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FBO DAILY - FEDBIZOPPS ISSUE OF JANUARY 24, 2016 FBO #5175
SPECIAL NOTICE

R -- FDA/CBER Ve dor Fair - Special Notice

Notice Date

1/22/2016
 

Notice Type

Special Notice
 

NAICS

541990 — All Other Professional, Scientific, and Technical Services
 

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-16-223-1161487
 

Archive Date

3/5/2016
 

Point of Contact

Monica (Burts) Young, Ph.D., Phone: 240-402-6735
 

E-Mail Address

monica.burts@fda.hhs.gov
(monica.burts@fda.hhs.gov)
 

Small Business Set-Aside

N/A
 

Description

SPECIAL NOTICE is issued solely to survey the market and does not constitute a SUBJECT: The Food and Drug Administration's Center for Biologics Evaluation and Research (FDA/CBER) relocated to the FDA Headquarters in Silver Spring, MD in 2014. Previously, the research labs were located at the National Institutes of Health and Nicolson Lane Research Center. Since relocating, the researcher and regulatory lab staff no longer has access to the annual scientific Vendor Fairs at NIH and therefore, the Center would like to sponsor a Scientific Vendor Fair that would be open to all FDA Centers. The purpose of the scientific Vendor Fair is to ensure that FDA researchers and regulatory scientists are aware of the latest and most cutting edge equipment and products that will allow CBER to continue to carry out cutting edge science to meet the regulatory mission of FDA. CBER scientists will take the information it obtains from the Vendor Fair into account as it determines what types of equipment, reagents, services and supplies that should be a part of the CBER laboratory infrastructure in the future. DISCLAIMER : This SPECIAL NOTICE is issued solely to survey the market and does not constitute a solicitation. Neither unsolicited proposals nor any other kind of offers will be considered in response to this NOTICE. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. Respondents are solely responsible for all expenses associated with responding to this NOTICE. All information received in response to this NOTICE marked as "proprietary" will be handled accordingly. Information provided as a response to the NOTICE will not be returned. FDA/CBER will not entertain any questions concerning the composition, requirements, or the nature of services to be performed under any future request for proposal (RFP). BACKGROUND : CBER/FDA wants to maintain cutting edge research and regulatory laboratories with the latest equipment, reagents, services and supplies relevant to Biologics. It is envisioned that such would provide FDA/CBER with an infrastructure that includes centrally managed, end user mobile devices, enterprise licensing agreements (ELAs), enterprise service desks (ESDs), servers and other hardware. Desired key attributes of the toolset that the FDA envisions include: 1. Scientifically proven processes, procedures, and technologies for general laboratory applications. 2. Proven processes, procedures, and technologies to ensure data processing, categorization, and dissection. 3. Scientifically proven processes, procedures, and technologies to ensure security of intellectual property. 4. Scientifically proven processes, procedures, and technologies to optimize laboratory and capacity utilization. 5. Scientifically proven processes, procedures, and technologies to optimize product test methodology. 6. Scientifically proven processes, procedures, and technologies to optimize pathogen detection. 7. Proven processes, procedures, and technologies facilitate adverse event reporting. 8. Scientifically proven processes, procedures, and technologies to identify short-term biomarkers of long-term harm (e.g., proteomics, metabolomics). 9. Scientifically proven processes, procedures, and technologies to measure Communication of Health Effects. FDA/CBER seeks information about academic, prototype, developmental, and domestic commercially available products that meet or can be readily modified to meet the requirements discussed above. SUBMISSION INSTRUCTIONS : Responses are due to this SPECIAL NOTICE by 12:00 PM on February 19,2016. Space is limited to 80 vendors. Note that of the 80 spaces, 20 spaces will be reserved for Small Businesses to respond with the information requested below. Vendors are allowed no more than two (2) representatives total for an entire company and FDA reserves the right to reduce that number to one (1) in order to mitigate overcrowding. Individual divisions or groups of a single company are considered a single parent company. It is strongly recommended that at least one (1) of the participants be from one of the vendor's technical division(s). FDA envisions that the Vendor Fair will provide the opportunity for parties in the field to network and potentially make teaming/subcontracting arrangements. Vendors selected will be notified no later than February 29, 2016. The Vendor Fair will be held in Silver Spring, Maryland on April 20 & 21, 2016, 9:00am-2:00pm. Note: Vendors can only attend one of the two days to allow more Vendors to participate in the Vendor Fair. Date, times and specific location of the meeting are to be determined and will be communicated via email and/or telephone call to those selected. Vendors interested in attending the Vendor Fair shall furnish a capability statement to FDA/CBER. The capability statement shall summarize the organization's products/technologies/capabilities with respect to items 1-9 (above). The capability statement shall also describe work or solutions that your organization has successfully completed or implemented that are similar in nature to FDA/CBER's goal to stay up-to-date on the currently available equipment, reagents and supplies relevant to biologics research. Submissions are limited to 2 pages in length. Vendors are strongly encouraged to provide tailored information, not general marketing information. If a vendor's products or services are available through existing purchasing vehicles (e.g. GSA schedule/GWACS), the capability statement shall list these vehicles. If a vendor is a Small Business, this should be indicated in the capability statement. Response to this SPECIAL NOTICE must be submitted to FDA/CBER Office of the Director VIA EMAIL to Monica Young (monica.burts@fda.hhs.gov). Responses must be received by this office on or before 12:00 PM on February 19, 2016. This NOTICE is strictly for market survey purposes only and is not a commercial solicitation. The Government will not pay for any information submitted, or for any costs associated with providing the information. Please include a point of contact, phone number, e-mail address, website information, and indicate whether the company is a foreign or domestic entity in the contents of the e-mail. LATE SUBMISSIONS : Responses to the SPECIAL NOTICE received by FDA after the submittal deadline and time indicated may be considered if openings for the Vendor Fair remain. OWNERSHIP OF RESPONSE TO THE SPECIAL NOTICE : All informational material submitted in response to this request become property of FDA. RELEASE OF CLAIMS, LIABILITY, AND PREPARATION EXPENSES : Under no circumstances shall FDA be responsible for any response preparation expenses, submission costs, or any other expenses, costs, or damages, of whatever nature incurred as a result of the Respondent's participation in this market research process. Respondent understands and agrees that it submits its response at its own risk and expense, and releases FDA from any claim for damages or other liability arising out of this SPECIAL NOTICE. ERRORS IN RESPONSE : FDA shall not be liable for any errors in the Respondent's response. Respondent is responsible for careful review of its entire response to ensure that all information is correct and complete. Respondents are liable for all errors or omissions contained in their responses. ADDENDUM : FDA reserves the right to issue an addendum to this SPECIAL NOTICE at any time for any reason. CONTACT INFORMATION : Monica (Burts) Young monica.burts@fda.hhs.gov
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-16-223-1161487/listing.html)
 

Place of Performance

Address: 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001, United States

Zip Code: 20857-0001
 

Record

SN03998759-W 20160124/160122233909-88f02704ee81e4568f77c02bbbf2f4d4 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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