Department of Health and Human Services September 15, 2008 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Generic New Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2009
The Food and Drug Administration (FDA) is announcing the rates and payment procedures for fiscal year (FY) 2009 generic new animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the 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 a generic new animal drug, 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 2009. For FY 2009, the generic new animal drug user fee rates are: $41,400 for each abbreviated application for a generic new animal drug; $3,005 for each generic new animal drug product; $56,350 for each generic new animal drug sponsor paying 100 percent of the sponsor fee; $42,265 for each generic new animal drug sponsor paying 75 percent of the sponsor fee; and $28,175 for a generic new animal drug sponsor paying 50 percent of the sponsor fee. FDA will issue invoices for FY 2009 product and sponsor fees by December 31, 2008, or within 30 days of enactment of an appropriation for these fees, whichever is later. These fees will be due and payable within 30 days of the issuance of the invoices. The application fee rates are effective for all abbreviated applications for generic new animal drugs submitted on or after July 1, 2008, and will remain in effect through September 30, 2009. However, FDA may not collect application fees until enactment of an appropriation for these fees. Within 30 days of enactment of an appropriation for these fees, FDA will issue invoices for applications received on or after July 1, 2008, and will publish a Federal Register notice stating that for the remainder of fiscal year 2009 FDA will not accept any further abbreviated applications for generic new animal drugs for review until FDA has received full payment of application fees and any other generic new animal drug user fees owed. That Federal Register notice will also provide instructions for payment of abbreviated applications for generic new animal drug fees.
Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2009
The Food and Drug Administration (FDA) is announcing the rates and payment procedures for fiscal year (FY) 2009 for user fees under the Animal Drug User Fee Act program (ADUFA). The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Animal Drug User Fee Act of 2003 (ADUFA I), and the Animal Drug User Fee Amendments of 2008 (ADUFA II), authorizes FDA to collect user fees for certain animal drug applications, 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 2009. For FY 2009, the animal drug user fee rates are: $246,300 for an animal drug application; $123,150 for a supplemental animal drug application for which safety or effectiveness data is required and for an animal drug application subject to certain criteria; $4,925 for an annual product fee; $59,450 for an annual establishment fee; and $52,700 for an annual sponsor fee. FDA will issue invoices for FY 2009 product, establishment, and sponsor fees by December 31, 2008, and these invoices will be due and payable on or before January 31, 2009. FDA will issue invoices in November 2009 for any products, establishments, and sponsors that are subject to fees for FY 2009 but that qualified for fees after the December 2008 billing. The application fee rates are effective for applications submitted on or after October 1, 2008, and will remain in effect through September 30, 2009. Applications will not be accepted for review until FDA has received full payment of application fees and any other animal drug user fees owed.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Testimony by Employees and the Production of Documents in Proceedings Where the United States Is Not a Party
This rule amends Part 2 of Title 45 of the Code of Federal Regulations, which provides that employees and former employees of the Department of Health and Human Services (HHS or Department) may not provide testimony as part of their official duties in litigation where the United States or a federal agency is not a party, without the approval of the head of the agency. The purpose of these amendments is to modify the definition of ``employee'' contained in 45 CFR part 2. Under these amendments, the definition of employee will be revised to reflect changes in Medicare contracting, including changes brought about by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173). In addition, the definition of employee will be modified to include employees of a state agency performing survey, certification, or enforcement functions under Title XVIII of the Social Security Act or Section 353 of the Public Health Service Act. Further, the definition of employee with respect to employees of entities covered by the Federally Supported Health Centers Assistance Act, as amended, 42 U.S.C. 233(g)-(n) (FSHCAA), will be limited to testimony requested in medical malpractice tort litigation which relates to medical functions performed at a time when the center was covered under FSHCAA.
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