SOLICITATION NOTICE
A -- Additional Hours for In-Scope Pain Screening Work for the NINDS Epilepsy Therapy Screening Program Contract, HHSN271201600048C
- Notice Date
- 7/20/2018
- Notice Type
- Presolicitation
- NAICS
- 541714
— Research and Development in Biotechnology (except Nanobiotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6001 Executive Boulevard, Room 4211, MSC 9559, Bethesda, Maryland, 20892-9559, United States
- ZIP Code
- 20892-9559
- Solicitation Number
- NIH-NINDS-NOI-18-HHSN271201600048C
- Archive Date
- 8/19/2018
- Point of Contact
- Sneha V Singh, Phone: 3014802443
- E-Mail Address
-
sneha.singh@nih.gov
(sneha.singh@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- NOTICE OF INTENT to Sole Source 1. SOLICITATION NUMBER: NIH-NINDS-NOI-18-HHSN271201600048C 2. TITLE: Additional Hours for In-Scope Pain Screening Work 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: August 4, 2018 at 11:59 PM EST 6. PRIMARY POINT OF CONTACT: Sneha Singh, Contract Specialist sneha.singh@nih.gov Phone: 301-480-2443 7. DESCRIPTION: INTRODUCTION THIS IS A PRE-SOLICITATION NOTICE OF INTENT TO ADD ADDITIONAL HOURS ON A SOLE-SOURCE BASIS FOR IN-SCOPE WORK ON AN ACTIVE CONTRACT WITH THE UNIVERSITY OF UTAH. THIS IS NOT A REQUEST FOR QUOTE/PROPOSALS. Additional labor effort and associated funding are needed for the NINDS Epilepsy Therapy Screening Program contract, HHSN271201600048C, to allow for pre-clinical testing of small molecules, biologics, and/or devices in rodent models to evaluate their potential efficacy as non-addictive analgesics for treating human pain disorders. The Scope of the Statement of Work of the subject contract indicates that "The Contractor during the performance period of the contract shall perform various preclinical pharmacological evaluations of potential therapeutic agents for the treatment of epilepsy and related disorders. On an "as needed" basis, 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". Pain is considered a "related disorder" to epilepsy for reasons including evidence citing the pain condition migraine as a comorbidity of epilepsy (Keezer 2016; Lancet Neurol 15, 106). Note also, it is stated in Technical Requirements, Section I.D., "Ancillary Studies": "The government may require, depending on the evolving needs of the ETSP, studies and models including but not limited to the following: (a) Models associated with recognized co-morbidities of epilepsy; (b) Supporting pharmacokinetic studies." The objectives of this added labor effort and funding are to: (1) Provide efficacy test data in designated rodent models of pain; (2) Provide test data on tolerability in rodent models of side effect liability; (3) Provide pharmacokinetic data as needed to guide testing and facilitate interpretation of results. 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: a) The most significant rationale for using the current NINDS ETSP contract is the fact most of the necessary infrastructure and expertise already exist at the selected facility. The existing capabilities at the University of Utah allow the government to take advantage of economies of scale. It is recognized that drug testing and drug discovery are lengthy processes. It is clearly in the governments' interest to jump start this program as early as possible by taking advantage of an existing internationally-recognized infrastructure. The NINDS ETSP already has one of the most established, highly trained, drug screening research staffs in the world. The program utilizes proven methodologies (e.g. Smith et al., 2017; Neurochem Res 42, 1995) and possesses excellent animal facilities that are already fully compliant with all government requirements. b) The University of Utah's principle investigator and key personnel have over 50 years of combined experience in the areas of in vivo and in vitro techniques used in the evaluation of the pharmacodynamic and pharmacokinetic aspects of drug action in modulating neuronal excitability. c) Further using as a compound source the hundreds of participants to the current ETSP contract will further provide a significant jump-start in the search for novel compounds to be presented for screening. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION The determination by the Government to add this in-scope work to an existing contract without providing for full and open competition is based upon the following rationale: Due to the urgency in tackling the opioid crisis, this project is an important component of the NIH "Helping to End Addiction Longterm" (HEAL) Initiative to alleviate the burden of the opioid crisis. NINDS is planning the proposed research activities to openly compete a comprehensive pain screening program, but the time frame for this award is late FY2019. Given the critical need to initiate pain therapy screening efforts to find effective non-addictive agents, including pain therapy screening activities under the current ETSP contract is intended to "fill the gap" (provide important initial