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Public Comments on Proposed Federal Rules Newsletter for 2024-08-23 ( 33 items )  
CFPB Releases Public Communication From 21 Organizations, 61 Individuals (10)
WASHINGTON, Aug. 22 -- The Consumer Financial Protection Bureau has released the following public communication on Aug. 12, 2024, signed by 21 organizations and 61 individuals: * * * To: The Hon. Rohit Chopra, Director Consumer Financial Protection Bureau 2024 NPRM Overdraft c/o Legal Division Docket Manager 1700 G Street NW Washington, DC 20552 Re: Docket No. CFPB-2024-0002 or RIN 3170-AA42 * * * Medical debt prevents far too many Hoosiers from being able to meet their basic needs and  more ST

EPA Releases Public Communication From Basin Electric Power Cooperative (10)
WASHINGTON, Aug. 22 -- The U.S. Environmental Protection Agency has released the following public communication dated Aug. 9, 2024, from Basin Electric Power Cooperative. Here are excerpts: * * * COMMENTS ON: AIR PLAN PARTIAL APPROVAL AND PARTIAL DISAPPROVAL;NORTH DAKOTA; REGIONAL HAZE STATE IMPLEMENTATION PLAN FOR THE SECOND IMPLEMENTATION PERIOD; PROPOSED RULE 89 FED. REG. 56,693 (JULY 10, 2024) SUBMITTED ELECTRONICALLY TO THE ENVIRONMENTAL PROTECTION AGENCY DOCKET NO. EPA-R08-OAR-2023 more ST

EPA Releases Public Communication From Fleetwood Limousine (10)
WASHINGTON, Aug. 22 -- The U.S. Environmental Protection Agency has released the following public communication dated Aug. 15, 2024, from Fleetwood Limousine Ltd.: * * * Fleetwood Limousine LTD urgently calls upon the EPA to reject the California Air Resources Board's (CARB) request for an Advanced Clean Fleets (ACF) waiver. The waiver poses serious threats to our organization, employees, and the broader economy. The ACF waiver sets harsh, unrealistic standards on fleet operators, hitting smal more ST

EPA Releases Public Communication From Minnkota Power Cooperative (10)
WASHINGTON, Aug. 22 -- The U.S. Environmental Protection Agency has released the following public communication on Aug. 19, 2024, from Minnkota Power Cooperative Inc., Grand Forks, North Dakota: * * * To: Ms. Holly DeJong Mr. Joe Stein Air and Radiation Division, Region 8 U.S. Environmental Protection Agency 1595 Wynkoop Street Denver, CO 80202 Re: Minnkota Power Cooperative's Comments on the Proposed Rule: Air Plan Partial Approval and Partial Disapproval; North Dakota; Regional Haze St more ST

EPA Releases Public Communication From National Mining Association (10)
WASHINGTON, Aug. 22 -- The U.S. Environmental Protection Agency has released the following public communication dated Aug. 9, 2024, from the National Mining Association: * * * To: The Honorable Michael S. Regan Administrator U.S. Environmental Protection Agency 1200 Pennsylvania Avenue, N.W. Washington, D.C. 20460 * Holly DeJong, Air and Radiation Division Joe Stein, Air and Radiation Division U.S. Environmental Protection Agency Region 8 1595 Wynkoop Street, Mailcode 8ARD-IO Denver, more ST

EPA Releases Public Communication From North American Coal (10)
WASHINGTON, Aug. 22 -- The U.S. Environmental Protection Agency has released the following public communication dated Aug. 9, 2024, from the North American Coal, Plano, Texas: * * * To: U.S. Environmental Protection Agency EPA Docket Center ID No. EPA-R08-OAR-2023-0495; FRL-12052-01-R8 1200 Pennsylvania Avenue N.W. Washington, D.C. 20460 ATTENTION Docket ID No. EPA-R08-OAR-2023-0495; FRL-12052-01-R8 Re: Air Plan Partial Approval and Partial Disapproval; North Dakota; Regional Haze State I more ST

