N0025920RCF0004-Milk_Fortifier-Prolacta-NMCSD-Attachment_V-JA_Redacted.pdf

LOG #: 19-10028

PR N0025920RCF0004 Page 1 of 3 1 Nov 12

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the agency and the contracting activity.

This justification is executed by the Naval Medical Logistics Command, Fort Detrick, MD on behalf of Naval Medical Center San Diego (NMCSD) to meet their requirements.

2. Nature and/or description of the action.

Award of a contract on a sole source basis for a pasteurized human-based milk product/fortifier in support of NMCSD. The Government intends on awarding a Firm Fixed Price (FFP) contract. The proposed source is Prolacta Bioscience, Inc. of 757 Baldwin Park Blvd, City of Industry, CA, 91746-1504.

3. Description of the supplies/services required.

The Neonatal Intensive Care Unit (NICU) is requesting the ability to purchase 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.

4. Identification of the statutory exceptions permitting other than full and open competition.

The statutory exception permitting other than full and open competition for this acquisition is 41 U.S.C.

1901 (see also FAR 13.501(a)).

5. Demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

Prolacta Bioscience is currently the only company on the market that manufactures and distributes pasteurized human-based milk products and fortifiers used for breastmilk fortification.

6. Description of efforts made to ensure that offers are solicited from as many potential sources as practicable.

Market research was performed, the results of which are in paragraph 8. This requirement will be posted to Federal Business Opportunities (FBO) in accordance with FAR 5.202. A Request for Information (RFI) was posted from 04 June 2019 to 10 June 2019 to FBO followed by a Notice of Intent (NOI) from 18 July 2019 to 03 July 2019. No responses were received to the RFI or the NOI.

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

PR N0025920RCF0004 Page 2 of 3 1 Nov 12

The Contracting Officer will determine the anticipated cost to the Government of the supplies/services covered by this Justification and Approval to be fair and reasonable by conducting a price analysis before an award is made.

8. Description of the market survey conducted and the results, or statement of the reasons a market survey was not conducted.

An internet search was conducted for pasteurized human-based milk fortifiers and products. Local hospitals and military treatment facilities were also contacted to determine the use of a pasteurized human-based milk products and fortifiers. Prolacta Bioscience is currently the only company on the market that manufactures and distributes pasteurized human-based milk products and fortifiers used for breastmilk fortification. Tripler Army Medical Center, Madigan Army Medical Center, San Antonio Military Medical Center, Sharp Mary Birch, Loma Linda, Miller Children’s Hospital in Long Beach and Cedar Sinai are currently using Prolacta products and fortifiers. Similac and Enfamil do make a human milk fortifier but these fortifiers are cow-based fortifiers that are added to human breastmilk or donor breastmilk. Prolacta is not available via GSA or ECAT.

9. Other facts supporting the use of other than full and open competition.

N/A

10. Listing of Sources, if any, which expressed, in writing, an interest in the acquisition.

To date, no other sources have written to express an interest. This requirement will be posted on FBO in accordance with FAR 5.201. Any sources expressing interest in response to the synopsis will receive consideration.

11. Statement of actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

Future requirements will be synopsized in accordance with FAR 5.203.

PR N0025920RCF0004 Page 3 of 3 1 Nov 12

TECHNICAL AND REQUIREMENTS CERTIFICATION REQUIRED

BY FAR 13.501(a)(2)

I certify that the facts and representations under my cognizance which are included in this justification and approval and which form a basis for this justification are complete and accurate.

Technical and Requirements Cognizance

CONTRACTING OFFICER CERTIFICATION

I certify that this justification is accurate and complete to the best of my knowledge.

LEGAL SUFFICIENCY REVIEW AND CONCURRENCE

I have reviewed the facts set forth in the above Justification and Authority (J&A) and find this J&A to be legally sufficient, based on these facts, to the best of my knowledge and belief.

APPROVAL BLOCK COMPETITION ADVOCATE

($700,000-$12.5M)