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FDA issues guidance to support the responsible development of nanotechnology products

June 24, 2014 Comments off

FDA issues guidance to support the responsible development of nanotechnology products
Source: U.S. Food and Drug Administration

Today, three final guidances and one draft guidance were issued by the U.S. Food and Drug Administration providing greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products.

One final guidance addresses the agency’s overall approach for all products that it regulates, while the two additional final guidances and the new draft guidance provide specific guidance for the areas of foods, cosmetics and food for animals, respectively.

Nanotechnology is an emerging technology that allows scientists to create, explore and manipulate materials on a scale measured in nanometers—particles so small that they cannot be seen with a regular microscope. The technology has a broad range of potential applications, such as improving the packaging of food and altering the look and feel of cosmetics.

The three final guidance documents reflect the FDA’s current thinking on these issues after taking into account public comment received on the corresponding draft guidance documents previously issued (draft agency guidance in 2011; and draft cosmetics and foods guidances in 2012).

The FDA does not make a categorical judgment that nanotechnology is inherently safe or harmful, and will continue to consider the specific characteristics of individual products. All four guidance documents encourage manufacturers to consult with the agency before taking their products to market. Consultations with the FDA early in the product development process help to facilitate a mutual understanding about specific scientific and regulatory issues relevant to the nanotechnology product, and help address questions related to safety, effectiveness, public health impact and/or regulatory status of the product.

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New from the GAO

May 21, 2014 Comments off

New GAO Reports and Testimonies
Source: Government Accountability Office

Reports
 
1. Tax Policy: Economic Benefits of Income Exclusion for U.S. Citizens Working Abroad Are Uncertain. GAO-14-387, May 20.
http://www.gao.gov/products/GAO-14-387
Highlights – http://www.gao.gov/assets/670/663323.pdf
 
2. State Department: Process to Track Responses to Congressional Correspondence Can Be Improved. GAO-14-424, May 20.
http://www.gao.gov/products/GAO-14-424
Highlights – http://www.gao.gov/assets/670/663330.pdf
 
Testimonies
 
1. Federal Autism Activities: Funding and Coordination Efforts, by Marcia Crosse, director, health care, before the Subcommittee on Government Operations, House Committee on Oversight and Government Reform. GAO-14-613T, May 20.
http://www.gao.gov/products/GAO-14-613T
Highlights – http://www.gao.gov/assets/670/663314.pdf
 
2. Nanomanufacturing and U.S. Competitiveness: Challenges and Opportunities, by Timothy M. Persons, chief scientist, applied research and methods, before the Subcommittee on Research and Technology, House Committee on Science, Space, and Technology. GAO-14-618T, May 20.
http://www.gao.gov/products/GAO-14-618T
Highlights – http://www.gao.gov/assets/670/663320.pdf
 
3. Medicare: Further Action Could Improve Improper Payment Prevention and Recoupment Efforts, by Kathleen M. King, director, health care, before the Subcommittee on Energy Policy, Health Care and Entitlements, House Committee on Oversight and Government Reform. GAO-14-619T, May 20.
http://www.gao.gov/products/GAO-14-619T
Highlights – http://www.gao.gov/assets/670/663317.pdf

New From the GAO

February 7, 2014 Comments off

New GAO Reports
Source: Government Accountability Office

1. Nanomanufacturing: Emergence and Implications for U.S. Competitiveness, the Environment, and Human Health. GAO-14-181SP, January 31.
http://www.gao.gov/products/GAO-14-181SP
Highlights – http://www.gao.gov/assets/670/660592.pdf
Podcast – http://www.gao.gov/multimedia/podcasts/660285

2. K-12 Education: Characteristics of the Investing in Innovation Fund. GAO-14-211R, February 7.
http://www.gao.gov/products/GAO-14-211R

CRS — Nanotechnology: A Policy Primer (updated)

December 27, 2013 Comments off

Nanotechnology: A Policy Primer (PDF)
Source: Congressional Research Service (via Federation of American Scientists)

Nanoscale science, engineering, and technology—commonly referred to collectively as nanotechnology—is believed by many to offer extraordinary economic and societal benefits. Congress has demonstrated continuing support for nanotechnology and has directed its attention primarily to three topics that may affect the realization of this hoped for potential: federal research and development (R&D) in nanotechnology; U.S. competitiveness; and environmental, health, and safety (EHS) concerns. This report pr ovides an overview of these topics—which are discussed in more detail in other CRS reports—and two others: nanomanufacturing and public understanding of and attitudes toward nanotechnology.

See also: The National Nanotechnology Initiative: Overview, Reauthorization, and Appropriations Issues (PDF)

The “Nasty Effect:” Online Incivility and Risk Perceptions of Emerging Technologies

October 30, 2013 Comments off

The “Nasty Effect:” Online Incivility and Risk Perceptions of Emerging Technologies
Source: Journal of Computer-Mediated Communication

Uncivil discourse is a growing concern in American rhetoric, and this trend has expanded beyond traditional media to online sources, such as audience comments. Using an experiment given to a sample representative of the U.S. population, we examine the effects online incivility on perceptions toward a particular issue—namely, an emerging technology, nanotechnology. We found that exposure to uncivil blog comments can polarize risk perceptions of nanotechnology along the lines of religiosity and issue support.