EPA Releases Public Communication From Sacramento-Yolo Mosquito & Vector Control District District Manager Goodman (10)
WASHINGTON, Aug. 22 -- The U.S. Environmental Protection Agency has released the following public communication dated Feb. 28, 2024, from Gary Goodman, district manager of Sacramento-Yolo Mosquito and Vector Control District: * * * To: U.S. Environmental Protection Agency Public Comment re: Docket ID No. EPA-HQ-OPP-2020-0028 * * * The spread of Aedes aegypti mosquitoes poses a daunting challenge for the Sacramento-Yolo Mosquito and Vector Control District and many other mosquito control d more ST

EPA Releases Public Communication From Ventura County Vector Control Program Lead Svoboda (10)
WASHINGTON, Aug. 22 -- The U.S. Environmental Protection Agency has released the following public communication dated March 5, 2024, from Cary Svoboda, program lead of Ventura County Vector Control: * * * To: U.S. Environmental Protection Agency Public Comment re: Docket ID No. EPA-HQ-OPP-2020-0028 * * * The spread of Aedes aegypti mosquitoes poses a daunting challenge for Ventura County Vector Control and many other mosquito control districts throughout California. As we face new challenge more ST

FDA Releases Public Communication From AHIP (10)
WASHINGTON, Aug. 22 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Aug. 20, 2024, from AHIP: * * * To: The Honorable Robert M. Califf, M.D. Commissioner U.S. Food and Drug Administration 10903 New Hampshire Ave. Silver Spring, MD 20993-0002 RE: Considerations in Demonstrating Interchangeability with a Reference Product: Update; Draft Guidance for Industry -- AHIP Comments * * * Dear Commissioner Cali more ST

FDA Releases Public Communication From American College of Rheumatology (10)
WASHINGTON, Aug. 22 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Aug. 20, 2024, from American College of Rheumatology: * * * To: The Honorable Robert Califf Administrator Food and Drug Administration Department of Health and Human Services RE: Considerations in Demonstrating Interchangeability With a Reference Product: Update * * * Dear Administrator Califf: On behalf of the 9,600 American College  more ST

FDA Releases Public Communication From American Gastroenterological Association (10)
WASHINGTON, Aug. 22 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Aug. 20, 2024, from the American Gastroenterological Association, Bethesda, Maryland: * * * To: Robert M. Califf, M.D. Commissioner Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, Maryland 20993 RE: Considerations in Demonstrating Interchangeability with a Reference Product, Draft Guidance, Docket No. FDA-2017-D-0 more ST

FDA Releases Public Communication From Arnold Ventures (10)
WASHINGTON, Aug. 22 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Aug. 19, 2024, from Arnold Ventures: * * * To: Dockets Management Staff (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: FDA-2017-D-0154 Dear Commissioner Califf: Arnold Ventures welcomes the opportunity to provide comments to the Food and Drug Administration (FDA) on the following draft guidan more ST

FDA Releases Public Communication From Association for Clinical Oncology (10)
WASHINGTON, Aug. 22 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Aug. 20, 2024, from Association for Clinical Oncology, Alexandria, Virginia: * * * To: Robert Califf, MD Commissioner U.S. Food and Drug Administration 5630 Fishers Lane Room 1061 Rockville, MD 20852 Subject: Considerations in Demonstrating Interchangeability with a Reference Product (Docket No. FDA-2017-D-0154) * * * Dear Dr. Califf, more ST

FDA Releases Public Communication From Biosimilars Forum (10)
WASHINGTON, Aug. 22 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Aug. 16, 2024, from the Biosimilars Forum. Here are excerpts: * * * To: Dockets Management Staff Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 RE: Docket #: FDA-2017-D-0154, "Considerations in Demonstrating Interchangeability With a Reference Product: Update" * * * The Biosimilars Forum ("The Forum") app more ST

FDA Releases Public Communication From Blue Cross Blue Shield Association (10)
WASHINGTON, Aug. 22 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Aug. 20, 2024, from the Blue Cross Blue Shield Association: * * * To: Robert Califf, M.D. Commissioner Food and Drug Administration Department of Health and Human Services 10903 New Hampshire Avenue Silver Spring, MD 20993 Re: Considerations in Demonstrating Interchangeability With a Reference Product: Updated Draft Guidance * * * De more ST

FDA Releases Public Communication From Center for Science in the Public Interest, 4 Collaborators (10)
WASHINGTON, Aug. 22 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated July 31, 2024, from the Center for Science in the Public Interest and four collaborators. The collaborators are Breakthrough Institute, Consumer Federation of America, Environmental Defense Fund and Nature Conservancy: * * * To: Dockets Management Food and Drug Administration 5630 Fishers Lane, Rm 1061 Rockville, MD 20852 To whom it may more ST

