Effect of Radiation Quality and Galactic Cosmic Radiation Simulation on the Risk of Carcinogenesis in an Outbred Mouse Model (HS/Npt)

Questions & Answers / Clarifications

This document provides responses to questions submitted by potential offerors regarding solicitation 80JSC026Q0003. It aims to clarify requirements and ensure all bidders have access to the same information.

• Animal Housing: Onsite tissue collections and evaluations are acceptable at BNL, with post-tissue evaluations permitted at the offeror's home institution.
• Eligibility: The solicitation is a Full and Open competition, meaning all responsible sources may submit an offer regardless of NAICS classification or size status, provided it is clearly stated.
• Technical Approach: Biomedical ultrasound-based methods are acceptable if they can demonstrate radiation quality calculation. The PI (Principal Investigator) is responsible for defining experimental parameters, including the choice of GCRsim regimens, and designing experiments and protocols.
• Deliverables: NASA will compute the output for the Cancer Risk model; offerors need to provide specific inputs. Organs must be banked as specified in Attachment B, with no specific molecular assays expected beyond standard histopathology.
• Subcontractor Past Performance: Offerors can submit past performance from subcontractors, but only prime contractor past performance will be evaluated and rated.
• FAR Provision: FAR 52.224-3 "Privacy Training" has been removed from the solicitation.

This document clarifies several aspects of the solicitation, including eligibility, technical requirements, and submission details. Offerors should review these clarifications carefully as they may impact proposal preparation and strategy. No changes to proposal deadlines are indicated.

Solicitation

This solicitation, identified by Solicitation Number 80JSC026Q00030002, is for research related to radiation effects on biological systems, specifically focusing on cancer testing and studies of the central nervous system and cardiovascular disease in outbred mice. The goal is to determine the effects of radiation quality, dose, and dose rate on cancer initiation, promotion, and progression, and to establish relative biological effectiveness (RBE) and quality factor estimates for space-relevant radiation exposures. The period of performance is from April 1, 2026, to March 29, 2030.

• Base - Cancer Testing: General cancer testing services.

• Central Nervous System Study: Outbred mouse studies to analyze behavior, cognition, and molecular/histological aspects to aid in translating past research to humans and validating previous rat studies.

• Cardiovascular Disease Study: Research in outbred animals to corroborate past data and inform future cardiovascular disease research, potentially for astronaut health.

• Sex Differences Study: Research to understand sex-dependent long-term health outcomes post-radiation exposure to better quantify radiation risk for astronauts.

• Requirements: Determine the effects of radiation quality, dose, and dose rate on cancer initiation, promotion, and progression in HS/Npt outbred mice. Establish RBEs and quality factor estimates for space-relevant radiation exposures.

• Contract Type: Firm Fixed Price.

• Period of Performance: April 1, 2026, to March 29, 2030.

• Offer Due Date: March 13, 2026, at 1:00 PM CT.

• Evaluation Factors: Technical Acceptability, Past Performance, and Price. Technical and past performance are considered significantly more important than price.

• The acquisition is listed as "Unrestricted."

• NAICS Code: 541715 (Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)).

• The solicitation incorporates FAR clauses by reference, including instructions to offerors (52.212-1), contract terms and conditions (52.212-4), and evaluation criteria (52.212-2).

• Offerors must complete representations and certifications electronically via SAM.gov or as specified in the solicitation.

• Several attachments are referenced, including a PWS, specifications, evaluation criteria, and questions/answers.

Questions & Answers / Clarifications

This document provides responses to questions submitted by potential offerors regarding solicitation 80JSC026Q0003. It aims to clarify requirements and ensure all teams have access to the same information.

• Animal Housing: Post-tissue evaluations can be performed at the offeror's home institution, but onsite tissue collections and evaluations must occur at BNL. Housing at any AAALAC-accredited U.S. institution is acceptable.
• Eligibility: The acquisition is a Full and Open competition, meaning responsible sources may submit an offer regardless of NAICS classification or size status, provided size status is clearly stated.
• Ultrasound Methods: Biomedical ultrasound-based methods are acceptable for early detection of cancer and cardiovascular diseases, provided radiation quality can be calculated using this method.
• Deliverables & Budget: Specific expectations and deliverables for the 3-6 month definition phase are detailed in Attachment A – PWS Radiation Outbred Mouse. The budget submission details should also refer to this attachment.
• Genotyping Data: NASA will not provide pre-existing genotyping/haplotype data for the mice; contractors must perform additional genotyping if required.
• Tissue Collection: Organs must be banked as specified in Attachment B. No specific molecular assays are expected beyond standard histopathology. Palpable/visible tumors not captured in organ collection should be collected and split for paraffin embedding and freezing.
• Past Performance: Offerors can submit past performance from subcontractors, but only prime contractor past performance will be evaluated and rated.
• FAR Provision Removal: FAR 52.224-3 "Privacy Training" has been removed from the solicitation.

