2022 – Federal Register Recent Federal Regulation Documents

Results 4,501 - 4,550 of 18,253
Fisheries of the Exclusive Economic Zone off Alaska; Revisions to the Economic Data Reports Requirements; Amendment 52 to the Fishery Management Plan for the Commercial King and Tanner Crab Fisheries of the Bering Sea and Aleutian Islands
Document Number: 2022-23306
Type: Proposed Rule
Date: 2022-11-01
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS issues a proposed rule to implement Amendment 52 to the Fishery Management Plan for the Commercial King and Tanner Crab Fisheries of the Bering Sea and Aleutian Islands (Crab FMP) and a regulatory amendment to revise regulations on Economic Data Reports (EDR) requirements for groundfish and crab fisheries off Alaska. If approved, this proposed rule would remove third party data verification audits and blind formatting requirements from the Bering Sea and Aleutian Islands (BSAI) crab fisheries EDR, the Bering Sea American Fisheries Act (AFA) pollock fishery, Chinook Salmon EDR, and the BSAI Amendment 80 fisheries EDR. This action would also eliminate the EDR requirements for the Gulf of Alaska (GOA) trawl fisheries. This proposed rule is intended to promote the goals and objectives of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson- Stevens Act), the Crab FMP, the Fishery Management Plans for Groundfish of the Gulf of Alaska Management Area (GOA FMP), the Groundfish of the BSAI Management Area (BSAI FMP), and other applicable laws.
Monthly Notice; Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving No Significant Hazards Considerations
Document Number: 2022-23247
Type: Notice
Date: 2022-11-01
Agency: Nuclear Regulatory Commission, Agencies and Commissions
Pursuant to section 189.a.(2) of the Atomic Energy Act of 1954, as amended (the Act), the U.S. Nuclear Regulatory Commission (NRC) is publishing this regular monthly notice. The Act requires the Commission to publish notice of any amendments issued, or proposed to be issued, and grants the Commission the authority to issue and make immediately effective any amendment to an operating license or combined license, as applicable, upon a determination by the Commission that such amendment involves no significant hazards consideration (NSHC), notwithstanding the pendency before the Commission of a request for a hearing from any person.
Energy Conservation Program: Energy Conservation Standards for Direct Expansion-Dedicated Outdoor Air Systems
Document Number: 2022-23185
Type: Rule
Date: 2022-11-01
Agency: Department of Energy
In this final rule, DOE is establishing energy conservation standards for direct expansion-dedicated outdoor air systems (``DX- DOASes'') that are of equivalent stringency as the minimum levels specified in the most recent publication of the American Society of Heating, Refrigerating and Air-Conditioning Engineers (``ASHRAE'') Standard 90.1 ``Energy Standard for Buildings Except Low-Rise Residential Buildings'' (``ASHRAE 90.1-2019'') when tested pursuant to the DOE test procedure for DX-DOASeswhich incorporates by reference the most recent applicable industry standard for this equipment. DOE has determined that it lacks clear and convincing evidence to adopt standards more stringent than the levels specified in ASHRAE 90.1-2019.
Approval of Air Quality Implementation Plans; New York; Gasoline Dispensing Stage I, Stage II, and Transport Vehicles
Document Number: 2022-23019
Type: Proposed Rule
Date: 2022-11-01
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is proposing to approve a revision to the New York State Implementation Plan (SIP) for ozone concerning the control of volatile organic compounds. The proposed SIP revision consists of amendments to regulations in New York's Codes, Rules and Regulations (NYCRR) applicable to gasoline dispensing sites and transport vehicles. The intended effect of today's action is to approve control strategies, required by the Clean Air Act, which will result in emission reductions that will help attain and maintain national ambient air quality standards for ozone and will reduce volatile organic compounds throughout the State.
Energy Conservation Program: Test Procedure for Automatic Commercial Ice Makers
Document Number: 2022-22927
Type: Rule
Date: 2022-11-01
Agency: Department of Energy
In this final rule, the U.S. Department of Energy (``DOE'') amends the test procedure for automatic commercial ice makers to update incorporated references to the latest version of the industry standards; establish a relative humidity test condition; provide additional detail regarding certain test conditions, settings, setup requirements, and calculations; include a voluntary measurement of potable water use; clarify certification and reporting requirements; and add enforcement provisions. This final rule also provides additional detail to the DOE test procedure to improve the representativeness and repeatability of the current test procedure.
