S. 3187, "Food and Drug Administration Safety and Innovation Act" passes in Senate

Prior to adjourning for the Memorial Say recess, the Senate, on 05/24/2012, by a vote of 96-1, passed  S. 3187, the "Food and Drug Administration Safety and Innovation Act", " To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes", after previously adopting an amendment in the nature of a substitute-  an amendment in the nature of a substitute strips all of the language of a bill following the enacting clause and replaces it with new language - offered by Senator Tom Harkin (D-Iowa). Included as part of the language of the amendment was Title XI - Other Provisions, Subtitle C- Misc. Provisions, Section 1133, "Nanotechnology Regulatory Science Program":

SEC. 1133. NANOTECHNOLOGY REGULATORY SCIENCE PROGRAM.

    (a) In General- Chapter X (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 Food and Drug Administration Safety and Innovation Act, the Secretary, in consultation as appropriate with the Secretary of Agriculture, shall establish within the Food and Drug Administration a Nanotechnology Regulatory Science Program (referred to in this section as the `program') to enhance scientific knowledge regarding nanomaterials included or intended for inclusion in products regulated under this Act or other statutes administered by the Food and Drug Administration, to address issues relevant to the regulation of those products, including 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) may include--

    `(1) assessing scientific literature and data on general nanomaterials interactions with biological systems and on specific nanomaterials of concern to the Food and Drug Administration;

    `(2) in cooperation with other Federal agencies, developing and organizing 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) promoting Food and Drug Administration programs and participate in collaborative efforts, to further the understanding of the science of novel properties of nanomaterials that might contribute to toxicity;

    (4) promoting and participating in collaborative efforts to further the understanding of measurement and detection methods for nanomaterials;

    (5) collecting, synthesizing, interpreting, and disseminating scientific information and data related to the interactions of nanomaterials with biological systems;

    (6) building scientific expertise on nanomaterials within the Food and Drug Administration, including field and laboratory expertise, for monitoring the production and presence of nanomaterials in domestic and imported products regulated under this Act;

    (7) ensuring ongoing training, as well as dissemination of new information within the centers of the Food and Drug Administration, and more broadly across the Food and Drug Administration, to ensure timely, informed consideration of the most current science pertaining to nanomaterials;

    (8) encouraging the Food and Drug Administration to participate in international and national consensus standards activities pertaining to nanomaterials; and

    (9) carrying out other activities that the Secretary determines are necessary and consistent with the purposes described in paragraphs (1) through (8).

    (c) Program Administration-

    (1) DESIGNATED INDIVIDUAL- In carrying out the program under this section, the Secretary, acting through the Commissioner of Food and Drugs, may designate an appropriately qualified individual who shall supervise the planning, management, and coordination of the program.

    (2) DUTIES- The duties of the individual designated under paragraph (1) may include--

    (A) developing a detailed strategic plan for achieving specific short- and long-term technical 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; and

    (C) developing 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) Report- Not later than March 15, 2015, the Secretary shall publish on the Internet Web site of the Food and Drug Administration 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 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) Effect of Section- Nothing in this section shall affect the authority of the Secretary under any other provision of this Act or other statutes administered by the Food and Drug Administration.'.

    (b) Effective Date; Sunset- The Nanotechnology Regulatory Science Program authorized under section 1013 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)) shall take effect on October 1, 2012, or the date of the enactment of this Act, whichever is later. Such Program shall cease to be effective October 1, 2017.

Except for some stylistic changes and the removal of a subparagraph on appropriations, Sect. 1133 is the language of S. 1662 , the "Nanotechnology Regulatory Science Act of 2011", introduced on 10/06/2011 by Senator Mark Pryor (D-Arkansas) andSenator Ben Cardin (D-Maryland) and subsequently assigned to the Senate Committee on Health, Education, Labor and Pensions . No hearings were ever held on the bill nor was it ever reported out of committee.

During floor debates on S. 3187, Senator Cardin urged his felllow Senators to support and pass S. 3187, focusing on the language of Sec. 1134:

Mr. CARDIN. Madam President, I rise to discuss the FDA Safety and Innovation Act, the bill now under consideration here in the Senate.. . .

I express my appreciation to Senator Pryor for his leadership on nanotechnology. I am pleased to join him in this effort and am hopeful that the language we have sponsored can be included in this bill.

   Nanotechnology has become increasingly indispensible in our daily lives--everything from cellphones and MP3 players, to packaging of our snack foods, to cancer treatments in development employ the use of nanotechnology.

   As this burgeoning technology continues to power more of our consumer products and drive job creation in America, it is essential that we fully assess, understand, and address any risks that it may pose to safety, public health and our environment.

   By soundly assessing the safety of nanotechnology and developing best practices, the Nanotechnology Regulatory Science Act of 2011 will further job creation, public safety and growth in the industry.