This document clarifies several aspects of the solicitation, including eligibility, technical approaches, data requirements, and submission details. Offerors should review these clarifications carefully to ensure their proposals are responsive. Key attachments referenced include Attachment A (PWS), Attachment B (tissue collection), Attachment D (regimens), and Attachment E (Evaluation Criteria).

Amendment / Modification

This amendment modifies the solicitation by:

• Removing provision FAR 52.224-3.

• Adding the updated Attachment F - Pricing Sheet.

• Adding Attachment G - Questions and Answers.

• Solicitation/Contract Form: "Ship To" information has been updated.

• Contract Clauses: Numerous FAR clauses have been modified or added, including but not limited to:

  • 52.212-5 Deviation - Contract Terms and Conditions Required To Implement Statutes or Executive Orders—Commercial Products and Commercial Services.
  • Various clauses related to prohibitions on certain technologies, supply chain security, and small business concerns.
  • Clauses related to equal opportunity, employment reports, and labor standards.
  • Clauses related to sustainable products, privacy, and foreign purchases.

This amendment introduces updated attachments (Pricing Sheet and Q&A) and modifies several contract clauses. Bidders should review these changes carefully to ensure their proposals are compliant and accurate. Specific impacts on proposal deadlines or evaluation factors are not detailed in this amendment, but the inclusion of updated attachments and clauses necessitates a thorough review.

Form / Attachment / Pricing Sheet

This document is an updated pricing sheet (Attachment F) for the solicitation. Bidders are required to complete and submit this sheet as part of their proposal. It outlines the pricing structure for the base period of performance and any optional work or extensions.

• CLIN/SLINS: Identifies contract line items, including the Base Period of Performance and optional work for Central Nervous System (CNS), Cardiovascular Disease (CVD), and Sex Differences.
• Description: Provides a brief description for each CLIN/SLIN.
• List Price: Bidders must complete this section. For the Base Period, the list price is currently set at 0.0, with optional work listed as 'Information Only'.
• 52.217-8 Option to Extend Services: This clause is included by reference. The pricing sheet indicates a 6-month extension, and the rates from the Base Period will be applied.
• TOTAL FIRM FIXED PRICE: Currently listed as 0.0, to be completed by the Offeror.
• Cost Breakout Detail: This section provides a breakdown of estimated costs (Animal Housing, Personnel Salaries, Supplies, etc.) for the Base Award and Options. All estimated costs are currently listed as 0.0.
• Offeror Information: Fields for Company Name, Quote Number, and Quote Validity Period (minimum 90 days) must be completed by the Offeror.

Bidders must use this sheet to detail their proposed pricing for the base period and any optional services. The completed pricing sheet is a critical component of the proposal submission and will be used for evaluation. Ensure all fields are accurately completed, and the quote remains valid for the minimum required period.

Solicitation / RFP / RFQ

This solicitation, identified by Solicitation Number 80JSC026Q0003, is issued by NASA Johnson Space Center for services related to research studies. The primary objective is to procure services for various research studies, including cancer testing, central nervous system studies, cardiovascular disease studies, and sex differences studies.

The solicitation outlines several research study areas:

• Base - Cancer Testing: This involves research services with a Product Service Code of AN21. It is a Firm Fixed Price contract.

• Central Nervous System Study: Focuses on outbred mouse studies of the CNS, including behavior, cognition, molecular, and histological studies. The goal is to assist in translating past results to humans, compare and validate past outbred rat studies, and serve as a test bed for pharmaceutical CM screening.

• Cardiovascular Disease Study: Requires additional research in outbred animals to corroborate past research data and inform future CVD studies, potentially translating findings to the astronaut core.

• Sex Differences Study: Aims to understand sex-dependent long-term health outcomes post-radiation exposure to better quantify radiation risk for the astronaut core.

• Period of Performance: The period of performance for all listed studies is from April 1, 2026, to March 29, 2030.

• Contract Type: The document indicates a Firm Fixed Price contract for the Base - Cancer Testing item.

• Offer Due Date: March 13, 2026, at 1:00 PM CT.

• Evaluation Factors: Offers will be evaluated based on Technical Acceptability, Past Performance, and Price. Technical and past performance are considered significantly more important than price.

• The acquisition is listed as "UNRESTRICTED."