Commission Information Collection Activities (FERC-725M); Comment Request; Extension
Document Number: 2022-23665
Type: Notice
Date: 2022-11-01
Agency: Department of Energy, Federal Energy Regulatory Commission
In compliance with the requirements of the Paperwork Reduction Act of 1995 (PRA), the Federal Energy Regulatory Commission (Commission or FERC) is soliciting public comment on the currently approved information collection, FERC-725M (Mandatory Reliability Standard: Transmission Vegetation Management).
Commission Information Collection Activities (FERC-574) Comment Request; Extension
Document Number: 2022-23662
Type: Notice
Date: 2022-11-01
Agency: Department of Energy, Federal Energy Regulatory Commission
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 currently approved information collection FERC-574 (Gas Pipeline Certificates: Hinshaw Exemption).
Adjustments to Mango Board Representation
Document Number: 2022-23661
Type: Proposed Rule
Date: 2022-11-01
Agency: Agricultural Marketing Service, Department of Agriculture
This proposal invites comments on changes to the representation of the National Mango Board (Board) under the Mango Promotion, Research and Information Order (Order). This action would allocate the seven foreign producer Board seats to the top five mango exporting countries, based on mango volume exported to the United States, with an additional seat allocated to the top exporting country, and one at-large seat. In addition, the proposal would require no more than one Board member be employed by or be affiliated with the same company. The Board administers the Order with oversight by Agricultural Marketing Service (AMS). This rule was recommended by the Board and is issued with the concurrence of AMS.
Request for Public Comment on the African and Diaspora Young Leaders Forum-U.S.-Africa Leaders Summit
Document Number: 2022-23660
Type: Notice
Date: 2022-11-01
Agency: Department of State
President Biden will host leaders from across the African continent from December 13-15, 2022, in Washington, DC, for the U.S.- Africa Leaders Summit. The Summit will demonstrate the United States' enduring commitment to Africa and will underscore the importance of U.S.-Africa relations and increased cooperation on shared global priorities. An important component of the Summit's three-day agenda is the African and Diaspora Young Leaders Forum, which will be held on December 13. A full agenda with speakers will be announced in the coming weeks. The Department is requesting self-nominations from the public of exceptional young leaders to participate in the event.
Energy Conservation Program: Energy Conservation Standards for Consumer Furnace Fans
Document Number: 2022-23626
Type: Proposed Rule
Date: 2022-11-01
Agency: Department of Energy
The U.S. Department of Energy (``DOE'') announces the availability of the preliminary analysis it has conducted for purposes of evaluating the needed for amended energy conservation standards for consumer furnace fans, which is set forth in the Department's preliminary technical support document (``TSD'') for this rulemaking. DOE will hold a public meeting via webinar to discuss and receive comment on the preliminary analysis. The meeting will cover the analytical framework, models, and tools used to evaluate potential standards; the results of preliminary analyses performed by DOE; the potential energy conservation standard levels derived from these analyses (if DOE determines that proposed amendments are necessary); and other relevant issues. In addition, DOE encourages written comments on these subjects.
Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products: Small Entity Compliance Guide; Availability
Document Number: 2022-23573
Type: Rule
Date: 2022-11-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance entitled ``Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/ Ps): Small Entity Compliance Guide.'' The small entity compliance guide (SECG) is intended to help small entity establishments that manufacture HCT/Ps better understand the comprehensive regulatory framework for HCT/Ps set forth in the regulations and comply with certain HCT/P- related final rules. The SECG announced in this notice supersedes the SECG of the same title dated August 2007.
Medicare and Medicaid Programs; Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Program of All-Inclusive Care for the Elderly (PACE), Medicaid Fee-For-Service, and Medicaid Managed Care Programs for Years 2020 and 2021; Extension of Timeline To Finalize a Rulemaking
Document Number: 2022-23563
Type: Proposed Rule
Date: 2022-11-01
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Social Security Act (the Act) requires us to publish a Medicare final rule no later than 3 years after the publication date of the proposed rule. This document announces an additional 3 month extension of the timeline for publication of a Medicare final rule in accordance with the Act, which allows us to extend the timeline for publication of the ``Medicare and Medicaid Programs; Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Program of All-inclusive Care for the Elderly (PACE), Medicaid Fee-For-Service, and Medicaid Managed Care Programs for Years 2020 and 2021'' final rule under exceptional circumstances.
Debt Collection Practices (Regulation F); Corrections
Document Number: 2022-23559
Type: Rule
Date: 2022-11-01
Agency: Bureau of Consumer Financial Protection
The Consumer Financial Protection Bureau (CFPB) published ``Debt Collection Practices (Regulation F)'' on January 19, 2021, to revise Regulation F, which implements the Fair Debt Collection Practices Act. Omissions in that document resulted in certain paragraphs in the Official Interpretations (Commentary) not being incorporated into the Code of Federal Regulations (CFR). This document corrects the Official Interpretations to Regulation F by adding the missing paragraphs to the CFR.
