B. Justification_and_Approval_for_Sole_Source_2025_FE.pdf

Justification and Approval for Sole Source (J&A) (Template)

Justification and Approval for Sole Source

“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.

Department of Health and Human Services National Institute of Health National Institute on Drug Abuse

b. Sponsoring organization.

National Institute on Aging Translational Gerontology Branch

c. Project Officer information.

• Project Officer name: Eleanor Simonsick, PhD

• Mailing address. 3001 S Hanover St., Baltimore, MD 21225

• E-mail address: simonsickel@grc.nia.nih.gov

• Telephone number. 410.350.3965

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

a. Acquisition purpose and objectives.

The purpose of this requirement is to obtain laboratory and related analytic services for the evaluation of genome-wide methylation in archived DNA samples of the Baltimore Longitudinal Study of Aging (BLSA) using DNA methylation microarrays consistent with previously acquired DNA methylation data.

b. Project background.

Epigenetic change has been proposed as a ‘hallmark’ of aging and an element of the biological mechanisms underlying the aging process. DNA methylation is the most commonly studied epigenetic mark in humans and has been associated with aging phenotypes and age-related diseases in cross-sectional studies. However, longitudinal characterization of DNA methylation and change over time in the same individuals has been rarely ascertained. Archived samples from the BLSA offer a unique opportunity to fully describe the trajectory of DNA methylation over time and across the life course as well as the ability to relate change in DNA methylation to a broad range of aging phenotypes.

To capture potential nonlinear change in DNA methylation this project interrogates genome-wide DNA methylation using serial samples from a large number of BLSA participants collected over several follow-up visits.

To address the volume of samples required to characterize trajectories, microarray processing services are required to evaluate genome-wide DNA methylation in stored DNA samples.

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

a. Project title.

DNA methylation microarray processing services for the Baltimore Longitudinal Study of Aging (BLSA).

b. Project description.

The Baltimore Longitudinal Study of Aging is the longest running study of human aging in the United States. In the modern era of the study a program of measurement and testing has been implemented to enhance the National Institute on Aging’s (NIA) understanding of age-associated physical and biological changes in health and disease. Consistent with the widely accepted framework of the ‘hallmarks of aging’ the NIA investigates epigenetic change as a potentially fundamental mechanism in the aging process. Archived samples from the BLSA offer a unique opportunity to measure DNA methylation over time as well as the ability to relate changes in DNA methylation to a broad range of aging phenotypes.

The purpose of the proposed procurement is to provide the government with state-of-the art microarray processing services for the evaluation of genome-wide DNA methylation in a large volume of stored DNA samples.

Specifically, this acquisition aims to build and capitalize on previously acquired longitudinal DNA methylation data.

• 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: POTS 25-005243

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

The contract period will be 12 months after receipt of the order. The total estimated dollar amount is $279,496.00 (992 samples at $281.75 per sample).

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.) 3304(a)(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).

UCLA Neuroscience Genomics Core 695 Charles E. Young Drive S., Room 3506 Los Angeles, CA 90095-1761 Tel: 310-825-2390 Fax: 310-794-9613 E-Mail: jdeyoung@mednet.ucla.edu

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

This acquisition involves continued processing of archived BLSA DNA samples using DNA methylation microarray assays for which the UCLA Neuroscience Genomics Core has demonstrated excellent past performance. The samples that will be processed under this acquisition are part of a larger study for which a substantial amount of data has already been collected: the planning for the first stage of this project began five years ago and over 3500 samples have been processed to date. Given the primary objective of the project is to compare change over time, an essential requirement is the minimization of technical variation to the greatest extent possible. If another service provider is used, NIA would have to first evaluate the presence and extent of differences in assay results between previously acquired data and results from potential providers. Such a comparability substudy would require previously assayed samples to be pulled from the biorepository and run by the new service provider followed by analyses to compare old and new data. This step in and of itself is time and cost prohibitive. Additionally, even if data were found to be moderately compatible, NIA would still have to analytically account for remaining differences through complex statistical methods. Clearly, any change in service provider would require substantial additional laboratory and analytic efforts and the possibility remains that the data could be irreconcilable. This potential situation would seriously deplete non-renewable resources (i.e., banked specimens) and substantially negatively impact all planned and future projects. Further, the UCLA Neuroscience Genomics Core has demonstrated experience handling BLSA archival DNA samples which present unique challenges due to the variety and complexity of the collection and storage protocols used during different periods of the long-running BLSA. The quality of the data from assays previously processed by the UCLA Neuroscience Genomics Core has been of the highest quality.

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

A sources sought notice was posted on September 09, 2025 and responses were due by September 24, 2025. No companies responded to the sources sought notice. A combined synopsis/solicitation will be posted on SAM.gov.

While this will be a sole source procurement, any interested party may submit a capability statement, proposal, or quotation, which shall be considered by the agency.

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

A contract will only be awarded if during negotiations, the cost is fair and reasonable. A quotation will be obtained from the contractor and additional quotations or public pricing information identified via market research will be reviewed. Price reasonableness determination will be included in the acquisition file.

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.

Knowledgeable individuals within the NIA and colleagues in academia were contacted regarding cost and logistics associated with processing large volumes of microarray assays and current DNA methylation assay service providers.

Additional market research was conducted by reviewing previous contracts, and internet keyword searches,. Market research is documented in the acquisition file.

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

Establishing new processes with a different service provider would result in a substantial delay in deliverables because of start-up time and requirement for comparability studies described above (9 months – 1 year), these studies would also increase cost (replicate assays, 96 samples > $27,048, and analytic resources, minimum a postbaccalaureate fellow stipend > $38,000/year). Further use of a new service risks loss of limited samples if the new service provider is unable to establish appropriate methods for handling the archival samples.

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

No companies expressed interest in the sources sought notice, however NIA requires UCLA to ensure continuity of data.

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.

It is expected that the present acquisition will complete the current phase of the BLSA longitudinal DNA methylation project. NIH will attempt to compete future requirements when at all possible, if new projects arise.

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

Eleanor M. Simonsick 9/25/25

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