Department of Health and Human Services June 6, 2013 – Federal Register Recent Federal Regulation Documents

National Committee on Vital and Health Statistics: Meeting
Document Number: 2013-13479
Type: Notice
Date: 2013-06-06
Agency: Department of Health and Human Services
National Committee on Vital and Health Statistics: Meeting Standards Subcommittee
Document Number: 2013-13476
Type: Notice
Date: 2013-06-06
Agency: Department of Health and Human Services
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requirements Under the Comprehensive Smokeless Tobacco Health Education Act of 1986, as Amended by the Family Smoking Prevention and Tobacco Control Act
Document Number: 2013-13448
Type: Notice
Date: 2013-06-06
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.
``Script Your Future'' Medication Adherence Campaign
Document Number: 2013-13447
Type: Notice
Date: 2013-06-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of grant funds for the continuing support of a national effort to promote the importance of medication adherence to enhance the health of Americans. Medication adherence is taking medicine as directed to treat an illness or disease in order to get the best health outcome possible for each patient. Nearly three out of four Americans report that they do not take their medication as directed. One in three people never fill their prescriptions. The annual price tag for medication adherence failure is estimated to be $290 billion, and the impact on the medical system and patients from this lack of adherence may result in relapses or recurrences of medical symptoms, increases in hospital visits, or even death. FDA is committed to addressing this issue, which has enormous implications for public health and the U.S. economy, by, in part, continuing its financial and other contributions to a carefully planned, well-executed effective national campaign begun in 2010 by the National Consumers League (NCL) called ``Script Your Future''. To continue and enhance this important public health initiative, the Division of Health Communications (DHC)/Office of Communications (OCOMM)/Center for Drug Evaluation and Research (CDER) in FDA seeks to assist the National Consumers League in the development of new online resources and tools for patients, engagement of public and private partners to build on and complement existing medication adherence programs, education of health care professionals with strategies to share with patients, continuous evaluation of the campaign to enhance and improve it, expansion of public-private partnerships, strengthening of this national forum focused on informing consumers about medication adherence, and tailoring messaging to subpopulations of consumers who may need adaptations or special efforts to inform and educate them.
Determination That SUBOXONE (Buprenorphine Hydrochloride and Naloxone Hydrochloride) Sublingual Tablets, 2 Milligrams/0.5 Milligrams and 8 Milligrams/2 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2013-13446
Type: Notice
Date: 2013-06-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined that SUBOXONE (buprenorphine hydrochloride (HCl) and naloxone HCl) sublingual tablets, 2 milligrams (mg)/0.5 mg and 8 mg/2 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for buprenorphine HCl and naloxone HCl sublingual tablets, 2 mg/0.5 mg and 8 mg/2 mg, if all other legal and regulatory requirements are met.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-13434
Type: Notice
Date: 2013-06-06
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Comment Request; University Centers for Excellence in Developmental Disabilities Education, Research, and Service-Annual Report
Document Number: 2013-13421
Type: Notice
Date: 2013-06-06
Agency: Department of Health and Human Services
The Administration on Intellectual and Developmental Disabilities (AIDD), now part of the Administration for Community Living, 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.
Proposed Information Collection Activity; Comment Request
Document Number: 2013-13384
Type: Notice
Date: 2013-06-06
Agency: Department of Health and Human Services, Administration for Children and Families
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2013-13374
Type: Notice
Date: 2013-06-06
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2013-13373
Type: Notice
Date: 2013-06-06
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Document Number: 2013-13372
Type: Notice
Date: 2013-06-06
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2013-13371
Type: Notice
Date: 2013-06-06
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-13341
Type: Notice
Date: 2013-06-06
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: ``A Prototype Consumer Reporting System For Patient Safety Events.'' 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 September 11th, 2012 and allowed 60 days for public comment. AHRQ received 45 substantive comments and 64 personal stories from members of the public. These comments and personal stories raised 37 issues in the wording of the intake form, two issues with wording in other supporting documentation to the intake form, and 69 design issues that we categorized into 18 types of design concerns. To address these comments substantial revisions were made to the data collection tools and supporting documentation. The purpose of this notice is to allow an additional 30 days for public comment.
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