[Congressional Record Volume 157, Number 149 (Thursday, October 6, 2011)]
[Senate]
[Pages S6332-S6334]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. PRYOR (for himself and Mr. Cardin):
  S. 1662. A bill to amend the Federal Food, Drug and Cosmetic Act to 
establish a nanotechnology regulatory science program; to the Committee 
on Health, Education, Labor, and Pensions.
  Mr. PRYOR. Mr. President, I rise today with Senator Cardin to 
introduce the Nanotechnology Regulatory Science Act of 2011 which will 
authorize a program of regulatory science by the U.S. Food and Drug 
Administration on nanotechnology-based medical and health products.
  Nanotechnology holds great promise to revolutionize the development 
of new medicines, drug delivery, and orthopedic implants while holding 
down the cost of health care. However, Congress and the FDA must assure 
the public that nanotechnology-based products are both safe and 
efficacious. The Nanotechnology Regulatory Science Act of 2011 will 
enable the FDA to properly study how nanomaterials are absorbed by the 
human body, how nanomaterials designed to carry cancer fighting drugs 
target and kill tumors, and how nanoscale texturing of bone implants 
can make a stronger joint and reduce the threat of infection.
  Nanotechnology, or the manipulation of material at dimensions between 
1 and 100 nanometers, is a challenging scientific area. To put this 
size scale in perspective, a human hair is 80,000 nanometers thick.
  Nanomaterials have different chemical, physical, electrical and 
biological characteristics than when used as larger, bulk materials. 
For example, nanoscale silver has exhibited unique antibacterial 
properties for treating infections and wounds. Nanomaterials have a 
much larger ratio of surface area to mass than ordinary materials do. 
It is at the surface of materials that biological and chemical 
reactions take place and so we would expect nanomaterials to be more 
reactive than bulk materials.
  The novel characteristics of nanomaterials 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.
  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 2007, the FDA Nanotechnology Task Force published a report 
analyzing the FDA's scientific program and regulatory authority for 
addressing nanotechnology in drugs, medical devices, biologics, and 
food supplements. A general finding of the report is that nanoscale 
materials present regulatory challenges similar to those posed by 
products using other emerging technologies. However, these challenges 
may be magnified because nanotechnology can be used to make almost any 
FDA-regulated product. Also, at the nanoscale, the properties of a 
material relevant to the safety and effectiveness of the FDA-regulated 
products might change.

