SOURCES SOUGHT
B -- Cryopreservation Services - Sources Sought Notification
- Notice Date
- 4/27/2017
- Notice Type
- Sources Sought
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Rockville, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001, United States
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA_17-223-SOL-1182347
- Archive Date
- 5/23/2017
- Point of Contact
- Yolanda T. Peer, Phone: 8705437479
- E-Mail Address
-
yolanda.peer@fda.hhs.gov
(yolanda.peer@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Sources Sought Notification for Cryopreservation Services THIS IS A SOURCES SOUGHT ANNOUNCEMENT, A MARKET SURVEY FOR WRITTEN INFORMATION ONLY. THIS IS NOT A SOLICITATION ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL BE MADE FOR ANY COSTS ASSOCIATED WITH PROVIDING INFORMATION IN RESPONSE TO THIS ANNOUNCEMENT OR ANY FOLLOW-UP INFORMATION REQUESTS. NO TELEPHONE CALLS WILL BE ACCEPTED REQUESTING AN RFQ PACKAGE OR SOLICITATION. THERE IS NO RFQ PACKAGE OR SOLICITATION. IN ORDER TO PROTECT THE PROCUREMENT INTEGRITY OF ANY FUTURE PROCUREMENT, IF ANY, THAT MAY ARISE FROM THIS ANNOUNCEMENT, INFORMATION REGARDING THE TECHNICAL POINT OF CONTACT WILL NOT BE GIVEN AND NO APPOINTMENTS FOR PRESENTATIONS WILL BE MADE. The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) has issued this sources sought announcement on behalf of the Center for Biologics Evaluation and Research (CBER)/Center for Drug Evaluation and Research (CDER) and the Center for Device and Radiological Health (CDRH) in order to determine if there are existing small business sources capable of providing a Blanket Purchase Agreement's (BPA's) for Cryopreservation Services with a four (4) year ordering period. If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 541380 - Testing Laboratories; with a Small Business Size Standard of $15 Million, and believe that your firm would be able to provide the FDA with the services described below, please submit an email to Yolanda.peer@fda.hhs.gov. The vendor should include information about the company and demonstrate that it can meet all of the minimum performance requirements. Background: The Food and Drug Administration (FDA)/Center for Biologics Evaluation and Research (CBER)/Center for Drug Evaluation and Research (CDER) and the Center for Device and Radiological Health (CDRH) intends to acquire a BPA for Cryopreservation Services for the Principal Investigators (PIs) from the following agencies: FDA/CBER/CDER and CDRH Minimum Requirements for the Cryopreservation Services with a base year and three (3) 1-year Option periods: TASKS •FDA PIs require various animal-related services that include services listed below: •Shall provide cryopreservation of embryos or sperm from genetically-modified mice. •FDA will provide 5-10 male and 5-20 female homozygous mice, between 3 -12 weeks old and up to 6 months old for production of embryos. Alternatively, when the line can be maintained in a heterozygous state and/or has only a single mutation, the genotype of certain background strains may be preserved by freezing sperm. For this procedure, FDA will provide three males of the appropriate genotype between 12 weeks and 6 months old. For embryos, the vendor shall: •Superovulate and breed the mice, collect embryos, and cryopreserve embryos. A minimum of 100 and a maximum of 300 embryos will be cryopreserved. •Perform quality control check of reconstituted embryos and inform FDA of the outcome. •Store frozen embryos securely in a manner that allows their identity to be known and not mixed up with other stored embryos. •Be prepared to thaw embryos and implant into pathogen-free surrogate mothers and return weaned mice to FDA (minimum 6 females, 4 males). For sperm cryopreservation, the vendor shall provide the following services on the issuance of a Task Order: •Shall collect sperm and freeze scientific straws plus additional straws for quality assurance. •Shall perform quality assurance of pre- & post thawed sperm and inform FDA of the outcome. •Shall store frozen sperm in a manner that preserves their identity and prevents mix-ups with other stored materials. •Shall be prepared to perform artificial insemination or in vitro fertilization (IVF) using the thawed sperm to effectively reconstitute the heterozygous line in pathogen-free mice of the appropriate background strain. Additional animal-related services that may be requested: •Shall provide storage of cryopreserved embryo/sperm in a manner that preserves their identity and prevents mix-ups with other stored materials. FDA has several previously frozen lines of embryos that will require transfer and prolonged storage. •Shall produce customized transgenic mice by pronuclear microinjection of fertilized mouse eggs •Shall provide the creation of new engineered mouse models using CRISPR/Cas9 technology •Shall provide embryonic stem cell microinjection •Shall provide dual site cryo storage •Shall provide transportation services to include all materials for shipping live animals, cryopreserved sperm and embryos to/from FDA, and cryopreservation transfer of existing mouse lines stored off-site. PERIOD OF PERFORMANCE: The anticipated period of performance for this BPA is for a four (4) year ordering period. Base Year Ordering Period: 06/19/2017 - 06/18/2018 Year 1 Ordering Period: 06/19/2018 thru 06/18/2019 Year 2 Ordering Period: 06/19/2019 thru 06/18/2020 Year 3 Ordering Period: 06/19/2020 thru 06/18/2021 Place of Delivery: Food and Drug Administration Center for Biologics Evaluation and Research 10903 New Hampshire Avenue, Bldg 71 Silver Spring, MD 20993 FOB Point Destination. All items shall include shipping, handling and in-side delivery to the destination identified herein. FOB Point of Delivery for Services and Supplies will be the FDA located at Center for Biologics Evaluation and Research, 10903 New Hampshire Avenue, Bldg 71, Silver Spring, MD 20993. The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services and components meet the technical requirements identified above. Though the target audience is small business all interested parties may respond. At a minimum, responses shall include the following: • Business name and bio, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address. Provide this same information again if responding to provide a product and service offered by another firm. • Past Performance information for the cryopreservation of embryo and sperm, reconstitution of embryo/sperm and the storage and maintenance of the cryopreserved material of same or substantially similar product and service to include date of sale, description, dollar value, client name, client address, client contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include DUNS number and size status) if not the respondent. • Descriptive literature, brochures, marketing material, etc. detailing the nature of the product and service for the Government to conclusively determine that the offered products/services and components meet the technical requirements identified above. • Though this is not a request for quote, informational pricing is required. • If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement are also requested. If a large business, provide if subcontracting opportunities exist for small business concerns. The Government is not responsible for locating or securing any information, not identified in the response. Interested Contractors must respond with capability statements which are due in person, by postal mail or email to the point of contact listed below on or before May 8, 2017 by 13:00 hours (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, Field Operations Branch, FDA|OO|OFBA|OAGS|DAP, Attn: Yolanda Peer, 3900 NCTR Road, HFT‐320, Bldg. 50, Rm 420 Jefferson, AR 72079‐9502 or email yolanda.peer@fda.hhs.gov. Reference: FDA_17-223-SOL-1182347. Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre‐solicitation synopsis and solicitation may be published in FedBizOpps. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non‐proprietary technical information in any resultant solicitation(s). Additional Notes: If the stated requirements appear restrictive, please submit comments detailing the concern. Responses to this sources sought announcement will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA_17-223-SOL-1182347/listing.html)
- Place of Performance
- Address: Food and Drug Administration, Center for Biologics Evaluation and Research, 10903 New Hampshire Avenue, Bldg 71, Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN04488431-W 20170429/170427235309-f8ce754f002d41d92a4d7c8c54db6c3c (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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