SOLICITATION NOTICE
65 -- Hearing Pill Clinical Study
- Notice Date
- 12/9/2005
- Notice Type
- Solicitation Notice
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- 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
- N00259-06-T-0017
- Response Due
- 12/14/2005
- Archive Date
- 12/16/2005
- Description
- Naval Medical Center San Diego intends to solicit and negotiate on a sole source basis in accordance with FAR Part 6.302-1, Only one responsible source and no other suppliers or services will satisfy the agency requirement for NAICS 325412, Pharmaceutical Preparation Manufacturing. NMCSD intend to award a Firm Fixed Price contract with American Biohealth Group, 15721 Bernardo Heights Pkwy, Ste 151, San Diego, CA 92125-1999. This is a combined synopsis/solicitation for commercial items, prepared in accordance with the format in FAR subpart 12.6, using Simplified Acquisition Procedures for Commercial items found at FAR 13, 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. Paper copies of this solicitation will not be available. The solicitation number, N00259-06 -T-0017 is issued as a request for quotations (RFQ. It is the responsibility of the contractor to be familiar with the applicable clauses and provisions. The clauses and provisions maybe accessed in full text at these addresses: www.arnet.gov/far and http:// farsite.hill.af.mil. This is an unrestricted basis due to this requirement being considered to be Sole Source. NMCSD requests responses from qualified sources capable of providing the following items. CLIN 0001: Hearing Pill Clinical Study, Off-site non-personal service contract to provide support for clinical research study CIP# S-04-123 "A Prospective Study Assessing the Efficacy of the Nutritional Supplement N-Acetyl-Cysteine in the Treatment of Acute Acoustic Trauma" including packaging, labeling, and shipping study kits to specified study site locations IAW the Statement of Work. CLIN 0002: N-Acetylcysteine (NAC), Contractor will provide the following, The study active drug, N-Acetylcysteine (NAC) for a total of 104 kits, consisting of 182 doses per kit, for a Grand total of 18,928 individual capsules. Delivery shall be IAW the schedule set forth in the Statement of Work. CLIN 0003: Placebo, Contractor will provide, placebo capsules for a total of 104 kits, consisting of 182 doses per kit, for a Grand total of 18,928 individual capsules. Delivery shall be IAW the schedule set forth in the Statement of Work. STATEMENT OF WORK- REACTOR STUDY as follows. Task Title: CIP# S-04-123: A PROSPECTIVE STUDY ASSESSING THE EFFICACY OF THE NUTRITIONAL SUPPLEMENT N-ACETYLCYSTEINE IN THE TREATMENT OF ACUTE ACOUSTIC TRAUMA. (Rapid Employment of Acetylcysteine Treatment for Otologic Recovery a.k.a. REACTOR TRIAL). CDR Ben Balough, MC, USN, PI. INTRODUCTION: The Department of Defense Spatial Orientation Center (DSOC) of Naval Medical Center (NMCSD), San Diego, conducts ongoing projects in auditory and vestibular research. The NMCSD wishes to engage the services of a biopharma company for a field study that determines the efficacy of the antioxidant nutritional supplement N-acetylcysteine (NAC) in protecting ears exposed to loud sounds. ABREVIATIONS: DOD = Department of Defense; NMCSD = Naval Medical Center San Diego; GPOC = Government Point of Contact; DSOC = DOD Spatial Orientation Center; IRB = Institutional Review Board; PI = Principal Investigator; CCR = Commercial Contractor Registry; WAWF = Wide Area Work Flow; EFT = electronic funds transfer; CDR = Commander; MC = Medical Corps; USN = United States Navy; NAC = N-acytelcysteine; TAMC = Tripler Army Medical Center; MAMC = Madigan Army Medical Center; WAMC = Womac Army Medical Center. TECHNICAL REQUIREMENTS: The contractor shall provide support for clinical research study CIP# S-04-123 ?A Prospective Study Assessing the Efficacy of the Nutritional Supplement N-Acetyl-Cysteine in the Treatment of Acute Acoustic Trauma? including randomization of study drug and placebo, and packaging, labeling, and shipping study kits to specified study site locations as needed per PI guidance. Contractor shall provide a total of 18,928 N-Acetylcysteine (NAC) capsules (182 doses for 104 kits), and a total of 18,928 placebo capsules (182 doses for 104 kits, 26 kits per site). Contractor shall: 1.Provide and Manage the Randomization codes for each clinical site to keep the study a ?double blind? study. Label each kit with the appropriate randomization code. Randomization codes will be generated by an in-house mechanism that will result in a true randomization between active and placebo dosing. 2.Ensure that each kit will contain 182- 400mg capsules of NAC in a white HDPE bottle with a pressure sensitive clinical label affixed to the outside. The bottle must be inside a box labeled with the randomization codes necessary for the specific site. 3.Ship 26 kits, of 182 doses per kit, to each of the following four sites: Tripler Army Medical Center (TAMC), Madigan Army Medical Center(MAMC), Ft. Bragg and Ft. Hood. 4.Interface with study clinical research organization manager: Duke Clinical Research Institute (DCRI) for study drug preparation, assigning codes and managing changes. 