JOFOC.pdf

Template for Justification and Approval for Other Than Full and Open Competition

Completion Instructions: The Department of Health and Human Services (HHS) has established a standard template for the preparation of a J&A for Other Than Full and Open Competition. If this is an B(a) set-aside, please note this form is not required unless the acquisition is valued (including all options) at greater than $22 million. This template is NOT applicable for actions using simplified acquisition procedures (FAR Part 13). Federal Supply Schedule orders (FAR 8.4) or task or delivery orders subject to fair opportunity (FAR 16.505).

Tailor all aspects of this template to the individual acquisition. Consult FAR Subpart 6. 3 for guidance. An addendum may be added in case additional space is needed.

When this document is printed, the blue italic instructions are automatically deleted on the printed version.

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

Acquisition Title: Add ACIP recommended pneumococcal vaccine to adult contract

Agency: lcDc

Acquisition Year (FY): �120_2 _2_�

Author and Title: Jeanne Trapper, Lead Public Health Analyst

2. Description of Action:

Nature: D New Requirement D Follow-on Requirement

1ZJ Modification to Existing Purchase Order/Contract Number: 75D 3 012 1D 113 5 4

Pricing: 1ZJ Firm-Fixed Price D Time & Materials D Cost

D Other:

Funds: IZI OMA D Other Funds:

Name of Proposed Contra ctor(s): �'M_ e_r _ck_ S_h_a _rp _&_D_o _h _m_e _ C_o_r _p. ______________________ �

Street Address: �l2_o _oo_G_al _lo_p _in_g_H_ i _ll _R _d ________________________ �

City, State, Zip: �IK_e _n _ilw_ o_ rt_ h_ ,_N_J _ 0_ 7_03_ 3 _- _13_ 1_ o _______________________ _,

3. Description of Services or Supplies:

asis for Approval (FAR 6.3 03 - 1 (d)): 1ZJ Individual Basis D Class Basis

The total estimated value of the proposed action, including all options is $ 5 9,96 2,000 ( 400,000 doses at estimated $149.9 05/<g

As applicable, briefly describe the services or supplies required to meet the agency's needs, including make & model number where appropriate. Include quantities of supplies or period of performance for services. Provide information for any options included. If the action is a modification to an existing contract, distinguish clearly between the work covered by the original contract and the work to be obtained by the proposed modification.

The National Center for Immunization and Respiratory Diseases (NCIRD) awarded multiple indefinite delivery, indefinite quantity (IDIQ) contracts for the purchase of standard commercial adult vaccines, manufactured under a current establishment and product license issued by the U.S. Food and Drug Administration (FDA). The vaccines awarded under these contracts will be purchased for NCIRD's immunization awardees (the fifty state health departments, several large city program and current and former U.S.

Territories) to support immunization programs as provided under Section 3 170) of the Public Health Service Act and Section 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 Merck contract will be modified to support purchase of PCV 15 vaccine (VAXNEUVANCE) 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.

VAXNEUVANCE vaccine from Merck is the only vaccine being considered for this request. Currently, there is only one manufacturer with an FDA-approved license for PCVl 5 at this time-Merck. The current Merck 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.

com a invasive pneumococca e vaccine mar etp ace, e Government will ensure transparency in the contracting process by posting the approved J&A within 30 days of award in accordance with FAR 6.305(b).

9. Procurement History:

Purchase order or contract number: 175D30121011354 lwas action competed? I IZI Yes ID No

If action was not competed, state the cited authority, summarize rationale, and describe the actions that were supposed to be taken to increase competition and the results thereof:

N/A

10. Additional Information to support the justification:

If applicable, explain why technical packages or specifications to facilitate competition were not developed or available;

describe actions taken to remedy the situation.

N/A

11. Technical / Requirements Certification: By my signature below, I certify that the supporting data included in this J&A is accurate and complete.

Program Manager

Name: Ray Lopez

Position Title: Public Health Analyst

Email address: gsz8@cdc.gov

Phone: 404-639-8924

Program Manager Sugervisor {or one level above Program Manager)

Name: Jeanne Trapper

Position Title: Lead Public Health Analyst

Email address: jwu0@cdc.gov

Signature: Jeanne Tropper -5 Digitally signed by Jeanne Tropper -S

Date: 2021.11.16 14:54:27 -05'00'

Date:

12. Fair and Reasonable Price/Cost Determination: As Contracting Officer, by my signature below, I hereby determine that the anticipated price/cost to the Government for this contract action will be fair and reasonable.

Provide the basis for this determination, e.g., describe techniques to be used to determine fair and reasonable price (FAR Subpart 15.402), such as price analysis, cost analysis, cost realism. Per FAR Subpart 15.403-4(a)(1 ). the threshold for obtaining cost or pricing data is $750,000.

Vaccine pricing will be determined to be fair and reasonable prior to award of the modification. Price analysis will be used. Certified cost or pricing data will not be requested, as these are commercial items.

Pellumbeshe Hoxhaj -S Digitally signed by Pellumbeshe Hoxhaj -S Date: 2021.11.30 09:07:02 -05'00'

Pellumbeshe Hoxhaj -S

Digitally signed by Pellumbeshe Hoxhaj -S Date: 2021.11.30 15:47:46 -05'00'