Inactive

NOTICE OF INTENT to Sole Source 1. SOLICITATION NUMBER: NIH-NINDS-NOI-21-HHSN271201600048C 2. TITLE: Period of Performance Extension Modification for the NINDS Epilepsy Therapy Screening Program Contr... NOTICE OF INTENT to Sole Source 1. SOLICITATION NUMBER: NIH-NINDS-NOI-21-HHSN271201600048C 2. TITLE: Period of Performance Extension Modification for the NINDS Epilepsy Therapy Screening Program Contract, HHSN271201600048C 3. CLASSIFICATION CODE: A – Research and Development 4. NAICS CODE: 541714 – Biotechnology Research and Development (except Nanotechnology) 5. RESPONSE DATE: June 5, 2021 at 5:00 PM EST 6. PRIMARY POINT OF CONTACT: Michael Horn, Contract Specialist Michael.horn@nih.gov Phone: 301-827-5871 7. DESCRIPTION: INTRODUCTION THIS IS A PRE-SOLICITATION NOTICE OF INTENT TO AWARD AN OUT OF SCOPE MODIFICATION FOR A PERIOD OF PERFORMANCE EXTENSION ON A SOLE-SOURCE BASIS WITH THE UNIVERSITY OF UTAH. THIS IS NOT A REQUEST FOR QUOTE/PROPOSALS. A period of performance extension and associated funding are needed for the NINDS Epilepsy Therapy Screening Program contract, HHSN271201600048C, to allow for pre-clinical testing of small molecules, large molecules and biologics in rodent and in vitro models to identify treatments for pharmacoresistant epilepsy, special epilepsy populations, epilepsy prevention and modification. The Scope of the Statement of Work of the subject contract includes the performance of various preclinical pharmacological evaluations of potential therapeutic agents for the treatment of epilepsy and related disorders. On an as needed basis, the Contractor shall also adapt, develop, validate and implement new models to support the ETSP mission and conduct supporting pharmacokinetic studies using normal or epileptic animals. The contract requires the Contractor to conduct studies evaluating investigational compounds in the following performance areas: 1) pharmacoresistant epilepsy, 2) models of special epilepsy populations, genetic epilepsies and syndromes and 3) models of disease modification and anti-epileptogenesis. In addition, the Contractor shall be required to perform ancillary studies to support the evolving requirements of the ETSP. The NINDS Epilepsy Therapy Screening Program contract was awarded to the University of Utah, effective September 30, 2016. This requirement was competed via solicitation RFP-NIH-NINDS-16-02 on the basis of an unrestricted, full and open competition. REGULATORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements. The reasons for using the cited authority areas follow: The proposed contractor is the incumbent contractor, and this modification will be a period of performance extension to the current contract. This contractor has been satisfactorily meeting all contract requirements for the duration of the current contract. To allow the Government to conduct a full and open competition of this contract for the next cycle, this extension is sought as a sole-source to the current contractor to ensure continuity of services for a short period (no more than 6 months with an initial period of 3 months and one option period of 3 months). This period of time will allow the Government to 1) continue to better define the scope of the next contract and what potential contractors will need to do, and 2) maintain the current level of services during this process and avoid disrupting ongoing research. Given the short-term nature of the proposed modification, the lead time needed to compete R&D contracts, and the infrastructure and resources that need to be in place, it is not possible to compete this short follow-on contract. Only University of Utah, as the incumbent contractor, has all required infrastructure, information technology interfaces, and demonstrated expertise currently in place for the ETSP program. If this short follow-on contract was competed, it would require additional cost to transition activity from the incumbent contractor to a new contractor, which also risks data and/or sample loss and/or damage. The competition for the subsequent contract may identify yet another contractor (especially as this subsequent contract will have a different scope), which would create yet another transition of data, samples, and processes. These transitions risk unreasonable delays, increased cost, and/or loss of research. The disruption of this research while executing a full and open competition would be costly to the Government and damage ongoing studies into investigational agents, including the loss of data already collected. For the short additional period required, it is only possible to maintain the current contractor through to the competition for the subsequent contract. Award to any other contractor would pose an unacceptable level of risk to the NINDS mission. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION The determination by the Government to extend the period of performance to an existing contract without providing for full and open competition is based upon the following rationale: This extension will allow continuity of services as the Government more accurately defines technical requirements in the new contract to ensure potential offerors have the best information and that services to be provided best meet both the current and future needs of the ETSP. Many of these requirements were presented as recommendations in the NANDS Working Group’s May 27, 2020 report and have been consistently refined with additional expert input over the course of the past year. At a high level, the recommendations include increased emphasis on new research and models that are progressing in the research community to identify novel therapies for epilepsy prevention, an area that has not advanced as much as desired (e.g., models of post-traumatic epilepsy, epileptogenesis, disease progression and predictive biomarkers). As described in the Working Group’s report, these are rapidly evolving areas of research and model development that the ETSP was tasked with carefully monitoring and discussing in future meetings with the program’s External Consultant Board. These consultations will continue to advise on the most suitable new models and potential biomarkers to expand the program’s capabilities in identifying novel treatments for epilepsy prevention and modification. The requirements development process and SOW changes enacted by the NANDS Working Group address novel, emerging, and challenging research areas. The best approach is difficult to define and has required extensive stakeholder input. Consequently, NINDS is engaging in a lengthier process of about 10 months. In consideration of the time spent developing requirements and the re-competition’s remaining total acquisition lead time, a period of performance extension of 3 to 6 months is necessary to prevent an unacceptable lapse in fulfilling the agency’s requirements. The intended source is: University of Utah 75 South 2000 East, 2nd Floor Salt Lake City, UT 84112-8930 Period of Performance: The period of performance for this particular extension under contract HHSN271201600048C will be limited to six months, from September 30, 2021, to December 22, 2021, with an option to extend another three months to March 22, 2022. A full and open competition is planned after this extension, and advance notice will be given for the full and open competition. The advance notice for the full and open competition will be improved by the time afforded by this follow-on contract. Contract Type: This period of performance extension will be awarded as an out of scope modification on a cost-reimbursement, level-of-effort basis consistent with the contract terms and conditions of contract HHSN271201600048C. Specific Requirements: The current contract requires the contractor to conduct studies evaluating investigational compounds in the following performance areas: 1) established workflow for pharmacoresistant epilepsy, 2) models of special epilepsy populations, genetic epilepsies and syndromes and 3) models of disease modification and anti-epileptogenesis. In addition, the contractor is required to perform ancillary studies to support the evolving requirements of the ETSP. CLOSING STATEMENT THIS NOTICE OF INTENT TO AWARD AN OUT OF SCOPE MODIFICATION FOR A PERIOD OF PERFORMANCE EXTENSION ON A SOLE-SOURCE BASIS IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. However, interested parties may identify their interest and capability to respond to this notice. A determination by the Government not to compete this proposed work based upon responses to this notice is solely within the discretion of the Government. All responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the Comprehensive Service Agreement requirements contained in this notice and include your Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. All responses must provide evidence that they can provide the requested screening services immediately upon order and in accordance with all Federal Information System Security requirements. All responses must be received by the closing date and time of this announcement and must reference the notice number, NIH-NINDS-NOI-21-HHSN271201600048C. Responses must be submitted electronically to Michael Horn, Contract Specialist, at michael.horn@nih.gov. U.S. Mail and Fax responses will not be accepted.