Department of Health and Human Services April 4, 2013 – Federal Register Recent Federal Regulation Documents
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Submission for OMB review; 30-day Comment Request: A Generic Submission for Formative Research, Pretesting, and Customer Satisfaction of NCI's Communication and Education Resources (NCI)
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on January 2, 2013 (Volume 78, Page 105) and allowed 60-days for public comment. Two public comments were received and responded to. The purpose of this notice is to allow an additional 30 days for public comment. The National Cancer Institute (NCI), the National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.
Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of Meeting
The Food and Drug Administration (FDA) is postponing the meeting of the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee scheduled for April 5, 2013. The meeting was announced in the Federal Register of November 29, 2012 (77 FR 71195). The meeting is postponed because key participants were unavailable due to unforeseen scheduling conflicts. In the meantime, FDA analysis of industry-submitted documents is ongoing. A new meeting date will be announced in the Federal Register.
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review.
Draft Compliance Policy Guide Sec. 100.250 Food Facility Registration-Human and Animal Food; Availability
The Food and Drug Administration (FDA) is announcing the availability of draft Compliance Policy Guide Sec. 100.250 Food Facility RegistrationHuman and Animal Food (the draft CPG). The draft CPG, when finalized, will provide guidance for FDA staff on issues related to food facility registration under a section of the Federal Food, Drug, and Cosmetic Act (FD&C Act), including the requirement that certain food facilities register with FDA, the requirement that registered facilities biennially renew their registrations with FDA, and FDA's authority to suspend a food facility's registration.
Effective Date of Requirement for Premarket Approval for Three Class III Preamendments Devices; Reclassification of Sorbent Hemoperfusion Devices for the Treatment of Poisoning and Drug Overdose
The Food and Drug Administration (FDA) is issuing a proposed administrative order to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following three class III preamendments devices: Sorbent hemoperfusion devices for the treatment of hepatic coma and metabolic disturbances; cranial electrotherapy stimulator for the treatment of depression, anxiety, and insomnia; and transilluminator for breast evaluation. FDA is also announcing the opportunity for interested persons to request that the Agency change the classification of any of the aforementioned devices based on new information. In addition, FDA is proposing to reclassify sorbent hemoperfusion devices for the treatment of poisoning and drug overdose, a preamendments class III device, into class II (special controls) based on new information respecting the device. This action implements certain statutory requirements.
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. During the April meeting, the Advisory Council will hear a presentation from an international partner on their efforts to address Alzheimer's disease. There will be a presentation on the priorities set during the May 2012 research summit and the milestones for achieving the 2025 goal. The federal partners will provide an update on progress implementing the National Plan to Address Alzheimer's Disease and discuss highlights of the 2013 Update to the National Plan.
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