AAAS Policy Alert -- September 14, 2011
IN THIS ISSUE
BUDGET NEWS
The House Appropriations Committee approved its Transportation, Housing and Urban Development bill for FY 2012 on September 8. The Research and Innovative Technology Administration (RITA) of the Department of Transportation would receive $11.9 million in the bill, $1.1 million (8.6% less than in FY 2011, and the Federal Transit Administration's Research and University Research Centers program is funded at $45 million, $13.9 million (23.6%) less than FY 2011. A markup of the Health and Human Services bill was scheduled for last Friday, but it was postponed.
The Senate Appropriations Committee approved its 302(b) subcommittee allocations on September 7, along with the Agriculture, Energy and Water Development, and Homeland Security appropriations bills. The 302(b) allocations provide a budgetary framework by allocating total discretionary spending among the 12 appropriations subcommittees. The total budget authority allocated by the Senate is $1.043 trillion, $23 billion greater than the House's total. Under the Senate committee's plan, the Labor-HHS Subcommittee (which has oversight of NIH) would have an additional $18 billion to spend; Commerce-Justice-Science (with jurisdiction over NSF, NASA, NOAA, and NIST) would have an additional $2.5 billion; and Energy-Water would have an additional $986 million. A summary table comparing the House and Senate 302(b) allocations is available here (PDF file).
The Senate Appropriations Committee also approved several bills last week. The Agriculture bill provides $2.3 billion for the National Institute on Food and Agriculture (NIFA) and the Agricultural Research Service (ARS), $39 million (1.7%) less than FY 2011. In the Homeland Security bill, Science and Technology programs were funded at $800 million, $28 million (3.3%) less than FY 2011 but $261 million (48.4%) more than the House bill which had proposed a large cut. Finally, in the Energy and Water Development bill, the Advanced Research Projects Agency-Energy (ARPA-E) is funded at $250 million, $70 million (39.2%) more than FY 2011; the Office of Science is funded at $4.8 billion, the same level as in FY 2011; and Energy Efficiency and Renewable Energy (EERE) programs are funded at $1.8 billion, the same as in FY 2011 but $498 million (38.3%) more than the House bill. On September 15 the Senate Appropriations Committee plans to mark up the appropriations bills for Defense; Financial Services; Commerce, Justice, and Science; and Legislative Branch.
Visit the AAAS R&D Budget and Policy Program Website to stay up-to-date on the latest congressional action on the FY 2012 budget.
OTHER CONGRESSIONAL NEWS
Senate Passes Patent Reform Legislation. On September 8 the Senate passed, by a vote of 89-9, the American Invents Act (H.R. 1249), a bill to reform the nation's patent system and the first major overhaul of that system in over 50 years. The final bill reflects a compromise between the House and Senate and would change the current standard of "first-to-invent" to "first-to-file," bringing the U.S. into line with the standard used by most other countries (see bill summary). The legislation was sent to the President, who is expected to sign it into law.
Senate Oceans Caucus Launched. The Senate is holding the first meeting of a new Oceans Caucus this week. According to a press release, the bipartisan caucus will have 18 inaugural members and will "work to increase awareness and find common ground in responding to issues facing the oceans, which support millions of jobs in America and contribute more to the country's GDP than the entire farm sector, grossing more than $230 billion in 2004."
EXECUTIVE BRANCH
NSF Issues Report on Science in the Information Age. NSF has issued a report of an international workshop on Changing the Conduct of Science in the Information Age. The report (found here) acknowledges that "[n]ew digital technologies are transforming the practice of science" and discusses the implications for data access, sharing, and reproducibility. Among the recommendations of workshop participants was the creation of a system of "reliable and unique identifiers for individual researchers, organizations, and publications to create linkages between publications and their appropriate data." The purpose of such a system would be to "ensure that data sets are linked to subsequent publications and other research outputs, further aiding attribution and the reproducibility of research," thereby encouraging creators of data sets to share widely and users of those data sets to credit their originators.
FDA Issues Medical Device Guidance Documents. On August 15 the Food and Drug Administration (FDA) issued a draft guidance document seeking public comments on the design of clinical trials for medical devices (see FDA press release). The agency seeks comments on topics such as minimizing data bias and choosing study participants. In related news, that same day the agency issued another draft guidance (PDF file) to clarify how it calculates benefit-risk ratios of medical devices during pre-market review determinations.
Public Comments Sought on Limiting "Exculpatory Language" in Informed Consent. The Office for Human Research Protections (OHRP) and the FDA released for public comment a joint draft guidance document entitled "Guidance on Exculpatory Language in Informed Consent." The document refers to language in which the research subject waives his/her legal rights to sue, or that purports to release the investigator, the sponsor, the institution, or its researchers from liability for negligence. The joint draft document offers, among other things, guidance on the regulatory prohibition of including exculpatory language in informed consent, and includes examples of language that OHRP and FDA consider acceptable, as well as examples of language that the agencies would consider exculpatory. When finalized, the draft document will supersede OHRP's November 15, 1996, guidance. The draft document is posted here. Comments must be submitted by November 7.
