On August 4, 2010, FASEB submitted
comments in response to the Department of Health and Human Services (HHS) Notice of Proposed Rule Making on financial conflicts of interest. The response letter articulates FASEB’s support of efforts to maintain public trust and ensure scientific integrity, but calls on HHS to 1) exclude “reasonable and customary reimbursements” from the definition of significant financial interests, and 2) exclude income from “non-profit, member-based professional scientific or engineering societies” from the reporting requirements.
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NIFA Director
Meets With Stakeholders To Seek Input And
Address Concerns
National Institute of Food and Agriculture (NIFA) Director, Dr. Roger Beachy, addressed concerns of the agricultural research community and asked for additional input at a stakeholder meeting on July 29th. During the meeting, Dr. Beachy stated he hoped to reach a broad audience beyond the scientific societies that participated in previous NIFA listening sessions.
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House Holds Hearing on Status of Open Access
On July 29, 2010, the Information Policy, Census, and National Archives Subcommittee of the House Oversight and Government Reform Committee convened a hearing entitled “Public Access to Federally-Funded Research.” Subcommittee Chairman William Lacy Clay explained that the purpose of the hearing was to examine the current level of accessibility to federally-funded research and discuss increasing access.
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HHS and CDC Solicit Input on Select Agents and
Toxins List
The Department of Health and Human Services (HHS) and the Centers for Disease Control (CDC) are undertaking their biennial review and republication of the HHS list of select agents and toxins.
An Advance Notice of Proposed Rule Making (ANPRM) was published in the July 21st Federal Register seeking comments on the revision. HHS and CDC are interested in input on the content of the list (i.e., should agents be added or removed), whether the list should be tiered or stratified based on the risk posed by the agents, the criteria that should be used to designate high-risk and low risk agents, and the security measures that should be in place for those agents, among other issues. Stratification of the list was recommended by the National Science Advisory Board for Biosecurity and the National Research Council.
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HHS Proposes Modifications to HIPAA Research
Provisions
On July 14th, the Department of Health and Human Services (HHS) released a
Notice of Proposed Rule Making (NPRM) on “Modifications to the HIPAA Privacy, Security, and Enforcement Rules Under the Health Information and Technology for Economic and Clinical Health (HI-TECH) Act.” The Notice proposes modifications to the Health Insurance Portability and Accountability Act (HIPAA) in order to: implement recent statutory amendments enacted through the HI-TECH act, strengthen the privacy and security of protected health information (PHI), and improve the workability and effectiveness of HIPAA.
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