SPECIAL NOTICE
99 -- NOI1198014 - JOFOC
- Notice Date
- 5/31/2018
- Notice Type
- Special Notice
- NAICS
- 813920
— Professional Organizations
- 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
- NOI1198014
- Point of Contact
- Telisha Wilson, Phone: 2404027572
- E-Mail Address
-
telisha.wilson@fda.hhs.gov
(telisha.wilson@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Toxic Software Last Modified: August 11, 2017 Page 1 of 4 SMG 2610.7 Stream-lined Acquisition Plan Template: Attachment 1 TMPLT 2017.07-022 Stream-lined Acquisition Plan Template For Actions Greater than the Micro-Purchase Threshold and Less Than or Equal to the Simplified Acquisition Threshold Completion Instructions: ACTION DESCRIPTION A. CENTER ITEM NUMBER (REQUIRED IF OVER $25K): CDER-18-C-0337 B. IDENTIFICATION OF OVERARCHING ACQUISITION STRATEGY BY NAME/NUMBER: C. REQUIREMENT TITLE/DESCRIPTION: OCP/DARS TOXIC SOFTWARE / PURCHASE OF ANNUAL TOXIC SOFTWARE LICENSE D. BASE AWARD REFERENCE NUMBER*: NA E. REQUISITION NUMBER: TBD F. PROGRAM CENTER/OFFICE: CDER/OTS/OCP/DARS G. PROGRAM POINT OF CONTACT (USUALLY THE PROSPECTIVE COR): KEITH BURKHART / ROBERT J. PARKER H. REQUIREMENT FULFILLMENT DEADLINE*: NEED BEFORE CURRENT LICENSE EXPIRES ON 5/19/18 I. PROCUREMENT CATEGORY: Commercial (See FAR Part 12) Construction/A&E IT* R&D Services Supplies/Equipment States Other (describe): J. INDEPENDENT GOVERNMENT COST ESTIMATE (IGCE), including Base Period and all Options: $60,000 I. BACKGROUND A. BRIEF DESCRIPTION OF REQUIREMENT/STATEMENT OF NEED: The ToxIC registry is a proprietary database maintained by the American College of Medical Toxicology. The ToxIC acronym refers to the Toxicology Investigator Consortium. The ToxIC registry is a nationwide repository of clinical toxicology data. The registry was established 8 years ago. A recent publication notes 47 unique sites, including two international sites, participate in the registry. The site has now grown to 90 sites. All patients in the registry have been evaluated by medical toxicologists. De-identified, Last Modified: August 11, 2017 Page 2 of 4 data obtained by medical toxicologists during bedside encounters are entered prospectively into the database. The registry has been a subcontractor on NIH funded projects to provide data, e.g. to NIDA for drug abuse case analysis. The database is unique in that unlike the Poison Center database cases have much more detailed information recorded. The database also retains the ability to link back to cases to obtain additional information should it be required. FDA access to this registry can be another data source in the analysis of safety issues. The database includes cases of drug-drug interactions. When a new drug is released to the market, the FDA could monitor for reports of overdose or adverse events. If a safety issue arises the FDA could search for cases now over the last 7 years. As the database continues to mature trend analyses will be possible. Investigators have also created sub-registries in which additional supplemental data is collected prospectively on cases. One such registry includes opioid cases. Manuscripts from this database have been used in recent DARS consultations. The American College of Medical Toxicology has expressed interest in creating a sub-registry that may be of interest to the FDA as part of a trial subscription. B. CONDITIONS: None C. CONTRACTING HISTORY: FDA has had access for the last 2 years at a cost of $50,000 per year (previous contract 05/09/2017-05/08/2018 HHSF223201710104P0 D. PERFORMANCE PERIOD: Twelve month beginning 5/09/2018 thru 5/08/2019 following expiration of existing license under HHSF223201710104P on 5/09/2018 E. DELIVERY/PERFORMANCE REQUIREMENTS: Not applicable F. SHIPMENT/DESTINATION: None. II. PLAN OF ACTION A. MARKET RESEARCH RESULTS/INTERESTED SOURCES: The American College of Medical Toxicology is the holder of this unique database. B. SMALL BUSINESS: None Last Modified: August 11, 2017 Page 3 of 4 (1) Contract type. Select all that apply. Performance-Based X Fixed-Price Cost-Plus-Fixed-Fee Cost-Reimbursement Labor Hour Time-and-Materials Other (describe): [Description.] C. COMPETITION: (See FAR 7.105(b)(2) and 6.302): Select all that apply. Brand Name or Equal Direct 8(a) Brand Name* Full-and-Open Competitive Small Business Set-Aside, Explain: [Description.] X Other/Sole Source*, Explain: [Description.] ACMT is the only provider for access to this registry D. BASIS FOR EVALUATION: E. CONTRACTING CONSIDERATIONS OR INCENTIVES: NA F. GOVERNMENT-FURNISHED PROPERTY (GFP)/INFORMATION (GFI):NA G. ACCEPTANCE/SURVEILLANCE: DARS and other CDER offices will evaluate. H. UNIQUE CONSIDERATIONS: 1. Severability & Funding Determination Last Modified: August 11, 2017 Page 4 of 4 III. PROGRAM REVIEW AND APPROVAL Robert J. Parker -S Digitally signed by Robert J. Parker -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=1300062894, cn=Robert J. Parker -S 1/25/2018 Date: 2018.01.25 14:58:23 -05'00' Robert J. Parker, COR Date CDER/OTS/OCP/DARS
- Web Link
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- Record
- SN04939154-W 20180602/180531231213-91d213b808dcb745bcdf259fd7c03390 (fbodaily.com)
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