Radiological or Nuclear Medical Countermeasure Product Development Support (PDS)

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

World events have underscored the escalating threat of terrorism in its various forms, including the 1995 Oklahoma City bombing, the 1995 Tokyo sarin gas attack, and the September 11, 2001, terrorist attacks in the United States. Additionally, nuclear disasters such as the Fukushima Daiichi meltdowns and explosions on March 11, 2011, have heightened awareness of radiation exposure risks to civilians. Furthermore, global unrest in regions such as Ukraine and Middle East  has intensified concerns about the potential use of chemical, biological, and radiological/nuclear weapons. Radiological or nuclear attacks could involve the use of stolen or improvised nuclear devices, assaults on nuclear power plants or reactors, the detonation of radiological dispersal devices (commonly known as "dirty bombs," which combine radioactive material with conventional explosives), or the placement of radiation sources in public locations, food, or water supplies.

The effects of radiation on the body may appear within minutes or develop many years after exposure. Radiation injury is directly proportional to the dose absorbed by the body and radiosensitive tissues. Depending on the dose of whole-body or partial-body exposure to external radiation, the effects can range from an increased risk of cancer years after exposure to more acute effects, including transient nausea and vomiting; hematopoietic and gastrointestinal injury, leading to immunosuppression and infection; metabolic abnormalities; hemorrhage and anemia; damage to the cardiovascular, pulmonary, and central nervous systems; and death.

The Government intends to award one Indefinite Delivery, Indefinite Quantity (IDIQ) contract to support these activities. Task Orders will be issued in the following areas:

• Task Area A: Administrative and Technical Support
• Task Area B: Animal Model and New Approach Methodologies (NAMs) Development, and Efficacy Testing of Candidate MCMs
• Task Area C: Non-Clinical Studies in Support of Investigational New Drug (IND)/New Drug Application (NDA)/Biologics License Application (BLA) Submissions
• Task Area D: Chemistry, Manufacturing, and Control (CMC) Support
• Task Area E: Phase I Clinical Studies and Support

Purpose and Objectives

Ionizing radiation exposure can cause both immediate and long-term injuries to multiple organs, including the hematopoietic, gastrointestinal, cardiovascular, and central nervous systems, as well as the skin and mucosal tissues. This underscores the urgent need to develop clinical tools and strategies to treat multi-organ injuries and restore the function of critical organs after exposure. Despite advancements in counteracting the immediate effects of hematopoietic acute radiation syndrome (H-ARS), significant gaps remain in developing treatments for other radiation sub-syndromes and the persistent inflammation that follows acute radiation exposure. To address these needs, NIAID is issuing a Request for Proposals (RFP) entitled “Radiological or Nuclear  Medical Countermeasure Product Development Support (PDS).”

Project requirements

The purpose of the proposed solicitation, entitled “Radiation/Nuclear Medical Countermeasure Product Development Support,” is to recompete the effort to provide facilities, expertise, and capabilities for the development of radiation/nuclear medical countermeasures (MCMs) for 1) the mitigation or treatment of ARS and delayed effects of acute radiation exposure (DEARE). The Contractor will not identify or conduct basic research on new medical countermeasures. NIAID anticipates that products selected by the government for screening, testing, and development will come from industry, academia, and government agencies. The work to be performed under this contract will be initiated by NIAID.

NIAID intends to solicit proposals for a multi-year Product Development Contract that will encompass some or all of the work described below, depending on contract type and program need:

• Animal models of radiation injury;
• MCM testing in animal models of radiation injury;
• Sample collection to detect biomarkers for radiation injury;
• The spectrum of existing and planned IND-enabling product development support;

• Performing animal safety studies, including pharmacokinetic and pharmacodynamic assessments;
• Managing manufacturing and formulation processes;
• Overseeing quality assurance activities;
• Conducting Phase I Clinical Studies.

SCOPE

The Contractor shall establish a robust research and development framework to facilitate the progression of candidate MCMs towards obtaining FDA approval, licensure, or clearance. This infrastructure should focus on the following key areas: 1) mitigation and treatment of ARS and DEARE; 2) management and treatment of internal radionuclide contamination; and 3) support for biodosimetry efforts. This comprehensive approach will ensure that promising MCMs and biodosimetry tools are effectively developed, rigorously tested, and made available for public health medical preparedness and response use.

This IDIQ will be administered and used primarily to support NIAID Radiation and Nuclear Countermeasures Program (RNCP). However, Task Orders under this IDIQ may be initiated to support other NIAID medical countermeasure programs as necessary to help accomplish their mission.

