Department of Health and Human Services February 26, 2015 – Federal Register Recent Federal Regulation Documents
Results 1 - 16 of 16
Submission for OMB Review; Emergency Clearance Request Human Influenza Surveillance of Health Care Centers in the United States and Taiwan
In accordance with Section 3507(j) of the Paperwork Reduction Act of 1995, the National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request for emergency review and processing of this information collection by March 7, 2015. NIAID is requesting emergency processing of this information collection, pursuant to 5 CFR 1320.13, because NIAID cannot reasonably comply with the normal clearance procedures which would cause a delay and likely prevent or substantially disrupt the collection of information. A delay in starting the information collection would hinder the agency in accomplishing its mission to the detriment of the public good. Public harm could result through the loss of critically needed information to understand the causes of severity of influenza and associated morbidity and mortality during the Northern hemisphere 2014-15 influenza season. 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. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. 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.
Pediatric Stakeholder Meeting; Request for Comments
The Food and Drug Administration's (FDA) Office of Pediatric Therapeutics (OPT), the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) are announcing a public meeting seeking input from patient groups, consumer groups, regulated industry, academia and other interested parties to obtain any recommendations or information relevant to the report to Congress that FDA is required to submit concerning pediatrics, as outlined in section 508 of the Food and Drug Administration Safety and Innovation Act (FDASIA) (see the SUPPLEMENTARY INFORMATION section for additional background information).
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
This document corrects a notice that was published in the Federal Register on February 9, 2015, Volume 80, Number 26, pages 6971 and 6972. The times and dates should read as follows:
Future Directions for the Surveillance of Agricultural Injuries; Public Meeting; Request for Comments
The National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention announces a public meeting and an opportunity to comment on future directions for the surveillance of injuries within the agricultural production industry. To view the notice and related materials visit https:// www.regulations.gov and enter CDC-2015-0005 in the search field and click ``Search.'' Public comment period: Comments must be received May 27, 2015.
Medical Devices; Obstetrical and Gynecological Devices; Classification of the Assisted Reproduction Embryo Image Assessment System
The Food and Drug Administration (FDA) is classifying the Assisted Reproduction Embryo Image Assessment System 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 Assisted Reproduction Embryo Image Assessment System 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.
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