JA Redacted.pdf

Justification for Other than Full and Open Competition Taconic Biosciences Contract No. HHSN272201700058C

Type of action.

New requirement Follow-on

X Other (specify): _Modification to bilaterally extend the period of performance and increase contract ceiling.

Proposed contract/order type.

Firm-fixed-price Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ X Cost-plus-fixed-fee with firm fixed price line items

Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________

Time and materials Indefinite delivery:

Other (specify): ___________ Completion Form Term form

Acquisition identification number: HHSN272201700058C

a. Total estimated dollar value and performance/delivery period.

The current ceiling of this acquisition is $8,530,916.00. This J&A will increase the contract ceiling by $715,143.00 to $9,246,059.00. The period of performance of the contract will be extended by 10 weeks, from September 30, 2017 through March 29, 2023 to September 30, 2017 through June 10, 2023.

4. Identification of the statutory authority permitting other than full and open competition.

X This acquisition is conducted under the authority of 41 United States Code (U.S.C.) 253(c)(1) as set forth in Federal Acquisition Regulation (FAR) 6.302-1, only one responsible source and no other supplies or services will satisfy agency requirements, and HHS Acquisition Regulation 306.302-1, only one responsible source and no other supplies or services will satisfy agency requirements.

This acquisition is conducted under the authority of section

4202 of the Clinger-Cohen Act of 1996.

This acquisition is conducted under the authority of the Services Acquisition Reform Act of 2003 (41 U.S.C. 428a).

fair and reasonable and is in line with the cost/price paid by others in the market, the data from the IGCE will be compared with the proposal received from the offeror. The Contract Specialist and Contracting Officer will conduct cost analysis and cost realism of the proposal to evaluate the reasonableness of individual cost elements. An award will be made only if during negotiations; it is shown that the anticipated cost to the government will be fair and reasonable.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

As discussed in Item #7, a Sources Sought noticed was published and resulted in no responses from small businesses. Despite a prospective offeror expressing interest, no capability statements were received. While market research and the Sources Sought show a potential source capable of fulfilling the requirement other than the incumbent, the risk and impact on existing research would be significant if this procurement was competed. The follow-up notice issued on March 23, 2022 on SAM.gov demonstrated NIAID’s intent to sole source and provided an additional opportunity for interested sources to submit a capability statement. As of closing date of April 4, 2022, no other sources expressed interest.

9. Any other facts supporting the use of other than full and open competition.

Supplemental Cost Burden: As described in 5.b. above, the additional cost burden incurred by any new contractor proposing to take over the NIAID mouse repository would be excessive. The contractor is required to aseptically re-derive and separately perform extensive health testing on all individual mouse lines that are to be imported into a NIAID mouse repository. This requirement would apply to all animals that are imported into or transferred between housing facilities. A competing contractor would therefore be required to incur the cost of importing all currently maintained NIAID mouse lines into any newly established animal facility when determining their cost proposal. The incumbent would not be burdened with these costs.

Disruptive Time Delay: There would be a significant delay of up to one year before the mouse repository would be fully established at another venue. This delay would be very disruptive to the ongoing work and current studies of NIAID investigators that depend on regular mouse shipments from the repository. The time frame for re-deriving and health-testing a mouse line is 4 to 6 months. It would not be realistic to expect that all NIAID mouse lines would undergo the re- derivation and health-testing service simultaneously. The process of importing ~120 mouse lines into a new animal facility would take up to one year barring any unforeseen difficulties. Furthermore, the transition of all ~120 animal lines into a new animal facility would involve the time-consuming expansion of these newly imported mice into fully functioning mouse colonies capable of providing for the needs of NIAID investigators. To elaborate, the Standard Operation Protocol (SOP) mandates that the importation of any mouse line into an established mouse barrier shall require that the donor mice that will be used to establish the line be sterilely rederived prior to import into the barrier mouse breeding colony. Therefore, a functioning mouse colony shall be defined as a newly established mouse line population that has been: 1) generated from breeders that were re-derived under sterile conditions, 2) reinfected with the defined altered Schaedler flora, 3) health tested for pathogens under the FELASA guidelines “International Health Monitoring System”, 4) imported into murine pathogen-free animal barrier and 5) has reached a population density such that it can supply offspring for all relevant mouse orders currently being filled for NIAID investigators.

Last year, NIAID investigators ordered and received over 33,000 mice from the NIAID repository. The time delay in re-establishing the breeding proficiency and shipping efficiency currently provided by our current contractor would be highly disruptive for the many NIAID investigators that now depend on regular shipments of mice to maintain the quality and consistency in their experiments. If done, it would negatively impact the NIAID mission by disrupting almost all ongoing experiments.

