May 20, 2021 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Implanted Brain- Computer Interface (BCI) Devices for Patients with Paralysis or AmputationNon-Clinical Testing and Clinical Considerations.'' Implanted brain-computer interface (BCI) devices are neuroprostheses that interface with the central or peripheral nervous system to restore lost motor and/or sensory capabilities in patients with paralysis or amputation. This guidance provides recommendations for nonclinical testing and study design considerations for investigational device exemptions feasibility and pivotal clinical studies.

The Rural-Business Cooperative Service (the Agency) announces the availability of funds in the total amount of $2 million reserved for projects located in rural coastal communities, with priority given to National Scenic Areas that were devastated by wildfires that are in need of economic development assistance, to support innovation and job growth. All applicants are responsible for any expenses incurred in developing their applications.

The American Rescue Plan provides $100 million to the Medical Reserve Corps (MRC) program. To inform a strategic and impactful plan for execution of this funding, HHS is issuing this Request for Information (RFI). The RFI solicits specific input regarding current strengths and needs of MRC units and stakeholders, resource gaps highlighted during the COVID-19 response, and recommendations for short- and long-term priorities for the MRC. The set of questions is available in the SUPPLEMENTARY INFORMATION section below.

The Environmental Protection Agency (EPA) is proposing to approve revisions to the Mojave Desert Air Quality Management District (MDAQMD), Placer County Air Pollution Control District (PCAPCD) and the South Coast Air Quality Management District (SCAQMD) portion of the California State Implementation Plan (SIP). These revisions concern emissions of: Volatile organic compounds (VOCs) and particulate matter (PM) from metal coating operations. We are proposing to approve local rules and rescissions to regulate these emission sources under the Clean Air Act (CAA or the Act). We are taking comments on this proposal and plan to follow with a final action.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``ICH Q12: Implementation Considerations for FDA-Regulated Products.'' The International Council for Harmonisation (ICH) guidance for industry entitled ``Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management'' and its Annexes (ICH Q12, May 2021) provide a framework to facilitate the management of postapproval chemistry, manufacturing, and controls (CMC) changes in a more predictable and efficient manner. ICH Q12 includes regulatory tools and enablers with associated guiding principles that should enhance industry's ability to manage postapproval changes and increase transparency between industry and regulatory authorities, supporting innovation and continual improvement. This guidance complements ICH Q12 by clarifying how its tools and enablers can be implemented within the U.S. regulatory system. This draft guidance is not final nor is it in effect at this time.

In accordance with the Paperwork Reduction Act of 1995 (PRA), we, the U.S. Fish and Wildlife Service (Service), are proposing to renew an information collection.

The FAA is adopting a new airworthiness directive (AD) for all CFM International, S.A. (CFM) CFM56-5B and CFM56-7B model turbofan engines with a certain high-pressure turbine (HPT) inner stationary seal installed. This AD was prompted by cracks found in the rotating air HPT front seal. This AD requires removal, inspection, and replacement of the affected HPT inner stationary seal and, depending on the findings, replacement of the rotating air HPT front seal, HPT rotor blades, and No. 3 ball bearing. The FAA is issuing this AD to address the unsafe condition on these products.

The FAA is adopting a new airworthiness directive (AD) for certain Airbus Helicopters Deutschland GmbH Model BO-105A, BO-105C, BO- 105S, and BO-105LS A-3 helicopters. This AD was prompted by the FAA's determination that aging of the elastomeric material in a tension torsion strap (TT-strap) could affect the structural characteristics of the TT-strap. This AD requires replacement of certain TT-straps with serviceable parts and implementation of a new storage life limit for TT-straps, as specified in a European Aviation Safety Agency (now European Union Aviation Safety Agency) (EASA) AD, which is incorporated by reference. The FAA is issuing this AD to address the unsafe condition on these products.

As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.

Petition for Reconsideration (Petition) has been filed in the Commission's rulemaking proceeding by Joshua M. Bercu, on behalf of USTelecomThe Broadband Association.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the final guidance entitled ``Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment.'' FDA developed this guidance to provide FDA's recommendations on the testing needed for assessing the safety and compatibility of medical devices in the Magnetic Resonance (MR) Environment and the recommended format for Magnetic Resonance Imaging (MRI) Safety Information in medical device labeling. This guidance document is anticipated to aid in consistency of reviews, testing, and MRI safety labeling across a variety of medical devices.

The U.S. Nuclear Regulatory Commission (NRC) is publishing this notice regarding the issuance of a final Environmental Assessment (EA) and a Finding of No Significant Impact (FONSI) for its review and approval of the initial decommissioning funding plans (DFPs) submitted by independent spent fuel storage installation (ISFSI) licensees for ISFSIs listed in the ``Discussion'' section of this document.

