SOLICITATION NOTICE
99 -- Preclinical in vitro and in vivo Testing for Combat Casualty Care Medical Device and Drug Products to Support FDA Approval
- Notice Date
- 3/23/2007
- Notice Type
- Solicitation Notice
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH-CCC-041807
- Response Due
- 4/18/2007
- Archive Date
- 6/17/2007
- Small Business Set-Aside
- N/A
- Description
- In support of continuing improvements in combat casualty care capabilities for the US military, the US Army Medical Research Acquisition Activity (USAMRAA) requests proposals for services to evaluate the pre-clinical in vitro and in vivo safety of me dical devices and/or drugs (referred to as medical products through the remainder of this document) to support the U.S. Food & Drug Administration medical product approval process. Example products are for the diagnosis and treatment of combat injuries an d may include wound care products, surgical devices, implants, resuscitation fluids, and dental products. All studies are required to be performed under Good Laboratory Practices (GLP) to support regulatory submissions to FDA for consideration of approval . Scope of Work: Services requested shall include all necessary services, qualified personnel, materials, supplies, equipment, facilities, as required to perform the items as outlined below. ? Preclinical in vitro and in vivo testing performed in accordance with applicable U.S. and international standards and FDA or other guidance for the medical product under consideration. o For medical devices, these include International Organization for Standardization (ISO) 10993 Biological Evaluation of Medical Devices series, FDA blue book memorandum #G95-1 Required Biocompatibility Training and Toxicology Profiles for Evaluation of Me dical Devices, and other device/indication-specific FDA guidance. o For drugs, these include but are not limited to the following: ? Pharmacology/Safety Pharmacology (see ICH Guideline S7A) ? Pharmacokinetics/Toxicokinetics (see also ICH Guidelines S1C, S3A, S3B) ? Pharmacodynamics ? Toxicology " Acute Toxicology " Repeat Dose Toxicology ? Local Tolerance ? Genotoxicity (see ICH Guidelines S2A, S2B) ? Carcinogenicity (see ICH Guidelines S1A, S1B, S1C) ? Reproductive Toxicology (see ICH Guidelines S5A, S5B) ? Immunotoxicology ? In vitro and in vivo Drug Metabolism/Drug Interaction (see also ICH Guidelines S1C and S3A) ? Developmental Toxicology (see Guidance for Industry: Nonclinical Safety Evaluation of Pediatric Drug Products) ? Animal Models of Efficacy ? Consulting services to help identify study design and strategies to select appropriate studies for the product development of the medical products. ? Development of study protocols that are unique to the medical product. ? Preparation of test documentation, and responses to deficiencies or other questions regarding testing conducted, in order to support regulatory submissions to FDA. ? Preparation of final study reports. Submissions will be accepted electronically by e-mail to brian.d.miller1@us.army.mil. Submissions should use commonly accepted file formats, such as MS Office products or Adobe PDF. E-mailed submissions should include RFP# CCC-041807 in the subject line . Submissions should be emailed by the close of this notice on 04/18/07 by 4:00pm EST. Submissions should be kept to a maximum of 50 pages. All interested parties need to be registered with the Central Contractor Registration (CCR) website at http://www.ccr.gov/.
- Place of Performance
- Address: US Army Medical Research Acquisition Activity ATTN: MCMR-AAA, 820 Chandler Street Frederick MD
- Zip Code: 21702-5014
- Country: US
- Record
- SN01258218-W 20070325/070323222831 (fbodaily.com)
- Source
-
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