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

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.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Alzheimer's Disease: Developing Drugs for the Treatment of Early Stage Disease.''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.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked Questions.'' This draft guidance provides responses to questions FDA has received regarding the issuance of civil money penalties for violations of regulations issued under the Federal Food,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 This draft guidance is not final nor is it in effect at this time.

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.

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.

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 (https://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 (https:// 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 (https://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.

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.

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.

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.

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: