JA.pdf

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TMPLT 2016.06-011

Justification for Other than Full and Open Competition

1. Identification of the agency and contracting activity:

a. Federal agency and contracting activity.

Dept. of Heath and Human Services, Food and Drug Administration

b. Sponsoring organization.

CDER/OPQR

c. Contracting Officer’s Representative (COR)/Requiring Activity Point of Contact (POC) information.

i. Name: Michael Karfunkle

ii. Mailing address: 645 S. Newstead Ave, Saint Louis, MO 63110

iii. E-mail address: Michael.Karfunkle@fda.hhs.gov

iv. Telephone number: 314 539-3870

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

Ongoing ISO accreditation activities for the OPQR St. Louis quality management system and lab.

a. Acquisition purpose and objectives.

OPQR St. Louis was awarded ISO 17025 accreditation in 2023 by A2LA. To maintain accreditation the site needs to establish a contract for regularly scheduled accreditation services with A2LA, including annual evaluation of compliance with ISO and A2LA requirements.

b. Project background.

The Office of Pharmaceutical Quality and Research (OPQR) St. Louis was accredited by a third-party vendor signifying the site has a quality management system that meets ISO 17025 standards and is competent to provide valid results. The site generates results for various FDA offices to use as supporting evidence for regulatory decisions and actions related to new drug products, existing drug products, and public health emergencies. Accreditation provides customers assurance that data is consistent, accurate, and valid to support their mission.

A2LA was selected for accreditation services in 2021 and a pre-assessment was completed to evaluate the site’s preparedness for the initial assessment. The site was audited for compliance with ISO 17025 and A2LA’s policies in May 2023 and accreditation was granted in November 2023. Ongoing assessments are required to maintain accreditation to ISO requirements and the current vendor’s policies and procedures.

Template mailto:Michael.Karfunkle@fda.hhs.gov

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

Biennial full accreditation/renewal audit, with biennial surveillance audit/annual review on the year between full audits.

a. Project title.

OPQR St. Louis ISO Accreditation

b. Project Description.

See attached Statement of Work (SOW)

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:

Type of action.

☒ New requirement

☐ Follow-on

☐ Other:

Proposed contract/order type.

☐ Firm-fixed-price

☐ Other fixed-price:

☐ Cost-plus-fixed-fee

☐ Other cost reimbursement:

☒ Time and materials

☐ Indefinite delivery:

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☐ Other:

☐ Completion Form

☐ Term Form

Acquisition identification number.

OPQR St. Louis ISO Accreditation

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

$66,307.58

4. Identification of the statutory authority permitting other than full and open competition. Check the applicable block below based on the acquisition circumstance.

Federal Acquisition Regulation (FAR):

☒ 6.302-1 Only one responsible source and no other supplies or services will satisfy agency requirements. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(1) or 41 U.S.C. 3304(a)(1).

☐ 6.302-2 Unusual and compelling urgency. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(2) or 41 U.S.C. 3304(a)(2).

☐ 6.302-3 Industrial mobilization; engineering, developmental, or research capability; or expert services. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(3) or 41 U.S.C. 3304(a)(3).

☐ 6.302-4 International agreement. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(4) or 41 U.S.C. 3304(a)(4).

☐ 6.302-5 Authorized or required by statute. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(5) or 41 U.S.C. 3304(a)(5).

☐ 6.302-6 National security. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(6) or 41 U.S.C. 3304(a)(6).

☐ 6.302-7 Public interest. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(7) or 41 U.S.C. 3304(a)(7).

☐ 13.501(a)(1)(ii) Sole source, including brand name, under Simplified Procedures for Certain Commercial Items. This acquisition is using this justification format, modified to reflect that the procedures in FAR subpart 13.5 were used in accordance with 41 U.S.C. 1901 or the authority of 41 U.S.C. 1903.

https://www.acquisition.gov/far/html/Subpart%206_3.html http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-chapter33&edition=prelim https://www.acquisition.gov/far/html/Subpart%206_3.html http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-chapter33&edition=prelim https://www.acquisition.gov/far/html/Subpart%206_3.html http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-chapter33&edition=prelim https://www.acquisition.gov/far/html/Subpart%206_3.html http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-chapter33&edition=prelim https://www.acquisition.gov/far/html/Subpart%206_3.html http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-chapter33&edition=prelim https://www.acquisition.gov/far/html/Subpart%206_3.html http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-chapter33&edition=prelim https://www.acquisition.gov/far/html/Subpart%206_3.html http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-chapter33&edition=prelim https://www.acquisition.gov/far/html/Subpart%2013_5.html https://www.acquisition.gov/far/html/Subpart%2013_5.html http://uscode.house.gov/view.xhtml?req=(title:41%20section:1901%20edition:prelim) http://uscode.house.gov/view.xhtml?req=(title:41%20section:1903%20edition:prelim)

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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).

