Sunday - May 19, 2024
Public Comments on Federal Rules Tipoffs from TNS Newsletter for Saturday April 20, 2024 ( 61 items )  

Adnovate Clinical Issues Public Comment to HHS
WASHINGTON, April 20 -- Adnovate Clinical has issued a public comment to the U.S. Department of Health and Human Services. The comment was posted on April 18, 2024. The comment was signed by Caroline Morgan, COO. The comment was on Docket No. FDA-2001-D-0219-0016. * * * 2 comments on the FDA draft DMC guidance, Feb 2024. 1. The agency's caution against "Defining independence too narrowly and rigidly" in line 861 is very welcome, as well as the statement in line 321 that "it is important tha  more

Advanced Medical Technology Association Issues Public Comment to HHS
WASHINGTON, April 20 -- The Advanced Medical Technology Association has issued a public comment to the U.S. Department of Health and Human Services. The comment was written and posted on April 19, 2024. The comment was signed by Tara Federici, Vice President, Technology and Regulatory Affairs. The comment was on Docket No. FDA-2016-D-3561. Here are excerpts: * * * To: Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 R  more

Association of Clinical Research Organizations Issues Public Comment to HHS
WASHINGTON, April 20 -- The Association of Clinical Research Organizations has issued a public comment to the U.S. Department of Health and Human Services. The comment was written and posted on April 19, 2024. The comment was signed by Karen A. Noonan, Senior Vice President, Global Regulatory Policy. The comment was on Docket No. FDA-2023-N-4489-0001. * * * To: Dockets Management Staff (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 RE: ACRO comment  more

Centers for Medicare & Medicaid Services Releases Public Communication From Accreditation Commission for Health Care
WASHINGTON, April 20 -- The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services has released the following public communication on April 17, 2024: * * * Notice of Proposed Rulemaking at 89 Fed. Reg. 11996 (Feb. 15, 2024): Comment Letter Section Regarding CMS' Lack of Authority to Dictate an Accrediting Organization's Operations Congress delegated to the Secretary of the U.S. Department of Health and Human Services, and by extension, its subagency, the Cent  more

Centers for Medicare & Medicaid Services Releases Public Communication From Accreditation for Cardiovascular Excellence
WASHINGTON, April 20 -- The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services has released the following public communication dated April 15, 2024: * * * To: Chiquita Brooks-LaSure Administrator Centers for Medicare & Medicaid Services 200 Independence Avenue, S.W Washington, D.C. 20201 Re: Strengthening Oversight of Accrediting Organizations (AO) and Preventing AO Conflict of Interest, and Related Provisions CMS-3367-P Dear Administrator Brooks-LaSu  more

Centers for Medicare & Medicaid Services Releases Public Communication From Advocate Health
WASHINGTON, April 20 -- The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services has released the following public communication dated April 15, 2024: * * * To: The Honorable Chiquita Brooks-LaSure Administrator Centers for Medicare & Medicaid Services U.S. Department of Health and Human Services P.O. Box 8010 Baltimore, MD 21244-8010 RE: CMS 3367-P, Strengthening Oversight of Accrediting Organizations (AOs) and Preventing AO Conflict of Interest, and R  more

Centers for Medicare & Medicaid Services Releases Public Communication From Allina Health
WASHINGTON, April 20 -- The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services has released the following public communication dated April 15, 2024: * * * To: Chiquita Brooks-LaSure, Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Attention: CMS-3367-P P.O. Box 8010 Baltimore, MD 21244-8010 RE: Medicare Program; Strengthening Oversight of Accrediting Organizations (AOs) and Preventing AO Conflict of Inter  more

Centers for Medicare & Medicaid Services Releases Public Communication From American College of Physicians
WASHINGTON, April 20 -- The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services has released the following public communication dated April 11, 2024: * * * To: Chiquita Brooks-LaSure Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-3367-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. Dear Administrator Brooks-LaSure: On behalf of the American College of Physicians (ACP), I am p  more

