Justification Exception to Fair Opportunity Central Lab for LB Study signed...pdf

Justification for an Exception to Fair Opportunity Authority: FAR 16.505(b)(2)

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) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

b. Sponsoring organization

Division of Intramural Population Heath Research (DIPHR)

c. Contracting Officer’s Representative (COR) Information

Jill Long, M.D., Medical Officer 6710B Rockledge Drive Bethesda, MD 20892 E-mail: jill.long@nih.gov

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

a. Acquisition purpose and objectives:

The purpose of this Justification for an Exception to Fair Opportunity Authority FAR 16.505(b)(2) is to award a task order to Oregon Health & Sciences University (OHSU) to serve as a central laboratory for measurement of hormones for the “Pharmacokinetic/ Pharmacodynamic Evaluation of Levonorgestrel Butanoate for Female Contraception Study.”

b. Project Background:

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) has a mission to develop safe and effective contraceptives for women, including obese women. Obesity is the number one public health issue facing the US population and is an independent risk for venous thromboembolism (VTE). Therefore, there is a public health need to develop effective contraception for obese woman that does not increase the risk of VTE. One Food and Drug Administration (FDA) approved contraceptive method is the progestin-only pill (POP) or so-called “mini pill,” which is used mainly by lactating women only for several months and requires strict adherence to taking the POP at the same time every day. A long-acting injectable form of levonorgestrel butanoate (LB) that is estrogen-free will provide a regimen that is easier to follow than a POP and have a theoretically lower risk of VTE especially for obese women. To provide evidence that LB could be effective for contraception, a clinical trial

Attachment 5 will be conducted in the NICHD Contraceptive Clinical Trials Network (CCTN). The study will be conducted in women of reproductive age to evaluate pharmacokinetics, the mechanisms of contraceptive efficacy, and safety of this new contraceptive. The enrolled subjects will receive a single injection of LB. Drug administration via intramuscular and subcutaneous routes of injection will be evaluated. Levonorgestrel levels will be measured to determine the pharmacokinetic profile of the drug.

Progesterone, Estradiol, LH, FSH, and SHBG hormone levels also will be measured throughout the study.

Prior clinical experience with LB

A preliminary pharmacokinetic study had been performed previously at one of the CCTN clinical sites (OHSU). In that initial study, the duration of effectiveness of the drug was shorter than the targeted duration of action. OHSU was the central lab for the initial study. The drug has been reformulated to improve the duration of action. The new formulation will be evaluated using two routes of injection, intramuscular and subcutaneous. Results obtained with the new formulation will be compared to the original formulation to determine if there are similar or improved pharmacokinetic drug levels and similar or improved pharmacodynamic effectiveness as measured by serum hormone levels (P, LH, FSH, Estradiol and SHBG).

The current study is a continuation of the previous project to evaluate the contraceptive effectiveness of LB. In order to compare results from the current study with those of the previous study, it is necessary to use OHSU as the central lab for hormone evaluation.

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

a. Project title. Central Laboratory for Pharmacokinetic/Pharmacodynamic Evaluation of Levonorgestrel Butanoate for Female Contraception.”

b. Project description. See attached Statement of Work.

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 (Task Order) 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): _Cost no fee__ Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________ Other (specify): ___________ Completion Form Term form

Acquisition identification number:

Indefinite Delivery Indefinite Quantity (IDIQ) Contract Number 75N94020D00016

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

The total estimated dollar value for this project is $133,488 and the performance period is 12/1/2020 – 12/1/2022.

4. Identification of the exception to fair opportunity (see 16.505(b)(2)) and the supporting rationale, including a demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the exception cited. If the contracting officer uses the logical follow-on exception, the rationale shall describe why the relationship between the initial order and the follow-on is logical (e.g., in terms of scope, period of performance, or value).

a. Exception to Fair Opportunity.

Only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized. [see FAR 16.505(b)(2)(i)(B)].

b. Name and address of the proposed contractor(s).

Oregon Health & Science University 3181 SW Sam Jackson Park Road Portland, OR 97239

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

OHSU was the central lab for the initial clinical trial. Use of the same central lab is necessary for continuity, comparability, and integrity of the results.

