WASHINGTON, Oct. 2 -- The U.S. Department of Agriculture Agricultural Marketing Service has released the following public communication dated Sept. 26, 2024, from the International Food Additives Council: * * * To: National Organic Standards Board USDA-AMS-NOP 1400 Independence Avenue SW Room 2642, STOP 0268 Washington, DC 20250-0268 Re: AMS-NOP-24-0023; Meeting of the National Organic Standards Board * * * Dear National Organic Standards Board, The International Food Additives Council more ST

WASHINGTON, Oct. 2 -- 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 AARP: * * * To: The Honorable Chiquita Brooks-LaSure Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services 200 Independence Avenue, S.W. Washington, DC 20201 Re: CMS-1809-P - Medicare Program: Calendar Year 2025 Hospital Outpatient Prospective Payment System * * more ST

WASHINGTON, Oct. 2 -- 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 Advanced Medical Technology Association. Here are exceprts: * * * To: Chiquita Brooks-LaSure, Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Attn: CMS-1809-P P.O. Box 8010 Baltimore, MD 21244-1810 Re: Medicare Program: Hospital Outpatient Prospective  more ST

WASHINGTON, Oct. 2 -- 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 Alabama Association of Ambulatory Surgery Centers, Tuscaloosa, and 28 collaborators: * * * To: The Honorable Chiquita Brooks-LaSure, Administrator Centers for Medicare and Medicaid Services Department of Health and Human Services CMS-1809-P Mail Stop C4-26-05 7500 Security Boulevard Baltimore, MD 21244 more ST

WASHINGTON, Oct. 2 -- 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 Katy Johnson, senior counsel at the American Benefits Council: * * * To: Centers for Medicare & Medicaid Services Department of Health and Human Services Attention: CMS-1809-P P.O. Box 8010 Baltimore, MD 21244-8010 Re: Department of Health and Human Services Proposed Regulations Regarding Medicare Progra more ST

WASHINGTON, Oct. 2 -- 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 American College of Emergency Physicians and 10 collaborators: * * * To: The Honorable Chiquita Brooks-LaSure Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services PO Box 8016 Baltimore, MD 21244-8016 * * * Dear Administrator Brooks-LaSure: On behalf of the pat more ST

WASHINGTON, Oct. 2 -- 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 College of Gastroenterology, North Bethesda, Maryland, and two collaborators: * * * To: Chiquita Brooks-LaSure Administrator Centers for Medicare & Medicaid Services US Department of Health & Human Services 200 Independence Avenue SW Washington, DC 20543 Re: Medicare and Medicaid Programs:  more ST

WASHINGTON, Oct. 2 -- 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 College of Surgeons: * * * To: Chiquita Brooks-LaSure, MPP Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Attention: CMS-1809-P P.O. Box 8010 Baltimore, MD 21244-8010 RE: Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment more ST

WASHINGTON, Oct. 2 -- 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 Psychological Association Services Inc.: * * * To: Department of Health and Human Services Centers for Medicare & Medicaid Services Attention: CMS-1809-P P.O. Box 8010 Baltimore, MD 21244-8010 Dear Administrator Brooks-LaSure, On behalf of the American Psychological Association Services (AP more ST

WASHINGTON, Oct. 2 -- The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services has released the following public communication dated Aug. 9, 2024, from the American Society of Gene and Cell Therapy, Waukesha, Wisconsin: * * * 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 20201 Re: CMS-1807-P - Medicare and Medicaid P more ST

WASHINGTON, Oct. 2 -- 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 Society of Hematology: * * * To: Chiquita Brooks-LaSure Centers for Medicare & Medicaid Services U.S. Department of Health and Human Services Attention: CMS-1784-P P.O. Box 8016 Baltimore, MD 21244-8016 RE: CY 2025 Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and  more ST

WASHINGTON, Oct. 2 -- 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 Society of Nuclear Cardiology, Fairfax, Virginia: * * * To: The Honorable Chiquita Brooks-LaSure Administrator Centers for Medicare & Medicaid Services U.S. Department of Health and Human Services Hubert Humphrey Building, Room 445-G 200 Independence Avenue, SW Washington, DC 20001 Re: [CM more ST

