JOFOC - SAM - Exec.pdf

Justification and Approval for Sole Source

“Source Selection Information – see FAR 2.101 and 3.104”

1. Identification of the agency and contracting activity. NEI/NIH/HHS (Division of Epidemiology and Clinical Applications, Clinical Trials Branch)

a. Federal agency and contracting activity. HHS. NIH/NEI/DECA/CTB

b. Sponsoring organization. Division of Epidemiology and Clinical Applications (DECA)

c. Project Officer information.

• Project Officer name. .xxx

• Mailing address. NIH, Bldg 10, CRC, rm 3-2531, 10 center Dr.

MSC 1204, Bethesda, MD 20892-1204

• E-mail address. .xxx

• Telephone number. .xxx

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

Acquisition purpose and objectives. The purpose of this study is to evaluate the metabolites using a non-targeted metabolomics on serum/plasma of men and women aged 55 and older who are enrolled in the controlled clinical trial of Age-Related Eye Disease Study 2[AREDS2] (2006-2012) of oral supplements for treatment of age-related macular degeneration (AMD). AMD is a chronic neurodegenerative disease that is the leading cause of blindness in the United States and the developed world. This study will consist of 2001 samples of 556 AREDS participants.

a. Project background. This would not be considered a continuation of a project although we have submitted for a pilot study of a different project with bloods (AREDS pilot). We were originally interested in combining the AREDS2 with the AREDS data. However, this is not possible because the blood samples are very different and may need different standards for the analyses. But we are using the same vendor as the one used for the AREDS pilot study. However, this project is different because of the different types of blood draw. The principles for both studies are similar, the measurement of metabolites on all the available serum collected over the duration of the study.

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

a. Project title. Study of metabolomics in Age-Related Macular Degeneration (AMD) in the Age-Related Eye Disease Study 2 (AREDS2).

Project description.

The purpose of study is to perform a non-targeted metabolomics evaluation of participants aged 55 and older who were enrolled in the randomized controlled clinical trial Age-Related Eye Disease Study 2 (AREDS2 [2006 to 2012]) with varying severity of age-related macular degeneration (AMD) at baseline and followed longitudinally. The AREDS2 evaluated the role of adding lutein and zeaxanthin and/or omega3 polyunsaturated fatty acids to the original AREDS supplement which contains vitamins C, E, beta-carotene, zinc, and copper for the treatment of AMD. AMD is a chronic neurodegenerative disease that is the leading cause of blindness in the United States and the developed world.

We will evaluate the baseline metabolites in a non-targeted manner and compare the metabolomic results between placebo and treatment. We have 556 AREDS2 participants who were followed over 5 years with 2001 AREDS serum samples available in total. We will also assess the differences in the metabolites in those who progressed vs. those who did not progressed to vision-threatening late AMD. In addition, we have whole genome sequencing on this cohort and will evaluate the relationship of the specific genes and genetic risk score with the metabolites, specifically pathways will be examined. The potential goals include identifying metabolites associated with and mediate AMD risk for the following sets of highly influential SNPs: (1) in complement genes (CFH, C3, C2/CFB, CFI, C9), (2) in lipid metabolism genes (ABCA1, CETP, APOE, and LIPC), and (3) in HTRA1/ARMS2. These identified metabolites can be useful as biomarkers, which in combination with genotypic information, can predict AMD status and prognose progression risk with high accuracy. Other pathways may include oxidative stress, mitochondrial dysfunction, etc.

b.

• Requirement type.

x 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.

• X New requirement

Follow-on Other (specify): ______________________

• Proposed contract/order type.

X 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.

N/A

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

$xxx,xxx to be completed 12 months.

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

X 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).

• Metabolon . xxx@metabolon.com

• 617 Davis Drive, Suite 100, Morrisville NC 27560 USA mailto:xxx@metabolon.com

• PO Box 110407, Research Triangle Park, NC 27709 USA

Nature of the acquisition and proposed unique qualifications of the contractor(s). Metabolon is the leader in metabolomics analyses and has developed and patented the industry’s leading high-throughput discovery platform, providing measurements in > 1,000 identified metabolites. The company is at the forefront of metabolomics and has the required state-of-the-art equipment to perform this analysis.

Services include running the samples through HPLC columns, identification of > 1,000 metabolites, mapping of these metabolites to relevant unique IDs and biological pathways, data pre-processing and quality control, and preliminary statistical analyses. All these services can be performed in a small amount of biospecimens (150 uL) in an expedited manner, which is expected to be 2-3 months. Metabolon is the only company which can provide these services in a timely manner using this small amount of material and can provide them at the high quality necessary for the study.

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

a. We have discussed with xxx regarding their platform. They are not able to work on such a large sample size.

b. We also discussed with xxx from the Broad Institute associated with Harvard medical School. His lab will not take on such a large study for at least for one year and the cost will be about .xxx than our current vendor.

c. We also discussed with xxx. Human Metabolome and the price quoted was $xxx/sample. xxx. Metabolon, our current vendor, would be charging

us. Their experience at Human Metabolome xxx as that of Metabolon.

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

Certified cost or pricing data will be required as none of the exceptions in FAR 15.403-1(b) apply. All proposed costs will be subjected to rigorous comparisons with BLS data, historical data and interest rate calculations.

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.

We have conducted market research on this service of measuring metabolites in over 2000 samples. As noted previously, I have discussed this project with other companies that provide this service. Please see point #6 and the 3 companies that I spoke with. We did not issue an announcement in FedBizOpps because this is highly specialized. Most companies would not be reviewing such announcements to make this an effective platform to conduct market research.

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

There is some urgency in getting these data. We are planning the next phase of a new trial for the early and intermediate AMD. These data are crucial for our decisions to identify potential candidates for testing in a new trial. These data will also help us identify participants who responded to the micronutrient supplementation for the treatment of AMD. Using the data from the metabolites for progression and for responding to the AREDS/AREDS2 supplements, we will gain a great deal of information that will help us plan our studies which are urgently needed.

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

There were no sources that expressed an interest in this acquisition.

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 project will be completed for AREDS2 data using this format. A separate project will be designed to complete the AREDS blood analyses for the metabolomics of this population recruited in 1992 to 2001. This will likely be conducted also at Metabolon.

Metabolon will more than likely be used for the follow-on study due their involvement in this primary testing phase. They will gain the expertise working with the stated samples. It would be not only difficult but could compromise the follow on study since Metabolon will set the parameters and establish protocols that would have to be duplicated by another vendor.

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 Chief, Clinical Operations Branch

Project Officer’s

Immediate Supervisor

Clinical Director

Head of the Sponsoring

Program Office

Director, DECA

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 Contracting

Office

N/A

Head of the Contracting

Activity

N/A

15. Competition Advocate signature.

Competition Advocate

16. HHS Senior Procurement Executive signature.

HHS Senior Procurement

Executive

Justification and Approval for Sole Source