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FDA Epi-INFORM Scientific Program


Maryland, United States
Government : Federal
RFI
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Request for Information (RFI)

Purpose

This Request for Information (RFI) is being issued by the Food and Drug Administration (FDA) in accordance with Federal Acquisition Regulation Part 10, Market Research. It is for information, planning and market research purposes only and shall not be construed as either a solicitation or obligation on the part of the FDA or its Centers. The purpose of this RFI is to help the FDA understand industry best practices and the technical solutions capable of fulfilling FDA's requirements as described in this RFI. FDA will use this market research information to assess the market's capability to successfully provide FDA with a complete decision support solution.


FDA welcomes responses from all interested parties. THERE IS NO SOLICITATION AT THIS TIME. This request for sources and vendor information does not constitute a request for proposal; submission of any information in response to this market survey is purely voluntary; the Government assumes no financial responsibility for any costs incurred. Acknowledgment of receipt of responses will not be made, nor will respondents be notified of the outcome of the FDA's review of the information received. Additionally, the FDA does not intend to hold discussions concerning this RFI with any interested parties. However, FDA reserves the right to contact vendors if additional information is required.


Responses to this notice are not offers and cannot be accepted by the Federal Government to form a binding contract. Information obtained because of this notice may be used by the FDA for program planning on a non-attribution basis. Eligibility in participating in a future acquisition does not depend upon a response to this notice. Responses will be reviewed only by FDA personnel and will be held in a confidential manner. Requests for a solicitation will not receive a response.


The Request for Information (RFI) process will consist of a fourteen (14) day information response phase. The applicable North American Industry Classification System (NAICS) code assigned to this is 518210 - Data Processing, Hosting, and Related Services (Small Business Size Standard - $32.5) employees).



Background

A vital part of the U.S. Food and Drug Administration (FDA) mission is to protect and advance the public's health. The FDA Center for Drug Evaluation and Research (CDER) Office of Surveillance and Epidemiology (OSE) contributes to this effort by promoting the safe use of FDA-regulated drug products by the American people and evaluating post market drug safety and effectiveness in the real-world setting. FDA is authorized by the FDA Amendments Act (FDAAA 2007), PDUFA V and the FDA Safety and Innovations Act (FDASIA, 2012) to develop collaborations with multiple public and private entities to obtain and expand database resources for providing advanced analytics of drug safety data, gaining access to outside expertise, and enhancing the ability of the FDA to make timely assessments of drug safety data.

In the 21st Century Cures Act, Congress mandated that the FDA develop a framework to evaluate the potential use of Real-World Evidence (RWE) to support regulatory decision making for new indications of approved drugs or to satisfy post-marketing study requirements. In accordance with the Cures Act, the FDA is expanding the use of Real World Data (RWD) and advanced computing technologies to better understand how RWE can support drug safety oversight, evaluation of comparative effectiveness, and regulation.

As part of the FDA Epi-INFORM scientific program, there are continuing efforts to build the capacity for using and developing advanced, innovative approaches (e.g., artificial intelligence/ machine learning approaches and natural language processing) for optimizing evidence generation when utilizing RWD for drug safety and effectiveness efforts. This requirement seeks to identify and develop new methods or approaches to address complex drug safety and effectiveness issues using a variety of data sources including electronic health records (EHR), medical claims, product and disease registries, and other forms of RWD (e.g., laboratory test results, informatics knowledgebase(s), social media, consumer mobile applications and devices). Work performed under the Epi-INFORM Program is intended to expand and complement FDA's safety and effectiveness work and provide insights into the disciplines of pharmacovigilance, pharmacoepidemiology, effectiveness of risk management programs and communications, and the nature, prevalence and contributing factors of medication errors. These are areas where collaborative research can benefit FDA in meeting its public health mission and to better address the 21st Century Cures Act pertaining to utilization of RWD.

Anticipated Task Areas:

The RFI is to also broaden FDA's understanding of the market's capability to conduct drug safety and effectiveness studies to address unique and complex issues of importance to the FDA for products regulated by CDER, using RWD and advanced, innovative approaches. This anticipated requirement seeks to align the program to meet FDA's RWE efforts and emerging challenges over the next five years. To this end, the anticipated program task areas include:


1. Coordinating Center: Provide the resources and support to establish and maintain a coordinating center, enable access to diverse U.S. healthcare and informatics data resources for addressing emergent drug safety issues. In addition, provide rapid assess to qualitative information from physicians, pharmacists, and/or patients for less than 10 individuals per setting or population.


2. Methods Development: Develop new capabilities and build additional capacity for using advanced, innovative approaches (e.g., artificial intelligence/ machine learning approaches and natural language processing).