• The solicitation incorporates FAR clauses 52.212-1, 52.212-4, and 52.212-5 by reference, with addenda.

• Several attachments are listed, including a Performance Work Statement (PWS) for Radiation Outbred Mouse, Tissue Collection Description, NSCOR NSRL Information, GCR Sim Table, Evaluation Criteria, and a Pricing Sheet.

Form / Attachment / Pricing Sheet

This document is a pricing sheet (Attachment F) for the solicitation. It requires offerors to provide their pricing for various CLINs (Contract Line Item Numbers) and options. Bidders must complete this sheet as part of their proposal submission.

• CLINs: Includes Base Period of Performance, optional work for Central Nervous System (CNS), Cardiovascular Disease (CVD), and Sex Differences, as well as the Option to Extend Services (CLIN 52.217-8).
• Pricing Fields: Requires List Price for the base period and specific optional work. For CLIN 52.217-8, offerors must complete the "To be completed by the Offeror" section, noting that rates from the base period will apply.
• Total Firm Fixed Price: A field to sum up the total firm fixed price.
• Cost Breakout Detail: Provides a breakdown of estimated costs by category (Animal Housing, Personnel Salaries, Supplies, etc.) for the Base Award and each Option.
• Quote Validity: The quote must be valid for a minimum of 90 days from submission.

This pricing sheet is critical for bidders to accurately calculate and submit their proposed costs. It outlines the structure for pricing the base contract period, optional services, and provides a template for cost breakdown. Failure to complete this document accurately may impact proposal evaluation.

Form / Attachment / Pricing Sheet

This document, "Attachment C - NSCOR NSRL Information.pdf", provides detailed information about the NASA Space Radiation Laboratory (NSRL) at Brookhaven National Laboratory. It is intended to inform potential users about the facility's capabilities, operational schedule, and requirements for accessing its services.

• Facility Description: An overview of the NSRL as an irradiation facility capable of supplying various particles with specific energy ranges.
• Irradiation Capabilities: Details on dose rates, beam area, dose fractionation, and exposure structure.
• Schedule: Information on the three annual operational runs (Spring, Summer, Fall).
• Cell Culture and Vivarium Capabilities: Description of laboratory spaces and capacity for animal experiments.
• Ion Species and Energies: A table (Table 1) listing available ion species, their maximum energies, LET, range in H2O, and maximum intensity.
• Other Capabilities: Information on shielding caves, biological experiment stations, laboratory space, and equipment.
• Requirements for Use: Outlines the process for applying for beam time, which involves a separate application reviewed by a BNL-appointed panel, and adherence to BNL rules and policies.
• Contacts: Provides contact information for the NSRL science team.

This document is crucial for bidders interested in opportunities involving radiation research, particularly those requiring the use of the NSRL. It helps potential users understand the facility's technical specifications, operational availability, and the application process for beam time, enabling them to assess the feasibility and scope of their proposed research or services in relation to the NSRL's capabilities.

Form / Attachment / Pricing Sheet

This document, "Attachment D - GCR Sim Table.pdf", defines the parameters for a Galactic Cosmic Ray (GCR) Simulation. It provides a table listing the ions and their energies used in the simulation, along with a graphical representation of a sample exposure.

• Table of Ions and Energies: Lists specific ions (H, He, Si, Ti, O, C, Fe) and their corresponding energies in MeV/n, ordered by delivery.
• Simulation Overview: States that the GCR Simulation comprises seven different ion species and fourteen different energies of H and He, for 33 separate beams in a single GCRSim exposure.
• Exposure Duration: Indicates that each exposure should take approximately one hour.
• Graphical Sample: Includes a plot showing a sample GCR Simulation exposure over time, with different colored lines representing various ion species.

This attachment is crucial for bidders to understand the specific simulation parameters required for the opportunity. It details the exact composition and energy levels of the cosmic rays to be simulated, which will inform technical approaches, resource allocation, and proposal development related to the GCR simulation requirements.

Statement of Work (SOW) / Performance Work Statement (PWS)

To determine the effects of radiation quality, dose, and dose rate on cancer initiation, promotion, and progression in outbred HS/Npt mice, and to establish Relative Biological Effectiveness (RBE) and quality factor estimates for space-relevant radiation exposures. The study also aims to provide bio-banked tissue and metadata for future NASA investigations, with an optional component to assess cardiovascular and CNS outcomes.

• Design and execute experiments using outbred HS/Npt mice.

• Conduct radiation exposures at the NASA Space Radiation Laboratory (NSRL), including gamma irradiation, full GCR simulation (acute and fractionated), and single-ion exposures, with doses relevant to Mars design reference missions (300-450 mGy).

