WASHINGTON, Oct. 8 -- The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services has released the following public communication dated Sept. 9, 2024, from the American Academy of PAs, Alexandria, Virginia: * * * To: The Honorable Chiquita Brooks-LaSure, MPP Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services 7500 Security Boulevard Baltimore, MD 21244-1850 RE: Medicare and Medicaid Programs: Hospital Outpatient P  more

WASHINGTON, Oct. 8 -- The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services has released the following public communication dated Sept. 9, 2024, from the American Glaucoma Society, San Francisco, California: * * * To: Chiquita Brooks-LaSure Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Attention: CMS-1809-P P.O. Box 8010 Baltimore, Maryland 21244-1810 Re: CMS-1809-P; Medicare Program: Hospital Outpati  more

WASHINGTON, Oct. 8 -- The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services has released the following public communication dated Sept. 9, 2024, from Marcia K. Horn, executive director of the Exon 20 Group, Phoenix, Arizona: * * * To: Ms. Chiquita Brooks-LaSure, Administrator Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore, MD 21244-1850 Dear Administrator Brooks-LaSure, I am writing in support of the proposed changes will  more

WASHINGTON, Oct. 8 -- The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services has released the following public communication dated Sept. 9, 2024, from the Los Angeles County Public Defender's Office, California: * * * To: The Honorable Chiquita Brooks-LaSure Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services RE: Medicare and Medicaid Programs: Medicare Hospital Outpatient Prospective Payment and Ambulatory Sur  more

WASHINGTON, Oct. 8 -- The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services has released the following public communication dated Sept. 9, 2024, from Roger D. Des Prez, cardiologist at Oklahoma Heart Institute, Tulsa: * * * To: The Honorable Chiquita Brooks-LaSure, Administrator Centers for Medicare and Medicaid Services Attention: CMS-1809-P P.O. Box 8010 Baltimore, MD 21244-8010 Submitted electronically via Regulations.gov Re: Comment regarding AI-  more

WASHINGTON, Oct. 8 -- The U.S. Department of Energy Office of Energy Efficiency and Renewable Energy has released the following public communication dated Sept. 26, 2024, from James Broughel, economist at the Competitive Enterprise Institute: * * * The Social Cost Of Carbon Is A Flawed Metric For Policy Decisions The U.S. Department of Energy (DOE) is updating its social cost of carbon (SCC) estimate as part of a proposed rulemaking setting energy efficiency standards for commercial refriger  more

WASHINGTON, Oct. 8 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Sept. 30, 2024, from Nemera Services, Lyon, France: * * * To: Food & Drug Administration USA Ref: Nemera Comments on FDA Draft Guidance "Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products"/1 * * * Dear Sir/Madam, Nemera is an international company with development and manufacturing sites in the   more

WASHINGTON, Oct. 8 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Sept. 30, 2024, from Novo Nordisk Inc., Plainsboro, New Jersey. Here are excerpts: * * * To: Dockets Management Food and Drug Administration 5630 Fishers Lane, Rm 1061 Rockville, MD 20852 RE: Docket No. FDA-2024-D-2560 Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products * * * Dear Sir/Madam,   more

WASHINGTON, Oct. 8 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Sept. 30, 2024, from the Parenteral Drug Association, Bethesda, Maryland. Here are excerpts: * * * To: Dockets Management Staff (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Reference: Docket No. FDA-2024-D-2560 for "Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biologi  more

WASHINGTON, Oct. 8 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Sept. 30, 2024, from the Pharmaceutical Research and Manufacturers of America: * * * To: Dockets Management Staff (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products; Draft Guidance for Industry (Docket No.   more

WASHINGTON, Oct. 8 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Sept. 27, 2024, from RB Health, Parsippany, New Jersey: * * * To: Division of Dockets Management (HFA-305) U.S. Food and Drug Administration Department of Health and Human Services 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Re: Comments on The Scientific Review Supporting Proposed Administrative Order OTC000035 Published Document:   more

WASHINGTON, Oct. 8 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Sept. 27, 2024, from Regeneron Pharmaceuticals Inc., Tarrytown, New York: * * * To: Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 RE: Docket No. FDA-2024-D-2560, Essential Drug Delivery Outputs for Devices Intended To Deliver Drugs and Biological Products * * * Reg  more

WASHINGTON, Oct. 8 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication on Oct. 1, 2024, from SHL Medical AG: * * * Please find summary comments to the draft guidance document: Comment 1: Please elaborate on FDA position on EDDO vs Primary Function (PF) for needle injection systems (NIS) covered under ISO 11608-1:2022, a standard recognized by the Agency. Does ISO 11608 series and PF concept take priority over the ED  more

WASHINGTON, Oct. 8 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Sept. 30, 2024, from Southwest Michigan Neonatology P.C., Kalamazoo: * * * To: Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Dear Dr. Peter Marks and Dr. Donald Prater, On September 29, 2023, the U.S. Food and Drug Administration (FDA) issued a warning regarding use   more

WASHINGTON, Oct. 8 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Sept. 26, 2024, from Women of Color in Pharma: * * * To: Dockets Management Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Subject: FDA-2021-D-0789: Diversity Action Plan Second Draft Guidance * * * Dear Food and Drug Administration (FDA), Women of Color in Pharma (WOCIP) appreciates the opportunity to c  more

WASHINGTON, Oct. 8 -- The U.S. Department of Transportation Federal Transit Administration has released the following public communication dated Sept. 18, 2024, from the Texas Department of Transportation: * * * To: The Honorable Veronica Vanterpool Acting Administrator Federal Transit Administration U.S. Department of Transportation 1200 New Jersey Avenue, SE Washington, DC 20590 RE: Docket Number FTA-2024-0007 * * * Dear Administrator Vanterpool: The Texas Department of Transportati  more

WASHINGTON, Oct. 8 -- The U.S. Department of Transportation Federal Transit Administration has released the following public communication on Oct. 1, 2024, from Jay M. Fox, executive director of the Utah Transit Authority: * * * Subject: Comments on FTA Docket No. FTA-2024-0007 - Buy America Waiver for Utah Transit Authority * * * To The Federal Transit Administration: I am providing comments on behalf of the Utah Transit Authority (UTA) for the review of the Federal Transit Administration'  more

WASHINGTON, Oct. 8 -- The U.S. Army Corps of Engineers has released the following public communication dated Sept. 30, 2024, from DigDeep: * * * COMMENTS FOR UNITED STATES ARMY CORPS OF ENGINEERS CIVIL WORKS ENVIRONMENTAL JUSTICE STRATEGIC PLAN AND VISION Docket No. COE-2024-0003 OVERVIEW We submit these comments in response to the U.S. Army Corps of Engineers' Request for Input on the Civil Works Environmental Justice Strategic Plan and Vision, Docket No. COE-2024-0003. We appreciate the o  more