JOFOC-2.pdf

Justification for Other than Full and Open Competition

“Source Selection Information – see FAR 2.101 and 3.104”

1. Identification of the agency and contracting activity.

NICHD Office of Acquisitions

a. Federal agency and contracting activity. HHS.

National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development

b. Sponsoring organization.

National Center for Medical Rehabilitation and Research

c. Contracting Officer’s technical Representative (COTR) information.

COTR name: Nancy Shinowara, Ph.D.

Mailing address.

Spinal Cord & Musculoskeletal Disorders & Assistive Devices

NCMRR, NICHD

6100 Executive Blvd., Room 2A03, MSC 7510 Bethesda, Maryland 20892-7510

E-mail address: Shinowara@nih.gov

Telephone number: 301-402-2242

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

a. Acquisition purpose and objectives.

The purpose of this contract initiative is to develop a prototype for an external Functional Electrical Stimulation (FES) control system that is designed to restore function to one or more movements in paralyzed upper limbs of individuals with severe paralysis due to high level cervical spinal cord injury or appropriate forms of brain stem stroke. The system design as proposed in the initial contract incorporates an interfacing system that will relay brain motor command signals to specific limb muscles in order to enable users with paralyzed upper limbs to carry out self-directed movement. The technology development required for this control system must be adaptable in order to accommodate future fully implantable FES control systems for upper limbs as well as other skeletal muscles such as those in the lower limbs.

mailto:Shinowara@nih.gov�

This FES controller will accept processed cortical signals and translate them into appropriate output sequence of command signals that will control the motor function of a simulated FES system applied to a virtual upper body limb. While future control systems may be implanted, the objective of this current initiative is to develop the specifications of a system that can utilize cortical signals to activate a FES controller to facilitate the movement of upper limbs of individuals with severe paralysis.

b. Project background.

In the initial planning stages six years ago, this project was part of a coordinated 3-institute effort to develop a cortically-controlled neural prosthesis, NICHD, NINDS, and NIBIB. NICHD has been tasked with the development and testing of cortical electrode arrays in humans. NIBIB has provided research in the area of advanced connector and interface issues. The NINDS component has initiated the development of the hardware and software necessary to make existing functional electrical stimulation (FES) systems for paralyzed patients that will be able to accept signals from cortical arrays. The scientific background has its origins in previous, annual NIH Neural Prosthesis workshops and, more recently, Neural Interfaces Conferences in 2008 and 2010 and various conferences on Brain Control Interfaces/Brain Machine Interfaces attended by the communities of researchers, clinicians and stakeholder with interests in prosthetics and medical rehabilitation.

The NICHD scientific research that was begun in 2005 by Case Western Reserve University needs to continue for an additional two years in order to successfully meet the designing and developing of the objectives of a functional electrical stimulation system that will facilitate motor function in individuals with paralyzed upper limbs.

(i) Incumbent Contractor:

Case Western Reserve University 10900 Euclid Ave.

Cleveland, Ohio 44106-7015

(ii) Period of Performance:

Current: 09/02/2005 – 08/31/2011 Extension: 09/01/2011 – 08/31/2013

(iii) Total dollars obligated to date:

$4,775,124.00

(iv) Competition

The initial award was a Full and Open Competition. This award will be non-competitive to finish the project. There are no planned future awards.

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

a. Project title

CONTROLLER DEVELOPMENT FOR UPPER LIMB MOVEMENT

b. Project description.

This initiative will focus on the development of a controller prototype for a Functional Electrical Stimulation (FES) system that will enable improved function of paralyzed upper limbs of individuals with severe paralysis due to high level cervical spinal cord injury paralysis or appropriate brain stem stroke. For specific requirements, please reference the attached Statement of Work.

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.

New requirement X 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 X Cost reimbursement (with Educational Institution, no fee) Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________

Other (specify): ___________ X Completion Form Term form

Acquisition identification number.

RFP NIH-NICHD-NCMRR-2011-15

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

$2,057,808.00 – September 1, 2011 – August 31, 2013

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(a)(2)(ii).

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).

Case Western Reserve University 10900 Euclid Ave.

Cleveland, Ohio 44106-7015

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

• The collaborative CWRU and subcontractor team is currently the only known research group to achieve long term chronic intracortical recording signals from the human motor cortex. The team has more than five years of experience in this research activity, including how to recruit, select appropriate participants for this study and how to maintain a congenial working relationship with these individuals who have severe, neurological impairments. Team members have pioneered methods for translating results from one of the nation’s pre-eminent primate BCI laboratories into human applications, and thus have unique insight into the challenges of developing effective intracortical brain-computer interfaces for individuals with disabilities.

