N02RC79999-76-LSJ-FINAL-Redacted.pdf

Limited Source Justification

“Source Selection Information – see FAR 2.101 and 3.104”

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity. HHS/National Institute of Health

b. Sponsoring organization. National Cancer Institute/Center for Cancer Research/Surgery Branch

c. Technical Point of Contact information.

Name:

Mailing address:

E-mail address:

Telephone number:

2. Nature and/or description of the action being approved.

a. Acquisition purpose and objectives. The purpose of this acquisition is for off-site storage of biological materials within close proximity to the NIH Bethesda campus.

b. Project background. Off-site storage for biological materials is essential for the support that the Surgery Branch Cell Processing Laboratory (TIL Lab) provides the Immunotherapy Program in the Surgery Branch of the National Cancer Institute.

The storage space is used for refrigerated tissue culture media and components, cryopreserved cells, and frozen tissues from patients with metastatic cancer, and unique biologic reagents for identifying lymphocytes with anticancer activity. Surgery Branch staff use these materials to generate and test trillions of anticancer lymphocytes each year. The lymphocytes, derived from each patient, are used with autologous adoptive cell therapy for patients enrolled in Surgery Branch clinical protocols.

Currently active adoptive cell therapy clinical trials are 08C0121, 09C0082, 09C0161, 10,C166, 11C0011, 11C0013, 11C0123, 11C0260, 11C0266, 12C0111, 12C0114, 12C0116, 13C0093, 13C0214, 14C0022, 14C0052, 14C0058, 14C0062, 14C0104, 14C0110, and 15C0005.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Project title. Offsite storage for human biospecimens used in generating cellular therapy for patients with advanced cancer

b. Project description. Please refer to the attached SOW for specific project details and descriptions.

Requirement type.

Research & development (R&D) R & D support services Support services (non-R&D) Supplies/equipment Information technology (IT) Construction Architect-engineer (A & E) services Design-build Other (specify): ____________________

Type of action.

New requirement Follow-on (Prior contract = GS-07F-6003R_HHSN261201500076U)

Other (specify): ______________________

Proposed contract/order type.

Firm-fixed-price Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ Cost-plus-fixed-fee Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________ Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________ Other (specify): ___________ Completion Form Term form

Acquisition identification number. N02RC79999-76

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

$180,902.22; Period of performance shall be 12 months from date of award.

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

This acquisition is conducted under the authority of 41 United States Code (U.S.C.) 253(c)(__) as set forth in Federal Acquisition Regulation (FAR) 6.302- __.

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).

This acquisition is conducted under the authority of the Multiple Award Schedule Program. Consideration of schedule Contractors will be restricted only to the item/service peculiar to one manufacturer as provided in FAR 8.405-6(a)(1)(i)(B) and FAR 8.405- 6(b).

5. Demonstration of the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

Name and address of the proposed contractor(s).

Fisher BioServices, Inc.

14665 Rothgeb Dr. Rockville, MD 20850 Rockville, Maryland 20850

Nature of the acquisition and proposed contractor(s) unique qualifications.

The Fisher BioServices biorepository facility is within a thirty-minute drive from the NIH campus during non-rush hour conditions, so that materials can be sent and retrieved on short notice and designated Surgery Branch investigators can get to the facility quickly. This is important as the materials are used for supporting ongoing Surgery Branch clinical trials conducted in the NIH Clinical Center. Having a vendor who is not located in close proximity to the NIH Bethesda campus could jeopardize a) the viability of the unique, often times non-replaceable frozen, cryopreserved cells from patients associated with Surgery Branch clinical trials, b) the ability to provide contemporaneous vital patient treatment components requiring rapid transfer of materials from the contract site to the Surgery Branch, and ultimately c) the validity of on-going Surgery Branch clinical trials supported by this contract. The Proposed Vendor has a variety of required qualifications that together are a unique combination: 1) a biorepository facility and organization with demonstrated experience supporting clinical trials; 2) storage records in various media, which are auditable, on a regular basis, and 3) assured integrity and security of the products 24 hours daily, including an equipment monitoring alarm system standby storage units, and emergency reserve tanks of liquid nitrogen for the liquid nitrogen freezers.

Backup power generators are activated automatically within seconds following a power failure or a voltage loss of 25 percent or more.

Generators are tested at least once a week to ensure they are in proper working order with an electrical load test performed at least quarterly.

