Noting that
In his introductory remarks, Senator Pryor further noted that the Food and Drug Administration (FDA) expects "a significant increase in the use of nanomaterials in drugs, devices, biologics, cosmetics, food and over-the-counter products. This will require the FDA to devote more of its regulatory attention to nanotechnology based products. . . .the Nanotechnology Regulatory Science Act of 2011 will provide the FDA the authority necessary to scientifically study the safety and effectiveness of nanotechnology based drugs, delivery systems, medical devices, orthopedic implants, cosmetics, and food additives regulated by the agency. This bill is a sound investment on the promise of nanotechnology to improve human health and reduce costs in the 21st century."
As with S. 2942, S. 1662 would direct the Secretary of Health and Human Services (HHS), in consultation with the Secretary of Agriculture, (USDA), to "establish within the Food and Drug Administration a program for the scientific investigation of nanomaterials included or intended for inclusion in products regulated under this Act, to address the potential toxicology of such materials, the effects of such materials on biological systems, and interaction of such materials with biological systems."
This program's purpose would be to--
A - Developing "a detailed strategic plan for achieving specific short and long term techincal goals for the program"
B - Coordinating and integrating "the strategic plan with activities by the Food and Drug Administration and other departments and agencies participating in the National Nanotechnology Initiative"
C - Developing "intramural Food and Drug Administration programs, contracts, memoranda of agreement, joint funding agreements, and other cooperative arrangements necessary for meeting the long-term challenges and achieving the specific technical goals of the program."
The Secretary of HHS would be required to submit a report to Congress
Not later than March 15, 2014, . . . Such report shall include--
In S. 2942, this report would have been submitted to the Senate Committees on Health, Education Labor and Pensions (HELP), and Appropriations and the House Committees on Energy and Commerce and Appropriations.
The novel characteristics of nanoma terials mean that risk assessments developed for ordinary materials may be of limited use in determining the health and public safety of products based on nanotechnology.
Senator Mark Pryor (D-Ark)d, on October 6, 2011, introduced S. 1662, the "Nanotechnology Regulatory Science Act of 2011", a revised and slightly rewritten version of S. 2942, the "Nanotechnology Safety Act of 2010", introduced by Senator Pryor on January 21, 2010 and discussed here.The FDA needs the tools and resources to assure the public that nanotechnology-based medical and health products are safe and effective. The development of a regulatory framework for the use of nanomaterials in drugs, medical devices, cosmetics, sunscreens and food additives must be based on scientific knowledge and data about each specific technology and product. Without a robust regulatory science framework there is no way to know what data to collect. More than a dozen material characteristics have been suggested even for relatively simple nanomaterials. Without better scientific knowledge of nanomaterials and their behavior in the human body, we do not know what data to collect and examine.
In his introductory remarks, Senator Pryor further noted that the Food and Drug Administration (FDA) expects "a significant increase in the use of nanomaterials in drugs, devices, biologics, cosmetics, food and over-the-counter products. This will require the FDA to devote more of its regulatory attention to nanotechnology based products. . . .the Nanotechnology Regulatory Science Act of 2011 will provide the FDA the authority necessary to scientifically study the safety and effectiveness of nanotechnology based drugs, delivery systems, medical devices, orthopedic implants, cosmetics, and food additives regulated by the agency. This bill is a sound investment on the promise of nanotechnology to improve human health and reduce costs in the 21st century."
As with S. 2942, S. 1662 would direct the Secretary of Health and Human Services (HHS), in consultation with the Secretary of Agriculture, (USDA), to "establish within the Food and Drug Administration a program for the scientific investigation of nanomaterials included or intended for inclusion in products regulated under this Act, to address the potential toxicology of such materials, the effects of such materials on biological systems, and interaction of such materials with biological systems."
This program's purpose would be to--
As with S. 2942, the Secretary of HHS would designate a Program Manager who would be respobsible for:``(1) assess scientific literature and data on general nanomaterials interactions with biological systems and on specific nanomaterials of concern to Food and Drug Administration;``(2) in cooperation with other Federal agencies, develop and organize information using databases and models that will facilitate the identification of generalized principles and characteristics regarding the behavior of classes of nanomaterials with biological systems;``(3) promote intramural Food and Drug Administration programs and participate in collaborative efforts, to further the understanding of the science of novel properties at the nanoscale that might contribute to toxicity;``(4) promote and participate in collaborative efforts to further the understanding of measurement and detection methods for nanomaterials;``(5) collect, synthesize, interpret, and disseminate scientific information and data related to the interactions of nanomaterials with biological systems;``(6) build scientific expertise on nanomaterials within such Administration, including field and laboratory expertise, for monitoring the production and presence of nanomaterials in domestic and imported products regulated under this Act;``(7) ensure ongoing training, as well as dissemination of new information within the centers of such Administration, and more broadly across such Administration, to ensure timely, informed consideration of the most current science;``(8) encourage such Administration to participate in international and national consensus standards activities; and``(9) carry out other activities that the Secretary determines are necessary and consistent with the purposes described in paragraphs (1) through (8).
A - Developing "a detailed strategic plan for achieving specific short and long term techincal goals for the program"
B - Coordinating and integrating "the strategic plan with activities by the Food and Drug Administration and other departments and agencies participating in the National Nanotechnology Initiative"
C - Developing "intramural Food and Drug Administration programs, contracts, memoranda of agreement, joint funding agreements, and other cooperative arrangements necessary for meeting the long-term challenges and achieving the specific technical goals of the program."
The Secretary of HHS would be required to submit a report to Congress
Not later than March 15, 2014, . . . Such report shall include--
``(1) a review of the specific short- and long-term goals of the program;``(2) an assessment of current and proposed funding levels for the program, including an assessment of the adequacy of such funding levels to support program activities; and``(3) a review of the coordination of activities under the program with other departments and agencies participating in the National Nanotechnology Initiative.
In S. 2942, this report would have been submitted to the Senate Committees on Health, Education Labor and Pensions (HELP), and Appropriations and the House Committees on Energy and Commerce and Appropriations.
The amounts appropriated for this program are significantly reduced from the amounts that would have been appropriated under S. 2942. S. 2942 provided for $25 million each year from 2011 to 2015, a total of $125 million. S. 1662 reduces this total to $48 million from 2013 to 2015.
S. 1662 has been refered to the Senate Committee on Health, Education, Labor and Pensions. S. 2942 was also refered to this committee, but never came up for a hearing or mark up session and was never reported out of committee.
As with other bills affecting nanotechnology, we'll keep an eye on S. 1662 and report any updates if or when they occur.
