2019 – Federal Register Recent Federal Regulation Documents
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Death Valley National Park; Designation of Airstrip
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Review Transparency and Communication in Reviews of 351(k) Biologics License Applications in Biosimilars User Fee Act
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Collection of Information Under Review by Office of Management and Budget; OMB Control Number: 1625-0037
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.
General Updates and Elimination of Certain TAAF and PWEDA Regulations
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.
Safety Zone; Delaware River; Baker Range, DE and NJ
The Coast Guard is establishing two temporary moving safety zones in the Baker Range portion of the Delaware River. This action is necessary to provide for the safety of life and navigation on this portion of the Delaware River during submarine power cable laying operations. This regulation prohibits persons and vessels from entering or transiting through the safety zone without prior authorization from the Captain of the Port Delaware Bay or a designated representative.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Dear Health Care Provider Letters: Improving Communication of Important Safety Information
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.
Collection of Information Under Review by Office of Management and Budget; OMB Control Number: 1625-0067.
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: 1625-0067, Claims under the Oil Pollution Act of 1990; 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.
Safety Zone; Ohio River, Point Pleasant, WV
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.
Safety Zone; Kanawha River, Charleston, WV
The Coast Guard is establishing a temporary safety zone for all navigable waters on the Kanawha River. The safety zone is needed to provide for safety of life and protection of vessels and the marine environment from potential hazards associated with the fireworks display. Entry of vessels or persons into the zone is prohibited unless specifically authorized by the Captain of the Port Sector Ohio Valley or a designated representative.
Market Test of Experimental Product: “Plus One”
The Postal Service gives notice of a market test of an experimental product in accordance with statutory requirements.
Food and Drug Administration Science Forum 2019; Public Workshop
The Food and Drug Administration (FDA or the Agency) is announcing the following public workshop entitled ``FDA Science Forum 2019.'' The purpose of the public workshop is to share with the public the unique scientific research and collaborative efforts of FDA's 11,000 scientists and researchers, who use novel science and technologies to inform FDA's regulatory decision-makingand drive innovation.
Submission for OMB Review; General Services Administration Acquisition Regulation; Construction Manager as Constructor (CMc)
Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve a new information collection requirement regarding OMB Control No. 3090-XXXX, Adoption of Construction Project Delivery Method Involving Early Industry EngagementConstruction Manager as Constructor (CMc).
Special Conditions: The Boeing Company Model 777-9 Series Airplane; Overhead Flight Attendant Rest Compartment
This action proposes special conditions for The Boeing Company (Boeing) Model 777-9 series 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 associated with the installation of an overhead flight attendant rest (OFAR) compartment. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These proposed 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.
Special Conditions: Mitsubishi Aircraft Corporation Model MRJ-200 Airplane; Airplane Electronic-System Security Protection From Unauthorized Internal and External Access
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.
Certain Blood Cholesterol Testing Strips and Associated Systems Containing the Same; Commission Determination To Review in Part a Final Initial Determination Finding a Violation of Section 337; Schedule for Filing Written Submissions on the Issues Under Review and on Remedy, the Public Interest, and Bonding; Extension of the Target Date
Notice is hereby given that the U.S. International Trade Commission has determined to review in part a final initial determination (``ID'') issued by the presiding administrative law judge (``ALJ''), finding a violation of section 337 of the Tariff Act of 1930. The Commission requests briefing from the parties on certain issues under review, as indicated in this notice. The Commission also requests briefing from the parties, interested persons, and government agencies on the issues of remedy, the public interest, and bonding. The Commission has also determined to extend the target date for the completion of the above-captioned investigation to October 21, 2019.
Solicitation of Nominations for Appointment to the Advisory Council for the Elimination of Tuberculosis (ACET)
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.
National Institute for Occupational Safety and Health (NIOSH); World Trade Center Health Program Scientific/Technical Advisory Committee (WTCHP STAC)
In accordance with the Federal Advisory Committee Act, the CDC National Institute for Occupational Safety and Health (NIOSH), announces the following meeting for the World Trade Center Health Program Scientific/Technical Advisory Committee (WTCHP STAC). This meeting is open to the public, limited only by the number of telephone lines. The room will accommodate approximately 100 persons. The public is also welcome to listen to the meeting by dial-in 1 (800) 988-0212, the passcode 1440561, and will accommodate up to 50 callers. To view the web conference, enter the following web address in your web browser: https://odniosh.adobeconnect.com/wtchpstac19-1/.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
Proposed Establishment of the Candy Mountain Viticultural Area and Modification of the Yakima Valley Viticultural Area
The Alcohol and Tobacco Tax and Trade Bureau (TTB) proposes to establish the 815-acre ``Candy Mountain'' viticultural area in Benton County, Washington. TTB also proposes to expand the boundary of the existing 1,093-acre Yakima Valley viticultural area by approximately 72 acres in order to avoid a partial overlap with the proposed Candy Mountain viticultural area. Both the existing Yakima Valley AVA and the proposed Candy Mountain AVA are located entirely within the existing Columbia Valley AVA. TTB designates viticultural areas to allow vintners to better describe the origin of their wines and to allow consumers to better identify wines they may purchase. TTB invites comments on these proposals.
