Saturday - November 23, 2024
*New Hampshire Editor Tipoffs Newsletter for Friday November 08, 2024 ( 24 items )  

Bureau of Industry & Security Releases Public Communication From 23 Attorneys General
WASHINGTON, Nov. 7 -- The U.S. Department of Commerce Bureau of Industry and Security has released the following public communication dated Oct. 28, 2024, from West Virginia Attorney General Patrick Morrisey with 22 attorneys general: * * * To: The Honorable Elizabeth L.D. Cannon Executive Director Office of Information and Communications Technology and Services Bureau of Industry and Security U.S. Department of Commerce 14th St. and Constitution Ave., NW Washington, DC 20230 Re: Commen  more

FAA Issues Rule Involving Manchester Boston Regional Airport in N.H.
WASHINGTON, Nov. 7 -- The U.S. Department of Transportation Federal Aviation Administration posted a final rule in the Federal Register on Nov. 4 involving the airspace over Manchester Boston Regional Airport in Manchester, New Hampshire. Revocation of Class E Airspace; Manchester, NH AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Final rule; withdrawal. SUMMARY: A final rule was published in the Federal Register on August 19, 2024, revoking Class E surface airspace for Manch  more

FDA Releases Public Communication From AdvaMed Medical Imaging Division
WASHINGTON, Nov. 7 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Nov. 1, 2024, from the AdvaMed Medical Imaging Division: * * * To: James Swink Director, Advisory Panel Program Center for Devices and Radiological Health U.S. Food and Drug Administration 10903 New Hampshire Ave. Silver Spring, MD 20993 Re: Digital Health Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request  more

FDA Releases Public Communication From Alexion AstraZeneca Rare Disease
WASHINGTON, Nov. 7 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Oct. 30, 2024, from Alexion AstraZeneca Rare Disease: * * * To: Janet Goldberg, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002 * To: Cynthia Rothblum-Oviatt, Center for Drug Evaluation and Research, Food and Drug Administration, 10  more

FDA Releases Public Communication From American Academy of Child & Adolescent Psychiatry
WASHINGTON, Nov. 7 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Nov. 4, 2024, from the American Academy of Child and Adolescent Psychiatry: * * * To: Psychopharmacologic Drugs Advisory Committee Center for Drug Evaluation and Research U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 RE: Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the  more

FDA Releases Public Communication From Barth Syndrome Foundation Executive Director Milligan
WASHINGTON, Nov. 7 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Oct. 31, 2024, from Emily Milligan, executive director of the Barth Syndrome Foundation: * * * To: Patrizia Cavazzoni, MD Director, Center for Drug Evaluation and Research * Peter Marks, MD, PhD Director, Center for Biologics Evaluation and Research * U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993  more

FDA Releases Public Communication From Bionews
WASHINGTON, Nov. 7 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Oct. 31, 2024, from Bionews: * * * To: Robert M. Califf, M.D. Commissioner U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, Maryland 20993 * Patrizia Cavazzoni, MD Director of the Center for Drug Evaluation and Research U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, Maryland 209  more

FDA Releases Public Communication From Biotechnology Innovation Organization
WASHINGTON, Nov. 7 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Oct. 31, 2024, from the Biotechnology Innovation Organization: * * * To: U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Re: Docket No. FDA-2024-N-3528; Advancing Rare Disease Therapies Through a Food and Drug Administration Rare Disease Innovation Hub; Public Meeting; Request for Comments * * * Dear   more

FDA Releases Public Communication From Children Tumor Foundation
WASHINGTON, Nov. 7 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Oct. 31, 2024, from the Children's Tumor Foundation, New York: * * * To: Peter Marks, MD, PhD Director, Center for Biologics Evaluation and Research * Patrizia Cavazzoni, MD Director, Center for Drug Evaluation and Research * U.S. Food and Drug Administration 10903 New Hampshire Ave Silver Spring, MD 20993 Re: Docket No. FDA-2024-N-3  more

FDA Releases Public Communication From Cure LGMD2D Research Fund Co-Founder Vasu
WASHINGTON, Nov. 7 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Oct. 31, 2024, from Suji Vasu, co-founder of the Cure LGMD2D Research Fund: * * * To: Patrizia Cavazzoni, MD Director, Center for Drug Evaluation and Research * Peter Marks, MD, PhD Director, Center for Biologics Evaluation and Research * U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Dear Dr. Ca  more

FDA Releases Public Communication From Gillette Children Specialty Healthcare President Joers
WASHINGTON, Nov. 7 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Oct. 31, 2024, from Barbara Joers, president of Gillette Children's Specialty Healthcare, St. Paul, Minnesota: * * * To: Commissioner Robert Califf, MD Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Re: FDA-2024-N-3528 for "Advancing Rare Disease Therapies Through an FDA Rare Disease Innovation Hub; Public  more

FDA Releases Public Communication From Kohler Health Law Founder Kohler
WASHINGTON, Nov. 7 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Oct. 31, 2024, from Mary R. Kohler, founder of Kohler Health Law PC, Thousand Oaks, California: * * * To: Patrizia Cavazzoni, MD Director, Center for Drug Evaluation and Research * Peter Marks, MD, PhD Director, Center for Biologics Evaluation and Research * Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 209  more

FDA Releases Public Communication From N.Y. State Office of Mental Health Chief Medical Officer Smith
WASHINGTON, Nov. 7 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Oct. 29, 2024, from Thomas E. Smith, chief medical officer of the New York State Office of Mental Health: * * * To: Vincent Lo Re III, MD, MSCE, Chair Drug Risk Management Committee * Rajesh Narendran, MD, Chair Psychopharmacologic Drugs Advisory Committee * Center for Drug Evaluation & Research U.S. Food & Drug Administration 10903 N  more

