FDA

Funding Opportunity Announcements

FDA: Advancing Conformance with the Voluntary National Retail Food Regulatory Program Standards (VNRFRPS) (U18) (RFA-FD-17-007) NIH opportunities:  NCI: Revision Applications to NCI-supported R01 Awards to Include Research on the NCI’s Provocative Questions (R01) (RFA-CA-17-019), (U01) (RFA-CA-17-020), (P01) (RFA-CA-17-021), (P50) (RFA-CA-17-022) NHLBI: Sleep Health and Circadian Biology in HIV-Related Comorbidities (R01) (RFA-HL-18-005) NIBIB: Enhancing Science, Technology, EnginEering, and Math Educational Diversity (ESTEEMED) Research Education Experiences (R25) (PAR-17-221) NIH/FDA: Center for Coordination of Analytics, Science, Enhancement , and Logistics (CASEL) in Tobacco Regulatory Science (U54) (RFA-OD-17-002) [FDA Center for Tobacco Products, NIH: National Institute on Drug Abuse and Office of Disease Prevention] NIH/FDA:…

Federal Agencies Clarify Programmatic Goals and Specific Interests for Multiscale Modeling Initiative

In December 2016, seven federal agencies–National Institutes of Health (NIH), U.S. Army Research Office (ARO), Department of Energy (DOE), U.S. Food and Drug Administration (FDA), National Aeronautics and Space Administration (NASA), National Science Foundation (NSF), and the Office of Naval Research (ONR)–released a notice (NOT-EB-16-011) clarifying the programmatic goals and specific interests of the interagency funding opportunity announcement Predictive Multiscale Models for Biomedical, Biological, Behavioral, Environmental and Clinical Research (PAR-15-085).  See the notice for full details. Back to this issue’s table of contents.

Funding Opportunity Announcements

AHRQ: Pediatric Quality Measures Program (PQMP): Dissemination and Implementation of Child Health Quality Measures Cooperative Research Grants (U18) (RFA-HS-16-002) AHRQ: Optimizing Care for People Living with Multiple Chronic Conditions through the Development of Enhanced Care Planning (NOT-HS-16-013) AHRQ; Pediatric Quality Measures Program (PQMP): Dissemination and Implementation of Child Health Quality Measures Cooperative Research Grants (U18) (RFA-HS-16-002) FDA: Collaborating Centers of Excellence in Regulatory Science and Innovation (U01) (RFA-FD-16-036) NIH opportunities: NIH: Population Health Interventions: Integrating Individual and Group Level Evidence (R01) (PA-16-146), (R21) (PAR-16-146) [DPCPSI, OBSSR, NCI, NIAAA, NIDCR, NIDA, NIDCD] NIAID, NIMH: Understanding HIV Rebound (P01) (RFA-AI-16-028) NIDA: Growing…

Funding Opportunity Announcements

NIJ: Research and Evaluation on Victims of Crime (NIJ-2016-9600) NIJ: FY 2016 Comprehensive School Safety Initiative (NIJ-2016-9093) ED/IFLE: Fulbright-Hays Doctoral Dissertation for Research Abroad FDA: Development, Implementation, and Management of a Funding System to Advance Conformance with the Voluntary National Retail Food Regulatory Program Standards (VNRFRPS) (U18), (RFA-FD-16-016) FDA: Strengthen and Promote the Role of Local Health Departments in Retail Food Safety Regulation (U50), (RFA-FD-16-019) FDA: Strengthening Partnerships with State Legislatures to Promote the Safety of FDA Regulated Products and Advance Public Health (U18), (RFA-FD-16-041) AHRQ: AHRQ Announces Interest in Research that Uses Shared Decision Making as a Tool to…

White House Announces National Cancer Moonshot Task Force

On February 1, the White House announced a new $1 billion initiative to jumpstart the new national “moonshot” initiative announced by President Obama in his 2016 State of the Union Address. The President established the White House Cancer Moonshot Task Force via a presidential memorandum, which will be led by Vice President Biden. The goal of the initiative is “to eliminate cancer as we know it.” The Task Force’s membership will include the leadership of the Departments of Defense (DOD), Commerce (DOC), Health and Human Services (HHS), Energy (DOE), Veterans Affairs (VA), and the Office of Management and Budget, National…

FDA Tobacco Regulatory Science Fellowship Accepting Applications

The Center for Tobacco Products within the Food and Drug Administration (FDA) is accepting applications for its Tobacco Regulatory Science Fellowship. The year-long fellowship is open to mid-career professionals who have an advanced degree in fields including (but not limited to) behavioral science, communications, economics, political science, sociology, anthropology, public health, and public policy. Fellows work within the Center to “regulate the manufacture, marketing, and distribution of tobacco products and educate the public about tobacco products and their dangers.” Applications are due on March 1, 2016. Back to this issue’s table of contents.

