Notice Number: NOT-FD-13-008
Release Date: February 22, 2013
Response Date: April 1, 2013
U.S. Food and Drug Administration (FDA)
Office of the Chief Scientist/Office of the Commissioner
FDA plans to establish additional Centers of Excellence in Regulatory Science and Innovation (CERSI), and/or similar partnerships and relationships, to address regulatory science challenges and opportunities. It will do this by fostering collaborations across sectors, investing in and promoting innovation. FDA has previously identified eight major priority areas where new or increased investment in regulatory science research is critical to the success of its mission and to public health and safety. The establishment of new Centers of Excellence and/or similar partnerships is one strategy in FDA's commitment to leverage external resources and expertise to Advance Regulatory Science, the science that is essential for product development and evaluation and which underpins FDA’s regulatory decision-making.
The purpose of this Request for Information (RFI) is to solicit informal input from the broader public and private sectors, including industry, academia, Federally Funded Research and Development Centers (FFRDCs), Government laboratories, physician and pharmacist societies, patient-focused research foundations and advocacy groups, as well as other health care providers. The goal is to prepare for an anticipated Funding Opportunity Announcement (FOA) on CERSI by identifying and further defining specific new opportunities and strategies for FDA’s consideration in advancing regulatory science within FDA’s priority areas.
As a part of FDA's Regulatory Science Initiative, FDA supports innovation to improve the development, evaluation and monitoring of safe, and effective products. Following the release of its Strategic Plan for Regulatory Science in 2011, FDA provided funding to establish two pilot Centers of Excellence in Regulatory Science and Innovation (CERSI). These CERSIs are expanding on both the Critical Path and Advancing Regulatory Science Initiatives to modernize regulatory science through collaborations in applied science, professional development, training, and scientific exchanges. We intend to publish a Funding Opportunity Announcement (FOA) in 2013 to support one or more additional CERSIs. FDA plans to consider other models of collaboration, such as the development of designated affiliations and partners that might primarily leverage and utilize existing resources, rather than requiring additional funding.
This Notice of Intent to Publish a Request for Information for FDA Collaborating Centers of Excellence in Regulatory Science and Innovation is the first step in this FOA process. It is intended for information-gathering and planning purposes.
This RFI seeks input from all stakeholders to identify the most synergistic regulatory science areas leading to a major advance in the safety, effectiveness, and availability of FDA-regulated products through a partnership with FDA. FDA is especially interested in the following eight priority areas as primary focuses of the additional CERSIs:
1. Modernize Toxicology to Enhance Product Safety
2. Stimulate Innovation in Clinical Evaluations and Personalized Medicine to Improve Product
Development and Patient Outcomes
3. Support New Approaches to Improve Product Manufacturing and Quality
4. Ensure FDA Readiness to Evaluate Innovative Emerging Technologies
5. Harness Diverse Data through Information Sciences to Improve Health Outcomes
6. Implement a New Prevention-Focused Food Safety System to Protect Public Health
7. Facilitate Development of Medical Countermeasures to Protect Against Threats to U.S. and Global Health and Security
8. Strengthen Social and Behavioral Science to Help Consumers and Professionals Make Informed
Decisions about Regulated Products
FDA welcomes submissions of interest and ideas in all areas. We also wish to note that we particularly encourage submission of concepts concerning priority area 8, as the Agency recognizes major scientific needs and opportunities in areas such as improving its communication about product benefits, risks and use. Additional funding from FDA for these eight priorities including priority area 8 is available through the FDA Broad Agency Announcement .
Suggestions for other areas of research that may create a new generation of regulatory science bases or tools are also encouraged. Responses to this RFI should include some of the following information:
Tab 1 Introduction/Background:
Existing institutional expertise, capabilities, and leaderships in the field
Existing scientific infrastructures supporting multifaceted research and development activities, i.e. organizational structure, and shared resources and services, etc.
Existing programs that successfully interact with government agencies, international organizations, public or private partners and other groups, e.g. trade or patient-advocacy groups
Tab 2 Research Priorities and Opportunities:
Based on the priority areas enumerated above or based on any other emerging technologies, provide specific examples of innovative research opportunities, needs, and gaps to improve the Agency’s regulatory science capabilities, especially in areas that complement or enhance FDA’s existing resources.
Tab 3 Collaborative Models for Partnerships and Leaderships:
Strategies and opportunities to include private and public partners and create practical and over-reaching approaches for establishing common platforms, standards and training opportunities
Mechanism or model that can be leveraged to bring in broader perspectives, expertise, and coordination, such as domestic and international collaborations, consortia, partnerships, etc.
Potential approaches to leverage existing intellectual capital and expertise and attract additional partners and resources to become sustainable beyond initial FDA financial support
Potential strategies for effectively and continuously promoting technical training and scientific exchange between the center and FDA
Please adhere to the tab and sub-tab numberings above and to the page limit (5 pages total) but it is not necessary to cover all the areas. It will be helpful if examples of successful or failed lessons learned are included.
Responses to this RFI are voluntary but encouraged. Any personal identifiers (e.g., names, addresses, e-mail addresses, etc.) will be removed when responses are compiled. Only the de-identified comments will be used. Proprietary, classified, confidential, or sensitive information should not be included in your response. The Federal Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
This RFI is for information and planning purposes only, and should not be construed as a solicitation or as an obligation on the part of the Federal Government to provide support for any ideas identified in response to it. Please note that the Federal Government will not pay for the preparation of any information submitted or for its use of that information. Responses will be compiled and shared internally with FDA staff and its science councils, with one or more subcommittees of the councils, and with FDA scientific working groups, as appropriate. In all cases where responses are shared, the names of the respondents will be withheld.
Interested investigators and organizations are invited to respond.
Responses to this RFI will be accepted until April 1, 2013. You will not receive individualized feedback on any suggestions. No basis for claims against the United States government shall arise as a result of a response to this request for information or from the United States government's use of such information.
Responses should be limited to a maximum of 5 pages and should be identified with NOT-FD-13-008 (in the subject line for e-mails)
All respondents are asked to indicate the type and size of their organization, e.g., Large Business, Small Business, Veteran-Owned Small Business, Service-Disabled Veteran-Owned Small Business, HUBZone Small Business, Small Disadvantaged Business, Women-Owned Business, 8(a), Historically Black College or University/Minority Institution (HBCU/MI), educational institution, profit/non-profit hospital, or other nonprofit organizations including those within the federal government.This Notice is being provided to give potential applicants sufficient time to develop meaningful collaborations and responsive projects.
Please direct all inquiries to:
NOT-FD-13-008 should be in the subject line for e-mails.
Office of the Chief Scientist/Office of the Commissioner
FDA at White Oak
Silver Spring, MD 20993