GENERAL TASK ORDER REQUIREMENTS

The following requirements shall apply to each Task Order:

The activities carried out under this contract will adhere to the product development pathway outlined by the FDA Animal Rule, unless it is more appropriate to follow the traditional product development pathway. The FDA Animal Rule is typically used when it is not feasible or ethical to test the efficacy of certain products in humans. Therefore, the FDA will likely rely on data and information from adequate and well-controlled or Good Laboratory Practice (GLP) pivotal animal efficacy studies conducted under the Animal Rule. This is detailed in the Code of Federal Regulations (CFR) Title 21, Parts 314.600 (Subpart I) for drugs (https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-314/subpart-I) and 601.90 (Subpart H) for biologics (https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-601/subpart-H). For further guidance, the FDA has developed a document titled "Product Development under the Animal Rule" (https://www.fda.gov/downloads/drugs/guidances/ucm399217.pdf) and an Animal Model Qualification Program https://www.fda.gov/drugs/drug-development-tool-ddt-qualification-programs/animal-model-qualification-program-amqp).

1. All Task Orders involving animals shall be conducted in compliance with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, including environmental enrichment (http://grants.nih.gov/grants/olaw/references/phspol.htm). Furthermore, animal facilities utilized by the Contractor must maintain:

1. 1. Full and continuous accreditation by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC; https://www.aaalac.org/accreditation-program/rules-of-accreditation/) or equivalent;
   2. Current licensure with the US Department of Agriculture for animals covered under the Animal Welfare Act, or equivalent; and
   3. Current Animal Welfare Assurance number on file with the Office of Laboratory Animal Welfare (OLAW; http://grants.nih.gov/grants/olaw/olaw.htm), or equivalent.

1. The Contractor must be capable of satisfying GLP (21 CFR 58), current Good Manufacturing Practice (cGMP, 21CFR 210, 211, 314, 600, 610, 801, 803, 807, 812, 814, 820, 1270, 1271 and ICH Q1-Q12) and Good Clinical Practice (GCP, 21 CFR 11, 50, 54, 56, 812, 814, and ICH E6) requirements to address the need for submission of data and reports to the FDA.

1. The below-described Task Area E: Phase I Clinical Studies and Support will involve the use of human subjects. The rights and welfare of human subjects involved in research under this contract shall be protected in accordance with 45 CFR Part 46 and HHSAR 352.270-4 Protection of Human Subjects.

DESCRIPTION FOR INDIVIDUAL TASK AREAS

A.    TASK AREA A: Administrative and Technical Support

1. 1. 1. Scope of Task Area A: Conduct administrative and technical activities on a recurring basis to support all Task Orders awarded under the base contract.
      2. Requirements for Task Area A: The contractor shall have the capability to manage the various activities and units, including subcontractors, required for the execution of work performed under this contract. This includes Task Order and financial management, general administration, quality assurance and quality control, communications, data management, study specimen and document management, and regulatory activities.

B.    TASK AREA B: Animal Model and New Approach Methodologies (NAMs) Development, and Efficacy Testing of Candidate MCMs

1.  Scope of Task Area B: Develop, refine, and maintain animal and NAMs models of radiation injury and perform MCM efficacy studies (e.g., evaluation, characterization, optimization, and GLP protocols) and other supporting work, such as mechanism of action studies for candidate MCMs in models relevant for radiation exposure studies.

2.    Requirements for Task Area B: The contractor shall provide facilities, expertise, and scientific oversight necessary for performing model development, efficacy studies, and other supporting studies as directed by NIAID. Facilities where animal studies are performed must have the necessary accreditation, licensure, or assurance listed in section 3A1-3.  Facilities where irradiations are performed must have the necessary national, state, and local licensure or the equivalent. Facilities proposed for GLP studies must document GLP capabilities.

C.    TASK AREA C: Non-Clinical Studies in Support of Investigational New Drug (IND)/New Drug Application (NDA)/Biologics License Application (BLA) Submissions

1.   Scope of Task Area C: Test candidate MCMs for safety and/or toxicity and perform pharmacology studies as required to support their clinical use in humans.

2.   Requirements for Task Area C: The contractor shall provide facilities and staff capable of performing studies in compliance with Good Laboratory Practice (21 CFR Part 58).

D.    TASK AREA D: Chemistry, Manufacturing, and Control (CMC) Support

1. 1. 1. Scope of Task Area D: Manufacture candidate MCMs to support clinical use, including formulation development (including pediatric and special population formulations), stability testing, and current cGMP manufacture of drug candidates.

2.   Requirements for Task Area D: The contractor shall provide facilities and staff capable of drug and biologics manufacturing, testing, and formulation in compliance with current Good Manufacturing Practice (21CFR 210, 211, 314, 600, 1270, 1271 and ICH Q1-Q12).