Access is tightly controlled with a sign-in, sign-out process and continual staff escort of visitors in the specimen storage rooms. The Fisher BioServices facility is able to receive shipments from locations other than the NIH; e.g. from tissue culture media manufacturers, which relieves the storage space shortage in the NIH Clinical Center. They are able to deliver those materials as needed to the NIH Bethesda campus at ambient, wet ice, dry ice, or liquid nitrogen temperatures. The facility can also mail shipments. In addition, the Fisher BioServices repository offers rental freezer space, which is important for meeting peak storage needs of the active Surgery Branch biospecimen inventory.

The Surgery Branch has used Fisher BioServices for storing refrigerated and frozen biospecimens and products related to Surgery Branch clinical trials since January 1, 2008, when Fisher BioServices acquired Cryonix.

Since that time, the Fisher BioServices Bethesda organization and staff at the biorepository have become proficient in supporting the myriad adjustments in Surgery Branch needs associated with supporting clinical trials.

The Surgery Branch has not identified an alternative, independent organization that will meet the requirements described above and in the referenced Statement of Work The adoptive cell therapy clinical trials that the Surgery Branch designs and conducts for treating patients with advanced cancer in the NIH Clinical Center are on-going (See Section 2b above), The performance characteristics and quality of the needed services are required for maintaining the integrity of the on-going trials. A change would be disruptive to the ability to seamlessly continue supporting the clinical trials, and the possibility of destroying any of the unique, irreplaceable materials in transitioning to another Vendor biorepository is too great of a risk to the daily, mission-critical operations of the Surgery Branch. The patients enrolled in these trials receive cell-based therapy derived, in part, from the unique biomaterials being stored in the Vendor’s biorepository.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

A PreSolicitation notice was posted in FedBizOpps.gov (FBO) from Oct. 4, 2016 through Oct. 18, 2016; 3:30PM EDT. No responses were received to this posting.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable, consistent with FAR 8.404(d).

GSA has already determined the prices of most of the supplies and services under FSS contracts, including rates for services offered at fixed hourly and service rates, to be fair and reasonable. The NCI Contracting Officer has concluded that the order represents the best value (see FAR 2.101) and results in the lowest overall cost alternative. In addition, the NCI Contracting Officer will take in to consideration additional discounts given after receipt of quotation and/or negotiations and taking in to consideration the independent government cost estimate.

There is no reason to believe that price will not be fair and reasonable to the Government. A final determination will be conducted prior to the award of this purchase.

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.

Based on the NCI Project Officer and Laboratory staff’s knowledge of the technical, and scientific market place, Fisher BioServices is the only source currently known that can meet the technical requirements of the Statement of Work for this procurement, as stated above.

Searching on GSA eLibrary for SIN 873-2 Laboratory Testing and Analysis Services under Schedule 66 Laboratory Testing and Analysis Services yielded 41 vendors in the United States. 26 of those vendors are small businesses. Of those that were small businesses, only one company, Science Management & Engineering, is located in Maryland.

A-Tek is located in Ellicott City, MD, Science Management & Engineering is located in Silver Spring, MD, and Fisher BioServices is located in Rockville, MD. Due to the locations of A-Tek and Science Management & Engineering, these vendors would not meet the requirement of being 30 minutes by car from the main NIH Bethesda campus during non-rush hour conditions. This requirement is critical due to the nature of these reagents for use in supporting ongoing clinical trials and the need for Investigators to be able to acquire stored materials on short notice.

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

No additional information.

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

A PreSolicitation notice was posted in FedBizOpps.gov (FBO) from Oct. 4, 2016 through Oct. 18, 2016; 3:30PM EDT. No responses were received to this posting.

11. 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.

In the event that additional service is required, the NCI Program Office and the Contracting Officer will conduct market research to determine if the current state of the industry in this geographic location and market has changed, and to determine if there are other sources available that can provide the services required.

12. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

13. Contracting Officer Certification.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Official Name & Title Signature Date

Contracting Officer

Catherine A. Muir Catherine A. Muir -S

Digitally signed by Catherine A. Muir -S DN: c=US, o=U.S. Government, ou=HHS, ou=NIH, ou=People, 0.9.2342.19200300.100.1.1=0014307253, cn=Catherine A. Muir -S Date: 2016.10.19 10:15:22 -04'00'