WASHINGTON, Oct. 2 -- 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 Anumana: * * * To: Ms. Chiquita Brooks-LaSure Administrator Centers for Medicare and Medicaid Services Department of Health and Human Services Room 445-G Hubert H. Humphrey Building 200 Independence Ave, SW Washington, DC 20201 RE: Medicare and Medicaid Programs: Hospital Outpatient Prospective Paymen more ST

WASHINGTON, Oct. 2 -- 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 Association for Medical Imaging Management, Sudbury, Massachusetts: * * * To: The Honorable Chiquita Brooks-LaSure Administrator Centers for Medicare and Medicaid Services Attention: CMS-1809-P P.O. Box 8010 Baltimore, MD 21244-8016 Dear Administrator Brooks-LaSure: On behalf of AHRA, The Associati more ST

WASHINGTON, Oct. 2 -- 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 BayCare Health System Inc., Clearwater, Florida: * * * To: The Honorable Chiquita Brooks-LaSure Administrator, Centers for Medicare and Medicaid Services Department of Health and Human Services 200 Independence Avenue, SW Washington, DC 20201 RE: Hospital Outpatient Prospective Payment and Ambulatory more ST

WASHINGTON, Oct. 2 -- 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 Bipartisan Policy Center: * * * To: Centers for Medicare & Medicaid Services Department of Health and Human Services Attention: CMS-1809-P P.O. Box 8010 Baltimore, MD 21244-8010 RE: Calendar Year 2025 Medicare Hospital Outpatient Prospective Payment System, Ambulatory Surgical Center Payment System a more ST

WASHINGTON, Oct. 2 -- 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 Blue Earth Diagnostics, Monroe Township, New Jersey: * * * To: The Honorable Chiquita Brooks-LaSure Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Attention: CMS-1809-P 200 Independence Avenue S.W. Washington, DC 20201 Re: CY 2025 Hospital Outpatient  more ST

WASHINGTON, Oct. 2 -- The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services has released the following public communication on Aug. 14, 2024, from Carrie Collins, president of the Brain Injury Alliance of Arizona: * * * To: Centers for Medicare and Medicaid Services 7500 Security Boulevard Baltimore, MD 21244 * The Honorable Kyrsten Sinema 317 Hart Senate Building Washington, DC 20510 * The Honorable Mark Kelly 516 Hart Senate Building Washing more ST

WASHINGTON, Oct. 2 -- 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 Cepheid, Sunnyvale, California: * * * To: Chiquita Brooks-LaSure Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Attention: CMS-3421-NC Mail Stop C4-26-05 7500 Security Boulevard Baltimore, MD 21244-1850 RE: CY 2025 Medicare Hospital Outpatient Prospecti more ST

ASHINGTON, Oct. 2 -- 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 CommonSpirit Health, Chicago, Illinois: * * * To: Chiquita Brooks-LaSure Administrator Centers for Medicare and Medicaid Services Department of Health and Human Services 7500 Security Boulevard Baltimore, MD 21244 Re: Calendar Year 2025 Outpatient Prospective Payment System Proposed Rule, et. al. (CMS-18 more ST

WASHINGTON, Oct. 2 -- 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 Eisai Inc., Nutley, New Jersey: * * * To: The Honorable Chiquita Brooks-LaSure Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Attention: CMS-1809-P P.O. Box 8010 Baltimore, MD 21244-1810 Re: Medicare and Medicaid Programs: Hospital Outpatient Prospective  more ST

WASHINGTON, Oct. 2 -- 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 David Gruen, chairman of radiology at Griffin Hospital: * * * To: Centers for Medicare & Medicaid Services, Department of Health and Human Services Chair, Radiology, Griffin Hospital, Derby CT RE: Regulation no. CMS-1807-P (physician) and regulation no. CMS-1809-P (outpatient hospital) * * * I am writing  more ST

WASHINGTON, Oct. 2 -- The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services has released the following public communication on Aug. 14, 2024, from Illinois State Sen. Laura Ellman, 21st District: * * * To: Ms. Chiquita Brooks-LaSure, Administrator Centers for Medicare and Medicaid Services 7500 Security Boulevard Baltimore, MD 21244-1850 Dear Administrator Brooks-LaSure: I am writing to express my strong support for CMS's proposal to unbundle diagnost more ST