5. Assist in FDA filing for study drug as requested by the PI. 6.Provide certified Good Manufacturing Practices, as required by the FDA. 7. Contractor shall maintain current accounts, records, and other evidence supporting all expenditures chargeable to NMCSD under this contract for at least 6 months after completion or termination of this contract. Delivery Schedule: 24 February 2006: Shipment of 26 kits to TAMC, 24 February 2006: Shipment of 26 kits to MAMC,24 February 2006: Shipment of 26 kits to Ft. Bragg,24 February 2006: Shipment of 26 kits to Ft. Hood. Shipment addresses and POCs: TAMC: Michael R. Holtel, M.D., CAPT, MC, USN, Otolaryngology-Head and Neck Surgery, Tripler Army Medical Center, 1 Jarrett White Road Tripler AMC, HI 96859-5000, PH: (808) 433-3170 Fax: (808) 433-9033, Email: Michael.Holtel@amedd.army.mil. MAMC: James Crawford, M.D., Madigan Army Medical Center, 9404 Jackson Avenue, Tacoma, WA 98431, Ph: (253) 968-3472, Email: james.crawford@nw.amedd.army.mil . FT. BRAGG: LTC Vicki Tuten, Womac Army Medical Center, Department of Preventive Medicine Hearing Conservation Section, ATTN: LTC Tuten, Bldg. 1-2739, Hamilton Street, Fort Bragg, NC 28310, Ph: (910) 396-2558 /2568, Email: Vickie.tuten@amedd.army.mil. FT. HOOD: Leanne M. Cleveland, 1LT, Darnall Army Community Hospital, 36000 Darnall Loop Attn: MCXI-DOS-AUD (1LT Cleveland), Fort Hood, TX 76544, Ph: (254) 285-6186 Email: leanne.cleveland@amedd.army.mil . 7.0 SECURITY: No security clearance is needed for contractor. 8.0 PLACE OF PERFORMANCE: Contractor will complete the scope of services at contractor?s 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 BUMED, ONR and DOD Spatial Orientation Center?s (DSOC?s) research objectives. Government Point of Contact will be: Ronald Jackson, PhD, NMCSD Program Manager at (619) 532-9840 or pager (800) 732-1457 or FAX (619) 532-5444. 11.0 MISCELLANEOUS: None. Delivery (POP) is 16 December 2005 Thru 30 September 2006. This acquisition incorporates the following FAR clauses: This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-6 and DFAR Change Notices effective through 6/21/05. Applicable clauses are FAR 52.212-1, Instructions to Offerors, Commercial Items, 52.252-1 Solicitation Provisions Incorporated by Reference, 52.204-7 Central Contractor Registration, 252-225-7002 Qualifying Country Sources As Subcontractors, 52.212-4, Contract Terms and Conditions ? Commercial Items, 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders, Commercial Items applies with the following applicable clauses: 52.222-3 Convict Labor, 52.222-19 Child Labor, 52.222-21 Prohibition of Segregated Facilities, 52.222-26, Equal Opportunity; FAR 52.222-35, Affirmative Action for Disabled Veterans and Veterans of the Vietnam Era, FAR 52.222-36, Affirmative Action for Workers with Disabilities; FAR 52.222-37, Employment Reports on Disabled Veterans and Veterans of the Vietnam Era, 52.225-13 Restrictions on Certain Foreign Purchases. DFARS 252.212-7001, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Applicable to Defense Acquisitions of Commercial Items, applies with the following clauses: DFARS 252.225-7001, Buy American Act and Balance of Payment Program and 252.232-7003 Electronic Submission of Payment Requests, 52.232-18, AVAILABILITY OF FUNDS (4/84), 52.212-3, Offeror Representation and Certifications, Commercial Items. 52.217-9, Option to Extend the term of the Contract; 52.217-5, Evaluation of Options; 52.217-8, Option to extend Services; 52.212-2, EVALUATION ?COMMERCIAL ITEMS (1/99). The Government will award a firm-fixed price contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: Past Performance, Technical Capability, Price. Technical and past performance, when combined, are significant evaluation factors that will be used to arrive at a best value award decision. A price evaluation will only be conducted on offerors found to be technically acceptable and possess or have demonstrated qualified experience relevant to the scope of this solicitation. The following Evaluation factors will be used to determine Best Value: 1. Technical Capability. Defined as ?as an assessment of the prospective contractor's key management personnel to determine if they have the basic knowledge, experience, and understanding of the requirements necessary to produce the required product or provide the required service,? must specifically address a management plan in providing service IAW the Statement of Work (SOW). 2. Past Performance. Provide references, specifically addressing Clinical Studies and Pharmaceuticals manufacturing experience. services in the last 3 years. 3. Price. Contractors who do not meet the first 2 factors will not undergo a price evaluation. In submitting your quote, include your company?s complete mailing and remittance addresses, discounts for prompt payment, if any, Commercial and Government Enity (CAGE) code, Dun and Bradstreet number, and federal tax ID number. All required FAR 52.212-3 Certications and representations must be completed and submitted along with your quote. Quotes are accepted in any form by Fax or E-mail to: Becky LaGrone, Purchasing Agent, 619-532-5933, balagrone@nmcsd.med.navy.mil or Joyce Claridy, Contract Specialist, 619-532-8116, jmclaridy@nmcsd.med.navy.mil. Offers may be faxed to 619-532-5596. Please reference the RFQ number.
- Place of Performance
- Address: Various Locations as listed in the Statement of Work.
- Record
- SN00949054-W 20051211/051209212453 (fbodaily.com)
- Source
-
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