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 pursue dreams such as homeownership and a secure r more ST

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-2023-0495 * * * I. Introduction Basin Electric Powe more ST

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 small and medium-sized businesses hardest. These rules more ST

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 State Implementation Plan for the Second Implementat more ST

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, CO 80202-1129 Re: EPA's Proposed Air Plan Partia more ST

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 Implementation Plan for the Second Implementation P more ST

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 districts throughout California. As we face new cha more ST

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 challenges we must stay ahead of the curve and ensure that  more ST

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 Califf: AHIP is the national association that represe more ST

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 of Rheumatology (ACR) members, I write to provide  more ST

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-0154 * * * Dear Dr. Califf, On behalf of the mem more ST

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 guidance issued in June 2024: - Considerations in Demon more ST

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, The Association for Clinical Oncology (ASCO) app more ST

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") appreciates the opportunity to comment on the FDA dra more ST

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 * * * Dear Commissioner Califf: The Blue Cross Blue Shiel more ST

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 concern: The undersigned submit comments on Draf more ST

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 from Fresenius Kabi to Docket No. FDA-2017-D-0154;  more ST

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 The Federal Trade Commission ("FTC" or "the Comm more ST

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 Infusion Access Foundation is a community of patients a more ST

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] * * * Dear Sir or Madam, The National Council for Presc more ST

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 * * * Dear Dr. Califf, The National Infusion Center Associ more ST

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 Products; Draft Guidance for Industry * * * Dea more ST

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 - Docket No. FDA-2017-D-0154 * * * Dear Commissioner  more ST

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 * * * The Pharmaceutical Research and Manufacturers  more ST

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 opportunity to respond to the recent draft guidan more ST

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 respond to the Food and Drug Administration (FDA) draft more ST

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 17, 2024 Dear Administrator Criswell: On behalf more ST

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 Assistance Program and Policy Guide, FP 104-009-2" -  more ST

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 Emergency Management Agency's (FEMA) Public Assist more ST

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 of Interest * * * Dear Ms. Hayes: The American  more ST

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 Secretary Parker; The National Waste & Recycling Associat more ST

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 * * * Dear Assistant Secretary Parker: On February  more ST

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. SCVSAR currently has over 400 volunteers and typi more ST