Executive Branch News

Deadline for Comments on Common Rule NPRM Extended

The Department of Health and Human Services has announced that it will extend the period for public comment on the Notice of Proposed Rule Making (NPRM) for the Federal Policy for the Protection of Human Subjects (otherwise known as the Common Rule) by 30 days. The new deadline is January 6, 2016. A summary of the major changes to the regulations proposed in the NPRM is available here. Back to this issue’s table of contents.

NIH Issues Notice Clarifying its Health Economics Research Priorities

The National Institutes of Health (NIH) issued a Guide Notice on November 25, to “clarify NIH policy related to funding health economics research,” in an effort to delineate NIH’s “priority areas of health economics research as well as reach aims that generally fall outside of the NIH mission.” The notice is part of an ongoing issue that dates back to 2012 Congressional language in the Fiscal Year 2013 Labor, Health and Human Services and Education Appropriations bill that bans the National Institutes of Health (NIH) from supporting economics research. Representative Lucille Roybal-Allard (D-CA) responded to the language, along with 82…

NIH Issues Funding Opportunity to Support the PMI Cohort Program Direct Volunteer Pilot Studies

The National Institutes of Health (NIH) is seeking proposals for pilot studies and “the needed information technology support for the development of the Direct Volunteer component of the Precision Medicine Initiative (PMI) Cohort Program.” The agency plans to build a “national research cohort of one million or more volunteers who are engaged as partners in a longitudinal, long-term effort to identify the molecular, environmental and behavioral factors that contribute to diverse diseases, to facilitate the development and testing of novel therapies and prevention approaches, and to pioneer mHealth [mobile health] strategies for improving the efficacy of health care.” To that…

NIH Seeks Input for Alzheimer’s Disease-Related Dementia 2016 Plan

The National Institute of Neurological Disorders and Stroke (NINDS), National Institute on Aging (NIA), and the Office of Disease Prevention (ODP) within the National Institutes of Health recently released a time-sensitive request–for-information (RFI) (NOT-NS-15-045) seeking the input of the scientific and broader community regarding the “most important needs and promising opportunities for research” on Alzheimer’s Disease-Related Dementia (ADRD). The information received will be used to update the National Plan to Address Alzheimer’s Disease, which is congressionally mandated to be updated annually (see Update, August 10, 2015). Additionally, the RFI announces a March 29-30, 2016 ADRD 2016 Summit sponsored by NINDS…

NIDA Announces New Challenge: “Addiction Research: There’s an App for that”

The National Institute on Drug Abuse (NIDA) within the National Institutes of Health (NIH) has announced a new Challenge/Prize Competition, “Addiction Research: There’s an App for that.” The objective for the challenge is to “promote the development of innovative mobile applications (apps) for future addiction studies.” According to the notice, three prizes may be awarded: $50,000 (first place); $30,000 (second place); and $20,000 (third place). The NIDA Challenge is enabled by the DHHS IDEA Lab program. Challenge partners include U.S. General Services Administration; Substance Abuse and Mental Health Services Administration (SAMHSA); Centers for Disease Control and Prevention (CDC); Sage Bionetworks;…

NCATS Issues RFI for Input into Strategic Plan

The National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH) is seeking the scientific community’s input into the development of its five-year strategic plan. This is NCATS’ first strategic plan since its creation in the National Institutes of Health Reform Act of 2006 (P.L. 109-482).  Accordingly, NCATS has issued a request for information (RFI), “Soliciting Input for the National Center for Advancing Translational Sciences (NCATS) Strategic Planning Process” (NOT-TR-16-002). NCATS “focuses on what is common across diseases and the translational process” emphasizing “innovation and deliverables, relying on the power of data and new technologies to…

