The objective of this requirement is to obtain off-site, secure storage for hard-copy (paper) documents. The CDC is seeking a turnkey solution to provide off-site data protection, secure protected transport receiving, archiving, and record storage. The service will include approximately five-hundred sealed/tamper-proof boxes of paper clinical trial participant files received and stored at Iron Mountain in a climate-controlled vault in Atlanta, GA.

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 8(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:

Agency:

Acquisition Year (FY):

Author and Title:

2. Description of Action:

Nature: New Requirement Follow-on Requirement

Modification to Existing Purchase Order/Contract Number:

Pricing: Firm-Fixed Price Time & Materials Cost

Other:

Funds: OMA Other Funds:

Name of Proposed Contractor(s):

Street Address:

City, State, Zip:

3. Description of Services or Supplies:

Basis for Approval (FAR 6.303-1(d)): Individual Basis Class Basis

The total estimated value of the proposed action, including all options is $

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.

STRIVE Records Management

Anthony T. Smith, COR

Iron Mountain Information Management, LLC

85 New Hampshire Ave, STE 150

Portsmouth, NH 03801-2926

387,828.59

The commercial storage vendor, Iron Mountain, was initially identified, assessed, and selected as the sole eligible vendor for meeting all criteria required for the long-term maintenance of clinical trial files according to the regulatory requirements defined by the FDA and the European Medicines Agency (EMA). In addition to providing secure storage and temperature control, Iron Mountain uniquely meets the requirements for maintaining the chain of custody of clinical trial files and provides an inventory filing system which supports the meticulous archiving, ad-hoc retrieval, and final disposition required for these files. The Iron Mountain facility was inspected and approved by the official regulatory body, the Pharmacy Board of Sierra Leone (PBSL), the clinical trial Principal Investigator which has the authority and responsibility for these files. Moving these files out of Iron Mountain to another facility would be cost prohibitive to the program. On top of moving costs (~$12,000), clinical trial chain of custody rules requires a Contract Research Organization (CRO) to oversee the movement of files and inventory every single file in a manifest. This entire process would require an additional sub-contract for CRO services at Iron Mountain and at the new facility (packing and un-packing), as well as program staff time and travel, totaling at least $150,000. The requirements for this facility ensure the preservation of these files while stored, as well as the capacity to accommodate visitors should the European Medicines Agency (EMA), US Food and Drug Administration (FDA), or PBSL decide to audit the records at any time. Since EMA and FDA authorized and approved the vaccine in 2019, the files must be maintained until 2034. During this period, the maintenance of these files ensures the continued licensure of the Ebola vaccine in the United States and internationally. Without this licensure by FDA and EMA, Americans located domestically or abroad may not receive or utilize this vaccine for preventative or reactive measures in case of another Ebola outbreak.

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.

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.

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.

Other (See FAR Subpart 6.3 for additional authority)

No other actions were taken to remove or overcome barriers to the consideration of Iron Mountain as the sole source vendor since this facility uniquely met all requirements of clinical trial regulations and therefore was approved by both the clinical trial investigator and sponsor (CDC). The deputy director of CDC (Dr. Anne Schuchat) signed and issued an MOU with the Ministry of Health of Sierra Leone to establish this agreement.

Iron Mountain has been providing this service since May 3, 2023 under contract 75D30123P16523 which will end on May 2, 2026.

The Contractor shall provide storage services for current records that arrived from Sierra Leone. The period of performance is for one base year and four options periods.

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

Provide a full explanation to justify use of the exception.

5. Agency Actions to Take or Remove Barriers That Led to Other Than Full and Open Competition (If applicable):

Describe the actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration prior to any subsequent acquisition for the supplies of services is made. If no such actions have been taken, explain why.

6. Bridge Contracts:

For contract extensions or bridge contracts when a competitive follow-on is in the process of being developed, summarize history of current contract and explain the reasons for any delays in the acquisition. Include discussion of the milestones for the follow-on action; the milestones should be as efficient as possible. Discuss why it would be neither cost effective nor realistic to expect another contractor to perform during the brief interim period; include issues such as start-up costs, phase-in, transfer of GFP, recruitment and staffing, etc. If the action is because of a protest, provide a brief discussion of the protest including the date the protest was filed and the basis of the protest. Explain that the action will provide the minimum quantity or performance period.

7. Actions to Increase Competition:

Describe efforts made to compete the action, including whether a notice was or will be publicized as required by FAR Subpart

5.2 or which exception under FAR 5.202 applies. If a notice was publicized, discuss the number of written responses to the synopsis and the results of the assessment of the written responses. List sources, if any, that expressed, in writing, an interest in the acquisition. Provide rationale if interested sources were rejected. If applicable, state that no other sources have expressed interest, but all offers received shall be considered. Describe what actions will be taken to increase competition before subsequent acquisition of the supplies or services is required. You may state that an action is a one-time requirement, but if a similar requirement arises, every effort will be made to compete it to the maximum extent possible. If action is sole source because of proprietary data or licensing rights and there will be a continuing need for the requirement, there must be evidence that advanced planning has been initiated to overcome the barriers to competition, or there should be documentation to support an analysis that replacement costs/licensing purchase costs outweigh the benefits of competition.