Centers for Medicare & Medicaid Services Releases Public Communication From American Hospital Association
WASHINGTON, April 20 -- The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services has released the following public communication dated April 12, 2024. Here are excerpts: * * * To: The Honorable Chiquita Brooks-LaSure Administrator Centers for Medicare & Medicaid Services Hubert H. Humphrey Building 200 Independence Avenue, S.W. Room 445-G Washington, DC 20201 RE: Strengthening Oversight of Accrediting Organizations (AOs) and Preventing AO Conflict of   more

Centers for Medicare & Medicaid Services Releases Public Communication From American Society of Anesthesiologists
WASHINGTON, April 20 -- The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services has released the following public communication dated April 10, 2024: * * * To: Ms. Chiquita Brooks-LaSure Administrator Centers for Medicare and Medicaid Services Department of Health and Human Services Attn: CMS-3367-P P.O. Box 8016 Baltimore, MD 21244-8016 Re: [CMS-3367-P] Medicare Program; Strengthening Oversight of Accrediting Organizations (AOs) and Preventing AO Con  more

Centers for Medicare & Medicaid Services Releases Public Communication From Association of American Medical Colleges
WASHINGTON, April 20 -- The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services has released the following public communication dated April 15, 2024: * * * To: Ms. Chiquita Brooks-LaSure Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Attention: CMS-2439-P P.O. Box 8016 Baltimore, MD 21244-8016 Dear Administrator Brooks-LaSure: Re: Medicare Program; Strengthening Oversight of Accrediting Organizations (A  more

Centers for Medicare & Medicaid Services Releases Public Communication From Calif. Hospice & Palliative Care Association
WASHINGTON, April 20 -- The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services has released the following public communication dated April 15, 2024. Here are excerpts: * * * To: The Honorable Chiquita Brooks-LaSure Administrator Centers for Medicare and Medicaid Services U.S. Department of Health and Human Services 200 Independence Ave, SW Washington, DC 20201 RE: Comments on the Strengthening Oversight of Accrediting Organizations (AOs) and Preventi  more

Centers for Medicare & Medicaid Services Releases Public Communication From California Hospital Association
WASHINGTON, April 20 -- The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services has released the following public communication dated April 15, 2024: * * * To: Chiquita Brooks-LaSure Administrator Centers for Medicare & Medicaid Services Hubert H. Humphrey Building 200 Independence Avenue, SW Washington, DC 20201 SUBJECT: CMS-3367-P, Medicare Program; Strengthening Oversight of Accrediting Organizations (AOs) and Preventing AO Conflict of Interest, and  more

Centers for Medicare & Medicaid Services Releases Public Communication From Center for Improvement in Healthcare Quality
WASHINGTON, April 20 -- The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services has released the following public communication dated April 12, 2024: * * * Center for Improvement in Healthcare Quality PO Box 3620, McKinney, TX 75070 866-324-5080 * * * To: Centers for Medicare &Medicaid Services Department of Health and Human Services P.O. Box 8010, Baltimore, MD 21244-8010. Attention: CMS-3367-P Dear CMS: The Center for Improvement in Healthcare Qu  more

Centers for Medicare & Medicaid Services Releases Public Communication From Cleveland Clinic
WASHINGTON, April 20 -- The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services has released the following public communication dated April 15, 2024: * * * Cleveland Clinic Melissa Myers, JD, MPA Chief of Staff, Government Relations Senior Director, Policy * * * To: Centers for Medicare & Medicaid Services Department of Health and Human Services P.O. Box 8010 Baltimore, MD 21244-8010 RE: CMS-3367-P; Medicare Program; Strengthening Oversigh  more

Centers for Medicare & Medicaid Services Releases Public Communication From CMS Tribal Technical Advisory Group
WASHINGTON, April 20 -- The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services has released the following public communication dated April 9, 2024: * * * To: The Honorable Chiquita Brooks-LaSure Administrator Centers for Medicare and Medicaid Services Department of Health and Human Services 7500 Security Boulevard Baltimore, MD 21244 Re: Medicare Program; Strengthening Oversight of Accrediting Organizations (AOs) and Preventing AO Conflict of Interest  more

