Department of Health and Human Services November 29, 2013 – Federal Register Recent Federal Regulation Documents

Submission for OMB Review; 30-Day Comment Request; Data Collection To Understand How NIH Programs Apply Methodologies To Improve Their Research Programs (MIRP)
Document Number: 2013-28636
Type: Notice
Date: 2013-11-29
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, 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 September 9, 2013, page 55084 and allowed 60-days for public comment. One comment was received. However, the issues addressed in the comment were not related to the information collection proposed, and will not be considered in the finalization process. The purpose of this notice is to allow an additional 30 days for public comment. The National Institute of Allergy and Infectious Diseases (NIAID), 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.
Public Meeting of the Presidential Commission for the Study of Bioethical Issues
Document Number: 2013-28621
Type: Notice
Date: 2013-11-29
Agency: Department of Health and Human Services
The Presidential Commission for the Study of Bioethical Issues (the Commission) will conduct its fifteenth meeting on December 18, 2013. At this meeting, the Commission will discuss the BRAIN Initiative and ongoing work in neuroscience.
Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Program for Medical Products
Document Number: 2013-28600
Type: Notice
Date: 2013-11-29
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 the collection of information regarding the Adverse Event Program for medical devices.
Agency Information Collection Activities; Proposed Collection; Comment Request; Eye Tracking Study of Direct-to-Consumer Prescription Drug Advertisement Viewing
Document Number: 2013-28599
Type: Notice
Date: 2013-11-29
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on research entitled, ``Eye Tracking Study of Direct-to-Consumer Prescription Drug Advertisement Viewing.'' This study is designed to use eye tracking technology to explore how consumers view direct-to-consumer (DTC) prescription drug advertisements (ads) that include text regarding risk information and reporting side effects and that vary in the amount of distracting audio and visual content during the presentation of the risk information.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Designated New Animal Drugs for Minor Use and Minor Species
Document Number: 2013-28598
Type: Notice
Date: 2013-11-29
Agency: Food and Drug Administration, Department of Health and Human Services
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 Forms Undergoing Paperwork Reduction Act Review
Document Number: 2013-28592
Type: Notice
Date: 2013-11-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Cancer Institute; Notice of Closed Meeting
Document Number: 2013-28564
Type: Notice
Date: 2013-11-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Meeting
Document Number: 2013-28563
Type: Notice
Date: 2013-11-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2013-28562
Type: Notice
Date: 2013-11-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2013-28561
Type: Notice
Date: 2013-11-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2013-28560
Type: Notice
Date: 2013-11-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2013-28559
Type: Notice
Date: 2013-11-29
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2013-28558
Type: Notice
Date: 2013-11-29
Agency: Department of Health and Human Services, National Institutes of Health
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. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-28537
Type: Notice
Date: 2013-11-29
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.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2013-28524
Type: Notice
Date: 2013-11-29
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 (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.
Medicare and Medicaid Programs; Continued Approval of American Osteopathic Association/Healthcare Facilities Accreditation Program's Critical Access Hospital Accreditation Program
Document Number: 2013-28521
Type: Notice
Date: 2013-11-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final notice announces our decision to approve the American Osteopathic Association/Healthcare Facilities Accreditation Program (AOA/HFAP) for continued recognition as a national accrediting organization (AO) for critical access hospitals (CAH) that wish to participate in the Medicare or Medicaid programs.
Medicare Program; Town Hall Meeting on FY 2015 Applications for New Medical Services and Technology Add-On Payments
Document Number: 2013-28518
Type: Proposed Rule
Date: 2013-11-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces a Town Hall meeting in accordance with the Social Security Act (the Act) to discuss fiscal year (FY) 2015 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system (IPPS). Interested parties are invited to this meeting to present their comments, recommendations, and data regarding whether the FY 2015 new medical services and technologies applications meet the substantial clinical improvement criterion.
Food Additive Regulations; Incorporation by Reference of the Food Chemicals Codex, 7th Edition
Document Number: 2013-28439
Type: Rule
Date: 2013-11-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is amending select food additive regulations that incorporate by reference food- grade specifications from prior editions of the Food Chemicals Codex (FCC) to incorporate by reference food-grade specifications from the FCC 7th Edition (FCC 7). We are taking this action in response to a petition filed by the United States Pharmacopeial Convention (U.S.P. or petitioner).