WASHINGTON, Oct. 2 -- The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services has released the following public communication on Aug. 14, 2024, from Miguel F. Manzur, assistant professor of clinical surgery at Keck Medical Center of USC, Los Angeles, California: * * * To: Chiquita Brooks-LaSure Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services 7500 Security Boulevard Baltimore, MD 21244 Re: CMS-1809-P * * * more ST

WASHINGTON, Oct. 2 -- The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services has released the following public communication dated Aug. 5, 2024, from Rolando D. Rodriguez, cardiologist at Lee Health, Fort Myers, Florida: * * * To: Chiquita Brooks-LaSure Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services 7500 Security Boulevard Baltimore, MD 21244 Re: CMS-1809-P * * * Dear Administrator Brooks-LaSure, CM more ST

WASHINGTON, Oct. 2 -- 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 Trisha Schell-Guy, director of the Division of Program Development and Management in the New York State Department of Health Office of Health Insurance Programs: * * * To: Chiquita Brooks-LaSure, Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Attention: CMS-1 more ST

WASHINGTON, Oct. 2 -- The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services has released the following public communication dated Aug. 4, 2024, from Joseph Rahman, medical director of the Comprehensive Heart Failure Program at PIH Health System, Los Angeles, California: * * * Re: CMS-1809-P * * * Dear Administrator Brooks-LaSure, My name is Joseph Rahman and I am the medical director of the Comprehensive Heart Failure Program at PIH Health System. As an more ST

WASHINGTON, Oct. 2 -- 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 Dev Vaz, cardiologist at Prisma Health Carolina Cardiology Consultants, Greenville, South Carolina: * * * To: Chiquita Brooks-LaSure Administrator Centers for Medicare and Medicaid Services (CMS) Department of Health and Human Services Attention: CMS-1786-P PO Box 8010 Baltimore, MD 21244-1810 RE: CMS- more ST

WASHINGTON, Oct. 2 -- The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services has released the following public communication dated Sept. 8, 2024, from Andrew W. Ertel, advanced imaging cardiologist at the WellSpan Heart and Vascular Institute, York, Pennsylvania: * * * To: Chiquita Brooks-LaSure Administrator Centers for Medicare and Medicaid Services (CMS) Department of Health and Human Services Attention: CMS-1786-P PO Box 8010 Baltimore, MD 21244-1 more ST

WASHINGTON, Oct. 2 -- The U.S. Department of Transportation has released the following public communication dated Sept. 25, 2024, from the Montgomery County Department of Transportation, Maryland: * * * RE: Docket Number DOT-OST-2024-0090 * * * These comments pursuant to a Notice of Proposed Rulemaking (NPRM) by the United States Department of Transportation (USDOT) in Docket Number DOT-OST-2024-0090 are submitted on behalf of the Montgomery County (Maryland) Department of Transportation (MC more ST

WASHINGTON, Oct. 2 -- The U.S. Department of Education has released the following public communication dated Sept. 25, 2024, from Advance CTE, Silver Spring, Maryland, and Association for Career and Technical Education, Alexandria, Virginia: * * * To: Manager of the Strategic Collections & Clearance Governance and Strategy Division U.S. Department of Education 400 Maryland Ave, SW, LBJ, Room 4C210, Washington, DC 20202-1200 In re: Docket No.: ED-2024-SCC-0112 * * * To Whom It May Concern, more ST

WASHINGTON, Oct. 2 -- The U.S. Environmental Protection Agency has released the following public communication dated Sept. 24, 2024, from the Environmental Technology Council: * * * To: U.S. EPA Attn: Rachel Smoak Mail Drop: E143-02 109 T.W. Alexander Drive P.O. Box 12055 RTP, North Carolina 27711 RE: Docket ID No. EPA-HQ-OAR-2004-0022 * * * Dear Ms. Smoak: On behalf of its member companies, the Environmental Technology Council (ETC) respectfully submits the comment on EPA's proposed  more ST