E.    TASK AREA E: Phase I Clinical Studies and Support

1. Scope of Task Area E: Conduct Phase I safety (including safety, tolerability, pharmacokinetic, pharmacodynamic, absorption, distribution, metabolism, and excretion) studies on candidate MCMs.
2. Requirements for Task Area E: The contractor shall provide facilities and staff capable of performing studies in human volunteers in compliance with Good Clinical Practice (21 CFR 11, 50, 54, 56, 812, 814, and ICH E6).

Anticipated period of performance

It is anticipated that a single Indefinite Delivery, Indefinite Quantity (IDIQ) type contract will be awarded on or about July 1, 2027, for a period of 7 years, through June 30, 2034. Task Orders to be issued against the Base contracts will primarily be cost-reimbursement type, both term and completion form.  The Government reserves the right, however, to issue fixed-price type Task Orders, when appropriate.

The Government anticipates awarding the following number of Task Orders each year.  This list is provided to indicate the general scope of work of this contract and should be considered an estimate only.

Task

Area

Title

Estimated No. of

Task Orders Per Year

A

Administrative and Technical Support

1 with 6 options for additional 12-months each

B

Animal Model and New Approach Methodologies (NAMs) Development, and Efficacy Testing of Candidate MCMs 

2 per year

C

Non-Clinical Studies in Support of IND/NDA/BLA submissions

4 over the course of the contract’s total 7-year performance period

D

Chemistry, Manufacturing and Control (CMC) Support

2 over the course of the contract’s total 7-year performance period

E

Phase I Clinical Safety Studies and Support

1 over the course of the contract’s total 7-year performance period

At this time, upon award of the Base contracts for this single award IDIQ, the Government anticipates awarding one task order as follows:

Task Order #A-1, Administrative and Technical Support. The period of performance will be for a one (1) year (Base Period), plus 6 one-year options (terms) that may be exercised by the Government unilaterally, for a total possible performance period of seven (7) years, beginning on or about July 1, 2027.  The requirement will be for the delivery of 4.10 full time equivalents (FTEs) per year, for the Base Period (Year 1), and 4.10 FTEs per year for Options 1-6 (Years 2-7). The FTEs is inclusive of subcontractor and consultant effort.

Task Order #B-1, Animal Model and New Approach Methodologies (NAMs) Development, and Efficacy Testing of Candidate MCMs. The period of performance will be for one (1) year (Base), beginning on or about July 1, 2027.  The estimated effort will be for the delivery of 4.70 full time equivalents (FTEs). The FTEs is inclusive of subcontractor and consultant effort. The estimated effort is just an estimate and should not be considered restrictive.

Other important considerations

N/A

Capability statement/information sought

Interested contractors must submit individual capability statements for each Task Areas A through E (ten page limitation per Task Area, excluding resumes) describing their company’s experience and ability to perform this effort. Capability statements submitted as a result of this announcement should demonstrate the Offeror’s qualifications, expertise and experience, specifically providing evidence as to the capability to perform this requirement. Capability Statements should clearly convey information regarding the respondent’s capabilities, including: (1) a summary list of similar work and scope 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, which reflect education, and previous work relevant to the proposed requirement; (4) a general description of resources needed to perform the work; (5) corporate experience and management capability; (6) examples of prior completed Government contracts, references, and other related information; (7) demonstrated ability to carry out the work; and (8) brief description of the quality control methods that will be used to ensure the effective and efficient initiation, implementation, management, and oversight of contract requirements.

NIAID recognizes that no single organization or institution may have the expertise and facilities required to perform all of the tasks mentioned above. Therefore, the Contractor may need to utilize the expertise and resources of subcontractors and specialized consultants to provide the full spectrum of requested activities. The Contractor shall be responsible for ALL work performed under this contract including that performed by any subcontractors and consultants. The Contractor will ensure that any and all processes meet international, federal, local and state regulations to ensure the continuity and validity of the resulting product.

Page Limitations:

Interested qualified small business organizations should submit a tailored Capability Statement not to exceed 10 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:

• Unique Entity Identifier (UEI) number
• 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://sam.gov/content/home. 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) electronic 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 Karen Telphia, Contracting Officer, at karen.telphia@nih.gov in MS Word or Adobe Portable Document Format (PDF). The e-mail subject line must specify SBSS75N93026R00005. Facsimile responses will not be accepted.

Common Cut-off Date:

Electronically submitted tailored capability statements are due no later than 3:00 PM (E.S.T.), on February 17, 2026. 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.