The Food and Drug Administration (FDA or Agency) has determined that NORMODYNE (labetalol hydrochloride) injection, 5 milligrams per milliliter (mg/mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Peripheral Vascular Atherectomy DevicesPremarket Notification Submissions.'' This guidance provides updated recommendations for premarket submissions for a new or modified peripheral vascular atherectomy device.

The FAA is adopting a new airworthiness directive (AD) for all Airbus SAS Model A318, A319, A320, and A321 series airplanes. This AD was prompted by the loss of a windshield in flight, and the consequent rapid depressurization of the flight deck, which caused damage to flight deck items and systems and subsequent thermal shock and overheat, damage to windshield structural plies, and impaired structural integrity of the windshield. This AD requires repetitive inspections and electrical test measurements (EMTs) of affected windshields, and corrective actions if necessary, as specified in a European Union Aviation Safety Agency (EASA) AD, which is incorporated by reference. The FAA is issuing this AD to address the unsafe condition on these products.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of March 5, 2021. The document announced the withdrawal of approval of seven abbreviated new drug applications (ANDAs) from multiple applicants as of April 5, 2021. The document indicated that FDA was withdrawing approval of the following five ANDAs, after receiving a withdrawal request from Neopharma, Inc., 211 College Road East, Suite 101, Princeton, NJ 08540: ANDA 078383, Pioglitazone Hydrochloride (HCl) Tablets, Equivalent to (EQ) 15 milligrams (mg) base, EQ 30 mg base, and EQ 45 mg base; ANDA 078953, Irinotecan HCl Injection, 40 mg/2 milliliters (mL) (20 mg/mL) and 100 mg/5 mL (20 mg/mL); ANDA 079049, Alendronate Sodium Tablets, EQ 5 mg base, EQ 10 mg base, EQ 35 mg base, and EQ 70 mg base; ANDA 090732, Anastrozole Tablets, 1 mg; and ANDA 203161, Irbesartan Tablets, 75 mg, 150 mg, and 300 mg. Before FDA withdrew the approval of these ANDAs, Neopharma, Inc., informed FDA that it did not want the approval of the ANDAs withdrawn. Because Neopharma, Inc., timely requested that approval of these ANDAs not be withdrawn, the approval of ANDAs 078383, 078953, 079049, 090732, and 203161 is still in effect.

The Department of the Treasury's Office of Foreign Assets Control (OFAC) is amending the Terrorism List Governments Sanctions Regulations to implement changes resulting from the Secretary of State's December 14, 2020 rescission of the designation of Sudan as a State Sponsor of Terrorism. Specifically, OFAC is removing one general license in full and amending another general license to remove references to the Government of Sudan and Sudanese nationals because financial transactions with the Government of Sudan are no longer prohibited by the Terrorism List Governments Sanctions Regulations.

DoD is making technical amendments to the Defense Federal Acquisition Regulation Supplement (DFARS) to provide needed editorial changes.

DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to implement a section of the National Defense Authorization Act for Fiscal Year 2019 that establishes a requirement for use of the best available information regarding past performance of subcontractors and joint venture partners when awarding DoD contracts for construction and architect-engineer services.

DoD is issuing a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to permit expedited contract closeout through a waiver by the contractor and the Government of entitlement to any residual dollar amounts that are due to either party at the time of contract closeout. The changes are necessary to establish an expedited contract closeout agreement that will save administrative costs for both the contractor and the Government.

The Department of the Treasury, 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. Currently the Bureau of the Fiscal Service within the Department of the Treasury is soliciting comments concerning the Subscription for Purchase and Issue of U.S. Treasury SecuritiesState and Local Government Series.

On May 28, 2010, the Office of Management and Budget (OMB) issued Paperwork Reduction Act (PRA) guidance related to the ``generic'' clearance process. Generally, this is an expedited process by which agencies may obtain OMB's approval of collection of information requests that are ``usually voluntary, low- burden, and uncontroversial collections,'' do not raise any substantive or policy issues, and do not require policy or methodological review. The process requires the submission of an overarching plan that defines the scope of the individual collections that would fall under its umbrella. On October 23, 2011, OMB approved our initial request to use the generic clearance process under control number 0938-1148 (CMS- 10398). It was last approved on April 26, 2021, via the standard PRA process which included the publication of 60- and 30-day Federal Register notices. The scope of the April 2021 umbrella accounts for Medicaid and CHIP State plan amendments, waivers, demonstrations, and reporting. This Federal Register notice seeks public comment on one or more of our collection of information requests that we believe are generic and fall within the scope of the umbrella. Interested persons are invited to submit comments regarding our burden estimates or any other aspect of this collection of information, including: The necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

OSHA is proposing changes to the Walking-Working Surfaces standards to clarify which handrail and stair rail system requirements apply to new stair rail systems.