WASHINGTON, Oct. 2 -- The U.S. Environmental Protection Agency has released the following public communication dated Sept. 23, 2024, from the Florida Department of Agriculture and Consumer Services: * * * To: Ms. Jan Matuszko, Director Environmental Fate and Effects Division Office of Pesticide Programs U.S. Environmental Protection Agency (EPA) 1200 Pennsylvania Ave. NW Washington, DC 204600-0001 RE: Draft Insecticide Strategy Framework to Reduce Exposure of Federally Listed Endangered  more ST

WASHINGTON, Oct. 2 -- The U.S. Environmental Protection Agency has released the following public communication dated Sept. 17, 2024, from Groundswell: * * * To: David Widawsky Director, Greenhouse Gas Reduction Fund Environmental Protection Agency 1200 Pennsylvania Avenue NW Washington, DC 20460 (202) 564-4700 * * * Dear Director Widawsky, Subject: GGRF Accomplishment Reporting Information Collection Request (ICR) - Docket ID: EPA-HQ-OA-2023-0393 Thank you for the opportunity to provi more ST

WASHINGTON, Oct. 2 -- The U.S. Environmental Protection Agency has released the following public communication dated Sept. 23, 2024, from the Household and Commercial Products Association: * * * To: Bethany Masten Existing Chemicals Risk Management Division Office of Pollution Prevention and Toxics Environmental Protection Agency 1200 Pennsylvania Ave., NW. Washington, DC 20460-0001 Re: 1-Bromopropane (1-BP); Regulation Under the Toxic Substances Control Act (TSCA) * * * Dear Ms. Baste more ST

WASHINGTON, Oct. 2 -- The U.S. Environmental Protection Agency has released the following public communication dated Sept. 25, 2024, from Landmark Properties Inc., Athens, Georgia: * * * To: Joshua Silver Stratospheric Protection Division Office of Atmospheric Protection 6205A United States Environmental Protection Agency 1200 Pennsylvania Avenue, NW Washington, DC 20460 Re: Comment on EPA's Proposed Phasedown of Hydrofluorocarbons: Restrictions on the Use of HFCs Under the AIM Act in Va more ST

WASHINGTON, Oct. 2 -- The U.S. Environmental Protection Agency has released the following public communication dated Sept. 20, 2024, from MilliporeSigma, St. Louis, Missouri: * * * To: Document Control Office Office of Pollution Prevention and Toxics (OPPT) Environmental Protection Agency 1200 Pennsylvania Ave., NW Washington, DC 20460-0001 Re: 1-Bromopropane (1-BP) Proposed Rulemaking Under Section 6(a) of the Toxic Substances Control Act (TSCA); Proposed Rule (RIN 2070-AK73) * * * Dea more ST

WASHINGTON, Oct. 2 -- The U.S. Environmental Protection Agency has released the following public communication dated Sept. 23, 2024, from Morgan, Lewis and Bockius LLP. Here are excerpts: * * * Re: Proposed Regulation of 1-Bromopropane (1-BP) under the Toxic Substances Control Act (TSCA), 89 Fed. Reg. 65066 (August 8, 2024) Docket (EPA-HQ-OPPT-2020-0471) * * * Dear Ms. Masten: Morgan, Lewis & Bockius LLP appreciates the opportunity to provide comments on the U.S. Environmental Protection A more ST

WASHINGTON, Oct. 2 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Sept. 24, 2024, from Adult Polyglucosan Body Disease Research Foundation, Brooklyn, New York and 23 collaborators: * * * To: Lauren K. Roth Associate Commissioner for Policy Food and Drug Administration Dockets Management Staff (HFA-305 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Docket No. FDA-2021-D-0789 * * * Dear Associate Com more ST

WASHINGTON, Oct. 2 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Sept. 24, 2024, from Andrew Rosenberg, senior advisor at the Continuing Medical Education Coalition: * * * To: Dockets Management Food and Drug Administration 5630 Fishers Lane, Rm 1061 Rockville, MD 2085 RE: Docket No. FDA-2021-D-0789 * * * On behalf of the Continuing Medical Education (CME) Coalition, I am pleased to comment on the re more ST

WASHINGTON, Oct. 2 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication on Sept. 26, 2024, from Indy Hematology Education Inc.: * * * Indy Hematology Education (IHE) is deeply concerned about the absence of meaningful consequences for pharmaceutical companies that fail to meet the proposed diversity thresholds in clinical trials. While we applaud the FDA's effort to issue new guidelines promoting diversity, these guide more ST

