Blog Archives

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: Tobacco Centers of Regulatory Science for Research Relevant to the Family Smoking Prevention and Tobacco Control Act (U54) (RFA-OD-17-003) [NIH: NCI, NHLBI, NIDA, NIEHS, ODP; FDA: Center for Tobacco Products]

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Posted in Issue 6 (March 21), Update, Volume 36 (2017)

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.

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Posted in Issue 1 (January 10), Update, Volume 36 (2017)

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 Great Ideas: Research Education Course in Product Development and Entrepreneurship for Life Science Researchers (R25) (RFA-DA-17-007)
  • NIDDK: NIDDK Short-Term Research Experience Program for Underrepresented Persons (STEP-UP) (R25) (RFA-DK-16-021)
  • NIH: Mentored Quantitative Research Development Award (Parent K25) (PA-16-194) [NHLBI, NIA, NIAAA, NIAMS, NBIB,NICHD, NIDA, NIDCD, NIDCR, NIDDK, NIEHS, NIGMS]
  • NIMH: HIV Pre-exposure Prophylaxis (PrEP) Implementation Science in CDC-funded Public Health Demonstration Projects (Admin Supp) (PA-16-199)
  • NIH: Academic Research Enhancement Award (Parent R15) (PA-16-200) [NCCIH, NCI, NEI, NHGRI,NHLBI, NIA,NIAAA,NIAID, NIAMS, NBIB, NICHD, NIDA,NIDCD, NIDCR,NIDDK,NIEHS, NIGMS, NIMH, NIMHD, NINDS, NINR, NLM, DPCPSI (ORIP)
  • NIH: Midcareer Investigator Award in Patient-Oriented Research (Parent K24) (PA-16-206) [NCCIH, NHLBI, NIA, NIAAA, NIAID, NIAMS, NIDA, NIDCD, NIDDK, NIEHS, NIMH, NINR]

NCI: Improving Smoking Cessation in Socioeconomically Disadvantaged Populations via Scalable Interventions (R21) (PAR-16-201), (R01) (PAR-16-202)

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Posted in Issue 9 (May 3), Update, Volume 35 (2016)

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 Improve the Quality of Care for Low Income and Racial and Ethnic Minority Patients, (NOT-HS-16-010)

NIH Opportunities:

  • NIH: Director’s New Innovator Award Program (DP2), (RFA-RM-16-004)
  • NIH: Pioneer Award Program (DP1), (RFA-RM-16-005)
  • NIH: Director’s Transformative Research Awards (R01), (RFA-RM-16-007)
  • NIH: Research Project Grant (Parent R01), (PA-16-160) [NCCIH, NCI, NEI, NHGRI, NHLBI, NIA, NIAAA, NIAID, NIAMS, NIBIB, NICHD, NIDA, NIDCD, NIDCR, NIDDK, NIEHS, NIGMS, NIMH, NIMHD, NINDS, NINR, NLM]
  • NIH: Exploratory/Developmental Research Grant Program (Parent R21), (PA-16-161) [NCCIH, NEI, NHGRI, NIA, NIAAA, NIAID, NIAMS, NIBIB, NICHD, NIDCD, NIDCR, NIEHS, NIMHD, NINDS, NINR, NLM]
  • NIH: Small Research Grant Program (Parent R03), (PA-16-162) [NHGRI, NIA, NIAAA, NIAID, NIBIB, NICHD, NIDA, NIEHS, NIMH, NIMHD, NINDS,
  • NIH: Population Health Interventions: Integrating Individual and Group Level Evidence (R01), (PA-16-146), (R21) (PA-16-147), [OBSSR, NCI, NIAAA, NIDA, NIDCR]
  • NIMH/NIA: Adult Maturational Changes and Dysfunctions in Emotion Regulation (R21), (RFA-MH-17-400), (R01) (RFA-MH-17-405)
  • NIOSH: Cooperative Research Agreements Related to the World Trade Center Health Registry (U50) (RFA-OH-16-001)
  • NIMH: Collaborative Hubs to Reduce the Burden of Suicide among American Indian and Alaska Native Youth (U19) (RFA-MH-17-350)

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Posted in Issue 7 (April 5), Update, Volume 35 (2016)

White House Announces National Cancer Moonshot Task Force

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Photo Credit: The White House

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 Economic Council, Domestic Policy Council, Office of Science and Technology Policy, Food and Drug Administration (FDA), National Cancer Institute (NCI), National Institutes of Health (NIH), and the National Science Foundation, among others as designated.  NIH is directed to provide “funding and administrative support” for the Task Force. Additionally, the presidentially-appointed National Cancer Advisory Board (NCAB) is directed to also serve on the Task Force and is “strongly encouraged to establish a working group consisting of a Blue Ribbon Panel of scientific experts.” The Task Force is charged with producing a detailed set of findings and recommendations and delivering a report to the President before December 31, 2016.

The $1 billion initiative will provide research funding to “accelerate the development of new cancer detection and treatments.” It includes $965 million in funding for new cancer activities at the National Institutes of Health (NIH) in fiscal year (FY) 2016. For FY 2017, the President’s budget request will include $755 million in mandatory funds for activities at NIH and FDA. In addition, DOD and VA are directed to increase their investments in cancer research through the funding of “Centers of Excellence focused on specific cancers, and conducting large longitudinal studies to help determine risk factors and enhance treatment.” The initiative’s HHS-supported research areas also include prevention and cancer vaccine development, early cancer detection, cancer immunotherapy and combination therapy, genomic analysis of tumor and surrounding cells, enhanced data sharing, and pediatric cancer. FDA will support an oncology Center of Excellence to “leverage the combined skills of regulatory scientists and reviewers with expertise in drugs, biologics, and devices.”

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Posted in Issue 3 (February 9), Update, Volume 35 (2016)

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.

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Posted in Issue 3 (February 9), Update, Volume 35 (2016)

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 bills that are now ready for the full committee to consider, emphasizing the urgency required by the Senate to “finish its work and turn into law these ideas.”

Alexander specifically highlighted the committee’s work on legislation “to achieve interoperability of electronic health records” (EHRs). The Committee recently released a discussion draft of legislation along with a summary addressing health information technology (HIT), including EHRs, and is seeking comments. The discussion draft includes provisions to assist doctors and hospitals in improving quality of care for patients, establish Transparent Ratings on Usability and Security to Transform Information Technology (TRUST IT), provide the authority to investigate and establish deterrents to information blocking practices that interfere with appropriate sharing, foster a “network of networks” including establishing “an initial set of common data elements,” ensure that registries are certified to transmit and receive from certified HIT, provide “certification and development of patient-centered health record technology so that patients can access their health information through secure and user-friendly software, which may update automatically,” secure EHRs, and direct the Governmental Accountability Office (GAO) “to review methods for securely matching patient records to the correct patient.” (more…)

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Posted in Issue 2 (January 26), Update, Volume 35 (2016)

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 parallel track via its 21st Century Cures initiative (see Update, February 24, 2015). (more…)

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Posted in Issue 5 (March 24), Update, Volume 34 (2015)

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 guidance is appropriate for research under the Office’s purview (regulated under 45 CFR 46). As part of an effort to harmonize agencies’ regulations and guidance for human subjects research, OHRP is considering issuing the final guidance as a joint FDA-OHRP document. The Office will consider comments received from the public in its decision making.

Comments to OHRP are also due on May 8, 2015. More information and instructions are available in a separate Federal Register notice.

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Posted in Issue 4 (March 13), Update, Volume 34 (2015)

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). (more…)

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Posted in Issue 3 (February 24), Update, Volume 34 (2015)

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