June 10, 2021 – Federal Register Recent Federal Regulation Documents

Reader Aids
Document Number: FR-2021-06-10-ReaderAids
Type: Reader Aids
Date: 2021-06-10
Continuation of the National Emergency With Respect to the Western Balkans
Document Number: 2021-12383
Type: Administrative Order
Date: 2021-06-10
Agency: Executive Office of the President
Airworthiness Directives; Airbus SAS Airplanes
Document Number: 2021-12301
Type: Rule
Date: 2021-06-10
Agency: Federal Aviation Administration, Department of Transportation
The FAA is adopting a new airworthiness directive (AD) for all Airbus SAS Model A330-243, A330-243F, A330-341, A330-342, and A330-343 airplanes. This AD was prompted by a report of an in-flight turnback due to loss of green and blue hydraulic systems in cruise. This AD requires inspecting for discrepancies of the hydraulic pressure switch harnesses of affected engines, 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.
Board of Governors; Sunshine Act Meeting
Document Number: 2021-12281
Type: Notice
Date: 2021-06-10
Agency: Postal Service, Agencies and Commissions
Raw Honey From Argentina, Brazil, India, Ukraine, and Vietnam
Document Number: 2021-12223
Type: Notice
Date: 2021-06-10
Agency: International Trade Commission, Agencies and Commissions
National Small Business Development Center Advisory Board
Document Number: 2021-12222
Type: Notice
Date: 2021-06-10
Agency: Small Business Administration, Agencies and Commissions
The SBA is issuing this notice to announce the date, time and agenda for a meeting of the National Small Business Development Center Advisory Board. The meeting will be open to the public; however, advance notice of attendance is required.
Importer of Controlled Substances Application: Cambrex Charles City
Document Number: 2021-12215
Type: Notice
Date: 2021-06-10
Agency: Drug Enforcement Administration, Department of Justice
Cambrex Charles City has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice for Finished Pharmaceuticals, Including Medical Gases, and Active Pharmaceutical Ingredients
Document Number: 2021-12214
Type: Notice
Date: 2021-06-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) 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.
Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Maridose, LLC
Document Number: 2021-12213
Type: Notice
Date: 2021-06-10
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) is providing notice of an application it has received from an entity applying to be registered to manufacture in bulk basic class(es) of controlled substances listed in schedule I. DEA intends to evaluate this and other pending applications according to its regulations governing the program of growing marihuana for scientific and medical research under DEA registration.
Importer of Controlled Substances Application: Fisher Clinical Services, Inc.
Document Number: 2021-12212
Type: Notice
Date: 2021-06-10
Agency: Drug Enforcement Administration, Department of Justice
Fisher Clinical Services, Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-12211
Type: Notice
Date: 2021-06-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Program Evaluation of CDC's Core State Injury Prevention Program. The proposed project is intended to assess both recipient-level and program-level outcomes associated with the NCIPC's Core SIPP funded state injury prevention program.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2021-12210
Type: Notice
Date: 2021-06-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled The National Survey of Family Growth (NSFG), designed to provide nationally representative, scientifically credible data on factors related to birth and pregnancy rates, family formation and dissolution patterns, and reproductive health.
Importer of Controlled Substances Application: National Center for Natural Products Research
Document Number: 2021-12209
Type: Notice
Date: 2021-06-10
Agency: Drug Enforcement Administration, Department of Justice
National Center for Natural Products Research has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2021-12208
Type: Notice
Date: 2021-06-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
International Traffic in Arms Regulations: Notification of Temporary Suspensions, Modifications, and Exceptions to Regulations
Document Number: 2021-12206
Type: Rule
Date: 2021-06-10
Agency: Department of State
The Department of State is issuing this document to inform the public of a third extension to temporary suspensions, modifications, and exceptions to certain provisions of the International Traffic in Arms Regulations (ITAR) to provide for continued telework operations during the current SARS-COV2 public health emergency. This action is taken in order to ensure continuity of operations among members of the regulated community.