Centers for Medicare & Medicaid Services Releases Public Communication From Coalition to Transform Advanced Care
WASHINGTON, April 20 -- The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services has released the following public communication dated April 10, 2024: * * * To: Chiquita Brooks-LaSure, Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Attention: CMS-4201-P P.O. Box 8013 Baltimore, MD 21244 Re: Medicare Program; Strengthening Oversight of Accrediting Organizations (AOs) and Preventing AO Conflict of Interest,   more

Centers for Medicare & Medicaid Services Releases Public Communication From CommonSpirit Health
WASHINGTON, April 20 -- The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services has released the following public communication dated April 15, 2024: * * * To: Chiquita Brooks-LaSure Administrator Centers for Medicare & Medicaid Services Hubert H. Humphrey Building 200 Independence Avenue, SW Washington, DC 20201 Re: Strengthening Oversight of Accrediting Organizations (AOs) and Preventing AO Conflict of Interest Dear Administrator Brooks-LaSure: Comm  more

Centers for Medicare & Medicaid Services Releases Public Communication From DNV Healthcare USA
WASHINGTON, April 20 -- The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services has released the following public communication dated April 15, 2024: * * * To: The Honorable Chiquita Brooks-LaSure Administrator Department of Health and Human Services Centers for Medicare & Medicaid Services 7500 Security Blvd Baltimore, MD 21244 ATTENTION: CMS-3367-P Dear Administrator Brooks-LaSure: DNV Healthcare received initial approval in 2008 as a National Accr  more

Centers for Medicare & Medicaid Services Releases Public Communication From Essentia Health
WASHINGTON, April 20 -- The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services has released the following public communication dated April 15, 2024: * * * To: The Honorable Chiquita Brooks-LaSure Centers for Medicare and Medicaid Services Department of Health and Human Services Attention: CMS-3367-P Mail Stop: C4-26-05 7500 Security Boulevard Baltimore, MD 21244-1850 Re: Medicare Program; Strengthening Oversight of Accrediting Organizations (AOs) and  more

Centers for Medicare & Medicaid Services Releases Public Communication From Joint Commission
WASHINGTON, April 20 -- The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services has released the following public communication dated April 15, 2024. Here are excerpts: * * * To: The Honorable Chiquita Brooks-LaSure Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Hubert H. Humphrey Building 200 Independence Avenue S.W. Washington, D.C. 20201 [Docket: CMS-3367-P. Submitted electronically via regulations.g  more

Centers for Medicare & Medicaid Services Releases Public Communication From LeadingAge
WASHINGTON, April 20 -- The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services has released the following public communication dated April 15, 2024: * * * To: The Honorable Chiquita Brooks-LaSure Administrator Centers for Medicare & Medicaid Services U.S. Department of Health and Human Services 200 Independence Avenue, SW Washington, DC 20101 RE: Medicare Program; Strengthening Oversight of Accrediting Organizations (AOs) and Preventing AO Conflict of  more

Centers for Medicare & Medicaid Services Releases Public Communication From National Association for Behavioral Healthcare
WASHINGTON, April 20 -- The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services has released the following public communication dated April 15, 2024: * * * To: Chiquita Brooks-LaSure Administrator, Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore, MD 21244-1850 Re: CMS-3367-P, Medicare Program; Strengthening Oversight of Accrediting Organizations (AOs) and Preventing AO Conflict of Interest, and Related Provisions Dear Administr  more

Centers for Medicare & Medicaid Services Releases Public Communication From National Organization of State Offices of Rural Health
WASHINGTON, April 20 -- The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services has released the following public communication dated April 15, 2024: * * * NOSORH Comments - CMS Proposed Strengthened Oversight of Accrediting Organizations Introduction On February 15, 2024, the Centers for Medicare and Medicaid Services (CMS) issued a Notice of Proposed Rulemaking (NPRM), CMS-3367-P, entitled Medicare Program; Strengthening Oversight of Accrediting Organiza  more

