Sources Sought Notice.pdf

SOURCES SOUGHT NOTICE

EVALUATION AND TESTING SERVICES FOR VACCINES AND OTHER

BIOLOGICS FOR INFECTIOUS DISEASES (ETSV)

75N93023R00026

Sources Sought Reference Number:__ 75N93023R00026__

Type of Requirement

New Requirement Follow-on (Contract No.:___ _) Other (specify):_

The purpose of the planned solicitation is to recompete the current Evaluation and Testing Services for Vaccines and Other Biologics for Infectious Diseases contract in place whose period of performance ends in September 2028.

Place of Performance

Place of performance is unknown at this time Place of performance is known. Address or general location:_______________

Re-competition (if applicable)

HHSN272201800013I

Battelle Memorial Institute 505 King Avenue Columbus, OH 43201

Contracting Office Address

Department of Health and Human Services, National Institutes of Health, National Institutes 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

Research supported by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), strives to understand, treat, and ultimately prevent the myriad infectious, immunologic, and allergic diseases that threaten millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research for the investigation, control and prevention of diseases caused by all infectious agents other than HIV. Support for basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics is provided through a variety of research grants and contracts. DMID also supports an array of research resources and services to assist investigators, including programs that provide or make available genomic data and technologies; organisms and state-of-the-art reagents; biocontainment facilities; and preclinical and clinical translational research services (https://www.niaid.nih.gov/research/resources?search=dmid).

The development and introduction of new vaccines and biologics against potential agents of bioterrorism, drug-resistant pathogens, emerging and reemerging infectious diseases, as well as infectious diseases prevalent in resource-limited countries remain a high public health priority.

To assist in filling these public health gaps, the NIAID requires a coordinated evaluation and testing services program to provide preclinical, non-clinical, and clinical testing support for multiple vaccine and biologic candidates that emerge from academia, the private sector, or other sources. The suite of testing services will encompass those activities commonly associated with the testing of vaccine and biologic products for infectious disease required for Investigational New Drug (IND) application and/or Biologic License Application (BLA). Consequently, DMID recognizes that to obtain the full spectrum of expertise or facilities required to perform all activities set forth in the solicitation, individual organizations will likely need the expertise and resources of other organizations or persons through consortia agreements, partnerships, subcontracts, and/or consultants. The Contractor shall be responsible for all work performed and shall be responsible for project planning, initiation, implementation, management, and communication; evaluation, selection, and management of subcontractors; and for all deliverables specified in the contract and each awarded Task Order.

Purpose and Objectives

The purpose of the solicitation will be to recompete a NIAID resource entitled “EVALUATION

AND TESTING SERVICES (ETS) FOR VACCINES AND OTHER BIOLOGICS FOR

INFECTIOUS DISEASES” that provides a suite of preclinical, non-clinical, and clinical testing services for vaccines and other biologic products. While the overall suite of testing services is comprehensive, the intent is to provide individual services on a case-by-case basis for a diverse https://www.niaid.nih.gov/research/resources?search=dmid collection of vaccine and biological product candidates, rather than carry a single product candidate through an entire preclinical development pathway. These services are intended to help a wide variety of investigators in a broad number of scientific areas obtain critical data needed to acquire additional funding, gain prospective partnerships (either for further development or to support Phase I/II/III clinical trials), fulfill regulatory requirements, and complete studies needed to apply for an IND and enter Phase I/II/III clinical trials. These testing capabilities may also support vaccines or other biological products that are intended to interrupt or block pathogen transmission (such as vector-borne diseases) or for use in animals that constitute a disease reservoir for, or other disease threat from, a pathogen that has public health significance. Support for efforts associated with zoonotic diseases may be considered on a case-by-case basis dependent on adequate justification for public health considerations.

Project requirements

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, materials, equipment, and facilities, not otherwise provided by the Government as needed to perform the tasks below. The Contractor shall be prepared to develop a response to individual Task Orders as they are assigned and to specify the methods it will employ in accomplishing the key components of each Task Order. The Indefinite Delivery/Indefinite Quantity (IDIQ) contract will be administered and used primarily to support DMID initiatives as necessary to help the Division accomplish its mission.

Contracts awarded from the solicitation will provide the capacity and capability for evaluation and testing services to support preclinical, non-clinical, and clinical studies for promising candidate vaccines and other related biologics when such products emerge from investigator-initiated research studies or other sources identified by NIAID Program staff. These testing capabilities support early feasibility through Phase III clinical studies, to 1) provide the ability to combine, develop, test, evaluate and refine different evaluation and testing technologies from multiple developers; 2) create capacity for the evaluation and testing of candidate vaccines and other biologics for infectious diseases and/or related toxins; 3) increase the federal government’s response to emerging disease threats; and 4) improve surge capabilities. The Contractor shall also provide appropriate documentation and support for pre-IND, IND, and BLA submissions.

