Department of Health and Human Services August 1, 2011 – Federal Register Recent Federal Regulation Documents
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Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Calculation of Annual Federal Medical Assistance Percentages for Indian Tribes for Use in the Title IV-E Foster Care, Adoption Assistance, and Kinship Guardianship Assistance Programs
This notice finalizes the methodology that will be used to calculate reimbursement rates applicable to fiscal years 2010 and beyond for assistance payments under the tribal Foster Care, Adoption Assistance and Guardianship Assistance Programs authorized by title IV- E of the Social Security Act. A Notice with Comment Period on this topic was previously published on October 8, 2010.
Center for Devices and Radiological Health 510(k) Clearance Process; Institute of Medicine Report: “Medical Devices and the Public's Health, The FDA 510(k) Clearance Process at 35 Years;” Request for Comments
The Food and Drug Administration (FDA) is requesting comments on the Institute of Medicine (IOM) report entitled: ``Medical Devices and the Public's Health, The FDA 510(k) Clearance Process at 35 Years.'' The establishment of this public docket does not signify FDA endorsement or concurrence with any of the conclusions or recommendations contained within the report. FDA may, in the future, take additional measures to solicit public input in the report and specific recommendations contained therein. FDA will not adopt any of the recommendations contained in the report before the close of this comment period.
Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2012
The Food and Drug Administration (FDA) is announcing the rates and payment procedures for fiscal year (FY) 2012 animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Animal Drug User Fee Act of 2003 (ADUFA) and the Animal Drug User Fee Amendments of 2008 (ADUFA II), authorizes FDA to collect user fees for certain animal drug applications and supplements, on certain animal drug products, on certain establishments where such products are made, and on certain sponsors of such animal drug applications and/or investigational animal drug submissions. This notice establishes the fee rates for FY 2012.
Medical Device User Fee Rates for Fiscal Year 2012
The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2012. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device User Fee Amendments of 2007 (title II of the Food and Drug Administration Amendments Act of 2007 (FDAAA)), authorizes FDA to collect user fees for certain medical device submissions, and annual fees for certain periodic reports and for certain establishments subject to registration. The FY 2012 fee rates are provided in this document. These fees apply from October 1, 2011, through September 30, 2012. To avoid delay in the review of your application, you should pay the fee before or at the time you submit your application to FDA. The fee you must pay is the fee that is in effect on the later of the date that your application is received by FDA or the date your fee payment is received. In order to pay a reduced small business fee, you must qualify as a small business before you make your submission to FDA; if you do not qualify as a small business before you make your submission to FDA, you will be required to pay the higher standard fee. This document provides information on how the fees for FY 2012 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.
Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2012
The Food and Drug Administration (FDA) is announcing the rates and payment procedures for fiscal year (FY) 2012 generic new animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Animal Generic Drug User Fee Act of 2008 (AGDUFA), authorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, on certain generic new animal drug products, and on certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs. This notice establishes the fee rates for FY 2012.
Burden of Food and Drug Administration Food Safety Modernization Act Fee Amounts on Small Business; Request for Comments
The Food and Drug Administration (FDA) is announcing the establishment of a docket to obtain information that will be used to formulate a proposed set of guidelines in consideration of the burden of fee amounts on small business, as set forth in the FDA Food Safety Modernization Act (FSMA). FSMA provides the Agency with authority under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to assess and collect user fees, including those for costs associated with certain domestic and foreign facility reinspections, failure to comply with a recall order, and importer reinspections. The Agency is seeking public comment on what burdens these fees impose on small business, and whether and how the Agency should alleviate such burdens. In particular, the Agency is seeking public comments on whether a reduction of fees or other consideration for small business is appropriate, and if so, what factors the Agency should consider for each. In addition, the Agency is seeking public comment on how small business should be defined or recognized. FDA is establishing this docket in order to provide an opportunity for interested parties to provide data and share views that will inform future Agency actions with respect to these matters.
Prescription Drug User Fee Rates for Fiscal Year 2012
The Food and Drug Administration (FDA) is announcing the rates for prescription drug user fees for fiscal year (FY) 2012. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Prescription Drug User Fee Amendments of 2007 (Title 1 of the Food and Drug Administration Amendments Act of 2007 (FDAAA)) (PDUFA IV), authorizes FDA to collect user fees for certain applications for approval of drug and biological products, on establishments where the products are made, and on such products. Base revenue amounts to be generated from PDUFA fees were established by PDUFA IV, with provisions for certain adjustments. Fee revenue amounts for applications, establishments, and products are to be established each year by FDA so that one-third of the PDUFA fee revenues FDA collects each year will be generated from each of these categories. This document establishes fee rates for FY 2012 for application fees for an application requiring clinical data ($1,841,500), for an application not requiring clinical data or a supplement requiring clinical data ($920,750), for establishment fees ($520,100), and for product fees ($98,970). These fees are effective on October 1, 2011, and will remain in effect through September 30, 2012. For applications and supplements that are submitted on or after October 1, 2011, the new fee schedule must be used. Invoices for establishment and product fees for FY 2012 will be issued in August 2011, using the new fee schedule.
Food Safety Modernization Act Domestic and Foreign Facility Reinspections, Recall, and Importer Reinspection User Fee Rates for Fiscal Year 2012
The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2012 fee rates for certain domestic and foreign facility reinspections, failure to comply with a recall order, and importer reinspections that are mandated in the Federal Food, Drug, and Cosmetic Act (the FD&C Act), amended by the FDA Food Safety Modernization Act (FSMA). These fees are effective on October 1, 2011, and will remain in effect through September 30, 2012. Invoices for these fees for FY 2012 will be issued using the fee schedule established in this document. FDA is accepting comments to this document and intends to consider such comments in implementing these user fees in FY 2013.
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