Department of Health and Human Services June 2012 – Federal Register Recent Federal Regulation Documents

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the publication of the following document entitled ``NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2012.'' NIOSH is making available a copy of Appendix A at https:// www.cdc.gov/niosh/docs/2012-150. Background: The NIOSH Alert: NIOSH published Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings in September 2004 (https://www.cdc.gov/niosh/docs/ 2004-165/). Appendix A of this Alert defined hazardous drugs and provided a list of drugs that were considered hazardous and required special handling. In 2010, NIOSH published an update to this list (https://www.cdc.gov/niosh/docs/2010-167/). Since publishing the 2010 update to the list, NIOSH reviewed approximately 70 new drugs that received FDA approval and approximately 180 drugs that received new special warnings (usually black box warnings) based on reported adverse effects in patients covering the time period from October 2007 to December 2009. From this list of approximately 250 drugs, NIOSH determined 26 drugs to have one or more characteristics of a hazardous drug. In addition, NIOSH removed 15 drugs from the 2012 list because they did not meet the NIOSH definition, were no longer available in the U.S or were regulated by other government entities. NIOSH published this preliminary list for comment in NIOSH Docket Number 190. After expert panel review, public review and comment, and review of the scientific literature, NIOSH has developed a revised list of hazardous drugs. Along with drugs initially identified in the 2010 Hazardous Drug List, NIOSH is adding a total of 26 new drugs to the 2012 NIOSH List of Hazardous Drugs and is deleting 15 drugs. This guidance document does not have the force and effect of law.

This notice announces the public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). Notice of these meetings is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and (a)(2)). The Advisory Council on Alzheimer's Research, Care, and Services provides advice on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. The Advisory Council will discuss implementation of the National Plan to Address Alzheimer's Disease.

AHRQ has delisted Medical Informatics as a Patient Safety Organization (PSO) due to its failure to correct a deficiency. The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) authorizes the listing of PSOs, which are entities or component organizations whose mission and primary activity is to conduct activities to improve patient safety and the quality of health care delivery. HHS issued the Patient Safety and Quality Improvement Final Rule (Patient Safety Rule) to implement the Patient Safety Act. AHRQ administers the provisions of the Patient Safety Act and Patient Safety Rule relating to the listing and operation of PSOs.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the reinstatement without change for the information collection listed below. The proposed reinstatement without change for the information collection was previously published in the Federal Register on January 25, 2012, pages 3783-3784 and allowed 60 days for public comment. The National Institutes of Health received no comments. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, the collection of information that has been extended, revised, or implemented unless it displays a currently valid OMB control number. Proposed Collection: Title: The National Diabetes Education Program Survey of the Public. Type of Information Collection Request: Reinstatement without change for the approved information collection (0925-0552). Need and Use of Information Collection: The National Diabetes Education Program (NDEP) is a partnership of the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) and more than 200 public and private organizations. The longterm goal of the NDEP is to reduce the burden of diabetes and pre-diabetes in the United States, and its territories, by facilitating the adoption of proven strategies to prevent or delay the onset of diabetes and its complications. The NDEP objectives are to: (1) Increase awareness and knowledge of the seriousness of diabetes, its risk factors, and effective strategies for preventing type 2 diabetes and complications associated with diabetes; (2) increase the number of people who live well with diabetes and effectively manage their disease to prevent or delay complications and improve quality of life; (3) decrease the number of Americans with undiagnosed diabetes; (4) Among people at risk for type 2 diabetes, increase the number who make and sustain effective lifestyle changes to prevent diabetes; (5) facilitate efforts to improve diabetes-related health care and education, as well as systems for delivering care; (6) reduce health disparities in populations disproportionately burdened by diabetes; and (7) facilitate the incorporation of evidence-based research findings into health care practices. Multiple strategies have been devised to address the NDEP objectives. These have been described in the NDEP Strategic Plan and include: (1) Promoting and implementing culturally and linguistically- appropriate diabetes awareness and education campaigns for a wide variety of audiences; (2) identifying, disseminating, and supporting the adoption of evidence-based, culturally and linguistically- appropriate tools and resources that support behavior change, improved quality of life, and better diabetes outcomes; (3) expanding NDEP reach and visibility through collaborations with public, private, and nontraditional partners, and use of national, state, and local media, traditional and social media, and other relevant channels; and (4) conducting and supporting the evaluation of NDEP resources, promotions, and other activities to improve future NDEP initiatives. The NDEP evaluation will document the extent to which the NDEP program has been implemented, and how successful it has been in meeting program objectives. The evaluation relies heavily on data gathered from existing national surveys such as National Health and Nutrition Examination Survey (NHANES), the National Health Interview Survey (NHIS), and the Behavioral Risk Factor Surveillance System (BRFSS), among others for this information. This generic clearance request is for the collection of additional primary data from NDEP target audiences on key impact measures that are necessary to effectively evaluate the program. Approval is requested for a survey of audiences targeted by the National Diabetes Education Program including people at risk for diabetes and people with diabetes and their families and the public. Frequency of Response: One occasion. Affected Public: Individuals or households. Type of Respondents: Adults. The annual reporting burden is as follows: Estimated Number of Respondents: 3759; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: .153; and Estimated Total Annual Burden Hours Requested: 575. There are no Capital Costs, Operating or Maintenance Costs to report.

This notice announces a new opportunity for participation in the Advance Payment Model for certain accountable care organizations participating in the Medicare Shared Savings Program scheduled to begin in January 2013.

The Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR) announces the award of a single-source program expansion supplement grant to Baptist Children and Family Services (BCFS) in San Antonio, TX, for a total of $22,725,223. The additional funding provided by the awards will support services to refugees through September 30, 2012.

As a component of its ongoing update of respirator certification standards under Part 84 and in response to a petition to amend 42 CFR 84.83(F), HHS proposes a revision to the current requirement for open-circuit self-contained breathing apparatus (OC- SCBA) remaining service-life indicators (indicators), which are devices built into a respirator to alert the user that the breathing air provided by the respirator is close to depletion. HHS intends to revise the current standard, employed by the National Institute for Occupational Safety and Health (NIOSH) located within the Centers for Disease Control and Prevention (CDC), to allow greater latitude in the setting of the indicator alarm to ensure that the alarm more effectively meets the different worker protection needs of different work operations. This revision sets a default service life at 25 percent of the rated service time and allows the indicator to be adjusted higher by the manufacturer, at the request of the purchaser.

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 Institute of Mental Health (NIMH), 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.

This notice announces a meeting of the Advisory Panel on Outreach and Education (APOE) (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on opportunities to enhance the effectiveness of consumer education strategies concerning Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public.

The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for pacemaker programmers. The Agency has summarized its findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring this device to meet the statute's approval requirements and the benefits to the public from the use of the devices. This action implements certain statutory requirements.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Class II Special Controls Guidance Document: Implanted Blood Access Devices for Hemodialysis.'' This draft guidance document describes a means by which implanted blood access devices may comply with the requirement of special controls for class II devices. This draft guidance is not final nor is it in effect at this time.