   Our bill would establish a program within the FDA to assess the health and safety implications of using nanotechnology in everyday products, and develop best practices for companies using nanotechnology. This new program would bring more highly-skilled research jobs to Maryland.

   FDA's laboratories and research facilities at its consolidated headquarters are ideally suited to conduct the scientific studies required under the bill.

   The USDA's Beltsville Agricultural Research Center, BARC, is similarly equipped to provide innovative scientific technology, training, methods development, and technical expertise to improve public health.  . . . .

 I also will mention one other issue: nanotechnology. I congratulate Senator Pryor for his leadership in this area. Programs at FDA to access health safety facts and using nanotechnology in everyday products is something we need to do. This legislation advances that. I point out that I am proud that the lab facilities at the FDA are fully capable of dealing with the challenges presented by nanotechnology. This legislation acknowledges that.

   We also, in Maryland, are proud of the Beltsville Agricultural Research Center, which will advance nanotechnology and the impact it has on everyday products and safety. Those issues will be addressed also by the underlying bill. We very much appreciate the leadership of the committee.

On 05/30/2012, the House, under a suspension of the rules, passed H.R. 5651, the "Food and Drug Administration Reform Act of 2012". H.R. 5651 differs substantially from S. 3187; among these differences, H.R. 5651 contains no provisions regarding nanotechnology. These differences in language mean that a Conference Committee will be appointed to write a version of the two bills that should be adopted by both the Senate and the House. Although such a committee has not been appointed as of this date, one is expected to be formed soon. As with other legislation affecting nanotechnology we will monitor S.3187 and H.R. 5651 and update this site accordingly.  

The Nanotechnology Safety Act of 2010

On Thursday 01/21/2010, Senator Mark Pryor (D-Ark) introduced S. 2942, "The Nanotechnology Safety Act of 2010", the first nanotechnology related bill of the 2nd session of the 111th Congress. The bill is co-sponsored by Senator Benjamin Cardin (D-MD). The text of S. 2942 has not yet been made available by the Government Printing Office; the link above is to Senator Pryor's introductory remarks in the Congressional Record. The text of S. 2942 as introduced follows the Senator's remarks.

In his introductory remarks Senator Pryor stated that the bill would "authorize a program of scientific investigation by the Food and Drug Administration on nanotechnology based medical and health products . . . . [to] 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."

Senator Pryor also noted in his remarks that

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, and food additives must be based on scientific knowledge and data about each specific technology and product. Without a robust scientific 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.

. . . the Nanotechnology Safety Act of 2010 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.

The Nanotechnology Safety Act of 2010 would amend Chapter X of the Federal Food, Drug and Cosmetic Act  by adding section 1011. There would be three major parts to this new section.

Part 1 would establish a program within the FDA to investigate

(A)nanomaterials included or intended to be included in products regulated by the FDA

(B) the potential toxicity of such nanomaterials

(C) the effects of nanomaterials on biological systems

(D) the interaction of nanomaterials with biological systems.

S.2942 would also establish that the new program's purpose would include (1) assessment of the scientific literature and data on the general interaction of nanomaterials with biological systems and on specific nanomaterials of concern to the FDA (2) develop and organize information using databases and models that would enable the formation of general principles about the behavior of classes of nanomaterials with biological systems (3) promote collaborative efforts to understand the properties of nanomaterials that might contribute to possible toxicity (4) promote and participate in collaborative efforts at measurement and detection of nanomaterials (5) collect, interpret and make available scientific information and data about the interaction of nanomaterials and biological systems (6) build scientific expertise on nanomaterials (7) insure ongoing training and dissemination of new information (8) encourage FDA participation in international and national standards activities and (9) carrying out other activities that the Secretary of Health & Human Services (HHS) determines are necessary.

Part 2 of the new section, "Program Administration"  would create the position of a program manager. The position's duties would include developing "a detailed strategic plan for achieving specific short and long term technical goals . . . .", co-ordinate and integrate the strategic plan with investments from FDA and other agencies and departments that participate in the National Nanotechnology Initiative (NNI) and the development of the legal instruments (Memorandums of Understanding, etc) for cooperative arrangements necessary for meeting the long term goals of the program.

Part 2 would also require the Secretary of HHS to submit reports by 03/01/2011 and 03/01/2014 to the House and Senate Appropriations Committees, the Senate Health, Education, Labor and Pensions Committee and the House Committee on Energy and Commerce. The reports would review the short and long term goals of the program,  the coordination of activities under the program with other participants in the NNI and the current and proposed funding levels for the program and if those funding levels would support the work of the program adequately.

Part 3 would authorize an appropriation of $25 million per fiscal year from 2011 through and including 2015.

S. 2492 has been assigned to the Senate Committee on Heath, Education, Labor and Pensions. No hearings are scheduled at this time. As with legislation introduced in the first session of the 111th Congress, we will monitor and report on the bill's progress.