OBSSR Hosts Seminar on Video Games and Neuroscience

Neuroscientist Adam Gazzaley, University of California, San Francisco, discussed his research and what he described as “the new frontiers” in video games and neuroscience. The November 5 presentation was part of the NIH Behavioral and Social Sciences Seminar Series, sponsored by the National Institutes of Health (NIH) Office of Behavioral and Social Sciences Research (OBSSR). Gazzaley noted that humans have longed been consumed with achieving high-level performance, particularly when it comes to physical fitness. However, when it comes to the human brain and improving “those core functions that are really fundamental to what makes us humans—higher order cognitive ability, perception,…

NIH Office of Behavioral and Social Sciences Research Seeks Input on 2016-2020 Strategic Plan

The National Institutes of Health (NIH) Office of Behavioral and Social Sciences Research (OBSSR) has issued a request for information (RFI) (NOT-OD-16-018) seeking the broad input of the scientific community and the public, including academia, industry, health care professionals, patient advocates and advocacy organizations, scientific and/or professional organizations, and other federal agencies regarding the scientific priorities that should be considered as it begins its strategic planning process to update the Office’s 2007 strategic plan for FY 2016 – FY 2020. OBSSR is congressionally mandated to “coordinate research conducted or supported by the agencies of the NIH; and identify projects of…

NIH Announces Plans for ECHO Program

The National Institutes of Health (NIH) recently issued a notice, Announcement of NIH Plans for the Environmental Influences on Child Health Outcomes (ECHO) Program (NOT-OD-16-015), detailing the agency’s plans for program, also known as the National Children’s Study (NCS) alternative (see Update, July 17, 2015). The agency reports that it intends to “support multiple synergistic, longitudinal studies using extant maternal/pediatric cohorts that represent a broad range of environmental exposures,” including behavioral and social exposures. According to the notice, “all longitudinal studies will collect a standardized, targeted set of data (Core Elements), such as demographics, normative development, patient/person reported outcomes (PRO),…

HHS Seeks Comments on New Objectives Proposed For Healthy People 2020

The Department of Health and Human Services (HHS) is seeking comments on the proposed new objectives for Healthy People 2020. The Department intends to use the comments to “shape the framework, objectives, and targets” of the initiative. Comments are being sought in the areas of family planning; preparedness; social determinants of health; and lesbian, gay, bisexual, and transgender health. Additionally, the Department invites suggestions of “additional objectives for consideration that address critical public health issues within the existing 42 topic areas of Healthy People 2020.” Comments will be accepted through November 13, 2015. More information is available here. Back to…

NCHS Releases First National Data on Electronic Cigarette Usage

Electronic cigarettes (e-cigarettes) have seen a rapid increase in popularity over the past several years, leading to debate between those who see the products as a useful smoking cessation tool and those who are concerned about potential negative health consequences. To shed light on how prevalent e-cigarette smoking actually is, the National Center for Health Statistics (NCHS) has released the first nationally-representative estimates of e-cigarette use. The report shows 3.7 percent of adults currently use e-cigarettes, including 16 percent of current smokers and 22 percent of smokers who have quit in the past year. While only 0.4 percent of non-smokers…

NIH Blog Explains NIH Commons

Philip Bourne, Associate Director for Data Science (ADDS) at the National Institutes of Health (NIH), and Vivien Bonazzi, ADDS Senior Advisor for Data Science Technologies and Innovation, recently penned a blog post explaining the NIH Commons, which is described by Bourne and Bonazzi as “a shared virtual space where scientists can work with the digital objects of biomedical research.” The ADDS office is responsible for leading the development and coordination of NIH’s data science vision (see Update, October 1, 2015). The blog post provides examples of current Commons initiatives and requests input from the scientific community on the Commons’ concepts…

OBSSR and AHRQ Release Population Health: Behavioral and Social Science Insights

The National Institutes of Health (NIH) Office of Behavioral and Social Sciences Research (OBSSR) and the Agency for Healthcare Research and Quality (AHRQ) have jointly released, Population Health: Behavioral and Social Science Insights, which details what is known and remaining gaps in research “about the effects of various behavioral and social factors on longevity, disability and illness, and the quality of life, primarily at the population level.”