Centers for Medicare & Medicaid Services Releases Public Communication From National Partnership for Healthcare and Hospice Innovation
WASHINGTON, April 20 -- The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services has released the following public communication dated April 15, 2024: * * * To: The Honorable Chiquita Brooks-LaSure Administrator Centers for Medicare and Medicaid Services U.S. Department of Health and Human Services 200 Independence Ave, SW Washington, DC 20201 RE: Comments on the Strengthening Oversight of Accrediting Organizations (AOs) and Preventing AO Conflict of In  more

Centers for Medicare & Medicaid Services Releases Public Communication From Ohio Hospital Association
WASHINGTON, April 20 -- The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services has released the following public communication dated April 3, 2024: * * * To: Centers for Medicare & Medicaid Services Department of Health and Human Services Attention: CMS-3367-P Mail Stop C4-26-05 7500 Security Boulevard Baltimore, MD 21244-1850 To Whom It May Concern: The Ohio Hospital Association appreciates the opportunity to provide comment on the proposed 42 CFR P  more

Centers for Medicare & Medicaid Services Releases Public Communication From Patients for Patient Safety
WASHINGTON, April 20 -- The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services has released the following public communication dated on April 17, 2024: * * * PATIENT ADVOCATES' RESPONSE TO CMS 3367-P, STRENGTHENING OVERSIGHT OF ACCREDITING ORGANIZATIONS (AOs) AND PREVENTING AO CONFLICT OF INTEREST Background: Patients for Patient Safety US (PFPS US) is the United States branch of the World Health Organization's Patients for Patient Safety network. Our memb  more

Centers for Medicare & Medicaid Services Releases Public Communication From Patients for Patient Safety U.S.
WASHINGTON, April 20 -- The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services has released the following public communication dated on April 17, 2024: * * * PATIENT ADVOCATES' RESPONSE TO CMS 3367-P, STRENGTHENING OVERSIGHT OF ACCREDITING ORGANIZATIONS (AOs) AND PREVENTING AO CONFLICT OF INTEREST Background: Patients for Patient Safety US (PFPS US) is the United States branch of the World Health Organization's Patients for Patient Safety network. Our memb  more

Centers for Medicare & Medicaid Services Releases Public Communication From Society for Healthcare Epidemiology of America
WASHINGTON, April 20 -- The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services has released the following public communication dated April 15, 2024: * * * To: Ms. Chiquita Brooks-LaSure Administrator Centers for Medicare and Medicaid Services U.S. Department of Health and Human Services CMS-3367-P P.O. Box 8013 Baltimore, MD 21244-8013 RE: Strengthening Oversight of Accrediting Organizations (AOs) and Preventing AO Conflict of Interest, and Related P  more

Centers for Medicare & Medicaid Services Releases Public Communication From Trellis Supportive Care
WASHINGTON, April 20 -- The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services has released the following public communication dated April 15, 2024: * * * To: Chiquita Brooks-LaSure, Administrator Centers for Medicare and Medicaid Services, Department of Health and Human Services, Attention: CMS-3367-P PO Box 8010 Baltimore, MD 21244-1850 Submitted: April 15, 2024 at https://www.regulations.gov RE: CMS-3367-P Medicare Program; Strengthening Oversight   more

Centers for Medicare & Medicaid Services Releases Public Communication From Utilization Review Accreditation Commission
WASHINGTON, April 20 -- The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services has released the following public communication dated March 21, 2024. Here are excerpts: * * * To: Chiquita Brooks-LaSure Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Attention: CMS-3367-P P.O. Box 8010 Baltimore, MD 21244-8010 Delivered electronically to http://www.regulations.gov Re: Medicare Program; Strengthening Over  more

Centers for Medicare & Medicaid Services Releases Public Communication From Vizient Inc.
WASHINGTON, April 20 -- The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services has released the following public communication dated April 11, 2024: * * * Vizient, Inc. 799 9th Street NW Suite 210 Washington, DC 20001 T (202) 354-2600 vizientinc.com * * * To: The Honorable Chiquita Brooks-LaSure Administrator Centers for Medicare & Medicaid Services U.S. Department of Health and Human Services 7500 Security Boulevard Baltimore, MD 21244 Re: Med  more