American Association for Laboratory Accreditation (A2LA) 5202 Presidents Court, Suite 220 Fredrick, MD 21703

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

The St. Louis site received accreditation in 2023 from A2LA which means the site is compliant with not only ISO 17025, but also the additional requirements in A2LA’s policies. Site processes and procedures had to be modified for compliance with both sets of requirements. In order to maintain continuous accreditation, the site is required to participate in annual assessments to verify compliance to ISO 17025 and the A2LA requirements.

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

The services are not expected to exceed $15,000, so a notice may not need to be published per FAR

5.101 and 5.202.

No other vendors are authorized to perform the annual assessments against A2LA’s policies and accreditation is not transferrable between vendors, so if a new one is selected, the accreditation process would have to start over because each vendor has their own requirements beyond what is outlined in ISO 17025.

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

The accreditation services provider outlines a not to exceed price for all accreditation activities required to maintain accreditation. Accreditation activities occur annually. Onsite assessments are performed every other year. Remote assessments occur on the off years. The cost of each accreditation activity varies by vendor.

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.

Market research was not conducted for this contract proposal because the time to identify a new vendor, update site processes and procedures to meet new vendor requirements, provide training to the site, participate in a pre-assessment audit, and participate in a new initial accreditation audit would exceed the current certification expiration date of July 2025 and cause a lapse in accreditation.

https://www.acquisition.gov/far/html/Subpart%205_2.html https://www.acquisition.gov/far/html/Subpart%205_2.html https://www.acquisition.gov/?q=browse/far/10

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

A change in vendors and repeat of initial accreditation would duplicate activities and costs already incurred to date. Additionally, a change could take up to 2 years to complete the following actions.

• Reprioritize or halt work to research other vendors and their specific requirements

• Determine extent of changes required for St. Louis processes and procedures

• Revise St. Louis processes and procedures to comply with new vendor requirements

• Provide re-training to all staff to explain changes to processes and procedures

• Cost of a pre-assessment audit to determine compliance with new vendor

• Cost of another initial accreditation with a new vendor.

It is recommended to retain A2LA at this time since completion of all activities above would exceed the current accreditation expiration of July 2025.

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

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.

A change in vendors can be explored in the future once all time, cost, and activities have been planned to prevent a lapse in accreditation.

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.

Signature:____________________________________

Michael Karfunkle COR/Requiring Activity POC

Alicia Hoover COR/POC Immediate Supervisor

[Enter name here.] Head of the Sponsoring Program Office

13. Contracting Officer Certification.

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The CO shall complete the information required below and sign the certification in the block provided.

[NOTE: The CO’s signed certification may serve as approval of a J&A over $150,000 but not exceeding $700,000 (FAR 6.304(a)(1) and FAR 13.501(a)(2)(i)), depending on OPDIV procedures.]

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.

Contracting Officer

[Enter date here.]

14. Competition Advocate signature.

The designated OPDIV Competition Advocate (CA), upon acceptance of the rationale provided in the J&A, shall complete the information required below and sign in the block provided as the approving official for any J&A over $700,000 but not exceeding $13 million. [FAR 6.304(a)(2) and FAR 13.501(a)(2)(ii)]

Competition Advocate

15. Division Director and Head of the Contracting Activity signature(s).

The Division Director, if applicable, and the HCA shall indicate review of, and concurrence with, any J&A over $13 million, but not exceeding $68 million by providing the information required below and signing in the applicable block. [FAR 6.304(a)(3) and FAR 13.501(a)(2)(iii)]

Division Director

Head of the Contracting Activity

16. HHS Senior Procurement Executive signature.

https://www.acquisition.gov/far/html/Subpart%206_3.html https://www.acquisition.gov/far/html/Subpart%2013_5.html https://www.acquisition.gov/far/html/Subpart%206_3.html https://www.acquisition.gov/far/html/Subpart%2013_5.html https://www.acquisition.gov/far/html/Subpart%2013_5.html https://www.acquisition.gov/far/html/Subpart%2013_5.html

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The HHS SPE, upon acceptance of the rationale provided in the J&A, shall complete the information required below and sign in the block provided as the approving official for any J&A over $68 million.

[FAR 6.304(a)(4) and FAR 13.501(a)(2)(iv)]

HHS Senior Procurement Executive https://www.acquisition.gov/far/html/Subpart%2013_5.html