1) The current study is collecting samples at seven clinical sites. The PK and hormone assays for all subject samples must be done using the same methods of analysis, the same reagents and the same reference standards. The use of different reagents and reference standards across different labs creates variability in the results of these assays.

In order to directly compare results from the initial clinical trial of LB with results from the current trial of LB, it is essential that the same reagents and methods used in the initial study are used for the current study. Since OHSU was the central lab in the initial study, no other contractor can fulfill this condition.

requirement in this study is that the central lab must be able to detect very low levels of the hormones. The variability across different labs is much greater when the hormone levels are at the low end of the detectable range. OHSU has developed assays for steroid hormones that allows reproducible detection of amounts at the lower limit of detection. Based on this improved sensitivity, OHSU has the capability to detect low levels of hormones and compare their results with low levels from the prior clinical study.

If OHSU is not selected as the central lab for the current study, it will not be possible to directly compare the results of the present study with those of the prior study and high variability at the lower end of the detection range will introduce more error, compromising the integrity of the study.

Since OHSU was the central lab for the initial study, they developed the capability to measure levonorgestrel (LNG) from the investigational product (LB). This is a highly specialized assay. Since it is a highly specialized assay, the reagents for doing the assay are specialized as well and comparing results from one lab to another introduces a level of variability that will compromise quality. The results of a specialized assay at a new lab cannot be compared to the results obtained at OHSU in the earlier study.

In order to serve as the central lab for the prior study, OHSU developed a highly sensitive assay to measure LNG in serum (at very high and at very low serum levels).

This high level of specificity and sensitivity was necessary to evaluate pharmacokinetic profiles of LB in the previous clinical trial. The same specificity and sensitivity will be in the current study. It is essential to be able to detect both very high and very low levels of LNG in each subject and to be able to compare the serum levels in the current study with results from the earlier trial.

In summary, all required services for this study are considered highly specialized and demand a high level of quality, uniformity, and sensitivity. This capability especially applies to the main target assay, LNG. OHSU is the only contractor that can perform the assays in the same manner as the previous LB study and the integrity of the project will be compromised if results from the two studies are not comparable. OHSU is capable to begin work immediately and does not need to develop or improve any of the requisite assays. Therefore, OHSU is the only site under the CCTN that is qualified to conduct this new trial providing the continuity required between the studies.

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

The Contracting Officer’s Representative and Contracting Officer will evaluate all proposed costs then complete and sign the Project Officer Technical Questionnaire (POTQ) form the separate cost elements of the

OHSU proposal against the Independent Government Cost Estimate as well as historical contract cost data (See attached Independent Government Cost Estimate).

Any other facts supporting the justification.

A statement of the actions, if any, the agency may take to remove or overcome any barriers that led to the exception to fair opportunity before any subsequent acquisition for the supplies or services is made.

The Contraceptive Development Program has plans to continue the acquisition process to procure the same type of supplies and services. All efforts will be taken to overcome barriers to competition for future acquisitions.

Program Office Certification.

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

Contracting Officer’s Representative (COR)

Jill Long, M.D.

Medical Officer

COR’s Immediate Supervisor

Diana Blithe, Ph.D.

CDP Chief

Head of the Sponsoring Program

Office

Una Grewal, Ph.D., M.P.H. DIPHR Acting Director

Jill E.

Long -S

Digitally signed by Jill E. Long -S Date: 2020.11.20 09:41:42 -05'00'

Diana L.

Blithe -S

Digitally signed by Diana L. Blithe -S Date: 2020.11.20 17:19:51 -05'00'

Grewal, Jagteshwar (NIH/

NICHD) [E]

Digitally signed by Grewal, Jagteshwar (NIH/NICHD) [E] Date: 2020.11.23 13:18:53 -05'00'

9. Contracting Officer Certification and Approv l

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 Theresa Koomson

Team Leader Alice Pagán Pereira

Acting Branch Chief & OA Director

Olga Acosta

Theresa A.

Koomson -S

Digitally signed by Theresa A. Koomson -S Date: 2020.11.23 13:33:20 -05'00'

Alice M. Pagan Pereira -S

Digitally signed by Alice M. Pagan Pereira -S Date: 2020.11.25 15:47:02 -05'00'

Olga M.

Acosta -S

Digitally signed by Olga M.

Acosta -S Date: 2020.11.30 09:15:05 -05'00'