FY 2022 Senior Executive Service Performance Review Boards
Document Number: 2022-23557
Type: Notice
Date: 2022-11-01
Agency: Department of Homeland Security
This notice corrects the October, 25, 2022 notice announcing the appointment of members of the FY 2022 Senior Executive Service (SES) Performance Review Boards (PRBs) for the Department of Homeland Security (DHS). The purpose of the PRBs is to make recommendations to the appointing authority (i.e., Component head) on the performance of senior executives (career, noncareer, and limited appointees), including recommendation on performance ratings, performance-based pay adjustments, and performance awards. The PRBs will also make recommendations on the performance of Transportation Security Executive Service, Senior Level, and Scientific and Professional employees. To make its recommendations, the PRBs will review performance appraisals, initial summary ratings, any response by the employee, and any higher- level official's findings.
Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest
Document Number: 2022-23683
Type: Notice
Date: 2022-11-01
Agency: International Trade Commission, Agencies and Commissions
Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled Certain Bio-Layer Interferometers and Components Thereof, DN 3652; 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.
Stainless Steel Butt-Weld Pipe Fittings From Italy, Malaysia, and the Philippines; Institution of Five-Year Reviews
Document Number: 2022-23681
Type: Notice
Date: 2022-11-01
Agency: International Trade Commission, Agencies and Commissions
The Commission hereby gives notice that it has instituted reviews pursuant to the Tariff Act of 1930 (``the Act''), as amended, to determine whether revocation of the antidumping duty orders on stainless steel butt-weld pipe fittings from Italy, Malaysia, and the Philippines would be likely to lead to continuation or recurrence of material injury. Pursuant to the Act, interested parties are requested to respond to this notice by submitting the information specified below to the Commission.
High Pressure Steel Cylinders From China; Institution of Five-Year Reviews
Document Number: 2022-23680
Type: Notice
Date: 2022-11-01
Agency: International Trade Commission, Agencies and Commissions
The Commission hereby gives notice that it has instituted reviews pursuant to the Tariff Act of 1930 (``the Act''), as amended, to determine whether revocation of the antidumping and countervailing duty orders on high pressure steel cylinders from China would be likely to lead to continuation or recurrence of material injury. Pursuant to the Act, interested parties are requested to respond to this notice by submitting the information specified below to the Commission.
National Committee on Vital and Health Statistics; Meeting and RFC
Document Number: 2022-23678
Type: Notice
Date: 2022-11-01
Agency: Department of Health and Human Services
Pursuant to the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) announces the following advisory committee meeting and related Request for Comment (RFC). The meeting is open to the public. The public is welcome to obtain the link to attend this meeting by following the instructions posted on the Committee website: https://ncvhs.hhs.gov/ meetings/standards-subcommittee-hearing/. Name: National Committee on Vital and Health Statistics (NCVHS) Standards Subcommittee Meeting.
Agency Information Collection Activities; Comment Request; Application Package for AmeriCorps All-Partner Training and Technical Assistance Survey
Document Number: 2022-23676
Type: Notice
Date: 2022-11-01
Agency: Corporation for National and Community Service, Agencies and Commissions
In accordance with the Paperwork Reduction Act of 1995, the Corporation for National and Community Service (operating as AmeriCorps) is proposing a new information collection.
Medicaid and Children's Health Insurance Program (CHIP) Generic Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2022-23670
Type: Notice
Date: 2022-11-01
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
On May 28, 2010, the Office of Management and Budget (OMB) issued Paperwork Reduction Act (PRA) guidance related to the ``generic'' clearance process. Generally, this is an expedited process by which agencies may obtain OMB's approval of collection of information requests that are ``usually voluntary, low-burden, and uncontroversial collections,'' do not raise any substantive or policy issues, and do not require policy or methodological review. The process requires the submission of an overarching plan that defines the scope of the individual collections that would fall under its umbrella. On October 23, 2011, OMB approved our initial request to use the generic clearance process under control number 0938-1148 (CMS-10398). It was last approved on April 26, 2021, via the standard PRA process which included the publication of 60- and 30-day Federal Register notices. The scope of the April 2021 umbrella accounts for Medicaid and CHIP State plan amendments, waivers, demonstrations, and reporting. This Federal Register notice seeks public comment on one or more of our collection of information requests that we believe are generic and fall within the scope of the umbrella. Interested persons are invited to submit 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.
