August 29, 2019 – Federal Register Recent Federal Regulation Documents

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (HHS) is hereby giving notice that the President's Council on Sports, Fitness, and Nutrition (PCSFN) will hold its annual meeting. The meeting will be open to the public.

This notice contains a summary of a petition seeking relief from specified requirements of Federal Aviation Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products.'' This guidance provides recommendations to industry about using placebos and blinding in randomized controlled clinical trials in development programs for drug or biological products to treat hematologic malignancies and oncologic diseases regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This guidance finalizes the draft guidance entitled ``Hematologic Malignancy and Oncologic Disease: Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development'' issued August 24, 2018.

The Food and Drug Administration (FDA or we) is announcing a public meeting entitled ``Horizontal Approaches to Food Standards of Identity Modernization.'' The purpose of the public meeting is to give interested persons an opportunity to discuss FDA's effort to modernize food standards of identity (SOI) and provide information about changes we could make to existing SOI, particularly changes that could be made across categories of standardized foods (i.e., horizontal changes), to provide flexibility for the development of healthier foods. We are also interested in discussing horizontal changes that would better facilitate innovation. This effort is part of the FDA's comprehensive, multiyear Nutrition Innovation Strategy (NIS) designed to improve healthy dietary behavior and help reduce preventable death and disease related to poor nutrition by, among other things, providing incentives for food manufacturers to produce products that have more healthful attributes.

NMFS implements accountability measures for commercial red snapper in the exclusive economic zone (EEZ) of the South Atlantic. NMFS projects commercial landings for red snapper will reach the commercial annual catch limit (ACL) for the 2019 fishing year. Therefore, NMFS is closing the commercial sector for red snapper in the South Atlantic EEZ on August 30, 2019. This closure is necessary to protect the red snapper resource.

The Department of Defense has submitted to OMB for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.

Comments are requested on proposed flood hazard determinations, which may include additions or modifications of any Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area (SFHA) boundary or zone designation, or regulatory floodway on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the preliminary FIRM, and where applicable, the FIS report that the Federal Emergency Management Agency (FEMA) has provided to the affected communities. The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP). In addition, the FIRM and FIS report, once effective, will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings.

On August 8, 2019, FEMA published in the Federal Register a final flood hazard determination notice that contained an erroneous table. This notice provides corrections to that table. The table provided here represents the final flood hazard determinations and communities affected for San Diego County, California and Incorporated Areas.

This notice lists communities where the addition or modification of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or the regulatory floodway (hereinafter referred to as flood hazard determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports, prepared by the Federal Emergency Management Agency (FEMA) for each community, is appropriate because of new scientific or technical data. The FIRM, and where applicable, portions of the FIS report, have been revised to reflect these flood hazard determinations through issuance of a Letter of Map Revision (LOMR), in accordance with Federal Regulations. The LOMR will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings. For rating purposes, the currently effective community number is shown in the table below and must be used for all new policies and renewals.

The Department of Defense has submitted to OMB for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.

The registrants listed below have applied for ad been granted registration by the Drug Enforcement Administration (DEA) as importers of schedule I and II controlled substances.

The registrants listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as importers of schedule I and II controlled substances.

The Department of Defense (DoD) is publishing this notice to announce that the following Federal Advisory Committee meeting of the Defense Advisory Committee on Military Personnel Testing will take place.

In compliance with the requirements of the Paperwork Reduction Act of 1995, the Federal Energy Regulatory Commission (Commission or FERC) is soliciting public comment on the requirements and burden of the information collections described below.

The Federal Emergency Management Agency (FEMA) will submit the information collection abstracted below to the Office of Management and Budget for review and clearance in accordance with the requirements of the Paperwork Reduction Act of 1995. The submission will describe the nature of the information collection, the categories of respondents, the estimated burden (i.e., the time, effort and resources used by respondents to respond) and cost, and the actual data collection instruments FEMA will use.

The National Institute of Standards and Technology (NIST) invites organizations to provide products and technical expertise to support and demonstrate security platforms for the Securing Telehealth Remote Patient Monitoring Ecosystem for the healthcare sector use case. This notice is the initial step for the NCCoE in collaborating with technology companies to address cybersecurity challenges identified under the healthcare sector program. Participation in the use case is open to all interested organizations.

Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled Certain Semiconductor Devices, Products Containing the Same, and Components Thereof (I), DN 3407; 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.

The New England Fishery Management Council (Council) is scheduling a public meeting of its Monkfish Committee to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.