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

The Food and Drug Administration (FDA) is issuing a final 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 special controls guideline entitled ``Temporary Mandibular Condyle Reconstruction Plate Class II Special Controls Guideline'' that sets forth the special controls that are necessary to provide a reasonable assurance of the safety and effectiveness of the device.

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.

The Food and Drug Administration (FDA) is requesting interested persons to submit comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of 26 drug substances. These comments will be considered in preparing a response from the United States to the World Health Organization (WHO) regarding the abuse liability and diversion of these drugs. WHO will use this information to consider whether to recommend that certain international restrictions be placed on these drugs. This notice requesting comments is required by the Controlled Substances Act (CSA).

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 Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), 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. Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) The quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Dr. Sarah L. Glavin, Deputy Director, Office of Science Policy, Analysis and Communication, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, 31 Center Drive, Room 2A18, Bethesda, Maryland 20892, or call a non-toll free number (301) 496-1877 or Email your request, including your address to glavins@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing.

To prevent a lapse in comprehensive primary care services for persons living with HIV/AIDS, HRSA will provide a one-time noncompetitive Ryan White HIV/AIDS Program Part C award to Our Lady of the Lake Regional Medical Center, Inc. (OLOL), Baton Rouge, Louisiana.

In accordance with the requirements of the Privacy Act of 1974, as amended (5 U.S.C. 552a), HHS is altering an existing system of records, ``National Disaster Medical System (NDMS) Patient Treatment and Tracking,'' system number 09-90-0040. The system of records was originally published June 26, 2007 (see 72 FR 35052) and previously revised March 27, 2008 (see 73 FR 16307). The alterations include: (1) Changing the system name to ``National Disaster Medical System (NDMS) Disaster Medical Information Suite (DMIS);'' (2) revising the categories of individuals to reflect that patients may include disaster workers and others who are provided medical countermeasures; (3) dividing the records into three categories (patient treatment, patient tracking, and veterinarian treatment) instead of two (patient treatment and veterinarian treatment); (4) adding, as a purpose for which information from this system is used, that the system provides HHS' NDMS claims processing system with records needed to reimburse NDMS providers for their services; (5) revising the first routine use to include these additional disclosure recipients: state and city governmental agencies, Non-Governmental Organizations (NGOs; e.g., American Red Cross), and hospitals that provide care to NDMS patients; and (6) adding one new routine use, pertaining to security breach response.

The National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention announces the availability of a draft Criteria Document entitled Criteria for a Recommended Standard: Occupational Exposure to Heat and Hot Environments for public comment. To view the notice and related materials, visit https://www.regulations.gov and enter CDC-2013-0025 in the search field and click ``Search.'' Comments may be provided to the NIOSH docket, as well as given orally at the meeting.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

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.

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for renewal of the approved information collection assigned OMB control number 0990-0162 scheduled to expire on January 31, 2014 Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.

In this final rule, the Office of Inspector General (OIG) amends the safe harbor regulation concerning electronic health records items and services, which defines certain conduct that is protected from liability under the Federal anti-kickback statute, section 1128B(b) of the Social Security Act (the Act). Amendments include updating the provision under which electronic health records software is deemed interoperable; removing the electronic prescribing capability requirement; extending the sunset provision until December 31, 2021; limiting the scope of protected donors to exclude laboratory companies; and clarifying the condition that prohibits a donor from taking any action to limit or restrict the use, compatibility, or interoperability of the donated items or services.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information request regarding the guidance for industry and FDA staff entitled ``Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products.''

The Food and Drug Administration (FDA) is withdrawing approval of five new animal drug applications (NADAs) for roxarsone oral dosage form products at the sponsor's request because the products are no longer manufactured or marketed.