Critical Path Institute Issues Public Comment to HHS
WASHINGTON, April 20 -- The Critical Path Institute, Tucson, Arizona, has issued a public comment to the U.S. Department of Health and Human Services. The comment was written on April 18, 2024, and posted on April 19, 2024. The comment was signed by Huong Huynh, Director of Regulatory Science (US). The comment was on Docket No. FDA-2023-N-4489. * * * To: Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm 1061 Rockville, MD 20852 Re: Enhancing Adop  more

Education Dept. Releases Public Communication From University of Northern Colorado
WASHINGTON, April 19 -- The U.S. Department of Education has released the following public communication on April 11, 2024: * * * Perhaps the most important concern that we have is that by limiting this to Title IV recipients, you are negatively impacting those students you most state you wish to help. This could result in institutions with programs given the negative Employment Premium designation systematically excluding Pell and other Title IV recipients by not awarding Title IV funds for t  more

EPA Releases Public Communication From 3 Harvard Environmental Toxicology Students
WASHINGTON, April 20 -- The U.S. Environmental Protection Agency has released the following public communication on April 18, 2024: * * * Comment on PFNA We are three Harvard environmental toxicology students with a diverse array of expertise. First is Natural Premier, a senior at Harvard College pursuing a joint degree in computer science and environmental science and engineering. He is from Washington DC, a city with its own brand of environmental hazards and injustice, and has done researc  more

EPA Releases Public Communication From Ashland, Ky., Utility Director
WASHINGTON, April 20 -- The U.S. Environmental Protection Agency has released the following public communication dated March 12, 2024: * * * City of Ashland, Kentucky Office of the Utility Director 1700 Greenup Ave PO BOX 1839 Ashland, KY 41101 www.ashlandky.gov 606-385-3400 * * * Re: Request for 60-Day Extension of Public Comment Period - Draft Guidance for Future NPDES Permitting of Combined Sewer Systems Chris Kloss, Water Permits Division Director United States Environmental Pr  more

FAA Releases Public Communication From Air Medical Operators Association
WASHINGTON, April 19 -- The U.S. Department of Transportation Federal Aviation Administration has released the following public communication dated April 15, 2024: * * * To: U.S. Department of Transportation Docket Operations, M-30 | Room W12-140 1200 New Jersey Ave SE Washington, D.C. 20590 RE: Comments to the Final Rule, Request for Comments, Airworthiness Directives; Airbus Helicopters Deutschland GmbH (AHD) Helicopters, 89 FR 15431, March 4, 2024 ("AD"), Docket No.: FAA-2024-0453 Dear   more

Federal Highway Administration Releases Public Communication From American Road & Transportation Builders Association
WASHINGTON, April 19 -- The U.S. Department of Transportation Federal Highway Administration has released the following public communication dated April 17, 2024: * * * To: Honorable Shailen Bhatt Administrator US Department of Transportation Federal Highway Administration 1200 New Jersey Avenue, SE Washington, DC 20590 RE: Highway Safety Improvement Program; Docket No. FHWA-2023-0045 Dear Administrator Bhatt: On behalf of the American Road & Transportation Builders Association (ARTBA)  more

Genentech Inc. Issues Public Comment to HHS
WASHINGTON, April 20 -- Genentech Inc., South San Francisco, California, a member of the Roche Group, has issued a public comment to the U.S. Department of Health and Human Services. The comment was written and posted on April 19, 2024. The comment was signed by Rasika Kalamegham, Executive Director, U.S. Head, Product Development Regulatory Policy. The comment was on Docket No. FDA-2023-N-4489-0001. * * * To: Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishe  more

HUD Releases Public Communication From 10 Organizations
WASHINGTON, April 20 -- The U.S. Department of Housing and Urban Development has released the following public communication dated April 15, 2024. Here are excerpts: * * * To: Regulations Division Office of General Counsel U.S. Department of Housing and Urban Development 451 Seventh St., SW, Room 10276 Washington, DC 20410-0500 Request for Information Regarding Iron, Steel, Construction Materials, and Manufactured Products Used in Housing Programs Pursuant to the Build America, Buy Ameri  more

