Department of Health and Human Services June 2014 – Federal Register Recent Federal Regulation Documents
Results 301 - 338 of 338
Official Symbol, Logo, and Seal
The U.S. Department of Health and Human Services (HHS) published a direct final rule in the Federal Register on April 14, 2014, that would have adopted requirements on the use of HHS's official logo and seal. HHS stated in the direct final rule that if it received a significant adverse comment, HHS would publish a notice of withdrawal. HHS received two comments and considers at least one of these comments a significant adverse comment. The direct final rule was not withdrawn prior to its effective date. As a result, HHS is now publishing this removal of the direct final rule.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for revision of the approved information collection assigned OMB control number 0990-0331, which expires on August 31, 2015. Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Agency Information Collection Activities; Proposed Collection; Comment Request; Third Party Disclosure and Recordkeeping Requirements for Reportable Food
The Food and Drug Administration (FDA or we) 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 invites comments on the information collection provisions of FDA's third party disclosure and recordkeeping requirements for reportable food.
Agency Information Collection Activities; Proposed Collection; Comment Request; Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations
The Food and Drug Administration (FDA or we) 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 invites comments on information collection provisions of FDA's guidance for industry entitled, ``Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations.''
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Request for Information From United States Processors That Export to the European Community
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Request for Information from U.S. Processors that Export to the European Community'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guide To Minimize Microbial Food Safety Hazards of Fresh-Cut Fruits and Vegetables
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guide to Minimize Microbial Food Safety Hazards of Fresh-Cut Fruits and Vegetables'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Medical Devices; General and Plastic Surgery Devices; Classification of the Powered Surgical Instrument for Improvement in the Appearance of Cellulite
The Food and Drug Administration (FDA) is classifying the powered surgical instrument for improvement in the appearance of cellulite into class II (special controls). 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.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Pet Event Tracking Network-State, Federal Cooperation To Prevent Spread of Pet Food Related Diseases
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Pet Event Tracking Network (PETNet)State, Federal Cooperation to Prevent Spread of Pet Food Related Diseases'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Determination of Regulatory Review Period for Purposes of Patent Extension; XIAFLEX
The Food and Drug Administration (FDA) has determined the regulatory review period for XIAFLEX and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human biological product.
Product Development Under the Animal Rule, Revised Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled ``Product Development Under the Animal Rule.'' When human efficacy studies are neither ethical nor feasible, FDA may rely on adequate and well-controlled animal efficacy studies to support approval of a drug or licensure of a biological product under the Animal Rule. This revised draft guidance replaces the 2009 draft guidance for industry entitled ``Animal ModelsEssential Elements to Address Efficacy Under the Animal Rule'' and addresses a broader scope of issues for products developed under the Animal Rule. Once finalized, this guidance is intended to help potential sponsors (industry, academia, and government) understand FDA's expectations for product development under the Animal Rule.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Extension of Certification of Maintenance of Effort for the Title III and the Certification of Long-Term Care Ombudsman Program Expenditures
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.
Compliance Policy Guide Regarding Food Facility Registration-Human and Animal Food; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of Compliance Policy Guide Sec. 100.250 Food Facility RegistrationHuman and Animal Food (the CPG). The CPG provides guidance for our staff on enforcement of food facility registration requirements.
Current List of HHS-Certified 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 HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or 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.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities: Proposed Collection; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
General and Plastic Surgery Devices: Reclassification of Ultraviolet Lamps for Tanning, Henceforth To Be Known as Sunlamp Products and Ultraviolet Lamps Intended for Use in Sunlamp Products
The Food and Drug Administration (FDA or the Agency) is reclassifying ultraviolet (UV) lamps intended to tan the skin from class I (general controls) exempt from premarket notification to class II (special controls) and subject to premarket notification, and renaming them sunlamp products and UV lamps intended for use in sunlamp products. FDA is designating special controls that are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is reclassifying this device on its own initiative based on new information.
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