Technology Law Source

Tag Archives: Maryland

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

Progress in the Commercialization of Graphene

European Plastics News posted an article on it’s site last week,("Graphene developers seek routes out of the lab"), focusing on challenges to and progress in the commercialization of graphene, specifically its "potential as a mutlifunctional reinforcement in composites".

Among the challenges the article raises are:

1) Entangling of 3D carbon nanotubes (CNTS) bundles

2) Individual graphite sheets restacking themselves

3) Handling of such shets during transportation to processing facilities

4) Reduction of costs of production and transportation

5) A need to develop standard operating procedures for potential health hazards

While these challenges may seem daunting, the success of three companies – Vorbeck Materials of Maryland,Cabot Corporation of Massachusetts, and Thomas Swan & Co., based in the United Kingdom – are highlighted.

The article also discusses the ongoing support of  the European Commission (EC) and the UK’s government of research in graphene and how to commercialize it.:

The European Commission is planning to channel €1bn over 10 years into co-ordinated graphene research and commercialisation. The UK government has announced it wants to spend another £50m (€60.7m) to keep the UK at the forefront of graphene research, with the University of Manchester set to host a national institute of graphene research. Commercialisation of graphene by this route could arrive by late 2012.

Converted in US dollars, the EC will be spending $1.278 billion and the UK $78.153 million.…

Chapter 163, MD Task Force to Study Nanobiotechnology

The General Assembly of Maryland has concluded its annual 90 day session. Among the bills that were passed during this year’s session was House Bill 795, introduced by Delegate Susan C. Lee

As introduced, HB 795 was to establish a "Task Force to Study Nanotechnology and Nanobiotechnology", but was amended to focus solely on Nanobiotechnology and was passed by both the MD State Senate and the House of Delegates on April 1, 2010, signed into law by Governor Martin O’Malley on April 13, 2010 and Chapterized as Chapter 163 Acts of 2010.

The Task Force is to be composed of members appointed by the President of the MD State Senate, the Speaker of the House of Delegates – these individuals will serve as co-chairs of the task force – the Secretary of Business and Economic Development, Chair of the MD Technology Development Corporation or their designees. The Governor is empowered to appoint three representatives to the task force from universities and colleges in Maryland that are involved in research in nanobiotechnology and two CEOs of nanobiotech companies. In addition, the Directors of NIH, NIST, FDA and the USPTO or their designees are also to be invited to become part of the task force.

The task force is charged with studying the benefits  of the nanobiotech industry, ranging from job creation to "the generation of revenues for the state", the state’s role in supporting nanobiotech, including promoting private-public partnerships, offering financial incentives for nanobiotech companies to establish themselves in Maryland, etc.. The …

LexBlog