Department of Health and Human Services August 2012 – Federal Register Recent Federal Regulation Documents
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Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Mepur H. Ravindranath, Ph.D., John Wayne Cancer Institute: Based on the report of an investigation conducted by the John Wayne Cancer Institute (JWCI) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Mepur H. Ravindranath, former Director of the Laboratory of Glycoimmunotheraphy, JWCI, engaged in research misconduct in research supported by National Cancer Institute (NCI), National Institutes of Health (NIH), awards R21 CA107316 and R03 CA107831. ORI found that the Respondent engaged in research misconduct by falsifying results reported for research supported by U.S. Public Health Service (PHS) grants R21 CA107316 and R03 CA107831, in progress reports for those grants and in two publications in scientific journals. It is expressly understood that by entering into a Voluntary Settlement Agreement (Agreement), Respondent is not admitting to any of the allegations made against him by JWCI and/or ORI, or any of their respective agents, employees, associates, or related persons, including but not limited to the findings made by ORI listed in the Agreement. Respondent agreed to enter into the Agreement and not to contest the findings contained therein solely because contesting the findings would cause Respondent undue financial hardship and stress, and Respondent wished to seek finality.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments and Listing of Ingredients in Tobacco Products
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.
Implementation of Device Registration and Listing Requirements Enacted in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, the Medical Device User Fee and Modernization Act of 2002, and Title II of the Food and Drug Administration Amendments Act of 2007
The Food and Drug Administration (FDA) is amending its regulations to reflect recent statutory amendments to the device registration and listing provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The Food and Drug Administration Amendments Act of 2007 (FDAAA), enacted on September 27, 2007, amended the FD&C Act by requiring domestic and foreign device establishments to begin submitting their registration and device listing information to FDA by electronic means rather than on paper forms, and also specified the timeframes when establishments are required to submit such information. In addition, this final rule would facilitate FDA's collection of additional registration information from foreign establishments as required by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act). The final rule will update certain provisions in the regulations to improve the quality of registration and listing information available to FDA. FDA relies on having complete and accurate registration and listing information in order to accomplish a number of important public health objectives.
Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2013
This notice updates the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs), for fiscal year (FY) 2013.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Reclassification Petitions for Medical Devices
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Reclassification Petitions for Medical Devices'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Applications for Food and Drug Administration Approval To Market a New Drug; Revision of Postmarketing Reporting Requirements-Discontinuance
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information including each proposed extension of an existing collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the reporting requirements contained in FDA's regulations on postmarketing reporting of information pertaining to drug shortages.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use
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.
Biosimilar User Fee Rates for Fiscal Year 2013
The Food and Drug Administration (FDA) is announcing the rates for biosimilar user fees for fiscal year (FY) 2013. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Act of 2012 (BsUFA) (Title IV of the Food and Drug Administration Safety and Innovation Act, Public Law 112-144, which was signed by the President on July 9, 2012), authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development, for certain applications and supplements for approval of biosimilar biological products, on establishments where approved biosimilar biological product products are made, and on biosimilar biological products after approval. BsUFA directs FDA to establish, before the beginning of each fiscal year, the initial and annual biosimilar biological product development (BPD) fees, the reactivation fee, and the biosimilar biological product application, establishment, and product fees. Under BsUFA, the initial and annual BPD fee rates for a fiscal year are equal to 10 percent of the fee rate established under the Prescription Drug User Fee Act (PDUFA) for an application requiring clinical data for that fiscal year (FY). The reactivation fee is equal to 20 percent of the fee rate established under PDUFA for an application requiring clinical data for that fiscal year. Finally, the application, establishment, and product fee rates under BsUFA are equal to the application, establishment, and product fee rates under PDUFA, respectively. This document, which establishes FY 2013 rates for BsUFA fees, uses the PDUFA application, establishment, and product fee amounts for FY 2013 published elsewhere in this issue of the Federal Register. The FY 2013 rates for BsUFA fees are as follows: Initial and annual biosimilar BPD fees ($195,880), reactivation fee ($391,760), fee for a biosimilar biological product application requiring clinical data ($1,958,800), fee for a biosimilar biological product application not requiring clinical data ($979,400), fee for a biosimilar biological product supplement requiring clinical data ($979,400), biosimilar biological product establishment fee ($526,500), and biosimilar biological product fee ($98,380). These fees are effective on October 1, 2012, and will remain in effect through September 30, 2013.
Prescription Drug User Fee Rates for Fiscal Year 2013
The Food and Drug Administration (FDA) is announcing the rates for prescription drug user fees for fiscal year (FY) 2013. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Prescription Drug User Fee Amendments of 2012 (Title 1 of the Food and Drug Administration Safety and Innovation Act (FDASIA), Public Law 112- 144, which was signed by the President on July 9, 2012) (PDUFA V)), 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 V, 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 2013 for application fees for an application requiring clinical data ($1,958,800), for an application not requiring clinical data or a supplement requiring clinical data ($979,400), for establishment fees ($526,500), and for product fees ($98,380). These fees are effective on October 1, 2012, and will remain in effect through September 30, 2013. For applications and supplements that are submitted on or after October 1, 2012, the new fee schedule must be used. Invoices for establishment and product fees for FY 2013 will be issued in August 2012 using the new fee schedule.
Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2013
The Food and Drug Administration (FDA) is announcing the rates and payment procedures for fiscal year (FY) 2013 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, for certain generic new animal drug products, and for 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 2013.
Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2013
The Food and Drug Administration (FDA) is announcing the rates and payment procedures for fiscal year (FY) 2013 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, for certain animal drug products, for certain establishments where such products are made, and for certain sponsors of such animal drug applications and/or investigational animal drug submissions. This notice establishes the fee rates for FY 2013.
Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies Federal agencies of the Laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently certified Laboratories and Instrumented Initial Testing Facilities (IITF) is published in the Federal Register during the first week of each month. If any Laboratory/IITF's certification is suspended or revoked, the Laboratory/IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any Laboratory/IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// www.workplace.samhsa.gov and https://www.drugfreeworkplace.gov.
Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2013
The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2013 fee rates for certain domestic and foreign facility reinspections, failures to comply with a recall order, and importer reinspections that are authorized by the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). These fees are effective on October 1, 2012, and will remain in effect through September 30, 2013.
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