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.  

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 Initiative (NNI) that was launched in 2001. The goals of the NNI are to: advance a world-class nanotechnology research and development (R&D) program; foster the transfer of new technologies into products for commercial and public benefit; develop and sustain educational resources, a skilled workforce, and the supporting infrastructure and tools to advance nanotechnology; and support responsible development of nanotechnology. As a participant in the NNI, DOD leverages its own and other federal investments, primarily in basic research, to discover and exploit unique properties of materials at the nanoscale to enable new applications enhancing future weapon systems capabilities.

Given the broad applicability of nanotechnologies to important areas such as power and energy, electronics and sensors, and advanced materials and coatings, the committee seeks to ensure that the DOD is engaging with as broad a research community as possible to maximize its access to innovative ideas and products. Hence, the committee directs the Department to provide a briefing to the Committees on Armed Services of the Senate and the House of Representatives no later than 180 days after the enactment of this Act reviewing its sources of nanotechnology research and engineering for defense purposes. Furthermore, the briefing should address whether these sources are adequate to ensure that the Department has sufficient scientific and technical access across the spectrum

S. 1253 now awaits debate in thge Senate, as does HR. 1540, the House version of the FY 2012 National Defense Authorization Act. A likely scenario for both bills would be for the Senate to call up HR 1540 and amend it by substituting the language of S. 1253 after the enacting clause, which would send the amended bill back to the House. If the House agrees to the amendment, the bill would be passed and sent to President Obama to be signed into law or vetoed. A more likely scenario would be for the House to disagree with the amendment, sending it to a Conference Committee , which would be tasked with producing a comprise version that both the Senate and the House could agree to pass.

As with other legislation affecting nanotech, we'll monitor S. 1253's progress and provide updates.

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 into nanotechnology science in furtherance of national security objectives.

 

Following debate in the House, H.R. 1540 passed by a vote of 322 for and 96 against, sending the bill into the Senate for it's consideration. Senator Claire McCaskill (D-MO), in a letter to Chairman McKeon and Ranking Member Rep. Adam Smith (D-WA-9th) - the ranking member of either a House or Senate Committee or Subcommittee is usually the most senior member of the minority party in the House or Senate - has raised objections to H.R. 1540, specifically citing Sec. 1647 as violating the House Republican's recently adopted ban on earmarks:

May 26, 2011

Dear Chairman McKeon and Ranking Member Smith:

I write today to express concerns about the process used in your committee's mark-up of the Fiscal Year 2012 National Defense Authorization Act (NDAA), which has obviously been structured to circumvent the earmark ban adopted by the House of Representatives. As someone who has worked tirelessly to end the non-competitive, arbitrary process of earmarking, I celebrated the decision, first made by House Republicans, to put a moratorium on earmarks. However, you have now instituted a process that allows members of your committee to circumvent the ban through the use of non-transparent amendments that effectively act as traditional earmarks. This is disappointing and disingenuous. . . .

What is remarkable is that the new earmarking procedure you have instituted not only circumvents the current moratorium but is actually less transparent than the earmarking process that was in place prior to the moratorium. In the process used by your committee, neither exact dollar amounts nor intended recipients of the earmarks can be clearly discerned. Under pre-moratorium rules, earmark requests were publicly posted and funded earmarks were listed in reports accompanying bills with the sponsor, amount and intended recipient all clearly detailed. You may assert that amendments adopted to your bill do not require a specific dollar amount be directed to a specific entity. You may also argue that the amendments require competition in awarding additional funding. Unfortunately, such arguments appear insincere. It has been reported that the members of your committee have been assured that they will be able to direct the funds provided for in their amendments to their desired recipients using informal contacts with the Department of Defense and the leverage of the Armed Services Committee. The press releases of your members issued when the FY12 NDAA won passage in your committee bear this out, as illustrated in the example below. . . .

