December 13, 2021 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 114
Request for Comments and Notice of a Public Hearing Regarding the 2022 Special 301 Review
Each year, the Office of the United States Trade Representative (USTR) conducts a review to identify countries that deny adequate and effective protection of intellectual property (IP) rights or deny fair and equitable market access to U.S. persons who rely on IP protection. Based on this review, the U.S. Trade Representative determines which, if any, of these countries to identify as Priority Foreign Countries. USTR requests written comments that identify acts, policies, or practices that may form the basis of a country's identification as a Priority Foreign Country or placement on the Priority Watch List or Watch List.
Advisory Committee on Bankruptcy Rules; Meeting of the Judicial Conference
The following virtual public hearing on proposed amendments to the Federal Rules of Bankruptcy Procedure has been canceled: Bankruptcy Rules Hearing on January 7, 2022. The announcement for this hearing was previously published in the Federal Register on August 11, 2021.
Cover Letter Attachments for Controlled Correspondences and Abbreviated New Drug Application Submissions; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Cover Letter Attachments for Controlled Correspondences and Abbreviated New Drug Application Submissions.'' This guidance is intended to assist prospective applicants, applicants, and holders of abbreviated new drug applications (ANDAs) with optional attachments that can be used when preparing cover letters that accompany controlled correspondence to the Office of Generic Drugs (OGD), as well as original ANDAs, amendments to ANDAs, and supplements to approved ANDAs submitted to FDA.
Actavis LLC, et al.; Withdrawal of Approval of Six Abbreviated New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of six abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Q3C(R8) Impurities: Guidance for Residual Solvents; International Council for Harmonisation; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Q3C(R8) Impurities: Guidance for Residual Solvents.'' The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. This guidance provides recommendations for permitted daily exposures (PDEs) for three additional residual solvents: 2-Methyltetrahydrofuran, cyclopentyl methyl ether, and tert-butyl alcohol. The PDEs were developed according to the methods for establishing exposure limits included in the guidance for industry ``Q3C: Impurities Residual Solvents'' (Q3C guidance). The Q3C PDE levels are added and revised as new toxicological data for solvents become available. This guidance finalizes the draft guidance entitled ``Q3C(R8) Recommendations for the Permitted Daily Exposures for Three Solvents2-Methyltetrahydrofuran, Cyclopentyl Methyl Ether, and Tert-Butyl AlcoholAccording to the Maintenance Procedures for the Guidance Q3C Impurities: Residual Solvents'' issued on May 27, 2020.
Notice of Public Meetings for the Southeast Oregon Resource Advisory Council
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) Southeast Oregon Resource Advisory Council (RAC) will meet as follows.
Agency Information Collection Activities; Comment Request; Mandatory Civil Rights Data Collection
The U.S. Department of Education (ED) is issuing this notice to inform the public that Federal Register Notice (Docket ID Number ED- 2021-SCC-0158; FR DOC #2021-25246), published on November 19, 2021, and entitled ``Mandatory Civil Rights Data Collection'' has been withdrawn as of December 13, 2021 and replaced with this notice, which includes replacement documents related to the information collection listed in this notice. In accordance with the Paperwork Reduction Act of 1995, ED is proposing a revision to an existing information collection.
Certain Corrosion-Resistant (CORE) Steel Products From China, India, Italy, South Korea, and Taiwan; Scheduling of Full Five-Year Reviews
The Commission hereby gives notice of the scheduling of full five year reviews pursuant to the Tariff Act of 1930 (``the Act'') to determine whether revocation of the antidumping duty and countervailing duty orders on certain corrosion-resistant (CORE) steel products from China, India, Italy, South Korea, and Taiwan would be likely to lead to continuation or recurrence of material injury within a reasonably foreseeable time. The Commission has determined to exercise its authority to extend the review period by up to 90 days.
Closed Captioning of Video Programming; Telecommunications for the Deaf and Hard of Hearing Inc. Petition for Rulemaking
This document corrects a typographical error in the final rules portion of a Federal Register document published on September 14, 2021.
Cold-Rolled Steel Flat Products From Brazil, China, India, Japan, Korea, and the United Kingdom; Scheduling of Full Five-Year Reviews
The Commission hereby gives notice of the scheduling of full reviews pursuant to the Tariff Act of 1930 (``the Act'') to determine whether revocation of the countervailing duty orders on cold-rolled steel flat products from Brazil, China, India, and Korea and the antidumping duty orders on cold-rolled steel flat products from Brazil, China, India, Japan, Korea, and the United Kingdom would be likely to lead to continuation or recurrence of material injury within a reasonably foreseeable time. The Commission has determined to exercise its authority to extend the review period by up to 90 days.
Federal Voting Assistance Program (FVAP)
DoD is finalizing policy for the Federal Voting Assistance Program (FVAP) based on a March 6, 2020, interim final rule. The FVAP assists overseas Service members and other overseas citizens with exercising their voting rights by serving as a critical resource to successfully register to vote.
Advisory Committee on Civil Rules; Meeting of the Judicial Conference
The following virtual public hearing on proposed amendments to the Federal Rules of Civil Procedure has been canceled: Civil Rules Hearing on January 6, 2022. The announcement for this hearing was previously published in the Federal Register on August 11, 2021.