FDA Releases Public Communication From Fresenius Kabi (10)
WASHINGTON, Aug. 22 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication on Aug. 20, 2024, from Fresenius Kabi LLC: * * * To: The Honorable Dr. Robert Califf Commissioner U.S. Food and Drug Administration U.S. Department of Health and Human Services 1401 Rockville Pike Rockville, MD 20852 Dockets Management Staff (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Comments f more ST

FDA Releases Public Communication From FTC (10)
WASHINGTON, Aug. 22 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Aug. 20, 2024, from the Federal Trade Commission. Here are excerpts: * * * To: UNITED STATES FOOD AND DRUG ADMINISTRATION Docket No. FDA-2017-D-0154 Considerations in Demonstrating Interchangeability with a Reference Product: Update; Draft Guidance for Industry COMMENT OF THE UNITED STATES FEDERAL TRADE COMMISSION * * * I. Introduction more ST

FDA Releases Public Communication From Infusion Access Foundation (10)
WASHINGTON, Aug. 22 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Aug. 20, 2024, from the Infusion Access Foundation: * * * To: Robert M. Califf, M.D. Commissioner Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 RE: Considerations in Demonstrating Interchangeability with a Reference Product: Update, Draft Guidance, Docket No. FDA-2017-D-0154 Dear Dr. Califf, The Infus more ST

FDA Releases Public Communication From National Council for Prescription Drug Programs (10)
WASHINGTON, Aug. 22 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Aug. 12, 2024, from the National Council for Prescription Drug Programs Inc., Scottsdale, Arizona: * * * To: Dockets Management Staff (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Re: Considerations in Demonstrating interchangeability with a Reference Product [Docket No. FDA-2017-D-0154] * * *  more ST

FDA Releases Public Communication From National Infusion Center Association (10)
WASHINGTON, Aug. 22 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Aug. 20, 2024, from the National Infusion Center Association, Austin, Texas: * * * To: Robert M. Califf, M.D. Commissioner Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 RE: Considerations in Demonstrating Interchangeability with a Reference Product, Draft Guidance, Docket No. FDA-2017-D-0154 * * * Dea more ST

FDA Releases Public Communication From National Multiple Sclerosis Society (10)
WASHINGTON, Aug. 22 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Aug. 20, 2024, from the National Multiple Sclerosis Society: * * * To: Mustafa Unlu and James Myers U.S. Food and Drug Administration Division of Drug Information, Center for Drug Evaluation and Research 10903 New Hampshire Ave., Bld. 22, Rm. 1139 Silver Spring, MD 20993 - 0002 Re: Labeling for Biosimilar and Interchangeable Biosimilar  more ST

FDA Releases Public Communication From Pharmaceutical Care Management Association (10)
WASHINGTON, Aug. 22 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Aug. 20, 2024, from the Pharmaceutical Care Management Association: * * * To: The Honorable Robert M. Califf, M.D. Commissioner U.S. Food and Drug Administration 10903 New Hampshire Ave. Silver Spring, MD 20993-0002 RE: Considerations in Demonstrating Interchangeability With a Reference Product: Update; Draft Guidance for Industry - Doc more ST

FDA Releases Public Communication From PhRMA (10)
WASHINGTON, Aug. 22 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Aug. 20, 2024, from the Pharmaceutical Research and Manufacturers of America. Here are excerpts: * * * To: Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Re: Docket No. FDA-2017-D-0154: Considerations in Demonstrating Interchangeability With a Reference Product * * more ST

FDA Releases Public Communication From Prime Therapeutics (10)
WASHINGTON, Aug. 22 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Aug. 20, 2024, from Prime Therapeutics LLC, Eagan, Minnesota: * * * To: Food and Drug Administration 10903 New Hampshire Ave Silver Spring, MD 20993-0002 Re: Considerations in Demonstrating Interchangeability With a Reference Product: Update Docket No. FDA-2017-D-0154 * * * Dear Sir/Madam: Prime Therapeutics LLC (Prime) appreciates the more ST

