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

The Food and Drug Administration (FDA) is issuing a final rule to establish a system to adequately identify devices through distribution and use. This rule requires the label of medical devices to include a unique device identifier (UDI), except where the rule provides for an exception or alternative placement. The labeler must submit product information concerning devices to FDA's Global Unique Device Identification Database (GUDID), unless subject to an exception or alternative. The system established by this rule requires the label and device package of each medical device to include a UDI and requires that each UDI be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI will be required to be directly marked on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, 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 May 7, 2013, pages 26639-41 and allowed 60-days for public comment. No public comments were received. The National Heart, Lung, and Blood Institute (NHLBI), 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. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.

This final rule amends the current regulatory text of the regulations for FTCA Coverage of Certain Grantees and Individuals with the key text and examples of activities that have been determined, consistent with provisions of the existing regulation, to be covered by the FTCA, as previously published in the September 25, 1995 Federal Register Notice (September 1995 Notice). Additionally, HRSA has added examples of services covered under the FTCA involving individual emergency care provided to a non-health center patient and updated the September 1995 Notice immunization example to include events to immunize individuals against infectious illnesses. The amended regulation will supersede the September 1995 Notice.

Pursuant to the Improving Head Start for School Readiness Act of 2007, Public Law 110-134, notice is hereby given of two 1-day Tribal Consultation Sessions to be held between the Department of Health and Human Services, Administration for Children and Families, Office of Head Start leadership and the leadership of Tribal Governments operating Head Start (including Early Head Start) programs. The purpose of these Consultation Sessions is to discuss ways to better meet the needs of American Indian and Alaska Native children and their families, taking into consideration funding allocations, distribution formulas, and other issues affecting the delivery of Head Start services in their geographic locations [42 U.S.C. 9835, 640(l)(4)].

This interim final rule with comment period specifies the process and timeline for expanding CMS' existing Medicare Secondary Payer (MSP) Web portal to conform to section 201 of the Medicare IVIG and Strengthening Medicare and Repaying Taxpayers Act of 2012 (the SMART Act). The interim final rule specifies a timeline for developing a multifactor authentication solution to securely permit authorized users other than the beneficiary to access CMS' MSP conditional payment amounts and claims detail information via the MSP Web portal. It also requires that we add functionality to the existing MSP Web portal that permits users to: notify us that the specified case is approaching settlement; obtain time and date stamped final conditional payment summary forms and amounts before reaching settlement; and ensure that relatedness disputes and any other discrepancies are addressed within 11 business days of receipt of dispute documentation.

National Toxicology Program (NTP) Office of the Report on Carcinogens (ORoC) requests information on 20 substances, mixtures, and exposure circumstances (collectively referred to as ``substances'') nominated for possible review for future editions of the Report on Carcinogens (RoC).

The ``System for Locating People Using Electricity Dependent Medical Equipment During Public Health Emergencies'' Ideation Challenge seeks ideas to establish a system for monitoring the location and status of life-sustaining durable medical equipment (DME) during a prolonged power outage or disaster situation. This information would be used by a network of family and friends, formal caregivers, emergency responders and others responding to a disaster to better assist individuals who are dependent on DME. The current Challenge focuses on obtaining information about DME; however, this is part of a larger effort to ensure that these people get the necessary help as quickly as possible. Submissions can be existing applications, or applications developed specifically for this challenge. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111-358).

Section 401(a) of the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA), Public Law 111-3, amended the Social Security Act (the Act) to enact section 1139A (42 U.S.C. 1320b- 9a). Section 1139A(b) charged the Department of Health and Human Services with improving pediatric health care quality measures. This effort includes development of several new pediatric quality measures, including a pediatric readmission measure. The Agency for Healthcare Research and Quality (AHRQ) is requesting comments from the public on an algorithm for identifying pediatric planned procedures as part of the readmission measure. The purpose of the algorithm is to identify, using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) procedure codes, pediatric procedures that are usually planned so that admissions for these procedures can be excluded from calculations of readmission rates. To identify planned procedures, expert pediatric clinicians in 14 different procedure-oriented specialties reviewed procedures typically performed by their specialty. The reviewers indicated which procedures (1) are usually planned (defined as planned in more than 80% of cases) and (2) could require hospitalization. Admissions for which the primary procedure coded was one of these procedures are excluded from the count of readmissions. The list of ICD-9-CM codes and code descriptions for the planned procedures is available at: https://www.ahrq.gov/policymakers/chipra/ pedprocedurecodes.html.