Sources Sought - 75N93025R00019.pdf

SOURCES SOUGHT NOTICE

Clinical Research Operations Core

RFP- 75N93025R00019

Sources Sought Reference Number: 75N93025R00019

Type of Requirement

☒New Requirement

☐Follow-on

☐Other (specify):

Place of Performance

☒Place of performance is unknown at this time

☐Place of performance is known. Address or general location:

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

Through multiple grant- and contract-funded research programs, the National Institute of Allergy and

Infectious Diseases (NIAID), Division of Microbiology and Infectious Diseases (DMID) supports a broad range of clinical research, including single-center and multi-center Phase 0-4 clinical trials of therapeutics and vaccines, including new vaccine formulations, schedules and modes of delivery;

surveillance or natural history, and cohort studies for pathogens of interest; and evaluation of novel diagnostics. Much of this research is devoted to addressing critical public health needs, such as those related to emerging and re-emerging infectious diseases (e.g., SARS-CoV-2, Ebola, influenza, etc.), potential agents of bioterrorism, and (National Institutes of Allergy and Infectious Diseases) NIAID priority pathogens and may include finding additional uses for already approved therapies for selected infectious diseases via clinical trials and clinical studies. These clinical research activities are crucial from a public health perspective because they help guide policy decisions regarding product use and/or facilitate development and evaluation of therapeutic candidates critical to advancing product development and, therefore, aid in public health preparedness.

Purpose and Objectives

The purpose of this pending solicitation is to provide the resources and services needed to implement clinical research in support of NIAID’s mission. This will allow NIAID to respond to public health needs including public health emergencies and produce high quality data supporting regulatory and policy decisions.

Project Requirements

Under the award of the Indefinite Delivery Indefinite Quantity (IDIQ) contract, the future Contractor will support the full range of activities for implementation and conduct of clinical trials using qualified clinical staff with expertise in carrying out all aspects of clinical trial implementation and their operations, biospecimen management, and collaboration specified NIAID grant recipients and

Contractors. The IDIQ contract may also serve as NIAID’s mechanism for responding to emerging infectious diseases by establishing domestic or international clinical trials and clinical research activities.

Anticipated Period of Performance

NIAID anticipates awarding a single IDIQ contract to fulfill the technical requirements of the upcoming solicitation with a ten (10) year period of performance and an ordering period of seven (7) years. The anticipated start date is on or about July 2026.

Other important considerations:

Respondents are expected to respond to all areas, including the Parent Contract and Task Areas A, B, and C. Respondents that do not include a response to the Parent Contract and all Task Areas will be considered non-responsive and will not be evaluated.

Respondents lacking the expertise to address all the technical requirements are encouraged to identify collaborations and partnerships that, through combined expertise, can address all these technical requirements.

Capability Statement/Information Sought

Interested Sources are expected to have the expertise, personnel, and facilities to meet the requirements of the project. Tailored Capability Statements submitted as a result of this notice shall demonstrate and document the offerors’ qualifications and experience, specifically providing evidence as to its capability to perform this requirement, with particular attention to the following technical areas:

1. Relevant experience in design, preparation, and conduct of clinical trials and clinical research activities and associated documents for Phase 0-4 clinical trials. These trials target viral, bacterial, and parasitic infectious diseases; fungal pathogens and toxins; or NIAID Priority

Biodefense Pathogens and emerging infectious diseases.

2. Relevant experience in execution, in compliance with current Good Clinical Practices (GCP) and

US Food and Drug Administration (FDA) regulations, of Phase 0-4 clinical trials to assess safety or efficacy of novel therapeutics or approved/licensed and investigational drugs or biologics.

3. Relevant experience in managing domestic and international clinical trials for products to prevent, diagnose, and treat disease, including knowledge of regulations governing trial operations and product development, and experience engaging constructively with a range of stakeholders.

4. Relevant experience in soliciting, evaluating, negotiating, awarding, managing, remediating problems, and terminating subcontracts in accordance with Federal regulations.

5. Relevant experience in scientific project management in a complex biomedical research environment.

6. Ability to provide personnel who have the training, expertise, and experience necessary to accomplish the work related to design of protocols and associated documents for, and conduct and analysis of, Phase 0-4 clinical trials to determine and safety or efficacy of novel therapeutics or approved/licensed and investigational drugs or biologics.

7. Ability to provide a technical and administrative management infrastructure to ensure the efficient planning, implementation, oversight, and completion of all required activities, while successfully interfacing with various regulatory bodies; and management of subcontractors.

In addition, capability statements shall address the following:

Technical Plan/Approach: appropriateness and adequacy of the plans for conducting all the activities described above.

Facilities/Resources/IT Security: adequacy and appropriateness of the facilities and resources dedicated to the project.

Average number of specific tasks offerors should assume the following will be awarded under the contract. The following list is provided to indicate the general scope of work of the contract:

Assume that the period of performance of task orders may range from less than one year to multiple years. The quantities identified below are estimates only and are provided for informational purposes. The actual quantities may be higher or lower.

Assume that:

• Task Area A: Project Management and Protocol Development

• Execution of Base Period upon contract award

• Task Area B: Protocol Implementation and Clinical Operations

• Execution of three (3) Task Orders in Contract Year 1

• Execution of six (6) Task Orders in following Contract Years 2-7.

• Task Area C: Research Laboratory Analysis

• Execution of two (2) Task Orders every Contract Year, starting in Year 2

Page Limitations:

Interested qualified small business organizations should submit a tailored Capability Statement not to exceed 5 pages, excluding resumes. 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. Print setup should be single sided on standard letter size paper (8.5” x 11” in the U.S., A4 in outside the U.S.).

All proprietary information should be marked as such.

Required Business Information:

• UEI.

• Company Name.

• Company Address.

• Company Point of Contact, Phone and Email address

• Current GSA Schedules and/or Government-wide Acquisition Contracts (GWACs) appropriate to this

Sources Sought.

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

• Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the

System for Award Management (SAM) located at https://www.sam.gov/index.html/#1. This indication should be clearly marked on the first page of your Capability Statement (preferable placed under the eligible small business concern’s name and address).

Number of Copies:

Please submit one (1) electric copy of your response as follows:

All Capability Statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via e-mail) to Chase Sullivan, Contract Specialist, at chase.sullivan@nih.gov in

MS Word or Adobe Portable Document Format (PDF). The e-mail subject line must specify reference number 75N93025R00019]. Facsimile responses will not be accepted.

4.11. Common Cut-off Date

Electronically submitted tailored capability statements are due no later than 3:00 PM (Eastern Time) on

07/02/2025. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE

CONSIDERED.

Disclaimer and Important Notes

This notice does not obligate the Government to award an IDIQ contract or Task Order 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).