SOLICITATION NOTICE
Q -- RESEARCH OF NOISE INDUCED HEARING LOSS
- Notice Date
- 3/6/2003
- Notice Type
- Solicitation Notice
- Contracting Office
- Department of the Navy, Bureau of Medicine and Surgery, NMC San Diego, Bldg 1 38400 Bob Wilson Drive, San Diego, CA, 92134-5000
- ZIP Code
- 92134-5000
- Solicitation Number
- N00259-03-T-0039
- Archive Date
- 3/27/2003
- Point of Contact
- Phyllis Kennedy, Purchasing Agent, Phone (619) 532-8100, Fax (619 532-5596, - Joan Balazs, SPVY, Contract Specialist, Phone 619-532-5944, Fax 619-532-5596,
- E-Mail Address
-
pjkennedy@nmcsd.med.navy.mil, jbalazs@nmcsd.med.navy.mil
- Description
- The Naval Medical Center San Diego intends to procure on an Other Than Full and Open Competition basis from Research Foundation of SUNY in behalf of University at Buffalo, Ste 11, UB Commons, 520 Lee Entrance, Amherst, NY 14228. The Sole Source is based on unique capabilities to perform kurtotic noise exposure and extensive knowledge and experience in audiologic physiology and small animal models for testing of pharmacological and toxicologic agents that affect inner ear function. The following services are required: CLIN 0001: 12 months ? Provide non-personal services in accordance with the following Statement of Work: INTRODUCTION: The Department of Defense Spatial Orientation Center of Naval Medical Center, San Diego staff conducts ongoing projects in auditory and vestibular research. ABREVIATIONS: DOD = Department of Defense, ONR = Office of Naval Research, NMCSD = Naval Medical Center San Diego, SUNY = State University of New York, CRADA = cooperative research and development agreement, GPOC = Government Point of Contact, DSOC = DOD Spatial Orientation Center, AO = antioxidant, ROS = reactive oxygen species, FR = free radicals, NAC = N-acetyl-L-cysteine, ALCAR = acetyl-L-carnitine, IP = intraperitoneally, SPL = sound pressure level, kHz = kilohertz, sec = second, COL = Colonel, MC = Medical Corp, FY = Fiscal Year. SCOPE: Contractor will conduct research into noise-induced hearing loss protection in support of funded investigations under the ONR Military Operational Medicine program and NMCSD local Clinical Investigation Protocol (CIP# S-02-040 ?Prevention of Impulse and Kurtotic Noise Induced Hearing Loss with Antioxidants in a Chinchilla Model?. This program encompasses research into developing countermeasures for the prevention of tissue/organ damage prior to exposures to high-energy sources (loud sounds) and to develop methods for prevention and rescue of neurosensory tissues with exposures to exotic energy sources. This work entails performing a series of experiments over a 12-month period. AIM: This study will extend our previous noise-induced hearing loss model to impulse noise and kurtotic noise. The investigation entails utilizing the antioxidant (AO) compounds, NAC and ALCAR. For this series of studies we will investigate the effects of AOs in protecting (prevention) and rescuing (treatment) hearing after exposure to impulse noise and kurtotic noise. TECHNICAL REQUIREMENTS: SUNY will investigate the effects of AOs in protecting and rescuing hearing after exposure to impulse and kurtotic noise. In the first set of experiments AO protection will be studied using four groups or 24 animals exposed to two noise conditions, impulse (1 control n = 6; 1 ALCAR n = 6) and kurtotic noise (control n = 6; ALCAR n = 6). AOs will be given before and after exposure to noise to investigate protective effects. In a second set of experiments 6 groups or 36 animals will receive the AO treatment only after exposure to investigate rescue effects using the two noise conditions, impulse (control n = 6; ALCAR n = 6 and NAC n = 6) and kurtotic noise (control n = 6; ALCAR n = 6 and NAC n = 6). Impulse noise consists of simulated M16 rifle fire (150 dB peak SPL; 100 shots, interval of 1 impulse/sec). Kurtotic noise consists of continuous octave band noise centered at 4 kHz; 84-86 dB SPL and 113 dB peak SPL applied 1/sec impulse noise 3h duration, replicating occupational noise exposure. A total of 60 animals will be utilized for these series of experiments (Animals in the protection arm equals 24 and the rescue arm equals 36). Duties: The contractor shall perform a full range of research procedures, within the scope of his/her training and experience, on site using SUNY furnished facilities, supplies and equipment. Workload occurs as a result of scheduled and unscheduled requirements for research activities. Primary workload is a result of experiments generated to pursue the specific aims of research protocols funded by the Office of Naval Research and the DoD Spatial Orientation Center (DSOC), Naval Medical Center, San Diego (NMCSD). Contractor is responsible for a full range of experimental requirements in auditory physiologic research including: animal preparation and care, calibration and quality control of sound equipment and measurements, impulse and kurtotic noise exposures, physiologic assessments, collection and