Additional Cost for Redundant Animal Facilities: The significant delay in transferring and reestablishing the already existing mouse repository from Taconic to another service provider would mandate the continued maintenance of the current repository until the transition is complete. It would be estimated that the entire transition process would take approximately one year to complete. During this time, it would be necessary to continue the supply of 700 mice per week of various strains to NIAID investigators. This would require that the current contractor (Taconic Biosciences) continue to maintain the existing mouse repository as well as all shipment arrangements with NIAID.

The yearly expenditures of our contract with Taconic Biosciences average about for maintaining mice in a facility with a double barrier design (physical facilities that will house the animals in an isolated environment separate from other mouse breeding at the vendors facility) along with shipping arrangements to NIAID. The cost of supporting two contracts as the new one is established to avoid an adverse impact on the NIAID mission for a transition of 9 to 12 months would be at least and this would likely extend up to a year for some lines adding even more.

The existence of two separate mouse repositories during the transition period would impose these significant additional costs on NIAID that could be avoided if the mouse repository was retained at Taconic Biosciences.

Cryopreservation: Finally, over the past 20-years numerous repository mouse line embryos and sperm have been cryopreserved by Taconic Biosciences. These embryos are being maintained at their facility as part of our current contract. Taconic is maintaining 187 individual strains in cryopreservation at a cost of , for approximately

. Total inventory is approximately 3300 cryovials. Transitioning to another contractor would also mandate the transfer of these embryos to another facility unless a separate agreement was enacted with Taconic Biosciences to continue this service and additional costs would be incurred. The transfer of these cryopreserved samples is limited by the number of samples that can be shipped via liquid Nitrogen dry shipper (< 100 vials/shipment), requiring numerous shipments. Each individual shipment risks losing these irreplaceable mouse strains due to handling or shipping delays which can lead to thawing of the samples rendering them worthless.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

No other sources have expressed interest in the acquisition as explained in Items #6 and #8 of this J&A.

A Presolicitation Notice was published on March 10, 2023 on SAM.gov for a period of 15 days. This notice described the work to be performed, stated NIAID’s intent to negotiate with the present Contractor on a sole source basis, under the authority of FAR 6.302-1 and HHSAR 306.302-1, and provided responsible sources with the opportunity to express their interest by submitting a capability statement.

No expressions of interest or capability statements were received in response to the notice.

12. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

The NIAID is in the process of issuing the follow on sole source purchase order, inclusive of the transition period. This will provide adequate time to solicit a full and open competition follow on award, including the proper timing to accommodate a new vendor if needed. . We anticipate awarding a new purchase order by June 10, 2023.

13. Program office certification

Statement of Work (SOW)

HHSN272201700058C

Modification # 16 Dated 03/29/2023

Statement of Work

(SOW)

Operation and Maintenance of a Murine Pathogen-Free (MPF) Mouse

Breeding Facility

1. Background

The National Institute of Allergy and Infectious Diseases (NIAID) has numerous colonies of congenic, transgenic and knockout mice that are not available from commercial sources. The animals (live and/or cryo-preserved) are maintained in NIH facilities or the NIAID Taconic mouse repository. The NIAID repository provides mice for the purposes of intramural NIAID scientists.

2. Introduction and Scope

The congenic, transgenic and knockout mice bred and maintained in the NIAID mouse repository are used by multiple investigators in the institute for projects ranging from infectious disease research to cellular immunology. The NIAID repository provides a source of animals from a professional breeder who has the skills to carry out complex genetic breeding schemes required for the development of these lines for research purposes.

3. Technical Requirements

3.1. Mouse Breeding

a. The Contractor shall maintain barrier designed facilities for approximately 3400 breeding and production cages of inbred, congenic, transgenic and DNA-mediated gene targeted mutant mice and their offspring.

The Government reserves the right to add additional breeding and/or production cages to meet increased future requirements. Such additions shall be based on space availability at the facility.

b. The Contractor shall provide staff who are experienced in the breeding of the types of mice mentioned in paragraph 1. The staff shall be capable of making decisions regarding replacement of poor and old breeders and have sufficient knowledge of mouse genetics to carry out complicated backcrosses and inbreeding on newly created transgenic and mutant mice. The staff shall also be experienced in the observation of mutant mice for external phenotypes that can be used to identify gene carriers.

c. The Contractor shall perform laboratory procedures involved in taking samples of tissues required for genetic typing of the animals. These procedures include, but are not limited to, obtaining blood samples, tail clips and ear punches. The samples shall be collected and shipped to a third party, as identified by the COR, or the requesting NIAID Investigator for genotyping.

