Sole Source justifiaction Dog study .pdf

USDA, APHIS, MARKETING AND REGULATORY SERVICES

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

(JOFOC)

LESS THAN $150,000

POLICY:

In accordance with the authority granted under FAR Part 13.4, the contracting officer must promote competition to the maximum extent practicable to obtain supplies and services from the source whose offer is the most advantageous to the Government, considering the administrative cost of the purchase.

(a) The contracting officer must not—

Solicit quotations based on personal preference; or Restrict solicitation to suppliers of well-known and widely distributed makes or brands.

(b) If using simplified acquisition procedures and not using either FACNET or providing access to the notice of proposed contract action and solicitation information through the Government-wide point of entry (GPE), maximum practicable competition ordinarily can be obtained by soliciting quotations or offers from sources within the local trade area. Unless the contract action requires synopsis pursuant to FAR 5.101 and an exception under FAR 5.202 is not applicable, consider solicitation of at least three sources to promote competition to the maximum extent practicable. Whenever practicable, request quotations or offers from two sources not included in the previous solicitation.

Each justification shall contain sufficient facts and rationale to justify the use of the specific authority cited, and shall include evidence that any supporting data that is the responsibility of technical or requirements personnel (e.g., verifying the Government’s minimum needs or schedule requirements or other rationale for other than full and open competition) and which form a basis for the justification have been certified as complete and accurate by the technical or requirements personnel.

(TEMPLATE)

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

(SOLE OR SINGLE SOURCE – LESS THAN $150,000)

In accordance with the authority granted under FAR Part 13, this request for a noncompetitive acquisition is hereby submitted for consideration for acquisition approval.

1. IDENTIFICATION OF THE AGENCY AND THE CONTRACTING

ACTIVITY:

Requesting Agency:

AHPIS CVB PEL Bacteriology 1920 Dayton Ave Ames, IA 50010

Contracting Activity:

USDA APHIS MRPBS AAMD

Minneapolis Procurement Branch

250 MARQUETTE AVE

SUITE 410

MINNEAPOLIS MN 55401

2. NATURE AND/OR DESCRIPTION OF THE ACTION BEING

APPROVED:

USDA regulates veterinary biological products to ensure they are pure, safe, potent, and effective. We needed an outside contractor to perform a study in Dogs to evaluate a currently conditionally licensed product. CVB PEL doesn’t currently have the capacity to preform studies in Dogs at the Ames, Iowa facility due to regulatory constraints (ACUC requirements).

3. A DESCRIPTION OF THE SUPPLIES, EQUIPMENT, OR SERVICES

REQUIRED TO MEET AGENCY NEEDS (INCLUDING THE ESTIMATED

VALUE OF THE ACQUISITION INCLUSIVE OF OPTIONS):

The contractor will provide 10 dogs to be used in the study. CVB will provide the vaccine used in the study.

The contractor will observe the dogs at least once daily with normal animal husbandry practices. Unfavorable reactions are not anticipated in most situations. If an unfavorable reaction does occur it can be systemic or localized including anaphylaxis. Dogs should be monitored for localized (injection site swelling, necrosis at the injection site) and systemic adverse reactions (abnormal behavior, decreased appetite, vomiting, respiratory distress). Any systemic treatments needed should be consulted prior to administering as it might affect the study, but topical medication can be used to help with symptoms upon consultation with a veterinarian.

Prior to vaccination a blood sample for serum will be obtained from each dog to compare to the post-vaccination neutralizing antibody content.

At the time of vaccination, disinfect the top of each sample vial with 70% alcohol swab before withdrawing product for vaccination. Each of 5 dogs per test serial (10 dogs total for 2 test serials) will be vaccinated subcutaneously in the back of the neck or scruff-region between the shoulder blades with 1.0 mL of the conditionally licensed toxoid using 1, 3, or 5-mL luer-lok syringes fitted with 18-20 gauge, 1-1½" needles. Repeat the vaccination 28-30 days later with appropriate test serials (maintain dog identifiers to ensure each dog receives the same sample).

Blood collection for serum: Shave and prepare blood collection area with appropriate antiseptic. Two, three, and four weeks after final vaccination, each animal will be bled via jugular vein or cephalic vein routes using 18-21-gauge needles. The blood tubes shall not contain anti-coagulant. Allow the blood to clot, centrifuge, and decant serum into a new, plain tube labeled with dog identifier and bleed date. Store test samples and serum samples at 2-7oC.

