Department of Health and Human Services September 29, 2014 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2014-23132
Type: Notice
Date: 2014-09-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Issuance of Final Publications
Document Number: 2014-23086
Type: Notice
Date: 2014-09-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability of the following 10 Skin Notation Profiles:
Submission for OMB Review; 30-day Comment Request; A Generic Submission for Formative Research, Pre-Testing, Stakeholder Measures and Advocate Forms at NCI
Document Number: 2014-23081
Type: Notice
Date: 2014-09-29
Agency: Department of Health and Human Services, National Institutes of Health
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 July 18, 2014 (Volume 79, P. 42023) and allowed 60-days for public comment. There were no comments received. 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, OIRAsubmission@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.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Voluntary Cosmetic Registration Program
Document Number: 2014-23066
Type: Notice
Date: 2014-09-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Voluntary Cosmetic Registration Program'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices; Draft Guidance for Industry; Reopening of the Comment Period
Document Number: 2014-23064
Type: Notice
Date: 2014-09-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is reopening the comment period for the notice of availability of the draft guidance entitled ``Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices,'' published in the Federal Register of June 18, 2014. FDA is reopening the comment period in response to a request for additional time and to allow interested persons more time to submit comments.
Internet/Social Media Platforms With Character Space Limitations: Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices; Draft Guidance for Industry; Reopening of the Comment Period
Document Number: 2014-23063
Type: Notice
Date: 2014-09-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is reopening the comment period for the notice of availability of the draft guidance entitled ``Internet/Social Media Platforms with Character Space Limitations: Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices,'' published in the Federal Register of June 18, 2014. FDA is reopening the comment period in response to a request for additional time and to allow interested persons more time to submit comments.
Agency Information Collection Activities; Proposed Collection; Comment Request; Records and Reports Concerning Experiences With Approved New Animal Drugs: Adverse Event Reports
Document Number: 2014-23059
Type: Notice
Date: 2014-09-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) 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 solicits comments on adverse event reporting by FDA on new animal drugs and product/manufacturing defects collected on paper forms.
Guidance for Industry and Food and Drug Administration Staff; Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007; Availability
Document Number: 2014-23058
Type: Notice
Date: 2014-09-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007.'' This guidance provides information on how a manufacturer may establish that a tobacco product was commercially marketed in the United States as of February 15, 2007. The guidance includes a description of the types of evidence recommended to demonstrate that a tobacco product was commercially marketed in the United States as of February 15, 2007.
Request for Nominations of Candidates To Serve on the Board of Scientific Counselors (BSC), Office of Infectious Diseases (OID)
Document Number: 2014-23055
Type: Notice
Date: 2014-09-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)
Document Number: 2014-23054
Type: Notice
Date: 2014-09-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute on Aging; Notice of Closed Meetings
Document Number: 2014-23045
Type: Notice
Date: 2014-09-29
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2014-23044
Type: Notice
Date: 2014-09-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2014-23037
Type: Notice
Date: 2014-09-29
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meetings
Document Number: 2014-23036
Type: Notice
Date: 2014-09-29
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2014-23035
Type: Notice
Date: 2014-09-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting
Document Number: 2014-23019
Type: Notice
Date: 2014-09-29
Agency: Department of Health and Human Services, National Institutes of Health
Final Policy on Conferring With Urban Indian Organizations
Document Number: 2014-23005
Type: Notice
Date: 2014-09-29
Agency: Department of Health and Human Services, Indian Health Service
The Indian Health Service (IHS or ``the Agency'') is issuing this Notice to implement the final Policy for conferring with Urban Indian Organizations (UIOs). In March 2010, the Indian Health Care Improvement Act (IHCIA) was reauthorized and amended as part of the Patient Protection and Affordable Care Act, Public Law 111-148, as amended by the Health Care and Education Reconciliation Act (together, the Affordable Care Act), Public Law 111-152. One of the changes made to the IHCIA was to create a new requirement that the IHS ``confer'' with UIOs, to the maximum extent practicable, in carrying out the IHCIA.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2014-22700
Type: Notice
Date: 2014-09-29
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Patient Safety Organization Certification for Initial Listing and Related Forms, Patient Safety Confidentiality Complaint Form, and Common Formats.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on July 18th, 2014 and allowed 60 days for public comment. AHRQ did not receive any substantive comments. The purpose of this notice is to allow an additional 30 days for public comment.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2014-22698
Type: Notice
Date: 2014-09-29
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Improving Hospital Informed Consent with Training on Effective Tools and Strategies.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously titled and published as ``Improving Hospital Informed Consent with an Informed Consent Toolkit'' in the Federal Register on July 9th, 2014 and allowed 60 days for public comment. AHRQ received one substantive comment. The purpose of this notice is to allow an additional 30 days for public comment.
Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
Document Number: 2014-22448
Type: Proposed Rule
Date: 2014-09-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is revising certain provisions of the proposed rule, issued in July 2013, on foreign supplier verification programs (FSVPs) for importers of food for humans and animals. We are primarily revising the proposed requirements concerning compliance status review of food and foreign suppliers, hazard analysis, and supplier verification activities. We are taking this action in response to the extensive public input we have received regarding these provisions and in coordination with revisions we are concurrently making to the proposed rule on current good manufacturing practice (CGMP) and hazard analysis and risk-based preventive controls for human food. We are seeking public comment on the revised proposed FSVP regulations. We are reopening the comment period on the proposed rule only with respect to the specific provisions identified in this Federal Register document.
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
Document Number: 2014-22447
Type: Proposed Rule
Date: 2014-09-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is proposing to amend certain specific provisions of the proposed rule, ``Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.'' We are taking this action because the extensive information received in public comments has led to significant changes in our current thinking on certain key provisions of the proposed rule. We are reopening the comment period only with respect to the specific issues identified in this document.
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food
Document Number: 2014-22446
Type: Proposed Rule
Date: 2014-09-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is proposing to amend our 2013 proposed rule for Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls for Human Food. In that 2013 proposed rule, we proposed to amend the CGMP requirements to modernize them and to add requirements for certain domestic and foreign facilities to establish and implement hazard analysis and risk-based preventive controls for human food. We also proposed to revise certain definitions in our current regulation for Registration of Food Facilities to clarify the scope of an exemption from registration requirements for ``farms'' and, in so doing, to clarify which domestic and foreign facilities would be subject to the proposed requirements for hazard analysis and risk-based preventive controls for human food. We are taking this action because the extensive input we have received from public comments has led to significant changes in our current thinking on certain key provisions of these proposed rules. We are reopening the comment period only with respect to specific issues identified in this proposed rule.
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
Document Number: 2014-22445
Type: Proposed Rule
Date: 2014-09-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is proposing to amend our 2013 proposed rule for Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals. In that 2013 proposed rule, we proposed to add CGMP requirements for animal food and to add requirements for certain domestic and foreign facilities to establish and implement hazard analysis and risk-based preventive controls for food for animals. We are taking this action because the input we have received from public comments has led to significant changes in our current thinking on certain key provisions of this proposed rule. We are reopening the comment period only with respect to specific issues identified in this proposed rule.