Drizly, LLC; Analysis of Proposed Consent Order To Aid Public Comment
Document Number: 2022-23669
Type: Notice
Date: 2022-11-01
Agency: Federal Trade Commission, Agencies and Commissions
The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices. The attached Analysis of Proposed Consent Order to Aid Public Comment describes both the allegations in the draft complaint and the terms of the consent orderembodied in the consent agreement that would settle these allegations.
Conference of the Parties to the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES); Nineteenth Regular Meeting; Tentative U.S. Negotiating Positions for Agenda Items and Species Proposals Submitted by Foreign Governments, the Permanent CITES Committees, and the CITES Secretariat
Document Number: 2022-23668
Type: Notice
Date: 2022-11-01
Agency: Fish and Wildlife Service, Department of the Interior
The United States, as a Party to the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES), will attend the nineteenth regular meeting of the Conference of the Parties to CITES (CoP19) in Panama City, Panama, November 14-25, 2022. This notice announces the availability of tentative U.S. negotiating positions on proposed resolutions, decisions, and amendments to the CITES Appendices (species proposals), as well as other agenda items that have been submitted by other Parties, the permanent CITES committees, and the CITES Secretariat for consideration at CoP19. With this notice, we announce that prior to CoP19 we will make available a summary of our proposed negotiating positions and the reasons for our proposed positions.
BB&T Capital Partners, LLC; Surrender of License of Small Business Investment Company
Document Number: 2022-23667
Type: Notice
Date: 2022-11-01
Agency: Small Business Administration, Agencies and Commissions
Notice of Public Meeting of the Puerto Rico Advisory Committee
Document Number: 2022-23707
Type: Notice
Date: 2022-11-01
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 (FACA), that a meeting of the Puerto Rico Advisory Committee to the Commission will convene by virtual web conference on Wednesday, November 16, 2022, at 1 p.m. (AT). The purpose is to discuss the committee's draft project proposal on the civil rights impacts of the Insular Cases and the doctrine of the unincorporated territory.
Information Collection; Improving Customer Experience (OMB Circular A-11, Section 280 Implementation)
Document Number: 2022-23706
Type: Notice
Date: 2022-11-01
Agency: Department of Agriculture
The Department of Agriculture, as part of its continuing effort to reduce paperwork and respondent burden, is announcing an opportunity for public comment on a new proposed collection of 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, and to allow 60 days for public comment in response to the notice. This notice solicits comments on new collection proposed by the Agency.
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine and Oral Fluid Drug Testing for Federal Agencies
Document Number: 2022-23705
Type: Notice
Date: 2022-11-01
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine or Oral Fluid (Mandatory Guidelines).
Presidential Declaration Amendment of a Major Disaster for Public Assistance Only for the State of Arizona
Document Number: 2022-23704
Type: Notice
Date: 2022-11-01
Agency: Small Business Administration, Agencies and Commissions
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Arizona (FEMA-4668-DR), dated 09/02/2022. Incident: Severe Storms. Incident Period: 07/17/2022 through 07/18/2022.
Proposed Collection; Comment Request
Document Number: 2022-23703
Type: Notice
Date: 2022-11-01
Agency: Department of the Treasury
The Department of the Treasury, as part of its continuing effort to reduce paperwork burdens, invites the general public and other Federal agencies to comment on revisions of an information collection that are proposed for approval by the Office of Management and Budget. The Office of International Affairs within the Department of the Treasury is soliciting comments concerning the revisions of the Treasury International Capital (TIC) Forms BC, BL-1, BL-2, BQ-1, BQ-2, and BQ-3 (called the ``TIC B forms'').
Submission for OMB Review; Comment Request
Document Number: 2022-23702
Type: Notice
Date: 2022-11-01
Agency: Department of Agriculture
Transportation and Related Equipment Technical Advisory Committee; Notice of Partially Closed Meeting
Document Number: 2022-23701
Type: Notice
Date: 2022-11-01
Agency: Department of Commerce, Bureau of Industry and Security
Office of the Secretary, Interagency Pain Research Coordinating Committee Call for Committee Membership Nominations
Document Number: 2022-23700
Type: Notice
Date: 2022-11-01
Agency: Department of Health and Human Services, National Institutes of Health
The Department of Health and Human Services (HHS) (Department) has created the Interagency Pain Research Coordinating Committee and is seeking nominations for this committee.
Submission for OMB Review; Comment Request
Document Number: 2022-23699
Type: Notice
Date: 2022-11-01
Agency: Department of Agriculture
Agency Information Collection Activities; Broad Agency Announcement for Water Monitoring Technologies
Document Number: 2022-23698
Type: Notice
Date: 2022-11-01
Agency: Geological Survey, Department of the Interior
In accordance with the Paperwork Reduction Act of 1995, the U.S. Geological Survey (USGS) is proposing a new information collection.
