Department of Health and Human Services August 14, 2013 – Federal Register Recent Federal Regulation Documents

In accordance with the requirements of the Privacy Act of 1974, as amended, this notice announces the establishment of a CMP that CMS plans to conduct with the Internal Revenue Service (IRS), a Bureau of the Department of the Treasury.

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public on imaging techniques for the surveillance, diagnosis, and staging of hepatocellular carcinoma. Scientific information is being solicited to inform our review of Imaging Techniques for the Surveillance, Diagnosis, and Staging of Hepatocellular Carcinoma, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information on imaging techniques for the surveillance, diagnosis, and staging of hepatocellular carcinoma will improve the quality of this review. AHRQ is conducting this comparative effectiveness review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173, and Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a).

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Radio Frequency Wireless Technology in Medical Devices; Guidance for Industry and Food and Drug Administration Staff.'' This guidance document is intended to assist industry and FDA staff in identifying and appropriately addressing specific considerations related to the incorporation and integration of radio frequency (RF) wireless technology in medical devices. This guidance discusses issues that may affect the safe and effective use of medical devices that incorporate RF wireless technology, including selection of wireless technology, quality of service, coexistence, security, and electromagnetic compatibility, and provides recommendations for information to be included in FDA premarket submissions for such devices.

The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research, in cosponsorship with the American College of Gastroenterology, the American Gastroenterological Association, the Crohn's and Colitis Foundation of America, Inc., the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition, and the Pediatric IBD Foundation, is announcing a 2-day public workshop entitled ``Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT II).'' Partners and stakeholders planning the workshop also include patients and representatives from the Eunice Kennedy Shriver National Institute of Child Health and Human Development at the National Institutes of Health. The purpose of this workshop is to provide a forum to consider issues related to endpoints that can support drug development in the following disease areas: Pediatric and adult inflammatory bowel diseases.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following public meeting: ``Conformity Assessment Meeting on Non-Respiratory Personal Protective Equipment (PPE).'' To view the notice and related materials, visit www.regulations.gov and enter CDC-2013-0015 in the search field and click ``search.'' Stakeholder Meeting Time and Date: 8:00 a.m. to 12:00 p.m. EDT, September 17, 2013. Place: NIOSH Pittsburgh Research Center located at 626 Cochrans Mill Road, Building 140, Pittsburgh, Pennsylvania 15236. This meeting will also be available by remote participation through ``live meeting.'' Purpose of the Meeting: This meeting is being held to provide 1) a summary of the work conducted by the NIOSH Personal Protective Technology (PPT) Conformity Assessment Working Group 2) provide an overview of model Conformity Assessment programs, and 3) solicit input to define a national framework for PPE conformity assessment. This meeting will include presentations on Product and Standards, Risk Assessment, Surveillance and Compliance and Enforcement targeting General Industry, Healthcare, Public Safety, and Mining stakeholders. Moderated breakout sessions will discuss preferred Conformity Assessment (CA) components (as detailed in the background below); existing U.S. CA infrastructure capabilities; and gaps in legislation, standards, and infrastructure that need to be filled to define the framework. These breakout discussions will not be available through remote participation; however, the breakout reports will be available to remote participants when the groups reconvene. Status: The meeting is open to the public, limited only by the capacity (150) of the conference room. Registration will be accepted on a first-come first-served basis. Participants are encouraged to consider remote participation through ``live meeting.'' Registration by September 13, 2013 is required for both attendance in person and ``live meeting'' participation. Registration for both options is available on the NIOSH Web site. Non-U.S. citizens, attending in person, need to register on or before August 16, 2013, to allow sufficient time for mandatory CDC facility security clearance procedures to be completed. An email confirming registration will be sent from NIOSH to all participants. Government-issued photo identification is required to obtain entrance to the NIOSH location. An opportunity for individuals or organization representatives wishing to offer verbal comments (five minute time limit) will be provided as time permits after the breakout reports. Time slots are limited and available on a first-come first-served basis. Preregistration for providing verbal comment can be requested when registering for the meeting. Submit electronic comments through www.regulations.gov. All information received in response to this notice and meeting must include the agency name and docket number (CDC-2013-0015; NIOSH 237-A). All relevant comments received will be posted without change to www.regulations.gov, including any personal information provided. All electronic comments should be formatted in Microsoft Word. Please make reference to CDC-2013-0015 and NIOSH Docket Number 237-A. Background: In response to recommendations made by the National Academies of Science during a programmatic review, the NIOSH Personal Protective Technology Conformity Assessment Working Group was established in 2011. The goal of this group is to prepare a national framework establishing criteria, including comprehensive and consistent processes, to address conformity assessment of non-respiratory personal protective equipment. Conformity assessment is defined as the ``demonstration that specified requirements relating to a product, process, system, person or body are fulfilled.'' Conformity assessment processes for PPT products are focused on product effectiveness and include the following primary components: Certification (ISO/IEC 17065), Inspection (ISO/IEC 17020), Testing (ISO/IEC 17025), Accreditation (ISO/IEC 17011), Surveillance (ISO/IEC 17011, ISO/IEC 17065), Supplier's Declaration of Conformity (ISO/IEC 17050), Registration (ISO/IEC 17021) and Quality Management Systems (ISO/9001). The Conformity Assessment Project Report and preliminary framework documents will be available at www.regulations.gov.

In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service (DHHS) is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA) will hold a meeting to discuss the Ryan White Program. The meeting will be open to the public.