FDA Releases Public Communication From National Alliance on Mental Illness Chief Medical Officer Duckworth
WASHINGTON, Nov. 7 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication on Nov. 5, 2024, from Ken Duckworth, chief medical officer of the National Alliance on Mental Illness, Arlington, Virginia: * * * To: Vincent Lo Re III, MD, MSCE, Chair Drug Risk Management Committee * Rajesh Narendran, MD, Chair Psychopharmacologic Drugs Advisory Committee * Center for Drug Evaluation & Research U.S. Food & Drug Administrat  more

FDA Releases Public Communication From National Alliance on Mental Illness-New Hampshire Director of Public Policy Stevens
WASHINGTON, Nov. 7 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Oct. 28, 2024, from Holly A. Stevens, director of public policy at the National Alliance on Mental Illness-New Hampshire, Concord: * * * To: Vincent Lo Re III, MD, MSCE, Chair Drug Risk Management Committee * Rajesh Narendran, MD, Chair Psychopharmacologic Drugs Advisory Committee * Center for Drug Evaluation & Research U.S. Food & Dru  more

FDA Releases Public Communication From National Organization for Rare Disorders
WASHINGTON, Nov. 7 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Oct. 31, 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 * Peter Marks, M.D. Director, Center for Biologics Evaluation and Research U.S. Food and Drug Administ  more

FDA Releases Public Communication From Sen. Casey
WASHINGTON, Nov. 7 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Oct. 31, 2024, from Sen. Robert Casey Jr., D-Pennsylvania: * * * To: The Honorable Robert Califf, M.D. Commissioner Food and Drug Administration U.S. Department of Health and Human Services 10903 New Hampshire Ave Silver Spring, MD 20993 Dear Commissioner Califf: I write to share my thoughts on the new Rare Disease Innovation Hub and t  more

FDA Releases Public Communication From Soft Bones Founder Fowler
WASHINGTON, Nov. 7 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Oct. 30, 2024, from Deborah Fowler, founder of Soft Bones Inc., Boonton, New Jersey: * * * To: Patrizia Cavazzoni, MD Director, Center for Drug Evaluation and Research * Peter Marks, MD, PhD Director, Center for Biologics Evaluation and Research * U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 De  more

HHS FDA Schedules Nov. 20 Meeting
WASHINGTON, Nov. 7 -- The U.S. Department of Health and Human Services Food and Drug Administration has issued a meeting notice, published in the Federal Register on Nov. 1, 2024. The meeting is scheduled for Nov. 20, 2024. * * * SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is hosting a public meeting to discuss proposed recommendations for the reauthorization of the Over-The-Counter [OTC] Monograph Drug User Fee Program (OMUFA) for fiscal years (FYs) 2026 through 2030.   more

House Ways & Means Committee Issues Report on Chronic Disease Flexible Coverage Act
WASHINGTON, Nov. 7 -- The House Ways and Means Committee issued a report (H.Rpt. 118-680) on the Chronic Disease Flexible Coverage Act (H.R. 3800), which aims to codify Internal Revenue Service guidance relating to treatment of certain services and items for chronic conditions as meeting the preventive care deductible safe harbor for purposes of high deductible health plans in connection with health savings accounts. The report was advanced by Rep. Jason Smith, R-Missouri, on Sept. 17, 2024. He  more

N.H. A.G. Formella: Officer-Involved Shooting Investigation in Plymouth, New Hampshire
CONCORD, New Hampshire, Nov. 8 -- New Hampshire Attorney General John Formella issued the following news release on Nov. 7, 2024: Attorney General John M. Formella announces that members of the Attorney General's Office are responding to a report of an officer-involved shooting that occurred early this morning in Plymouth, New Hampshire. An adult male was fatally shot at the Federal House Inn located at 27 Route 25 in Plymouth. The identity of that individual is being withheld pending notifica  more

Sen. Hassan Issues Statement on Election Results
WASHINGTON, Nov. 8 -- Sen. Maggie Hassan, D-New Hampshire, issued the following statement on Nov. 7, 2024: * * * U.S. Senator Maggie Hassan (D-NH) released the following statement on the election of Donald Trump as the next President of the United States: "Foundational to our democracy is the right for people to make their voices heard at the ballot box, and last night the American people elected Donald Trump. While neither I nor a majority of Granite Staters voted for him, we must now work t  more

Shaheen Statement on Re-Election of Donald Trump
WASHINGTON, Nov. 6 -- Sen. Jeanne Shaheen, D-New Hampshire, issued the following news release: Senator Jeanne Shaheen (D-NH) issued the following statement after it was projected that Donald Trump has been re-elected as President of the United States: "In America, when the people have spoken and every vote has been counted, we declare a winner and there's a peaceful transfer of power. I join the millions of Americans who are deeply disappointed by these results and share their concerns for the  more

U.S. Access Board Releases Public Communication From ReVision Energy
WASHINGTON, Nov. 8 -- The U.S. Access Board has released the following public communication dated Nov. 4, 2024, from ReVision Energy: * * * Comments on Docket No. ATBCB-2024-001 RE: Americans With Disabilities Act and Architectural Barriers Act Accessibility Guidelines; EV Charging Stations; Docket No ATBCB-2024-001, RIN 3014-AA48 * * * Introduction In a Notice of Proposed Rulemaking ("Notice") posted September 3, 2024, the Architectural and Transportation Barriers Compliance Board ("the B  more