Agency Information Collection Activity Under OMB Review: VA Health Professional Scholarship and Visual Impairment and Orientation and Mobility Professional Scholarship Programs (HPSP and VIOMPSP)
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.
Exelon Generation Company, LLC; Three Mile Island Nuclear Station, Unit 1
The U.S. Nuclear Regulatory Commission (NRC) has granted the request of Exelon Generation Company, LLC to withdraw its application dated September 20, 2018, for a proposed amendment to Renewed Facility Operating License No. DPR-50 for the Three Mile Island Nuclear Station, Unit 1. The proposed amendment would have revised Technical Specification 4.4.2.1, ``Inservice Tendon Surveillance Requirements,'' to add the words ``except where an alternative, exemption, or relief has been authorized by the NRC'' to allow NRC-approved exceptions.
Single Family Housing Guaranteed Loan Program; Correction
On July 22, 2019, the Rural Housing Service (RHS) published a final rule concerning construction to permanent loan financing, repair or rehabilitation financing, and the removal of a maximum the interest rate cap for the Single Family Housing Guaranteed Loan Program. The effective date was published as August 21, 2019 and is being deferred to October 1, 2019.
Agency Information Collection Activities: Proposed Collection; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Proposed Extension of Information Collection Request Submitted for Public Comment; Comment Request Concerning Information Reporting for Notice 99-43, Nonrecognition Exchanges Under Section 897
The Internal Revenue Service, as part of its continuing effort to reduce paperwork and respondent burden, invites the public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. Currently, the IRS is soliciting comments concerning information reporting for Notice 99-43, Nonrecognition Exchanges under Section 897.
Agency Information Collection Activity: Environmental Hazards Registry (EHR) Worksheet (VA Form 10-10176)
Veterans Health Administration, Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of a currently approved collection, and allow 60 days for public comment in response to the notice.
Air Plan Approval; Minnesota; Flint Hills Sulfur Dioxide (SO2
The Environmental Protection Agency (EPA) is approving a revision to the Minnesota sulfur dioxide (SO2) State Implementation Plan (SIP) for the Flint Hills Resources, LLC Pine Bend Refinery (FHR) as submitted on October 23, 2018. The SIP revision pertains to the shutdown and replacement of certain equipment at the refinery as well as amendments to certain emission limits, resulting in an overall decrease of SO2 emissions from FHR.
Air Plan Approval; Ohio; Second Limited Maintenance Plans for 1997 Ozone NAAQS
Pursuant to the Clean Air Act (CAA), the Environmental Protection Agency (EPA) is proposing to approve a state implementation plan (SIP) revision submitted by the State of Ohio. On April 12, 2019, the state submitted the 1997 8-hour ozone national ambient air quality standards (NAAQS or standard) Limited Maintenance Plan (LMP) for the Canton-Massillon (Stark County), Lima (Allen County), and Toledo (Lucas and Wood Counties) areas and the Ohio portion of the Parkersburg- Marietta [OH-WV] (Washington County), Steubenville-Weirton [OH-WV] (Jefferson County), Wheeling [OH-WV] (Belmont County), and Youngstown- Warren-Sharon [OH-PA] (Columbiana, Mahoning, and Trumbull Counties) multi-state areas. EPA is proposing to approve these Ohio LMPs because they provide for the maintenance of the 1997 8-hour ozone NAAQS through the end of the second 10-year portion of the maintenance period. The effect of this action would be to make certain commitments related to maintenance of the 1997 8-hour ozone NAAQS in these areas federally enforceable as part of the Ohio SIP.
Air Plan Approval; Illinois; Emissions Reduction Market System Sunsetting
The Environmental Protection Agency (EPA) is proposing to approve a State Implementation Plan (SIP) revision submitted by the Illinois Environmental Protection Agency (Illinois EPA) on January 11, 2019, concerning the state's Emissions Reduction Market System (ERMS) program for the Chicago ozone nonattainment area (NAA) in Illinois. The revision sunsets the ERMS program and effectively removes from the SIP provisions in 35 Illinois Administrative Code (35 IAC) Part 205, as the ERMS program is no longer effective in providing any additional emissions reductions or environmental benefit. The submittal also includes a demonstration under section 110(l) of the Clean Air Act (CAA) that addresses emission impacts associated with the sunsetting of the program.
