The Neonatal Intensive Care Unit (NICU) has a requirement for a pasteurized human-based milk product/fortifier. The standard of care for feeding premature infants according to the American Academy of Pediatrics (AAP) is exclusive breastmilk feeding. Research clearly demonstrates that the benefits of an exclusive human milk diet are significant. The 2012 AAP policy statement on "Breastfeeding and the Use of Human Milk" states that "all preterm infants should receive human milk...pasteurized donor human milk, appropriately fortified, should be used if mother's own milk is unavailable." An exclusive human milk diet improves feeding tolerance, allowing preterm infants to achieve full enteral feeds sooner and decreasing complications from indwelling central lines for parenteral nutrition. Preterm infants fed an exclusive human milk diet compared with those fed formula or human milk supplemented with cow-milk based infant formula products have significant reductions in the incidence of necrotizing enterocolitis (NEC) and late-onset sepsis. Neurodevelopmental outcomes are improved by feeding human milk, and this effect is more pronounced in preterm infants whom are at high risk for neurodevelopmental disabilities.

The system, including claims made for the product, shall be compliant with Food and Drug Administration (FDA) regulations, with respect to marketing and delivering medical products for use in the United States of America. These requirements shall apply even if delivery is requested outside of the United States of America. The system shall be installed in compliance with OSHA requirements.

Contractor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor, or authorized reseller for the proposed equipment/system such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty, and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

Upon delivery, the contractor shall be responsible for uncrating the unit/system, transporting it through the facility to the location of intended use for installation, and removing of all trash created in this process. If interim storage is required, the vendor shall make arrangements for the storage. The vendor is also responsible for the initial instrument operational and performance validations.

There are not set-aside restrictions for this requirement. The intended procurement will be classified under North America Industry Classification System (NAICS) 325414. This notice of intent is not a request for competitive proposals and no solicitation document exists for this requirement. However, parties interested in responding to this notice will need to submit technical data sufficient to determine capability in providing the same product. All capability statements received by the closing date of this synopsis will be considered by the Government. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement.

If a vendor challenges the basis of this requirement, please email product capability statements (formats for submission: PDF, MS Word, or MS Excel) to Derek Bell at [email protected]. Closing date for challenges is no later than 11:00 AM ET on 03 July 2019. No phone calls will be accepted.