5409340_SSJ.doc.pdf

Sole Source Justification under Simplified Procedures for Certain Commercial Items in Accordance with FAR 13.5

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity.

Department of Health and Human Services (DHHS) National Institutes of Health (NIH) National Institute on Drug Abuse (NIDA) Office of Acquisition (OA)

b. Sponsoring organization.

Department of Health and Human Services (DHHS) National Institutes of Health (NIH) National Center for Advancing Translational Sciences (NCATS) Division of Preclinical Innovation (DPI)

c. Project Officer information.

Anna Rossoshek 9800 Medical Center Drive, Building B, Rockville, Maryland 20850 asirota@mail.nih.gov 301.827.0922

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

a. Acquisition purpose and objectives.

The purpose of this acquisition is to obtain mass balance studies for a lead compound that the NIH is advancing into the clinic. These studies will provide important information on the absorption, metabolism, and excretion of the lead compound by using a radiolabeled (14C) version of the lead compound.

b. Project background.

NCATS has a need for animal (dog and rat) mass balance studies for a lead compound that the NIH is currently advancing into clinical trials. These studies utilize a radiolabeled version of the lead compound, and enable accurate tracking of the absorption, metabolism, distribution, and excretion of the lead compound. This data provides critical understanding on the fate of the lead compound, as well as an understanding of the metabolism of the compound. These preclinical studies can be critical towards advancing the lead compound further through clinical trials.

mailto:asirota@mail.nih.gov

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

a. Project title.

Mass Balance Study (Pharmacokinetics, Distribution, Metabolism, and Excretion) for Ketamine Project.

b. Project description.

The Contractor will conduct mass balance studies for a lead compound. Specifically, the Contractor will perform mass balance studies with the lead compound in rats, and the Contractor will perform mass balances studies with the lead compound in dogs. In addition, the Contractor will provide a comprehensive report detailing a full assessment of the mass balance studies and the pharmacokinetics of the radiolabeled compound in rats and dogs.

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

$407,400.

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

FAR 13.501(a) and 41 U.S.C. 1901.

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

a. Name and address of the proposed contractor.

Covance Inc.

210 Carnegie Center, Princeton, New Jersey 08510 671 South Meridian Road, Greenfield, IN 46140

b. Nature of the acquisition and proposed unique qualifications of the contractor.

The proposed contractor performed all earlier range-finding toxicology and definitive GLP toxicology studies for 2R,6R-HNK in rat and dog models. Thus, the proposed contract has already developed the required bioanalytical methods for those species.

This is critical as proper extraction on the drug product is critical to performing the mass balance studies being required with this order.

Further, the proposed contractor has the needed experience to administer the drugs based on their previous work.

Another key point is that it is the proposed contractor’s subcontract that is producing and will ultimately provide the radiolabeled 2R,6R-HNK.

Finally, the outcomes of the mass balance studies will be incorporated into future regulatory documents including amendments to the IND; the proposed contractor is currently contracted for all regulatory support for this work and will be able to seamlessly incorporate the outcomes of the mass balance studies into those documents.

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 non-competitive combined synopsis/solicitation (CSS) was posted to FedBizOpps to invite responses and allow the program office an opportunity to examine the results of industry inquiries and reach a conclusion concerning the potential degree of competition.

No responses, other than that of Covance Inc., were received in response to the CSS. The lack of responses strengthens the Government’s justification for issuing a sole source.

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

The price reasonableness determination was based on: (1) a review of past, similar purchases;

(2) reliance on the program office’s expertise in the area and evaluation of the price quote; and

(3) a review catalog prices.

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.

These services are of a type that are customarily available in the commercial marketplace with modifications. The program office searched previous purchase of similar/identical acquisitions.

Because Covance is the only source reasonably available, limited market research was conducted.

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

N/A

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

N/A

11. A statement of any actions the agency will take to remove or overcome any future barriers to competition.

New studies being conducted on new compounds will be competed to ensure sole sources are not perpetuated. In addition, more extensive market research will be conducted when new studies on new compounds are being considered.

12. Program Officer certification.

I certify that the facts and representations under my cognizance that are included in this justification and that form a basis for this justification are complete and accurate.

13. Contracting Officer certification.

I certify that this justification is accurate and complete to the best of my knowledge and belief.