Justification consolidated - redacted.pdf

Justification for Other than Full and Open Competition:

at or Below the Simplified Acquisition Threshold

Project Title: Human milk oligosaccharide (HMO) analysis in milk samples from the Vitality study.

I. Identification of the agency and contracting activity

II. DHHS, NIH, NIAID, LAD

III.

IV.

V.

VI.

VII. Description of the project, and supplies or services required to meet the agency’s needs (including the estimated value)

A. Type of action:

☒ New requirement ☐ Follow-on

• Name of the previous contractor(s): ________________________________

• Sequence number(s), if available: ____________________________________

• Was the initial and any subsequent awards competed? ☐ Yes ☐ No

B . AMBIS Sequence number for this requirement: 2136715 C. Total estimated dollar value of the requirement (including options, if applicable D. Period of performance, inclusive of options: __indefinite_____ E. Project Background

The likelihood of babies developing food allergy is more closely tied to atopic status of their mother than father.

One possibility is the composition of breast milk. This project will compare the oligosaccharide compositions of breast milk from mothers with and without food allergy and children with or without food allegy to determine if there are any correlations.

F. Description of the supplies/services to be purchased

Human milk oligosaccharide (HMO) analysis of breast milk samples.

The Bode lab will analyze these samples for human milk oligosaccharide (HMO) composition. A known amount of internal standard will be added at beginning of sample preparation to enable absolute HMO quantification. Lipids, proteins and salts will be removed through solid-phase Sep-Pak C18 and porous graphite carbon (PGC) microcolumns. The reducing end of the isolated oligosaccharides will be labelled with 2-aminobenzamide (2AB). The reaction will be facilitated in a thermocycler to guarantee constant and reliable conditions. Unreacted 2AB will be removed from 2AB-labeled oligosaccharides through solid-phase Sep-Pak silica microcolumns. 2AB-labeled oligosaccharides from different samples will be placed into the HPLC autosampler and chromatographically separated over an amide column and detected by an online-coupled fluorescence detector. The system allows for absolute quantification of the following 19 most abundant and structurally distinct HMO (constitute > 95% total human milk HMO):

2’-fucosyllactose (2’FL), 3-fucosyllactose (3FL), 3’-sialyllactose (3’SL), 6’-sialyllactose (6’SL), difucosyllactose (DFLac), lacto-N-tetraose (LNT), lacto-N-neotetraose (LNnT), lacto-Nfucopentaose (LNFP) I, LNFPII, LNFPIII, sialyl-LNT (LST) b, LSTc, difucosyl-LNT (DFLNT),disialyl-LNT (DSLNT), lacto-N-hexaose (LNH), fucosyl-LNH (FLNH), difucosyl-LNH (DFLNH),fucosyl-disialyl-LNH (FDSLNH), disialyl-LNH (DSLNH).

The Bode lab will provide external partner with an excel data sheet that lists the absolute concentrations (in nmol/mL and ug/mL) as well as relative concentrations (in % total) of the 19 HMOs in the provided samples. The data will also include information on Secretor status, HMO diversity and evenness, HMObound sialic acid and HMO-bound fucose.

VIII. Identification of the statutory authority permitting other than full and open competition (SELECT ONE)

☒ 41 USC 3304(a)(1) a n d F A R P a r t 6 . 3 0 2 - 1 : Only one responsible source/Brand Name

☐ F A R P a r t 8 . 4 0 5 - 6 : Federal Supply Schedule (FSS), limited competition/Brand Name ☐ 41 USC 3304(a)(5) a n d F A R P a r t 6 . 3 0 2 - 2 : A u t h o r i z e d o r r e q u i r e d b y s t a t u t e / B r a n d N a m e

IX. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

A. Name and address of the proposed contractor(s)

Lars Bode Principal Investigator Professor of Pediatrics

B. Describe why only the requested brand or brand name feature of the supply/service will meet the government’s needs Dr. Bode has been working on human milk oligosaccharides (HMOs) for over 20 years. His main research objectives are to elucidate (i) how milk components are synthesized in the mother’s mammary gland, (ii) how milk composition is affected by external factors such as nutrition, pathogens, or medications, (iii) how milk components affect immediate as well as long-term health and development of infants and mothers, and (iv) how they can serve as natural templates for the development of preventatives, therapeutics, and diagnostics for people of all ages. The Bode lab is one of the very few labs in the world to provide absolute concentration analysis of human milk oligosaccharides (HMOs) and, to our knowledge, is the only lab in the US to provide this service. The lab routinely uses the analytical platform to analyze HMO concentration in human milk, urine, amniotic fluid, cord blood and feces.