d. The Contractor shall hold all mice arriving at the facility in a quarantine area physically removed and independently staffed and maintained from the barrier facility. The quarantine area shall provide NIAID with ample cages for housing and strain expansion when necessary before derivation. Each strain shall be derived into the barrier facility by embryo transfer using donor and recipient strains designated by the Contracting Officer's Representative (COR). The Contractor shall provide defined flora and gnotobiotic foster mothers housed in gnotobiotic isolators as the recipients. Re-derived mice shall be held in sterile isolators or individually ventilated cages (IVCs) physically separated from the barrier facility until their health status is verified to confirm their defined flora status. Testing should include a comprehensive list of murine pathogenic and opportunistic agents in compliance with the Federation of Laboratory Animal Science Associations (FELASA) guidelines. It is recommended, but not mandatory, that an independent diagnostic laboratory performs health testing. In special circumstances the COR may request that 1) the foster mothers be gnotobiotic and that the offspring be kept gnotobiotic, 2) the offspring be tested for alpha hemolytic Streptococcus and/or Segmented Filamentous Bacteria (SFB) prior to entry into a NIAID barrier unit and (3) the mouse colony be indefinitely housed in a separate isolator with dedicated filtered air supply and health monitoring.

e. The Contractor shall provide veterinary care to identify causes of illness or death as needed and to monitor both the quarantine and breeding areas of the colony for bacteria, viruses and protozoa. The Health Monitoring Program for the re-derived mice shall be overseen by a qualified veterinarian. The Contractor's monitoring program shall consist of panels and schedules of testing in compliance with Europe’s Federation of European Laboratory Animal Science Associations (FELASA) guidelines. In addition, the Contractor shall abide by the following panels and schedules of testing:

1. Virus serology panel performed every month

2. Necropsy, microbiology and serology performed quarterly

3. Expanded necropsy, microbiology and serology panels performed bi-annually

4. Comprehensive necropsy, microbiology and serology panels performed annually

Additionally, monthly monitoring for bacterial opportunists, including alpha hemolytic Streptococcus and Segmented Filamentous Bacteria, will be performed in each barrier. All standard monitoring costs are included in the weekly cage rental fee. Requests for monitoring services that are not standard to Taconic’s International Health Monitoring Standards (IHMS) program shall be charged to the government as per agreed upon pricing.

Notification of a change in health status will be provided in writing to the CO and COR within 72 hours of receiving test results. There shall be open disclosure to the COR and distribution of test results shall be provided to the COR within 14 calendar days of completion of each test, with sufficient detail to identify the mouse strains that may be affected to include the rack numbers and Line numbers of mice housed on the effected rack.

f. The Contractor shall positively identify animals entering the facility or born thereafter by a reliable numbering system and provide a computerized relational database capable of recording the number, strain, sex, date of birth and/or date of entry. A pedigreed registration log shall be maintained for all pair-bred strains in the foundation colony. A computerized system shall be maintained to record breeder performance and a defined numerical indicator of production efficiency shall be provided to the COR on request. An internet-based inventory and information database shall be maintained to provide the following details on all viable and cryopreserved repository mouse lines: genotypic designation, provenance, research applications, testing protocols, literature references, inventory and availability.

g. The Contractor shall provide, in consultation with the COR, a guideline sheet that provides specific breeding instructions and production goals for each strain held under the contract.

h. The Contractor shall provide the following electronic reports to the COR and CO or those designated by him/her on a schedule as delineated below:

1. Weekly barrier reports. Delivery is due every Friday.

2. Monthly status reports listing concerns involving derivations, inventory, husbandry and genotyping. Delivery is due no later than 5 working days of the start of each month.

3. Monthly invoices.

4. Quarterly guideline sheets providing detailed descriptions, clarifications, and changes of breeding instructions. Delivery due no later than 15 days after the end of each 3-month contract performance period.

5. Monthly shipping reports. Delivery due no later than 15 days after the end of each month contract performance period.

i. The Contractor shall deliver mice to buildings and rooms at NIH as specified by the COR between the hours of 7:00AM and 2:00PM, Monday through Friday, excluding Federal Holidays or other occasions when the Federal Government may be closed due to weather or emergency situations. Delivery is to be made in sterilized transit cages equipped with polypropylene or equivalent type air filters. The mice shall be packed within the barrier unit of origin to maintain their health status and thus permitting entry of the mice directly into all NIAID mouse facilities without quarantine. Notification to the Contractor for such delivery shall be made by 9:00 AM of the day preceding delivery. Preparation of tissue samples for typing shall be scheduled on an individual, first- come, first-served basis.