• Perform survival, tumor incidence, and tumor spectrum analyses.

• Conduct comprehensive tissue collection, preservation, and metadata management, including biobanking of required samples.

• Prepare interim and final reports.

• The majority of the 3500 mice (1750 in year 1, 1750 in year 2) will be available in the first two years to allow for aging post-irradiation. Both male and female mice will be used.

• Evaluation of carcinogenesis RBEs for GCRsim and reference ions.

• Overall survival.

• Solid tumor-free survival.

• Leukemia/lymphoma-free survival.

• Tumor spectrum/type analysis.

• Comprehensive digital data management plan for animal, sample, and metadata tracking.

• Period of Performance: April 1, 2026 to March 31, 2030.

• Place of Performance: NASA Space Radiation Laboratory (NSRL) for exposures; PI's site for other experimental work.

• Required Tissue Collection and Preservation: Collect and preserve biospecimens according to NASA requirements (snap freezing, paraffin embedding, or ethanol preservation). All samples and metadata to be transferred to NASA at the conclusion of the performance period.

• NASA will provide animal breeding, shipping to NSRL, and beam time at no cost to the PI.

• The PI shall budget for animal housing, travel, experimental execution, and sample processing.

• Required Deliverables: Evaluation of carcinogenesis RBEs, biobanking of specified organs/tissues with metadata, comprehensive digital data management plan, Annual Reviews (interim progress reports at 12-month intervals), and a Final Report at project completion (Month 48).

• Optional Deliverables: Assessment of cardiovascular injury and evaluation of CNS functional/physiological decrements, assessment of dose-rate effects, and analysis of sex-specific responses.

Form / Attachment / Pricing Sheet

This document, "Attachment E - Evaluation Criteria Radiation Outbred Mouse.pdf", outlines the evaluation instructions and criteria for the associated Request for Quotation (RFQ).

• Step One (1) – Meeting Key RFQ Requirements: Bidders must answer specific Yes/No questions. Failure to answer "Yes" to all questions will result in elimination.
• Step Two (2) – Trade-Off: Evaluation is based on three factors in descending order of importance:
  • Factor 1: Technical Acceptability: Evaluated by Space Radiation experts based on scientific and technical merit, relevance to RFQ objectives, and ability to evaluate the specified radiation effects on mice. Ratings include Outstanding, Acceptable, or Unacceptable. Consistency with price is also assessed.
  • Factor 2: Past Performance: Rated as Acceptable, Neutral, or Unacceptable. Bidders must submit up to three past performance references and biosketches for key personnel, detailing relevant experience, publications, and qualifications. The government may also consult external sources.
  • Factor 3: Price: Evaluated for reasonableness, unbalanced pricing, and completeness. This includes the Total Evaluated Price (TEP) and detailed pricing sheets, with consideration for option periods.

This document is critical for bidders to understand how their proposals will be evaluated. It details the specific requirements for the initial screening (Step One) and the criteria for the subsequent trade-off evaluation (Step Two), emphasizing the relative importance of Technical Acceptability, Past Performance, and Price. Bidders must ensure their submissions directly address these evaluation factors to maximize their chances of award.

Form / Attachment / Pricing Sheet

This document, "Attachment B - Required Sample Collection and Preservation for Biospecimen and Tissue Sharing," outlines the specific requirements for collecting and preserving biospecimens and tissues. It details the methods to be used upon animal sacrifice, unless a reasonable justification is provided otherwise.

• Required Tissues: Table 1 lists the specific tissues and samples (n=10 per control and treatment group) that require collection and preservation.
• Preservation Methods: For each tissue, two preservation methods are specified: "Preservation Method 1 (Left)" and "Preservation Method 2 (Right)." These include methods such as Snap Freeze Liquid Nitrogen and Paraffin Embed.
• Ownership and Sharing: Tissues required for study deliverables remain with the Principal Investigator (PI) during the contract period. These tissues and associated metadata are NASA's sole property and cannot be shared or used without express written permission from a Government representative.
• PWS Reference: All required samples and metadata will be collected by NASA according to the Performance Work Statement (PWS).
• Auxiliary Tissues: Samples not listed in Table 1 can be collected and preserved but are not required for ingestion into the NASA HRP Biospecimen and Tissue Sharing Collection (BTSC). NASA is not responsible for resources needed to collect these auxiliary tissues.

This attachment is crucial for bidders involved in studies requiring biospecimen collection and preservation. It clearly defines the types of samples, the required preservation techniques, and the ownership/sharing protocols, which will directly impact the bidder's operational planning, resource allocation, and compliance with NASA's requirements.