PRESOL | A | Radio Active Labeled Tracers and Research Hours

FBO DAILY ISSUE OF JULY 28, 2011 FBO #3533
SOLICITATION NOTICE

A -- Radio Active Labeled Tracers and Research Hours

Notice Date: 7/26/2011
Notice Type: Combined Synopsis/Solicitation
NAICS: 541711 — Research and Development in Biotechnology
Contracting Office: Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
ZIP Code: 20857-0001
Solicitation Number: 1090094
Archive Date: 8/13/2011
Point of Contact: Howard Nesmith, Phone: 870-543-7459
E-Mail Address: howard.nesmith@fda.hhs.gov
(howard.nesmith@fda.hhs.gov)
Small Business Set-Aside: Total Small Business
Description: This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) 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. The government intends to issue a Purchase Order in accordance with FAR PART 13.106 for the attached requirement under Simplified Acquisition Procedures. The solicitation number is 1090094. This solicitation is issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-53, July 5, 2011. The associated North American Industry Classification System (NAICS) Code is- 541711 - Research and Development in Biotechnology; Small Business Size Standard is 500 in number of employees. This combined synopsis/solicitation is set-aside for Small Business. Respondents are responsible for delivery in person, by e-mail, fax, mail or other delivery method their complete proposal and any additional documents before 9:00 am (Central Standard Time - Local Prevailing Time in Jefferson, Arkansas) on July 29, 2011 to howard.nesmith@fda.hhs.gov, Fax (870) 543-7990, or mail to the U. S. Food and Drug Administration, OC/OSS/OAGS, Attention of Howard Nesmith, 3900 NCTR Road, Jefferson, AR 72079-9502. PLEASE NOTE - The above contact information is for the Contracting Office and not necessarily the delivery address. The delivery address is indicated in the FOB Destination section below. When appropriate, Respondents should consult with delivery providers to determine whether their documents will be delivered prior to the scheduled time. For information regarding this solicitation, please contact Howard Nesmith by e-Mail at howard.nesmith@fda.hhs.gov, Phone (870) 543-7459, or FAX (870) 543-7990. The Food and Drug Administration is soliciting for Synthesis for Radio Active Labeled Tracers and Research Hours. Item #1 Deliverables: The contractor must work closely with the Food and Drug Administration, National Center of Toxicological Research (FDA/NCTR) Division of Neurotoxicology to provide specifically designed radioactive labeled tracers that meet particular needs of our unique research demands. The contractor must be able to provide the same unique requirements that have been utilizing for the research protocols E07285.01, E07264.01, and E07264.11, as identified below. The contractor shall provide applicable lab research and development of radioactive labeled tracers by purchasing chemical precursors, performing chemical syntheses and verifying chemical structures. The contractor must be able to deliver radioactive labeled tracers on a fixed delivery time-line not to exceed 120 minutes, which is essential for adequate use tracers due to there radioactive life span. The contractor must be wholly responsible for the delivery of the following Radio Labeled Tracers with an Activity Range of 2 mCi - 20 mCi: Isotope/ Supplier Compound - *Estimated Yearly Doses Requested F-18 Annexin V - 0 F-18 WC-II-89 - 40 F-18 AV-45 - 20 F-18 Fluoroethylspiperone - 10 F-18 FEPPA - 70 F-18 DFNSH - 20 F-18 nanoparticles - 0 F-18 DTBZ - 10 F-18 MPF-3 - 10 F-18 AFA - 10 F-18 FLT - 30 F-18 FMPEP-d2 - 20 F-18 Flumazenin -20 I-124 Labeled Tracers (antibodies, FIAU) - 0 *Shall allow for a +/- 20% variance. The Government reserves the right to add additional Tracers throughout the life of the contract. Unit price shall be exclusive of research and material which is chargeable as a separate per Labor Hour Line Item. Unit Price per Dose:____________ In the event per Dose price is different according to specific Tracer please identify the Tracer and Price per Dose. Cyclotron and Radiochemistry Facility Location and Ownership The contractor shall identify the physical location (Facility Name, Address, City, State) of the Cyclotron and Radiochemistry Facility and its Ownership. In the event the contractor does not own the Cyclotron and Radiochemistry Facility they must identify a contingency plan to fulfill any resulting contract from this solicitation in the event the Cyclotron and/or Facility are not available. Protocol E07285.01: Assessment of Gaseous Anesthetics in the Developing Nonhuman Primate Objective: I. To evaluate