SOURCES SOUGHT
A -- Housing of Squirrel Monkeys
- Notice Date
- 5/27/2009
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-09-1058034
- Point of Contact
- Karen R. Petty, Phone: 301-827-8774
- E-Mail Address
-
karen.petty@fda.hhs.gov
(karen.petty@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- Solicitation: FDA-09-1058034 Agency/Office: Food and Drug Administration Project Title: Housing of Squirrel Monkeys-- Potential of Candidate Cell Substrate for Vaccine Production to Propagate TSE Agents Request for Information (RFI): This is a RFI in accordance with FAR 15.201 (e) to determine the availability and capability of small businesses (including certified 8(a), Small Disadvantaged, and HUBZone firms; veteran and service-disabled veteran-owned small businesses, and women-owned small businesses. This notice is for planning purposes only, and does not constitute an Invitation for Bids, a Request for Proposals, Solicitation, Request for Quotes, or an indication that the Government will contract for the items contained herein. This notice is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. This RFI is part of a continuous process for obtaining the latest information on the commercial status of the industry with respect to their current and near-term abilities. The information provided herein is subject to change and in no way binds the Government to solicit for or award a competitive contract. It is emphasized that this is a notice solely for planning and informational purposes only and is not be construed as a commitment by the government to enter into a contractual agreement, nor will the government pay for information solicited. The Government does not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this RFI. Any responses received will not be used as a proposal. The U.S. Food and Drug Administration (FDA) is solely seeking to identify any sources with capabilities or prior experience that can perform the following: Background: Since the early 1990s, FDA has expressed a concern about the theoretical risk that the infectious agents causing transmissible spongiform encephalopathies (TSEs) might accidentally contaminate cell substrates used to prepare fda-regulated biological products (1, 2). In the past, some cell cultures were experimentally infected with TSE agents, though infections have generally been difficult to achieve and maintain (3). Recent work of two groups, successfully infecting murine cultures with scrapie agent (4, 5), rekindled interest in the phenomenon. However, relatively little has been done to investigate the susceptibility of cell cultures used or under investigation as substrates to produce vaccines and other biologics. We are investigating the ability of several relevant cell lines to sustain infection and propagate TSE agents, with special emphasis on the agent of bovine spongiform encephalopathy (BSE). We assay cultures for infectivity using several lines of transgenic (tg) mice engineered to increase their potential sensitivity to various TSE infections. We are also attempting to develop cell culture assays that might reduce the future need to perform bioassays of TSE agents in animals. FDA Objectives: Contractor would provide a USDA-approved BSL-3 facility (acceptable to FDA safety staff) for housing up to 48 squirrel monkeys. FDA presented an animal study proposal to its own Institutional Animal Care and Use Committee and Safety Committee and received approvals; the Contractor is expected to have for, received and maintained required approvals from its own authorities. In addition, the Contractor shall have current USDA approval and certification to handle the BSE agent in its BSL-3 animal and laboratory facilities. BSE-inoculated and cell-substrate-inoculated squirrel monkeys are to be observed daily by Contractor’s staff for signs of neurological illness (marked behavioral change, incoordination, weakness, and failure to eat, drink or groom), and FDA is to be notified if illness is suspected. No other special procedures are needed. Contractor is to provide routine veterinary care and necropsy service. RFI Submission Instructions: FDA will not award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted or FDA’s use of such information. Responses will be separated from, and have no bearing on subsequent evaluations of proposals submitted in response to any resulting formal RFP. Eligibility in participating in a future acquisition does not depend upon a response to this notice. Proprietary information is not being solicited. Information considered proprietary, if any, should be identified as such. Responses will be reviewed only by FDA personnel and will be held in a confidential manner. Responses to the RFI should address the following: Companies are encouraged to respond if they have the capability and capacity to provide the services. However, be advised that generic capability statements are not sufficient for effective analysis of respondents' capacity and capability to enable FDA to examine, analyze, review, verify, improve upon existing and develop, if necessary, mechanisms related to food safety and defense (protection) to protect, promote and preserve the public’s health and well-being. Responses shall directly demonstrate the company's capability, experience, and/or ability to marshal resources to effectively and efficiently perform while in compliance with FAR 52.219-14 ("Limitations on Subcontracting"). Part A: Technical and Capabilities--Provide a capability statement describing how your company would provide a USDA-approved BSL-3 facility (acceptable to FDA safety staff) for housing up to 48 squirrel monkeys and enable FDA to keep vaccines and other injectable medicinal products free of contaminating agents—especially infectious agents pathogenic for humans. Part B: Cost Estimate--Provide a cost estimate for the services to provide a USDA-approved BSL-3 facility (acceptable to FDA safety staff) for housing up to 48 squirrel monkeys and enable FDA to keep vaccines and other injectable medicinal products free of contaminating agents—especially infectious agents pathogenic for humans. Part C: Organizational Conflict of Interest--If any, provide disclosure of business activities of your company, your affiliates, your team members and affiliates of your team members which create either a conflict of interest or the appearance of a conflict of interest to provide a USDA-approved BSL-3 facility (acceptable to FDA safety staff) for housing up to 48 squirrel monkeys and enable FDA to keep vaccines and other injectable medicinal products free of contaminating agents—especially infectious agents pathogenic for humans. Part D: Security Requirements--At project completion, while the generated data, information and recommendations are considered public property, describe your ability to provide cleared contractor personnel for the project ensuring data accuracy and integrity. Part E: Business Size—Provide your business size, ie. Small businesses (including certified 8(a), Small Disadvantaged, and HUBZone firms; veteran and service-disabled veteran-owned small businesses, and women-owned small businesses. Although anticipated NAICS code is identified in the Fedbizopps posting, all NAICS codes will be reviewed. Part F: Small Business--Describe your ability to meet the requirements in accordance with 52.219.14—Limitation on Subcontracting. Responses shall be: 1.Identified with the RFI number; and include: Company’s name, mailing address, e-mail address, telephone and fax numbers, website address (if available), and the name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives. 2.No more than ten (10) pages in length; 3.NOT submitted using the marketing materials; 4.Submitted to the email as indicated above. SUBMISSIONS ARE DUE no later than 5:00pm, on Wednesday, June 3, 2009, Eastern Standard Time. The RFI response shall be e-mailed to: Karen.petty@fda.hhs.gov. All information received in response to this notice that is marked proprietary will be handled accordingly. FDA makes no implied or in fact contracts by issuing this RFI. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the FDA’s view of the information received. Do not send any material that requires a non-disclosure agreement or identify information that is business sensitive will not be accepted. Responses to this notice will not be returned. Telephone calls/questions or inquiries will not be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-09-1058034/listing.html)
- Place of Performance
- Address: 1401 Rockville Pike, Rockville, Maryland, 20852, United States
- Zip Code: 20852
- Zip Code: 20852
- Record
- SN01828089-W 20090529/090527235234-f6f5b40e2e6a1c1f33afb513f6441e23 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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