Blood and tissue samples shall be shipped to the third party identified by the COR, or the requesting Investigator on wet ice unless otherwise specified.

j. The Contractor shall make scheduled deliveries of mice and tissue samples a minimum of twice weekly except for the third week of November. The Contractor shall also be able to achieve next-day delivery under special circumstances (i.e., critical need for a selective group of animals for time-dependent experiments). There shall be no deliveries or acceptance of deliveries on weekends, Federal holidays, or anytime the Federal Government is closed due to weather or emergency situations.

k. The Contractor shall carry out instructions for the culling or breeding of animals within 5 days of written notice from the COR or his designees.

l. The Contractor shall provide facilities and expertise in cryopreservation of mouse embryos.

The Contractor shall be capable of freezing embryos from strains, maintaining them in appropriate liquid nitrogen containers with proper duplication and safeguards to prevent loss in case of power failure or nitrogen leaks and bringing back live animals from them.

Use of the embryos to regenerate an active mouse strain at the Contractor or shipment of frozen embryos to the NIH will be performed if requested by the COR.

3.2 Mouse Care

a. The Contractor shall house all re-derived mice in a facility that achieves a minimum double barrier design. This ensures that no direct contact will occur between the caretakers and the animals and that all barrier-reared mice may be brought into any NIAID available animal facility without undergoing quarantine. All caretaker personnel shall wear the appropriate uniform necessary to maintain the health profile of the animals/colony as determined by the Contractor. The existing barriers holding NIAID animals/colony as of the execution date of this SOW will be classified as Murine Pathogen Free (MPF) and fall under the animal husbandry and health monitoring protocols requisite to the MPF health standard.

b. As requested by the COR, the Contractor shall provide isolators or IVCs for housing problematic strains after re-derivation.

c. The Contractor shall provide all appropriately sterilized caging material (e.g., cages, tops, water bottles), sterile food and bedding.

d. The Contractor shall provide food that shall be NIH-31M autoclavable or of comparable quality as determined by the Government. Bedding shall be hardwood low dust bedding that is free of pesticides and aromatic resins as determined by the Government. Under special circumstances alternative food and bedding may be requested by the Government at its expense.

e. The Contractor shall provide drinking water that has either been hyperchlorinated or acidified (.001 M HCI) and subsequently passed through a series of mechanical filters, ending with two 0.2 microns filters.

f. The Contractor shall replace water, feed and bedding once per week. Replacement cages, food and bedding shall be sterilized at each change.

g. The Contractor shall have a program in place for routine assays of the NIH-31M diet for nutritional content and for monitoring both feed and contact bedding semi-annually for possible chemical contamination.

3.3 Physical Facilities

a. The Contractor shall ensure that building construction and maintenance are in compliance with The Guide for the Care and Use of Laboratory Animals (The Guide). All rooms shall have sealed washable finishes on walls, floors and ceilings.

b. The Contractor shall ensure that the housing, care and use of mice are in compliance with The

Guide.

c. The Contractor shall operate and maintain facilities capable of Opportunistic Flora (OF) Murine Pathogen-Free (MPF) health standards using the concept of a barrier design to minimize acquisition or spread of infectious disease. Barrier personnel are required to don sterilized uniforms and a respirator or surgical mask before entering the barrier area.

Barrier personnel shall have experience using protective equipment.

d. The Contractor shall provide physically separate areas for:

1. Quarantine and receiving

2. Breeding and housing of the mice

3. Storing food and bedding

4. Autoclaving

5. Laboratory space

e. The Contractor shall operate a facility with an independent HEPA-filtered air supply system that is separate from the systems servicing other animal space owned by the Contractor in order to minimize airborne contamination of the barrier.

f. The Contractor shall provide a barrier facility that is physically separated from all other animal facilities managed by the Contractor, i.e., there shall be no common rooms or corridors.

g. The Contractor shall use a vehicle for animal transportation that has a fully enclosed cargo area equipped to provide fresh air without injurious drafts and without allowing the ingress of vehicle exhaust. The cargo area shall be heated and air conditioned as needed to maintain ambient temperature (68-76 degrees). The cargo area shall be cleaned and sanitized prior to loading animals.

3.4 Special Restrictions

a. The Contractor shall be AAALAC International accredited and shall maintain the accreditation throughout performance under this contract.

b. Contractor personnel conducting duties that require handling of NIAID animals/colonies shall follow the Contractor’s documented personnel movement policies intended to secure the biosecurity of all facilities.

3.5 Environmentally Sustainable Acquisition Plan

The Contractor shall make every effort to utilize environmentally preferable products in the execution of this contract. Environmentally preferable products include energy-efficient, water- efficient, biodegradable, bio-based, and those containing recycled content materials.