• The CWRU is a consortium member of the Cleveland FES Center and the associated team members form a unique group that is currently capable of actually implementing the targeted, implantable FES system that will be needed in the future to realize the study’s ultimate goal of enabling arm and hand function in individuals with upper limb paralysis. They are the national leaders in FES system development and deployment, and have already deployed advanced, state-of-the-art FES systems in several individuals with high cervical spinal cord injuries. They plan to continue the development and deployment of such systems.

• CWRU has unrivaled expertise in the regulatory (FDA IDE and IRB) issues associated with surgically implanted devices, both for the brain interfacing aspects and for the FES system aspects. Obtaining the appropriate regulatory approvals is a time-consuming and costly process that has already been completed by Case Western and they along with their subcontractor have experienced, well-developed regulatory infrastructures that monitor these activities and interact regularly with the FDA and the local IRBs for human subject research.

• CWRU has developed an effective, proven process for collaboration across two geographically distant locations because of their subcontractor, allowing the groups to combine their nationally recognized expertise in the neuroscience and engineering aspects of BCI research.

• The CWRU biomedical engineering team members have formed highly developed clinical relationships and collaborations, both in terms of the brain computer interface activities (neurologists and neurosurgeons) and in FES activities (orthopedic surgeons and physical medicine and rehabilitation physicians), which take many years to develop.

• CWRU is currently expanding their collaboration to include studies of human intracortical (BrainGate*) participants at a Cleveland clinical site that is under the FDA IDE of their subcontractor. This arrangement will allow recruitment of a larger number of participants (to add to those that have already been studied), thereby improving the statistical significance and generality of their results. The Cleveland site, because of their long-standing clinical and research activities in the area of spinal cord injury, will also allow a more concentrated focus on the issues specifically relevant to spinal cord injured individuals.

*BrainGate is a trade name for a hardware/software system that can acquire and decode signals from multiple cortical neurons. Neuronal signals are acquired through an implanted micro electrode array in the brain.

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 small Business announcement was published in the Federal Business Opportunities on February 2, 2011 with a response due date ten days after the publication of the notice. No inquiries were received by the due date. A pre-solicitation notice was published in the Federal Business Opportunities on April 4, 2011 with a response due date fifteen days after the publication of the notice.

Again, no inquiries or responses were received.

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

An IGCE has been developed for the anticipated costs of the project.

Negotiations will be conducted with Case Western and the final budget and justification will be reviewed by the COTR. Recommendations will be provided to the Contracting Officer concerning the necessity and reasonableness of the costs. The Contracting Officer will perform a cost analysis to determine the reasonableness of individual cost elements in accordance with FAR 15.404-1 (c) and (d). Further, the contractor has been performing the work for the past six years, which will aide in the cost analysis by the comparison of monthly vouchers. Likewise, an audit is deemed not to be necessary.

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.

As stated above in section #6, a Small Business Sources Sought and a Pre-solicitation notice were published in FedBizOpps without a response from any other source. The COTR has based her opinion on extensive, current knowledge gained from a range of qualified sources regarding the scientific, engineering, clinical issues that concern development testing FES control system designed for human participants. She has determined that there is not another source who could perform the work to meet the government requirements as outlined in the Statement of Work.

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

Case Western has the resources, personnel, and the subcontractors currently in place to complete this complex development of the FES system. Premature discontinuation of this research contract research could have a very negative impact not only for the continued progress of this important research, but also for the welfare of the current participants, one of whom has contributed cortical brain signals via a continuous BrainGate implant for well over 1000 days (JD Simeral, S-PKim, MJ Black, JP Donoghue and LR Hochberg, J. Neural Eng. 8(2011). One of the most important contributions of this research to date has been enabling this long term demonstration of the feasibility of maintaining the cortical interface between implant and motor cortex for the clinical goals of this contract.

Tremendous effort and training, thoughtful commitment, and health management considerations are required for successful and meaningful long term partnership among the research team, clinical staff and a dedicated participant who has severe disabilities. It would cost the Government an inordinate amount of time and effort to train, recruit, and duplicate the effort of the expertise acquired by Case Western and its subcontractors over the past six years. Termination of the current involvement of the BrainGate participants with implants would be very unfortunate and counter-productive.

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

NONE

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.

There are currently no future plans to acquire the same type of services.

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

COTR Nancy Shinowara, Ph.D.

COTR’s Immediate Supervisor

Michael Weinrich, M.D.

Center Director, NCMRR

Michael Weinrich, M.D.

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

Elizabeth Osinski

14. Chief of the Contracting Office and Head of the Contracting Activity signature(s).

Official Name & Title Signature Date

Chief of the Contracting

Office

Erin Goldstein

Director of NICHD Office of Acquisitions

Olga Acosta-Polston

Head of the Contracting

Activity

Diane Frasier

15. Competition Advocate signature.

Competition Advocate

Walter Schaffer

16. HHS Senior Procurement Executive signature.

HHS Senior Procurement

Executive

N/A