Sol_75N98027Q00007.pdf

75N98027Q00007

1. REQUEST NO.

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IMPORTANT: This is a request for information, and quotations furnished are not offers. If you are unable to quote, please so indicate on this form and return it to the address in Block 5a. This request does not commit the Government to pay any costs incurred in the preparation of the submission of this quotation or to contract for supplies or services. Supplies are of domestic origin unless otherwise indicated by quoter. Any representations and/or certifications attached to this Request for Quotations must be completed by the quoter.

11. SCHEDULE (Include applicable Federal, State and local taxes)

THIS RFQ

REQUEST FOR QUOTATION

(THIS IS NOT AN ORDER)

IS IS NOT A SMALL BUSINESS SET ASIDEX

10/13/2026

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OD - Office of Logistics and Acquisition Operations 6100 Executive Blvd., Room 6B05

National Institutes of Health

Bethesda, MD 20892-7511

Multiple

+10 000-000000NICHOLAS CAPOBIANCO

10/23/2026 0900 ED

FOB DESTINATION

OTHER

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ITEM NO.

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The purpose of this NON-COMPETITIVE COMBINED SYNOPSIS / SOLICITATION is to provide NHLBI with research support to develop and validate circulating cell-free DNA (cfDNA) as a blood-based biomarker of chlorine-induced acute lung injury.

The following FAR clauses and Provisions are applicable to this award.

FAR 52.204-13 System for Award Management Maintenance (Oct 2018);

FAR 52.204-18 Commercial and Government Entity Code Maintenance (Aug 2020);

HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015).

FAR 52.212-4 Contract Terms and Conditions -In Continued ...

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75N98027Q00007 addition to all the applicable commercial

Products and Commercial Services (Nov 2023)

FAR 52.217-8 Option to Extend Services (Nov 1999)

FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)

NON-COMPETITIVE COMBINED SYNOPSIS / SOLICITATION

Title: A Non-Invasive Prognostic Biomarker – Circulating Cell-Free DNA

(i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested, and a separate written solicitation will not be issued.

(ii) The solicitation number is 75N98027Q00007. This solicitation is issued as a Notice of Intent (NOI) for a non-competitive combined synopsis/solicitation to award a contract or purchase order without providing for full and open competition (including brand-name, if applicable).

This acquisition is conducted under the authority of FAR 12.603, Streamlined Solicitation for Commercial Products or Commercial Services, and is not expected to exceed the simplified acquisition threshold. Additional authority includes 41 U.S.C. 1901 and FAR 6.302-3(a)(2)(ii).

The National Institutes of Health (NIH), Office of the Director, Office of Acquisitions, intends to negotiate and award a firm-fixed-price purchase order on a non-competitive basis to University of Alabama at Birmingham, 701 S 20th Street, Birmingham, AL 35294- 0001-0001, for research support to develop and validate circulating cell-free DNA (cfDNA) as a blood-based biomarker of chlorine-induced acute lung injury, using the Matalon Laboratory's sole-source validated murine chlorine inhalation injury model, established mechanistic expertise, access to its actively enrolling aspiration pneumonitis biorepository (human proxy cohort), existing collaborative infrastructure with the NHLBI Laboratory of Precision Omics, and continuity with peer-reviewed federal funding (NIH R01 HL031197).

These capabilities are not available from any other source and are essential to the project's feasibility.

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2026-01, effective 03/13/2026.

(iv)The associated NAICS code is 541380, Testing Laboratories and Services, and the small business size standard is $19.0 million. This requirement is not set aside for small business.

(v) Description of Requirement: The National Heart, Lung, and Blood Institute (NHLBI), Division of Intramural Research, requires non-competitive research support from the University of Alabama at Birmingham (UAB), Matalon Laboratory, to develop and validate circulating cell-free DNA (cfDNA) as a blood-based biomarker of lung injury. Acute lung injury and acute respiratory distress syndrome (ARDS) following chlorine gas exposure remain significant public health concerns because clinical presentation early after exposure does not reliably predict disease severity. The NHLBI Laboratory of Precision Omics (APO), led by Dr. Sean Agbor-Enoh, and the UAB laboratory led by Dr. Sadis Matalon are collaborating to combine the Matalon laboratory's expertise in established murine chlorine exposure models with the APO laboratory's expertise in cfDNA biomarker development, tissue-of-origin profiling, and translational studies. The goal is to establish the mechanistic relationship between chlorine-induced lung injury and circulating cfDNA and to support future development of rapid diagnostic and triage tools for chemical exposure events.

The requirement encompasses use of the established murine chlorine exposure model and associated mechanistic groundwork, access to the actively enrolling aspiration pneumonitis biorepository serving as the human proxy cohort, existing collaborative infrastructure, and continuity with peer-reviewed federal funding. Work includes exposure of equal numbers of male and female mice to Cl2 gas and evaluation of acute lung injury post-exposure, including measurement of bronchoalveolar lavage protein content and cell counts, plasma cytokines/chemokines, lung injury histology scoring, lung edema (wet-to-dry weight ratio), blood gases, epithelial sodium channel activity, alveolar fluid clearance, hemopexin and heme quantitation, and lung mitochondrial DNA concentration and DNA lesion analysis, as described in the Government's statement of work.

(vi) Delivery Location: University of Alabama at Birmingham 701 S 20th Street Birmingham, AL 35294

(vii) [Reserved]

(viii) FAR 52.204-7, System for Award Management, applies to this acquisition.

