an increased consistency of test results within a laboratory as well as for a better comparison of results between laboratories.

Estimated value:

Base Year: $100,000.00 Option Year 1: $100,000.00 Option Year 2: $100,000.00

Option Year 3: $100,000.00 Option Year 4: $100,000.00

Total IDIQ Value (inclusive of base and all option years): $500,000.00

4. The statutory authority permitting other than full and open competition.

41 U.S.C § 1901 - Simplified Acquisition Procedures up to $7.5 million, as authorized by FAR 13.500(a) and implemented by FAR 13.501(a).

5. A statement demonstrating the unique qualifications of the proposed contractor or the nature of the action requiring the use of the authority.

The Title 9 Code of Federal Regulations (9 CFR) section 113.209 (3) outlines the parameters for the NIH potency test as well as and the authority for the production and distribution of the rabies challenge virus used for the evaluation of rabies pivotal immunogenicity and duration of immunity total rabies program (challenge virus, mouse challenge virus and inactivated rabies reference vaccine) have been validated using Envigo, female CF-1 mice from colony 206. The rabies program at the CVB, includes the evaluation of inactivated of rabies vaccine, has been established using Envigo female CF-1 mice from colony 206. This decision has been based upon the time required to validate rabies reagents.

The inactivated rabies reference vaccine validation study was conducted May 2006 through August, 2006. This was a collaborative study with all US rabies manufactures and the CVB. The resultant data was statistically analyzed, and a statistical difference in test results was observed between mice from different sources, with Harlan Sprague Dawley/Envigo mice producing a higher Protective Dose 50 (PD50) in the test. Our agency has had little experience working with female CF-1 mice from alternate vendors, as the rabies program has been validated using Harlan Sprague Dawley female CF-1 mice from colony 206, as previously stated.

isease monitoring in mouse colonies, assures our agency of a predictable response of mice in rabies tests.

Harlan Sprague Dawley mice consistently arrive at our facility as healthy, female CF-1 mice within our weight specifications. Our death loss at the time of challenge is below 1%, which is indicative of using mice within the appropriate weight range at the time of challenge. Harlan Sprague has been able to supply our needs for additional mice on short notice.

6. A description of efforts made to ensure offers are solicited from as many potential sources as is practicable.

vaccine was conducted May 2006 through August 2006. This was a collaborative study included US rabies manufacturers and the CVB. The resultant data was statistically analyzed and a statistical difference in test results was observed between mice from different sources, with Envigo mice producing a higher protective dose 50 (PD50) in the test. Our agency has limited experience working with female CF-1 mice from alternate vendors, as the rabies program has been validated using Envigo female CF-1 mice.

Our laboratory has coordinated the production and testing of a new Rabies Reference Vaccine using Envigo, female CF-1 mice from colony 206. This Reference Vaccine has been validated for use by comparison to the World Health Organization (WHO) 6th International reference through a collaborative study with all United States rabies vaccine manufacturers. During this study, the mouse source utilized by CVB, and US rabies manufacturers was Envigo, female CF-1 mice. Data from both the CVB and the firms were submitted for statistical analysis and indicated that the source of mice influenced the estimated value for the PD50 of the vaccine. Simply put, the source of mice used in the test influences the test results. If the decision is made to purchase mice from a new

7. A determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

13.106-3(ii) - Comparison of proposed price with prices found reasonable on previous purchases.

8. A description of the market research conducted and the results or a statement of the reason Market Research was not conducted.

Comparative of CF-1 Mice Between Vendors (Required Studies)

Cost Factors Associated with Comparative Study

Vendor ID Number of CF-1 Mice Required

Est.

Cost/animal

Est. Per diem cost of animals

Personnel Hours

Timeline

1000 mice/vendor

Ave. study length 42 days.

780 - Laboratory

120 - Data

Evaluation

80- Reagent review release

3-4 months/vendor

Cost Factors Associated with Reagent Validation

Reagent

Identification Animals Number of

Animals Required

Est.

Cost/animal

Est. Per diem cost of animals/day

Personnel Hours

Timeline