SSN IRF.pdf

SOURCES SOUGHT NOTICE

NIAID High Containment Integrated Research Facility Fort Detrick, Frederick, MD (IRF-Frederick) 75N93025R00016

Sources Sought Reference Number: HHS-NIH-NIAID-75N93025R00016

Type of Requirement

New Requirement Follow-on (Contract No.: HHSN272201800013C) Other (specify):________________

Place of Performance

Place of performance is unknown at this time.

Place of performance is known. Address or general location: IRF-Fort Detrick, Frederick, MD.

Recompetition (if applicable)

Laulima Government Solutions Corporate Office:

12565 Research Pkwy, Suite 300 Orlando, FL 32826

Contracting Office Address

Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions, 5601 Fishers Lane, MSC 9821, Bethesda, MD, 20892-9821

Sources Sought Notice Information

Introduction

This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible.

An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice.

Background

The National Institute of Allergy and Infectious Diseases (NIAID) conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. Since the establishment of NIAID in 1955, the Institute’s research has led to new therapies, vaccines, diagnostic tests, and other technologies that have improved the health of millions of people in the United States (U.S.)

and around the world.

NIAID has a unique mandate, which requires the Institute to respond to emerging public health threats. Toward this end, NIAID manages a complex and diverse research portfolio that aims to do the following:

• Expand the breadth and depth of knowledge in all areas of infectious, immunologic, and allergic diseases; and

• Develop flexible domestic and international research capabilities to appropriately respond to emerging and re-emerging disease threats at home and abroad.

NIAID’s research portfolio has expanded over the past two decades in response to challenges including bioterrorism and emerging and re-emerging infectious diseases. NIAID Division of Clinical Research (DCR) is actively engaged in clinical research networks world-wide to include conducting clinical trials and emergency responses to outbreaks. Research initiatives are aimed at mitigating the threat of bioterrorism, as well as counteracting emerging infectious diseases associated with hemorrhagic fever-causing viruses such as Ebola, Marburg, Lassa and Nipah viruses, as well as high consequence respiratory pathogens such as SARS-CoV-1, SARS-CoV-2, MERS-CoV, and influenza viruses.

Characterization of novel or newly discovered infectious disease agents is also a priority.

To facilitate its efforts, NIAID created the Integrated Research Facility (IRF-Frederick) as a part of the National Interagency Biodefense Campus located at Ft. Detrick, MD. The IRF- Frederick mission is to serve as a responsive and collaborative resource that facilitates multidisciplinary research to understand, treat, prevent, and eradicate diseases caused by novel, emerging, and highly virulent viruses. The IRF-Frederick serves as a resource for both NIH research scientists and independent investigators. The IRF-Frederick incorporates NIH expertise to perform world-class maximum-containment research. Researchers use well-characterized animal models of human diseases to ask and answer questions that cannot be addressed with classical approaches. The study of disease pathogenesis and intervention strategies is at the core of the IRF Frederick’s portfolio. Leveraging the capabilities of the IRF-Frederick, areas of focus include:

• Establishment and assessment of disease progression in animal models using diverse medical and optical imaging modalities.

• Refinement of established small and large animal models.

• High and maximum containment (biosafety level 3 and 4 [BSL-3/-4]) and animal high and maximum containment (ABSL-3/-4) studies relevant to human disease.

• Establishment and refinement of biological systems, including state-of-the-art 3D and organ-on-chip ex vivo systems.

• Studies that examine therapeutics, vaccines, and other medical countermeasures.

The IRF-Frederick is a specialized biocontainment facility with the appropriate infrastructure to support basic research and animal studies with various infectious disease agents including those requiring the highest level of biocontainment (BSL-4), to evaluate therapeutics, vaccines, and diagnostics as well as to determine the natural history and pathogenesis associated with these agents. Central to the mission of the IRF-Frederick is the ability to develop and use animal models of disease in high and maximum biocontainment laboratories to measure the efficacy of medical countermeasures.

The IRF-Frederick has the rare capacity to employ sophisticated imaging modalities for dissecting pathologies associated with especially dangerous pathogens. Studies are conducted to systematically evaluate the pathogenic processes and clinical courses of disease in animal models exposed to high consequence pathogens using imaging methods such as computed tomography (CT), magnetic resonance imaging (MRI), single positron emission computed tomography (SPECT), and positron emission tomography (PET).