(ix) The provision at FAR 52.212-1, Instructions to Offerors—Commercial Items, applies to this acquisition. Add any additional instructions as required.

(x) The provision at FAR 52.212-2, Evaluation—Commercial Items, applies to this acquisition.

(a) A written notice of award or acceptance of an offer, issued to the successful offeror within the time specified in the offer, shall result in a binding contract without further action by either party. The Government reserves the right to accept any offer (or part of an offer) before the expiration date, whether or not discussions are conducted, unless a written notice of withdrawal is received prior to award. Add additional evaluation criteria as required.

(xi) FAR 52.212-4, Contract Terms and Conditions—Commercial Items, applies to this acquisition.

(xii) Additional contract requirements or terms and conditions, as determined necessary by the Contracting Officer and consistent with customary commercial practices: None.

(xiii) The Defense Priorities and Allocations System (DPAS) is not applicable to this requirement.

(xiv) Submission Requirements: Responses must include sufficient information to demonstrate the respondent's capability to provide the required product or service. Price quotations shall include, at a minimum: unit price, list price, shipping and handling costs, delivery timeframe after award, delivery terms, prompt payment discount terms, F.O.B.

point (destination or origin), product or catalog numbers, product descriptions, and any other relevant information.

Evaluation factors may include, but are not limited to: past performance, technical capability, special features, trade-in considerations, expected lifecycle, warranty, maintenance availability, and environmental or energy efficiency considerations.

Respondents claiming to be manufacturers or authorized resellers of a specified brand-name product must provide: (a) Product, catalog, model, and/or part number(s); (b) Product description; (c) Documentation demonstrating that the offered item meets all required salient characteristics; (d) Quantity; (e) Estimated price or cost; (f) Shipping, handling, and/or installation charges; and (g) Delivery timeframe after receipt of order.

Responses must also include the Unique Entity Identifier (UEI), Taxpayer Identification Number (TIN), and business size certification. All offerors must be actively registered in the System for Award Management (SAM) at www.sam.gov.

All responses must be received by October 23, 2026, 09:00 AM EDT and must reference solicitation number 75N98027Q00007. Responses may be submitted electronically to nicholas.capobianco@nih.gov.

(xv) Point of Contact: Nicholas Capobianco, Contracting Specialist, National Institutes of Health. Email: nicholas.capobianco@nih.gov

Study design: Sex as a biological variable. While we have not previously observed differences in mortality or the extent of lung injury between male and female mice after Cl2 exposure, gender differences have not been systematically explored. To address this issue, we will study equal numbers of male and female mice exposed to Cl2 gas (500 or 400 ppm for 30 min) and returned to room air. Exposure to Cl2. Mice will be exposed to Cl2 in our state-of-the art Halogen Exposure Facility, which has been designed and is under the direction of Dr. Matalon for the last 14 years.

The Occupational Health and Safety routinely inspect this facility, located inside a negative pressure room inside the Vivarium, (see complete description in the Facilities Section as well as in our numerous publications).

Evaluation of acute lung injury post Cl2 exosure1. Mice will be exposed to Cl2 gas (500 ppm for 30 min) in environmental chambers as described previously. At the end of the exposure period, they will be returned to their cages where they will breathe room air. We have chosen this regiment, because it results in the development of ARDS-type injury with 50% mortality within 5- 6 d post exposure and resembles closely accidental human exposures. Mice will be weighted daily and oxygen saturation and respiratory rate will be measured as described previously. They will be sacrificed at 1, 3 and 7 d post exposure. Mouse lungs will be lavaged and protein content (both biochemically and by SDS-PAGE and Western blots against plasma proteins), and cell count (total and differential) will be measured. Cytokines and chemokines will be quantified in plasma. Lung tissues will be dissected, paraffin-processed, stained with H&E and myeloperoxidase, imaged and scored for lung injury, according to the guidelines laid down by the most recent American Thoracic Society group. Lung edema will be assessed by the lung wet to dry weight ratio. Blood gases will be measured from blood collected from the abdominal aorta blood by the EPOC Reader with E-BUN cassettes. The activity of epithelial sodium channels in precision cut lung slices and alveolar fluid clearance will be assessed as described previously.

Quantitation of hemopexin and heme (a) Plasma levels of hemopexin will be measured using an ELISA kit (product no. GWB-4B6D1A [40-374-130039]; GenWay Biotech, Inc.). (b) Heme. Non-encapsulated heme and hemoglobin levels will be measured in plasma samples by two different methods by using the QuantiChrom heme assay kit (Product No. DIHM-250; BioAssay Systems, Hayward, CA), and by spectral deconvolution with least square fitting analyses, which allows for separate measurements of non-encapsulated hemoglobin and heme, as described previously.

Lung Mitochondrial DNA concentrations and DNA lesion Assay. The total DNA will be extracted using 25 mg of lung tissue from the mix of left and right lobe, by using QIAamp DNA mini kit, (cat# 51306, Qiagen, Germany. The mitochondrial DNA concentration and DNA lesions will be measured by using Mouse Real-Time PCR Mitochondrial DNA Damage Analysis Kit from Detroit R&D (Cat. No. DD2M; Detroit, MI) following manufacturer’s instructions and in-house primers.

Animal numbers: Two exposure regiments (air, Cl2) x male and female mice) X 10 mice per group x 3 sacrifice times ( 0, 3 and 7 d post exposure) x 2 experimental groups (histology and lung edema have to be performed in different groups of mice but we will use one lung per condition; all other can be combined)=240 mice. Allow 20% for mortality=288 mice