Specific Task Orders will depend on the status of the candidate(s) as part of an overall product development plan and/or regulatory submission plan to the U.S. Food and Drug Administration (FDA). NIAID will issue a Task Order Request for Proposal after determination of a specific need that is appropriate to the Statement of Work. The Contractor shall be prepared to develop a response in which the Contractor specifies the methods it will employ in accomplishing the key components of each Task Order and the associated costs. The needs, funding, product maturity and timelines of the product as specified in the Task Order establishes requirements for compliance with current Good Laboratory Practices (GLP) and CGMP [21 CFR Parts -11, -58, - 210, -211, -600].

The services shall be directed at the following:

• diseases caused by pathogens and toxins on the NIAID Category A, B, and C Priority Pathogens list (https://www.niaid.nih.gov/topics/biodefenserelated/biodefense/pages/cata.aspx)

• emerging and reemerging infectious diseases;

• antimicrobial resistant and multi drug resistant infections;

• other bacterial infections;

• fungal infections;

• viral infections excluding HIV; and

• parasitic diseases.

The Contractor shall be required to carry out, either directly, or through its partners, collaborators, subcontractors, and/or consultants, the Scope and Activities defined in the following four Task Areas. All Offerors must submit separate proposals to Task Area A and at least one other Task Area, in any combination (from Task Areas B, and/or C and/or D). Offerors must submit one proposal per Task Area proposed. If submitting to all four Task Areas, you are required to submit four separate proposals. Technical Requirements will be defined in the individual Task Orders. The Technical Requirements have been assembled into the following Task Areas:

Task Area A: Administrative and Management Support Activities

Task Area B: Assay Development, Clinical and Non-clinical Sample Testing

The scope of activities under Task Area B includes assay development activities including qualification of assays and if required validation of assays. This Task Area also includes testing of clinical and non-clinical samples provided from internal and external sources. This scope includes providing reagent control, assay control, assay monitoring, and statistical review to support the conduct of the analysis. The Contractor shall conduct tasks in accordance with quality oversight that is appropriate to the phase of product development; under the appropriate level of biocontainment (BSL-2, BSL-3, BSL-4); and within all applicable and current Federal, state, and local laws, codes, ordinances, and regulations, as well as all Public Health Service (PHS) Safety and Health provisions.

Task Area C: Non-clinical Immunogenicity and Efficacy Testing

The scope of Task Area C includes the design, development, qualification and if required validation of in vitro and in vivo assays as needed for characterization and testing of a vaccine, vaccine component, or other biologic. Other activities under this Task Area include method assessment/feasibility studies, method comparability studies, redevelopment or improvement of existing assays, and technology transfer of assays to/from other facilities.

The Contractor shall conduct tasks in accordance with quality oversight that is appropriate to the phase of product development; under the appropriate level of biocontainment (BSL-2, BSL-3, BSL-4); and within all applicable and current federal, state, and local laws, codes, ordinances, and regulations, as well as all PHS Safety and Health provisions. The Contractor shall be https://www.niaid.nih.gov/topics/biodefenserelated/biodefense/pages/cata.aspx responsible for the acquisition, care, and housing of animals in an appropriate level bio-containment facility, and ensuring all work is conducted in accordance with the Animal Welfare Act and Public Health Service Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/phspol.htm), including the implementation of an animal care and use program and an animal use protocol approval process.

Task Area D: Safety and Toxicity Testing including specialty toxicology

The scope of activities under Task Area D includes designing and performing IND-enabling Good Laboratory Practice (GLP) compliant testing of products as required prior to initiating human clinical trials. This scope includes testing of candidate products for safety and toxicity by in vitro tests, small animal studies, and studies in non-human primates as required by the FDA.

This scope also includes any additional testing required by the FDA which may include biodistribution studies and reproductive toxicology studies. These studies shall be performed in accordance with GLP regulations (21 CFR 58).

The Contractor shall conduct tasks in accordance with quality oversight that is appropriate to the phase of product development; under the appropriate level of biocontainment (BSL-2, BSL-3, BSL-4); and within all applicable and current Federal, state, and local laws, codes, ordinances, and regulations, as well as all PHS Safety and Health provisions. The Contractor shall be responsible for the acquisition, care, and housing of animals in an appropriate level bio-containment facility, and ensuring all work is conducted in accordance with the Animal Welfare Act and Public Health Service Policy on Humane Care and Use of Laboratory Animals (https://olaw.nih.gov/policies-laws/phs-policy.htm,) including the implementation of an animal care and use program and an animal use protocol approval process.

