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NIH Issues New Stem Cell Research Guidelines

Yesterday, July 6th, the National Institutes of Health issued new guidelines for the use of embryonic stem cells in research. The new guidelines reflect feedback received during a public comment period. Several higher education associations have praised NIH for addressing concerns with the initial draft guidelines.

SUMMARY: The National Institutes of Health (NIH) is hereby publishing final “National Institutes of Health Guidelines for Human Stem Cell Research” (Guidelines).

On March 9, 2009, President Barack H. Obama issued Executive Order 13505: Removing Barriers to Responsible Scientific Research Involving Human Stem Cells. The Executive Order states that the Secretary of Health and Human Services, through the Director of NIH, may support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell (hESC) research, to the extent permitted by law.

These Guidelines implement Executive Order 13505, as it pertains to extramural NIH-funded stem cell research, establish policy and procedures under which the NIH will fund such research, and helps ensure that NIH-funded research in this area is ethically responsible, scientifically worthy, and conducted in accordance with applicable law. Internal NIH policies and procedures, consistent with Executive Order 13505 and these Guidelines, will govern the conduct of intramural NIH stem cell research.

EFFECTIVE DATE: These Guidelines are effective on July 7, 2009.

SUMMARY OF PUBLIC COMMENTS ON DRAFT GUIDELINES: On April 23, 2009 the NIH published draft Guidelines for research involving hESCs in the Federal Register for public comment, 74 Fed. Reg. 18578 (April 23, 2009). The comment period ended on May 26, 2009.

The NIH received approximately 49,000 comments from patient advocacy groups, scientists and scientific societies, academic institutions, medical organizations, religious organizations, and private citizens. The NIH also received comments from members of Congress. This Notice presents the final Guidelines together with the NIH response to public comments that addressed provisions of the Guidelines.

Full NIH Guidelines on Embryonic Stem Cell Research

This Week on Capitol Hill, July 6-10

Monday, 7/6

In the Senate:

  • The Senate will resume consideration of a Legislative Branch appropriations bill (HR 2918).  Vote on final passage is expected today.
  • Appropriations subcommittee will mark up draft legislation for FY10 appropriations for Military Construction and Veterans Affairs.
  • Committee on Health, Education, Labor & Pensions will mark up draft legislation for Affordable Health Choices Act.

The House is not in session.

 Tuesday, 7/7

In the Senate:

  • Full Committee on Appropriations will mark up legislation for FY10 for Agriculture and Military Construction-Veterans Affairs.
  • Subcommittee of Banking, Housing & Urban Affairs will hold a hearing on “Public Transit and Climate Change.”

 In the House:

  • Will convene at 2:00 pm to consider several measures under suspension of the rules.
  • The Full Committee on Appropriations will mark up FY 2010 appropriations for Energy and Water, and Financial Services.

Wednesday, 7/8

In the Senate:

  • Appropriations Subcommittees will mark up legislation for FY10 for Energy and Water Development and Financial Services.
  • Full Committee on Commerce, Science and Transportation will mark up bills on transportation, technology, and environment
  • Finance Committee will hold a full committee hearing on “International Trade, Climate Change.”

Thursday, 7/9

In the House:

  • Will convene at 10:00 am to consider HR 2997, Fiscal 2010 Agriculture Appropriations.

 Friday, 7/10

In the House:

  • Will convene at 9:00 am and is expected to consider HR 3081, Fiscal 2010 State-Foreign Operations Appropriations, and HR 3082, Fiscal 2010 Military Construction-VA Appropriations.
  • Appropriations Subcommittee will mark up FY 2010 appropriations for Labor-HHS-Education.

 Source: CQ Today

Proposed FY10 Funding for Oceans Research

Below, please find an overview of funding provided for ocean research — thus far — in the FY10 appropriations process. The FY10 appropriations process will continue to play out over the course of the summer and early fall, with final bills expected by the start of the new fiscal year on October 1, 2009.

