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NIH Releases Precision Medicine Initiative Framework for Cohort of One Million
On September 17, the National Institutes of Health (NIH) Advisory Committee to the Director (ACD) presented its recommended design framework for building a national research participant group, or âcohort,â of one million or more Americans, that would be part of the President’s proposed Precision Medicine Initiative (PMI) (see Update, April 21, 2015 and June 15,2015). In a statement accepting the ACD’s recommendations, NIH Director Francis Collins pointed to the need to remain nimble and adaptable as the Initiative progresses. The agency intends to move quickly to build the necessary infrastructure so that participants can begin enrolling in the cohort in…
HHS Releases Proposed Updates to the Common Rule
The Department of Health and Human Services has released its proposal to update the regulations that govern research involving human subjects (the Common Rule). The long-awaited Notice of Proposed Rulemaking (NPRM) explains the proposed changes and poses a number of questions for which the department is seeking public comment, to be submitted within 90 days of the NPRMâs publication. The Office of Human Research Protections (OHRP) plans to hold several webinars in the coming weeks to explain the changes as well as an in-person town hall meeting in Washington, DC in October. The Common Rule has not been updated since…
NIH Plans for Redirection of National Childrenâs Study Funds
National Institutes of Health (NIH) Principal Deputy Director Lawrence Tabak provided an update on the âredirectionâ of National Childrenâs Study (NCS) appropriated funding at the September 1 meeting of the NIH Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI) Council of Councils. Despite the NIHâs discontinuation of the NCS, in FY 2015, Congress provided $165 million for the study with direction to the agency to continue to support the mission and goals of the study, along with flexibility on how to carry this task out. Tabak announced that the awards associated with this funding will be made in September. As…
Evidence-Based Policymaking Bill Advances through House
On July 27, the U.S. House of Representatives passed the bipartisan Evidence-Based Policymaking Commission Act of 2015 (H.R. 1831). Introduced by Rep. Paul Ryan (R-WI) with companion legislation introduced in the Senate (S. 991) by Sen. Patty Murray (D-WA), the bill would establish a 15 member commission tasked with studying how best to expand the use of and/or coordinate federal administrative data for use in evaluation of federal programs. The commission would also explore whether to establish a federal clearinghouse for program and survey data, which would be accessible to âqualified researchersâ from the public and private sectors. More information…
Congressional Briefing Explores the Impact of Education on Mortality
On July 27, the Population Association of America (PAA) held a congressional briefing, âLive Long and Prosper: The Impact of Education on Mortality,â which focused on the federal investments in longitudinal demographic research that have allowed researchers to identify and measure how educational attainment affects important life factors, including long-term health and mortality. COSSA joined PAA, a COSSA Governing Member, along with several other COSSA member organizations in sponsoring the briefing. Sharing the latest findings with a standing-room-only audience, the panel of distinguished researchers included Robert M. Kaplan, Agency for Health Care Research and Quality and former director of the…
NIH Seeks Comments on Proposed Alternative to National Childrenâs Study
The National Institutes of Health (NIH) is inviting comments on its proposed plan for the Environmental influences on Child Health Outcomes (ECHO) program and has issued a time-sensitive Request for Information (RFI). Background The ECHO program responds to the NIHâs decision to discontinue the National Childrenâs Study (NCS) in December 2014, per the recommendations of a working group of the Advisory Committee to the Director (ACD) of NIH (See Update, December 19, 2014). NIH emphasizes that in keeping with the spirit of the NCS, ECHO aims to address the critical goal of understanding the impact of environmental influences on childrenâs…
21st Century Cures Act Passes the House with Bipartisan Support
On July 10, the House of Representatives passed the bipartisan 21st Century Cures Act (H.R. 6) by a 344 to 77 vote. In addition to reauthorizing the National Institutes of Health (NIH) for three years, the bill as passed would provide $9.3 billion in advanced appropriations for fiscal years (FY) 2016-2020 for a new NIH Cures Innovation Fund and $110 million annually for the Food and Drug Administrationâs (FDA) regulatory modernization activities. (See COSSAâs analysis of the bill here.)
Members of Congress Address NIH Precision Medicine Working Group Workshop on Digital Health Data and Research Cohort Design
Senator Lamar Alexander (R-TN) and Representative Marsha Blackburn (R-TN) addressed a special session of the National Institutes of Health (NIH) Advisory Council to the Director (ACD) Precision Medicine Initiative Working Group at the Public Workshop, Digital Health Data and Research Cohort Design, on the campus of Vanderbilt University on May 28-29. The workshop is part of series by the ACD Working Group and builds on the April 28-29 workshop held on the NIH campus that focused on the development and implementation of a large national cohort, as well as identification of the unique scientific questions and opportunities of using such…
NIH: Input Sought on Precision Medicine Cohort
The National Institutes of Health (NIH) is seeking feedback from the scientific community via a Request for Information (RFI): NIH Precision Medicine Cohort (NOT-OD-15-096) to guide it in creating a longitudinal cohort of one million or more Americans who have volunteered to participate in research as part of the Presidentâs proposed Precision Medicine Initiative (PMI) (see Update, April 21, 2015). Specifically, the agency is seeking information on characteristics, purpose, or other overall aspects in the development and implementation of a large U.S. precision medicine cohort. As participants in PMI, individuals will be asked to give consent for extensive characterization of…
COSSA Washington Update, Volume 34 Issue 7
Featured News House COMPETES Bill Targets Social Science Federal Agency & Administration News NIH Appoints Working Group for Precision Medicine Initiative AHRQ 2014 Healthcare Quality and Disparities Report Shows Improved Overall Quality and Access, Lingering Disparities BTS Releases Annual Report Funding Opportunities NIH: Collaborative Innovation Award, Clinical and Translational Science Award Program COSSA Member Spotlight PAA/PRB Briefing Explores the Changing Landscape of Marriage Events Calendar View the archived email.
