2019 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions.'' This guidance document describes FDA's current approach to considering uncertainty in making benefit-risk determinations to support certain FDA premarket decisions for medical devicespremarket approval applications (PMAs), De Novo requests, and humanitarian device exemption applications. This guidance document elaborates on the consideration of uncertainty as part of our overarching approach to a benefit-risk based framework that is intended to assure greater predictability, consistency, and efficiency through the application of least burdensome principles. This guidance also provides examples of how the principles for considering uncertainty could be applied in the context of clinical evidence and circumstances where greater uncertainty could be appropriate in premarket decisions, balanced by postmarket controlsPMAs for Breakthrough Devices and PMAs for devices for small patient populations.

The Department of Defense (DoD) is publishing this notice to announce that the following Federal Advisory Committee meeting of the Defense Advisory Committee on Investigation, Prosecution, and Defense of Sexual Assault in the Armed Forces (DAC-IPAD) will take place.

NMFS announces that the Pacific Fishery Management Council submitted Amendment 21-4 to the Pacific Coast Groundfish Fishery Management Plan to the Secretary of Commerce for review. If approved, Amendment 21-4 would adjust the Pacific Coast Groundfish Fishery Catch Share Program to complete outstanding elements of the program, respond to problems identified after program implementation, and modify outdated regulations. The proposed Amendment would convert bycatch allocations of canary and widow rockfish to set-asides in the at-sea whiting fishery and remove fixed formulas used to determine bycatch amounts of Pacific Ocean Perch, darkblotched rockfish and widow rockfish in the at-sea whiting sectors. Bycatch amounts would instead be determined through the biennial harvest specification process, which would offer more flexible bycatch management for the at-sea sectors. The proposed rule implementing this proposed FMP amendment includes other regulatory changes which would provide increased opportunity to trade individual fishing quota, accumulation limits for catcher-processor permits, and expand economic data collections. The rule will help to ensure the Pacific Coast Groundfish fishery achieves optimum yield, minimize costs of participation, provide fair and equitable access to fishery resources, and avoid adverse economic impacts to fishing communities.

This action adds a service to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities, and deletes services from the Procurement List previously furnished by such agencies.

The Rural Utilities Service (RUS), an agency within the U.S. Department of Agriculture (USDA), has issued a Supplemental Draft Environmental Impact Statement (Supplemental Draft EIS) for Central Electric Power Cooperative's (Central Electric) proposed McClellanville Area 115-kV Transmission Project (Project) in South Carolina. In this document, RUS analyzes the environmental impacts associated with an anticipated decision request to approve or deny funding for Central Electric's proposed Project. The Supplement Draft EIS was prepared to address substantial changes to the proposed action and assesses new circumstances and information relevant to potential environmental impacts originally evaluated in the Draft Environmental Impact Statement (Draft EIS). In April 2014, RUS issued a Draft EIS that evaluated six 115-kV transmission line corridors originating in Georgetown County, South Carolina and terminating in the McClellanville area of Charleston County, South Carolina. Since publication of the Draft EIS, updated engineering data has resulted in substantial changes to the proposed action, including the need to evaluate new transmission line corridors originating from the Jamestown and Charity areas of Berkeley County, South Carolina, and to account for a new winter weather operating agreement between the former South Carolina Electric and Gas (now Dominion Energy South Carolina) and Berkeley Electric Cooperative that addresses load concerns during the winter months. In addition, the following changes made it necessary to supplement the Draft EIS: The promulgation of a new environmental regulation applicable to RUS (7 CFR part 1970, which replaced the former 7 CFR part 1794, RUS Environmental Policies and Procedures), issuance and implementation of Executive Order 13807: ``Establishing Discipline and Accountability in the Environmental Review and Permitting Process for Infrastructure Projects'' (known as the ``One Federal Decision Executive Order''), and publication of the Francis Marion National Forest's Forest Plan. The Supplemental Draft EIS addresses the construction, operation, and maintenance of Central Electric's proposed Project. The Project includes the construction of a new 115 kV transmission line needed to energize the new McClellanville Substation located near the McClellanville service area. The Supplemental Draft EIS considers three alternatives, encompassing three potential corridor locations with one corridor including two different alignments. The overall project area encompasses parts of Berkeley, Georgetown and Charleston counties in coastal South Carolina, and potentially crosses the Francis Marion National Forest. The Supplemental Draft EIS has identified the potential for impacts to various resources, including wetlands, biological resources and cultural resources (including historic properties). Central Electric does not hold easements across these areas. Once a final right-of-way (ROW) is selected within the preferred corridor, coordination with federal and state agencies and other interested parties would occur to identify, evaluate and, if needed, mitigate any adverse effects. RUS will compile public comments received on the Supplemental Draft EIS and produce a Final EIS that considers and responds to those substantive public comments. Based on this analysis in additional to technical and financial reviews, RUS will decide to approve or deny an application for funding.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BEVYXXA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), NESHAP for Miscellaneous Coating Manufacturing (EPA ICR Number 2115.07, OMB Control Number 2060-0535), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through November 30, 2019. Public comments were previously requested, via the Federal Register, on May 6, 2019 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An Agency may neither conduct nor sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