CRS — The National Nanotechnology Initiative: Overview, Reauthorization, and Appropriations Issues

September 3, 2013 Comments off

The National Nanotechnology Initiative: Overview, Reauthorization, and Appropriations Issues (PDF)
Source: Congressional Research Service (via Federation of American Scientists)

Nanotechnology—a term encompassing the science, engineering, and applications of submicron materials—involves the harnessing of unique physical, chemical, and biological properties of nanoscale substances in fundamentally new and useful ways. The economic and societal promise of nanotechnology has led to investments by governments and companies around the world. In 2000, the United States launched the world’s first national nanotechnology program. From FY2001 through FY2013, the federal government invested approximately $17.9 billion in nanoscale science, engineering, and technology through the U.S. National Nanotechnology Initiative (NNI). President Obama has requested $1.7 billion in NNI funding for FY2014. U.S. companies and state governments have invested billions more. The United States has, in the view of many experts, emerged as a global leader in nanotechnology, though the competition for global leadership is intensifying as countries and companies around the world increase their investments.

Nanotechnology’s complexity and intricacies, early stage of development (with commercial payoff possibly years away for many potential applications), and broad scope of potential applications engender a wide range of public policy issues. Maintaining U.S. technological and commercial leadership in nanotechnology poses a variety of technical and policy challenges, including development of technologies that will enable commercial scale manufacturing of nanotechnology materials and products, as well as environmental, health, and safety concerns.

Congress established programs, assigned responsibilities, and initiated research and development related to these issues in the 21st Century Nanotechnology Research and Development Act of 2003 (P.L. 108-153). Although many provisions of this act have no sunset provision, FY2008 was the last year of agency authorizations included in the act. Legislation to amend and reauthorize the act was introduced in the House (H.R. 5940, 110th Congress) and the Senate (S. 3274, 110th Congress) in the 110th Congress. The House passed H.R. 5940 by a vote of 407-6; the Senate did not act on S. 3274. In January 2009, H.R. 554 (111th Congress), the National Nanotechnology Initiative Amendments Act of 2009, was introduced in the 111th Congress. The act contained essentially the same provisions as H.R. 5940. In February 2009, the House passed the bill by voice vote under a suspension of the rules. The bill was referred to the Senate Committee on Commerce, Science, and Transportation; no further action was taken. On May 7, 2010, the House Committee on Science and Technology reported the America COMPETES Reauthorization Act of 2010 (H.R. 5116, 111th Congress) which included, as Title I, Subtitle A, of the National Nanotechnology Initiative Amendments Act of 2010. This title was removed prior to enactment. No comprehensive reauthorization bill was introduced in the 112th Congress. No comprehensive reauthorization bill has been introduced in the 113th Congress, though several bills have been introduced that contain provisions that would affect nanotechnology research and regulation. These bills include the Safe Cosmetics and Personal Care Products Act of 2013 (H.R. 394) and the Nanotechnology Advancement and New Opportunities Act (H.R. 1385).

Proponents of the NNI assert that nanotechnology is one of the most important emerging and enabling technologies and that U.S. competitiveness, technological leadership, national security, and societal interests require an aggressive approach to its development and commercialization. Critics of the NNI voice concerns that reflect disparate underlying beliefs. Some critics assert that the government is not doing enough to move technology from the laboratory into the marketplace. Others argue that the magnitude of the public investment may skew what should be market-based decisions in research, development, and commercialization. Still other critics say that the inherent risks of nanotechnology are not being addressed in a timely or effective manner.

CRS — Science and Technology Issues in the 113th Congress

July 5, 2013 Comments off

Science and Technology Issues in the 113th Congress (PDF)
Source: Congressional Research Service (via U.S. Department of State Foreign Press Center)

Science and technology have a pervasive influence over a wide range of issues confronting the nation. Public and private research and development spurs scientific and technological advancement. Such advances can drive economic growth, help address national priorities, and improve health and quality of life. The constantly changing nature and ubiquity of science and technology frequently creates public policy issues of congressional interest.

The federal government supports scientific and technological advancement by directly funding research and development and indirectly by creating and maintaining policies that encourage private sector efforts. Additionally, the federal government establishes and enforces regulatory frameworks governing many aspects of S&T activities.

This report briefly outlines an array of science and technology policy issues that may come before the 113 th Congress. Given the ubiquity of science and technology and its constantly evolving nature, some science and technology related-issues not discussed in this report may come before the 113 th Congress. The selected issues are grouped into 11 categories:

  • Overarching S&T issues,
  • Workforce and Education,
  • Agriculture,
  • Biomedical Research and Development,
  • Defense,
  • Space,
  • Nanotechnology,
  • Environment,
  • Energy,
  • Homeland Security, and
  • Information Technology.

Each of these categories includes concise analysis of multiple policy issues. The information and analysis presented in this report should be view ed as introductory rather than comprehensive.

Each section identifies available CRS reports and the appropriate CRS expert for further information and analysis.

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