dose-response effects of gaseous anesthetics; to determine if prolonged exposure to nitrous oxide or isoflurane alone will result in an increase in neuronal cell death; to determine if combinations of nitrous oxide and isoflurane will prevent or enhance each other's effects on the developing nonhuman primate. II. To determine if a relative high dose or prolonged exposure of the developing nonhuman primates to nitrous oxide or isoflurane alone, or their combination will induce long-term behavioral deficits, as well as long-lasting pathological changes. III. To determine, using noninvasive imaging techniques [High resolution dedicated positron emission tomography (microPET) and MRI], if a high dose or prolonged exposure of the developing nonhuman primates to nitrous oxide or isoflurane alone, or in combination will induce long-lasting pathological changes. MRI will be used to verify pathological evidence and look for volume changes. MicroPET will be used to examine the sensitivity for tracing low picomolar concentrations of radiolabeled molecules, which is useful for studying dynamic imaging in animal models of human diseases. IV. To identify potential underlying mechanisms that could link alteration of mitochondrial function and elevation of reactive oxygen species (ROS) to gaseous anesthetic-induced neuronal cell death. L-carnitine will be used to attenuate neurological brain injury associated with mitochondria-related degenerative effects induced by gaseous anesthetics in the developing nonhuman primate. Protocol E07264.01: Methods Development for High Resolution Dedicated Positron Emission Tomography (microPET) to Rodent Neuroplasticity and Toxicity during Development Objective: Advances in pediatric and obstetric surgery have resulted in an increase in complexity, duration, and number of anesthetic procedures. To minimize risks to children resulting from the use of anesthesia, it is necessary to understand the effects of anesthetic drugs on the developing nervous system. This study will utilize microPET to screen and evaluate in vitro and in vivo measurements from a broad range of pathophysiological or pharmacological parameters using specific tracers in the developing rat. Three different age groups of developing rats will be used: pregnant day 18 female rats, PND-7 rat pups and PND-35 rats. This study will also attempt to elucidate the relationship between apoptosis identifying ligands (specific tracers) and subsequent behavioral deficits Protocol E07264.11: Addend: Methods Development for High-Resolution Dedicated Positron Emission Tomography (microPET) to Rodent Neuroplasticity and Toxicity During Development Objective : Determine whether the Annexin V protein, with a molecular weight of 36,000, crosses the blood brain barrier (BBB) is critical for determining its usefulness in labeling apoptotic neurons. To address the issue, the degree of transfer of Annexin V across the BBB will be determined by evaluating fluorescent intensity after infusion of Annexin V-Fluorescin through the left internal carotid artery. Requesting additional animals for this study. Item #2 Research: The contractor shall provide extensive consultation and collaboration in the selection and synthesis of specialized radioactive labeled tracers to support bio-imaging experiments at NCTR. The contractor shall accomplish extensive literature searches, review current research programs and present recommendations on the use and development of radiopharmaceuticals to support imaging programs at the NCTR. The contractor shall provide chemical testing and validation of the radioactive labeled tracers prior to being accepted for use in research at the NCTR. The contractor shall be required to be on an "On Call' schedule and provide timely deliveries of the required radioactive labeled compounds to the NCTR. The contractor shall be covered under the NRC licensure with the Arkansas State Department of Health. The contractor shall submit a monthly report no later than the 5th calendar day following the end of the month. Comprehensible detailing research accomplished for the month and the labor hours associated with same. PRICE QUOTE MUST INCLUDE A STATEMENT OF ASSUMPTION The Contractor will be required to provide a Statement of Assumption which fully explains Research Hours provided on which the Per Labor Hour Price is based. Estimated Annual Labor Hours - 400 Per Labor Hour Price:____________ For both Deliverables (Item #1) and Research Hours (Items #2) Base Period of Performance: August 1, 2011 - July 31, 2012 Item #3 Optional Additional One Year Period of Deliverables Unit Price per Dose:____________ In the event per Dose price