JA_BRIDGE MRC Operations and Maintenance_OC-2024-115546.pdf

Justification for Other than Full and Open Competition

1. Identification of the agency and contracting activity:

a. Federal agency and contracting activity.

U.S. Food and Drug Administration, Office of Acquisitions and Grants Services, Division of Acquisition Programs, Facilities Support Branch

(FDA/OAGS/DAP/FSB)

b. Sponsoring organization.

Office of the Commissioner, Office of Operations, Office of Facilities Engineering and Mission Support Services, Division of Operations Management and Community Relations, Facilities Maintenance and Operations Branch

(OC/OO/OFEMS/DOMCR/FMOB)

c. Contracting Officer’s Representative (COR)/Requiring Activity Point of Contact (POC) information.

i. Name: Sean Davis

ii. Mailing address: U.S. Food and Drug Administration, MOD 1, 8301 Muirkirk Rd, Laurel, Maryland 20708

iii. E-mail address: Sean.Davis@fda.hhs.gov

iv. Telephone number: 240-402-9437

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

FDA/OAGS/DAP/FSB intends to award, on a sole source basis, a 12-month bridge contract for 24/7 operational and maintenance (O&M) support services in support of the FDA-owned Muirkirk Road Complex (MRC) buildings and facilities to incumbent contractor, NVE Inc.

a. Acquisition purpose and objectives.

The mission of OFEMS is to provide vital facilities and mission support services to meet the needs of its FDA customers and stakeholders nationwide. In support of this mission, DOMCR/FMOB is tasked with ensuring energy management, preventative maintenance, small project oversight, and safe environment and emergency management for all facilities and buildings utilized by FDA customers and stakeholders. Therefore, the need to maintain ongoing facility support services at the MRC is critical to FDA’s overall success.

b. Project background.

The U.S. Food and Drug Administration's (FDA) laboratory research and animal testing facilities located at 8301, 8401, and 8501 Muirkirk Road, Laurel, Maryland 20708 also referred to as Module I, Module II, and Beltsville Research Facility, respectively, is hereafter referred to as the FDA Muirkirk Road Complex (MRC). This complex consists of 195 acres of land.

FDA's Module I (Mod I) was built in 1984 and dedicated in August 1990, consists of 246,853 gross square feet. Mod I, houses research programs for the Center for Food Safety and Applied Nutrition (CFSAN), and Office of Regulatory Affairs (ORA). Research is designed to provide credible scientific information upon which informed decisions can be based. These facilities permit the Agency to improve its science base and address the challenges of the 21st century. Animal studies are conducted according to contemporary scientific standards and in accordance with the Animal Welfare Act and the Guide for the Care and Use of Laboratory Animals, and with the flexibility to keep pace with technological developments. In particular, research is directed to assess significant health questions in areas that include pharmaceuticals, drug interaction, toxicology, and drug chemistry and food nutrition. The facility is accredited by the “American Association for the Accreditation of Laboratory Animal Care” (AAALAC).

Module II (Mod II) houses the Center for Veterinary Medicine (CVM). The facility consists of 18 buildings totaling approximately 100,406 gross square feet and is designed with the most modern equipment available to facilitate the research mission. CVM is responsible for assuring the safety and efficiency of food, drugs, and food additives that will be given to animals. These include animals from which human foods are derived, as well as companion animals. This component of the regulatory testing group performs bioassays using animals.

CVM is also presently AAALAC accredited.

Operational since 1964, the Beltsville Research Facility (BRF) is 35,061 gross square feet.

The facility also houses research programs for CVM. The facility includes the main research building renovated in 2014, a mechanical equipment building, a small block storage building, a maintenance building, three Hazmat containment units used for processing hazardous waste, one machine shop/fitness center building, and one steel storage building.

A need for MRC facility O&M support services has been a recurring requirement performed by small business (SB) contractors since October 2012. The current contract (GS06Q16BQDS115/ HHSF223201810350G), a task order under the General Services Administration’s (GSA) Building Maintenance and Operations (BMO) schedule was awarded by OAGS/DAP/FSB in September 2018 as a competitive SB set-aside for a base period of 12-months, plus five 12-month options to NVE, Inc. All options have been exercised. The contract is set to expire September 30, 2024. The value of the current contract is approximately $32.4M.