If the action is a contract extension or bridge, explain actions to compete the follow-on. If action is an urgent new requirement and a competitive follow-on is anticipated, explain that efforts are underway to facilitate a full and open competition.

8. Market Research:

Describe the extent of the market research conducted to identify all qualified sources and the results thereof. “Market Research” is defined as those attempts you made to ascertain whether other qualified sources exist, and can include contact with knowledgeable experts regarding similar or duplicate requirements, contact with industry, results of a sources sought synopsis, or draft solicitations. Research of the marketplace may consist of written, electronic (i.e. email) telephonic, or world wide web inquiries. Lack of advanced planning is not an acceptable reason for the lack of market research, but true urgency may necessitate abbreviated market research that is limited to readily available historical and commercial information. If action is a contract extension or bridge contract, describe the market research efforts underway or completed for the follow-

on. See FAR 10.002(b)(2).

9. Procurement History:

Purchase order or contract number:

Was action competed? Yes 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:

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.

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: Christina Ottis

Position Title: Project Officer

Email address: lwv1@cdc.gov

Phone: 678-381-6731

Program Manager Supervisor (or one level above Program Manager)

Name: Kimberley Fox

Position Title: Division Director

Email address: kaf6@cdc.gov

Signature: KIMBERLEY K. FOX -S Digitally signed by KIMBERLEY K. FOX -S Date: 2026.01.05 10:02:31 -05'00'

. Market research was conducted after review of the regulatory requirements for the clinical trial. The commercial storage vendor, maintenance of clinical trial files according to the regulatory requirements defined by the FDA and the European Medicines Agency the program. On top of moving costs ($12,000), clinical trial chain of custody rules requires a Contract Research Organization (CRO) contract for CRO services at Iron Mountain and at the new facility (packing and unpacking), as well as program staff time and travel, 75D30123P16523 mailto:lwv1@cdc.gov mailto:kaf6@cdc.gov

Iron Mountain Government Solutions currently holds GSA schedule contracts where rates have already been reviewed and deemed fair and reasonable. Review and negotiation will be conducted to confirm the proposed level of effort in commensurate with the requirement as described in the Statement of Work; however, while similar price points of those on Iron Mountain's Commercial GSA Data Management services, the Government is still getting the advantages of the GSA negotiated rates, even though Iron Mountain is proposing an Open Market order based on the terms of our GSA Schedule. The Government will be receiving GSA rates but for a non-GSA task order.

Date: Jan 5, 2026

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.

Name: Robin C. Meyer

Phone: 678-475-4924

Signature: ROBIN C. MEYER -S

Digitally signed by ROBIN C.

MEYER -S

Date: 2026.04.17 16:33:03 -04'00'

Date: Apr 17, 2026

13. Contracting Officer's Approval (Required for proposed contract not to exceed $700,000 (value calculated including all options)): I hereby certify that this justification is accurate and complete to the best of my knowledge. I approve this justification subject to availability of funds, and provided that the services and supplies herin describe have otherwise been authorized for acquisition.

Name: Robin C. Meyer

Phone: 678-475-4924

Signature: ROBIN C. MEYER -S

Digitally signed by ROBIN C.

MEYER -S

Date: 2026.04.17 16:34:21 -04'00'

Date: Apr 17, 2026

14. Legal Review:

All J&As greater than $68 million must have a legal review from the General Law Division of the Office of the General Counsel prior to sending it to the Department.

15. OPDIV Competition Advocate Approval (Required for proposed contract over $700,000 but not exceeding $13.5 million value calculated including all options)):

I have reviewed this justification and find that it adequately supports other than full and open competition.

Name:

Phone:

Signature:

Date:

16. Office of Small and Disadvantaged Business Utilization:

I have reviewed this justification and find that it adequately supports other than full and open competition.

17. OPDIV HCA Approval (Required for proposed contract over $13.5 million but not exceeding $68 million value calculated including all options)):

18. Department Competition Advocate:

Concur:

Non-Concur:

The objective of this requirement is to obtain off-site, secure storage for hard-copy (paper) documents. The CDC is seeking a turnkey solution to provide off-site data protection, secure protected transport receiving, archiving, and record storage. The service will include approximately five-hundred sealed/tamper-proof boxes of paper clinical trial participant files received and stored at Iron Mountain in a climate-controlled vault in Atlanta, GA.

(The below approval paragraph is required if the cumulative contract value, including all options, exceeds $68 million.)

19. HHS Senior Procurement Executive (SPE) Approval:

Based on the foregoing justification, I hereby approve other than full and open competition for the above stated procurement, subject to the availability of funds, and provided that the services herein described have otherwise been authorized for acquisition.

State supplies/services being procured:

State the full statutory authority and FAR cite and title, consistent with paragraph 4, e.g. 41 U.S.C. 3304: