Department of Health and Human Services October 26, 2011 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Request, 30-Day Public Comment Request
Document Number: 2011-27733
Type: Notice
Date: 2011-10-26
Agency: Department of Health and Human Services
Agency Information Collection Request, 30-Day Public Comment Request
Document Number: 2011-27730
Type: Notice
Date: 2011-10-26
Agency: Department of Health and Human Services
Pilot Program for Parallel Review of Medical Products; Correction
Document Number: 2011-27694
Type: Notice
Date: 2011-10-26
Agency: Food and Drug Administration, Department of Health and Human Services, Centers for Medicare and Medicaid Services, Centers for Medicare & Medicaid Services
The Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) are correcting a notice that appeared in the Federal Register of October 11, 2011 (76 FR 62808). The document announced a pilot program for sponsors of innovative device technologies to participate in a program of parallel FDA-CMS review. The document was published with an incorrect Web page address and an incorrect email address. This document corrects those errors.
Announcement of Requirements and Registration for Leading Health Indicators App Challenge
Document Number: 2011-27681
Type: Notice
Date: 2011-10-26
Agency: Department of Health and Human Services
October 31, 2011 marks the national release of the Healthy People 2020 leading health indicators (LHIs). The LHIs were developed to communicate high-priority health issues to the public, and actions that can be taken to address them. The Office of Disease Prevention and Health Promotion, in partnership with Health 2.0 and the Office of the National Coordinator of Health IT, is launching an LHI App Challenge to encourage teams of developers and health professionals to build an application that addresses one or more LHI topics on a community level. The overall purpose of the Challenge is to provide public health practitioners, business, elected officials, clinicians and the public with applications to help achieve national priority health goals.
Draft Documents To Support Submission of an Electronic Common Technical Document; Availability
Document Number: 2011-27658
Type: Notice
Date: 2011-10-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the following draft versions of documents that support making regulatory submissions in electronic format using the electronic Common Technical Document (eCTD) specifications entitled ``The eCTD Backbone Files Specification for Module 1, version 2.0'' (which includes the U.S. regional document type definition, version 3.0) and ``Comprehensive Table of Contents Headings and Hierarchy, version 2.0.'' Supporting technical files are also being made available on the Agency Web site. These draft documents represent FDA's major updates to Module 1 of the eCTD, which contains regional information.
Bar Code Technologies for Drugs and Biological Products; Retrospective Review Under Executive Order 13563; Request for Comments
Document Number: 2011-27657
Type: Proposed Rule
Date: 2011-10-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a review of the ``Bar Code Final Rule,'' under Executive Order 13563, ``Improving Regulation and Regulatory Review.'' The Bar Code Final Rule, which was published in 2004, requires certain human drug products and biological products to have a bar code. Information submitted can help FDA to reassess the costs and benefits of the rule and to identify any relevant changes in technology that have occurred since it went into effect. FDA is establishing a public docket to receive information relevant to reassessing the Bar Code Rule. This is an opportunity for interested persons to share information, research, and ideas on the need, maturity, and acceptability of alternative identification technologies for the identification, including the unique identification, of drugs and biological products. FDA will use the information received to assess whether the Bar Code Final Rule is achieving its intended benefits as effectively as possible or should be modified.
Proposed Information Collection Activity; Comment Request
Document Number: 2011-27611
Type: Notice
Date: 2011-10-26
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Submission for OMB Review; Comment Request
Document Number: 2011-27602
Type: Notice
Date: 2011-10-26
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Scientific Information Request on Phototherapy for Treatment of Chronic Plaque Psoriasis
Document Number: 2011-27563
Type: Notice
Date: 2011-10-26
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from manufacturers of Phototherapy medical devices for treatment of chronic plaque psoriasis. Scientific information is being solicited to inform our Comparative Effectiveness Review of Biologic and Nonbiologic Systemic Agents and Phototherapy for Treatment of Chronic Plaque Psoriasis, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information on this device will improve the quality of this comparative effectiveness review. AHRQ is requesting this scientific information and conducting this comparative effectiveness review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173.
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2011-27497
Type: Notice
Date: 2011-10-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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