SOLICITATION NOTICE
B -- Single Dose Toxicity Study of A Drug Product
- Notice Date
- 8/13/2014
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- HHS-NIH-NHLBI-CSB-EB-2014-222-CDB
- Archive Date
- 9/9/2014
- Point of Contact
- Chris Bocus, Phone: 3014027888
- E-Mail Address
-
chris.bocus@nih.gov
(chris.bocus@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- (i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. (ii) The solicitation number is HHS-NIH-NHLBI-CSB-EB-2014-222-CDB and the solicitation is issued as a request for proposal (RFP). Questions shall be submitted no later than 4:00 p.m. Eastern Standard Time (EST) on Friday, August 15, 2014. Offerors shall submit their proposals no later than 12:00 p.m. Eastern Standard Time(EST) on Monday, August 25, 2014. (iii) The solicitation document, the incorporated provisions and clauses are those in the Federal Acquisition Circular 2005-76, effective July 25, 2014. (iv) The associated North American Industry Classification System (NAICS) code for this procurement is 541711 and the small business size standard is 500 employees. The acquisition is being conducted in accordance with the procedures of FAR Part 12 and FAR Part 13. PURPOSE: The purpose of this requirement is to provide a single dose toxicity study of a proposed drug product for the National Institute of Biomedical Imaging and Bioengineering (NIBIB), Laboratory of Molecular Imaging and Nanomedicine (LOMIN).   (v) Background: The National Institute of Biomedical Imaging and Bioengineering (NIBIB) aims to improve health by leading the development and accelerating the application of biomedical technologies. NIBIB supports research and development of new biomedical imaging and bioengineering techniques and devices to fundamentally improve the detection, treatment, and prevention of disease; enhancing existing imaging and bioengineering modalities; supporting related research in the physical and mathematical sciences; encouraging research and development in multidisciplinary areas; supporting studies to assess the effectiveness and outcomes of new biologics, materials, processes, devices, and procedures; developing technologies for early disease detection and assessment of health status; and developing advanced imaging and engineering techniques for conducting biomedical research at multiple scales. The Laboratory of Molecular Imaging and Nanomedicine (LOMIN) specializes in synthesizing molecular imaging probes for positron emission tomography (PET), single-photon emission computed tomography (SPECT), magnetic resonance imaging (MRI), optical (bioluminescence, fluorescence and Raman), contrast enhanced ultrasound, photoacoustic imaging, as well as multimodality imaging. This research group aims to develop a molecular imaging toolbox for better understanding of biology, early diagnosis of disease, monitoring therapy response, and guiding drug discovery/development. LOMIN puts special emphasis on high-sensitivity nanosensors for biomarker detection and theranostic nanomedicine for imaging, gene and drug delivery, and monitoring of treatment. The Laboratory of Molecular Imaging and Nanomedicine conducts research into the development of novel materials to allow in vivo imaging of biological targets. One of the goals is to develop novel imaging agents that can be translated into clinical applications. The lab requires a toxicity study to be performed for two separate drug compounds. This must be conducted under the guidelines of Good Laboratory Practice and demonstrate the safety of the drug product for administration to human subjects. CONTRACTOR REQUIREMENTS: LOMIN is seeking a contractor to perform a toxicity study on two separate drug compounds. The requirements of the study are as follows: • 24 rats of each sex (12/sex/group, 6/sex/sacrifice time point) • Assigned to two groups: (a dose group and a vehicle group) • Administered drug substance peptide intravenously via the tail vein at 0 (vehicle only) and xx ug/kg/day as a single dose on study day 0. • Groups of 6 animals/sex are sacrificed on study days 1 (24 hours) and 14 for evaluation of clinical pathology and organ toxicity. All work must be conducted under Good Laboratory Practices and meet criteria for submission to the FDA. The drug substance will be provided by LOMIN. Two separate compounds will be analyzed with a dose specified by LOMIN. The data will be archived for a minimum of one (1) year following the issuance of the final report. Deliverable and Performance Measurement: The contractor shall submit deliverables to the Government per the below schedule: Deliverable Description and date to be completed: Draft report due two (2) months after final necroscopy. Final Report due fifteen (15) working days after LOMIN provides comments on draft report. Reports will be based off the following topics: 1. Survival 2. Clinical Observations 3. Body Weights 4. Food and Water Consumption 5. Clinical Pathology (Hematology, Clinical Chemistry) 6. Pathology (Gross Pathology, Organ Weights, Histopathology) (vi) Period of Performance: To be negotiated upon award. (vii) The provision FAR clause 52.212-1, Instructions to Offerors - Commercial Items, applies to this acquisition and is hereby incorporated by reference. (viii) The provision at FAR clause 52.212-2, Evaluation - Commercial Items, applies to this acquisition and is hereby incorporated by reference. Awards shall be made to the lowest priced, technically acceptable offeror. The Government will evaluate proposals based on the following evaluation criteria: A. Technical capability to meet the outlined required tasks B. Price (ix) In accordance with FAR Clause 52.212-3, Offeror Representations and Certifications - Commercial Items, Offerors must complete annual representations and certifications on-line at https://www.sam.gov/portal/public/SAM/. (x) FAR clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. (xi) FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items, applies to this acquisition. (xii) The Defense Priorities and Allocations System (DPAS) and assigned rating does not apply to this acquisition. Questions shall be submitted no later than 4:00 p.m. Eastern Standard Time (EST) Friday August 15, 2014. Offerors shall submit their proposals no later than 12:00 p.m. Eastern Standard Time (EST) on Monday, August 25, 2014. The proposal must reference the RFP Number: HHS-NIH-NHLBI-CSB-(EB)-2014-222-CDB. All responsible offerors may submit a proposal, which if timely received, shall be considered by the agency. Proposals can be emailed to the Contract Specialist, Chris Bocus at chris.bocus@nih.gov; Quotations shall not be deemed received by the Government until the quotation is entered into the e-mail address inbox set forth above. Faxed proposals will NOT be accepted. All quotes shall contain the following: 1. Name of Contracting Organization; 2. Contract Number/RFP Number (for subcontracts, provide the prime contract number and the subcontract number); 3. Contract Type; 4. Total Contract Value and Discounts; 5. Description of Requirement; 6. Contracting Specialist's Name and Telephone Number; 7. North American Industry Classification System (NAICS) Code; and 8. DUNS Number.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/HHS-NIH-NHLBI-CSB-EB-2014-222-CDB/listing.html)
- Place of Performance
- Address: Contractor's address, United States
- Record
- SN03464649-W 20140815/140814000954-00f445a3b8d88ca13c277dae4c0cc2ad (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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