Department of Health and Human Services August 2, 2013 – Federal Register Recent Federal Regulation Documents
Results 1 - 22 of 22
Pfizer, Inc.; Withdrawal of Approval of a New Drug Application for BEXTRA
The Food and Drug Administration (FDA) is withdrawing approval of a new drug application (NDA) for BEXTRA (valdecoxib) 10 milligram (mg) and 20 mg Tablets, held by Pfizer, Inc. (Pfizer), 235 East 42nd St., New York, NY 10017-5755. Pfizer has voluntarily requested that approval of this application be withdrawn and has waived its opportunity for a hearing.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Medical Device User Fee Cover Sheet, Form FDA 3601
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Medical Device User Fee Cover Sheet, Form FDA 3601'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Cooperative Agreement to Support the Food and Agriculture Organization
The Food and Drug Administration (FDA) is announcing its intention to receive and consider a single source application for award of a cooperative agreement in fiscal year 2013 to the Food and Agriculture Organization (FAO) of the United Nations to support global strategies that address food safety and public health. The goal of this collaborative project between FDA and FAO is to contribute to the knowledge base and development of food safety systems globally due to the increasingly diverse and complex food supply. The project is also designed to enhance and broaden FDA's ability to address global food safety and public health issues associated with food as well as provide opportunities to leverage additional resources of other countries. The collaborative project will also support the FDA's implementation of the FDA Food Safety Modernization Act (FSMA), including FDA's International Food Safety Capacity Building Plan, which emphasizes the concept of preventing food safety-related problems before they occur and the importance of establishing strong relationships and mutual support among all stakeholders, including multilateral organizations, to improve worldwide food safety. In addition, the collaborative project will support food safety, nutrition, and public health programs that align with FDA's mission.
Human Immunodeficiency Virus Patient-Focused Drug Development and Human Immunodeficiency Virus Cure Research; Reopening of Comment Period
The Food and Drug Administration (FDA) is reopening the comment period for the notice of public meeting entitled ``Human Immunodeficiency Virus (HIV) Patient-Focused Drug Development and HIV Cure Research,'' published in the Federal Register of May 21, 2013 (78 FR 29755). In that notice, FDA requested public comment regarding patients' perspective on current approaches to managing HIV, symptoms experienced because of HIV or its treatment, and issues related to HIV cure research. FDA is reopening the comment period to allow interested persons additional time to submit comments.
Draft Guidance for Industry on Bioequivalence Recommendations for Mesalamine Rectal Suppositories; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Bioequivalence Recommendations for Mesalamine.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for mesalamine rectal suppositories. The draft guidance is a revised version of a previously issued draft guidance on the same subject.
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.
Generic Drug User Fee-Abbreviated New Drug Application, Prior Approval Supplement, Drug Master File, Final Dosage Form Facility, and Active Pharmaceutical Ingredient Facility Fee Rates for Fiscal Year 2014
The Food and Drug Administration (FDA) is announcing the rate for the abbreviated new drug application (ANDA), prior approval supplement to an approved ANDA (PAS), drug master file (DMF), generic drug active pharmaceutical ingredient (API), and finished dosage form (FDF) facilities user fees related to the Generic Drug User Fee Program for fiscal year (FY) 2014. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Generic Drug User Fee Amendments of 2012 (GDUFA), as further amended by the FDA User Fee Correction Act of 2012, authorizes FDA to assess and collect user fees for certain applications and supplements for human generic drug products, on applications in the backlog as of October 1, 2012 (only applicable to FY 2013), on FDF and API facilities, and on type II active pharmaceutical ingredient DMFs to be made available for reference. GDUFA directs FDA to establish each year the Generic Drug User Fee rates for the upcoming year, and publish those rates in the Federal Register 60 days before the start of the upcoming FY. This document establishes FY 2014 rates for an ANDA ($63,860), PAS ($31,930), DMF ($31,460), domestic API facility ($34,515), foreign API facility ($49,515), domestic FDF facility ($220,152), and foreign FDF facility ($235,152). These fees are effective on October 1, 2013, and will remain in effect through September 30, 2014.
Prescription Drug User Fee Rates for Fiscal Year 2014
The Food and Drug Administration (FDA) is announcing the rates for prescription drug user fees for fiscal year (FY) 2014. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Prescription Drug User Fee Amendments of 2012, 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 2014 for application fees for an application requiring clinical data ($2,169,100), for an application not requiring clinical data or a supplement requiring clinical data ($1,084,550), for establishment fees ($554,600), and for product fees ($104,060). These fees are effective on October 1, 2013, and will remain in effect through September 30, 2014. For applications and supplements that are submitted on or after October 1, 2013, the new fee schedule must be used. Invoices for establishment and product fees for FY 2014 will be issued in August 2013 using the new fee schedule.
Medical Device User Fee Rates for Fiscal Year 2014
The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2014. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device User Fee Amendments of 2012, which was signed by the President on July 9, 2012 (MDUFA III), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. The FY 2014 fee rates are provided in this document. These fees apply from October 1, 2013, through September 30, 2014. 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 recognized by the U.S. Treasury. If you want 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 have to pay the higher standard fee. This document provides information on how the fees for FY 2014 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.
Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2014
The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2014 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, 2013, and will remain in effect through September 30, 2014.
Biosimilar User Fee Rates for Fiscal Year 2014
The Food and Drug Administration (FDA) is announcing the rates for biosimilar user fees for fiscal year (FY) 2014. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Act of 2012 (BsUFA), 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. These fees are effective on October 1, 2013, and will remain in effect through September 30, 2014.
Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2014
The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for fiscal year (FY) 2014 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 Amendments of 2013, which was signed by the President on June 13, 2013 (AGDUFA II), 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 2014.
Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2014
The Food and Drug Administration (FDA) is announcing the rates and payment procedures for fiscal year (FY) 2014 animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Animal Drug User Fee Amendments of 2013, which was signed by the President on June 13, 2013 (ADUFA III), 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 2014.
Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance for Industry: Use of Serological Tests To Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion
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 concerning establishment notification of a consignee and consignee notification of a recipient's physician of record regarding a possible increased risk of Trypanosoma cruzi (T. cruzi) infection.
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