gathering of biological specimens, shipping of biological material, planning and execution of research within the personnel and equipment capabilities of the SUNY facility, and the quality and timeliness of experimental records and reports required to document procedures performed and services provided. Contractor shall closely supervise the conduct of the study including all physiological measures, tissue collections and staining for accuracy and completeness, and shall monitor supply and materials levels and work with appropriate personnel to reorder supplies, animals, and materials as needed to support ongoing and planned research. Details of work: Contractor will expose chinchillas to impulse and kurtotic noise. Impulse noise consists of 100 shots at 150 dB peak SPL in intervals of 1 impulse/sec. Kurtotic noise consists of continuous octave band noise centered at 4 kHz; 84-86 dB SPL and 113 dB peak SPL applied 1/sec impulse noise 3h duration. In the first set of protection experiments groups of animals will be designated as Control and ALCAR groups. The ALCAR group will receive IP injections twice daily of ALCAR (100mg/kg) 48 hrs and one-hour before and one hour following noise exposure, then BID the following two days after exposure to noise to investigate protective effects. The Control group will be given saline injections at the same volume on the same schedule as the ALCAR group. The second set of rescue experiments groups of six animals each (Control; ALCAR; NAC), will receive an equivalent total dose of the AOs in the same concentrations as in first set of experiments but the treatments will be administered only after exposure to investigate rescue effects. All injections will be given by intraperitoneal (IP) injection (ALCAR at 100mg/kg and NAC at 325 mg/kg. Again the control animals will be noise-exposed but received the volume saline injections on the same schedule as the AOs. Contractor is responsible for performing hearing assessments measured at 1, 2, 4, 6 1n3 8 kHz using auditory brainstem response (ABR) via subcutaneous needle electrodes placed in the skin of the head and proximal to the ear on all animals. In the protective group, the ABRs will be obtained prior to injections of AOs or saline, after injection of AOs or saline but before noise exposure, one hour after noise exposure, and 11 and 21 days post-noise. ABRs will be obtained in the rescue group before noise exposure, one hour after noise exposure, and on day 11 and day 21 post-noise exposure. Contractor will, immediately upon completion of the final threshold measurements, euthanized the animal and then the cochleae will be harvested. Cochleae will be perfused with warmed (37o C) succinic dehydrogenase solution containing 1% nitrotetrazolium chloride blue, 0.2M sodium succinate and 0.2M PBS and then incubated at 37o C for one hour. After incubation the cochleae will be perfused with PBS and then 4% paraformaldehyde solution buffered with 0.1 Molar phosphate buffered saline (PBS). After suitable fixation time, the specimens will then be perfused and rinsed with 0.1M PBS and then stored and shipped in this solution at 4o C to NMCSD for hair cell counts. Contractor will closely provide oversight and guidance for all procedures and data analysis of all experiments at the State University New York, Hearing Research Laboratory, Buffalo, NY. Contractor will also work closely with COL. Richard Kopke, MC, USA, NMCSD Program Manager who has scientific and technical responsibility for this research project, to coordinate investigational efforts, trouble shoot problems that develop and to collate data from the different work sites. Contractor will organize all data collected for this project in a database/spreadsheet format that is compatible with the NMCSD data manager. Contractor will organize data for publications and oversee the preparation of manuscripts and summary figures resulting from the work performed in this grant proposal. Payment Schedule: Electronic Funds transfer will be used as payment method. It is mandatory for the contractor or their representative (SUNY) to acquire a Dun and Bradstreet registry number (DUNS) and for registering on the Central Contractor Registry (CCR). After acquiring a DUNS and CCR registration, contractor shall submit an invoice with hours of work completed to the GPOC (Dr Kopke or authorized representative) for certification of work completed. Then after processing through NMCSD receipt control and DOD Finance and Accounting System San Diego, electronic funds transfer for services to the contractor?s bank account will be executed. Payment terms are Net 30. Contractor shall maintain current accounts, records, and other evidence supporting all its expenditures chargeable to NMCSD under this contract for at least 12 months after completion or termination of this contract. SUNY shall provide NMCSD with a report within four months of completing performance under this contract. Reports and Publications: SUNY shall submit quarterly