NSF Appropriations Account FY09 Final FY10 Request FY10 House FY10 Senate
Total NSF 6490.4 7045.0 6936.5 6916.8
Research and Related Activities 5183.1 5733.2 5642.1 5618.0
   Polar Programs 470.7 516.0    
    Geosciences Directorate 807.1 909.0    
        Ocean Sciences 330.4 359.1    
      Atmospheric Sciences 244.6 269.2    
      Earth Sciences 171.0 186.9    
Major Research Equipment 152.0 117.3 114.3 122.3
AdvLIGO 51.4 46.3 46.3  
    Atacama Large Millimeter Array 82.3 42.8 42.8  
    IceCube Neutrino Obs. 11.3 1.0 1.0  
    Advanced Solar Telescope   10.0    
    Neon        
    OOI   14.3 14.3  
   ARRV        
Education and Human Resources 845.3 858.0 862.9 0.0
NASA Appropriations Account FY09 Final FY10 Request FY10 House FY10 Senate
Total NASA 17782.4 18686.0 18203.3 18686.0
Science 4503.0 4477.2 4496.1 4517.0
Earth Science   1379.6 1405.0 1443.0 1405.0
Heliophysics 591.6 605.0 605.0 646.6
Planetary Science 1325.6 1346.2 1348.3 1354.8
Astrophysics 1206.2 1120.9 1170.9 1169.8
         
Earth System Missions 898.9 715.5 730.5 720.5
  NPOESS Prepatory Mission 57.1 112.8 112.8 112.8
  Decadal Survey 82.3      
  Ocean Surface Topography 8.0      
         
     Exploration Systems 3905.5 3963.1 3293.2 3940.4
     Aeronautics Research 650.0 507.0 501.0 507.0
     Education Programs 169.2 126.1 175.0 140.1
NOAA Program or Account FY09 Final FY10 Request FY10 House FY10 Senate
         
Total NOAA 4373.9 4483.8 4602.9 4772.8
Office of Oceanic & Atmospheric Research 396.7 394.2 426.7 419.8
   Ocean & Coastal Research 122.8 107.4 114.4 119.8
      Sea Grant College Program 55 55.1 59.1 63.1
      National Undersea Research Program 8.9 0 9 8.9
      Ocean Exploration 18.6 27.8 21.8 22.8
      Coastal, Ocean & Great Lakes Labs & Inst. 24.2 21.8 21.8 25.0
  Total Climate Research 196.5 209.8 229 209.8
      Climate & Atmos. Labs and Insts. 49.3 54.5 55.1 52.7
      Climate Data and Information 8.3 12.1 12.1 12.1
      Competitive Research Program  132 144.2 149.2 144.2
      Climate Operations 0.9 0.9 0.9 913.0
      Regional Climate Assessments     12  
     Weather Laboratories and Cooperative Institutes 53.3 52.7 54.9 54.5
   Info Tech, R&D, Science Education 14 13.1 13.1 13.2
         
 National Ocean Service (ORF) 497 462.7 482 511.6
Navigation Services 166.4 155.1 152.3 163.4
Ocean Resources Conserv. & Assess. 164 159.7 164.9 161.4
National Centers for Coastal Ocean Science 53.3 52 49.2 53.8
         Competitive External Research (HABS) 15.8 15.8 15.8 16.0
   Ocean Assessment Program 94.5 83.4 89.6 107.6
         Ocean Health Initiative 4 1 1 4.0
         Integrated Ocean Observing System – Grants 20 14.6 20 27.5
            IOOS Program Office 6.5 6.6 6.6 6.6
          Ocean Research Priorities Plan Implementation 0 6   6.0
   Ocean & Coastal Management 155.1 147.9 155.4 152.7
       Coastal Zone Management Grants 66.1 67.2 67.5 66.5
       Estuarine Research Reserve System 22.3 22.3 23.5 22.8
       National Marine Sanctuary Program 47.4 45 49.9 49.9
         
