October 2019 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or we) is classifying the orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

In February 2017, the U.S. Consumer Product Safety Commission (CPSC) published an update to the consumer product safety standard for toddler beds. The standard incorporated by reference the applicable ASTM voluntary standard. ASTM has since published two revised versions of the voluntary standard for toddler beds. We are publishing this direct final rule revising the CPSC's mandatory standard for toddler beds to incorporate by reference, the most recent version of the applicable ASTM standard.

The Department of Labor (DOL) is submitting the Mine Safety and Health Administration (MSHA) sponsored information collection request (ICR) titled, ``Operations Mining Under a Body of Water,'' to the Office of Management and Budget (OMB) for review and approval for continued use, without change, in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.

The Occupational Safety and Health Administration announces that OMB extended approval for information collection requirements found in OSHA's standards and regulations outlined in this notice. OSHA sought approval of these requirements under the Paperwork Reduction Act of 1995 (PRA), and, as required by that Act, is announcing the approval numbers and expiration dates for these requirements and regulations.

Comporting with Executive Order 13563, ``Improving Regulations and Regulatory Review,'' and consistent with Executive Order 13777, ``Enforcing the Regulatory Reform Agenda,'' OSHA removed or revised outdated, duplicative, unnecessary, and inconsistent requirements in safety and health standards. Standards Improvement ProjectPhase IV (SIP-IV) was published May 14, 2019 (84 FR 21416, Docket Number OSHA- 2012-0007). This final rule reduces regulatory burden while maintaining or enhancing worker safety and health, and improving privacy protections. The Occupational Safety and Health Administration announces an OMB extension of approval for a number of information collection requirements found in the final rule. OSHA sought approval of these requirements under the Paperwork Reduction Act of 1995 (PRA), and, as required by that Act, is announcing the approval numbers and expiration dates for these requirements.

The Committee is proposing to add products to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities.

The FAA is adopting a new airworthiness directive (AD) for all Airbus SAS Model A330-200, -200F, and -300 series airplanes. This AD was prompted by a determination that new or more restrictive airworthiness limitations are necessary. This AD requires revising the existing maintenance or inspection program, as applicable, to incorporate new or more restrictive airworthiness limitations. The FAA is issuing this AD to address the unsafe condition on these products.

Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Florida Advisory Committee (Committee) will hold a meeting on Thursday, October 31, 2019, at 3:00 p.m. (EST). for the purpose of reviewing received testimony and discussing next steps in hearing testimony regarding Voters Suppression and Disenfranchisement Issues.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 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 collection for the guidance on planning for the effects of high absenteeism to ensure availability of medically necessary drug products.

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 Department of Defense has submitted to OMB for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.

The Food and Drug Administration's (FDA or the Agency) Office of Pediatric Therapeutics (OPT), the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) are announcing a public meeting seeking input from patient/ parent groups, consumer groups, regulated industry, academia, and other interested parties to obtain any recommendations or information relevant to the report to Congress that FDA is required to submit concerning pediatrics, as outlined in section 508 of the Food and Drug Administration Safety and Innovation Act (FDASIA) (see the SUPPLEMENTARY INFORMATION section for additional background information).