reports to NMCSD during the term of this contract on the progress of its research and the results obtained, to the extent reasonably requested. SUNY shall submit a final report of its results, including a listing of all Subject Inventions, to NMCSD within four months after completing the work under this contract. SUNY and NMCSD agree to confer and consult prior to the publication of research data. Prior to submitting a manuscript(s) for review (or without review) which contains the results of research under this contract, each site must have ample opportunity and time to review such proposed publication and to file patent applications a timely manner. COL Richard Kopke, MC, USA, NMCSD Program Manager and Dr. D. Henderson, SUNY Program Manager, are the responsible individuals for review of materials and the designated point of contacts for each respective site. QUALIFICATIONS: Contractor is an expert in the field of inner ear anatomy as well as the ultrastructural, histological and methodological assessment of the auditory system especially in response to noise damage or trauma induced by high-energy sources. Contractor has completed a doctoral degree in the field of Biology; has more than 25 years experience in the area of research interest; SUNY has the medical research laboratory with lab space, equipment, technical and administrative staff to support this project; expertise in the physiology and neuroanatomy of the inner ear. has expert knowledge of the histology and ultrastructure of the auditory system; has 20 years experience with experience noise-induced hearing loss and hair cell regeneration; has a proven publication tract in the area of inner ear biology and physiology; contractor is an internationally recognized researcher in the area of inner ear biology and physiology. SECURITY: No security clearance is needed for contractor. PLACE OF PERFORMANCE: Contractor will work 100% of the time at the SUNY site. INSPECTION AND ACCEPTANCE: Receives supervision from the Government Point of Contact (GPOC). Work is reviewed by GPOC for adequacy of method, completeness, scientific importance, and for applicability to ONR and DOD Spatial Orientation Center?s (DSOC?s) research objectives. This is a combined synopsis/solicitation for commercial items, prepared in accordance with the format in FAR subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation, quotations are being requested and a written solicitation will not be issued. The solicitation number, N00259-03-T-0039, is issued as a request for quotation (RFQ). The Period of Performance is 01 Apr 2003 through 31 Mar 2004. The solicitation document and incorporated provisions and clauses are those in effect through FAC 2001-07. The proposed contract action is for items for which the Government intends to solicit and negotiate with only one source under the authority of FAR 6.302. Interested persons may identify their interest and capability to respond to the requirement or submit proposals. This notice of intent is not a request for competitive proposals. However, all proposals received by 12 March 2003 will be considered by the Government. A determination by the Government not to compete with this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. This acquisition incorporates the following FAR clauses: 52.222-3 CONVICT LABOR (AUG 1996); the following clauses are incorporated by reference in paragraph (b): 52.222-26 EQUAL OPPORTUNITY (E.O. 11246); 52.222-35 AFFIRMATIVE ACTION FOR SPECIAL DISABLED AND VIETNAM ERA VETERAN (38 U.S.C. 4212); 52.222-37 EMPLOYMENT REPORTS ON SPECIAL DISABLED VETERANS AND VETERANS OF THE VIETNAM ERA (38 U.S.C. 4212); 52.222-36 AFFIRMATIVE ACTION FOR HANDICAPPED WORKERS (29 U.S.C. 793); 52.225-13 RESTRICTIONS ON CERTAIN FOREIGN PURCHASES (JUL 2000); 52.232-33 PAYMENT BY ELECTRONIC FUNDS TRANSFER?CENTRAL CONTRACTOR REGISTRATION (MAY 1999); 52.233-3 PROTEST AFTER AWARD (AUG 1996); 52.246-9 INSPECTION OF RESEARCH AND DEVELOPMENT (SHORT FORM)(APR 1984); 52.249-5 TERMINATION FOR CONVENIENCE OF THE GOVERNMENT (EDUCATIONAL AND OTHER NONPROFIT INSTITUTIONS) (SEP 1996); 52.227-1 AUTHORIZATION AND CONSENT (JUL 1995); 52.227-11 PATENT RIGHTS?RETENTION BY THE CONTRACTOR (SHORT FORM)(JUN 1997); DFAR Clauses: 252-225-7001 BUY AMERICAN ACT AND BALANCE OF PAYMENTS PROGRAM (MAR 1998). Responsible firm?s believing they can provide the above, should submit a written response to the Contracting Officer on or before 12 March 2003, providing detailed information, clearly showing their ability to do so without causing programmatic hardship to the program. Responses shall be made in writing via fax at 619-532-5596 Attn: Phyllis Kennedy or email pjkennedy@nmcsd.med.navy.mil.
- Place of Performance
- Address: Research Foundation of SUNY, In Behalf of University at Buffalo, Ste. 11, UB Commons, 520 Lee Entrance, Amherst, NY
- Zip Code: 14228
- Zip Code: 14228
- Record
- SN00272656-W 20030308/030306213655 (fbodaily.com)
- Source
-
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