SPECIAL NOTICE
B -- RFI - Availability of National Level Poisoning Data in the US
- Notice Date
- 3/31/2009
- 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, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- RFI-FDA-1055754
- Archive Date
- 4/22/2009
- Point of Contact
- Patricia Wright,,
- E-Mail Address
-
patricia.wright@fda.hhs.gov
- Small Business Set-Aside
- N/A
- Description
- This Request for Information is issued solely for information and planning purposes only. It does not constitute a solicitation (Request for Proposal (RFP) or Request for Quotations (RFQ)) or a promise to issue a solicitation in the future. This RFI does not commit the Government to contract for any supply or service whatsoever. Furthermore, we are not at this time seeking proposals and will not accept unsolicited proposals. Responses to this notice are not offers and cannot be accepted by the U.S. Government to form a binding contract or agreement. The Government will not pay for any information or administrative costs incurred in a response to this RFI. All costs associated with responding to this RFI will be solely at the responding party’s expense. All information received in response to this RFI that is marked proprietary will be handled accordingly. The Government shall not be liable for or suffer any consequential damages for any proprietary information not properly identified. Proprietary information will be safeguarded in accordance with the applicable Government regulations. Proprietary information or trade secrets should be clearly identified. Project Title: Availability of National Level Poisoning Data in the United States for the Identification and Understanding of Adverse Drug Reactions, and Medication Errors Associated with Therapeutic Products Background A vital part of FDA and CDER’s mission is to protect the public health. The Office of Surveillance and Epidemiology (OSE) contributes to this effort by evaluating the safety of marketed drugs and biologic products and promoting their safe use by the American people. Two major reports, the Institute of Medicine’s (IOM) Future of Drug Safety and the GAO report Improvement needed in FDA’s Decision Making Oversight Process have emphasized the need for more tools, resources, staff and authority to the FDA to improve drug safety. In response to these reports, FDA has devoted greater resources to the area of post marketing safety and has expanded the roles and responsibilities of OSE within CDER. The passage of the Food and Drug Administration Amendments Act of 2007 (FDAAA, September 27, 2007)) has greatly increased the responsibilities of FDA, provided FDA with new authorities, and reauthorized several FDA critical programs. The act, primarily Title IX, also provides FDA with additional requirements, authorities, and resources with regard to both pre- and postmarket drug safety. The statute contains important new authorities to require postmarket studies and clinical trials, safety labeling changes, and Risk Evaluation and Mitigation Strategies (REMS). The act requires increased activities for active post market risk identification and analysis particularly those related to tools and methods for data access and analysis. FDA currently has several tools and data resources available to address post marketing safety issues. These include a passive surveillance system for medication errors and adverse events related to drug therapy; several drug utilization databases; and access to automated healthcare data of various types for pharmacoepidemiology studies. Passive reporting systems are limited by underreporting, attribution problems, reporting biases, and a lack of denominator information. To strengthen and complement these resources, FDA is soliciting responses from national organizations which collect and expeditiously provide national level data on human poisonings associated with drug products in the United States. In the past the FDA has used published national level data on poisonings available in the public domain to help assess the safety of drugs in the postmarketing phase of their lifecycle. The FDA has used these data in a number of reviews and/or presented these data at important public advisory committee meetings which included discussions of 1) the public health importance of acetaminophen-related poisonings, 2) over-the-counter cough and cold product-related poisonings in children less than 6 years of age, and 3) propoxyphene-related poisonings. However, the published reports of national level data on poisonings that are available in the public domain have limited or no information that permits comprehensive root cause analyses; additionally, they cannot be customized to preferred age categories. Purpose The purpose of this RFI is to identify an organization(s) which collects and has direct access to national level data on poisonings. Such data have the potential to provide the Agency with more complete information about poisonings and overdoses and provide the context required to best analyze poisoning and overdose-associated variables including adverse drug reactions, medication errors, major clinical effects, and outcomes, including deaths, associated with commonly used therapeutic products. FDA must have timely access to detailed national level data to enable root cause analyses of poisonings and overdose cases. Through this RFI, FDA is seeking responses to the Research Criteria (below) to determine the feasibility and utility of obtaining poisoning/overdose data from a national resource. Description of Services In general, FDA is interested in: 1) National level data systems with data on human poisonings associated with drug products that can provide the following desirable minimum data elements: a) Gender and customized age ranges such as 0-5 years; 6-11 years; 12-17; 18-64, >65. b) geographic region c) generic and trade name of products involved d) availability of multiple years of data e) adverse outcomes including deaths 2) National level systems or data resources that have the capability to provide information on the following safety areas such as, a) abuse or misuse of prescription and over-the counter drugs that have serious public health consequences b) drug-related medication errors c) drug-related deaths and major clinical effects and outcomes 3) National level systems or data resources that have direct access to the detailed data themselves and the capability to provide specified customized reports to FDA. Research Criteria In general, FDA is interested in organizations that have direct access to multiple years of national level data on human poisonings/overdoses/medication errors and associated outcomes and have the capability to provide the following: 1) Provide abstract record information about cases of poisonings/overdoses with certain drugs that resulted in deaths. 2) Provide the reasons for exposures (unintentional or intentional) for specified drugs that resulted in a major adverse effect with description of the effect. 3) Provide an analysis of medication errors involving specified drugs with reasons for administration and errors and details about any adverse outcomes. 4) Provide information on specific proprietary names (brand) of prescription or over-the-counter medications in which the wrong medication was administered and the root cause of such errors. Interested organizations are invited to submit a description of their capabilities for providing this type of information. Submitted information shall include a discussion addressing research criteria, described in a concise review of drug-related and medication error related poisoning systems. Cost Estimates All submissions shall contain cost estimates for FDA to obtain customized data reports on unintentional/intentional poisoning or medication errors. Responses Responses are preferred in electronic format (word or PDF). Responses shall provide their business size status (large, small business, 8(a), HUBZone, Small Disabled Veteran owned Business, Women-owned Small Business, etc.) The information above shall also include the following: Submitter’s Name Street Address, City, State, Zip code Point of Contact (POC), POC Telephone and facsimile numbers North American Industry Classification System (NAICS) Code All information submitted to the FDA will be kept confidential as allowed by relevant federal law. All information submitted will be reviewed; however, FDA will not acknowledge or respond to any submissions. Information must be submitted not later than 4:30 PM Eastern Standard time on April 7, 2009 and e-mailed to the attention of Patricia Wright, Contract Specialist at patricia.wright@fda.hhs.gov. Telephone calls will not be accepted.
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