The Management & Operations contract for the IRF-Frederick was initially awarded in 2007, while facility construction was still in progress. Early occupancy was obtained in December 2008 for accommodating administrative functions of core FTE and contract staff. BSL-2 research was initiated in 2010. Substantial completion of the IRF-Frederick was declared in August 2013 and the Division of Select Agents and Toxins of the Centers for Disease Control and Prevention (CDC) granted approval for initiation of BSL-4 research in March 2014 with BSL-4 research initiated in August 2014. The most recent contract supports one hundred and eleven (111) contract positions at the IRF-Frederick.

The incumbent contract #HHSN272201800013C, with Laulima Government Solutions, LLC, was selected through a competitive negotiated acquisition, effective from February 2020 through February 2027.

Purpose and Objectives

The purpose of this contract is to obtain highly skilled scientific, operational, and programmatic support services necessary for the IRF-Frederick at Fort Detrick to manage, coordinate, and facilitate the conduct of research with emerging infectious diseases and biodefense pathogens as directed by the Government in accordance with the portfolio approved by the IRF-Frederick Scientific Steering Committee (SSC) in a timely, professional, and effective manner.

As a result of this Sources Sought Notice, NIAID may issue a Request for Proposals (RFP) if it is deemed necessary and appropriate. THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NIAID shall arise as a result of a response to this Sources Sought Notice or NIAID’s use of such information as either part of our evaluation process or in developing specifications of any subsequent requirement.

Project requirements

Independently and not as an agent of the Government, the contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work as stated herein.

Specifically, the contractor shall:

Provide day-to-day operations of the IRF-Frederick function in three distinct categories:

• Scientific Services – A range of scientific, operational, and programmatic services necessary to ensure the IRF-Frederick meets its research objectives, including imaging services. This effort includes work within a BSL-4 environment.

• Animal Care & Technical Services - Technical services required for the proper care, use and humane treatment of laboratory animals and a wide range of technical skills required for the scientific study and manipulation of animals exposed to infectious agents.

• Administrative Services - Administrative services necessary to ensure that all facets of the IRF- Frederick function effectively and efficiently and that contract personnel are appropriately supervised.

Anticipated period of performance

It is anticipated that a cost reimbursement, term/level of effort, type of contract will be awarded.

The anticipated period of performance for this contract is a one-year base period, with the potential for six (6) additional one-year options for extension. If all options are exercised, the total period of performance would extend to seven (7) years. The Base Period is from 02/18/2027 to 02/17/2028 with 6 Annual Term Options for a total possible period of 7 years. The acquisition includes Quantity Options to account for unanticipated increased need in the Level of Effort.

Options 7-90 allows for increased effort to address unexpected demand, with each option adding 1.0 FTE to support additional research needs, exercisable during the corresponding contract term.

Option 91 allows Option to Extend Services (no more than six (6) months).

Other important considerations

Hours of Operation:

The core hours of the IRF-Frederick are 0700 – 1900 EST/EDT. The majority of work will be performed during the core hours. Due to the nature of the research at the IRF-Frederick, the facility will be in operation 24-hours a day 365-days a year and the contractor will be expected to provide scientific and operational staff outside of the defined core hours when required to execute ongoing studies. Sufficient services shall be provided commencing at a time approved by the Contracting Officers Representatives (CORs), on all Federal Holidays, Saturdays, Sundays, and during Government, NIH, or Fort Detrick closures in order to satisfactorily accomplish regular scientific activities and/or operational project support as required to meet various task goals. Services beyond the core hours of the facility may be required on an ongoing basis in locations where limitations preclude completion of work during core hours such as cleaning, maintenance, or repairs. NIAID reserves the right to alter facility core hours with 30-days advance notice.

Remote work: No positions are designated as remote only and remote work will be at the discretion of the Government. No telework may be performed from outside the United States.

Emergency/Disaster Preparedness:

The contractor shall organize the workforce in a way that critical functions are performed even when unforeseen absences of personnel occur. The contractor shall work with the COR and IRF-Frederick Director to identify personnel designated as "essential employees."

