Department of Health and Human Services April 21, 2009 – Federal Register Recent Federal Regulation Documents
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Meeting of the Advisory Committee on Minority Health
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. This meeting is open to the public. Preregistration is required for both public attendance and comment. Any individual who wishes to attend the meeting and/or participate in the public comment session should e-mail acmh@osophs.dhhs.gov.
Notice of Availability of Federal Matching Shares for Medicaid and Foster Care and Adoption Assistance
The Federal Medical Assistance Percentages (FMAPs) for the first two quarters of Fiscal Year 2009 have been recalculated pursuant to the American Recovery and Reinvestment Act (ARRA). These percentages will be effective from October 1, 2008 through March 31, 2009. This notice announces the calculated FMAPs that the U.S. Department of Health and Human Services (HHS) will use in determining the amount of Federal matching for State medical assistance under Title XIX and Title IV-E. The table gives figures for each of the 50 States and the District of Columbia. Adjusted figures are not shown for Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands since territories have a choice between two methodologies to determine their recalculated figures. Programs under title XIX of the Act exist in each jurisdiction. The percentages in this notice only apply to State expenditures for most medical services and medical insurance services. The statute provides separately for Federal matching of administrative costs.
Guidance for Industry on Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document.'' Since FDA began accepting new drug application (NDA) and biologics license application (BLA) submissions in the common technical document (CTD) format, there has been confusion regarding where within the CTD to include an integrated summary of effectiveness (ISE) and integrated summary of safety (ISS), both of which are required components of an NDA submission and recommended components of a BLA submission. This guidance informs applicants where to place the ISE and
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