SH Flu JA _Redacted.pdf

Controlled Unclassified Information (CUI)

Justification for Other than Full and Open Competition

In accordance with 10 US 2304 (c)(1)

Source Selection Information – See FAR 2.101 and 3.104

1. Defense Logistics Agency (DLA) Troop Support, Medical Supply Chain, is the contracting activity.

2. The action being approved is the ability to solicit for DLA requirements on an other than full and open competition basis.

3. The proposed acquisition will result in a one (1) year firm fixed price definite quantity contract for the Southern Hemisphere Influenza Vaccine. The sole source for this vaccine is Sanofi Pasteur Inc.

National Stock Number (NSN): 6505-01-697-1021

Annual Quantity: 6,000 Packages (PG), 60,000 doses

Maximum Quantity: 6,000 PG, 60,000 doses

Estimated Unit Price:

Federal Excise Tax (FET):

Estimated Dollar Value:

Maximum Dollar Value:

The annual quantity is based on the requirements received from the Services.

4. The applicable statutory authority permitting other than full and open competition is

10 U.S.C. 2304(c)(1), FAR 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements.

5. Fluzone® Quadrivalent Southern Hemisphere is a vaccine indicated for active immunization for the prevention of the influenza virus. Fluzone® Quadrivalent Southern

Hemisphere is approved for use in persons six (6) months of age and older. For the 2022-

2023 flu season, Sanofi Pasteur has United States Food and Drug Administration (FDA) approval to market a quadrivalent flu vaccine, which means it includes four (4) different strains of the flu virus. Multiple strains of influenza virus circulate in the population every year and the immune response is different to each of these strains, so an effective vaccine gives protection against each. The Southern Hemisphere Influenza Vaccine is considered necessary for that sector of the population that is located in the Southern

Hemisphere, where the Influenza season runs from April through September.

Controlled by: DLA Troop Support

Controlled by: FSA Pharmaceutical Manufacturer/Distributor Division

CUI Category: SSEL (Source Selection)

Distribution/Dissemination Control: FED ONLY

POC: Jenna L. Wesolowski , Jenna.wesolowski@dla.mil mailto:Jenna.wesolowski@dla.mil

In accordance with 10 US 2304 (c)(1)

6. In accordance with FAR 5.2, this requirement will be synopsized on Sam.gov. In addition, this justification will be made available for public inspection, after award, in accordance with FAR.6.305(a). This procurement is being solicited under a specification with essential characteristics.

7. As the Contracting Officer, I hereby determine that the anticipated cost to the

Government will be fair and reasonable based on an analysis of other than cost and pricing data.

8. Market research indicates that Sanofi Pasteur has been the sole manufacturer of the

Southern Hemisphere Flu vaccine;

As part of the market research, a Sources Sought Notice (SSN) was posted on Sam.gov on August 13, 2021 for thirty (30) days, in an attempt to find additional sources for the vaccine, and also to investigate if alternate sources are currently being developed. The SSN closed on September 13, 2021, with only one response received from Sanofi Pasteur. DLA Troop Support, in conjunction with The

Defense Health Agency Immunization Healthcare Division (DHA-IHD) at Falls Church, VA will continue to perform market research prior to any future acquisitions for the requirement.

9. There are no other facts supporting the use of Other Than Full and Open Competition.

10. The only known source for the supply of Southern Hemisphere Influenza Virus

Vaccine in the US is Sanofi Pasteur, located in Swiftwater, Pennsylvania, and they have expressed interest in fulfilling the Government’s requirements for this vaccine.

11.

In an effort to foster competition, however, the

Government has produced a specification with essential characteristics and will advertise the requirements as stated in paragraph six (6) above. In accordance with FAR 6.302-

1(d)(2), any proposal in response to this notice will be considered.

In accordance with 10 US 2304 (c)(1)

12. The undersigned Contracting Officer hereby certifies that the information contained in this justification is accurate and complete to the best of her knowledge and belief.

Date JENNA WESOLOWSKI

Contracting Officer

I hereby certify that the requirements which form the basis of this justification are accurate, that these supplies meet the Government’s needs in accordance with applicable specifications and that this justification is accurate and complete to the best of my knowledge and belief.

Date WILLIAM A. AGBO, LCDR, MSC, USN

PharmD, MBA, BCGP

Deputy Chief, Customer Pharmacy Operations Center

I have reviewed this justification and recommend approval.

Date ALEXANDER QUINONES

Chief, Distribution IST

Pharmaceutical Mfg/Dist Div.

I have reviewed this justification and recommend approval.

Date DANIEL KEEFE

Director, Medical Supplier Operations

In accordance with 10 US 2304 (c)(1)

I have reviewed this justification for legal sufficiency.

Date

DLA Counsel – Troop Support

I have reviewed and hereby approve this justification.

Date ROBERT J. PANICHELLE

DLA Troop Support Competition Advocate