NRC Allows Yucca Shutdown to Proceed. The Nuclear Regulatory Commission said in an order that plans should proceed for the Yucca Mountain nuclear waste site in Nevada to close, citing budget considerations. The commission was deadlocked 2-2 on an appeal of the ruling of its Atomic Safety and Licensing Board that had prevented the closure from moving forward. Leaders of the House Energy and Commerce Committee disagreed, saying in a statement that the tied vote "means the Yucca Mountain license application remains alive," and the committee's fall priorities will include "its ongoing investigation into the Obama Administration's politically motivated efforts to terminate the Yucca Mountain nuclear repository." The NRC order can be found here (PDF file). The House Committee statement is available here. A New York Times blog provides a clear description of this procedurally muddled issue.
Public Comments Sought on Report of Panel Investigating Guatemala Research Abuses.
A panel of the Presidential Commission for the Study of Bioethical Issues, looking into federally funded research on sexually transmitted diseases in Guatemala in the late 1940s that had involved intentionally infecting persons for study, has issued its findings and recommendations (PDF file). The International Research Panel was established by the Commission as directed by President Obama when the U.S. government disclosed the Guatemala research in October 2010. Among the Panel's recommendations: that the U.S. "should implement a system to compensate research subjects for research-related injuries;" and that "[g]reater efforts are needed to enhance transparency, monitor ongoing research, and hold researchers and institutions responsible and accountable for violations of applicable rules, standards, and practices." The Commission invites public comment, due by October 11, on the Panel's findings and recommendations (see details for commenting here (PDF file)).
ELSEWHERE
National Research Council Releases Health Impact Assessment Report. A report recently released by the National Research Council recommends using health impact assessments (HIAs) to determine the potential public health effects of public policy decisions. In "Improving Health in the United States: The Role of Health Impact Assessment (2011)" (summarized here and here) a six-step framework is proposed to conduct such assessments "us[ing] scientific data, professional expertise, and stakeholder input to identify and evaluate the public-health consequences of proposals." These steps could be applied to a broad spectrum of policy areas -- such as agriculture, transportation, and housing -- that range from local to federal levels.
U.S. Drops to Fifth Place on Global Competitiveness List. For the third year in a row, the U.S. has slipped down on the World Economic Forum's (WEF) annual competitiveness survey. The rankings are based on an international survey of 14,000 executives combined with a set of indicators in 12 categories, including infrastructure, economic environment, innovation, and education. Switzerland came in first for the third year in a row, followed by Singapore, Sweden, and Finland. Behind the U.S. were Germany, the Netherlands, and Denmark. The U.S. had been first in 2008. The full report is available on the WEF web site.
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Australia Implements Significant R&D Tax Credit. In late August the Australian Parliament passed a new R&D tax credit for Australian businesses, which is retroactive to July 1, 2011. The core provisions, which may be among the most generous tax credits offered by a nation, include a 45% refundable R&D tax offset ("equivalent to a 150 per cent deduction") for small businesses under A$20 million in annual turnover, and a 40% non-refundable tax offset ("equivalent to a 133 per cent deduction") for all other eligible businesses. Further details can be found here.
Nanotechnology Researchers in Mexico Targeted By Unabomber-Inspired Group. In the latest attack on Mexican nanotechnology researchers, two professors at the Monterrey Institute of Technology and Higher Education were injured last month by a package bomb. The group claiming responsibility for the attack, "Individualities Tending Toward Savagery," strongly criticizes nanotechnology in its online manifesto written in Spanish. According to various articles (some excerpted in Physics Today), this Unabomber-inspired group has connections to earlier attacks in France, Spain, Chile, and Mexico, and has put nanotechnology scientists on alert across the globe.
People in the News. Environmental endocrinologist John C. Wingfield was named head of NSF's Directorate for Biological Sciences effective September 6 (see NSF announcement). Previously, he was division director of Integrative Organismal Systems. He joined NSF in September 2010.
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Publisher: Alan I. Leshner
Editor: Steve Nelson
Contributors: Joanne Carney, Patrick Clemins, Edward Derrick, Mark Frankel, Erin Heath, Anne Poduska, Gretchen Seiler, Al Teich, Kasey White
NOTE: The AAAS Policy Alert is a newsletter provided to AAAS Members to inform them of developments in science and technology policy that may be of interest. Information in the Policy Alert is gathered from published news reports, unpublished documents, and personal communications. Although the information contained in this newsletter is regarded as reliable, it is provided only for the convenience and private use of our members. Comments and suggestions regarding the Policy Alert are welcome. Please write to alert@aaas.org.