Before a Federal agency can collect certain information from the public, it must receive approval from the Office of Management and Budget (OMB). Under procedures established by the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), before seeking OMB approval, Federal agencies must solicit public comment on proposed collections of information, including extensions and reinstatements of previously approved collections. This document describes an Information Collection Request (ICR) for which NHTSA intends to seek OMB approval.

Pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, this final rule provides the 2018 and 2019 adjustments to the civil penalties that the NTSB may assess against a person for violating certain NTSB statutes and regulations.

The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.

In accordance with the Paperwork Reduction Act of 1995, ED is proposing a new information collection.

The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), NESHAP for Stationary Combustion Turbines (EPA ICR Number 1967.08, OMB Control Number 2060-0540), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through November 30, 2019. Public comments were previously requested, via the Federal Register, on May 6, 2019 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An agency may neither conduct nor sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

The Food and Drug Administration (FDA or the Agency) is reopening the submission period for the notice entitled ``Modernizing Pharmaceutical Quality Systems; Studying Quality Metrics and Quality Culture; Quality Metrics Feedback Program'' that published in the Federal Register of June 29, 2018. The Agency is taking this action to allow interested persons additional time to participate in the program.

The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). A notice listing all currently HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the internet at https:// www.samhsa.gov/workplace.

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 FAA proposes to adopt a new airworthiness directive (AD) for certain Airbus SAS Model A350-941 airplanes. This proposed AD was prompted by the results of a structural analysis, which identified that the upper frame fittings (UFF) of the forward cargo door surrounding structure have a low fatigue life. This proposed AD would require repetitive inspections of the forward cargo door UFF and brackets for discrepancies and, depending on the findings, doing applicable corrective actions, as specified in a European Union Aviation Safety Agency (EASA) AD, which will be incorporated by reference. The FAA is proposing this AD to address the unsafe condition on these products.

The FAA proposes to adopt a new airworthiness directive (AD) for all Fokker Services B.V. Model F28 Mark 0070 and 0100 airplanes. This proposed AD was prompted by reports of lavatory waste bin fire extinguishers found depleted. This proposed AD would require a one-time inspection of the installation of the waste bins for interference (the inspection also includes a weight check of the waste bin fire extinguisher and an inspection of the discharge tubes for damage), modification of affected waste bins, and replacement of affected fire extinguishers, as specified in a European Union Aviation Safety Agency (EASA) AD, which will be incorporated by reference. This proposed AD would also require replacement of the fire extinguisher if any damaged discharge tube is found or the weight of the waste bin fire extinguisher is too low. The FAA is proposing this AD to address the unsafe condition on these products.

The Advisory Committee (Committee) to the U.S. Section to the International Commission for the Conservation of Atlantic Tunas (ICCAT) announces a special meeting to be held September 5-6, 2019. The meeting is open to the public and will be accessible via conference call and webinar.

The Department of Labor (DOL) is submitting the Bureau of Labor Statistics (BLS) sponsored information collection request (ICR) revision titled, ``American Time Use Survey,'' to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act (PRA) of 1995. Public comments on the ICR are invited.

The Department of Labor (DOL) is submitting the Employment Training Administration (ETA) sponsored information collection request (ICR) revision titled, ``Standard Job Corps Contractor and Grantee Information Gathering,'' to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act (PRA) of 1995. Public comments on the ICR are invited.

In compliance with the Paperwork Reduction Act of 1995, and as part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, the Defense Technical Information Center announces a proposed generic information collection and seeks public comment on the provisions thereof. Comments are invited on: Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the agency's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.