Bridge_JOFOC_for_Recruitment_Services_Contract_Final_1.pdf

SOLE SOURCE JUSTIFICATION FOR

ACQUISITIONS UNDER THE SIMPLIFIED ACQUISITION THRESHOLD

1. In accordance with Federal Acquisition Regulation 13.106-1(b)(1), I hereby determine that the service listed on 68HERD20C0001 is available from only one source, and competition is precluded for the reasons indicated below. There are no substitutes available.

2. This acquisition is restricted to the following source:

Company: MPF Federal, LLC Company Address: 702 Russell Avenue, Suite 400, Gaithersburg MD Company Point of Contact and Phone Number: Anna Gilmore-Hall and (202) 776-0655

3. The service is estimated to cost $178,488.61 and is required begin performance by June 1, 2023.

The service is to support the research programs of the Center for Public Health and Environmental Assessment (CPHEA), Public Health and Integrated Toxicology Division (PHITD), U.S. Environmental Protection Agency (EPA).

Mission critical services include the recruitment, screening, testing, scheduling, payment, and other incidental support activities for paid volunteer subjects participating in clinical and epidemiological studies.

PHITD studies are also included. The PHITD research programs are conducted in the EPA 's Human Studies Facility (HSF) located on the campus of the University of North Carolina at Chapel Hill (UNC-CH), Chapel Hill, North Carolina, as well as off-site. Research is conducted by staff from the EPA, UNC-CH, guest and visiting researchers, and other organizations granted privileges to conduct research studies by PHITD.

For example, PHITD clinical and epidemiological studies projects typically involve:

• measurement of human health effects endpoints associated with controlled exposures to environmental pollutants such as ozone, carbon monoxide, volatile organic compounds, sulfur dioxide, particulate matter, nitrogen oxides, diesel exhaust, and noise, either alone or in combinations, and occasionally in combination with drugs or other substances;

• measurement of human health effects endpoints associated with environmental exposures in the atmosphere

• in vitro exposures of cells or fluids to known or suspected toxicant agents;

• physiological and neurobehavioral assessment of populations potentially exposed to toxicant agents; and/or

• pharmacokinetics and dosimetry studies that characterize the fate and clearance of environmental agents.

Developed by Virtual Acquisition Office™ for Federal Government use and customization.

This requested Bridge Justification for Other than Full and Open Competition (JOFOC) is for two (2) one (1) month option periods to be extended onto EPA Contract 68HERD20C0001.

The recruitment and support services for human research are critical to the research being conducted by National Health and Environmental Effects Laboratory (NHEERL)/ Environmental Public Health Division (EPHD) at Chapel Hill while the new contract award is being finalized. The contract provides the recruitment, screening, testing, scheduling, payment, and other incidental support activities to support human research. A lapse in contractual support would have an adverse impact on the EPA. Because of the urgency of this requirement, only one source will be solicited. The service must be performed, beginning 6/1/2023. If the required performance is not met, the agency would be adversely impacted in the following way by not being in compliance with regulations set forth by EPA.

Currently this recruitment contract supports LOCONOZ, REPEATCAP, CRU, and FACEFIT along with three UNC studies SMOKISONE, SMOKEYSAL, and SMOKESCREEN. Additionally, these studies are all in support of research for PHITD, performing clinical research to access the impact of environmental exposures on human health by developing and validating biological measures in aspects of human health. All of these studies involve Human Subjects Research. Every project involving Human Subjects Research conducted or supported by the EPA goes through multiple levels of approval. All Human Subjects Research projects must be approved by the Human Subjects Research Review Official (HSRRO) before any work involving human subjects can begin. EPA conducted or supported studies must also comply with EPA Order 1000.17A, Policy and Procedures on Protection of Human Subjects in EPA Conducted or Supported Research. Part of this requirement is for monitoring the conduct of the study for compliance with the agreed upon procedures and methods for protecting the rights and welfare of human subjects. Such monitoring may involve various management techniques such as site visits, documentation review, and communication with the researchers. MPF is moreover the first point of contact if any existing or previous volunteer need to contact the medical station in the event they have any issues related to a study.

Therefore, due to a lapse in service on this contract, EPA would not be able to ensure compliance with EPA Order 1000.17A. Moreover, if this contract was to expire, EPA would have no way to recruit, screen, test, schedule, or pay volunteers for participating in these studies which would ultimately lead to their cancellation.

5. Check and fill in all that are applicable:

The material or service must be compatible in all aspects (form, fit, and function) with existing systems presently installed. The current equipment is <insert description of current equipment>, and the new item/service must coordinate, connect, or interface with the existing system by <insert description of how the new item/service must coordinate or interface>.

A patent, copyright, proprietary data, or licensing agreement limits competition. The proprietary data are described as follows:

Developed by Virtual Acquisition Office™ for Federal Government use and customization.

<Insert description>

These are "direct replacement" parts/components for existing equipment.

Other information to support a sole-source buy:

MPF Federal, LLC is the only contractor that can perform this service considering the short period of performance contemplated. No other contractor could transition this workload from MPF Federal, LLC and efficiently continue performance without potential for reduced services, increased costs, and unnecessary risks to the Government. Given MPF Federal, LLC’s current contract expires on 5/31/2023 and a new award is close to being completed, there is insufficient time to conduct a another contract procurement for recruitment services. Therefore, an extension to the current contract is required to continue services.

CERTIFICATION

I certify that statements checked and information provided above are complete and correct to the best of my knowledge. In accordance with FAR 13.106-1(b)(1). The facts of this acquisition preclude the use of full and open competition.

Digitally signed by ALBERT

LITTLE

Date: 2023.05.16 17:49:37 -04'00'

Al Little Date Project Officer

Patrice Cunningham Date Contracting Officer

ALBERT LITTLE

5/16/23

5/16/23