SOLICITATION NOTICE
B -- Evaluation of phenserine tartrate and a Pomalidomide analog in a mouse model of moderate traumatic brain injury
- Notice Date
- 7/17/2018
- Notice Type
- Presolicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- 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
- NIHDA201800327
- Archive Date
- 8/16/2018
- Point of Contact
- Jon J Gottschalk, Phone: 3014439456, Yvette Brown, Phone: 301-443-8402
- E-Mail Address
-
jon.gottschalk@nih.gov, yvette.brown@nih.gov
(jon.gottschalk@nih.gov, yvette.brown@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- PRE-SOLICITATION NOTICE OF INTENT NON-COMPETITIVE INTRODUCTION PURSUANT TO FAR Subpart 5.2-Synopses of Proposed Contract Actions, THIS IS A PRE-SOLICITATION NOTICE OF A PROPOSED CONTRACT TO ACTION. THIS IS A PRE-SOLICITATION NON-COMPETITIVE NOTICE OF INTENT TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institute on Drug Abuse (NIDA), Office of Acquisition, Contracts Management Branch Blue, NIA Section on behalf of the National Institute on Aging intends to negotiate and award a contract for the evaluation of Phenserine Tartrate and a Pomalidomide Analog in a mouse model of moderate traumatic brain injury to Case Western Reserve University. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 541990 - All Other Professional, Scientific and Technical Services with a Size Standard of $15.0 million. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses of the Federal acquisition Requlation (FAR) in effect through the Federal Acquisition Circular (FAC) 2005-98, dated May 31, 2018. STATUTORY AUTHORITY This acquisition is conducted as non-competitive under the authority of 41 U.S.C. 253(c) under provisions of the statutory authority of FAR Subpart 6.302-1 -- Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source. DESCRIPTION OF REQUIREMENT Project Description Evaluation of phenserine tartrate and a Pomalidomide analog in a mouse model of moderate traumatic brain injury. General Requirements Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below: The preclinical evaluation of Phenserine tartrate and a Pomalidomide analog in a mouse model of controlled cortical impact moderate TBI. The SOW includes outcome measures 1.Histochemical 2.Behavioral. 3.Biochemical Specific Requirements Histochemical, behavioral and biochemical analysis of TBI mice after treatment with phenserine tartrate and a Pomalidomide analog. Six groups of mice, 30 animals per group (15 males and 15 females), will be exposed to telencephalic CCI or sham injury followed by administration within 5 h after injury of either (1) vehicle, (2) phenserine tartrate, or (3) a Pomalidomide analog. Each group of 30 will be subdivided into two groups for assessment of behavior and biochemical changes in 18 and 12 animals, respectively. The phenserine dose administered will be 2.5 mg/k BID x 5 days after injury and the Pomalidomide analog dose will be 28 mg/kg once daily x 5 days. Both of these experimental drugs will be provided by Dr. Nigel H. Greig, NIA, NIH, at no cost to the contract. Since hypothermia is neuroprotective, monitoring and regulating body temperature during and after CCI surgery and drug administration will be undertaken to obviate this potential caveat. Although CCI produces a relatively stable and reproducible injury, righting reflex time will be measured postoperatively after CCI to further document comparability between the various treatment groups. Behavior Assay (18 animals per group): Animals will undergo motor testing and behavioral testing as detailed below at baseline. After CCI or sham injury, animals will undergo motor and behavioral testing again at 24 h after injury (9 animals) or at 7 days after injury (9 animals), followed by histological analysis using cresyl violet and fluoroJade C (FJC) staining. Motor Behavior: Evaluations will consist of a modified neurological severity score (mNSS) assessment, a tactile adhesive removal test, an elevated body swing test and a beam walk test. All will be performed by an observer blinded to the experimental groups. Overall motor activity will be measured in automated chambers. To compare neurological deficit severity in TBI mice, a mNSS (a composite of motor, sensory, reflex and balance tests) will be performed. One point is scored for inability to perform the test or for the lack of a tested reflex; thus, the higher the score, the more severe the injury. Neurological function is graded on a scale of 0-18 (normal score, 0; maximal deficit score, 18). A tactile removal test will be used to evaluate somatosensory function. In this test, two small adhesive-backed stickers are used as bilateral tactile stimuli that are placed on the distal-radial region on the wrist of each forelimb. Mice will be pre-trained daily for 3 days before CCI. The time required (not to exceed 180 s) for the mouse to remove the sticker from the forelimb will be recorded. Cognitive Behavior: The Novel Object Recognition (NOR) and Y-Maze paradigms will be used. The NOR paradigm will evaluate recognition memory in mice. This task is based on the innate tendency of rodents to explore new objects within their environment. A discrimination preference index is calculated as follows: (time spent near the new object minus time spent near the old object) / (time spent near the new object plus time spent near the old object). After each session, the objects and arenas will be thoroughly cleaned with 70% ethanol to prevent odor recognition. The Y maze paradigm will assess rodent spatial memory based upon observing the preference of the animal for a ‘new' location over a ‘familiar' location on two separate