2010-08-19

Congress Advances FY 2011 NIH Funding Bills; Grassroots Advocacy Needed
On July 29, the Senate Appropriations Committee approved its version of the FY 2011 Labor, Health and Human Services (HHS), Education, and Related Agencies Appropriations bill. The Senate bill recommends just over $32 billion to fund biomedical research at the National Institutes of Health (NIH), an amount equal to the President's request and the amount contained in a bill approved by the House Subcommittee on July 15. The full Senate will not vote on the Labor-HHS Appropriations bill before September. ASH will continue its advocacy efforts on Capitol Hill during the FY 2011 budget debate and encourages all members to visit the ASH Advocacy Center to join the Society’s campaign to support increased funding for NIH. Read more.

House and Senate Introduce Legislation to Reauthorize National Bone Marrow and Umbilical Cord Programs
The U.S. House of Representatives and the U.S. Senate have introduced legislation to reauthorize federally funded programs that provide for the collection and maintenance of human cord blood stem cells for the treatment of patients and research. Read more.

ASH Submits Comments in Response to NIH Conflict of Interest Proposed Revisions
ASH submitted comments in response to a May 21 Notice of Proposed Rulemaking  that seeks to amend current regulations governing "Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding Is Sought” (more commonly referred to as NIH’s conflict of interest regulations). Read more.

ASH Submits Comments on Inclusion of Clinical Trials Coverage Provision Among Health Reform Benefits Deemed Not Applicable to “Grandfathered” Health Plans
ASH has joined with a number of organizations to submit comments in response to a proposed regulation that includes coverage of routine patient costs associated with clinical trial participation among the benefits deemed to be not applicable to certain health plans in existence prior to enactment of the health reform law. Read more.

NIH Announces New Policy on Grant Application Supplementary Materials
NIH has announced a new policy, effective for applications received on or after September 25, 2010, on the submission of supplementary materials after application deadlines for peer-reviewed grants. Post-submission grant application materials are those submitted after submission of the grant application but prior to the initial peer review. This option is to be used for unforeseen administrative issues and unexpected events, such as the departure of a participant, natural disaster, etc., not to correct oversights/errors discovered after submission of the application. Read more.

NIH Office of Extramural Research Releases August 2010 Newsletter
The NIH Office of Extramural Research has released its August 2010 newsletter, which includes information on the importance of communicating the intent and potential value of research in grant applications. Read more.

NRC to Develop Policy on CsCl Radiation Sources Recommending Security Over Replacement; ASH Seeks Member Participation in Stakeholder Meeting
The Nuclear Regulatory Commission (NRC) is developing a policy on cesium chloride (CsCl)-containing irradiators recommending security over replacement – a direction that ASH strongly supported. The NRC is adapting an earlier staff report that included these recommendations, based on a 2008 workshop and focus groups conducted in 2009 in which ASH participated. The NRC is seeking comments on the draft policy, and will hold a public meeting in November. ASH will be submitting comments on this proposed policy and is looking for interested members to participate in the stakeholder meeting. Read more.

CMS Decides That Stem Cell Transplantation for Myelodysplastic Syndrome Should be Offered Through Coverage With Evidence Development (CED)
The Centers for Medicare and Medicaid Services (CMS) has determined that allogeneic hematopoietic stem cell transplantation (HSCT) for Myelodysplastic Syndrome (MDS) should be available only through participation in an approved clinical study. CMS has chosen this course of action because it determined that there was inadequate evidence to demonstrate that HSCT improves outcomes for MDS patients. Read more.

FDA Announces Reorganization of the Office of Oncology Drug Products
As part of recent organizational changes within the Food and Drug Administration (FDA), the Office of Oncology Drug Products (OODP) is planning a reorganization that is expected to take effect in 2011. The OODP, which currently comprises three divisions, will change its name to the Office of Hematology and Oncology Products (OHOP) and create a new structure with four divisions. Read more.