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

Results 51 - 100 of 284
Determination That OPANA ER (Oxymorphone Hydrochloride) Drug Products Covered by New Drug Application 21-610 Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2013-15099
Type: Notice
Date: 2013-06-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined that OPANA ER (oxymorphone hydrochloride (HCl)) Extended-Release Tablet products approved under new drug application (NDA) 21-610 were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs for oxymorphone HCl extended-release tablets if all other legal and regulatory requirements are met.
Building Research Capacity in Global Tobacco Product Regulation Program (U18)
Document Number: 2013-15097
Type: Notice
Date: 2013-06-25
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 support of the Center for Tobacco Product's (CTP's) Building Research Capacity in Global Tobacco Product Regulation Program. FDA intends to accept and consider a single source application for award to the World Health Organization (WHO) to identify, support, develop, conduct, and coordinate research efforts relating to tobacco control laws and rules in foreign countries that will directly inform and support FDA's exercise of its authority to regulate the manufacture, distribution, marketing, and sale of tobacco products in the United States. The Building Research Capacity in Global Tobacco Product Regulation Program seeks to advance and expand research in support of tobacco product regulation, in order to reduce the morbidity and mortality associated with tobacco use both within the United States and internationally. The program will advance FDA's and CTP's mission by utilizing WHO Member States' expertise and extensive international contacts in global tobacco control, as well as WHO's own programmatic expertise, to inform and support adequate manufacture, distribution, and market regulations of tobacco products for the protection of public health in the United States.
Authorization of Emergency Use of an In Vitro Diagnostic for Detection of the Novel Avian Influenza A(H7N9) Virus; Availability
Document Number: 2013-15096
Type: Notice
Date: 2013-06-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for an in vitro diagnostic device for detection of the novel avian influenza A(H7N9) virus. FDA is issuing this Authorization under the Federal Food, Drug, and Cosmetic (FD&C) Act, as requested by the Centers for Disease Control and Prevention (CDC). The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the determination by the Secretary of Health and Human Services (HHS) that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad that involves the novel avian influenza A(H7N9) virus. On the basis of such determination, the Secretary also declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of the novel avian influenza A(H7N9) virus subject to the terms of any authorization issued under the FD&C Act. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.
Office of the Director, National Institutes of Health; Notice of Closed Meetings
Document Number: 2013-15066
Type: Notice
Date: 2013-06-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2013-15065
Type: Notice
Date: 2013-06-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings
Document Number: 2013-15064
Type: Notice
Date: 2013-06-25
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: 2013-15063
Type: Notice
Date: 2013-06-25
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2013-15062
Type: Notice
Date: 2013-06-25
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-15061
Type: Notice
Date: 2013-06-25
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-15060
Type: Notice
Date: 2013-06-25
Agency: Department of Health and Human Services, National Institutes of Health
Request for Information on Toluene Diisocyanates
Document Number: 2013-15040
Type: Notice
Date: 2013-06-24
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) intends to evaluate the scientific data on toluene diissocyanate (TDI) and other TDI-based isocyanate products to develop a Criteria Document to establish an updated Recommended Exposure Limit (REL) for toluene diisocyanate. The current NIOSH REL for 2,4-TDI is the lowest feasible concentration with no ceiling due to the potential carcinogenicity of 2,4-TDI. NIOSH is requesting information on the following: (1) Published and unpublished reports and findings from in vitro and in vivo toxicity studies with toluene diisocyanate; (2) information on possible health effects observed in workers exposed to toluene diisocyanate, including exposure data and the method(s) used for sampling and analyzing exposures; (3) description of work tasks and scenarios with a potential for exposure to toluene diisocyanate; (4) information on control measures (e.g. engineering controls, work practices, personal protective equipment, exposure data before and after implementation of control measures) that are being used in workplaces with potential exposure to toluene diisocyanate; and (5) surveillance findings including protocol, methods, and results.
Submission for OMB review; 30-Day Comment Request; Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics System Data Access Request
Document Number: 2013-15014
Type: Notice
Date: 2013-06-24
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 (PRA) of 1995, the National Institute of Neurological Disorders and Stroke (NINDS), 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 February 22, 2013, pages 12334-12335 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 Institute of Neurological Disorders and Stroke, 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.
Proposed Information Collection Activity; Comment Request
Document Number: 2013-14998
Type: Notice
Date: 2013-06-24
Agency: Department of Health and Human Services, Administration for Children and Families
Meeting of the National Vaccine Advisory Committee
Document Number: 2013-14996
Type: Notice
Date: 2013-06-24
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will be holding a special meeting. This meeting will be held utilizing a means of virtual technology; the meeting will be conducted as an audio telephone conference call. The meeting will be open to the public. Individuals may call in to attend this virtual meeting. A public comment session will be provided. Participation in this meeting is limited to 60 people. Therefore, pre-registration is required for both public participation and comment. Individuals who wish to participate in the meeting by audio telephone conference call and/or provide public comment should pre-register by sending an email to nvpo@hhs.gov or calling (202) 690-5566. Individuals will be required to provide their name, organization, and email address to pre-register. The meeting agenda will be posted on the NVAC Web site at http://www.hhs.gov/nvpo/ nvac as soon as it becomes available.