To date, the lab has analyzed HMOs in over 30,000 samples from small pilot studies to large international cohorts, including the NSF-funded INSPIRE cohort, the Bill & Melinda Gates Foundation funded IMiC cohort, the Canadian CHILD Study cohort, the AustralianMACS and BIS cohorts to name a few. With relevance to the proposed Vitality cohort analysis and its focus on food allergy, sensitization, and eczema, the Bode lab has analyzed HMO composition in milk samples from various cohorts with similar focus as follows:

• Cow’s milk allergy: Seppo AE et al. J Allergy Clin Immunol 2017,139(2):708-711

• Food sensitization in the CHILD cohort: Miliku K et al. Allergy 2018;73(10):2070-2073

• Allergic disease in the MACS cohort: Lodge CJ et al. J Allergy Clin Immunol 2021;147(3):1041-1048 Analyzing Vitality cohort samples with the same analytical platform will allow for direct comparison of datasets.

X . Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable

XI. Certification

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support my request (for the requestor) and approval (for the CO) of is accurate and complete.

Sole Source JUSTIFICATION

Dr. Bode has been working on human milk oligosaccharides (HMOs) for over 20 years. His main research objectives are to elucidate (i) how milk components are synthesized in the mother’s mammary gland, (ii) how milk composition is affected by external factors such as nutrition, pathogens, or medications, (iii) how milk components affect immediate as well as long-term health and development of infants and mothers, and (iv) how they can serve as natural templates for the development of preventatives, therapeutics, and diagnostics for people of all ages.

The Bode lab is one of the very few labs in the world to provide absolute concentration analysis of human milk oligosaccharides (HMOs) and, to our knowledge, is the only lab in the US to provide this service. The lab routinely uses the analytical platform to analyze HMO concentration in human milk, urine, amniotic fluid, cord blood and feces. To date, the lab has analyzed HMOs in over 30,000 samples from small pilot studies to large international cohorts, including the NSF-funded INSPIRE cohort, the Bill & Melinda Gates Foundation funded IMiC cohort, the Canadian CHILD Study cohort, the Australian MACS and BIS cohorts to name a few. With relevance to the proposed Vitality cohort analysis and its focus on food allergy, sensitization, and eczema, the Bode lab has analyzed HMO composition in milk samples from various cohorts with similar focus as follows:

• Cow’s milk allergy: Seppo AE et al. J Allergy Clin Immunol 2017,139(2):708-711

• Food sensitization in the CHILD cohort: Miliku K et al. Allergy 2018;73(10):2070-2073

• Allergic disease in the MACS cohort: Lodge CJ et al. J Allergy Clin Immunol 2021;147(3):1041-

Analyzing Vitality cohort samples with the same analytical platform will allow for direct comparison of datasets.

Based on scientific literature, multiple laboratories around the around the world are engaged in the collaborative research of analyzing human milk oligosaccharides, and many of them have worked with and/or requested the services of the Bode Lab. Based on our research, the Bode Lab is one of the few, if not the only, labs that can analyze human milk HMO. Program’s scientists learned of the Bode Lab’s work when collaborating with scientists in Australia on a different human milk research project. In that Australian scientific research study, the Bode Lab analyzed samples for the Barwon Infant Study (BIS) birth cohort. Program’s work will build upon this BIS study. Program needs to use the Bode Lab’s exact method of analysis to retain the same scientific protocols and analysis methodologies so that the results of Program’s current VITALITY infant cohort study can be directly compared to the BIS birth cohort.