Event Volume &

Route Day

Pre-vaccination blood collection 30-40 mL IV 0 1st vaccination 1 mL SQ 0 2nd vaccination 1 mL SQ 28-30 2-week post-vaccination (14-16 day) blood collection

30-40 mL IV 42-46

3-week post-vaccination (21-23 day) blood collection

30-40 mL IV 49-53

4-week post-vaccination (28-30 day) blood collection

30-40 mL IV 56-60

Cost Estimate for USDA Anti-venom Serology and Safety Study of two serials (10 dogs total) Budget Item Estimate

Animal Use, Feed and Care (per diem basis) $15,750 Facility Use Fee for set-up, acclimation, occupancy, clean up and decontamination $0

Facility Use of Necropsy (Not Expected) $0 Feed $0 Supplies and Materials $1,100 Shipping Fees and containers (Fedex number provided by sponsor) $1,100 Disposable Biosecurity Materials $945 Total Service Cost $21,640 Regulatory Cost Share (IACUC and IBC) $1,000 Animal Disposal by Incineration (Not Expected) $0 Total Estimated Cost $41,535 Preferred Customer Discount -$4,328 Net Estimated Cost $37,207

4. IDENTIFICATION OF THE STATUATORY AUTHORITY PERMITTING

NONCOMPETITIVE ACQUISITIONS:

FAR 6.302-1 Only one responsible source - Citations: 10 U.S.C. 2304(c)(1) or 41 U.S.C. 3304(a)(1).related to the cited exception and authorities.

5. A DEMONSTRATION THAT THE PROPOSED CONTRACTOR’S UNIQUE

QUALIFICATIONS OR THE NATURE OF THE ACQUISITION REQUIRES

USE OF THE AUTHORITY CITED:

This contractor had in place the proper ACUC structure to be able to fulfill the needed experimental work in Dogs that was required to evaluate the conditionally licensed product for USDA. Also, they had the animals that we were able to use in the experiment in house. The plan is to use the dogs for the current study and allow them to be reused by the contractor after the contracted USDA animal study work is complete. This will allow the USDA and the contractor to follow the current stated 3 R’s policy (Reduce, Replacement and Refinement) stated in our current ACUC policy. They are also have the required inspections in place to conduct the work.

6. A DESCRIPTION OF EFFORTS MADE TO ENSURE THAT OFFERS ARE

SOLICITED FROM AS MANY POTENTIAL SOURCES AS IS

PRACTICABLE, INCLUDING WHETHER A NOTICE WAS, OR WILL BE,

PUBLICIZED AS REQUIRED BY FEDERAL ACQUISITION REGULATION

(FAR) SUBPART 5.2, AND IF NOT, WHICH EXCEPTION UNDER FAR 5.202

APPLIES:

This is difficult as we needed a specialized contractor that had specific regulatory frameworks in place to conduct this work. Working with dogs requires additional inspections and approvals from the USDA and state agencies.

7. A DETERMINATION BY THAT THE ANTICIPATED COST TO THE

GOVERNMENT WILL BE FAIR AND REASONABLE, AND THE BASIS

FORTHAT DETERMINATION:

The per diem cost are in line with what it cost to board a dog at a private facility. The service costs are what can be expected to vaccinate and bleeding a dog with technician time and supplies needed to complete the task. This averages out to approx. $360 for each procedure/dog. 6 total procedures/ dog 10 dogs total in the study.

8. A DESCRIPTION OF THE MARKET RESEARCH CONDUCTED (FAR

PART 10) AND THE RESULTS, OR AN EXPLANATION OF THE REASON

MARKET RESEARCH WAS NOT PERFORMED:

This is difficult as we needed a specialized contractor that had specific regulatory frameworks in place to conduct this work. Working with dogs requires additional inspections and approvals from the USDA and state agencies.

9. ANY OTHER FACTS SUPPORTING THE USE OF OTHER THAN FULL

AND OPEN COMPETITION - FAR 6.303-2(a)(9):

We needed a contractor that had in place all the proper regulatory framework to be able to do the work. They needed a functional ACUC to be able to approve the study, their facilities needed to be licensed by the state that they are located in to be able to conduct the study, they needed to be current on their inspections to be able to house dogs, they needed to have trained staff to be able to conduct the study.

10. A LISTING OF SOURCES, IF ANY, THAT EXPRESSED, IN WRITING, AN

INTEREST IN THE ACQUISITON:

None

11. A STATEMENT OF THE ACTIONS, IF ANY. THE AGENCY MAY TAKE

TO REMOVE OR OVERCOME ANY BARRIERS TO COMPETITION

BEFORE ANY SUBSEQUENT ACQUISITION FOR THE SUPPLIES,

EQUIPMENT, OR SERVICES REQUIRED:

We might need a list of approved vendors for potential studies in animals (Dogs, Cats) that are not covered by our ACUC at APHIS CVB PEL in Ames, Iowa. This study in Dogs is a rare occurrence.

12. I HEREBY CERTIFY THAT THE INFORMATION PROVIDED IN THIS

JOFOC IS ACCURATE AND COMPLETETOTHE BEST OF MY

KNOWLEDGE AND BELIEF.

(Certification requires the signature of the Contracting officer and program manager, and shall include the date)

Randy Atchison Name of CS - Date Contract Specialist

USDA APHIS MRPBS AAMD

Phone: 919-855-7003 Office latisha.a.hollman@usda.gov

PROGRAM MANAGER

Date: 11/17/2022 Branch: CVB PEL Bacteriology Address:1920 Dayton Ave Ames, IA 50010 Phone Number: 515-337-7831 Print Name: Randy Atchison Title; Supervisory Microbiologist mailto:latisha.a.hollman@usda.gov