Senate HELP Committee Begins Consideration of Companion Legislation to the House 21st Century Cures Act

Senator Lamar Alexander (R-TN), Chair of the Senate Health, Education, Labor and Pensions (HELP) Committee, recently announced that the committee will hold the first of three executive sessions to consider legislation to address biomedical innovation. The legislation affects the National Institutes of Health (NIH) and the Food and Drug Administration (FDA). The bills would serve as the companion legislation to the 21st Century Cures Act passed by the House last summer (see Update, July 14, 2015). The executive sessions are planned for February 9, March 9, and April 6. Alexander stressed that the Committee worked throughout 2015 to produce the…

Senate HELP Committee Examines “U.S. Leadership in Medical Innovation”

On March 10, the Senate Health, Education, Labor and Pensions (HELP) Committee held its first in a series of anticipated hearings on “U.S. Leadership in Medical Innovation.” Opening the hearing, HELP Committee Chairman Lamar Alexander (R-TN) announced that he and Ranking Member Patty Murray (D-WA) intend to focus on three major actions over the next two years: (1) “fixing” the No Child Left Behind Act; (2) simplifying and reauthorizing the federal government’s supervision of higher education in America; and (3) dealing with the “exciting new era of medicine.” Regarding the latter, Alexander noted that the House is moving on a…

FDA, OHRP Seek Comment on Proposed Guidance on Electronic Consent

The Food and Drug Administration (FDA) has released draft guidance on using electronic media and processes to obtain informed consent in FDA-regulated clinical investigations. The guidance covers how and when electronic informed consent information should be presented, how to ensure subjects’ understanding of the information, how to maintain confidentiality and security, and how to keep appropriate documentation of the consent process. FDA is seeking public comment on the draft guidance by May 8, 2015. Instructions and more information are in in the Federal Register notice. The Office of Human Research Protections (OHRP) is soliciting comments on whether the FDA’s draft…

Senators Release Innovation for Healthier Americans Report, Request Feedback

On January 29, Senators Lamar Alexander (R-TN), Chairman of the Senate Health, Education, Labor and Pensions (HELP) Committee, and Richard Burr (R-NC), released Innovation for Healthier Americans: Identifying Opportunities for Meaningful Reform to Our Nation’s Medical Product Discovery and Development. The report addresses challenges to getting safe treatments, devices, and cures to patients more quickly and effectively, looking specifically at the Food and Drug Administration (FDA) and the National Institutes of Health (NIH).

White House Hosts Conference on BRAIN Initiative

On September 30, the White House hosted a conference on President Obama’s BRAIN (Brain Research through Advancing Innovative Neurotechnologies) Initiative. The Initiative is a large-scale effort to provide researchers with important insights to treat a variety of disorders, including Alzheimer’s disease, schizophrenia, and traumatic brain injury, among others. Four agencies, the National Institutes of Health (NIH), the National Science Foundation (NSF), the Food and Drug Administration (FDA), and the Defense Advanced Research Projects Agency (DARPA), have together committed more than $110 million to the Initiative in FY 2014 (see Update, April 7, 2014, pg. 26).

FDA Seeks Comments on its Strategic Priorities, 2014-2018

The Food and Drug Administration (FDA) is charged with “protecting the public health by ensuring the safety, effectiveness, and security of human and veterinary drugs, biological products, and medical devices; ensuring the safety of foods, cosmetics, and radiation-emitting products; and regulating tobacco products.” Every four years, the FDA updates its Strategic Priorities document, which outlines the agency’s strategic intentions and plans for the years ahead. The agency is currently seeking comments to help it refine its Strategic Priorities FY 2014-2018.

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