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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

FY 2012 National Defense Authorization Act: The Senate Version

On June 17, 2011, the Senate Committee on Armed Services announced that S. 1253, the National Defense Authorization Act for FY 2012 had been passed unanimously and had been reported out of Committee and sent on to the Senate for debate.

S. 1253 provided $200 million in funding for the "Rapid Innovation Program" established by PL 111-383, the 2011 National Defense Authorization Act.  $50 million of this is directed to the development of advanced materials, including nanomaterials, as described in S. Report 112-26

    2. Developing advanced materials: $50.0 million for increased investment in a broad range of materials technologies, both organic and inorganic, that can provide enhanced performance in extreme environments; enhanced strength and reduced weight for the spectrum of applications from aerospace to lighter soldier loads; enhanced survivability of ground, air, and naval systems; and tailored physical, optical, and electromagnetic properties for a wide variety of the challenging environments and unique properties demanded of military systems. Such materials could include advanced composites and metals, nanomaterials, and rare-earth alternatives. Investments could also address new techniques for manufacturing and processing these materials, including advancements in forming, joining, and machining. Whether increasing survivability or improving fuel efficiency for greater performance, advanced materials are a foundational enabling component of military systems across all services and all warfighting domains;

S. Rept. 112-26 also contains the following language, which doesnot appear in S. 1253 as reported:

Nanotechnology research

The Department of Defense (DOD) is one of 25 federal agencies that are part of the National Nanotechnology …

Nanotechnology and the FY 2012 National Defense Authorization Act

The Senate returned from its Memorial Day recess this week. Among the bills that it may begin debating is H.R. 1540, the FY 2012 National Defense Authorization Act. Introduced by Rep. Howard "Buck" McKeon (R-CA-25th), Chairman of the House Committee on Armed Services , on 04/14/2011, HR 1540 was amended during a "markup" session of the Committee on 05/17/2011. During this session, amendments offered by Rep. Nikki Tsongas (D-MA-5th)  (Sec. 1638)and Rep. Chris Gibson (R-NY-20th), (Sec. 1647) were adopted:

 

SEC. 1638. BUDGET ITEM RELATING TO MATERIALS TECHNOLOGY.

 

    (a) Additional, Discretionary Budget Authority- In the budget submitted to Congress under section 1105 of title 31, United States Code, for fiscal year 2012, the President requested $30,258,000 for Materials Technology. Of the amounts authorized to be appropriated by section 201, as specified in the corresponding funding table in division D, the Secretary of the Army shall obligate an additional $4,000,000 to develop innovative nanomaterials and nanomanufacturing processes for warfighter systems in furtherance of national security objectives.

SEC. 1647. BUDGET ITEM RELATING TO UNIVERSITY RESEARCH INITIATIVES.

 

    (a) Additional, Discretionary Budget Authority- In the budget submitted to Congress under section 1105 of title 31, United States Code, for fiscal year 2012, the President requested $80,977,000 for research, development, test, and evaluation, Army, for university research initiatives. Of the amounts authorized to be appropriated by section 201, as specified in the corresponding funding table in division D, the Secretary of Defense shall obligate an additional $7,000,000 for multidisciplinary research

Senate Amends and Passes H.R. 5116 America COMPETES Reauthorization Act of 2010

UPDATE

The House agreed to the Senate amendment to HR 5116 on 12/21/2010. We’ll discuss the implications of this in more detail after the Xmas holiday.

The Senate unanimously passed H.R. 5116 on Friday 12/17/2010, after first adopting an amendment in the nature of a substitute. As opposed to the version of H.R. 5116 that was passed in the House, the language of the amended version contains no provisions to reauthorize the National Nanotechnology Initiative (NNI). As amended and passed by the Senate, the language of H.R. 5116 contains no references to nanotechnology at all.

The amended bill, basically a reduced version of S. 3605 as reported out of committee on 12/10/2010, reduces the amounts appropriated for various agencies such as the National Science Foundation and the National Institute of Standards and Technology, from $84 billion to $43 billion over a three year period.

Having been passed by the Senate in an amended version, H.R. 5116 must now go back to the House for another vote to accept the Senate’s amendment. If this happens, then the bill will go to President Obama to be signed into law. However, if the House disagrees with the amendment, the bill would be sent to a Conference Committee, composed of Senators and Representatives appointed by Senate Majority Leader Harry Reid and Speaker of the House Nancy Pelosi, charged with the task of creating a comprise version that would be acceptable to both the House and Senate. It is possible that an amendment reauthorizing …

Nanotechnology Legislation in the 111th Congress: Part I The House of Representatives

Congress returned from it’s August recess this week, so it seems like a good moment to review legislation affecting nanotechnology that has been  introduced so far in the 111th Congress. Today in Part I we’ll examine legislation introduced in the House of Representatives.  Thursday, in Part II, we’ll examine legislation introduced in the Senate.

HR 554, the "National Nanotechnology Initiatives Amendments Act of 2009", was introduced by Rep. Bart Gordon (Dem – TN – 6th Dist) on 01/15/2009 and was passed by the House under suspension of the rules on 02/11/2009. Received in the Senate on 02/12/2009, it was referred to the Senate Committee on Commerce, Science and Transportation; it has not been reported out of committee and no hearings are currently scheduled.

Major amendments to the 21st Century Nanotechnology Research and Development Act ( P.L. 108-153 15 USC 7501 et seq) include:

Requiring the National Nanotechnology Coordination Office to " develop and maintain a database accessible by the public of projects funded under the Environmental, Health, and Safety, the Education and Societal Dimensions, and the Nanomanufacturing program component areas, or any successor program component areas, including a description of each project, its source of funding by agency, and its funding history. "

Requires the designation of an Associate Director of the Office of Science and Technology Policy as the Coordinator for Societal Dimensions of Nanotechnology. The Coordinator would be tasked with insuring that ethical, legal, environmental and other social concerns with nanotechnology are considered. The Coordinator would also be …

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