MODIFICATION
B -- Toxicity test of Vaccine
- Notice Date
- 1/21/2011
- Notice Type
- Modification/Amendment
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- National Institutes of HealthNational Institute of Child Health6100 Executive BlvdRoom 5Z00BethesdaMD20892-7511
- ZIP Code
- 20892-7511
- Solicitation Number
- NICHD2011094
- Response Due
- 1/27/2011
- Archive Date
- 2/4/2011
- Point of Contact
- Tina Robinson, Phone: 301-443-7796
- E-Mail Address
-
tr207f@nih.gov
(tr207f@nih.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- NOTE: MODIFICATION TO CHANGE THE NAICS CODE FROM 541380 TO 541712, THERE ARE NO OTHER CHANGES TO THIS NOTICE. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is conducting a market survey to determine the availability and technical capability of qualified small businesses, including 8(a) small businesses, small disadvantaged businesses, woman-owned small businesses, service-disabled veteran-owned small businesses or HUBZone small businesses capable of performing toxicity study(per Food and Drug Administration(FDA)request) of a mutant C. difficile toxin B,`BRUvaccine (to be injected into people)using New Zealand White Rabbits (NZW). The materials (experimental vaccine) to be tested will be provided by NICHD. The vendor shall provide everything else including rabbits, media, etc. Interested firms with the capability of providing the services required are requested to submit a capability statement to assist the Government in determining in accordance with Federal Acquisition Regulation (FAR) 19.502-2(b) whether or not this procurement will be set-aside for any of the programs described above. The intended procurement will be classified under North American Industrial Classification (NAICS) code 541712 with a size standard of 500 employees. All respondents are requested to identify their firms size and type of business. Interested firms responding to this market survey must provide (a) capability statement demonstrating their experience, skills and capability to fulfill the Governments requirements for the above. The capability statement shall be in sufficient enough detail, but not to exceed ten (10) pages, so that the Government can determine the experience and capability of your firm to provide the requirements above. Your capability statement should include a minimum of three references. Capability statement should also include pre-clinical toxicity data from animal studies performed using the formulation of product to be used clinically. In order to support the proposed clinical trial of this product, please submit adequate toxicological data from studies involving NZW rabbits on the basis of which you have concluded that it is reasonably safe to conduct the proposed clinical investigation using this product per Code of Federal Regulations(CFR)- 21CFR 312.23(a)(8). This toxicology information should include an integrated summary of the toxicological effects of the compound in animals, a description of the study design and a systematic presentation of the findings of toxicity study or studies with the same mode and regimen of administration. In addition, for each toxicology study that is intended primarily to support the safety of the proposed clinical investigation, a full tabulation of data suitable for detail review should be submitted. Furthermore, for each non-clinical laboratory study subject to the good laboratory practice (GLP) regulations under CFR part 58, a statement that the study was conducted in compliance with the GLP regulations, the in vitro test results shall be enclosed. Two (2) copies of the capability statement must be received at the contracting office address identified in this synopsis prior to 12:00 p.m.(noon)local time at designated location on January 27, 2011. Responses by fax or e-mail WILL NOT BE ACCEPTED. This synopsis is for information and planning purposes and is not to be construed as a commitment by the Government, nor will the Government pay for information solicited. Questions should be submitted via email to: robinsti@mail.nih.gov. Reference Solicitation No. in the subject line.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NICHD/NICHD2011094/listing.html)
- Record
- SN02364505-W 20110123/110121234132-fca19f1220c65b3b3214f1dc5ab50635 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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