SPECIAL NOTICE
B -- FDA Sentinel Initiative
- Notice Date
- 2/20/2009
- 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, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- HHS-FDA-RFI-09-002
- Archive Date
- 3/17/2009
- Point of Contact
- Tara R. Hobson,, Phone: 3018279691, Doreen Williams ,, Phone: 3018273366
- E-Mail Address
-
Tara.Hobson@fda.hhs.gov, doreen.williams@fda.hhs.gov
- Small Business Set-Aside
- N/A
- Description
- General Information: Document Type: Request for Information (RFI) Release Date:February 20, 2009 Response Date:March 2 at 12:00 p.m. local time via e-mail to Contracting Specialist Contracting Office Address: Food and Drug Administration, Tara Hobson, Contract Specialist Description: FDA Sentinel Initiative RFI: This is a Request for Information (RFI) and is not a Request for Proposal/Request for Quotation (RFP/RFQ) in accordance with FAR 15.201(e). This information is being sought for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Food and Drug Administration (FDA). No official solicitation exists; therefore, please do not request a copy of a solicitation. If in the future a official solicitation is released, there is no guarantee that sources responding to this RFI will be included on the source list No telephone inquiries will be accepted. Purpose: The purpose of this RFI is to identify potential sources that have the capability and qualifications to perform activities to support the planning and development of the FDA’s Sentinel Initiative. FDA is interested in evaluating and building upon models already developed by other organizations (e.g., academia, industry, other Federal agencies) in the fulfillment of this effort. FDA may consider soliciting services for a base year and four option years using an ID/IQ task order contract vehicle. RFI Submission Instructions: FDA will not award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted or FDA’s use of such information. Responses will be separated from, and have no bearing on subsequent evaluations of proposals submitted in response to any resulting formal RFP. Eligibility in participating in a future acquisition does not depend upon a response to this notice. Proprietary information is not being solicited. Information considered proprietary, if any, should be identified as such. Responses will be reviewed only by FDA personnel and will be held in a confidential manner. Background: In May 2008, the Secretary of Health and Human Services and the FDA Commissioner announced the Sentinel Initiative. The Sentinel Initiative is a long-term effort by the Agency to create a national electronic system for monitoring product safety. The Sentinel Initiative is intended to augment the Agency’s existing post-market (primarily passive) safety surveillance systems and to allow the Agency to actively gather information about the post-market safety and performance of its regulated products. As currently envisioned, the Sentinel Initiative will enable the Agency to capitalize on the capabilities of multiple, existing automated healthcare data systems (e.g. electronic health record systems, administrative claims databases, registries, or others) to augment the Agency’s current surveillance capabilities. The Sentinel Initiative will enable queries of disparate data sources quickly and securely for relevant product safety information. Data will continue to be managed by its owners, and only data of organizations who agree to participate in this system will be included. Questions would be sent to appropriate, participating data sources, who in turn would, in accordance with existing privacy and security safeguards, evaluate their data and send results for Agency review. The Sentinel Initiative is a response to various calls for this type of effort from the Agency. In September 2005, the HHS Secretary asked the Agency to expand its current system for monitoring medical product performance and to explore the possibility of working with multiple automated healthcare data systems to augment the Agency’s current capabilities of identifying and evaluating product safety information. The Secretary recommended that the Agency explore creating a public-private collaboration as a framework for such an effort, leveraging large, automated healthcare databases. In 2006, the IOM issued a report, entitled The Future of Drug Safety—Promoting and Protecting the Health of the Public. Among other suggestions, this IOM report recommended the Agency identify ways to access other health-related databases and create a public-private partnership to support safety studies. In 2007, Congress enacted the Food and Drug Administration Amendments Act of 2007 (FDAAA). Section 905 of this statute calls for the HHS Secretary to develop methods to obtain access to disparate data sources and to establish an active post-market risk identification and analysis system that links and analyzes safety data from multiple sources. The law sets a goal of access to data from 25 million patients by July 1, 2010, and 100 million patients by July 1, 2012. The law also requires the Agency to work closely with partners from public, academic, and private entities. The Agency views its Sentinel Initiative as a mechanism through which some of the requirements mandated in this legislation can be carried out. The Sentinel Initiative is a long-term effort that must proceed in stages. The initial stage of the Sentinel Initiative has allowed the Agency to further refine the requirements and develop the scope. The Agency has funded 8 contracts to support this initial stage. In