FDA Releases Public Communication From Vizient Inc. (10)
WASHINGTON, Aug. 22 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Aug. 20, 2024, from Vizient Inc.: * * * To: Robert M. Califf, M.D. Commissioner Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: Considerations in Demonstrating Interchangeability With a Reference Product: Update (FDA-2017-D-1054) * * * Dear Dr. Califf: Vizient, Inc. appreciates the opportunity to respo more ST

FEMA Releases Public Communication From Greater New York Hospital Association (10)
WASHINGTON, Aug. 22 -- The U.S. Department of Homeland Security Federal Emergency Management Agency has released the following public communication dated Aug. 19, 2024, from the Greater New York Hospital Association: * * * To: The Honorable Deanne Criswell Administrator Federal Emergency Management Agency Department of Homeland Security Attention: 9111-23-P P.O. Box 10055 Hyattsville, MD 20782-8055 Subject: Public Assistance Program and Policy Guide, Version 5; FR Doc. 2024-13306; June  more ST

FEMA Releases Public Communication From International Association of Plumbing & Mechanical Officials (10)
WASHINGTON, Aug. 22 -- The U.S. Department of Homeland Security Federal Emergency Management Agency has released the following public communication dated Aug. 9, 2024, from the International Association of Plumbing and Mechanical Officials: * * * To: Office of Response and Recovery, Public Assistance Division Federal Emergency Management Agency (FEMA) U.S. Department of Homeland Security (DHS) 500 C Street, SW Washington, DC 20472 SUBJECT: on the DHS/FEMA Proposed Revisions to "Public Ass more ST

FEMA Releases Public Communication From National Association of County Engineers (10)
WASHINGTON, Aug. 22 -- The U.S. Department of Homeland Security Federal Emergency Management Agency has released the following public communication dated Aug. 16, 2024, from the National Association of County Engineers: * * * To: The Honorable Deanne Criswell Administrator Federal Emergency Management Agency 500 C St SW Washington, DC 20024 Dear Administrator Criswell: The National Association of County Engineers (NACE) appreciates the opportunity to comment on the United States Federal  more ST

IRS Releases Public Communication From American Farm Bureau Federation (10)
WASHINGTON, Aug. 22 -- The U.S. Department of the Treasury Internal Revenue Service has released the following public communication dated Aug. 19, 2024, from the American Farm Bureau Federation: * * * To: Vivian Hayes United States Department of Treasury, Internal Revenue Service Attn: CC:PA:01:PR (REG-124593-23), Room 5203 P.O. Box 7604 Ben Franklin Station Washington, DC 20044 Re: Comments on REG-124593-2, Certain Partnership Related-Party Basis Adjustment Transactions as Transactions  more ST

OSHA Releases Public Communication From National Waste & Recycling Association (10)
WASHINGTON, Aug. 22 -- The U.S. Department of Labor Occupational Safety and Health Administration has released the following public communication dated July 21, 2024, from the National Waste and Recycling Association, Arlington, Virginia: * * * To: The Honorable Doug Parker Assistant Secretary Occupational Safety and Health Administration U.S. Department of Labor 200 Constitution Ave., NW Washington, DC 20210 RE: Docket ID OSHA-2007-0073 Emergency Response * * * Dear Assistant Secretar more ST

OSHA Releases Public Communication From PHI Health (10)
WASHINGTON, Aug. 22 -- The U.S. Department of Labor Occupational Safety and Health Administration has released the following public communication dated July 19, 2024, from PHI Health LLC, Phoenix, Arizona. Here are excerpts: * * * To: The Honorable Douglas L. Parker Assistant Secretary of Labor for Occupational Safety and Health United States Department of Labor 200 Constitution Avenue, NW Washington, DC 20210 RE: Docket No. OSHA-2007-0073 Emergency Response Standard RIN 1218-AC91 * * more ST

OSHA Releases Public Communication From Snohomish County Volunteer Search & Rescue (10)
WASHINGTON, Aug. 22 -- The U.S. Department of Labor Occupational Safety and Health Administration has released the following public communication on Aug. 20, 2021, from Snohomish County Volunteer Search and Rescue Inc., Washington: * * * RE: Docket No. OSHA -2007-0076 - Proposed Emergency Response Standard changes to 29 CFR 1910 Statement of opposition by Snohomish County Volunteer Search and Rescue, Inc (SCVSAR) * * * SCVSAR is a Washington State non-profit corporation established in 1967. more ST