4.0 Reporting Requirements

a. Weekly Reports

1. Weekly Barrier Reports indicating the location, colony type, total number of boxes in use, number of breeder females and males in use, number of replacement females and males and genotype status for each strain shall be delivered electronically to the NIAID COR every Friday.

b. Monthly Reports

1. Monthly Status Reports shall include the status of all lines that are going through the derivation process, inventory comments on particular lines, comments/issues/concerns on individual lines, the status of genotyping of individual lines and a budget status report and projection. This report shall be delivered electronically to the NIAID COR five workdays after the first of the month.

2. Monthly Shipping Reports shall include all animal usage reported by strain, number, ordering investigator, Z01 project number and date of shipment. The first reporting period consists of the first full three months of performance including any fractional part of the initial month. Thereafter, the reporting period shall consist of three full calendar months.

This report shall be delivered electronically to the NIAID COR no later than 15 days after the end of each three months of contract performance.

c. Quarterly Reports

1. Quarterly Guidelines Reports shall include all current line descriptions, locations, breeding box goals, holding goals, and any other relevant guidelines pertaining to the line’s usage and breeding goals. The first reporting period consists of the first full three months of performance including any fractional part of the initial month. Thereafter, the reporting period shall consist of three full calendar months. This report shall be delivered electronically to the NIAID COR no later than 15 days after the end of each three months of contract performance.

d. Other Reporting Requirements

1. Online Relational Database

Contractor shall maintain a real time, online relational database that is accessible via the Web by users of the contract for purposes of determining the availability of mice for experiments and for accessing information relevant to a specific mouse line. Newly imported mouse lines shall be inventoried on the database as soon as a maintenance-level breeding goal has been reached. The online database shall provide the following details on all viable and cryopreserved repository mouse lines: genotypic designation, provenance, research applications, testing protocols, literature references, inventory and availability.

4.1 Report Format

Reports shall include a cover page formatted as follows:

1. Contract Number and title

2. Period of Performance being reported

3. Contractor's Name and address

4. Author's name and title

5. Report Title (Weekly Monthly, etc.)

6. Date of submission

5.0 Panels and Schedules of Testing

Item

Panels and Testing to be Performed

SOW

Reference

Schedule

1. Virus serology panel 3.1e. Monthly

2. Necropsy, microbiology and serology 3.1e. Quarterly

3. Expanded necropsy, microbiology and serology panels 3.1e. Bi- Annually

4. Comprehensive necropsy, microbiology and serology panels

3.1e. Annually

5. Barrier Monitoring for bacterial opportunists 3.1e. Monthly

6.0 Option [#]: Final Transition:

“Final Transition” is defined as moving all or a portion of contract-related materials to NIAID, the Government, and/or another organization per the request of NIAID, followed by Contractor’s disposal of all contract-related materials remaining at the Contractor and stoppage of all Contractor activities related to the contract. Additional fees required for the preparation and handling of animals and contract-related materials for the Final Transition will be incurred by NIAID. Request for Final Transition and end of the contract requires 6 months advance written notice from NIAID to Contractor. NIAID and Contractor shall collaborate to ensure an orderly, secure, and efficient transition of contract-related materials and activities to the organization identified by NIAID or to the Government. A description of Final Transition activities, timelines, assigned staff, and fees shall be provided by Contractor to NIAID in a Draft and Final Transition Plan, which will be reviewed and approved by the COR. The Draft Transition Plan shall be submitted to the COR for review and approval within 30 days of receiving NIAID’s written request for same, and the Final Transition Plan shall be submitted to the COR and Contracting Officer for review and approval within 60 days of receiving NIAID’s written request for same.

Transition of Mouse Models: For a smooth transition, 8–12-week-old male mice and 3–4-week-old female mice of the appropriate genotypes shall be shipped to the successor for rederivation at least eight to twelve weeks before the end of the contract. The sequence of strains to be transferred and the numbers of male and female mice to be shipped are dependent on the size of the colony required to provide NIAID with the quantity of mice needed to meet the research demand. For example, more popular strains require 250-300 breeding females to meet the ongoing demand of the NIAID research program resulting in a larger number of animals to be transferred to the successor early in the transition, while other colonies require fewer breeding females and may be transferred later in the transition.

Transition of Cryopreserved sperm and embryos: Within 90 days of award, cryopreserved sperm and embryos must be shipped from incumbent to awardee or the Government as directed by the COR, if necessary. Awardee shall be ready to accept, catalog and store embryos, within 30 days of the award.