Submission for OMB Review; Comment Request
Document Number: 2013-14993
Type: Notice
Date: 2013-06-24
Agency: Department of Health and Human Services, Administration for Children and Families
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2013-14944
Type: Notice
Date: 2013-06-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2013-14943
Type: Notice
Date: 2013-06-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2013-14942
Type: Notice
Date: 2013-06-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2013-14941
Type: Notice
Date: 2013-06-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2013-14940
Type: Notice
Date: 2013-06-24
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2013-14939
Type: Notice
Date: 2013-06-24
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Alternative Medicine; Notice of Closed Meeting
Document Number: 2013-14938
Type: Notice
Date: 2013-06-24
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-14937
Type: Notice
Date: 2013-06-24
Agency: Department of Health and Human Services, National Institutes of Health
Tribal Self-Governance Program, Negotiation Cooperative Agreement, Announcement Type: New-Limited Competition
Document Number: 2013-14932
Type: Notice
Date: 2013-06-24
Agency: Department of Health and Human Services, Indian Health Service
Tribal Self-Governance Program Planning Cooperative Agreement
Document Number: 2013-14931
Type: Notice
Date: 2013-06-24
Agency: Department of Health and Human Services, Indian Health Service
Nonprescription Drugs Advisory Committee; Notice of Meeting
Document Number: 2013-14930
Type: Notice
Date: 2013-06-24
Agency: Food and Drug Administration, Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2013-14901
Type: Notice
Date: 2013-06-24
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2013-14900
Type: Notice
Date: 2013-06-24
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Laser Products; Proposed Amendment to Performance Standard
Document Number: 2013-14846
Type: Proposed Rule
Date: 2013-06-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is proposing to amend the performance standard for laser products to achieve closer harmonization between the current standard and the International Electrotechnical Commission (IEC) standards for laser products and medical laser products, to reduce the economic burden on affected manufacturers, to improve the effectiveness of FDA's regulation of laser products, and to better protect and promote the public health.
Request for Nominations for Voting and/or Nonvoting Consumer Representatives on Public Advisory Committees or Panels and Request for Notification From Consumer Organizations Interested in Participating in the Selection Process for Nominations for Voting and/or Nonvoting Consumer Representatives on Public Advisory Committees or Panels
Document Number: 2013-14889
Type: Notice
Date: 2013-06-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may either be self-nominated or may be nominated by a consumer organization. Nominations will be accepted for current vacancies and for those that will or may occur through December 2013.
Center for Substance Abuse Prevention; Notice of Meeting
Document Number: 2013-14882
Type: Notice
Date: 2013-06-21
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Center for Substance Abuse Treatment; Notice of Meeting
Document Number: 2013-14881
Type: Notice
Date: 2013-06-21
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-14878
Type: Notice
Date: 2013-06-21
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 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: 2013-14870
Type: Notice
Date: 2013-06-21
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.
Maternal Health Town Hall Listening Session; Notice of Meeting
Document Number: 2013-14837
Type: Notice
Date: 2013-06-21
Agency: Department of Health and Human Services, Health Resources and Services Administration
Cooperative Agreement To Support the North Carolina State University, Prestage Department of Poultry Science and the Piedmont Research Station
Document Number: 2013-14824
Type: Notice
Date: 2013-06-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing its intention to receive and consider a single-source application for the award of a cooperative agreement in fiscal year 2013 (FY13) to the North Carolina State University, Prestage Department of Poultry Science and the Piedmont Research Station Poultry Unit located in Salisbury, NC. Egg-associated illness due to Salmonella is a major public health concern, with table eggs being the primary source of Salmonella Enteritidis. Therefore, an FDA priority is to implement preventative measures to reduce the vertical and horizontal transmission of Salmonella Enteritidis and other Salmonella serovars to table eggs and poultry products. The goal of this collaborative project between FDA and the North Carolina State University, Prestage Department of Poultry Science and the Piedmont Research Station is to utilize a commercial research facility to parallel the transmission (vertical and horizontal) of Salmonella found within the egg-production industry and how alterations in physical feed characteristics and housing may influence vertical and horizontal transmission. Additionally, this study aims to examine how commercially utilized disinfection protocols affect horizontal transmission of Salmonella in alternative versus traditionally housed layer hens. Moreover, this study may reveal other serovars of Salmonella present within the commercial egg industry which may pose a potential health risk to consumers. While historically the concern over Salmonella has focused on Salmonella Enteritidis, there is a potential concern that other Salmonella serovars could be a source for egg-transmitted human salmonellosis. Hence, this study aims to investigate the occurrence, transmission, and virulence of varying Salmonella serovars.
Government-Owned Inventions; Availability for Licensing
Document Number: 2013-14821
Type: Notice
Date: 2013-06-21
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 Institute of General Medical Sciences; Notice of Closed Meetings
Document Number: 2013-14820
Type: Notice
Date: 2013-06-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meetings
Document Number: 2013-14819
Type: Notice
Date: 2013-06-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2013-14818
Type: Notice
Date: 2013-06-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2013-14817
Type: Notice
Date: 2013-06-21
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meeting
Document Number: 2013-14816
Type: Notice
Date: 2013-06-21
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2013-14815
Type: Notice
Date: 2013-06-21
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry on Planning for the Effects of High Absenteeism To Ensure Availability of Medically Necessary Drug Products
Document Number: 2013-14812
Type: Notice
Date: 2013-06-21
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 information collection in the guidance on planning for the effects of high absenteeism to ensure availability of medically necessary drug products.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Administrative Detention and Banned Medical Devices
Document Number: 2013-14810
Type: Notice
Date: 2013-06-21
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 ``Administrative Detention and Banned Medical Devices'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Evaluation of the Food and Drug Administration's General Market Youth Tobacco Prevention Campaigns
Document Number: 2013-14809
Type: Notice
Date: 2013-06-21
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 a 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 the Evaluation of FDA's General Market Youth Tobacco Prevention Campaigns.
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2013-14782
Type: Notice
Date: 2013-06-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Board of Scientific Counselors, National Center for Injury Prevention and Control, (BSC, NCIPC)
Document Number: 2013-14781
Type: Notice
Date: 2013-06-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Office for State, Tribal, Local and Territorial Support (OSTLTS); Meeting
Document Number: 2013-14779
Type: Notice
Date: 2013-06-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services