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Biologics Effectiveness and Safety (BEST) Initiative


Arkansas, United States
Government : Federal
RFP
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MARKET RESEARCH PURPOSES ONLY
NOT A REQUEST FOR PROPOSAL OR SOLICITATION

The U.S. Food and Drug Administration (FDA), is conducting market research to support the Center for Biologics Evaluation and Research (CBER) requirement for their Biologics Effectiveness and Safety (BEST) Initiative.


The FDA is seeking sources to determine the availability and capability of businesses capable of providing the required services. All business sources are encouraged to submit capability statements including small business concerns. The following information is provided to assist the FDA in conducting Market Research to identify potential sources for this effort:


The associated North American Industry Classification System (NAICS) Code is-518210- Data Processing, Hosting, and Related Services; Small Business Size Standard is $32.5 million.


BACKGROUND


The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, tobacco products, our nation's food supply, cosmetics and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines, devices, products, and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health. As part of its mission, the FDA conducts monitoring of the safety of regulated products.


In response to the FDA Amendments Act of 2007 (FDAAA 2007), the FDA established the Sentinel system and built a national electronic data system for monitoring the safety of FDA-regulated medical products. Sentinel is a distributed database system consisting of numerous data partners who retain operational control over their data within a secure environment; the Sentinel Operations Center manages, receives and processes FDA questions in the form of queries and returns summary results back to the FDA in a secure environment. The FDA Center for Biologics Evaluation and Research (CBER) established the Post Licensure Rapid Immunization Safety Monitoring (PRISM) system, within Sentinel, specifically to conduct studies and analyses of vaccine safety. CBER also established the Blood Safety Continuously Active Network (BloodSCAN) as an active post market system within Sentinel for evaluating the safety of blood and blood products. CBER uses the Sentinel system to conduct some of its epidemiological studies as part of its regulatory responsibilities.


However, CBER conducts several epidemiological studies outside of the Sentinel system. CBER's Office of Biostatistics and Epidemiology (OBE) initiated post market safety studies working collaboratively with federal partners such as the Veterans Health Administration, Indian Health Services and Center for Medicare and Medicaid Services (CMS). In 2005, FDA initiated studies with CMS in the areas of vaccine and blood safety and in 2013 in vaccine effectiveness. For the last decade, FDA has worked collaboratively with CMS to institute ‘near real time' surveillance or rapid cycle analysis (RCA) for Guillain-Barre Syndrome (GBS) following influenza vaccination. This work is ongoing and continues during each influenza season since its inception. OBE has conducted numerous epidemiological studies with private sector partners as well. In 2008, OBE began to work collaboratively with HealthCore to use population-based data to answer regulatory questions of public health importance for biologic products. This successful collaboration resulted in several peer-reviewed publications and contributed to FDA regulatory decision-making. In 2016, CBER funded a study using artificial intelligence, natural language processing and advanced analytics to evaluate biologic product adverse event reports to more efficiently analyze and review reported adverse events and trends in reports to support and enhance our post market safety surveillance work.


The purpose of the BEST initiative is to conduct biologic product safety and effectiveness studies for products such as vaccines, blood, tissue and advanced therapeutic products regulated by CBER. The Contractor shall provide resources and support to establish a Coordinating Center and an appropriate data source(s) or partner(s) to conduct active biologic product safety and effectiveness studies by CBER using a distributed data model using a large data source. The goal of this initiative is to develop new capabilities and build additional capacity in one or more of the following general areas including: 1) Blood safety surveillance as part of FDA's efforts to build a national hemovigilance program; 2) New, innovative approaches to conduct postmarket safety and effectiveness studies for biologic products to include approaches and applications such as query tools, machine learning, artificial intelligence, natural language processing and others; and 3) Biologics effectiveness and safety surveillance efforts that may include vaccines, tissues, and other biologic products. The data partner(s)/organization(s) may have their own team of epidemiologists, subject matter experts, bioinformaticists, programmers and others who are experienced in conducting post-market pharmacoepidemiological safety studies for drugs and biologics. Alternatively, data partners may work with an organization, such as a contract research organization or academic partner, which has its own team or may assemble its own team of such experts, which might serve as a Coordinating Center or Operations Center. See Attachment 1, Draft IDIQ SOW.


Place of Performance:
Contractor's facility.


