SOURCES SOUGHT
A -- Good Laboratory Practice Toxicology Study of Intramuscular Delivery of the cGMP InvaplexAR-Detox Subunit Vaccine
- Notice Date
- 5/17/2016
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of the Army, U.S. Army Medical Research Acquisition Activity, U.S. Army Medical Research Acquisition Activity, Attn: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014, Maryland, 21702-5014, United States
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH16T0206
- Archive Date
- 6/10/2016
- Point of Contact
- Nathaniel A. Reus, Phone: 3016199209
- E-Mail Address
-
nathaniel.a.reus.civ@mail.mil
(nathaniel.a.reus.civ@mail.mil)
- Small Business Set-Aside
- Total Small Business
- Description
- This is a Sources Sought for Market Research information and planning purposes only and is not to be construed as a commitment by the Government. No contract will be awarded as a result of this sources sought. No reimbursement will be made for any cost associated with providing information in response to this notice. The United States Army Medical Research Acquisition Activity (USAMRAA) is soliciting on behalf of Walter Reed Army Institute of Reseach (WRAIR), information from potential qualified businesses. WRAIR is seeking Small Business sources that have knowledge and capabilities for non-personal services to provide Good Laboratory Pratice (GLP) toxicology study of Intramuscular Delivery of the Good Manufacturing Practices (cGMP) InvaplexArtificial (AR)-Detox Subunit Vaccine. The Subunit Enteric Vaccine and Immunology group of the Bacterial Disease Branch at the WRAIR seeks to develop vaccines against Shigella as part of a greater effort toward a multivalent multi-agent diarrhea vaccine. A GLP toxicology study will be performed on the test product ((cGMP) InvaplexAR-Detox) at a contract research organization conducted in accordance with Food and Drug Administration (FDA )GLP as found in title 21 Code of Federal Register part 58. Three groups of rats (15 of each sex) will be administered four intramuscular doses of either a cGMP InvaplexAR-Detox, cGMP InvaplexAR-Detox administered with the adjuvant dmLT, or saline at two week intervals. Ten rats from each group and sex will be sacrificed 48 hours following the final dose. Each animal will undergo a complete necropsy and histopathologic analysis with organ weights. Serum will be collected prior to first inoculation and on the day of sacrifice. Body weight, dose site evaluations, body temperature, clinical chemistry, and clinical observations will also be collected and/or recorded. The purpose of this study is to investigate the local tolerance and potential local and systemic toxic effects induced by multiple injections of the test article and to evaluate the reversibility of toxic effects over a period of four (4) weeks after the last injection. Saline will be used as a negative control. This is not an all inclusive list, but one to indicate the areas of work that will be required Interested parties shall submit a Technical Capability Statement that clearly addresses their corporate capabilities and Past Performance References. All proprietary information should be marked as such. Responses will be held confidential if requested. The capability statement is not to exceed 3 pages and shall at a minimum address the following: (1) Name of Company; (2) Company Address; (3) Point of Contact Information: Name, Telephone number and Email address; (4)Company Size: The government is seeking vendors from the following Socio Economic Status: 100% Small Business, NAICS 541711 (5) Address whether the services identified in the requirement described above are of a type offered and sold competitively in the commercial marketplace based on market prices or whether these services are exclusively provided to the Government; (6) If commercially available, identify standard commercial terms and conditions typically associated with these services; (7) Describe experience and past performance with similar types of requirements of similar scope and magnitude and whether they were performed performance-based and include the contract number, Government agency name and address and contract funded amount; This synopsis is for information planning purposes only and is not a commitment by the Government. This is not a solicitation announcement for proposals and a contract will not be awarded from this announcement. No reimbursement will be made for any costs associated with providing information in response to this announcement and any follow-up information requests. Each response must reference the sources sought title. All fact sheets/capability statements must be submitted by email to the point of contact Nathaniel Reus, at nathaniel.a.reus.civ@mail.mil; no other method of transmittal will be accepted. This market research is for a new work effort. Respondents submitting a capability statement must do so by email on 26 May 2016.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH16T0206/listing.html)
- Place of Performance
- Address: WRAIR, Walter Reed Army Institute of Research, 503 Robert Grant Ave, Silver Spring, Maryland, 20910, United States
- Zip Code: 20910
- Zip Code: 20910
- Record
- SN04119341-W 20160519/160517234704-084fa16f6c75a6836d663fd58e6b5382 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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