City of Las Cruces, New Mexico and City of Mesa, Arizona v. El Paso Natural Gas Company, LLC; Notice of Complaint
Document Number: 2021-12202
Type: Notice
Date: 2021-06-10
Agency: Department of Energy, Federal Energy Regulatory Commission
Tucson Electric Power Company and UNS Gas, Inc. v. El Paso Natural Gas Company, LLC; Notice of Complaint
Document Number: 2021-12201
Type: Notice
Date: 2021-06-10
Agency: Department of Energy, Federal Energy Regulatory Commission
Modernizing Electricity Market Design; Notice Inviting Post-Technical Conference Comments
Document Number: 2021-12200
Type: Notice
Date: 2021-06-10
Agency: Department of Energy, Federal Energy Regulatory Commission
Determination of Regulatory Review Period for Purposes of Patent Extension; EVENITY
Document Number: 2021-12199
Type: Notice
Date: 2021-06-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for EVENITY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Electronic Study Data Submission; Data Standards; Support and Requirement Begin for Study Data Tabulation Model Version 1.8 With Standard for Exchange of Nonclinical Data Implementation Guide-Animal Rule Version 1.0; Correction
Document Number: 2021-12198
Type: Notice
Date: 2021-06-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a document that appeared in the Federal Register on March 11, 2020. The document announced that FDA will begin supporting the Clinical Data Interchange Standards Consortium (CDISC) for Study Data Tabulation Model version 1.8 (SDTM v1.8), and CDISC Standard for Exchange of Nonclinical Data Implementation GuideAnimal Rule version 1.0 (SENDIG- AR v1.0) on March 15, 2020, and that these new standards will be required in submissions to FDA effective March 15, 2022. The document omitted the 36-month implementation period for certain investigational new drugs applications (INDs) as required by the guidance for industry entitled ``Providing Regulatory Submissions in Electronic Format Standardized Study Data'' which is referenced in that document. This document corrects that error.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drugs for Investigational Use
Document Number: 2021-12197
Type: Notice
Date: 2021-06-10
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Passenger Vehicle and Light Truck Tires From Taiwan: Final Affirmative Determination of Sales at Less Than Fair Value; Correction
Document Number: 2021-12196
Type: Notice
Date: 2021-06-10
Agency: Department of Commerce, International Trade Administration
The Department of Commerce (Commerce) published notice in the Federal Register of May 27, 2021, in which Commerce announced the final affirmative determination of the antidumping duty (AD) investigation on passenger vehicle and light truck tires (passenger tires) from Taiwan. This notice contained a typographic error in the ``Scope of the Investigation'' in Appendix I.
Agency Information Collection Activities; Submission to the Office of Management and Budget (OMB) for Review and Approval; Comment Request; Services Surveys: BE-45, Quarterly Survey of Insurance Transactions by U.S. Insurance Companies With Foreign Persons
Document Number: 2021-12194
Type: Notice
Date: 2021-06-10
Agency: Department of Commerce, Bureau of Economic Analysis
The Department of Commerce, in accordance with the Paperwork Reduction Act of 1995 (PRA), invites the general public and other Federal agencies to comment on proposed and continuing information collections, which helps us assess the impact of our information collection requirements and minimize the public's reporting burden. The purpose of this notice is to allow for 60 days of public comment preceding submission of the collection to OMB.
Determination of Regulatory Review Period for Purposes of Patent Extension; SPRAVATO
Document Number: 2021-12193
Type: Notice
Date: 2021-06-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SPRAVATO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; OPTIMIZER
Document Number: 2021-12192
Type: Notice
Date: 2021-06-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for OPTIMIZER and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry and Food and Drug Administration Staff-Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Principle
Document Number: 2021-12191
Type: Notice
Date: 2021-06-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) 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.
Notice of Public Meetings of the Tennessee Advisory Committee
Document Number: 2021-12190
Type: Notice
Date: 2021-06-10
Agency: Commission on Civil Rights
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Tennessee Advisory Committee (Committee) will hold a meeting via web-conference on Thursday, June 17, 2021, at 12:00 p.m. Central Time. The purpose of the meeting is for the committee to discuss proposed civil rights topics of study.
Determination of Regulatory Review Period for Purposes of Patent Extension; SARCLISA
Document Number: 2021-12189
Type: Notice
Date: 2021-06-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SARCLISA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; National Agriculture and Food Defense Strategy Survey
Document Number: 2021-12188
Type: Notice
Date: 2021-06-10
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Regular Meeting; Farm Credit System Insurance Corporation Board
Document Number: 2021-12187
Type: Notice
Date: 2021-06-10
Agency: Farm Credit System Insurance Corporation, Agencies and Commissions
Notice is hereby given, in accordance with the provisions of Article VI of the Bylaws of the Farm Credit System Insurance Corporation (FCSIC), of a forthcoming regular meeting of the Board that a regular meeting of the Board of Directors of FCSIC will be held.