The respondents shall furnish sufficient technical information necessary for the Government to determine the capability of the respondent at meeting the requirement of this initiative identified above. The methodology must ensure that the offeror has the capacity to take part in a large-scale implementation of the initiative. Though the target audience is small businesses all interested parties may respond. Responses are limited to twenty (20) pages on 8.5 inch by 11 inch paper. At a minimum, responses shall include the following:


1. Provide a brief corporate profile of your company to include the following:
a) Business name
b) DUNS number
c) CAGE code
d) Business address
e) Business website
f) Business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB)
g) Point of contact name
h) Mailing address (if different from business address)
i) Phone number
j) Email address
2. Demonstrate capabilities and/or experience to establish a Coordinating Center with the resources such as relevant experts, methods and tools, access to large patient data sources to conduct biologic post market product safety and effectiveness assessments.
3. Describe sources of data that could be used that includes access to millions of patient records, with the ability to conduct medical chart review on a small number of records, either using electronic health records (preferred) or claims data.
4. Discuss sources of data that could be used to access existing or proposed distributed data model (with no direct FDA access to patient-identified data) with the ability to access and analyze data using an approach such as a common data model (CDM), query tools and programs. CDM formats could include the Observational Medical Outcomes Partnership (OMOP) CDM, Sentinel CDM, or others.
5. Demonstrate capabilities and or experience with using established methods and standardized tools to conduct rapid queries or simple safety studies using data, that include identifying patients with an exposure to the biologic product and outcomes of interest. For example, with respect to blood, exposure might include transfusion with whole blood, red blood cells, platelets, or other components. A health outcome of interest might include events such as transfusion-associated circulatory overload (TACO), hemolytic transfusion reactions (HTRs), and others to be determined on a task order basis by FDA) including ascertainment of incidence and prevalence rates.
6. Demonstrate capabilities and or experience with conducting moderately complex query studies using cohort identification tools (control, treated populations, age stratification, and others) and evaluate unadjusted exposure. Ability to compare, correlate outcomes in different populations.
7. Demonstrate capabilities and or experience with conducting highly complex epidemiological studies using a protocol that includes comparisons between cohort populations, and such methods as cohort designs, self-controlled risk intervals, and others. Demonstrate capability to validate coded exposure and outcome data using Medical Record Review (e.g., establish positive predictive value for the recorded health outcome of interest derived from electronic health records or claims data.
8. Demonstrate capabilities and or experience with providing or developing new, innovative approaches to conduct post market safety and effectiveness studies for biologic products (such as blood and blood products, vaccines, and advanced therapy products) or to conduct automated identification and reporting of blood and blood product adverse events to the FDA to include approaches and applications such as query tools, robotics, machine learning, artificial intelligence, natural language processing and others.
9. Provide three (3) years of past performance information in which the offeror has provided same or substantially similar service solutions. For each past performance reference include the date of award, description, dollar value, client name, client address, client point of contact name, client point of contact phone number, client point of contact email address. Include role in past experience (prime or subcontractor) or data analysts/epidemiologist role etc.
10. If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement.
11. If a large business, identify the subcontracting opportunities that would exist for small business concerns;
12. Describe your usual contract type, terms and conditions; and
13. Though this is not a request for quote, informational pricing is encouraged.


The government is not responsible for locating or securing any information, not identified in the response.


The Government encourages any comments and/or suggestions from any interested party, regarding the Statement of work. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation.

Interested Parties shall respond with capability statements which are due in person, by postal mail or email to the point of contact listed below on or before June 27, 2017 by 13:00 hours (Central Time in Jefferson, Arkansas) to nick.sartain@fda.hhs.gov, or mail to the Food and Drug Administration, OO/OFBA/OAGS/DAP, Attn: Nick Sartain, 3900 NCTR Road, Building 50, Room 422, Jefferson, AR 72079-9502. Reference FDA1181185.


Notice of Intent
Responses to this sources sought announcement will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures.


Disclaimer and Important Notes
This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in FedBizOpps. However, responses to this notice will not be considered adequate responses to a solicitation.


Confidentiality
No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).


Attachment:
Draft IDIQ SOW


Nicholas E Sartain, Contract Specialist, Phone 870-543-7370, Email nick.sartain@fda.hhs.gov

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