Air Plan Approval; Indiana; Limited Maintenance Plan for 1997 Ozone NAAQS; Evansville, Fort Wayne, Greene County, Jackson County, Muncie, and Terre Haute
The Environmental Protection Agency (EPA) is proposing to approve a submission from the State of Indiana as a state implementation plan (SIP) revision in according with the Clean Air Act (CAA). On April 25, 2019, the state submitted its 1997 8-hour ozone national ambient air quality standards (NAAQS or standard) Limited Maintenance Plan (LMP) for the following Indiana areas:] Evansville, Fort Wayne, Greene County, Jackson County, Muncie, and Terre Haute. EPA is proposing to approve the LMPs for these areas because they provide for the maintenance of the 1997 8-hour ozone NAAQS through the end of the second 10-year portion of the maintenance period. The effect of this action would be to make federally enforceable certain commitments related to maintenance of the 1997 8-hour ozone NAAQS in these areas as part of the Indiana SIP.
Migratory Bird Hunting; Final Frameworks for Migratory Bird Hunting Regulations
The U.S. Fish and Wildlife Service (Service or we) prescribes final frameworks from which States may select season dates, limits, and other options for the 2019-20 migratory bird hunting seasons. The effect of this final rule is to facilitate the States' selection of hunting seasons and to further the annual establishment of the migratory bird hunting regulations. We annually prescribe frameworks, or outer limits, for dates and times when hunting may occur and the number of birds that may be taken and possessed in hunting seasons. These frameworks are necessary to allow State selections of seasons and limits and to allow recreational harvest at levels compatible with population and habitat conditions.
HUD's Implementation of the Fair Housing Act's Disparate Impact Standard
Title VIII of the Civil Rights Act of 1968, as amended (Fair Housing Act or Act), prohibits discrimination in the sale, rental, or financing of dwellings and in other housing-related activities on the basis of race, color, religion, sex, disability, familial status, or national origin. HUD has long interpreted the Act to create liability for practices with an unjustified discriminatory effect, even if those practices were not motivated by discriminatory intent. This rule proposes to amend HUD's interpretation of the Fair Housing Act's disparate impact standard to better reflect the Supreme Court's 2015 ruling in Texas Department of Housing and Community Affairs v. Inclusive Communities Project, Inc., and to provide clarification regarding the application of the standard to State laws governing the business of insurance. This rule follows a June 20, 2018, advance notice of proposed rulemaking, in which HUD solicited comments on the disparate impact standard set forth in HUD's 2013 final rule, including the disparate impact rule's burden-shifting approach, definitions, and causation standard, and whether it required amendment to align with the decision of the Supreme Court in Inclusive Communities Project, Inc.
Chlorinated Isocyanurates From Spain: Preliminary Results of Antidumping Duty Administrative Review; 2017-2018
The Department of Commerce (Commerce) preliminarily determines that sales of chlorinated isocyanurates (chlorinated isos) from Spain by Ercros S.A. (Ercros) were not sold at less than normal value during the period of review (POR), June 1, 2017 through May 31, 2018. Interested parties are invited to comment on these preliminary results.
Performance Requirements for Residential Gas Furnaces and Boilers; Advance Notice of Proposed Rulemaking
The Consumer Product Safety Commission (Commission or CPSC) is considering developing a rule to address the risk of injury and death associated with carbon monoxide (CO) production and leakage from residential gas furnaces and boilers. This advance notice of proposed rulemaking (ANPR) initiates a rulemaking proceeding under the Consumer Product Safety Act (CPSA). We invite comments concerning the risk of injury associated with CO production and leakage from residential gas furnaces and boilers, the alternatives discussed in this ANPR, and other possible alternatives for addressing the risk. We also invite interested parties to submit existing voluntary standards or a statement of intent to modify or develop a voluntary standard that addresses the risk of injury described in this document.
Security Threat Disqualification Update
The FAA is amending and consolidating the security threat disqualification regulations. This final rule establishes the FAA's procedures in regulation for amending, modifying, suspending, and revoking FAA-issued certificates and any part of such certificates issued to individuals based on written notification by the Transportation Security Administration (TSA) that a certificate holder poses a security threat. The final rule also clarifies the FAA's process for denying or holding in abeyance applications for certificates and any parts of such certificates when the TSA notifies the FAA that an applicant poses a security threat.
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