 National Marine Fisheries Service (ORF) 754 890.6 915.9 872.4
         
 National Weather Service (ORF) 848 867.2 857.2 889.1
         
National Environmental Satellite, Data & Information Service (ORF) 187.4 171.7 199.5 176.1
NESDIS PAC 990.6 1256.9 1268.9 1232.4
NESDIS TOTAL (ORF+PAC) 1178 1428.6 1468.4 1408.5
         
 Program Support total (ORF) 451 420 436 432.2
   Education Initiative/Program 46.1 20.7 35.3 35.0
         
 Procurement Acquisition & Construction 1245.7 1393.3 1441.2 1397.7

The Week at a Glance on Capitol Hill June 29-July 3

Congress is in recess this week.  The Senate will reconvene Monday, July 6th and the House will reconvene Tuesday, July 7th. 

Next week the Senate Appropriations (Full) Committee will mark up the FY2010 Agriculture  and Military Construction appropriations.   The full committee on Health, Education, Labor & Pensions will continue its markup on Health Care Overhaul.

In the House, the full Appropriations Committee will mark up FY2010 Energy and Water, Financial Services, and Labor-HHS-Education.

House Approves Comprehensive Clean Energy Bill

Late Friday night, before the commencement of a July 4th District Work Period (a.k.a. recess), the House of Representatives approved the American Clean Energy and Security Act by a slim 219-212 vote margin. The legislation; sponsored by Rep. Henry A. Waxman (D-CA), Chairman of the House Energy and Commerce Committee, and Rep. Edward J. Markey (D-MA), Chairman of the House Select Committee on Energy Independence and Global Warming; is designed to reduce pollution that causes global warming while simultaneously reducing U.S. dependence on foreign oil.

According to the House Energy and Commerce Committee, major provisions of the 1000 page bill include:

  • Requires electric utilities to meet 20% of their electricity demand through renewable energy sources and energy efficiency by 2020.
  • Invests $190 billion in new clean energy technologies and energy efficiency, including energy efficiency and renewable energy ($90 billion in new investments by 2025), carbon capture and sequestration ($60 billion), electric and other advanced technology vehicles ($20 billion), and basic scientific research and development ($20 billion).
  • Mandates new energy-saving standards for buildings, appliances, and industry.
  • Reduces carbon emissions from major U.S. sources by 17% by 2020 and over 80% by 2050 compared to 2005 levels. Complementary measures in the legislation, such as investments in preventing tropical deforestation, will achieve significant additional reductions in carbon emissions.
  • Protects consumers from energy price increases. According to recent analyses from the Congressional Budget Office and the Environmental Protection Agency, the legislation will cost each household less than 50 cents per day in 2020 (not including energy efficiency savings).

From the higher education perspective, the absence of funding for research sufficient to meet the greenhouse gas emissions targets set in the bill is seen as a major shortcoming. Congressman Rush Holt (D-NJ) has been outspoken on this issue; “”I remain deeply concerned that this bill does not include the necessary research and development funding that is needed to reach the 80 percent reduction target set in H.R. 2454.  We will not be able to meet this goal with today’s technologies, and as written the bill does not provide the billions of dollars a year that will be needed to develop them.  This is not a small or parochial concern.  If Americans and others around the world are to embrace a transformation in the way we use and produce energy, they must know that our effort includes the engine to drive the innovation for that transformation.  Without a very robust research effort—many billions of dollars—the vision of transformation will be a mirage and the public will know it. I have been assured by Chairman Waxman, Chairman Markey, Speaker Pelosi, members of the Administration and members of the Senate that they understand this shortcoming and that they will work with me to increase the research funding to drive the innovation we need to transform the way we produce and use energy.”

The much talked about “Innovation Hubs,” now included in the bill, do not completely reflect the vision of “Innovation Hubs” that the Obama administration laid out in the FY 2010 budget request. The legislation has a strong emphasis on translational, near commercialization research, whereas, Chu’s “Hubs” are described as covering the spectrum of R&D from basic research to commercialization.

It is exptected that this legislation will face a much tougher time in the Senate, where a fillibuster can be used by a minority to effectively stop the legislation from moving forward. The Obama administration has articulated that it expects a vote in the Senate in the fall.

HR 2454 Report