CONGRESS PASSES CONTINUING RESOLUTION

Last week, the House and Senate considered and passed, H.J. Res. 52, a Continuing Resolution (CR) to keep the Government running at current funding levels until November 16, 2007.  That is the date by which Democratic leaders have indicated they would like to complete all their work for the year.  However, another CR is likely to be required before the Congress and Administration are able to resolve their differences.

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STATUS OF FY2008 APPROPRIATIONS BILLS:

FASEB’s Office of Public Affairs currently tracks the appropriations for six agencies (NIH, NSF, DOE, VA, NASA, and USDA). The CR funding levels for each of these agencies will be at the FY2007 level.

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INSIDE (The Beltway) SCOOP–Jon Retzlaff, Legislative Director

Last week, the Senate Appropriations Committee listened to Defense Secretary Robert Gates testify in support of the President’s FY2008 supplemental appropriations request for the wars in Iraq and Afghanistan. At the hearing, Mr. Gates explained that the Bush administration was requesting an additional $42 billion for war-related expenses in FY2008. The request increases to $184 billion the amount the Bush administration is seeking for FY2008 to finance military operations in Iraq and Afghanistan. Therefore, to simplify, the President is asking Congress to support the $42 billion supplemental request because he has begun to realize that he didn’t ask for enough money to support the wars when he submitted his original defense budget request to Congress (which was submitted during the first week of February, 2007).

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BILLS

FDA Amendments Act of 2007 (H.R. 3580) – Clinical Trials Registry

On September 27, 2007, the President signed H.R. 3580, the Food and Drug Administration Amendments Act of 2007, as Public Law 110-85. The Senate passed the legislation on September 20th by unanimous consent after the bill was passed by the House on September 19th by a vote of 405-7 under suspension of the rules. H.R. 3580 represents the conference agreement for S. 1082, which passed the Senate on May 9, and H.R. 2900, which passed the House on July 11. The bill is focused primarily on FDA and contains sections regarding user fees and drug safety monitoring procedures. The bill also contains the following provisions of interest to NIH: (1) Title III would require NIH to expand research on pediatric medical devices; (2) Title V would reauthorize the Best Pharmaceuticals for Children Act; (3) Title VIII would expand the Clinicaltrials.gov registry to include mandatory reporting of certain drug and device clinical trials; and (4) Title XI would make technical changes to Title IV of the PHS Act, where NIH statutory authorities are located. The bill would require the establishment within one year of a “basic results” database that would contain basic demographic information as well as information on primary and secondary outcome measures. The Secretary would be charged with promulgating regulations within three years to expand the results database to include adverse event information, as well as additional summary information regarding results.

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NIH Policy News

National Cancer Institute Publishes NCI Best Practices for Biospecimen Resources

The availability of high quality, privacy protected biospecimens is critical to supporting development of new genomic- and proteomic-based cancer interventions. Understanding the need to unify and standardize practices around the use of biospecimens and biospecimen resources, the National Cancer Institute (NCI) published the NCI Best Practices for Biospecimen Resources (NCI Best Practices) in June 2007, following significant due diligence and approval by the National Cancer Advisory Board. This document outlines best practices to optimize the quality and accessibility of biospecimens to the research community.

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CONGRESSIONAL SCHEDULE

The House and Senate are in session. The Senate has scheduled a one-week recess beginning October 8, 2007. The House plans to remain in session while the Senate is on recess that week.

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