August 19, 2019 – Federal Register Recent Federal Regulation Documents

The Coast Guard will enforce the special local regulation for the Thunder Over the Boardwalk Air Show on August 20 and August 21, 2019, from 10:30 a.m. through 4:30 p.m., to provide for the safety of life on navigable waterways during this event. Our regulation for marine events within the Fifth Coast Guard District identifies the regulated area for this event in Atlantic City, NJ. During the enforcement periods, the operator of any vessel in the regulated area must comply with directions from the Patrol Commander or any Official Patrol displaying a Coast Guard ensign.

In compliance with the Paperwork Reduction Act of 1995, the U.S. Coast Guard intends to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting an extension of its approval for the collection of information classified under OMB Control Number 1625-0056; without change. This collection of information is used for issuing vessel serial numbers and lables for the following: Hull Identification Numbers; U.S. Cast Guard Maximum Capacities; Gasoline Fuel Tank; USCG Type Fuel Hose and Certified Navigation Light Labels. Our ICR describes the information we seek to collect from the public. Before submitting this ICR to OIRA, the Coast Guard is inviting comments as described below.

The 21st Century Cures Act established HITAC to provide recommendations to the National Coordinator for Health Information Technology on policies, standards, implementation specifications, and certification criteria relating to the implementation of a health information technology infrastructure that advances the electronic access, exchange, and use of health information. The Act gave the Comptroller General of the United States responsibility for appointing a portion of HITAC's members. The Act requires that members at least reflect providers, ancillary health care workers, consumers, purchasers, health plans, health information technology developers, researchers, patients, relevant Federal agencies, and individuals with technical expertise on health care quality, system functions, privacy, security, and on the electronic exchange and use of health information, including the use standards for such activity. GAO is now accepting nominations for HITAC appointments that will be effective January 1, 2020. From these nominations, GAO expects to appoint at least two new HITAC members, including one advocate for patients or consumers of health information technology. Nominations should be sent to the email or mailing address listed below. Acknowledgement of submissions will be provided within a week of submission.

The Office of the United States Trade Representative (USTR) requests written comments that identify online and physical markets to be considered for inclusion in the 2019 Out-of-Cycle Review of Notorious Markets (Notorious Markets List). Conducted under the auspices of the Special 301 program, the Notorious Markets List identifies examples of online and physical markets based outside the United States that reportedly engage in and facilitate substantial copyright piracy or trademark counterfeiting. In 2010, USTR began publishing the Notorious Markets List separately from the annual Special 301 Report as an ``Out-of-Cycle Review.''

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #257 entitled ``Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Marker Residue Depletion Studies to Establish Product Withdrawal Periods in Aquatic Species'' (VICH GL57). This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document is intended to provide study design recommendations that will facilitate the universal acceptance of the generated residue depletion data to fulfill the national/regional requirements. This guidance document provides recommendations on what should be included in a marker residue depletion study design for aquatic food-producing species.

The National Park Service revises the special regulations for Death Valley National Park to designate the Saline Valley Warm Springs Airfield, commonly known as the Chicken Strip, within the Saline Valley Warm Springs Area as a location available for the operation of aircraft.

In compliance with the Paperwork Reduction Act of 1995 the U.S. Coast Guard is forwarding an Information Collection Request (ICR), abstracted below, to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting an extension of its approval for the following collection of information: 1625-0037, Certificates of Compliance, Boiler/Pressure Vessel Repairs, Cargo Gear Records, Shipping Papers, and NFPA 10 Certificates; without change. Our ICR describes the information we seek to collect from the public. Review and comments by OIRA ensure we only impose paperwork burdens commensurate with our performance of duties.

The Economic Development Administration (``EDA''), U.S. Department of Commerce (``DOC''), is publishing this notice of proposed rulemaking (``NPRM'') to request public comment on proposed updates to the agency's regulations implementing the Trade Adjustment Assistance for Firms (``TAAF'') provisions of the Trade Act of 1974, as amended (``Trade Act''), and the Public Works and Economic Development Act of 1965, as amended (``PWEDA''). The proposed changes to the TAAF program regulations would clarify the process for import-impacted U.S. manufacturing, oil and natural production and service firms to obtain technical assistanceidentified in the Trade Act as ``adjustment assistance''through the TAAF program, reorganize the regulations to make them easier to read and understand, incorporate best practices, and bring the regulations into closer alignment with the program's statutory requirements. The result will be to ease the burden on firms seeking adjustment assistance through the TAAF program and make it easier for Trade Adjustment Assistance Centers (``TAACs'') to work with firms. EDA also proposes the elimination of certain TAAF and PWEDA regulations that are unnecessary or duplicative because they describe requirements already established in other regulations or award documentation.

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 associated with Agency guidance entitled ``Dear Health Care Provider Letters: Improving Communication of Important Safety Information.'' The guidance offers specific recommendations to industry on the content and format of Dear Health Care Provider (DHCP) letters. These letters are sent by manufacturers or distributors to health care providers to communicate an important drug warning, a change in prescribing information, or a correction of misinformation in prescription drug promotional labeling or advertising. This guidance provides recommendations on when to use a DHCP letter, the types of information to include in the DHCP letter, how to organize the information so that it is communicated effectively to health care providers, and formatting techniques to make the information more accessible.

The Coast Guard is establishing a temporary safety zone for the navigable waters of the Ohio River, from mile marker (MM) 264.6 to MM 265.6, near Point Pleasant on August 31, 2019 for a Labor Day fireworks display. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards created by the fireworks display. Entry of vessels or persons into this zone is prohibited unless authorized by the Captain of the Port Sector Ohio Valley or a designated representative.

The Postal Service gives notice of a market test of an experimental product in accordance with statutory requirements.

These special conditions are issued for the Mitsubishi Aircraft Corporation (Mitsubishi) Model MRJ-200 airplane. This airplane will have a novel or unusual design feature when compared to the state of technology envisioned in the airworthiness standards for transport category airplanes. This design feature is avionics that allow internal and external connection to previously isolated data networks, which are connected to systems that perform functions required for the safe operation of the airplane. This feature creates a potential for unauthorized persons to access the aircraft-control domain and airline information-services domain, and presents security vulnerabilities related to the introduction of computer viruses and worms, user errors, and intentional sabotage of airplane electronic assets (networks, systems, and databases). The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the ACET. The ACET consists of 10 experts in fields associated with public health, epidemiology, immunology, infectious disease, pulmonary disease, pediatrics, tuberculosis, microbiology, or preventive health care delivery. They are selected by the Secretary of the U.S. Department of Health and Human Services (HHS). ACET provides advice and recommendations regarding eliminating tuberculosis (TB) to the Secretary, HHS; the Assistant Secretary for Health, HHS; and the CDC Director. ACET (a) makes recommendations regarding TB prevention and control policies, strategies, objectives, and priorities; (b) addresses development and application of new technologies; (c) provides guidance and review of CDC's TB prevention research portfolio and program priorities; and (d) reviews the extent to which progress has been made toward eliminating TB. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of ACET's objectives. Nominees will be selected on the basis of their expertise in public health, epidemiology, immunology, infectious diseases, pulmonary disease, pediatrics, tuberculosis, microbiology, or preventive health care delivery. Federal employees are ineligible for membership. Members may be invited to serve for up to four year terms. Selection of members is based on candidates' qualifications to contribute to the accomplishment of ACET's objectives.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the Tick-Borne Disease Working Group (TBDWG) will hold a meeting. The meeting will be open to the public. For this meeting, the Working Group will receive updates from the eight subcommittees formed at the June 4, 2019, meeting and continue to focus on plans to develop the next report to the HHS Secretary and Congress on federal tick-borne activities and research, taking into consideration the 2018 report. The 2020 report will address a wide range of federal activities and research related to tick-borne diseases, such as, surveillance, prevention, diagnosis, diagnostics, and treatment; identify gaps in tick-borne disease research; and provide recommendations to the HHS Secretary regarding changes or improvements to such activities and research. In developing the report, the TBDWG will solicit stakeholder input.