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

The requirement for 24/7 O&M support services for all buildings and facilities located within the MRC Complex includes the routine preventative maintenance of all the equipment and buildings, repair, and service of various unplanned and/or emergent non-standard work orders, and seasonal snow and ice removal services. This requirement also includes the facility maintenance and operations for an aquaculture and vivarium. The anticipated 12-month indefinite delivery indefinite quantity (IDIQ) bridge contract will be awarded with a maximum ceiling of $8M. These services are essential to ensure continued operational functionality and performance of the MRC research and animal testing facilities maintained by

OFEMS/DOMCR/FMOB.

a. Project title.

Muirkirk Road Complex (MRC) Operations and Maintenance Support Service Bridge Contract.

b. Project Description.

Please refer to the attached Bridge Statement of Work for Muirkirk Road Complex (MRC) Operational and Maintenance Support Services dated September 6, 2024.

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:

Type of action.

New requirement Follow-on Other: Interim/Bridge

Proposed contract/order type.

Firm-fixed-price Other fixed-price:

Cost-plus-fixed-fee Other cost reimbursement:

Time and materials Indefinite delivery: indefinite quantity to include task orders of various types: firm fixed price, time and material, and labor hour.

Other:

Completion Form Term Form

Acquisition identification number.

OC-2024-115546 / 75F40124R00200

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

The maximum ceiling for the anticipated 12-month contract is $8M.

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

Check the applicable block below based on the acquisition circumstance.

Federal Acquisition Regulation (FAR):

6.302-1 Only one responsible source and no other supplies or services will satisfy agency requirements. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(1) or 41 U.S.C. 3304(a)(1).

6.302-2 Unusual and compelling urgency. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(2) or 41 U.S.C.

3304(a)(2).

6.302-3 Industrial mobilization; engineering, developmental, or research capability;

or expert services. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(3) or 41 U.S.C. 3304(a)(3).

6.302-4 International agreement. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(4) or 41 U.S.C. 3304(a)(4).

6.302-5 Authorized or required by statute. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(5) or 41 U.S.C.

3304(a)(5).

6.302-6 National security. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(6) or 41 U.S.C. 3304(a)(6).

6.302-7 Public interest. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(7) or 41 U.S.C. 3304(a)(7).

13.501(a)(1)(ii) Sole source, including brand name, under Simplified Procedures for Certain Commercial Items. This acquisition is using this justification format, modified to reflect that the procedures in FAR subpart 13.5 were used in accordance with 41 U.S.C. 1901 or the authority of 41 U.S.C. 1903.

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

a. Name and address of the proposed contractor(s).

NVE, Inc 13800 Coppermine RD, Suite 301 Herndon, Virginia 20171-6165.

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

Currently, NVE provides the critical O&M services under a competitive GSA BMO task order [GS06Q16BQDS115/HHSF223201810350G], supporting FDA with essential functions like equipment maintenance, facility operations and repairs, environmental management, and snow removal services. Their performance meets the required standards. The task order, inclusive of all options, expires on September 30, 2024.

Although efforts to re-compete the follow-on acquisition have begun, the new competitive contract cannot be awarded and transitioned prior to the current task order’s expiration. Efforts to define the follow-on requirement scope changes began in early 2024, to include conducting multiple requirements meetings with OFEMS/DOMCR/FMOB. However, due to unforeseen delays, the solicitation is rescheduled for release in Q1 of FY2025. As the MRC O&M services are critical to FDA operations, continuity of services is a necessity.

NVE, as the incumbent service provider, holds a distinctive advantage in continuing to deliver O&M services at the animal research facility. Their on-site team is not only specialized but also security-cleared, with the requisite expertise and familiarity with the unique systems of the 400,000+ square-foot facility, which includes diverse laboratory environments like aquaculture and vivarium spaces. NVE's personnel are also adept in ensuring compliance with the stringent American Association for the Accreditation of Laboratory Animal Care (AAALAC) standards. This certification mandates strict protocols for repairs and services in sensitive research areas, safeguarding both the welfare of the research animals and the integrity of the scientific results.

