SPECIAL NOTICE
D -- Operations, Maintenance and Enhancements of the DataFit Data Validation Tool - Notice of Intent
- Notice Date
- 4/3/2015
- Notice Type
- Special Notice
- NAICS
- 518210
— Data Processing, Hosting, and Related Services
- 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-SSS-FY15-1145136
- Archive Date
- 5/5/2015
- Point of Contact
- Steven Chang, Phone: 240-402-7527
- E-Mail Address
-
Tzeleong.Chang@fda.hhs.gov
(Tzeleong.Chang@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- Notice of Intent The Food and Drug Administration (FDA) hereby issues a notice of intent in accordance with FAR 5.201. Pursuant to FAR 6.302-1, the FDA will sole source with Pinnacle 21, LLC., 531 Playmouth Rd, Ste 508, Plymouth, PA 19462-1642 for the operations, maintenance and enhancement of the DataFit program, FDA's data validation system. Pinnacle 21 is the only contractor able to meet the requirement of this procurement. The FDA intends to award a five (5) year Indefinite Delivery, Indefinite Quantity (IDIQ) contract to Pinnacle 21 for the Open CDISC Enterprise software license and operations, maintenance and enhancement of the DataFit program. Pinnacle 21 is the sole owner, seller and developer of the Open CDISC Enterprise software that performs the data validation for the DataFit program. DataFit validation of electronic clinical and non-clinical study submission data is a mission critical component of the FDA's JUMPSTART service. DataFit is the FDA platform for standards compliance and data-quality evaluation of electronic submission data. The DataFit custom installation version of Open CDISC Enterprise is the only system currently capable of meeting FDA's data fitness assessment needs. Pinnacle 21 is a CDISC technology partner which enables them to provide validation updates in sync with the CDISC standards. The NAICS code is 518210, Data Processing, Hosting, and Related Services. This notice is not a request for competitive quotes or proposal. No solicitation document is available and telephone requests will not be accepted. Respondents may submit information pertaining to their capabilities to perform the services required above within a timely manner to Steven Chang at Tzeleong.chang@ fda.hhs.gov, which may be considered by the agency. A determination to compete this procurement from the responses received shall be based upon the discretion of the Government. It is anticipated that an award will be issued the Pinnacle 21, LLC. approximately fifteen (15) days after the date of this notice unless, the Government determines another vendor has the capabilities of meeting this requirement. All responses to this notice of intent shall be received no later than noon Eastern Time (ET) on April 20, 2015 via email to Steven Chang at Tzeleong.chang@ fda.hhs.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SSS-FY15-1145136/listing.html)
- Place of Performance
- Address: 531 Playmouth Rd, Ste 508, Plymouth, Pennsylvania, 19462-1642, United States
- Zip Code: 19462-1642
- Zip Code: 19462-1642
- Record
- SN03688811-W 20150405/150403234408-8c4425a0859e0bed29023892f577a004 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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