MODIFICATION
99 -- Pre-clinical in vitro and in vivo safety of medical devices and/or drugs to support the U.S. FDA medical product approval process.
- Notice Date
- 3/27/2007
- Notice Type
- Modification
- 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
- 4/30/2007
- Archive Date
- 6/29/2007
- Small Business Set-Aside
- N/A
- Description
- Scope of work changed to read as follows: In support of continuing improvements in combat casualty care capabilities for the US military, the US Army Medical Research Acquisition Activity (USAMRAA) has a requirement for services to evaluate the pre-clinical in vitro and in vivo safety of medical d evices and/or drugs (referred to as medical products through the remainder of this document) to support the U.S. FDA medical product approval process. Example products are for the diagnosis and treatment of combat injuries an d may include wound care prod ucts, 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. Services requested shall i nclude 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 st andards and FDA or other guidance for the medical product under consideration. For medical devices, these include International Organization for Standardization (ISO) 10993 Biological Evaluation of Medical Devices series, FDA blue book memorandum #G95-1 R equired Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, and other device/indication-specific FDA guidance. For drugs, these include but are not limited to the following: Pharmacology/Safety Pharmacology (see ICH Guidel ine 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 Guideli nes 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 S afety 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 t hat 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. All interes ted parties need to be registered with the Central Contractor Registration (CCR) website at http://www.ccr.gov/. Expected release for this solicitation is going to be on April 30, 2007.
- Place of Performance
- Address: US Army Medical Research Acquisition Activity ATTN: MCMR-AAA, 820 Chandler Street Frederick MD
- Zip Code: 21702-5014
- Country: US
- Zip Code: 21702-5014
- Record
- SN01260185-W 20070329/070327221135 (fbodaily.com)
- Source
-
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