Office of Energy Efficiency & Renewable Energy Releases Public Communication From Senneca Holdings
WASHINGTON, April 19 -- The U.S. Department of Energy Office of Energy Efficiency and Renewable Energy has released the following public communication dated April 15, 2024: * * * Docket No. EERE-2017-BT-STD-0009-0053 To: Hon. Troy Watson U.S. Department of Energy Office of Energy Efficiency and Renewable Energy Building Technologies Office, EE-5B 1000 Independence Avenue SW, Washington, DC 20585-0121 * Hon. Matthew Schneider U.S. Department of Energy Office of the General Counsel, GC  more

PhRMA Issues Public Comment to HHS
WASHINGTON, April 20 -- The Pharmaceutical Research and Manufacturers of America has issued a public comment to the U.S. Department of Health and Human Services. The comment was written and posted on April 19, 2024. The comment was signed by Maria Apostolaros, Deputy Vice President, Science and Regulatory Advocacy; and Barbara Brophy, Director, Science and Regulatory Advocacy. The comment was on Docket No. FDA-2023-N-4489. * * * To: Dockets Management Staff (HFA-305) Food and Drug Administr  more

PTC Therapeutics Issues Public Comment to HHS
WASHINGTON, April 20 -- PTC Therapeutics Inc., South Plainfield, New Jersey, has issued a public comment to the U.S. Department of Health and Human Services. The comment was written on April 16, 2024, and posted on April 19, 2024. The comment was signed by Quintus Ngumah, VP Clinical Development and COS to the Chief Medical Officer; and Murad Husain, SVP and Head of Global Regulatory Affairs. The comment was on Docket No. FDA-2023-N-4489. * * * To: Food and Drug Administration Division of D  more

Regeneron Pharmaceuticals Issues Public Comment to HHS
WASHINGTON, April 20 -- Regeneron Pharmaceuticals Inc., Tarrytown, New York, has issued a public comment to the U.S. Department of Health and Human Services. The comment was written on April 12, 2024, and posted on April 18, 2024. The comment was signed by Kellie Taylor, Head of Global Regulatory Intelligence, Regulatory Affairs. The comment was on Docket No. FDA-2001-D-0219. Here are excerpts: * * * To: Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers L  more

Samsung Bioepis Issues Public Comment to HHS
WASHINGTON, April 19 -- Samsung Bioepis Co. Ltd., Incheon, South Korea, has issued a public comment to the U.S. Department of Health and Human Services. The comment was written on April 15, 2024, and posted on April 18, 2024. The comment was signed by Byoung In Jung, Vice President, Regulatory Affairs Team. The comment was on Docket No. FDA-2001-D-0219-0016. * * * To: Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 RE  more

Social Security Administration Releases Public Communication From Wise
WASHINGTON, April 19 -- The Social Security Administration has released the following public communication dated April 12, 2024: * * * To: Social Security Administration 6401 Security Blvd. Baltimore, MD 21235 RE: RIN 0960-AH88, SSA-2016-0039 Use of Electronic Payroll Data To Improve Program Administration To Whom It May Concern: Wise is a technical assistance and training organization which has been focused on competitive integrated employment for people with intellectual and development  more

Treasury Comptroller of Currency Releases Public Communication From Small Business Administration
WASHINGTON, April 19 -- The U.S. Department of the Treasury Office of the Comptroller of the Currency has released the following public communication dated April 15, 2024: * * * To: Michael J. Hsu Acting Comptroller of the Currency Office of the Comptroller of the Currency 400 7th Street SW Washington, DC 20219 Re: Business Combinations Under the Bank Merger Act; Docket ID OCC-2023-0017; RIN 1557-AF24 Dear Acting Comptroller Hsu: On February 13, 2024, the Office of the Comptroller of th  more