National Offshore Safety Advisory Committee; Vacancy
The Coast Guard is re-soliciting applications from persons interested in membership on the National Offshore Safety Advisory Committee (Committee) to fill a vacant position representing individuals employed in offshore operations. This recently established Committee will advise the Secretary of the Department of Homeland Security on matters relating to activities directly involved with, or in support of, the exploration of offshore mineral and energy resources, to the extent that such matters are within the jurisdiction of the Coast Guard.
Admissions Policies and Procedures for the School of Medicine, Uniformed Services University of the Health Sciences
This final rule removes the DoD regulation which is outdated, contains internal guidance for admissions to the School of Medicine, Uniformed Services University of the Health Sciences, reiterates statutory requirements, and is otherwise subject to the military function exemption to rulemaking.
Correction to Public Comment Period on VVSG Lifecycle Policy
The U.S. Election Assistance Commission published a notice in the Federal Register requesting public comments on a proposed VVSG Lifecycle Policy, which is available at https://www.regulations.gov (docket ID: EAC-2021-0001). The Notice appeared in the Federal Register on November 9, 2021 in FR Doc. 2021-24501, on pages 62156-62157 (86 FR 62156). The DATES section should be corrected to read:
Medical Devices; Neurological Devices; Classification of the Temporary Coil Embolization Assist Device
The Food and Drug Administration (FDA or we) is classifying the temporary coil embolization assist device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the temporary coil embolization assist device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
Request for Public Comment: 60-Day Proposed Information Collection: Addendum to Declaration for Federal Employment, Child Care and Indian Child Care Worker Positions (OMB No. 0917-0028)
In compliance with the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the general public to take this opportunity to comment on the information collection titled, ``Addendum to Declaration for Federal Employment, Child Care and Indian Child Care Worker Positions,'' Office of Management and Budget (OMB) Control Number 0917-0028. A copy of the supporting statement is available at www.regulations.gov (see Docket ID: IHS_FRDOC_0001).
Medical Devices; Gastroenterology-Urology Devices; Classification of the Pressure Ulcer Management Tool
The Food and Drug Administration (FDA or we) is classifying the pressure ulcer management tool into class I. We are taking this action because we have determined that classifying the device into class I will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
Bowel Cleansing for Colonoscopy: Efficacy and Safety Considerations for Developing New Products; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Bowel Cleansing for Colonoscopy: Efficacy and Safety Considerations for Developing New Products.'' The purpose of this draft guidance is to provide FDA's current thinking regarding the necessary attributes of patients for enrollment in clinical trials, efficacy assessments, and safety assessments. The draft guidance is intended to serve as a focus for continued discussion among FDA's Division of Gastroenterology, pharmaceutical sponsors, the academic community, and the public.
Safety Zones; Alderbrook Resort New Year's Fireworks Display, Hood Canal, Washington
The Coast Guard will enforce a safety zone surrounding the Alderbrook Resort dock involved in a fireworks display in Hood Canal, WA, from December 31, 2021, through January 1, 2022. This action is necessary to ensure the safety of the maritime public and vessels associated with the fireworks display. During the enforcement period, entry into the safety zone is prohibited, unless authorized by the Captain of the Port Sector Puget Sound or their Designated Representative.
Bulk Manufacturer of Controlled Substances Application: SpecGX, LLC
SpecGX, LLC, has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.
Importer of Controlled Substances Application: Noramco, Inc.
Noramco, Inc., 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.
Marine Mammals and Endangered Species
Notice is hereby given that permits and permit amendments have been issued to the following entities under the Marine Mammal Protection Act (MMPA) and the Endangered Species Act (ESA), as applicable.
Proposed Information Collection Activity; Federal Tax Refund Offset, Administrative Offset, and Passport Denial
The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF) is requesting the federal Office of Management and Budget (OMB) to approve the Federal Tax Refund Offset, Administrative Offset, and Passport Denial with minor edits to the ``Comments'' section of the record specifications to clarify the corresponding fields for an additional three years. The current OMB approval expires on June 30, 2022.
Proposed Collection; Comment Request for Regulation Project
The Internal Revenue Service, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on information collections, as required by the Paperwork Reduction Act of 1995. The IRS is soliciting comments concerning information collection requirements related to amortization of intangible property.
Proposed Information Collection Activity; Regional Partnership Grants National Cross-Site Evaluation and Evaluation Technical Assistance (OMB #0970-0527)
The Children's Bureau (CB), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting an extension with minor changes to the approved information collection: Regional Partnership Grants National Cross-Site Evaluation and Evaluation Technical Assistance (OMB #0970-0527). The proposed information collection will be used in a national cross-site evaluation of the fifth and sixth cohorts of CB's Regional Partnership Grants (RPG). The cross-site evaluation will use surveys, interviews, progress reports, and data on participant enrollment, services, and outcomes.
Proposed Information Collection Activity; Administration for Native Americans Annual Data Report (ADR) (OMB #0970-0475)
The Administration for Children and Families' (ACF) Administration for Native Americans (ANA) is requesting a 2-year extension to the following information collection: Annual Data Report (ADR) (OMB #0970-0475; expiration date: 2/28/2022). There are no changes requested to the form.
Foreign Censorship Part 2: Trade and Economic Effects on U.S. Businesses; Written Submission Deadline
The Commission seeks information from the public on the impacts of foreign censorship on U.S. businesses, in connection with Investigation No. 332-586, Foreign Censorship Part 2: Trade and Economic Effects on U.S. Businesses.
Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.
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