NIAID anticipates awarding multiple Indefinite Delivery/Indefinite Quantity (IDIQ) contracts that provides a guaranteed minimum award to the organization or consortium that best meets the overall qualifications needed to fulfill the technical requirements of the solicitation. Sample Task Orders will be provided in the solicitation solely to evaluate offeror responses and capabilities.

Task Orders for specific tasks will be issued after award of the Contract.

Task Order(s) may be comprised of only one Task Area or may be a combination of multiple Task Areas. Technical Requirements will be defined in the individual Task Orders. The list below represents the average number of specific tasks Offerors should assume to perform each year under the contract. This 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.

Task Area Title Estimated No.

of Awards/year

A Administrative and Management Support Activities – Task Area A

To each awardee

B Assay Development – Sample Task Area B 2 http://grants.nih.gov/grants/olaw/references/phspol.htm https://olaw.nih.gov/policies-laws/phs-policy.htm

B Non-Clinical and Clinical Sample Analysis – Sample Task Area B 2

C Non-Clinical Immunogenicity & Efficacy– Sample Task Area C 2

D Safety and Toxicity Testing – Sample Task Area D 3 This Table represents estimated number of task orders. Some of the task orders will crossover from one area to another.

Anticipated period of performance

NIAID anticipates awarding multiple Indefinite Delivery Indefinite Quantity (IDIQ) contracts to fulfill the technical requirements of the upcoming solicitation with an ordering period of seven

(7) years. The anticipated start date is on/or about August 2025.

Capability Statement / Information Sought

Capability Statements should clearly convey information regarding the respondent’s capabilities including: (1) staff expertise, including their availability, experience, and formal and other training; (2) current in-house capability and capacity to perform the work; (3) prior completed projects of similar nature; (4) corporate experience and management capability; and (5) examples of prior completed Government contracts, references, and other related information.

Interested Offerors/organizations must submit a capability statement describing their company’s experience and ability to perform this effort that includes the following:

(1) a summary list of similar work previously performed; (2) the professional qualifications and specific experience of staff who may be assigned to the requirement;

(3) resumes for proposed key personnel, including the Principal Investigator, that reflect education, and previous work relevant to the proposed requirement; (4) a general description of the facilities and other resources needed to perform the work; (5) demonstrated ability to carry out the work; (6) adequacy of the documented experience with, and appropriateness of plans for: (a) receiving, formatting, storing and shipping compounds and biological agents; (b) technology transfer processes; (c) shipping, handling and storing of reagents and formulated vaccine and biologic products, and highly infectious Select Agents; (d) shipping, handling and storing of highly infectious Select Agents; (e) experience working with potential biohazards, toxic chemicals, and radioisotopes; and (f) adequacy of the plan for training, implementation, and monitoring of safety procedures; (7) availability of adequate facilities, equipment, and resources with sufficient capacity necessary to safely and efficiently accomplish the work described in the Statement of Work in a timely manner, to include documented access to BSL-2, BSL- 3, and BSL-4 facilities; (8) perform work in accordance with the following guidelines:

“Biosafety in Microbiological and Biomedical Laboratories”, Centers for Disease Control and Prevention and the National Institutes of Health, Sixth Edition 2020 (https://www.cdc.gov/labs/BMBL.html); and Federal Guidelines for Research involving Recombinant DNA molecules at (https://osp.od.nih.gov/policies/biosafety-and-biosecurity-policy#tab2/) https://www.cdc.gov/labs/BMBL.html https://osp.od.nih.gov/policies/biosafety-and-biosecurity-policy#tab2/ https://osp.od.nih.gov/policies/biosafety-and-biosecurity-policy#tab2/

Page Limitations:

Interested qualified small business organizations should submit a tailored Capability Statement not to exceed five 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 Europe). 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/. This indication should be clearly marked on the first page of your Capability Statement (preferably 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 Mrs. Sharee Richardson, Contract Specialist, at sharee.richardson@nih.gov in MS Word or Adobe Portable Document Format (PDF). The e-mail subject line must specify SBSS-HHS-NIH-AI-75N93023R00026. Facsimile responses will not be accepted.

Common Cut-off Date:

Electronically submitted tailored capability statements are due no later than 04:00 PM (Eastern Prevailing Time) on April 22, 2024. CAPABILITY STATEMENTS RECEIVED AFTER THIS

DATE AND TIME WILL NOT BE CONSIDERED.

https://www.sam.gov/

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 in Federal Business Opportunities.

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).”