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Tag Archives: H.R. 5116

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 …

S.3605 America COMPETES Reauthorization Act of 2010

The Senate Committee on Commerce, Science and Transportation, on July 22, favorably reported S. 3605, the Senate version of the America COMPETES Reauthorization Act of 2010, sending it on the the full Senate for debate.

The text of the bill as reported is not yet available from THOMAS, however the text of the bill as introduced by Senator Jay Rockefeller of West Virginia on July 15, 2010, does show differences from H.R. 5116, the version passed in the House. The Senate version contains no provisions concerning the National Nanotechnology Initiative (NNI) or any other nanotechnology related provisions. It is possible that during debate, the bill may be amended to include provisions for NNI. It is also possible that, during debate, the language of H.R. 5116 may be substituted for the language of S. 3605, in the form of an amendment in the nature of a substitute. The Senate may also substitute the language of S. 3605 for that of H.R. 5116 and pass an amended version of H.R. 5116. Should that happen, the bill would be sent back to the House for its concurrence to the Senate amendment. Should the House vote not to concur, a conference committee would be established to produce a version that both the House and Senate could agree on.

Time is a factor in the passage of the bills. Congress will soon adjourn for the August recess and is expected to remain adjourned until after the November elections.

As with other House and Senate bills affecting …

Reporting Format for Nanotechnology Related Information in CMC Review

Recently, the Center for Drug Evaluation and Research (CDER)  Office of Pharmaceutical Science issued the above entitled addition to CDER’s Manual of Policies and Procedures(MAPP). This produced some uproar in the nanotech community by some who interpreted a single line as indicating that the FDA was about to start redefining nanomaterials.

The purpose of this new MAPP is to provide "chemistry, manufacturing, and controls (CMC) reviewers within the Office of Pharmaceutical Sciences (OPS) with the framework by which relevant information about nanomaterial- containing drugs will now be captured in CMC reviews of current and future CDER drug application submissions. This information will be used to develop policy regarding these products."

In its background section, the MAPP notes that "because development of nanotechnology based drugs is still in its infancy, there are no established standards for the study or regulatory evaluation of these products."  (Emphasis added). The MAPP then goes on to define nanomaterials/nanoscale materials as "any materials with at least one dimension smaller than 1,000 nm".

What is important to note here is the language contained in a footnote: "The definations described in this section apply only to this MAPP". (Emphasis added). This defination, in short, doesnot apply outside of the manual. While the accepted defination of nanomaterials is that of any material at smaller than 100 nm, there is currently no legal defining of nanomaterials. Title I Section 102 of H.R. 5116,  The America COMPETES Reauthorization Act of 2010 would define "nanoscale" as meaning "one or more dimensions of between approximately 1 and …

America COMPETES Reauthorization Act of 2010: Update

On Friday, May 28, 2010, debate on H.R. 5116, the America COMPETES Reauthorization Act of 2010, discussed here earlier, resumed. As readers may recall, in the earlier debate in the House, a motion to recommit the bill to committee and for it to be reported back with an amendment, had been adopted by the House.  On Friday, Rep. Bart Gordon, the sponsor of the bill, reported the bill back to the House, with amendments. In a series of votes, the majority of the proposed amendments, which would have reduced funding and the effectiveness of the bill in supporting innovative technologies and their commercialization, were defeated; only two amendments, adding sections 704, "No salaries for viewing pornography", which would prevent funds authorized under the bill from being used to pay the salaries of Federal employees disciplined for "viewing, downloading, or exchanging pornography, including child pornography, on a Federal government computer or while performing Federal government duties" and section 705,  which would prevent colleges and universities that have violated Section 983 of Title X from receiving any funds authorized by the America COMPETES Act for grants or contracts.

Title I, Subtitle A, the National Nanotechnology Initiative Amendments Act was not affected by the proposed amendments and survived intact.

Having been passed in the House, the bill now proceeds to the Senate for debate and hopefully passage in that body. Congress has now adjourned for the Memorial Day Recess and the Senate will not reconvene until June 8. As many observers have …

The America COMPETES Reauthorization Act of 2010

To retain respect for sausages and laws, one must not watch them in the making

Prince Otto von Bismarck

On April 22, 2010, Rep. Bart Gordon of Tennessee introduced HR 5116, the America COMPETES Reauthorization Act of 2010, which was then referred to the House Committee on Science and Technology and the House Committee on Education and Labor.

The bill’s focus, as it’s title implies, is on reauthorizing the America COMPETES Act passed in 2007. Both the original act provided government support for innovation, research and development, increased funding for science, technology, engineering and math (STEM for short) in high schools and colleges, and assistance in getting the results of research and development out to the private sector, ultimately leading to the emergence of new industries and an expansion of the economy. The Reauthorization act would have expanded on this and would have included other areas, such as a reorganization of the National Institutes of Standards and Technology.

The House Committee on Science and Technology reported the bill out of committee with an amendment in the nature of a substitute; all of the language after the enacting clause was stripped out and new language substituted. Both the bill as introduced and the bill as reported to the House have the same language for Title I, "Science and Technology Policy", Subtitle A, "The National Nanotechnology Initiatives Amendments Act of 2010", which will be our focus here.

Section 102, "National Nanotechnology Program Amendments" would require, within 12 months of the bill’s enactment into …

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