3. Unique and Complex Drug Safety and Effectiveness Studies: Identify and use large data source(s) to conduct drug safety and effectiveness studies that address unique and challenging issues of importance to the FDA for drug products regulated by CDER.


We anticipate that the contractor will provide an executive-level administrative and scientific-based Coordinating Center that will oversee all aspects of operations for the FDA scientific program entitled, "Epi-INFORM". The key activities are to coordinate with a variety of healthcare and informatics resources and organizations to conduct methodological and challenging drug safety and effectiveness studies as follows:
• Establish Organization and Infrastructure
• Obtain Access to Data Resources for Specific Projects (as needed)
• Program and Task Order Management
• Methods Development
• Unique and Complex Drug Safety and Effectiveness Studies
• Establish Drug Safety and Effectiveness Procedures
• Drug Product-Specific Data Resource Requirements


RFI Submission Instructions:

Interested organizations responding to this RFI are encouraged to structure capability statements in the order of the area of consideration noted above. All capability statements sent in response to this notice must be submitted electronically, via e-mail, to Richard Robinson at richard.robinson@fda.hhs.gov AND Matthew Bucher at matthew.bucher@fda.hhs.gov, either MS Word or Adobe Portable Document Format (PDF), no later than 2:00 pm on April 5, 2019. Responses shall be no more than 10 pages in length.

A complete response to the RFI should include answers to all of the questions below. Please note that a respondent's failure to provide a complete response to a question will be interpreted to mean that it does not understand the question and does not demonstrate the capability to provide services required. Responses should demonstrate capability, not merely affirm the respondent's capability (e.g.: The response must go beyond the statement that, "XYZ company can provide the task areas."). Do not send information that requires a non-disclosure agreement or sensitive business information. Telephone inquiries will not be accepted or acknowledged, and no feedback will be provided to companies regarding their submissions.

Questions:

1. Data Resources:


Does your organization have access or have the capability to obtain access to longitudinal administrative claims/Electronic Health Records (EHR) data which contain a minimum of 2 million currently enrolled patients or covered lives in the U.S. as of July 1, 2018, in at least one data resource that is not based on data that is transformed into a common data model? Does your organization have linked US electronic claims and EHR data? If yes, explain.

2. Medical Records Retrieval


Has your organization participated in peer-reviewed publications or final study reports (post-HIPAA) that illustrate the capability to access and retrieve complete, integrated medical records and charts, as required for completion and validation of studies? If yes, explain.

3. Diverse Healthcare Expertise


Does your organization have the capability to outreach and collaborate with a diverse mix of healthcare expertise (epidemiology, medicine, statistics and simulation expertise, data science, medical informatics, coordinating center/institution operations)? If yes, explain.

4. Notice to Small Businesses:
One purpose of this RFI/Sources Sought Notice is to seek declarations of technical capabilities and various information, data, and materials from qualified small business concerns [including 8A Businesses, Small Disadvantaged Businesses (SDB), Woman-owned Small Businesses (WOSB), Historically Underutilized Business Zone (HUBZone), Small Businesses, Veteran-Owned Small Businesses (VOSB), and Service-Disabled Veteran-owned Small Businesses (SDVOSB)]. FDA intends to provide maximum practicable opportunities in its acquisitions to small business, veteran-owned small business, service-disabled veteran-owned small business, HUBZone small business, and small disadvantaged business.


If you are a qualified small business concern, in addition to the above questions, please provide a capability statement and describe your potential role in providing these services.


5. Please provide the following information about your business:
a. Organization name
b. DUNS number
c. Organization's website
d. Contact Name
e. Contact Telephone
f. Contact E-mail address
g. Size designation
h. Number of employees in your organization
i. Your organization's current and past gross revenue
j. Type of company under NAICS, as validated via the System for Award Management (SAM). Additional information on NAICS codes can be found at www.sba.gov. Any potential government contract must be registered on the SAM located at http://www.sam.gov/index.asp.
k. Corporate structure (corporation, LLC, sole proprietorship, partnership, limited liability partnership, professional corporation, etc.)
l. Pricing information (i.e. labor categories and rates) in accordance with FAR Part 10 or a copy of your commercial price catalog as market research.


6. Provide information concerning contract vehicles available to be used by the FDA in acquiring the products and services outlined in the task areas (GSA Federal Schedules, Government-wide Acquisition Contract, etc.).


 


Richard Robinson, Lead Contract Specialist, Phone 3017966508, Email richard.robinson@fda.hhs.gov - Matthew Bucher, Contracting Officer, Phone 240-402-7570, Email Matthew.Bucher@fda.hhs.gov

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