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FBO DAILY - FEDBIZOPPS ISSUE OF MAY 09, 2013 FBO #4184
SPECIAL NOTICE

A -- Regulatory Science and Innovation - FDA-RFI-13-010

Notice Date

5/7/2013
 

Notice Type

Special Notice
 

NAICS

541711 — Research and Development in Biotechnology
 

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

FDA-RFI-13-010
 

Archive Date

6/30/2013
 

Point of Contact

Juana Quinteros, Phone: 3018276764
 

E-Mail Address

Juana.Quinteros@fda.hhs.gov
(Juana.Quinteros@fda.hhs.gov)
 

Small Business Set-Aside

N/A
 

Description

FDA-RFI-13-010 in MS Word Format. Request for Information (RFI) Regulatory Science and Innovation ________________________________________ Purpose FDA plans to invest in and promote innovation in regulatory science research which is critical to the success of its mission and to public health and safety. FDA is interested in leveraging external resources and expertise to promote 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 healthcare providers. The goal is to prepare for an anticipated solicitation by identifying and further defining specific new opportunities and strategies for FDA's consideration in advancing regulatory science within FDA's priority areas. Background As a part of FDA's Regulatory Science Initiative, FDA supports innovation to improve the development, evaluation and monitoring of safe, and effective products. The FDA intends to post a solicitation in 2013to support one or more additional initiatives in the area of regulatory science. This RFI is the first step in preparation for issuing a focused solicitation. It is intended for information-gathering and planning purposes, and no research proposal is requested at this time. If you have already responded to RFI NOT-FD-13-008, it is not necessary to resubmit. Information Requested This RFI seeks input from all stake holders to identify the most synergistic regulatory science areas leading to a major advance in the safety, effectiveness, and availability of FDA-regulated products. FDA is especially interested in the following eight priority areas as primary focuses of additional research: 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. 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 the following information: Tab 1 Introduction/Background: 1.1. Existing institutional expertise, capabilities, and leaderships in the field 1.2. Existing scientific infrastructures supporting multifaceted research and development activities, i.e. organizational structure, and shared resources and services, etc. 1.3. 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: 2.1. 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: 3.1. Strategies and opportunities to include private and public partners and create practical and over-reaching approaches for establishing common platforms, standards and training opportunities 3.2. Mechanism or model that can be leveraged to bring in broader perspectives, expertise, and coordination, such as domestic and international collaborations, consortia, partnerships, etc. 3.3. Potential approaches to leverage existing intellectual capital and expertise and attract additional partners and resources to become sustainable beyond initial FDA financial support 3.4. 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 (3 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. Confidentiality Responses to this RFI are voluntary. 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. 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. How to Submit a Response Interested investigators and organizations are invited to respond. Responses will be accepted until 6/15/13. 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. All comments must be submitted by e-mail to: (OC-OCS-Grants@fda.hhs.gov) Responses should be limited to a maximum of 3 pages and should be identified with FDA-RFI-13-010 (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. PROPOSALS ARE NOT BEING SOLICITED AT THIS TIME. Inquiries Please direct all inquiries to: OC-OCS-Grants@fda.hhs.gov with FDA-RFI-13-010 in the subject line for e-mails. Office of the Chief Scientist/Office of the Commissioner FDA at White Oak Silver Spring, MD20993
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-RFI-13-010/listing.html)
 

Place of Performance

Address: Silver Spring, Maryland, 20993, United States

Zip Code: 20993
 

Record

SN03054751-W 20130509/130507234517-7b9ebd6d2177196d9451f6480f3dd2e1 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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