The facility’s age and existing infrastructure further elevates the need for specialized technical roles such as high-voltage electricians, building automation system technicians, and HVAC mechanics. NVE has consistently managed to place and retain these critical positions, which are essential for the operation and maintenance of the facility’s complex systems, including its expansive boiler and chiller plants and water treatment programs.

Additionally, NVE’s established team and subcontractor network have proven highly capable in responding to the increasing frequency of non-standard work orders for unplanned or emergency projects. Their ability to swiftly mobilize and perform these urgent repairs has been crucial in preventing disruptions that could significantly impair the FDA’s operations and ongoing research efforts.

Transitioning to a new contractor prior to the successful completion of the competitive acquisition process is highly impractical and poses significant risks. Such a transition would likely result in service interruptions, increased operational costs, and offer minimal benefit to the Government. NVE’s ongoing support is critical to ensuring the continuity of essential operations at the facility, safeguarding FDA’s mission. Their familiarity with the facility’s unique infrastructure and their ability to respond to emergencies mitigates risks to personnel, ongoing research, and public safety. Maintaining NVE’s services ensures stability and uninterrupted support during this crucial period.

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

A review of existing GSA schedules and the Small Business Dynamic web search shows there are multiple SB firms capable of providing the required facility support services for the competitive follow-on acquisition. The competitive acquisition is anticipated to be awarded as a commercial services IDIQ, due to the number of non-standard project task orders awarded annually. Therefore, the competitive solicitation will be posted on the System for Award Management (SAM.gov), where the Government will be able to solicit from as many potentially eligible small business concerns as possible.

NVE having recently graduated from the small business program, under the proposed bridge IDIQ will perform as an other than small business and thus are required to submit a subcontracting plan in accordance with Health and Human Services (HHS) subcontracting goals and must seek competitive subcontracting bids in response to each non-standard work order request.

This justification will be publicized, after award, as required by FAR subpart 6.305 on SAM.gov.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

The Government developed an Independent Government Cost Estimate based upon same and/or similar positions and service rates in the marketplace. Additionally, the Government will rely on historical prices paid for same services and will request other than cost and price data to substantiate if the proposed rates and prices are competitively priced. Accordingly, the anticipated cost to the Government will be fair and reasonable because there is substantial and accurate information available to conduct a price analysis and negotiations.

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.

A Notice of Intent (NOI) to sole source was posted to SAM.gov on September 10-16, 2024, which allowed for SBs capable of performing the work to submit their capability statement.

Four expressed written responses were received from:

Upon completion of telecom and/or email discussions with each firm, the FDA determined that the Government had low confidence that the interested parties possessed the requisite staff or experience to assume a successful transition and performance of the 12 month bridge acquisition by September 30. Specifically, each firm failed to provide evidence of their experience in one or more of the following areas: operation of a 24/7 animal research facility, familiarity and maintenance of an aquaculture and vivarium, and facility boiler and chiller operations, to include water treatment facilities. Based on these results, the Government’s position that NVE is the only contractor capable of fulfilling the agency’s needs is substantiated.

Therefore, to ensure the Government does not experience an interruption of its essential MRC O&M services, the current contractor, NVE Inc will maintain services until FDA can reasonably competitively solicit, evaluate, award, and transition the five year follow-on contract during FY25.

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

Procurement history:

(a) Contract Number: HHSF223201210195C (competitive SB open-market acquisition) Period of Performance: October 2012 to September 2018

12. Program Office certification.

This is to certify that the portions of this justification that have been developed 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.

Signature:____________________________________

Sean Davis COR/Requiring Activity POC

Signature:____________________________________

Tracy Wilson Immediate Supervisor and

Head of the Sponsoring Program

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.

Signature:____________________________________

Sheneil R. Green Contracting Officer

Sean C. Davis -S

Digitally signed by Sean C.

Davis -S Date: 2024.09.11 15:50:45 -04'00'

Tracy P. Wilson -S Digitally signed by Tracy P. Wilson -S Date: 2024.09.11 16:07:17 -04'00'

Sheneil R. Green - S

Digitally signed by Sheneil R.

Green -S Date: 2024.09.23 08:55:41 -05'00'