36C24624P0374_1.docx

Justification and Approval Notice Justification and Approval Notice

GENERAL INFORMATION

CONTRACTING OFFICE ADDRESS

Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton VA 23667

POINT OF CONTACT*

Contracting Officer John J. Summers john.summers2@va.gov 757-315-3421

AWARD INFORMATION

MODIFICATION NUMBER

LINE ITEM NUMBER

AWARDEE NAME*

CONTRACTOR’S UEI

METABOLON, INC.

SBY5A7EK9PU3

AWARDEE ADDRESS LINE 1*

AWARDEE ADDRESS LINE 2*

AWARDEE ADDRESS LINE 4*

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 3C246-24-AP-0233

1. Contracting Activity: Department of Veterans Affairs, Department of Veterans Affairs, Network Contracting Office 6, 100 Emancipation Drive, Hampton VA 23667 in support of the Durham VA Medical Center at 508 Fulton Street Durham, NC 27705. Purchase request 558-24-1-304-0011.

2. Nature and/or Description of the Action Being Processed: This procurement is for metabolomic profiling of plasma samples and will be awarded as a new firm, fixed-price service contract.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

Durham Research will test a comprehensive set of metabolites assayed by the Metabolon metabolomics platform covering over 60 metabolic pathways in over 1046 Veterans in the Gulf War Era Cohort and Biorepository (GWECB), collected and made available to researchers by the VA Office of Research and Development Gulf War Program. Durham Research also will analyze these combined datasets to test whether smaller clusters of symptoms that make up GWI can identify specific subtypes of GWI related to the pathways found. These data will be returned to the GWECB data repository so that it can be made available to the Gulf War research community for additional research. Gulf War Illness (GWI) is a chronic, debilitating illness suffered by Veterans of the first Gulf War. Patients suffering from GWI are often subject to years of medical uncertainty as they make their way through multiple clinics to try to diagnose and ultimately treat their chronic symptoms, if possible. Complicating this medical journey is the absence of biomarkers that can be used to diagnose the conditions and that might provide clues as to treatments and etiology. A recent review of the evidence for biomarkers in GWI concluded that there were no validated biomarkers for GWI. The lack of biomarkers is accompanied by a lack of treatments demonstrated to work in a large number of Veterans.

Epidemiologic studies have been successful in identifying associations with exposures common to serving in the Gulf War through development of large cohorts of Gulf War Veterans. Biomarker studies in small numbers of Gulf War Veterans have identified biomarkers for testing. Among the most fruitful of these are studies of metabolomics, the analysis of all small molecules in blood or tissue measured by specialized instruments capable of detecting very small quantities of metabolites and then comparing them to known compounds. The metabolomics dataset will join data from other assays in GWECB designed to interrogate other biological systems. Genome-wide genotyping tests how up to 1 million genetic variants across the genome contribute to differences in Veterans with Gulf War Illness versus those without. Likewise, genome-wide epigenetic assays test how up to 800,000 DNA modifications contribute different levels of activity of genes across the genome. Putting these three modern biomedical technologies together provides a comprehensive view of physiological differences in individuals. In combining these data, the VA hopes to identify biological pathways that distinguish GWI Veterans and suggest treatments and biomarkers.

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

( X ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements ( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Metabolon is the sole authorized service provider of metabolomic profiling of plasma samples for the Million Veteran Program (MVP).

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: No other sources were consulted. Metabolon, Inc. is the sole authorized provider.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The CO will determine the anticipated cost to the Government to be fair and reasonable based on the comparison of proposed prices with prices for reasonable on previous purchases. Prior to award price analysis of the proposed contract price will be performed and documented to sufficiently determine that the cost to the Government of the proposed acquisition will be fair and reasonable. Additional discounts will be sought before placing an order.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: The VA Rule of Two cannot be met. The Small Business Rule of Two cannot be met. The Million Veteran Program (MVP) is conducting similar work with Metabolon, Inc. to ensure reproducibility of that data, the identical tests must be performed by Metabolon, Inc., a large business.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: None.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Metabolon, Inc.

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: The Government will continue to conduct thorough market research to gauge the commercial marketplace capabilities for future requirements. No actions can be taken, at this time, to increase competition because Durham Research requires the service of the same laboratory as the VA Million Veteran Program.

Justification and Approval Notice