MODIFICATION
B -- Toxicity test of Vaccine
- Notice Date
- 2/18/2011
- Notice Type
- Modification/Amendment
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Child Health and Human Development, Contracts Management Branch, 6100 Executive Blvd., Suite 7A07, MSC7510, Bethesda, Maryland, 20892-7510
- ZIP Code
- 20892-7510
- Solicitation Number
- NICHD2011094-A
- Archive Date
- 3/4/2011
- Point of Contact
- Tina Robinson, Phone: 301-443-7796
- E-Mail Address
-
tr207f@nih.gov
(tr207f@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Mod. to change Federal Acquistion Circular from 2005-46 to 2005-48. No other changes. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a separate written solicitation will not be issued. This solicitation number is NICHD2011094 -A and is issued as a Request for Quotation (RFQ). The solicitation/contract will include all applicable provisions and clauses in effect through Federal Acquisition Circular 2005-48. The North American Industry Classification (NAICS) Code is 541712 and the business size standard is 500 employees. This solicitation is not a set aside for small business. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) has a requirement for a vendor who is capable of performing toxicity study(per Food and Drug Administration(FDA)request) of a mutant C. difficile toxin B,‘BRU'vaccine (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, facilities, etc. The offeror must include a completed copy of the provision of FAR Clause 52.212-3, Offeror Representations and Certifications - Commercial Items with its offer. The provisions of FAR Clause 52.212-1 Instructions to Offerors - Commercial Items; FAR Clause 52.212-2, Evaluation - Commercial Items -Evaluation Procedures: The Government will select the best overall offer based on price and ability to meet the specifications identified in the requirement. The Government will award a contract resulting from this solicitation to the responsible offeror whose offer, conforming to the solicitation; will be the most advantageous to the Government in accordance with the requirement. Only those offerors determined to be in compliance with the requirements as stated in this solicitation will be considered for award. If additional information is required to support price reasonableness, each offeror may be required to provide a hard copy of their price break-down. Non-conformance with this requirement may result in the offeror's quote being determined unacceptable. FAR Clause 52.212-4, Contract Terms and Conditions - Commercial Items; and FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items - Deviation for Simplified Acquisitions applies to this acquisition. The offeror must include their Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. The clauses are available in full text at https://www.acquisition.gov/Far/. Interested vendors capable of furnishing the government with the service specified in this synopsis should submit two (2) copies of their quotation to the below address. Offerors quotation shall include information sufficient enough in detail (but not to exceed ten (10) pages) so that the Government can determine the experience and capability of your firm to provide the needed service above. Your quotation should include a minimum of three references. Quotation should include the study outline/proposed protocol to include but not limited to histological examination and tissue collection, administration information, injection site, etc. Quotation should include your turn-around time, proposed start/begin date, etc. 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. Pre-clinical toxicity data from animal studies performed using the formulation of product to be used clinically. 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. Quotations and other information will be due eleven (11) calendar days from the publication date of this synopsis or by February 28, 2011 by 3:00 p.m. EST. The quotation must reference "Solicitation number" NICHD2011094-A. All responsible sources may submit a quotation, which if timely received, shall be considered by the agency. Quotations must be submitted in writing to Eunice Kennedy Shriver National Institute of Child Health and Human Development, 6100 Executive Boulevard, Room 5Z00, Bethesda, MD 20852. Attention: Tina Robinson. Faxed or Email copies of responses/ quotations will not be accepted. Note: In order to receive an award, contractor must be registered and have valid certification in the Central Contractor Registration (CCR) http://www.ccr.gov
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NICHD/NICHD2011094-A/listing.html)
- Record
- SN02383468-W 20110220/110218234034-646521ee3ea4e4050dbb857d41530de7 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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