Draft Joint Food and Drug Administration/Health Canada Quantitative Assessment of the Risk of Listeriosis From Soft-Ripened Cheese Consumption in the United States and Canada
The Food and Drug Administration (FDA or we) is announcing the availability of a draft ``Joint Food and Drug Administration/Health CanadaSant[eacute] Canada Quantitative Assessment of the Risk of Listeriosis From Soft-Ripened Cheese Consumption in the United States and Canada.'' This draft Quantitative Risk Assessment (the draft QRA) includes an Interpretative Summary, a Technical Report, with Appendixes, and a risk assessment model. The purpose of the draft QRA is to evaluate the effect of factors such as the microbiological status of milk, the impact of cheese manufacturing steps, and conditions during distribution and storage on the overall risk of invasive listeriosis to the consumer in the United States or Canada of soft- ripened cheese. The draft QRA makes it possible to evaluate the effectiveness of some process changes and intervention strategies in reducing the risk of listeriosis. We are making the draft QRA available for public comment.
Draft Guidance for Industry on Alzheimer's Disease: Developing Drugs for the Treatment of Early Stage Disease; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Alzheimer's Disease: Developing Drugs for the Treatment of Early Stage Disease.''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
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Draft Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked Questions; Availability
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
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).
Government-Owned Inventions; Availability for Licensing
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.
Influenza Viruses Containing the Hemagglutinin From the Goose/Guangdong/1/96 Lineage
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
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.
Request for Nominations for Voting Members on Public Advisory Panels or Committees
The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Device Good Manufacturing Practice Advisory Committee, certain device panels of the Medical Devices Advisory Committee, the National Mammography Quality Assurance Advisory Committee, and the Technical Electronic Products Radiation Safety Standards Committee in the Center for Devices and Radiological Health. Nominations will be accepted for current vacancies and those that will or may occur through December 31, 2013. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees, and therefore encourages nominations of appropriately qualified candidates from these groups.
Issuance of Final Guidance Publication
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), announces the availability of the following publication: ``NIOSH Criteria for a Recommended Standard: Occupational Exposure to Hexavalent Chromium'' [2013-128].
National Institute for Occupational Safety and Health Respiratory Protection for Healthcare Workers: Stakeholder Meeting
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following public meeting: ``Stakeholder Meeting on Respiratory Protection for Healthcare Workers''. Stakeholder Meeting Time and Date: 8 a.m.-5:15 p.m. EDT, June 18, 2013. Place: CDC Tom Harkin Global Communications Center located at 1600 Clifton Road, Building 19, Atlanta, Georgia 30333. This meeting will also be available by videoconference at select CDC locations. Purpose of the Meeting: This meeting is being held to exchange ideas and solutions to improve healthcare worker compliance with personal protective technologies (PPT), with a focus on respiratory protection. Stakeholder feedback is sought to (1) provide input to future updates of the NIOSH PPT program research agenda and (2) assess progress toward better respirators for healthcare workers. This meeting will include presentations and moderated roundtable discussions on ``Improving the Evidence Base to Support Guidance on the Appropriate Level of Respiratory Protection'', ``Healthcare Worker Observational Studies of Respirator Use & New Educational Resources'', ``Considerations for Extending Respirator Supplies During an Outbreak or Pandemic'', ``Standards & Test Methods for Improved Respirators for Healthcare Workers'', and ``Advances toward Improved Respirators for Healthcare Workers''. Status: The meeting is open to the public, limited only by the capacity (100) of the conference room. Registration will be accepted on a first come first served basis. Participants are encouraged to consider attending by video conference, which will be provided at select CDC locations (to be announced). Registration for both in person and video conference attendance is available on the NIOSH NPPTL Web site, www.cdc.gov/niosh/npptl. Preregistration is required on or before May 31, 2013, even for remote attendees and US citizens. Non-US citizens need to register on or before May 18, 2013, to allow sufficient time for mandatory CDC facility security clearance procedures to be completed. An email confirming registration will be sent from NIOSH and will include details needed to participate. A government issued photo ID will be required to obtain entrance to any of the CDC locations. Background: The NIOSH PPT program publishes and periodically updates its research agenda on personal protective equipment (PPE) for healthcare workers (http://www.cdc.gov/niosh/docket/archive/ docket129.html). The research agenda, last updated in 2010, describes the near term and long term strategy for the PPT program's influenza pandemic research, development, and investigative testing activities. Recently, the Institute of Medicine (IOM) published a report (http:// www.iom.edu/Reports/2011/Preventing-Transmission-of-Pandemic- Influenza- and-Other-Viral-Respiratory-Diseases.aspx) that assessed the nation's progress on improving PPE for healthcare personnel exposed to infectious respiratory diseases and made recommendations to address research gaps. Furthermore, a chapter in the recent HHS 2009 H1N1 Influenza Improvement Plan (http://www.phe.gov/Preparedness/mcm/h1n1- retrospective/Documents/2009-h1n1-improvementplan.pdf) discusses research needs for respiratory protective devices as part of a broader non-vaccine medical countermeasures strategy. A key area of discussion at this stakeholder meeting will be progress on research gaps identified in the 2011 IOM and 2012 HHS reports and how NIOSH can use this information to update the 2010 PPT research agenda. The current version of PPT program research agenda for healthcare worker PPE focuses on conducting research to design and promote the appropriate use of PPE. Compliance with appropriate respirator use practices is important because healthcare workers often wear them incorrectly or fail to use them at all. Poor compliance has been linked to safety culture, workload issues, time constraints, risk perception, effectiveness concerns, availability, discomfort, interference with patient care, and communication difficulties. One strategy taken to improve healthcare worker compliance is to develop better respirators. In this stakeholder meeting, progress toward better respirators for healthcare workers will be discussed.