is different according to specific Tracer please identify the Tracer and Price per Dose. Item #4 Optional Additional One Year Period of Research Hours Per Labor Hour Price:____________ For both Deliverables (Item #3) and Research Hours (Items #4) Option One Period of Performance: August 1, 2012 - July 31, 2013 If there is an increase in price for the optional periods the Respondent must provide an explanation for the bases of each increase. FOB Destination - U.S. Food and Drug Administration, NCTR/DHHS/FDA, 3900 NCTR Rd., Jefferson, AR 72079. Payment Requirement Any resulting contract from this solicitation shall be paid monthly on two bases - Deliverables and Research Hours. For payment of Deliverables the contractor must identify each Radio Labeled Tracers delivered and its quantity on each Invoice. For payment on Research Hours the contractor must identify the number of Hours provided on each Invoice along with a summery identifying precisely what the Research produced. Contract Type - Commercial Item - Firm fixed price. Simplified procurement procedures will be utilized. An official authorized to bind the Offeror must sign the terms and conditions of the offer. Offerors that fail to furnish required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration. CCR REQUIREMENT - Company must be registered on Central Contractor Registration (CCR) before an award could be made to them. If company is not registered in CCR, they may do so by going to CCR web site at http://www.ccr.gov. The provision at FAR 52.212-1 Instructions to Offerors - Commercial Items applies to this solicitation. The provision at FAR 52.212-2 Evaluation-Commercial Items is applicable to this solicitation. The specific evaluation criteria to be included in paragraph (1) of that provision are as follows: The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be the most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: (i) Technical capability of the items offered to meet the Government's requirement. (ii) Price. The government will award the purchase order to the lowest price technically acceptable quote. Technical acceptability will be determined by review of information submitted by the quoter which must provide a description in sufficient detail to show that the product/service quoted meets the Government's requirement. The government is not responsible for locating or securing any information, which is not identified in the proposal. To ensure information is available, vendors must furnish as part of their proposal all descriptive material necessary for the government to determine whether the service meets the technical requirements. Quotes shall include technical specifications, descriptive material, literature, brochures and other information corresponding to each minimum required item, which demonstrates the capabilities of the offeror. The Provision at FAR 52.212-3, Offerors Representations and Certifications-Commercial Items, applies to this acquisition. An offeror shall complete only paragraph (b) of the provision if the offeror has completed the annual representations and certification electronically at http://orca.bpn.gov. The clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. The following addenda have been attached to the clause: None. The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items, applies to this acquisition. 52.216-31, Time-and-Materials/Labor-Hour Proposal Requirements-Commercial Item Acquisition. The following additional FAR clauses cited in this clause are applicable: 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-36, 52.225-3, 52.225-13, and 52.232-33. Clauses and provisions are incorporated by reference and apply to this acquisition. Clauses and provisions can be obtained at http://www.arnet.gov. CCR Requirement - Company must be registered on Central Contractor Registration (CCR) before an award could be made to them. If company is not registered in CCR, they may do so by going to CCR web site at http://www.ccr.gov. A standard commercial warranty on parts and workmanship is required. The Defense Priorities and Allocations System (DPAS) and assigned rating are not applicable to this solicitation notice.
Web Link: FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/1090094/listing.html)
Place of Performance: Address: U.S. Food and Drug Administration, NCTR/DHHS/FDA, 3900 NCTR Rd., Jefferson,, Arkansas, 72079, United States; Zip Code: 72079
Record: SN02511140-W 20110728/110726235630-312d24299588b9fd30cb4ad2434e92a2 (fbodaily.com)
Source: FedBizOpps Link to This Notice
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A -- Radio Active Labeled Tracers and Research Hours