July 21, 2020 – Federal Register Recent Federal Regulation Documents

FMCSA announces a public meeting: ``The FMCSA 2020 Trucking Safety Summit.'' This meeting will be held virtually on August 5, 2020, to solicit information on improving the safe operation of property- carrying commercial motor vehicles on our Nation's roadways. The virtual meeting will provide interested stakeholdersincluding motor carriers, drivers, safety technology developers and users, Federal and State partners, safety advocacy groupsas well as members of the publican opportunity to share their ideas on improving trucking safety. The event will be hosted virtually by FMCSA from the U.S. Department of Transportation headquarters building in Washington, DC.

The Centers for Disease Control and Prevention (CDC), a component of the U.S. Department of Health and Human Services (HHS), announces a second modification and extension of the No Sail Order and Other Measures Related to Operations that was issued on April 15, 2020. This Order applies to cruise ships defined as commercial, non-cargo, passenger-carrying vessels with the capacity to carry 250 or more individuals (passengers and crew) and with an itinerary anticipating an overnight stay onboard or a 24-hour stay onboard for either passengers or crew, that are operating in international, interstate, or intrastate waterways, subject to the jurisdiction of the United States. This Order shall additionally apply to cruise ships operating outside of U.S. waters if the cruise ship operator intends for the ship to return to operating in international, interstate, or intrastate waterways, subject to the jurisdiction of the United States during the period that this Order is in effect.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Appeal Options Available to Mammography Facilities Concerning Adverse Accreditation Decisions, Suspension/Revocation of Certificates, or Patient and Physician Notification Orders.'' This guidance document describes the processes available to mammography facilities to request additional review of an adverse appeals decision on a facility's accreditation, and/or a suspension or revocation of certificate, and/or a patient and physician notification order. This guidance, when final, will supersede section 4.5 of the Center for Devices and Radiological Health (CDRH) Appeals Processes guidance document dated July 2, 2019. This draft guidance is not final nor is it in effect at this time.

The New England Fishery Management Council (Council) is scheduling a public meeting of its Skate Committee via webinar to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.

The Mid-Atlantic Fishery Management Council's (Council) Northeast Trawl Advisory Panel (NTAP) will hold a meeting.

The U.S. African Development Foundation (USADF) will hold its quarterly meeting of the Board of Directors to discuss the agency's programs and administration. This meeting location will be held via teleconference. For teleconference details, see the provided contact information.

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

EPA has received applications to register pesticide products containing active ingredients not included in any currently registered pesticide products. Pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is hereby providing notice of receipt and opportunity to comment on these applications.

The National Credit Union Administration (NCUA) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995 on or after the date of publication of this notice.

In compliance with the requirements of the Paperwork Reduction Act of 1995 (PRA), the Federal Energy Regulatory Commission (Commission or FERC) is soliciting public comment on the currently approved information collection, FERC-561, (Annual Report of Interlocking Positions) and submitting the information collection to the Office of Management and Budget (OMB) for review. Any interested person may file comments directly with OMB and should address a copy of those comments to the Commission as explained below.

On May 12, 2020, the U.S. Nuclear Regulatory Commission (NRC) issued for public comment proposed amendments to its regulations regarding new alternative emergency preparedness requirements for small modular reactors and other new technologies. The public comment period was originally scheduled to close on July 27, 2020. The NRC is extending the public comment period to allow more time for members of the public and other stakeholders to develop and submit their comments.

The Food and Drug Administration (FDA, the Agency, or we) is hosting a public meeting entitled ``Independent Third-Party Assessment of IND FDA-Sponsor Communication Practices in PDUFA VI,'' and an opportunity for public comment. The meeting will include a presentation from an independent third-party contractor about its assessment of FDA- sponsor communications during the investigational new drug (IND) stage of drug/biologic development in the Prescription Drug User Fee Act (PDUFA) VI; a series of presentations by and a panel discussion with invited regulatory and industry representatives, and an open public comment period. This meeting is intended to satisfy FDA's commitment to host a public meeting about the assessment no later than March 2021.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 10 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

The Environmental Protection Agency (EPA) Region 2 is publishing a direct final Notice of Deletion of the FMC Dublin Road Superfund Site (Site), located in the Towns of Shelby and Ridgeway, Orleans County, NY, from the National Priorities List (NPL). The NPL, promulgated pursuant to section 105 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of 1980, as amended, is an appendix of the National Oil and Hazardous Substances Pollution Contingency Plan (NCP). The EPA and the State of New York, through the New York Department of Environmental Conservation, have determined that all appropriate response actions under CERCLA, other than operation and maintenance, monitoring, and five-year reviews, have been completed. However, this deletion does not preclude future actions under Superfund.

The Environmental Protection Agency (EPA) is proposing to approve a portion of State Implementation Plan (SIP) revisions for South Carolina submitted by the South Carolina Department of Health and Environmental Control (SC DHEC) through letters dated August 8, 2014, and August 12, 2015, and a portion of a SIP revision for Tennessee submitted by the Tennessee Department of Environment and Conservation (TDEC) through a letter dated February 17, 2014. The South Carolina SIP revisions modify a provision that requires fossil fuel-fired steam generators having a heat input capacity of more than 250 million British thermal units (Btu) per hour (Btu/hr) to submit continuous opacity monitoring reports required by the SIP on a quarterly basis. This provision is being modified to allow such reporting on a semiannual basis instead. The South Carolina SIP does not contain any other continuous opacity monitoring report requirements for the subject sources, and this rule revision has no impact on any federal reporting requirements. Specifically, the South Carolina SIP revisions do not override any other reporting requirements that might continue to require more frequent reporting. The Tennessee SIP revision would add a new provision that requires any source subject to the State's title V operating permit program to submit emission monitoring reports required by the SIP on a semiannual basis rather than on a quarterly basis. Much like the South Carolina SIP revisions, the Tennessee SIP revision has no impact on any federal reporting requirements and does not override any other reporting requirements that might continue to require more frequent reporting. EPA is proposing to approve these changes to the South Carolina and Tennessee SIPs because they are consistent with recent proposed changes to federal regulations and because EPA has preliminarily determined that the South Carolina and Tennessee SIP revisions are consistent with the Clean Air Act (CAA or Act).

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry and FDA staff entitled ``Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use.'' The guidance does not alter FDA's current thinking on the regulatory criteria of minimal manipulation and homologous use for human cells, tissues, and cellular and tissue-based product (HCT/P). The guidance announced in this notice supersedes the guidance of the same title dated November 2017 and corrected December 2017. The guidance revises section V of the November 2017 guidance to communicate that the Agency is extending the period of time during which FDA intends to exercise enforcement discretion regarding certain regulatory requirements for certain HCT/Ps; this time period will run through May 31, 2021, instead of November 30, 2020.

The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning negotiated service agreements. This notice informs the public of the filing, invites public comment, and takes other administrative steps.

This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of Alabama (FEMA- 4555-DR), dated 07/10/2020. Incident: Severe Storms, Tornadoes, Straight-line Winds, and Flooding. Incident Period: 04/12/2020 through 04/13/2020.