Department of Health and Human Services January 6, 2010 – Federal Register Recent Federal Regulation Documents
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Extramural Support Reimbursement of Travel and Subsistence Expenses Toward Living Organ Donation Program
Congress has provided specific authority under section 377 of the Public Health Service (PHS) Act, 42 U.S.C. 274f, as amended by Public Law 108-216 for providing reimbursement of travel and subsistence expenses for certain individuals donating their organs. Additionally, Congress authorized the Secretary to provide reimbursement for other incidental non-medical expenses as the Secretary determines by regulation to be appropriate.
Guidance for Industry on New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products,'' dated December 2009. As part of the Medical Device User Fee Amendments of 2007 (MDUFA) Commitment for the Performance Goals and Procedures commitment letter, FDA agreed to publish guidance for medical imaging devices for use with imaging contrast agents or radiopharmaceuticals. FDA intends this guidance to assist developers of medical imaging devices and imaging drug/biological products that provide image contrast enhancement. The final guidance announced in this document fulfills FDA's commitment to issue guidance called for by the commitment letter. The guidance supercedes the draft guidance of the same title dated September 30, 2008.
Anesthetic and Life Support Drugs Advisory Committee; Cancellation
The meeting of the Anesthetic and Life Support Drugs Advisory Committee scheduled for January 28, 2010, is cancelled. This meeting was announced in the Federal Register of December 8, 2009 (74 FR 64702). This meeting has been cancelled to allow time for the FDA to review new information that is relevant to the benefit risk balance for the proposed new indication. The agency intends to continue evaluating the application and, as needed, will announce future meeting dates in the Federal Register.
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