One amendment approved by your committee provides a clear example. During the markup of your bill, a Congressman with a nanotechnology-specific academic center in his district offered an amendment seeking a $7 million addition for "innovative nanomaterials and nanomanufacturing processes." The amendment was offset using funds in the MFET Fund. The amendment was later passed as part of a large block of similar amendments without debate. Subsequently, the Member who won inclusion of the amendment issued a press release celebrating the additional $7 million in funding. Curiously - or not - the press release also included a quote from a member of the leadership of the university with the nanotechnology center in the Congressman's district. It is apparent that both the member and the university have expectations that the funds will ultimately reach the university. This is tantamount to the classic earmarking process. Notably, the Member who sponsored this amendment, like his House colleagues, has publicly embraced an earmark ban for the 112th Congress.

On its face, the new process you have implemented in your committee to facilitate earmarking and circumvent the earmark moratorium in the House strikes me as a subversion of the trust of the American people who took your word about ending earmarks. Out of fidelity to your own commitment to ban earmarks, I urge you to seek to remove those amendments included in the FY12 NDAA that appear to be nothing more than earmarks in an alternate form.

 

What raised Senator McCaskill's ire were two press releases issued by Rep. Gibson's office on May 12, 2011, announcing that several of the amendments he had offered during the markup session had been adopted, including what became Sec. 1647:

“This action by the House Armed Services Committee represents great news for the Capital Region, New York State, and the nation.  Congressman Chris Gibson is to be applauded for his vision and leadership in advancing the concept of a Federally Funded Research and Development Center dedicated to nanotechnology for defense related innovations, and commended for his drive to make such a critical enterprise a reality.  An FFRDC for nanoscale defense applications represents a clear and present national priority, not only to provide our fighting men and women with the state-of-the-art technological tools to protect and safeguard this great country, but also to ensure its ability to maintain its scientific and economic competitiveness in the nanotechnology enabled global economy of the 21 century.  The Capital Region is uniquely predisposed to benefit from this FFRDC, leading to significant Federal investments and high tech jobs creation and retention,” said Alain Kaloyeros, the SUNY College of Nanoscale Science and Engineering Senior Vice President and CEO. . . .

Full List of Congressman Gibson Additions and Amendments to the 2012 NDAA

  • Commission a study by the Department of Defense to assess the desirability of establishing a Federally Funded Research and Development Center (FFRDC) for nanotechnology.  This would allow the SUNY Albany College of Nanoscale Science to compete for this designation, and associated federal support, if it is determined necessary.  The authorization also expresses the sense of the Committee that such a FFRDC should be designated.
  • Provide $7 million (fully offset) in funding for nanotechnology research in the defense field.  SUNY Albany would be able to compete for this funding as well.

and a second press release issued folowing the House passage of H.R. 1540 on 05/26/2011:

“Furthermore, the money designated for nanotechnology research, which the SUNY Albany College of Nanoscale could compete for, will help to provide state-of-the-art technology that will make military equipment more reliable, more durable, and lighter for our service members to carry.  Finally, I’m very glad the final bill included a provision expressing the sense of Congress that there be a national Yellow Ribbon Day, an important demonstration of support for our Armed Forces and their families, and modeled after the event on April 9 in New York State.”
 

As the Roll Call article linked to above points out, ". . . SUNY Albany College of Nanoscale Science and Engineering is not in Gibson's district. . . .". It's in the 21st district, the district for Paul Tonko.

H. Rpt. 112-78 provides clear justification for Sec. 1647:

Nanotechnology research

The committee is aware that the Department of Defense is pursuing research into a variety of nanotechnology applications for defense purposes. New capabilities enabled by the unique performance enhancements of nanostructure materials hold the potential of transforming the technology landscape. The committee encourages the Department to continue to make investments in nanotechnology research that is needed to create the next generation of sensors, electronics, weapons, and manufacturing processes.

However, the committee is concerned that the Department of Defense lacks sufficient expertise in some emerging research disciplines related to nanotechnology to support a long-term research investment strategy. The committee is aware that a dedicated federally funded research and development center (FFRDC) could support the Department in this effort, but that no such broad-based nanotechnology FFRDC exists.

Therefore, the committee directs the Assistant Secretary of Defense for Research and Engineering to provide a report to the Senate Committee on Armed Services and the House Committee on Armed Services within 90 days after the date of enactment of this Act on how the Department of Defense receives support from the research community on nanotechnology issues, including identifying where within the existing FFRDC community that expertise comes from, and assessing whether a dedicated FFRDC is needed.

