SOLICITATION NOTICE
B -- Validated scalable process
- Notice Date
- 7/15/2016
- Notice Type
- Presolicitation
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- Department of Health and Human Services, Centers for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, Georgia, 30341-4146
- ZIP Code
- 30341-4146
- Solicitation Number
- 2016-99759
- Archive Date
- 8/16/2016
- Point of Contact
- Maria S Shamburger,
- E-Mail Address
-
HEG9@cdc.gov
(HEG9@cdc.gov)
- Small Business Set-Aside
- N/A
- Description
- The Centers for Disease Control and Prevention, NCIRD/DVD/GR, 1600 Clifton Rd. NE, Atlanta, GA, 30333, hereby announces its intent to issue a sole source contract in accordance with FAR 6.302-1 to Meridian Life Science, Inc., 5171 Wilfong Road, Memphis, TN 38134 to develop a validated scalable process for the inactivation of rotavirus vaccine for testing in clinical trials. The statutory authority permitting other than full and open competition is 41 U.S.C. 253(c)(1) as cited in FAR 6.302-1, "Only one responsible source and no other supplies or services will satisfy agency requirements." Building off data on completed CDC SBIR work on IRV upstream and downstream processes this requirement is for a follow-on contract to complete rotavirus inactivation and establish an entire manufacturing process for inactivated rotavirus vaccine. Meridian Life Science is the only contract manufacturing organization in the US that has experience and expertise with manufacturing rotavirus vaccine pilot lots for testing in humans in accordance with strict regulatory guidelines. Meridian Life Science has made great progress in the establishment of upstream and downstream process, the need exists for a completed scalable process for the inactivation of CDC's human rotavirus vaccine strain. This is a critical step for the preparation of IRV pilot lots for pre-clinical toxicology testing in animals and clinical trials in humans. A follow-on contract with Meridian Life Science will allow for completion of the entire manufacturing process for this IRV. Given this is an ongoing project, we know of no other vendors or products that will be able to meet our needs in a timely and cost effective manner without duplication of cost or unacceptable delays. Responsible sources that believe they possess the expertise and capabilities identified above are encouraged to submit to the Contracting Officer within 15 days from the posting date of this notice, their written capabilities statement, proposal or quotation which shall be considered by the agency. Please forward the capability statement and/or pricing information to Maria Shamburger, Contracting Officer, Reference 2016-99759, Centers for Disease Control, Procurement and Grants Office, ATTN: Maria Shamburger, MS: K14, 2920 Brandywine Road, Atlanta, GA 30341. All vendors must be registered in the System for Award Management (SAM) prior to an award of a federal contract. The website is: www.sam.gov. The Government will review any/all capabilities statements and pricing information submitted and determine if other qualified sources do exist that could provide this requirement. Information received in response to this announcement will be used solely for the purpose of determining whether to conduct a competitive procurement. If no affirmative responses are received within 15 days, negotiations will be conducted with the Meridian Life Science as the only source and a contract will be issued without any additional notices being posted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/CDCP/PGOA/2016-99759/listing.html)
- Place of Performance
- Address: 1600 Clifton Road, Bldg 18, 7th Floor-Room7-107, Atlanta, Georgia, 30333, United States
- Zip Code: 30333
- Zip Code: 30333
- Record
- SN04184807-W 20160717/160715234759-b94d38359b5b00e9cf57f60a4a746efc (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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