October 2019 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Providing Regulatory Submissions in Electronic Format: IND Safety Reports.'' The draft guidance describes the electronic format sponsors will be required to use when they electronically submit to FDA investigational new drug (IND) safety reports to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER) for serious and unexpected suspected adverse reactions that are required under the Agency's regulations. FDA is establishing the electronic format requirements described in this guidance under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The draft guidance, once finalized and effective, will require sponsors submitting the specified IND safety reports electronically to submit the reports to FDA using the FDA Adverse Event Reporting System (FAERS) as structured data elements and will provide sponsors with a reporting format that is consistent with the International Council for Harmonisation (ICH) E2B(R2) format guidelines and reporting requirements to other regulatory agencies. Additional technical specification documents and instructions for submitting IND safety reports, including ``Electronic Submission of IND Safety Reports Technical Conformance Guide'' and an updated technical specifications document entitled ``Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments'' are available on the FAERS Electronic Submission web page (available at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInforma tion/ Surveillance/AdverseDrugEffects/ucm115894.htm).

With this document, EPA is opening the public comment period for review of anthraquinone. Registration review is EPA's periodic review of pesticide registrations to ensure that each pesticide continues to satisfy the statutory standard for registration, that is, the pesticide can perform its intended function without unreasonable adverse effects on human health or the environment. Registration review dockets contain information that will assist the public in understanding the types of information and issues that the Agency may consider during the course of registration reviews. Through this program, EPA is ensuring that each pesticide's registration is based on current scientific and other knowledge, including its effects on human health and the environment.

In accordance with the Paperwork Reduction Act of 1995, we, the U.S. Geological Survey (USGS) are proposing to renew an information collection.

Under the Paperwork Reduction Act of 1995 (PRA) and its implementing regulations, this notice announces that FRA is forwarding the Information Collection Request (ICR) abstracted below to the Office of Management and Budget (OMB) for review and comment. The ICR describes the information collection and its expected burden. On August 30, 2019, FRA published a notice providing a 60-day period for public comment on the ICR.

This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Northern New Mexico. The Federal Advisory Committee Act requires that public notice of this meeting be announced in the Federal Register.

This notice announces an open meeting of the Biomass Research and Development Technical Advisory Committee. The Federal Advisory Committee Act requires that agencies publish these notices in the Federal Register to allow for public participation.

The Department of State (``Department'') has submitted the information collection request described below to the Office of Management and Budget (``OMB'') for review and approval in accordance with the emergency review procedures of the Paperwork Reduction Act of 1995. The purpose of this notice is to allow for public comment from all interested individuals and organizations. Emergency review and approval of this collection has been requested from OMB by November 1, 2019. If granted, the approval is only valid for 180 days. The Department is separately submitting a 3 year approval through OMB's normal PRA clearance process.

We, the U.S. Fish and Wildlife Service (Service), announce the availability of the Draft Recovery Plan for the Streaked Horned Lark under the Endangered Species Act of 1973, as amended. The draft recovery plan includes specific goals, objectives, and criteria that should be met to remove the species from the Federal List of Endangered and Threatened Wildlife. We request review and comment on this draft recovery plan from Federal, State, and local agencies; Native American Tribes; and the public.

The Drug Enforcement Administration proposes placing methyl 2- (1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3-methylbutano ate (other names: FUB-AMB, MMB-FUBINACA, AMB-FUBINACA), including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, in schedule I of the Controlled Substances Act. If finalized, this action would make permanent the existing regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle FUB-AMB.

This notice sets forth the schedule and summary agenda for an open meeting of the President's Council of Advisors on Science and Technology (PCAST), and describes the functions of the Council. The Federal Advisory Committee Act (FACA) requires that public notice of these meetings be announced in the Federal Register.

The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), EPA Application Materials for the Water Infrastructure Finance and Innovation Act (EPA ICR Number 2549.02, OMB Control Number 2040-0292) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through December 31, 2019. Public comments were previously requested via the Federal Register on April 23, 2019 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), Motor Vehicle and Engine Compliance Program Fees (EPA ICR Number 2080.07, OMB Control Number 2060-0545) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through December 31, 2019. Public comments were previously requested via the Federal Register on April 11, 2019 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

The Department of Commerce (Commerce) determines that countervailable subsidies are being provided to producers and exporters of aluminum wire and cable from the People's Republic of China (China).