Department of Health and Human Services February 27, 2013 – Federal Register Recent Federal Regulation Documents

Submission for OMB Review; Comment Request: Clinical Mythteries: A Video Game About Clinical Trials
Document Number: 2013-04547
Type: Notice
Date: 2013-02-27
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 June 13, 2012, page 35407 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. Proposed Collection: Title: Clinical Mythteries: A Video Game About Clinical Trials. Type of Information Collection Request: NEW. Need and Use of Information Collection: New England Research Institutes as a contractor for the National Heart Lung and Blood Institute is planning to create an engaging, informational ``serious video game'' for adolescents about clinical studies which: (1) Incorporates core learning objectives; and (2) dispels misconceptions. Two types of information collection are planned: Usability testing to understand game-play/usability. This information will be collected by focus group and will be digitally recorded 90 minute groups. A pre/post randomized trial to measure change in knowledge. This information will be collected electronically through on-line questionnaire. The game will be incorporated with a larger initiative to provide information about clinical research (http://www.nhlbi.nih.gov/ childrenandclinicalstudies/index.php). Frequency of Response: Once. Affected Public: Individuals. Type of Respondents: Adolescentsaged 8- 14. The annual reporting burden is as follows: Estimated Number of Respondents: 280; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: Wave 190/60 (1.5 hours), Wave 2 80/60 (1.33 hours); and Estimated Total Annual Burden Hours Requested: 378. The annualized cost to respondents is estimated at: $3,783. There are no Capital Costs to report. The Operating Costs to collect this information is estimated at $42,425.00.
Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: 2013-04543
Type: Notice
Date: 2013-02-27
Agency: Food and Drug Administration, Department of Health and Human Services
Oncologic Drugs Advisory Committee; Notice of Meeting
Document Number: 2013-04542
Type: Notice
Date: 2013-02-27
Agency: Food and Drug Administration, Department of Health and Human Services
Psychopharmacologic Drugs Advisory Committee; Notice of Meeting
Document Number: 2013-04536
Type: Notice
Date: 2013-02-27
Agency: Food and Drug Administration, Department of Health and Human Services
Science Board to the Food and Drug Administration Advisory Committee; Amendment of Notice
Document Number: 2013-04535
Type: Notice
Date: 2013-02-27
Agency: Food and Drug Administration, Department of Health and Human Services
Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: 2013-04534
Type: Notice
Date: 2013-02-27
Agency: Food and Drug Administration, Department of Health and Human Services
Proposed Collection; Comment Request Healthy Communities Study: How Communities Shape Children's Health (HCS)
Document Number: 2013-04528
Type: Notice
Date: 2013-02-27
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program; Changes to the Semi-Annual Meeting of the Advisory Panel on Hospital Outpatient Payment (HOP Panel)-March 11 and March 12, 2013
Document Number: 2013-04524
Type: Notice
Date: 2013-02-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces changes to the meeting date and time, location, and format of the first semi-annual public meeting of 2013 that was announced and published in the Federal Register on November 26, 2012, entitled ``Medicare Program; Semi-Annual Meeting of the Advisory Panel on Hospital Outpatient Payment (HOP Panel)March 11 and 12, 2013.''
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2013-04510
Type: Notice
Date: 2013-02-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2013-04508
Type: Notice
Date: 2013-02-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Government-Owned Inventions; Availability for Licensing
Document Number: 2013-04481
Type: Notice
Date: 2013-02-27
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. 207 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.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-04462
Type: Notice
Date: 2013-02-27
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-04461
Type: Notice
Date: 2013-02-27
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-04460
Type: Notice
Date: 2013-02-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging: Notice of Closed Meeting
Document Number: 2013-04459
Type: Notice
Date: 2013-02-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2013-04458
Type: Notice
Date: 2013-02-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2013-04457
Type: Notice
Date: 2013-02-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meetings
Document Number: 2013-04456
Type: Notice
Date: 2013-02-27
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2013-04455
Type: Notice
Date: 2013-02-27
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 2013-04453
Type: Notice
Date: 2013-02-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2013-04452
Type: Notice
Date: 2013-02-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2013-04451
Type: Notice
Date: 2013-02-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences Notice of Closed Meetings
Document Number: 2013-04450
Type: Notice
Date: 2013-02-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meetings
Document Number: 2013-04449
Type: Notice
Date: 2013-02-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meetings
Document Number: 2013-04448
Type: Notice
Date: 2013-02-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2013-04447
Type: Notice
Date: 2013-02-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2013-04446
Type: Notice
Date: 2013-02-27
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Meeting
Document Number: 2013-04445
Type: Notice
Date: 2013-02-27
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Meetings
Document Number: 2013-04444
Type: Notice
Date: 2013-02-27
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2013-04443
Type: Notice
Date: 2013-02-27
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. 207 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.
Prospective Grant of Exclusive License: Food Quality Indicators
Document Number: 2013-04442
Type: Notice
Date: 2013-02-27
Agency: Department of Health and Human Services, National Institutes of Health
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of a worldwide exclusive patent license to practice the inventions embodied in: HHS Ref. No. E-093-1997/0 ``Food Quality Indicator;''
Patient Protection and Affordable Care Act; Health Insurance Market Rules; Rate Review
Document Number: 2013-04335
Type: Rule
Date: 2013-02-27
Agency: Department of Health and Human Services
This final rule implements provisions related to fair health insurance premiums, guaranteed availability, guaranteed renewability, single risk pools, and catastrophic plans, consistent with title I of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, referred to collectively as the Affordable Care Act. The final rule clarifies the approach used to enforce the applicable requirements of the Affordable Care Act with respect to health insurance issuers and group health plans that are non-federal governmental plans. This final rule also amends the standards for health insurance issuers and states regarding reporting, utilization, and collection of data under the federal rate review program, and revises the timeline for states to propose state- specific thresholds for review and approval by the Centers for Medicare & Medicaid Services (CMS).