data) between now and the end of FY2019. The contractor (University of Utah) has conducted pharmacokinetic studies, efficacy studies in pain and abuse liability rodent models, as well as extensive experience, familiarity and established standard operating protocols with the various interconnected components of the infrastructure that would be utilized (in its' present form, or in a close adapted form) for the planned Platform Screening Program for Pain (PSPP) to be competed and awarded in FY2019. The infrastructure, IT interfaces and demonstrated expertise currently in place for the Epilepsy Therapy Screening Program (formerly known as Anticonvulsant Screening Program) which can be immediately utilized for initial pain screening is unique to the University of Utah. This resource has been built and refined by NINDS via a series of successive contracts for the Anticonvulsant Screening Program (re-named Epilepsy Therapy Screening Program in 2016 when this project was last competed) over a period of approximately 40 years. No other source is known to have the infrastructure already in place to proceed with these initial pain studies and with NINDS Information Systems Security Officer -approved IT Security Infrastructure and interfaces with NINDS, familiarity with NIH processes for this particular pre-clinical screening activity and reporting and proven expertise such that they could initiate these studies upon order. Furthermore, this source has direct experience with previous pain screening under this same project under predecessor contracts. These studies were mainly as part of supporting information and completing the data package of rodent models as part of the Anticonvulsant Screening Program in the past (predecessor contracts to the active contract with the University of Utah). However, this proposal is to do these studies for pain products and not as part of a larger supporting information to complete the Epilepsy data package. This includes procedures for receiving, storing, analyzing, and testing substances (including DEA-scheduled drugs); uploading data into an NINDS database; etc. Given the short-term nature of the proposed modification and given the numerous required certifications before any the execution of any testing and the recently appropriated funds for FY 2018/2019, it is simply not possible for NINDS to consider a prospective offeror other than the existing contractor that has all the required infrastructure, previous direct experience and NINDS ISSO approved IT security interfaces in order to begin this work upon order. The University of Utah is uniquely situated to commence pain screening studies under the current Epilepsy Therapy Screening Program contract upon order from NINDS. 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 in-scope additional work under contract HHSN271201600048C will be limited to one year (09/30/2018 - 09/29/2019). A much larger project, focused solely on pain screening, will be competed on the open market in calendar year 2019 with a planned award date of 09/30/2019. This planned future contract, separate and distinct from this short-term contract add-on work, will have an anticipated period of performance of five years. The pain screening work being added to the active contract with the University of Utah on a short-term basis will cease upon award of the new, larger contract in calendar year 2019. Contract Type: This additional in-scope work will be awarded a cost-reimbursement, level-of-effort basis consistent with the contract terms and conditions of contract HHSN271201600048C. Specific Requirements: The contractor is tasked with evaluating agents (small molecules, biologics, natural products) in a series of screening assays for assessing potential activity as non-addictive analgesics. The contractor shall be responsible for providing any or all of the following assessments: (1) In vitro pharmacological profiling against opioid receptors (mu, kappa, delta) (2) In vitro pharmacological profiling against a battery of molecular targets (3) Pharmacokinetic assessment (intraperitoneal, oral routes of administration) (4) Testing in a battery of acute and chronic in vivo pain models and measures of sensory and motor side effects (5) Testing in selected abuse liability models It is estimated that approximately 25 compounds will be tested in the initial phases of the screening and through attrition, approximately 50% of those compounds will qualify for testing in the full battery of assays. CLOSING STATEMENT THIS NOTICE OF INTENT TO ADD ADDITIONAL IN-SCOPE WORK TO AN EXISTING CONTRACT 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-18-HHSN271201600048C. Responses must be submitted electronically to Sneha Singh, Contract Specialist, at sneha.singh@nih.gov. U.S. Mail and Fax responses will not be accepted.
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- Record
- SN05000854-W 20180722/180720230815-7729c7095766d00bf867e54b38ff07db (fbodaily.com)
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