Essential employees are defined as employees whose duties require on-site work at the IRF-

Frederick and who are required to report for duty at the IRF-Frederick during periods of inclement/severe weather, Government furlough, unforeseen circumstances, or other adverse working conditions, even in situations where Fort Detrick and surrounding jurisdictions have been temporarily closed (e.g., furlough), unless their absence is approved by their supervisor. In the event of emergencies and other unforeseen circumstances, personnel may at times be required to vary their work schedules to provide support to the activities of the IRF-Frederick with little, if any, advance notice. This may, during disaster situations, require contractor personnel to remain in the facility or local hotel overnight or for several days until relief becomes available. Emergency services shall be provided outside these hours by an "on call" system 24 hours per day, 365 days per year to maintain facilities, equipment, and research product in the event of emergencies (e.g., relocate specimens related to critical studies in the event of HVAC failures, water main breaks, fire, structural failure, etc.). The contractor shall maintain a current emergency telephone roster to mobilize personnel as required. This roster shall be a deliverable for receipt by the COR within thirty days of contract award and within one day of personnel changes.

The contractor shall provide the COR with appropriate information on emergency personnel that will be part of the developing emergency procedures with NIAID. Subsequent additions and revisions to the SOP’s shall be produced in conjunction with the contractor as deemed necessary by the IRF-F COR. The contractor’s Operations Director shall be responsible for maintaining critical emergency information at the IRF-Frederick and ensuring that all personnel are familiar with the current IRF-Frederick emergency management plan.

Capability statement/information sought

Capability statements submitted as a result of this announcement should demonstrate the offeror's qualification, expertise, and experience, specifically providing evidence as to the capability to immediately perform this requirement. Capability statements should clearly convey information regarding the respondent's capabilities.

Interested contractors must submit a capability statement (five-page limitation, excluding resumes) describing their company's experience and ability to immediately perform this effort, which includes the following:

(1) a summary list of similar work previously performed; examples of prior completed, or active, similar Government contracts, references, and other related information to the work to be performed

(2) the professional qualifications and specific experience of staff who may be assigned to the requirement; organizational experience and management capability to deliver comprehensive services of this scope and magnitude

(3) the professional qualifications and specific experience of staff who may be assigned to the requirement; resumes for proposed key personnel, including the Principal Scientists, which reflect education, and previous work relevant to the proposed requirement; staff expertise, including their availability, experience, and formal and other training

(4) current in-house capability and/or capacity to perform the work, a general description of the facilities, and other resources needed to perform the work demonstrated ability to carry out the work

Capability Statements must not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information. Font size must be 10 to 12 points. Spacing must be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text. Print margins must be at least one inch on each edge of the paper.

Each response should include the following Business Information:

1. UEI number

2. Company Name

3. Company Address

4. Company Points of Contact (both technical and administrative), including names, titles, addresses, telephone and fax numbers and Email addresses

5. Current GSA Schedule appropriate to this Sources Sought if applicable

6. Do you have a Government-approved accounting system? If so, please identify the agency that approved the system.

7. Type of Company (i.e., large business, non-profit, educational institute, small business, 8(a), woman owned, veteran owned, etc.), as validated via the System for Award Management (SAM). All offerors must be registered in the SAM, located at http://www.sam.gov/

Responses must be submitted no later than 5 PM (E.S.T.). Capability statements will not be returned and will not be accepted after the due date. These statements should be submitted electronically (via e-mail) to Matt Lear, Contracting Officer, at matt.lear@nih.gov. These statements should be submitted in Adobe Portable Document Format (PDF); however, capability statements in Microsoft Word will also be accepted. The e-mail subject line must specify HHS-NIH-NIAID-75N93025R00016. Facsimile responses will not be accepted.

Common Cut-off Date:

Electronically submitted, tailored capability statements are due not later than 5 PM (E.S.T.), on April 11, 2025. CAPABILITY STATEMENTS WILL NOT BE RETURNED AND WILL NOT BE

ACCEPTED AFTER THE DUE DATE.

Disclaimer and Important Notes

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published at SAM.gov. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality

No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).”

http://www.sam.gov/