WASHINGTON, Oct. 2 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication on Sept. 26, 2024, from MediPaCe: * * * MediPaCe and partners' consolidated comments on FDA Diversity Action Plans draft guidance Docket number: FDA-2021-D-0789 Document ID: FDA-2021-D-0789-0111 Draft guidance: Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies Draft Guidance for I more ST

WASHINGTON, Oct. 2 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Sept. 25, 2024, from MetroHealth System, Cleveland, Ohio: * * * To: Dockets Management Staff (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852. * * * We are writing to provide comments on the draft Diversity Action Plan Guidance (FDA-2021-D-0789) (the "Draft Guidance"). As representatives of The Metro more ST

WASHINGTON, Oct. 2 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Sept. 26, 2024, from Milken Institute: * * * To: Dr. Richard Pazdur Director Oncology Center of Excellence US Food and Drug Administration Beltsville, MD 20705 * Dr. Patrizia Cavazzoni Director Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring, MD 20993 * Dr. Peter Marks Director Center for Bi more ST

WASHINGTON, Oct. 2 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Sept. 25, 2024, from the Multi-Regional Clinical Trials Center of Brigham and Womens Hospital and Harvard, Boston, Massachusetts: * * * Re: Docket No. FDA-2021-D-0789 Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies * * * The Multi-Regional Clinical Trials Center of Brigham  more ST

WASHINGTON, Oct. 2 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Sept. 26, 2024, from Samuel Whitaker, co-founder and CEO at Mural Health Technologies Inc.: * * * To: Dr. Robert Califf Commissioner Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Re: Docket No. FDA-2021-D-0789, Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations more ST

WASHINGTON, Oct. 2 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Sept. 26, 2024, from National Alliance for Hispanic Health: * * * To: Robert M. Califf, MD Commissioner of Food and Drugs Food and Drug Administration Attn. Dockets Management Staff (HFA-305) 5630 Fishers Lane, Rm. 106; Rockville, MD 20852 Docket ID: FDA-2021-D-0789-0111 Diversity Action Plans to Improve Enrollment of Participants from  more ST

WASHINGTON, Oct. 2 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Sept. 26, 2024, from the National Association of Veterans Research and Education Foundations: * * * To: Dockets Management Food and Drug Administration 5630 Fishers Lane, Rm 1061 Rockville, MD 20852 RE: FDA-2021-D-0789 Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies * * * more ST

WASHINGTON, Oct. 2 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Sept. 26, 2024, from the National Comprehensive Cancer Network, Plymouth Meeting, Pennsylvania: * * * To: The Honorable Robert M. Califf, MD Commissioner Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 RE: Draft Guidance: Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Popul more ST

WASHINGTON, Oct. 2 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication on Sept. 26, 2024, from the National LGBTQI+ Cancer Network, Providence, Rhode Island, and 10 collaborators: * * * Subject: Comments on Docket #FDA-2021-D-0789 FDA: Please Urge LGBTQI+ Inclusion in Clinical Trial Diversity Action Plans * * * The National LGBTQI+ Cancer Network and allied undersigned organizations would like to submit the followi more ST

WASHINGTON, Oct. 2 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Sept. 24, 2024, from the National Multiple Sclerosis Society: * * * To: Lola Fashoyin-Aje, MD, MPH and Tamy Kim, PharmD U.S. Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Gu more ST

WASHINGTON, Oct. 2 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Sept. 26, 2024, from the National Organization for Rare Disorders: * * * To: Patrizia Cavazzoni, M.D. Director, Center for Drug Evaluation and Research U.S. Food and Drug Administration 10001 New Hampshire Ave Silver Spring, MD 20903 * Richard Pazdur, M.D. Director, Oncology Center of Excellence (OCE) U.S. Food and Drug Admin more ST

WASHINGTON, Oct. 2 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Sept. 25, 2024, from Novocure Inc.: * * * To: Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 RE: Docket No. FDA-2021-D-0789: Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies; Draft Guidance for Industry more ST