Treasury Comptroller of Currency Releases Public Communication From Starling Insights
WASHINGTON, April 19 -- The U.S. Department of the Treasury Office of the Comptroller of the Currency has released the following public communication dated April 15, 2024: * * * To: Chief Counsel's Office Attention: Comment Processing Office of the Comptroller of the Currency 400 7th Street, SW Suite 3E-218 Washington, DC 20219 Docket ID: OCC-2023-0017 RE: Notice of Proposed Rulemaking on Business Combinations Under the Bank Merger Act INTRODUCTION Starling Insights, Inc ("Starling In  more

U.S. Army Corps of Engineers Releases Public Communication From 137 Conservation, Social Justice, Community, and Faith Organizations
WASHINGTON, April 19 -- The U.S. Army Corps of Engineers has released the following public communication dated April 15, 2024: * * * To: Stacey M. Jensen Office of the Assistant Secretary of the Army (Civil Works) 108 Army Pentagon, Room 3E474 Washington, DC 20310-0108 Re: Docket ID: COE-2023-0005, Procedures To Implement the Principles, Requirements, and Guidelines for Federal Investments in Water Resources Dear Ms. Jensen: On behalf of our millions of members and supporters across t  more

U.S. Army Corps of Engineers Releases Public Communication From 8 Organizations
WASHINGTON, April 19 -- The U.S. Army Corps of Engineers has released the following public communication dated April 15, 2024. Here are excerpts: * * * To: Ms. Stacey M. Jensen Acting Director for Policy and Legislation Office of the Assistant Secretary of the Army (Civil Works) 108 Army Pentagon, Room 3E474 Washington, DC 20310-0108 Re: Agency Proposed Rule for Specific Procedures for PR&Gs for Water & Related Resources, Docket ID: COE-2023-0005 Dear Acting Director Jensen: The member  more

U.S. Army Corps of Engineers Releases Public Communication From American Association of Port Authorities
WASHINGTON, April 19 -- The U.S. Army Corps of Engineers has released the following public communication dated April 15, 2024: * * * To: The Honorable Michael L. Connor Assistant Secretary of Army for Civil Works 108 Army Pentagon Washington, D.C. 20310-0108 Re: Docket ID No. COE-2023-0005: Corps of Engineers Agency Specific Procedures To Implement the Principles, Requirements, and Guidelines for Federal Investments in Water Resources Dear Secretary Connor: American Association of Port   more

U.S. Army Corps of Engineers Releases Public Communication From American Shore & Beach Preservation Association
WASHINGTON, April 19 -- The U.S. Army Corps of Engineers has released the following public communication dated April 15, 2024: * * * American Shore & Beach Preservation Association P.O. Box 1451 Folly Beach, SC 29439 (843) 371-7082 Nicole.Elko@asbpa.org Advocating for healthy coastlines asbpa.org * * * To: The Honorable Michael L. Connor Assistant Secretary of Army for Civil Works 108 Army Pentagon Washington, D.C. 20310-0108 Re: Docket ID No. COE-2023-0005: Corps of Engineers Agen  more

U.S. Army Corps of Engineers Releases Public Communication From Association of State Floodplain Managers
WASHINGTON, April 19 -- The U.S. Army Corps of Engineers has released the following public communication dated April 15, 2024. Here are excerpts: * * * Association of State Floodplain Managers 8301 Excelsior Dr. Madison, WI 53517 www.FLOODS.org 608-828-3000 * * * ASFPM's Comments regarding Corps of Engineers Agency Specific Procedures to Implement the Principles, Requirements, and Guidelines for Federal Investments in Water Resources Docket ID: COE-2023-0005 The Association of State  more

U.S. Army Corps of Engineers Releases Public Communication From Earth Economics
WASHINGTON, April 19 -- The U.S. Army Corps of Engineers has released the following public communication dated April 15, 2024: * * * Earth Economics 1102 A Street, Suite 321 Tacoma, WA 98402 (253) 539-4801 EarthEconomics.org * * * To: Stacey M. Jensen Office of the Assistant Secretary of the Army (Civil Works) 108 Army Pentagon, Room 3E474 Washington, DC 20310-0108 Re: Docket ID: COE-2023-0005, Procedures to Implement the Principles, Requirements, and Guidelines for Federal Invest  more