COSSA Washington Update, Volume 34 Issue 5
Featured News Summaries Available from COSSA Annual Meeting COSSA in Action COSSA Joins Coalitions Requesting Strong FY 2016 Appropriations Congressional News House Funding Panel Discusses NSF Budget, Social Science Funding House Appropriations Funding Panel Subcommittee on Labor, Health and Human Services Discusses NIH Budget Senate HELP Committee Examines ‘U.S. Leadership in Medical Innovation,’ NIH/FDA Budgets House Panel Discusses Department of Education’s FY 2016 Budget Request Federal Agency & Administration News NSF Releases Public Access Plan NIGMS Releases 2015-2020 Strategic Plan White House Social and Behavioral Sciences Team Seeks Fellows and Associates Publications & Community Events COSSA/CPR Sponsor âNIH 101â Congressional…
House Panel Discusses Department of Education’s FY 2016 Budget Request
On March 4, Secretary of Education Arne Duncan appeared before the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies to discuss the President’s fiscal year (FY) 2016 budget request for the Department of Education. Subcommittee Chair Tom Cole (R-OK) opened the hearing by noting the “education of America’s children is critical, not only to prepare them for the workforce, but to strengthen the economic health of our nation as a whole.” Cole noted that he also sits on the House Budget Committee and expressed his hope for a bigger deal between Congress and the Administration…
NIH: Mobilizing Research – A Research Resource to Enhance mHealth
The National Institutes of Health (NIH) Office of Behavioral and Social Sciences Research (OBSSR), the National Heart, Lung, and Blood Institute (NHLBI), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute of Biomedical Imaging and Bioengineering (NBIB), and the National Institute on Neurological Disorders and Stroke (NINDS) have released a funding opportunity announcement (FOA) designed to support the development of Mobilizing Research, a research resource that would allow researchers to more efficiently and rapidly evaluate mobile and wireless (mHealth) technologies. Mobile and wireless health technologies offer the potential to transform and advance research, prevent disease, improve diagnosis, treatment, and…
21st Century Cures Act Discussion Draft Released
House Energy and Commerce Committee Chairman Fred Upton (R-MI) released a discussion draft of the 21st Century Cures Act on January 27. The draft bill is the culmination of a year of hearings and roundtable discussions held by the Committee. Its release was accompanied by a section-by-section discussion of the document and a one-pager highlighting the legislative ideas. The Committee has repeatedly stated that the draft is a “starting point in the legislative process to spur discussion.” Accordingly, they are seeking public feedback on the proposals. The Committee also cautioned that the “inclusion of a policy in the draft should…
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 Nationâs 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).
HELP Committee Approves Strengthening Education through Research Act
On January 28, the Senate Health, Education, Labor and Pensions (HELP) Committee passed the Strengthening Education through Research Act (S. 227). The bill reauthorizes the Education Sciences Reform Act (ESRA). ESRA authorizes funding for the research activities of the U.S. Department of Education, including the Institute for Education Sciences (IES). The legislation would authorize an appropriation of $612 million for fiscal year (FY) 2016 and $3.2 billion between 2016-2020 to support federal educational research, statistical analysis, and other activities.
Public Comment Sought for Death Master File Certification Program
On December 30, the National Technical Information Service (NTIS) published a Notice of Proposed Rulemaking in the Federal Register for the establishment of a certification program to âcertifyâ persons to access Death Master File (DMF) information about an individual within three years of that individual’s death. The new program would replace the temporary certification program in place since 2013. The deadline for comments has been extended to March 30. Back to this issueâs table of contents.
NIH: BD2K Biomedical Science Training Coordination Center
The National Institutes of Health (NIH) is seeking applications for a coordination center designed to narrow the gap between the availability of biomedical big data and the ability of biomedical scientists to utilize such data accurately, effectively, and efficiently. The funding opportunity announcement, NIH Big Data to Knowledge (BD2K) Biomedical Science Training Coordination Center (RFA-ES-15-004), responds to increasingly large, diverse, and complex biomedical datasets. These datasets tax conventional methods for sharing, managing, and analyzing data. Researchersâ abilities to capitalize on biomedical big data science-based approaches are limited by poor data accessibility and interoperability, the lack of appropriate tools, and insufficient…
Events Calendar
American Historical Association Annual Meeting, New York, NY, January 2-5, 2015 Association of American Law Schools Annual Meeting, Washington, DC, January 2-5, 2015 American Economic Association Annual Meeting, Boston, MA, January 3-5, 2015 Linguistic Society of America Annual Meeting, Portland, OR, January 8-11, 2015 COSSA Annual Meeting & Advocacy Day, Washington, DC, March 9-10, 2015 A list of COSSA member annual meetings and other events can be found on the COSSA web page. Back to this issueâs table of contents.
Gilbert White Lecture Focuses on Reducing Losses from Natural Hazards
The National Academiesâ Board on Earth Sciences and Resources held its annual Gilbert F. White Lecture in the Geographical Sciences on December 4. Susan Cutter, Distinguished Carolina Professor at the University of South Carolina (and a past president of COSSA), delivered the lecture, which focused on âWhy More Knowledge Is Not Reducing Natural Hazard Losses.â She explained that despite huge increases in our knowledge of the physical processes and social forces that interact during natural disasters, losses from such events have only grown.