addition to this ongoing contractual work, there are many ongoing activities in the public and private sector that will inform the Sentinel Initiative. The Agency has hosted a series of meetings with various stakeholder groups, to include other federal agencies; data sources and environments; academics and experts; patient, consumer, and provider groups; and IT vendors. In addition, in December 2008 a public workshop was held to discuss the Sentinel Initiative with the following objectives: •To provide an update on the current status of the Sentinel Initiative and allow for comment from all stakeholders •To discuss potential governance models and their implications •To discuss approaches to ensuring continued involvement of all stakeholders as the initiative evolves Future efforts will provide specific deliverables that would be integrated with what is learned from contractual work already ongoing to inform the Sentinel Initiative, as well as with other ongoing activities in both the public and private sectors to further understand the feasibility and utility of these data and methodologies primarily for active medical product surveillance. In addition, the FDA would seek to undertake new activities to support the Sentinel Initiative including test queries, methodology development, testing and implementation support projects, proof of concept development, and technical assistance. Examples of tasks of interest that might be awarded under this task order contract may include but not be limited to: 1)Formulate an approach for selecting marketed regulated products and specific outcomes for routine surveillance. 2)Develop, apply and/or evaluate advanced methodological approaches to safety signal detection, signal strengthening, and signal validation in automated healthcare data sources for regulated products during the postmarketing period. 3)Formulate an approach for confirmation of signals/hypotheses generated by active surveillance of automated healthcare data sources for marketed regulated products. This task may include observational studies requiring diagnosis and exposure confirmation via medical record review or other means. 4)Evaluate data model characteristics pertinent to postmarket safety analysis of automated healthcare data. 5)Identify or develop risk communication tools to facilitate responsible dissemination of findings from the queries evaluated. 6)Develop training materials and provide training to FDA staff to ensure that staff have a full understanding, proficiency and confidence in the advanced methods and models developed under a given contractor task. Responses shall be submitted addressing each part as follows: Part A. Capabilities and Technical Experience – Provide a capability statement describing the ability to perform activities to support the planning and development of the FDA’s Sentinel Initiative consistent with the example tasks described above. This statement should include, but is not limited, to information about the following topics: •The respondents’ ability to perform signal validation by accessing full-text medical records. •The range of marketed regulated products within the respondent's automated healthcare databases for which they have the ability to conduct active surveillance. •The respondents' ability to reliably identify active participation in health plans that populate their automated healthcare databases. •Whether the respondent's data sources utilize a particular data standard. •The periodicity within which new data is incorporated into the respondent's automated healthcare databases and accessible for analysis, as well as the time frame within which the respondent is able to provide results for a given query Part B. Technical and Management Approach - Provide a capability statement describing how your company would engage in performing activities to support the planning and development of the FDA’s Sentinel Initiative. Part C. Cost Estimate - Provide a cost estimate for the services (i.e. hourly rates, hours/days) and the number of hours in the performance of activities to support the planning and development of the FDA’s Sentinel Initiative. Part D. Organizational Conflict of Interest (OCI) - If any, provide disclosure of business activities of your company, your affiliates, your team members and affiliates of your team members which create either a conflict of interest or the appearance of a conflict of interest in the performance of activities to support the planning and development of the FDA’s Sentinel Initiative. Part E. Security Requirements – Describe your ability to provide cleared contractor personnel in accordance with the performance work statement security requirements. Part F. Small Business – Describe your ability to meet the requirements in accordance with 52.219.14 – Limitation on Subcontracting. Part G. Business Size- Provide your business size, i.e. small, large, disadvantage business, etc… Responses shall be: identified with the RFI Number ; no more than five (5) pages in length; not submit marketing materials; submitted to the email as indicated above. FDA makes no implied or in fact contract by issuing this RFI. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the FDA’s view of the information received. Do not send any material that requires a non-disclosure agreement or that may be business sensitive. Responses received that include a non-disclosure agreement or identify information that is business sensitive will not be accepted. Responses to this notice will not be returned.
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