U.S. Army Corps of Engineers Releases Public Communication From National Wildlife Federation, American Rivers
WASHINGTON, April 20 -- The U.S. Army Corps of Engineers has released the following public communication dated April 15, 2024. Here are excerpts: * * * To: The Honorable Michael Connor Assistant Secretary of the Army (Civil Works) 108 Army Pentagon (3E446) Washington, DC 20310-0108 * Stacey M. Jensen Office of the Assistant Secretary of the Army (Civil Works) 108 Army Pentagon, Room 3E474 Washington, DC 20310-0108 Re: Docket ID COE-2023-0005, Procedures To Implement the Principles, R  more

U.S. Army Corps of Engineers Releases Public Communication From Southern Environmental Law Center, 17 Collaborators
WASHINGTON, April 19 -- The U.S. Army Corps of Engineers has released the following public communication dated April 15, 2024. Here are excerpts: * * * To: The Honorable Michael Connor Assistant Secretary of the Army (Civil Works) Department of the Army 108 Army Pentagon Washington, DC 20310-0108 * Ms. Stacey M. Jensen Acting Director for Policy and Legislation Office of the Assistant Secretary of the Army (Civil Works) 108 Army Pentagon Washington, DC 20310-0108 Re: Comments on Co  more

U.S. Coast Guard Releases Public Communication From Virginia Maritime Association
WASHINGTON, April 19 -- The U.S. Department of Homeland Security Coast Guard has released the following public communication dated April 16, 2024: * * * To: Office of Navigation Systems (CG-NAV-2) Attn: Mr. George Detweiler 2703 Martin Luther King Jr. Avenue SE Washington, DC 20593 Re: Notice of Proposed Rulemaking for Atlantic Coast Shipping Safety Fairways (USCG-2019-0279) The Virginia Maritime Association is the 104-year-old trade association representing over 450 businesses directly a  more

USTR Releases Public Communication From Applied DNA Sciences
WASHINGTON, April 19 -- The U.S. Office of Trade Representative has released the following public communication dated April 20, 2024: * * * To: Ambassador Katherine Tai Office of the United States Trade Representative 600 17TH St NW Washington, DC 20508 RE: Docket Number USTR-2024-0002- Notice Seeking Public Comments on Promoting Supply Chain Resilience Dear Ambassador Tai, Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company") is grateful for the opportunity to submi  more

USTR Releases Public Communication From Parkdale Mills
WASHINGTON, April 19 -- The U.S. Office of Trade Representative has released the following public communication dated April 10, 2024: * * * To: The Honorable Katherine Tai United State Trade Representative 600 17th Street, NW Washington, DC 20508 RE: Docket Number USTR 2024-0002 Dear Ambassador Tai, I represent Parkdale Mills, Inc., a North Carolina-based textile yarn spinning company as director of government affairs. Thank you for the opportunity to provide comments on promoting supply  more

Wasco Veterinary Clinic Issues Public Comment to HHS
WASHINGTON, April 19 -- Wasco Veterinary Clinic has issued a public comment to the U.S. Department of Health and Human Services. The comment was posted on April 18, 2024. The comment was on Docket No. FDA-2018-N-4626-0001. * * * Pimobendan as an office stock drug in our clinic has been very crucial in providing to our patients. The efficiency of providing the drug the same day as the visit of the patient makes a difference for our client. The dosages available in a compounded form will ensu  more

WCG Issues Public Comment to HHS
WASHINGTON, April 20 - WCG, Princeton, New Jersey, has issued a public comment to the U.S. Department of Health and Human Services. The comment was posted on April 19, 2024. The comment was signed by Kelly FitzGerald, Executive IRB Chair and Vice President IRB Affairs. The comment was on Docket No. FDA-2022-D-2997. * * * Re: Docket No. FDA-2022-D-2997 Key Information and Facilitating Understanding in Informed Consent - Guidance for Sponsor, Investigators, and Institutional Review Boards WCG  more