JOFOC.pdf

Attachment C

Justification for Other than Full and Open Competition

“Source Selection Information – see FAR 2.101 and 3.104”

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity. HHS.

Health and Human Services National Institutes of Health Clinical Center Office of Purchasing and Contracts

b. Sponsoring organization.

National Institutes of Health Clinical Center Office of Purchasing and Contracts

c. Project Officer information.

• Project Officer name.

Rachel Evans

• Mailing address.

ATTN: Rachel Evans BLD 10, Room 10D10/11 10 Center Drive Bethesda, MD 20892

• E-mail address.

Rachel.evans2@nih.gov

• Telephone number.

240-762-0720 (work cell) 301-480-7942 (office)

2. Nature and/or description of the action being approved.

a. Acquisition purpose and objectives.

The bridge contract is to ensure continuity of cleaning the cGMP manufacturing facilities and compounding pharmacies and is essential to continue to protect human safety and human healthcare. This contract is in support of regulatory requirements and remaining within regulatory compliance.

b. Project background

To continue to provide essential cleaning services to all cleanroom facilities at NIH to continue operating and providing patient care and ensuring patient safety

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Project title. Bridge Contract for Essential Cleanroom Cleaning

• Project description. To continue cleaning cleanroom facilities to ensure patient safety and remain within regulatory compliance.

• Requirement type.

❑ Research & development (R&D) ❑ R & D support services

❑ Support services (non-R&D)

Supplies/equipment

❑ Information technology (IT)

❑ Construction

❑ Architect-engineer (A & E) services

❑ Design-build

❑ Other (specify): ____________________

• Type of action.

❑ New requirement Follow-on

❑ Other (specify): ______________________

• Proposed contract/order type.

Firm-fixed-price ❑ Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ ❑ Cost-plus-fixed-fee ❑ Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________ ❑ Time and materials ❑ Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________

❑ Other (specify): ___________

❑ Completion Form ❑ Term form

• Acquisition identification number.

c. Total estimated dollar value and performance/delivery period.

$249,000 starting from December 30, 2025 – February 28, 2026

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

This acquisition is conducted under the authority of 41 United States Code (U.S.C.) 253(c)(1) as set forth in Federal Acquisition Regulation (FAR) 6.302- 1.

❑ This acquisition is conducted under the authority of section 4202 of the Clinger-Cohen Act of 1996.

❑ This acquisition is conducted under the authority of the Services Acquisition Reform Act of 2003 (41 U.S.C. 428a).

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

a. Name and address of the proposed contractor(s).

ATTN: Daniel Brandt Advanced Cleanroom Microclean (Corporate Office) 3250 South Susan Street, Suite A Santa Ana, CA 92704

b. Nature of the acquisition and proposed unique qualifications of the contractor(s). Advanced Cleanroom Microclean is ISO 9001:2015 certified with 40 years of industry experience in Cleanroom Facilities and 5 years working at the NIH. They meet all regulatory requirements with their accreditations and meet objectives within the current and proposed SOWs.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

This is a bridge contract under JOFOC (FAR 6.302-2) as the services requested are urgent and immediate to provide continuity of service for patient safety and regulatory compliance. This is a temporary bridge from previous contract until the new contract is awarded.

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

This is a bridge contract under JOFOC (FAR 6.302-2) as the services requested are urgent and immediate to provide continuity of service for patient safety and regulatory compliance. This is a temporary bridge from previous contract until the new contract is awarded.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

This is a bridge contract under JOFOC (FAR 6.302-2) as the services requested are urgent and immediate to provide continuity of service for patient safety and

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

are urgent and immediate to provide continuity of service for patient safety and

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

are urgent and immediate to provide continuity of service for patient safety and regulatory compliance. The existing contractor: Advanced Microclean was included in the acquisition for the bridge contract. This is a temporary bridge from previous contract until the new contract is awarded.

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

This is a bridge contract under JOFOC (FAR 6.302-2) as the services requested are urgent and immediate to provide continuity of service for patient safety and regulatory compliance. This is a temporary bridge from previous contract until the new contract is awarded. The new contract will be an open and full acquisition however due to the short notice and criticality of this service; the existing contractor will continue until the new contract is awarded to the best applicant.

12. Program office certification..

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

Official Name & Title Signature Date

Project Officer Paula Snowden on behalf of Rachel

Evans, COR

Project Officer’s

Immediate Supervisor

Paula Snowden

Head of the Sponsoring

Program Office

Leslie Wehrlen, Deputy Chief on behalf of Virginia Guptill, Chief, ORSC

13. Contracting Officer certification.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Official Name & Title Signature Date

Contracting Officer

14. Chief of the Contracting Office and Head of the Contracting Activity signature(s).

Official Name & Title Signature Date

Chief of the

Office

Head of the

Activity

15. Competition Advocate signature.

Official Name & Title Signature Date

Competition Advocate

16. HHS Senior Procurement Executive signature.

Official Name & Title Signature Date

HHS Senior Procurement

Executive