It is possible that, once the Senate begins debate on H.R. 1540, Sec. 1647 may be amended out of the bill and that the bill could go into a Conference Committee. We'll keep track of the progress of the bill.

We'd like to gratefully acknowledge the folks at Bloomberg Government for providing a transcript of the House Committee on Armed Services markup session.

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 NNI could be adopted during House debate or in a Conference Committee; however, considering that the House is approaching adjournment, and that Rep. Bart Gordon, chairman of the House Science and Technology Committee and author of the House version of H.R. 5116,  has endorsed the bill, stating that "It keeps our basic research agencies on a doubling path, it continues to invest in high-risk, high-reward energy technology development, it will help improve STEM education, and it will help unleash American innovation", it is likely that the House will vote to agree to the Senate's amendment.

Rep. Ralph Hall, currently the Ranking Member of the Committee, stated that ". . . the bill that passed today spends too much money, authorizes duplicative programs, and shifts focus away from the bill's original intent." Rep. Hall will be Chairman of the House Science and Technology Committee in the 112th Congress.

Not having been reauthorized in this bill, the future of NNI is unclear.

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 responsible for convening a panel to develop a research plan for the environmental, health and safety program areas; the plan would be updated on annually.

The Director of the National Science Foundation (NSF) would be required to provide grants to establish Nanotechnology Education Partnerships. Nanobusinesses would be part of these Partnerships. The Partnerships would help to prepare secondary school students to pursue college courses in nanotechnology.

The bill would also provide for the establishment of  “Industry Liaison Groups”  for all industrial sectors that would benefit from nanotechnology applications.

The National Nanotechnology Coordination Office would be required to sponsor a public meeting to (1) solicit views on the relevance and value of nanomanufacturing  research, (2) receive recommendations on ways to strengthen research supported by the Nanomanufacturing program and (3) receive recommendations on improving nanomanufacturing facilities.

HR 820, the “Nanotechnology Advancement and New Opportunities Act”, was introduced by Rep. Michael Honda (Dem – CA – 15th Dist) on 02/03/2009 and was referred to the House Committees on Science and Technology, Energy and Commerce, Ways and Means, and Homeland Security.  No hearings have been held by any of these committees on this bill and no hearings are currently scheduled. It has not been reported out of any of the committees.

The bill would require the Secretary of Commerce to establish a “Nanomanufacturing Investment Partnership”, but only after and contingent upon the private sector raising $100 million within two years after the bill’s enactment. The Partnership would  provide funds, via direct investment, loans or loan guarantees or other unspecified mechanisms, to nanocompanies for pre-commercial research and development that would not be funded by either the private sector or under the 21st Century Nanotechnology Research and Development Act. Any such funds provided would have to be paid back.

The Secretary of Commerce would also be directed to establish an Advisory Board to assist in determining which nanocompanies would receive funding. The Advisory Board membership would consist of two groups, (1) representatives of those investors who had provided more than $10 million to the Nanomanufacturing Investment Partnership (in short, the stakeholders) and (2) Presidential appointees drawn from government agencies, industry, and academia. This second group would control 60% of the votes on the Advisory Board and thus would really be the ones deciding where the money goes. This would seem to be a flaw in the bill; as we have seen in the recent past and may see again under future administrations, it is possible to politicize government agencies and as currently written, this section of the bill opens up that possibility here. It is possible that the bill may be amended in one of the committees before it is reported out or an amendment  may be adopted during floor debates.

The tax code would also be amended by creating tax credits to encourage the purchase of stock in qualified nanotechnology developers, as defined by the bill. Tax credits would also be available to cover up to 50% of the cost of nanotechnology education and training courses and programs.

The Secretary of Commerce would be directed to establish the “Nanotechnology Start Up Advisory Council” with membership drawn from industry, marketing, venture capitalist firms, attorneys, and nanotechnology researchers. The Council’s duty would be to review the business plans of nanotech start up companies, to insure that they were really viable plans.

