Department of Health and Human Services October 17, 2016 – Federal Register Recent Federal Regulation Documents
Results 1 - 20 of 20
Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds
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 recordkeeping requirements for manufacturers of medicated animal feeds.
Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Drug User Fee Act Waivers and Reductions
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 paperwork burden of requesting a waiver or reduction of fees under Animal Drug User Fee Act (ADUFA).
Abbreviated New Drug Application Submissions-Prior Approval Supplements Under Generic Drug User Fee Amendments; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``ANDA SubmissionsPrior Approval Supplements Under GDUFA.'' The Generic Drug User Fee Amendments of 2012 (GDUFA) enables FDA to assess user fees to fund critical and measurable improvements to FDA's generic drugs program. This guidance is intended to assist applicants preparing to submit to FDA prior approval supplements (PASs) and amendments to PASs for abbreviated new drug applications (ANDAs). It describes FDA's performance metric goals for PASs and clarifies how FDA will handle a PAS and amendments to a PAS for an ANDA subject to GDUFA performance metric goals. This guidance finalizes the draft guidance issued on July 11, 2014.
Electronic Submission of Labeling for Certain Home-Use Medical Devices
The Food and Drug Administration (FDA) is proposing to implement provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to require electronic submission of the device label and package insert of certain home-use devices when these devices are listed with FDA. FDA plans to make this device labeling available to the public through the Internet and would also provide search tools to facilitate locating information concerning a particular home-use device or a particular type of home-use device.
Substitutability of Generic Drugs: Perceptions and Reality; Public Workshop
The Food and Drug Administration (FDA), in collaboration with the Johns Hopkins University Center of Excellence in Regulatory Science and Innovation, is announcing a public workshop entitled ``Substitutability of Generic Drugs: Perceptions and Reality.'' The objective of this workshop is to discuss FDA and industry practices related to postmarket surveillance of generic drugs, postmarket generic drug research activities, public perceptions of generic drug quality and effectiveness, and verification of therapeutic equivalence of generic drugs. This workshop will also give stakeholders, including scientists from government, academia, and industry, patient advocacy groups, clinicians, pharmacists, and the general public an opportunity to provide their insights on future research needs in postmarket surveillance of generic drugs.
Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Type A Medicated Articles
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 recordkeeping requirements for manufacturers of Type A medicated articles.
Medical Devices; Cardiovascular Devices; Classification of the Apical Closure Device
The Food and Drug Administration (FDA) is classifying the apical closure device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the apical closure device's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Advisory Council on Alzheimer's Research, Care, and Services; Meeting
This notice announces the public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). The Advisory Council on Alzheimer's Research, Care, and Services provides advice on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. The theme of the October meeting will be on racial and ethnic disparities in research and care for dementia. Presentations will focus on general demographics, gaps and barriers that various groups face in obtaining services, and successful interventions to reduce these gaps. Additional presentations in the afternoon will include further discussion of the 2016 Update to the National Plan, updates on progress towards a Care and Services Summit, and federal workgroup updates.
Issuance of Priority Review Voucher; Rare Pediatric Disease Product
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria. FDA has determined that EXONDYS 51 (eteplirsen), manufactured by Sarepta Therapeutics, meets the criteria for a priority review voucher.
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