WASHINGTON, Oct. 2 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Sept. 25, 2024, from the Obesity Action Coalition, Tampa, Florida: * * * To: The Honorable Robert M. Califf, MD Commissioner U.S. Food and Drug Administration Department of Health and Human Services 5630 Fishers Lane Rockville, MD 20852 RE: Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in more ST

WASHINGTON, Oct. 2 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication on Sept. 26, 2024, from OurHealth: * * * Re: FDA-2021-D-0789: Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies Guidance for Industry * * * We thank you for the opportunity to comment on this recently proposed United States Food and Drug Administration (FDA) guidance for trial spons more ST

WASHINGTON, Oct. 2 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Sept. 26, 2024, from the Personalized Medicine Coalition: * * * To: The Honorable Robert M. Califf, M.D. Commissioner U.S. Food and Drug Administration 5630 Fishers Lane Rockville, MD 20852 Re: Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies [Docket No. FDA-2021-D-0789]  more ST

WASHINGTON, Oct. 2 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Sept. 26, 2024, from the RWE Alliance: * * * To: Dockets Management Staff (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: Diversity Action Plans To Improve Enrollment of Participants From Underrepresented Populations in Clinical Studies; Draft Guidance for Industry; Availability (Docket No. FDA-2 more ST

WASHINGTON, Oct. 2 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Sept. 25, 2024, from TOTAL Diversity Clinical Trial Management, Dallas, Texas, and two collaborators. Here are excerpts: * * * Comments to FDA on the Draft Guidance on "Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies Guidance for Industry" Dockets Management Staff (HFA-305) more ST

WASHINGTON, Oct. 2 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Sept. 26, 2024, from the University of North Carolina Translational and Clinical Sciences Institute, Chapel Hill: * * * To: US Department of Health and Human Services Food and Drug Administration Dockets Management Staff (HFA-305) 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 RE: Diversity Action Plans to Improve Enrollment of Particip more ST

WASHINGTON, Oct. 2 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication on Sept. 26, 2024, from Walmart Healthcare Research Institute: * * * WHRI Summary for Commenting on FDA Guidance: Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies; Guidance for Industry - Draft Guidance Docket ID FDA-2021-D-0789-0111 * * * INTRODUCTION BACKGROUND Page 7, Line 11 more ST

WASHINGTON, Oct. 2 -- The U.S. Department of Transportation Federal Motor Carrier Safety Administration has released the following public communication dated Sept. 25, 2024, from America Outdoors Association: * * * To: Dockets Operations, U.S. DOT 1200 New Jersey Avenue SE West Building Ground Floor, Room W12-140 Washington, DC 20590-0001 Re: Notice of Review of Guidance, Docket Number FMCSA- 2024-0208 * * * Dear Ms. Winkle: Thank you for providing America Outdoors Association ("AOA") t more ST

WASHINGTON, Oct. 2 -- The Federal Trade Commission has released the following public communication dated Sept. 20, 2024, from professor Julie Dawson and Kiki Hubbard and Paulina Jenney, outreach program managers, all from the University of Wisconsin-Madison Department of Plant and Agroecosystem Sciences; and Philip Howard, professor in the Michigan State University Department of Community Sustainability. Here are excerpts: * * * Docket: FTC-2024-0028 RE: Comments on Serial Acquisitions, Roll more ST

WASHINGTON, Oct. 2 -- The U.S. Department of Labor Occupational Safety and Health Administration has released the following public communication on Sept. 26, 2024, from Charles L. Byrd, chief of safety and occupational health at the Bureau of Reclamation: * * * To: James S. Frederick, Deputy Assistant Secretary of Labor for Occupational Safety and Health Lana Morrison, Director, OSHA Office of Federal Agency Programs Subject: Nomination to serve on the Federal Advisory Council on Occupationa more ST

WASHINGTON, Oct. 2 -- The U.S. Department of Commerce Patent and Trademark Office has released the following public communication dated Sept. 16, 2024, from the Council for Innovation Promotion: * * * To: The Honorable Katherine K. Vidal Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office 600 Dulany Street Alexandria, VA 22314 Re: Docket No. PTO-P-2024-0026, 2024 Guidance Update on Patent Subject Matter Eligibility, Including more ST