Notice of Annual Factors for Determining Administrative Fees for the Section 8 Housing Choice Voucher, Mainstream, and Moderate Rehabilitation Programs for Calendar Year 2021; Correction
Document Number: 2022-23696
Type: Notice
Date: 2022-11-01
Agency: Department of Housing and Urban Development
On August 15, 2022, HUD published a notice in the Federal Register entitled, ``Notice of Annual Factors for Determining Administrative Fees for the Section 8 Housing Choice Voucher, Mainstream, and Moderate Rehabilitation Programs for Calendar Year 2021''. The notice published omitted specific information and included incorrect website links. To clarify any misinformation, this notice replaces the notice published on August 15, 2022, and republishes the methodology HUD used in determining the on-going administrative fees for public housing agencies (PHAs) administering the Housing Choice Voucher (HCV), Mainstream, and Moderate Rehabilitation programs, including the Moderate Rehabilitation Single Room Occupancy program, during calendar year (CY) 2021.
Emerging Technology Technical Advisory Committee; Notice of Partially Closed Meeting
Document Number: 2022-23695
Type: Notice
Date: 2022-11-01
Agency: Department of Commerce, Bureau of Industry and Security
Submission for OMB Review; Comment Request; Extension: Exchange Act Rule 3a71-3
Document Number: 2022-23693
Type: Notice
Date: 2022-11-01
Agency: Securities and Exchange Commission, Agencies and Commissions
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2022-23692
Type: Notice
Date: 2022-11-01
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2022-23691
Type: Notice
Date: 2022-11-01
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2022-23690
Type: Notice
Date: 2022-11-01
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2022-23689
Type: Notice
Date: 2022-11-01
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Closed Meetings
Document Number: 2022-23687
Type: Notice
Date: 2022-11-01
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2022-23686
Type: Notice
Date: 2022-11-01
Agency: Department of Health and Human Services, National Institutes of Health
Certain Video Security Equipment and Systems, Related Software, Components Thereof, and Products Containing Same; Notice of Request for Submissions on the Public Interest
Document Number: 2022-23684
Type: Notice
Date: 2022-11-01
Agency: International Trade Commission, Agencies and Commissions
Notice is hereby given that on October 24, 2022, the presiding administrative law judge (``ALJ'') issued an Initial Determination on Violation of Section 337. The ALJ also issued a Recommended Determination on remedy and bonding should a violation be found in the above-captioned investigation. The Commission is soliciting submissions on public interest issues raised by the recommended relief should the Commission find a violation. This notice is soliciting comments from the public only.
Agency Information Collection Activities; General Reclamation Requirements
Document Number: 2022-23732
Type: Notice
Date: 2022-11-01
Agency: Department of the Interior, Office of Surface Mining Reclamation and Enforcement
In accordance with the Paperwork Reduction Act of 1995, we, the Office of Surface Mining Reclamation and Enforcement (OSMRE), are proposing to renew an information collection.
Agency Information Collection Activities; Special Permanent Program Performance Standards-Operations in Alluvial Valley Floors
Document Number: 2022-23731
Type: Notice
Date: 2022-11-01
Agency: Department of the Interior, Office of Surface Mining Reclamation and Enforcement
In accordance with the Paperwork Reduction Act of 1995, we, the Office of Surface Mining Reclamation and Enforcement (OSMRE), are proposing to renew an information collection.
Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials; Draft Guidance for Industry; Availability
Document Number: 2022-23730
Type: Notice
Date: 2022-11-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials.'' The purpose of this draft guidance is to outline the most appropriate methods for measuring and recording growth and evaluating pubertal development for drugs or biological products in development for pediatric use when such an assessment is necessary to support safety. This draft guidance is intended to encourage a consistent approach to collecting interpretable and accurate growth and pubertal development data. This draft guidance does not address use of growth or pubertal development data to support primary evidence of efficacy in growth disorders and does not address evaluation of nutritional status.
Notice of Public Meeting of the District of Columbia Advisory Committee to the U.S. Commission on Civil Rights
Document Number: 2022-23729
Type: Notice
Date: 2022-11-01
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 District of Columbia Advisory Committee (Committee) to the U.S. Commission on Civil Rights will hold project planning meetings via WebEx on the below dates and times. The purpose of these meetings is to plan and discuss the Committee's civil rights project.
Agency Information Collection Activities; Proposed Collection; Comment Request; Biologics License Applications Procedures and Requirements
Document Number: 2022-23728
Type: Notice
Date: 2022-11-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency or we) 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 collection of information associated with biologics license application (BLA) procedures and requirements.
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