JOFOC.pdf

econcI IatIon ees may a so pure Vaccines will be ordered through the NCIRD electronic vaccine ordering system. The initial contracts, awarded in July 2021 were established to support public sector Advisory Committee on Immunization Practices (ACIP) recommended routine vaccinations for adults. The Pfizer contract will be modified to support purchase of PCV 20 vaccine (Prevnar20) for adults in light of the ACIP approval and CDC recommendation in October 2021. The ordering period for PCV 15 will be from the time of award of the modification through June 30, 2022.

4. Authority and Rationale: Identify the statutory authority, FAR title and FAR citation permitting other than full and open competition. It may be one of the following most commonly used citations by the operating divisions of the Department of Health and Human Services (HHS), but other exceptions may apply per FAR Subpart 6.3.

Actions other than simplified acquisition procedures (select only one and provide an explanation):

FAR 6.302-1: Only one responsible source and no other supplies or services will satisfy agency requirements, 41 U.S.C.

3304(a)(1)

Explain why the intended contractor is the only responsible source who can provide the required supplies or services.

Discuss the unique capabilities, expertise, etc. that support the lack of competition/why no other type of supplies or services will satisfy agency requirements. Explain factors/unique qualifications such as proprietary data or exclusive licensing rights, if applicable. When competition is limited to items particular to one manufacturer, this justification must explain why the particular brand name, product, or feature is essential to the Government's requirements, and that market research indicates other companies' similar products, or products lacking the particular feature, do not meet, or cannot be modified to meet the agency's needs in accordance with FAR 11.105. If in connection with a follow-on contract for continued development or production of highly specialized equipment, detail the substantial duplication of cost or unacceptable delays. May not Exceed one year, including all options, unless the head of the agency (Secretary of HHS) determines that exceptional circumstances apply.

On October 20, 2021, the Advisory Committee for Immunization Practices (ACIP) approved recommendations related to two new pneumococcal vaccines for adults. PCV20 (Pfizer's Prevnar20) alone or PCVl 5 (Merck's Vaxneuvance) in series with PPSV23 should be routinely recommended to US adults aged �65 years and for adults aged 19-64 years with certain underlying medical conditions or other risk factors.

The Prevnar20 vaccine from Pfizer is the only vaccine being considered for this request. Currently, there is only one manufacturer with an FDA-approved license for PCV20 at this time-Pfizer. The current Pfizer contract will be modified to include doses required to support the ACIP recommendation that US adults aged �65 years and adults aged 19-64 years with certain underlying medical conditions or other risk factors receive PCV20 (Pfizer's Prevnar20) alone or PCVl 5 (Merck's Vaxneuvance) in series with PPSV23.

D FAR 6.302-2: Unusual and compelling urgency, 41 U.S.C. 3304(a)(2)

If unusual and compelling urgency is the basis for the justification, explain the chronological events leading up to the requirement and explain why time constraints cannot permit even a limited competition. Describe the detrimental effects/ serious injury to the mission of the requiring activity or to the government, financial or otherwise, that will result if this justification is not approved. Describe impact of required delivery/performance date. Describe the detrimental effects/serious injury to the mission of the requiring activity or to the government, financial or otherwise, that will result if this justification is not approved and the product or service cannot be provided by the intended sole source contractor. Failure to plan for expiring funds is not a valid reason for citing this exception. May not exceed one year, including all options, unless the head of the agency determines that exceptional circumstances apply.

D FAR 6.302-5: Authorized or Required by Statute, 41 U.S.C. 3304(a)(5)

Provide a citation to the statutory authorization and a brief description of its content, or identify the specified source or other agency.

D Other (See FAR Subpart 6.3 for additional authority)

Provide the authority and citation to the applicable section of FAR 6.3.

Pellumbeshe Hoxhaj -S Digitally signed by Pellumbeshe Hoxhaj -S Date: 2021.11.30 09:11:36 -05'00'

Pellumbeshe Hoxhaj -S

Digitally signed by Pellumbeshe Hoxhaj -S Date: 2021.11.30 15:49:37 -05'00'