2020 – Federal Register Recent Federal Regulation Documents

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 revision of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection pertaining to ``Expedited Programs for Serious ConditionsDrugs and Biologics.''

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry, entitled ``Draft Guidance for Tiotropium Bromide.'' The draft guidance, when finalized, will provide product-specific recommendations on, among other things, the information and data needed to demonstrate bioequivalence (BE) to support abbreviated new drug applications (ANDAs) for tiotropium bromide inhalation spray.

This notice announces a meeting of the Fusion Energy Sciences Advisory Committee (FESAC). The Federal Advisory Committee Act requires that public notice of these meetings be announced in the Federal Register.

This notice announces a meeting of the Basic Energy Sciences Advisory Committee (BESAC). Federal Advisory Committee Act requires that public notice of these meetings be announced in the Federal Register.

The Department of Energy (DOE) has submitted an information collection request to the OMB for a new collection under the provisions of the Paperwork Reduction Act of 1995. The information collection would create an evergreen webform for meeting room requests from stakeholders for the Office of Legacy Management (LM) Interpretive Centers.

In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Veterans Health Administration, Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden, and it includes the actual data collection instrument.

Effective August 23, 2018, the U.S. Trade Representative imposed additional duties on goods of China with an annual trade value of approximately $16 billion as part of the action in the Section 301 investigation of China's acts, policies, and practices related to technology transfer, intellectual property, and innovation. The U.S. Trade Representative's determination included a decision to establish a product exclusion process. The U.S. Trade Representative initiated the exclusion process in September 2018, and stakeholders have submitted requests for the exclusion of specific products. The first set of exclusions was published in July 2019 and expired in July 2020. On April 30, 2020, the U.S. Trade Representative established a process for the public to comment on whether to extend particular exclusions granted in July 2019 for up to 12 months. In July 2020, the U.S. Trade Representative determined to extend certain exclusions through December 31, 2020. This notice announces the U.S. Trade Representative's determination to make one technical amendment to a previously extended exclusion.

The Food and Drug Administration (FDA or Agency) is announcing the availability of FDA guidance documents related to the Coronavirus Disease 2019 (COVID-19) public health emergency (PHE). This notice of availability (NOA) is pursuant to the process that FDA announced, in the Federal Register of March 25, 2020, for making available to the public COVID-19-related guidances. The guidances identified in this notice address issues related to the COVID-19 PHE and have been issued in accordance with the process announced in the March 25, 2020, notice. The guidances have been implemented without prior comment, but they remain subject to comment in accordance with the Agency's good guidance practices.

The FAA is adopting a new airworthiness directive (AD) for all Airbus SAS Model A350-1041 airplanes. This AD was prompted by a report that, during testing, wear was found on the drive strut anti-rotation knuckles and lever bearing assembly (LBA) bushes on a certain flap station. This AD requires repetitive inspections for wear or corrosion damage of the drive strut anti-rotation knuckles and LBA bushes, and applicable corrective actions, 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.

Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled Certain Sponge or Foam Products, DN 3506; the Commission is soliciting comments on any public interest issues raised by the complaint or complainant's filing pursuant to the Commission's Rules of Practice and Procedure.

Notice is hereby given that the U.S. International Trade Commission has determined not to review an initial determination (``ID'') (Order No. 6) of the presiding administrative law judge (``ALJ'') terminating the investigation with respect to respondents East West Manufacturing, LLC and East West Industries (collectively, ``Respondents'') based on a consent order stipulation. The Commission has entered a consent order and terminated the investigation in its entirety.

The Transportation Security Administration (TSA) invites public comment on one currently approved Information Collection Request (ICR), OMB control number 1652-0053, abstracted below that we will submit to the Office of Management and Budget (OMB) for an extension in compliance with the Paperwork Reduction Act. The ICR describes the nature of the information collection and its expected burden. The collections of information that make up this ICR include: (1) Applications from entities that wish to become Certified Cargo Screening Facilities (CCSFs), Third-Party Canine-Cargo (3PK9-C) Certifiers or Certified Cargo Screening Program-Canine (CCSP-K9) Holders; (2) personally identifiable information to allow TSA to conduct security threat assessments (STA) and/or Criminal History Records Check (CHRC) on certain individuals employed by the CCSFs, 3PK9-C Certifiers, Certified Cargo Screening Facilities-K9 (CCSF-K9) and those authorized to conduct 3PK9-C Program activities; (3) standard security program or submission of a proposed modified security program or amendment to a security program by CCSFs and CCSF-K9s or standards provided by TSA or submission of a proposed modified standard by 3PK9-C Certifiers; (4) recordkeeping requirements for CCSFs, CCSF-K9s and 3PK9-C Certifiers; (5) designation of a Security Coordinator (SC) by CCSP Holders, CCSP-K9 Holders and 3PK9-C Certifiers; and (6) significant security concerns detailing information of incidents, suspicious activities, and/or threat information by CCSP Holders, CCSP- K9 Holders and CCSP-K9 Holders. TSA is seeking an extension of this ICR for the continuation of the Certified Cargo Screening Program (CCSP) in order to secure passenger aircraft carrying cargo.

In accordance with the Federal Land Policy and Management Act of 1976 and the Federal Advisory Committee Act of 1972, the U.S. Department of the Interior, Bureau of Land Management's (BLM) Steens Mountain Advisory Council's (SMAC) Public Lands Access Subcommittee will meet as indicated below.

Notice is hereby given of the following determinations: I hereby determine that certain objects being imported from abroad pursuant to agreements with their foreign owners or custodians for temporary display in the exhibition ``Goya's Graphic Imagination'' at The Metropolitan Museum of Art, New York, New York, and at possible additional exhibitions or venues yet to be determined, are of cultural significance, and, further, that their temporary exhibition or display within the United States as aforementioned is in the national interest. I have ordered that Public Notice of these determinations be published in the Federal Register.

We, the U.S. Fish and Wildlife Service (Service), received two applications for enhancement of survival permits (permits) pursuant to the Endangered Species Act of 1973, as amended. The permits would authorize the incidental take of the threatened marbled murrelet associated with forest management actions on private lands. The applications each include a safe harbor agreement (SHA), describing the actions the applicants will take to achieve a net conservation benefit on their lands for the species. We also announce the availability of two draft environmental assessments (EAs) addressing the effects of the proposed permits and SHAs on the human environment in accordance with the National Environmental Policy Act. We invite comments from all interested parties.

FMCSA announces its decision to renew exemptions for nine individuals from the hearing requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) for interstate commercial motor vehicle (CMV) drivers. The exemptions enable these hard of hearing and deaf individuals to continue to operate CMVs in interstate commerce.