occasions. The time each mouse spends within the arms is recorded and used to generate a preference index, as initially described by Dix and Aggleton. Likewise, the maze will be cleaned using a 70% ethanol solution and dried in order to prevent any olfactory recognition between trials. Histology evaluation Cresyl violet and FJC staining will be used to assess contusion volume and neuronal degeneration, respectively. FJC (Biosensis, TR-100-FJ) binds selectively to degenerating neuronal cells. All sections will be observed and photographed under a fluorescence microscope with a blue (450-490 nm) excitation light with blinded observers and unbiased stereology (Microbright). Cresyl violet will be used to measure contusion volume, by staining sections followed by digitization and analysis using a 1× objective and computer image analysis system. Contusion area will be calculated from all images of cresyl violet-stained sections that contain contused brain. Hemisphere tissue loss will be expressed as a percent calculated by [(contralateral minus ipsilateral hemispheric volumes) / contralateral hemispheric volume) × 100%]. Biochemistry and Immunocytochemistry Assay (12 animals per group): Animals will be euthanized 8 h after injury for biochemical and immunofluorescence markers. Both the injured and non-injured sides will be used for these studies in both CCI and sham animals. Immunocytochemistry: Sections will be incubated with the appropriate primary antibodies, either mouse monoclonal anti-NeuN antibody (Millpore; 1:500, NeuN is a neuronal marker)/ anti-p53 antibody (GeneTex; 1:500) / anti-annexin V antibody (Abcam ; 1:500) / anti-p-p53 antibody (Cell signaling; 1:1000) / or anti-PUMA antibody (Abcam; 1:200) at 4°C overnight and with secondary antibodies (Alexa Fluor® 488 goat anti-rabbit IgG (1:200, Jackson ImmunoResearch, West Grove, PA); Alexa Fluor® 594 anti-mouse IgG (1:200 dilution, Jackson ImmunoResearch, West Grove, PA)). The numbers of NeuN-, p53-, annexin V-, p-p53-, and PUMA-positive cells are counted in 5 randomly selected fields by means of SPOT image analysis software using blinded observers and unbiased stereology (MBF biosystem). Statistical Analysis Evaluation of data will use T-tests for simple two group comparisons, ANOVA for multiple group comparisons with Tukey post-hoc analysis, and appropriate tests for nonparametric data as needed. The Bonferroni correction will be used for serial comparisons over time. In cases where the time course of changes is important, as in the current proposal, nonlinear regression analysis will be applied. For a two-sided test of a null hypothesis of equality in mean values with Type I error of 0.05, power = 0.85 for an effect size of 1.35 (estimated based on results of our previous studies), this study will require a minimum of 17 animals per group to detect the targeted outcome, so the proposed sample size should be sufficient. Numbers for all experiments will be subject to modification as more data on variance is obtained. Mandatory Requirements Extensive background in preclinical TBI rodent studies to evaluate the efficacy of experimental drugs. Contractor MUST have previous experience in the use and handling of Phenserine tartrate in preclinical studies to be familiar with its pharmacological actions Contractor MUST have previous experience in the use and handling of Pomalidomide and/or analogs thereof in preclinical studies to be familiar with its pharmacological actions Contractor MUST have an active and institutionally approved animal protocol to allow the use of CCI moderate TBI in a mouse The Contractor's Institution can take up to BUT NO MORE THAN 10% of the contract as overhead charges. Purpose and Objectives As a result of previous work/research, the Laboratory of Neurogenetics (LNG), National Institute on Aging (NIA) needs supplemental personnel qualified to integrate genetic, imaging and clinical data into complex machine learning models. Additionally, this is area of work will need computer infrastructure development for data collection, management and analytics that cannot be addressed by current LNG staff. Period of Performance The period of performance will consist of one six-month base period after award: CLOSING STATEMENT This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this solicitation must include clear and convincing evidence of the offeror's capability of fulfilling the requirement as it relates to the technical evaluation criteria. The price proposal must include the labor categories, an estimate of the number of hours required for each labor category, fully loaded fixed hourly rate or each labor category, breakdown and rationale for other direct costs or materials, and the total amount. The technical proposal must include CV information for proposed Key Personnel that meet the minimum requirements specified above. In addition the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. 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. All responses must be received by Wednesday August 1, 2018 at 04:00 PM Eastern Time and must reference number NIHDA201800327. Responses must be submitted electronically to Jon Gottschalk, jon.gottschalk@nih.gov. Fax responses will not be accepted. "All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency."
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-01/NIHDA201800327/listing.html)
- Place of Performance
- Address: 251 Bayview Blvd, Baltimore, Maryland, 21224, United States
- Zip Code: 21224
- Zip Code: 21224
- Record
- SN04995146-W 20180719/180717231119-853860d2a12fd385339c2378cd184eff (fbodaily.com)
- Source
-
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