NIA Director Reports on the Progress of Alzheimer’s Research and Funding

On October 26, Richard Hodes, director of the National Institute on Aging (NIA) within the National Institutes of Health (NIH), provided a progress report on the development of a bypass budget to the National Alzheimer’s Project Act (NAPA) Advisory Council on Alzheimer’s Research, Care, and Services. The “bypass” or “professional judgment” budget is transmitted directly from NIA to the President and Congress without being revised through the traditional Federal budget process. Hodes explained that a series of meetings between 2012 and 2015 provided the basis for the comprehensive set of priorities, milestones and budget estimates included in the congressionally-mandated bypass…

NIA Releases 10 Funding Opportunity Announcements Focused on Alzheimer’s Disease Research

The National Institute on Aging (NIA) within the National Institutes of Health (NIH) recently released 10 funding opportunity announcements (FOAs) in anticipation of a substantial increase in its budget for Alzheimer’s disease research. The topics of the FOAs are in the areas of health disparities, caregiving, epidemiology, diagnosis and prediction, molecular and cellular mechanism, brain aging, and clinical trials. Funding for the FOAs is available beginning in FY 2016. These FOAs have set-aside funds associated with them; as long as funds are available, they will be supported in FY 2016 through FY 2019. NIA director Richard Hodes provided additional details…

NIH/AHRQ Announce Policy Changes for Grant Applications

On October 13, the National Institutes of Health (NIH) and the Agency for Healthcare Research and Quality (AHRQ) issued a notice (NOT-OD-16-004) outlining policy changes for grant applications, forms, and instructions beginning in 2016. According to the notice, the policy will affect the following areas: rigor and transparency in research, inclusion reporting, research training, data safety monitoring, and biosketch clarification, among others. The changes will occur in two phases. For more information about the changes see the notice. Back to this issue’s table of contents.

NSF Seeks Candidates for Division Director of Social and Economic Sciences

The National Science Foundation (NSF) is accepting applications for the position of Division Director for the Social and Economic Sciences (SES) Division within the Directorate for Social, Behavioral, and Economic Sciences (SBE). The Division Director “provides leadership and direction for the support of research and education activities that develop and advance scientific knowledge focusing on political, economic, and social systems and how individuals and organizations function within them.” More information on the position can be found in the Dear Colleague Letter from SBE. Applications may be submitted through USAJOBS. Back to this issue’s table of contents.

Census Bureau Marks World Statistics Day

The United Nations has designated October 20 World Statistics Day. To commemorate the day, the Census Bureau has released a new infographic to highlight the many ways Census data helps fulfill the 2015 Statistics Day theme, “Better Data. Better Lives.” Back to this issue’s table of contents.

USDA Starts Collecting Data on Post-Harvest Food Safety Practices

The U.S. Department of Agriculture’s (USDA) National Agricultural Statistics Service (NASS), under an agreement with the Economic Research Service (ERS), has begun collecting data on food safety practices from fruit and vegetable packers and processors. The survey, the 2015 Produce Post-Harvest Microbial Food Safety Practices Survey, marks the first time since 1998 that USDA has collected such data. Information from the survey will be used to understand how businesses are implementing the 2011 Food Safety Modernization Act (FSMA). In addition, ERS will use the data to document changes in food safety practices, examine costs associated with compliance with the FSMA,…

White House Holds Forum on Citizen Science and Crowdsourcing; OSTP Issues Memorandum to Agencies

On September 30, the White House Office of Science and Technology Policy (OSTP) and the Domestic Policy Council (DPC) hosted a live-webcast forum on citizen science and crowdsourcing. The forum, Open Science and Innovation: Of the People, By the People, For the People, recognized that a small portion of Americans are formally trained as “scientists;” however, citizen science and crowdsourcing can “educate, engage, and empower the public to apply their curiosity and talents to a wide range of real-world problems.” Participants in the forum included citizen-science professionals, researchers, and stakeholders from Federal, state, local, and Tribal governments. It also included…

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