Department of Health and Human Services February 8, 2013 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-02905
Type: Notice
Date: 2013-02-08
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Delegation of Authorities
Document Number: 2013-02900
Type: Notice
Date: 2013-02-08
Agency: Department of Health and Human Services
Draft Guidance for Industry on Alzheimer's Disease: Developing Drugs for the Treatment of Early Stage Disease; Availability
Document Number: 2013-02863
Type: Notice
Date: 2013-02-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Alzheimer's Disease: Developing Drugs for the Treatment of Early Stage Disease.'' This guidance outlines FDA's current thinking as to how a sponsor could demonstrate efficacy in clinical trials in patients in the early stages of Alzheimer's disease that occur before the onset of overt dementia.
Medical Devices; Ophthalmic Devices; Classification of the Eyelid Weight
Document Number: 2013-02862
Type: Proposed Rule
Date: 2013-02-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is proposing to classify the eyelid weight into class II (special controls). The eyelid weight may be adhered to the outer skin of the upper eyelid (external eyelid weight) or implanted into the upper eyelid (implantable eyelid weight), and is intended for the gravity assisted treatment of lagophthalmos (incomplete eyelid closure). FDA is also giving notice of its intent to exempt the external eyelid weight device from the premarket notification requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act). After considering public comments on the proposed classification, FDA will publish a final regulation classifying this device type.
Draft Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked Questions; Availability
Document Number: 2013-02861
Type: Notice
Date: 2013-02-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked Questions.'' This draft guidance provides responses to questions FDA has received regarding the issuance of civil money penalties for violations of regulations issued under the Federal Food, Drug, and Cosmetic Act (FD&C Act) relating to tobacco products in retail outlets. This draft guidance is not final nor is it in effect at this time.
International Drug Scheduling; Convention on Psychotropic Substances; World Health Organization Scheduling Recommendations for Gamma-hydroxybutyric Acid
Document Number: 2013-02859
Type: Notice
Date: 2013-02-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is providing interested persons with the opportunity to submit written comments and to request an informal public meeting concerning recommendations by the World Health Organization (WHO) to impose international manufacturing and distributing restrictions, under international treaties, on certain drug substances. The comments received in response to this notice and/ or public meeting will be considered in preparing the U.S. position on these proposals for a meeting of the United Nations Commission on Narcotic Drugs (CND) in Vienna, Austria, in March 2013. This notice is issued under the Controlled Substances Act (the CSA).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable
Document Number: 2013-02858
Type: Notice
Date: 2013-02-08
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.
National Institute on Minority Health and Health; Disparities Notice of Meeting
Document Number: 2013-02842
Type: Notice
Date: 2013-02-08
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meeting
Document Number: 2013-02841
Type: Notice
Date: 2013-02-08
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-02840
Type: Notice
Date: 2013-02-08
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2013-02839
Type: Notice
Date: 2013-02-08
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Document Number: 2013-02838
Type: Notice
Date: 2013-02-08
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Meeting
Document Number: 2013-02837
Type: Notice
Date: 2013-02-08
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2013-02836
Type: Notice
Date: 2013-02-08
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2013-02835
Type: Notice
Date: 2013-02-08
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2013-02834
Type: Notice
Date: 2013-02-08
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.
National Committee on Vital and Health Statistics: Meeting
Document Number: 2013-02830
Type: Notice
Date: 2013-02-08
Agency: Department of Health and Human Services
Influenza Viruses Containing the Hemagglutinin From the Goose/Guangdong/1/96 Lineage
Document Number: 2013-02828
Type: Proposed Rule
Date: 2013-02-08
Agency: Department of Health and Human Services
With this notice, the Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces the re-opening of a public comment period for a request for information and comment published on October 17, 2012. The request for information sought information and comments from the public regarding whether highly pathogenic avian influenza (HPAI) H5N1 viruses that contain a hemagglutinin (HA) from the Goose/Guangdong/1/96 lineage, and their potential to pose a severe threat to public health and safety. The comment period closed on December 17, 2012. We are reopening the comment period to allow interested persons additional time to prepare and submit comments.
Medicare, Medicaid, Children's Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests
Document Number: 2013-02572
Type: Rule
Date: 2013-02-08
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule will require applicable manufacturers of drugs, devices, biologicals, or medical supplies covered by Medicare, Medicaid or the Children's Health Insurance Program (CHIP) to report annually to the Secretary certain payments or transfers of value provided to physicians or teaching hospitals (``covered recipients''). In addition, applicable manufacturers and applicable group purchasing organizations (GPOs) are required to report annually certain physician ownership or investment interests. The Secretary is required to publish applicable manufacturers' and applicable GPOs' submitted payment and ownership information on a public Web site.