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  The Task Force recommended that the FDA focus on improving its 
scientific knowledge of nanotechnology to help ensure the agency's 
regulatory effectiveness, particularly with regard to products not 
subject to premarket authorization requirements.
  The FDA has already reviewed and approved some nanotechnology-based 
products. In the coming years, they expect 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 FDA has already begun to devote some resources to the 
understanding of the human health effects and safety of nanotechnology. 
The FDA has established a Nanotechnology Core Facility at the National 
Center for Toxicological Research in Jefferson Arkansas. In August, 
Arkansas Governor Beebe and FDA Commissioner Hamburg signed a 
memorandum understanding creating a Virtual Center of Excellence in 
regulatory science pertaining to nanotechnology. Under the agreement, 
the state's five research universities--the University of Arkansas, 
Fayetteville; the University of Arkansas for Medical Sciences; the 
University of Arkansas at Little Rock; the University of Arkansas at 
Pine Bluff, and Arkansas State University--will work with the NCTR to 
establish a nanotechnology collaborative research program dealing 
specifically with toxicity. In addition, UAMS will offer a Master's 
degree and a certification program in regulatory science.
  Let me talk for a few minutes about two areas where nanotechnology is 
already being applied to health care, the early detection of cancer and 
multifunctional therapeutics.
  The early detection of cancer can result in significant improvement 
in human health care and reduction in cost. Nanotechnology offers 
important new tools for detection where existing and more conventional 
technologies may be reaching their limits. The present obstacle to 
early detection of cancer lies in the inability of existing tools to 
detect these molecular level changes directly during early phases in 
the genesis of a cancer. Nanotechnology can provide smart contrast 
agents and tools for real time imaging of a single cell and tissues at 
the nanoscale.
  Nanotechnology promises a host of minimally-invasive diagnostic 
techniques and much research is aimed at ultra-sensitive labeling and 
detection technologies. In the in vitro area, nanotechnology can help 
define cancers by molecular signatures denoting processes that reflect 
fundamental changes in cells and tissues that lead to cancer. Already, 
investigators have developed novel nanoscale in vitro techniques that 
can analyze genomic variations across different tumor types and 
distinguish normal from malignant cells.
  In the in vivo area, one of the most pressing needs in clinical 
oncology is for imaging agents that can identify tumors that are far 
smaller than is possible with today's technology. Achieving this level 
of sensitivity requires better targeting of imaging agents and 
generation of a larger imaging signal, both of which nanoscale devices 
are capable of accomplishing.
  Perhaps the greatest near-term impact of multifunctional therapeutic 
compounds will come in the area of tumor targeting and cancer 
therapies. Nanotechnology can be used to develop new methods of drug 
delivery that better target selected tissues and cells, and to improve 
on the efficiency of drug activity in the cytoplasm or nucleus. Drug 
delivery applications will provide a solution to solubility problems, 
as well as offer intracellular delivery possibilities.
  The introduction of nanotechnology to multifunctional therapeutics is 
at an early stage of development. The delivery of nanoscale 
multifunctional therapeutics could permit very precise site specific 
targeting of cancer cells. More sophisticated ``smart'' systems for 
drug delivery still have to be developed that sense and respond to 
specific chemical agents and are tailored to each patient. 
Multifunctional therapeutic devices need to be developed that 
simultaneously detect, diagnose, treat and monitor response to the 
therapy. For example, various nanomaterials can be made to link with a 
drug, a targeting molecule and an imaging agent to seek out cancers and 
release their payload when required.
  In conclusion, 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.
  Mr. President, I ask unanimous consent that the text of the bill be 
printed in the Record.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                S. 1662

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Nanotechnology Regulatory 
     Science Act of 2011''.

     SEC. 2. NANOTECHNOLOGY PROGRAM.

       Chapter X of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 391 et seq.) is amended by adding at the end the 
     following:

     ``SEC. 1013. NANOTECHNOLOGY REGULATORY SCIENCE PROGRAM.

       ``(a) In General.--Not later than 180 days after the date 
     of enactment of the Nanotechnology Regulatory Science Act of 
     2011, the Secretary, in consultation with the Secretary of 
     Agriculture, shall 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.
       ``(b) Program Purposes.--The purposes of the program 
     established under subsection (a) shall be to--
       ``(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).
       ``(c) Program Administration.--
       ``(1) Program manager.--In carrying out the program under 
     this section, the Secretary, acting through the Commissioner 
     of Food and Drugs, shall designate a program manager who 
     shall supervise the planning, management, and coordination of 
     the program.
       ``(2) Duties.--The program manager shall--
       ``(A) develop a detailed strategic plan for achieving 
     specific short- and long-term technical goals for the 
     program;
       ``(B) coordinate and integrate the strategic plan with 
     activities by the Food and Drug Administration and other 
     departments and agencies participating in the National 
     Nanotechnology Initiative; and
       ``(C) develop 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.
       ``(d) Reports.--Not later than March 15, 2014, the 
     Secretary shall submit to Congress a report on the program 
     carried out under this section. 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

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     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.
       ``(e) Authorization of Appropriations.--There is authorized 
     to be appropriated to carry out this section, $15,000,000 for 
     fiscal year 2013, $16,000,000 for fiscal year 2014, and 
     $17,000,000 for fiscal year 2015. Amounts appropriated 
     pursuant to this subsection shall remain available until 
     expended.''.
                                 ______