Service Standard Changes
Document Number: 2021-12186
Type: Notice
Date: 2021-06-10
Agency: Postal Regulatory Commission, Agencies and Commissions
The Commission is providing notice of a hearing on the Postal Service's direct case in this proceeding. This notice informs the public of the hearing dates and times.
Large Power Transformers From the Republic of Korea: Final Results of Antidumping Duty Administrative Review, Final Determination of No Shipments, and Final Successor-in-Interest Determination; 2018-2019
Document Number: 2021-12185
Type: Notice
Date: 2021-06-10
Agency: Department of Commerce, International Trade Administration
The Department of Commerce (Commerce) determines that Hyosung Heavy Industries Corporation (Hyosung) made sales of large power transformers from the Republic of Korea (Korea) at less than normal value during the period of review (POR) August 1, 2018, through July 31, 2019.
Revision of Categorical Eligibility in the Supplemental Nutrition Assistance Program (SNAP); Withdrawal
Document Number: 2021-12183
Type: Proposed Rule
Date: 2021-06-10
Agency: Department of Agriculture, Food and Nutrition Service
This document informs the public that the Food and Nutrition Service (FNS) of the U.S. Department of Agriculture (USDA) is withdrawing the proposed rule titled Revision of Categorical Eligibility in the Supplemental Nutrition Assistance Program (SNAP) that published in the Federal Register on July 24, 2019. This rule would have refined how receipt of the Temporary Assistance for Needy Families (TANF) benefits may confer categorical eligibility for SNAP. The rule would have also required State agencies to include in their SNAP State Plan of Operations all non-cash TANF benefits and certain cash TANF benefits that confer categorical eligibility. After reviewing and considering the comments received, the proposed rule is being withdrawn.
Government-Owned Inventions; Availability for Licensing
Document Number: 2021-12182
Type: Notice
Date: 2021-06-10
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Government-Owned Inventions; Availability for Licensing
Document Number: 2021-12181
Type: Notice
Date: 2021-06-10
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Government-Owned Inventions; Availability for Licensing
Document Number: 2021-12179
Type: Notice
Date: 2021-06-10
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Factoring Criteria for Firearms With Attached “Stabilizing Braces”
Document Number: 2021-12176
Type: Proposed Rule
Date: 2021-06-10
Agency: Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives
The Department of Justice (``Department'') proposes amending Bureau of Alcohol, Tobacco, Firearms, and Explosives (``ATF'') regulations to clarify when a rifle is ``intended to be fired from the shoulder.'' The Department proposes factors ATF considers when evaluating firearms equipped with a purported ``stabilizing brace'' to determine whether these weapons would be considered a ``rifle'' or ``short-barreled rifle'' under the Gun Control Act of 1968 (``GCA'') or a ``rifle'' or ``firearm'' subject to regulation under the National Firearms Act (``NFA''). This proposed rule is a separate action from the Notice on the Objective Factors for Classifying Weapons with ``Stabilizing Braces'' published on December 18, 2020, and withdrawn on December 31, 2020. No comments received under the withdrawn notice were considered for this proposed rule, and no comments received pursuant to that notice will be considered as part of this proposed rule. Commenters will need to submit new comments in connection with this proposed rule.
Advisory Committee; Medical Imaging Drugs Advisory Committee; Renewal
Document Number: 2021-12174
Type: Notice
Date: 2021-06-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the renewal of the Medical Imaging Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Medical Imaging Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the May 18, 2023, expiration date.
Applications for New Awards; Education Research and Special Education Research Grant Programs
Document Number: 2021-12173
Type: Notice
Date: 2021-06-10
Agency: Department of Education
The Department of Education (Department) is issuing a notice inviting applications for new awards for fiscal year (FY) 2022 for the Education Research and Special Education Research Grant Programs, Assistance Listing Numbers (ALNs) 84.305A, 84.305B, 84.305D, 84.305R, 84.305S, and 84.324X. This notice relates to the approved information collection under OMB control number 4040-0001.
Determination of Regulatory Review Period for Purposes of Patent Extension; MAYZENT
Document Number: 2021-12171
Type: Notice
Date: 2021-06-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for MAYZENT and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
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