Other sections of the bill would establish competitive grants to encourage the application of nanotechnologies to solving environmental problems, renewable energy sources,  health related uses, and homeland security programs.

The Secretary of Energy would be directed, six months following enactment, to deliver to Congress a report containing a plan to increase interaction on nanotech issues between scientists and engineers at DOE’s national laboratories and informal science education communities with the goal of developing exhibitions for school age children and the general public.

 

 

 

HR 2769, the “Commercializing Small Business Research and Development Act” introduced by Rep. Bobby Bright (Dem – AL -2nd Dist) on 06/09/2009, is not primarily a nanotechnology focused bill. It’s aim is to amend the Small Business Act . Section 4 of the bill is titled “Nanotechnology related research topics and is reprinted in it’s entirety below:

SEC. 4. NANOTECHNOLOGY-RELATED RESEARCH TOPICS.

(a) SBIR- Section 9(g)(3) of the Small Business Act (15 U.S.C. 638(g)(3)), as amended, is further amended--

(1) at the end of subparagraph (D) by striking `or';

(2) at the end of subparagraph (E) by adding `or'; and

(3) by adding at the end the following:

`(F) the national nanotechnology strategic plan required under section 2(c)(4) of the 21st Century Nanotechnology Research and Development Act (15 U.S.C. 7501(c)(4)) and in subsequent reports issued by the National Science and Technology Council Committee on Technology, focusing on areas of nanotechnology identified in such plan;'.

(b) STTR- Section 9(o)(3) of the Small Business Act (15 U.S.C. 638(o)(3)) is amended--

(1) at the end of subparagraph (A) by striking `or';

(2) at the end of subparagraph (B) by adding `or'; and

(3) by adding at the end the following:

`(C) by the national nanotechnology strategic plan required under section 2(c)(4) of the 21st Century Nanotechnology Research and Development Act (15 U.S.C. 7501(c)(4)) and in subsequent reports issued by the National Science and Technology Council Committee on Technology, focusing on areas of nanotechnology identified in such plan;'.

 

 

HR 2965, the “Enhancing Small Business Research and Innovation Act of 2009”, was introduced by Rep. Jason Altmire (Dem –PA – 4th Dist) on 06/19/2009. The bill would have amended and extended the Small Business Act sections on the  Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, which include nanobusinesses. HR 2965 was assigned to the House Committees on Small Business and Science and Technology. Both Committees reported the bill with amendments (H. Rept. 111-190 Pt. 1 and H. Rept. 111-190 Pt. 2).

 

 

Amended during floor debates, HR 2965 was passed by the House on a vote of 386-41 on 07/08/2009. On 07/09/2009, HR 2965 was received in the Senate, where it was called up for debate on 07/11/2009. The Senate amended HR 2965 by an amendment in the nature of a substitute. This means that the Senate voted to remove the language of the bill following the enacting clause and substituted the language of

S. 1233, the Senate version of the bill. The amended bill was then passed by unanimous consent. The amended bill does have a section (Sec. 206) that briefly treats nanotechnology:

 

 

SEC. 206. NANOTECHNOLOGY INITIATIVE.

 

(a) In General- Section 9 of the Small Business Act (15 U.S.C. 638), as amended by this Act, is amended by adding at the end the following:

`(ff) Nanotechnology Initiative- Each Federal agency participating in the SBIR or STTR program shall encourage the submission of applications for support of nanotechnology related projects to such program.'.

(b) Sunset- Effective October 1, 2014, subsection (ff) of the Small Business Act, as added by subsection (a) of this section, is repealed.

 

The bill was then returned to the calendar.

 

 

The House at some time will have to vote again on the amended HR 2695. If the House votes to pass the bill as amended by the Senate, it will be sent on to President Obama for his signature. If the House fails to pass the bill, it will not become law. There is the possibility that the House could further amend the bill and, if it insists on it’s amendment, a Conference Committee will be formed to come up with a compromise bill that both chambers could accept. Considering the popularity of these two programs, the bill in some form is likely to be passed before the end of the 1st Session.

 

Thursday, we'll examine the Senate bills.