Medicare Program; Request for Information on the Use of Clinical Quality Measures (CQMs) Reported Under the Physician Quality Reporting System (PQRS), the Electronic Health Record (EHR) Incentive Program, and Other Reporting Programs
This request for information solicits ways in which an eligible professional (EP) might use the clinical quality measures (CQM) data reported to specialty boards, specialty societies, regional health care quality organizations or other non-federal reporting programs to also report under the Physician Quality Reporting System (PQRS), as well as the Electronic Health Record (EHR) Incentive Program. It also solicits ways by which the entities already collecting CQM data for other reporting programs to submit this data on behalf of EPs and group practices for reporting under the PQRS and the EHR Incentive Program. It also requests information regarding section 601(b) of the American Taxpayer Relief Act of 2012 which provides for treating an EP as satisfactorily reporting data on quality measures if the EP is satisfactorily participating in a qualified clinical data registry. We are requesting information from medical specialty societies, boards, and registries, other third party registry vendors, eligible professionals using registries to report quality measures, and any other party interested in providing information on this request for information.
Dental Devices; Reclassification of Temporary Mandibular Condyle Prosthesis
The Food and Drug Administration (FDA) is issuing a proposed order to reclassify temporary mandibular condyle prosthesis, a preamendments class III device, into class II (special controls), and rename the device ``temporary mandibular condyle reconstruction plate.'' FDA is also issuing the draft special controls guideline, ``Class II Special Controls Guideline: Temporary Mandibular Condyle Reconstruction Plate,'' which sets forth the special controls that the Agency believes are necessary to provide a reasonable assurance of the safety and effectiveness of the device.
Agency Information Collection Activities; Proposed Collection; Comment Request
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: ``Improving Sickle Cell Transitions of Care through Health Information Technology Phase 1.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.
Medicare and Medicaid Programs; Part II-Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction
This proposed rule would reform Medicare regulations that CMS has identified as unnecessary, obsolete, or excessively burdensome on health care providers and suppliers, as well as certain regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This proposed rule would increase the ability of health care professionals to devote resources to improving patient care, by eliminating or reducing requirements that impede quality patient care or that divert resources away from providing high quality patient care. This is one of several rules that we are proposing to achieve regulatory reforms under Executive Order 13563 on improving regulation and regulatory review and the Department's plan for retrospective review of existing rules.
Request for Comment: Input on Recommendations from the Council of Councils Working Group on Use of Chimpanzees in NIH-Supported Research
The National Institutes of Health (NIH) Council of Councils received and adopted the recommendations and Report of the NIH Council of Councils Working Group on the Use of Chimpanzees in NIH-Supported Research on January 22, 2013. The report is posted on the NIH Web site at http://dpcpsi.nih.gov/council/working_group_message.aspx. The agency will consider the recommendations contained in the report as the agency formulates policy. The NIH also announces the opening of a Request for Comment (RFC) period to collect input on the recommendations from interested parties. Comments will be accepted until Saturday, March 23, 2013, via the comment database at http:// grants.nih.gov/grants/rfi/rfi.cfm?ID=31. In the interim, NIH will continue to apply its policy on Research Involving Chimpanzees (see NOT-OD-12-025; http://grants.nih.gov/grants/guide/notice-files/NOT-OD- 12-025.html.)
Proposed Collection; Comment Request: Women's Health Initiative Observational Study
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: The Women's Health Initiative (WHI) Observational Study. Type of Information Collection Request: Revision OMB 0925-0414. Need and Use of Information Collection: This study will be used by the NIH to evaluate risk factors for chronic disease among older women by developing and following a large cohort of postmenopausal women and relating subsequent disease development to baseline assessments of historical, physical, psychosocial, and physiologic characteristics. In addition, the observational study will complement the clinical trial (which has received clinical exemption) and provide additional information on the common causes of frailty, disability and death for postmenopausal women, namely, coronary heart disease, breast and colorectal cancer, and osteoporotic fractures. Continuation of follow-up for ascertainment of medical history update forms will provide essential data for outcomes assessment for this population of aging women. Frequency of Response: Annually. Affected Public: Individuals or households and health care providers. Type of Respondents: Study participants, next-of-kin, and physician's office staff. The annual reporting burden is as follows: