August 1, 2019 – Federal Register Recent Federal Regulation Documents

The Wireless Telecommunications Bureau (WTB or the Bureau) announces that the Office of Management and Budget (OMB) has approved the information-collection and recordkeeping requirements associated with the recently amended hearing aid compatibility provisions addressing wireless service provider record retention, website posting, and certification filing requirements and announces the date by which service providers must be in compliance with these provisions.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``E8(R1) General Considerations for Clinical Studies.'' The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance describes internationally accepted principles and practices for the design and conduct of clinical studies of drug and biologic products. In addition, the draft guidance provides an overview of the types of clinical studies that may be performed and data sources during the product's life cycle. The draft guidance is intended to promote the quality of the studies submitted to regulatory authorities, while allowing for flexibility.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products.'' This draft guidance is intended to assist sponsors of new drug applications (NDAs), biologics license applications (BLAs) for therapeutic biologics, and supplements who are planning to conduct clinical studies in neonatal populations. The issuance of this draft guidance on clinical pharmacology considerations for neonatal studies for drugs and biological products is stipulated under the FDA Reauthorization Act of 2017 (FDARA).

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 will take place.

The U.S. Nuclear Regulatory Commission (NRC) issued a confirmatory order to Idaho State University on May 2, 2019. The purpose of the confirmatory order was to document commitments made as part of a settlement agreement between Idaho State University and the NRC to address inadequate management oversight for Idaho State University's radiation protection program and a failure to prioritize resources for the radiation safety staff such that their responsibilities could be implemented. The confirmatory order also documented commitments to address Idaho State University's failure to effectively control radioactive materials in its possession, exhibited by multiple violations identified during inspections and the inadequate extent of condition review related to the violations involving a lost source.

As required under the Paperwork Reduction Act of 1995 (PRA), the Consumer Product Safety Commission (CPSC) announces that CPSC has submitted to the Office of Management and Budget (OMB) a new proposed collection of information by the agency on a survey that will evaluate consumer awareness or recognition of CPSC's ``Anchor It!'' campaign. On April 8, 2019, the CPSC published a notice in the Federal Register announcing the agency's intent to seek approval of this collection of information. The CPSC received no comments in response to that notice. Therefore, by publication of this notice, the CPSC announces that it has submitted to the OMB a request for approval of this collection of information.

The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.

The NMFS Assistant Administrator (Assistant Administrator) has renewed affirmative findings for the Governments of Ecuador, El Salvador, Guatemala, Mexico, Peru, and Spain (referred to hereafter as ``the Nations'') under the Marine Mammal Protection Act (MMPA). These affirmative findings will continue to allow the importation into the United States of yellowfin tuna and yellowfin tuna products harvested in the eastern tropical Pacific Ocean (ETP) for 1 year in compliance with the Agreement on the International Dolphin Conservation Program (AIDCP) by purse seine vessels operating under the Nations' jurisdiction or exported from the Nations. NMFS bases the affirmative finding annual renewals on reviews of documentary evidence submitted by the Governments of the Nations and of information obtained from the secretariat of the Inter-American Tropical Tuna Commission (IATTC).

The NMFS Assistant Administrator (Assistant Administrator) has issued a 5-year affirmative finding for the Government of Colombia under the Marine Mammal Protection Act (MMPA). This affirmative finding will allow importation into the United States of yellowfin tuna and yellowfin tuna products harvested in the eastern tropical Pacific Ocean (ETP) in compliance with the Agreement on the International Dolphin Conservation Program (AIDCP) by purse seine vessels operating under Colombian jurisdiction or exported from Colombia. NMFS bases the affirmative finding determination on reviews of documentary evidence submitted by the Government of Colombia and of information obtained from the secretariat of the Inter-American Tropical Tuna Commission (IATTC).

The mission of the Office of Special Education and Rehabilitative Services (OSERS) is to improve early childhood, educational, and employment outcomes and raise expectations for all people with disabilities, their families, their communities, and the Nation. As such, we are issuing a notice inviting applications for new awards for fiscal year (FY) 2019 for Educational Technology, Media, and Materials for Individuals with DisabilitiesNational Center on Accessible Educational Materials for Learning, Catalog of Federal Domestic Assistance (CFDA) number 84.327Z. This notice relates to the approved information collection under OMB control number 1820-0028.

The Department of Health and Human Services (HHS) is revising its regulations to update references to the International Classification of Disease (ICD) codes from ICD-9-CM to ICD-10-CM, and remove outdated references to chronic lymphocytic leukemia from Energy Employees Occupational Illness Compensation Program regulations. These technical amendments have no effect on the cancer eligibility requirement under the Program because all cancer types are eligible to receive a dose reconstruction from NIOSH. Thus, no eligible claimant will be adversely impacted by this rulemaking.

The Department of Commerce (Commerce) preliminarily determines that Oman Fasteners LLC (Oman Fasteners), a producer/exporter of certain steel nails (nails) from the Sultanate of Oman (Oman), did not sell subject merchandise at prices below normal value during the period of review (POR) July 1, 2017 through June 30, 2018. Additionally, we are rescinding the review with respect to three companies. Interested parties are invited to comment on these preliminary results.

The Department of Commerce (Commerce) preliminarily determines that countervailable subsidies are being provided to producers and exporters of vertical metal file cabinets (file cabinets) from the People's Republic of China (China). The period of investigation is January 1, 2018 through December 31, 2018. Interested parties are invited to comment on this preliminary determination.

We, the U.S. Fish and Wildlife Service, in response to a request from Hilcorp Alaska, LLC, Harvest Alaska, LLC, and the Alaska Gasline Development Corporation, finalize regulations authorizing the nonlethal, incidental take by harassment of small numbers of northern sea otters in State and Federal waters (Alaska and the Outer Continental Shelf) within Cook Inlet, Alaska, as well as all adjacent rivers, estuaries, and coastal lands. Take may result from oil and gas exploration, development, production, and transportation activities occurring for a period of 5 years. This rule authorizes take by harassment only; no lethal take is authorized. We will issue Letters of Authorization, upon request, for specific proposed activities in accordance with these regulations. Additionally, the Office of Management and Budget has approved a revision of the existing Information Collection control number 1018-0070, for incidental take of marine mammals in the Beaufort and Chukchi Seas, to include oil and gas activities in Cook Inlet.

The Department of Commerce (Commerce) determines that PT. Cheil Jedang Indonesia (CJ Indonesia), an Indonesian producer/exporter of monosodium glutamate (MSG) and the sole respondent in this review, did not make sales of MSG at prices below normal value during the period of review (POR) November 1, 2016 through October 31, 2017.

The Department of State (the Department) updates and revises the rules that implement Section 508 of the Rehabilitation Act of 1973, consistent with updates to accessibility standards from the U.S. Access Board.