Department of Health and Human Services June 2, 2016 – Federal Register Recent Federal Regulation Documents
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Informational Meeting: The Importation and Exportation of Infectious Biological Agents, Infectious Substances and Vectors; Public Webcast
The Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS) is hosting a public webcast to address import and export permit regulations for infectious biological agents, infectious substances, and vectors; and import and export permit exemptions. Presenters for this webcast will include representatives from the U.S. Department of Transportation (DOT), United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS), CDC Division of Global Migration and Quarantine, U.S. Customs and Border Protection, U.S. Department of Commerce, U.S. Food and Drug Administration, HHS/Office of the Assistant Secretary for Preparedness and Response/Biomedical Advanced Research and Development Authority (BARDA), U.S. Fish and Wildlife Service, and the Public Health Agency of Canada.
Agency Information Collection Activities: Submission for OMB Review; Comment Request; University Centers for Excellence in Developmental Disabilities Education, Research, and Service-Annual Report
The Administration on Intellectual and Developmental Disabilities (AIDD), Administration for Community Living (ACL) is announcing an opportunity to comment on the proposed collection of 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 collects comments on the information collection requirements relating to the continuation of an existing collection for University Centers for Excellence in Developmental Disabilities Education, Research, and Service.
Submission for OMB Review; 30-Day Comment Request; The Study of Center of Global Health's (CGH) Workshops (NCI)
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Instititue, the National Institutes of Health, 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 March 1, 2016 and page 10638 and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Cancer Institute, NCI, 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.
Submission for OMB Review; 30-Day Comment Request; Population Assessment of Tobacco and Health (PATH) Study (NIDA)
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 March 11, 2016, pages 12913-12914 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. 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 60 days of the date of this publication.
Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance entitled ``Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods.'' The draft guidance, when finalized, will describe our views on voluntary short- term and long-term goals for sodium reduction in a variety of identified categories of foods that are commercially processed, packaged, or prepared. These goals are intended to address the excessive intake of sodium in the current population and promote improvements in public health.
Determination That TRIVARIS (Triamcinolone Acetonide) Injectable Suspension, 80 Milligrams/Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that TRIVARIS (triamcinolone acetonide) injectable suspension, 80 milligrams/milliliters (mg/mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for triamcinolone acetonide injectable suspension, 80 mg/mL, if all other legal and regulatory requirements are met.
Collaborating To Strengthen Food, Drug, and Medical Device Safety Systems; Notice of Conference
The Food and Drug Administration (FDA) Philadelphia District Office, in co-sponsorship with the Association of Food and Drug Officials (AFDO), and the North Central Association of Food and Drug Officials, is announcing a conference entitled ``Collaborating to Strengthen Food, Drug, and Medical Device Safety Systems.'' This conference is intended to provide information about FDA drug and device regulation to the regulated industry.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Nonproprietary Naming of Biological 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.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Senior Medicare Patrol (SMP) Program Outcome Measurement
The Administration for Community Living (ACL) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Comprehensive Child Welfare Information System
This final rule replaces the Statewide and Tribal Automated Child Welfare Information Systems (S/TACWIS) rule with the Comprehensive Child Welfare Information System (CCWIS) rule. The rule also makes conforming amendments in rules in related requirements. This rule will assist title IV-E agencies in developing information management systems that leverage new innovations and technology in order to better serve children and families. More specifically, this final rule supports the use of cost-effective, innovative technologies to automate the collection of high-quality case management data and to promote its analysis, distribution, and use by workers, supervisors, administrators, researchers, and policy makers.
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