*New Hampshire Editor Tipoffs Newsletter for Friday December 13, 2024 ( 11 items ) |
HHS FDA Issues Guidance for Industry Entitled 'Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions'
WASHINGTON, Dec. 13 -- The U.S. Department of Health and Human Services Food and Drug Administration issued a notice of availability in the Federal Register on Dec. 4, 2024, entitled "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions; Guidance for Industry".
Here are excerpts:
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SUMMARY:
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance entitled
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HHS FDA Issues Notice Entitled 'Issuance of Priority Review Voucher; Rare Pediatric Disease Product; KEBILIDI'
WASHINGTON, Dec. 12 -- The U.S. Department of Health and Human Services Food and Drug Administration issued a notice in the Federal Register on Dec. 2, 28206, entitled "Issuance of Priority Review Voucher; Rare Pediatric Disease Product; KEBILIDI".
Here are excerpts:
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SUMMARY:
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) a
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HHS FDA Issues Notice Entitled 'Yong Sheng Jiao; Denial of Hearing; Final Debarment Order'
WASHINGTON, Dec. 12 -- The U.S. Department of Health and Human Services Food and Drug Administration issued a notice in the Federal Register on Dec. 5, 2024, entitled "Yong Sheng Jiao; Denial of Hearing; Final Debarment Order".
Here are excerpts:
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SUMMARY:
The Food and Drug Administration (FDA or Agency) is denying a request for a hearing submitted by Yong Sheng Jiao, also known as Yongsheng Jiao and Wilson Jiao (Jiao), and is issuing an order under the Federal Food, Drug, and Cosmetic
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Kuster Slams GOP's Partisan Defense Bill
WASHINGTON, Dec. 11 -- Rep. Ann Kuster, D-New Hampshire, issued the following news release:
Tonight, Congresswoman Annie Kuster (NH-02) issued the following statement after voting against House Republicans' partisan defense spending bill, the National Defense Authorization Act for Fiscal Year 2025:
"The brave men and women in uniform who sacrifice so much for our country and our freedoms deserve a defense spending bill that puts their well-being and our national security above all else.
"Yet
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N.H. PUC Issues Order Involving Electric, Gas Utilities
CONCORD, New Hampshire, Dec. 13 -- The New Hampshire Public Utilities Commission issued the following electric order (No. 27,087) on Dec. 12, 2024, involving Electric and Gas Utilities:
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2025 Adjustments to the Energy Efficiency Portion of System Benefits Charges and Local Distribution Adjustment Charges
Order Nisi Approving Requests to Modify Energy Efficiency Portion of System Benefit Charges and Local Distribution Adjustment Charges
In this order, the Commission approves on a nisi ba
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N.H. PUC Issues Order Involving Unitil Energy Systems
CONCORD, New Hampshire, Dec. 13 -- The New Hampshire Public Utilities Commission issued the following electric order (No. 27,086) on Dec. 12, 2024, involving Unitil Energy Systems Inc.:
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2024 Default Service Solicitations
Order Approving Solicitations; Establishing Deferral Accounts for Reconciliation-Related Balances; Requiring Re-Filing of Default Service Rates by December 20, 2024; and Requiring Filing of Company Proposal for Expanded Market-Based Procurements by January 31, 2025
Thi
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N.H. PUC Issues Order of Notice Involving Eversource Energy
CONCORD, New Hampshire, Dec. 13 -- The New Hampshire Public Utilities Commission issued the following order (No. DE 24-112) on Dec. 12, 2024, involving Public Service Co. of New Hampshire dba Eversource Energy:
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Petition for Adjustment of Stranded Cost Recovery Charge for Effect on February 1, 2025
COMMENCEMENT OF ADJUDICATIVE PROCEEDING AND NOTICE OF HEARING
On November 20, 2024, Public Service Company of New Hampshire d/b/a Eversource Energy (Eversource or the Company) filed a petitio
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Pappas Statement on House Passage of Defense Authorization Bill
WASHINGTON, Dec. 11 -- Rep. Chris Pappas, D-New Hampshire, issued the following news release:
Today, Congressman Chris Pappas (NH-01) released the below statement following the House vote to pass the National Defense Authorization Act (NDAA) for fiscal year 2025:
"As America continues to confront challenges across the globe, it is essential we reauthorize our national defense. This legislation will provide our dedicated service members with the pay raise they deserve and help save lives by tak
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Pappas's Bipartisan Legislation to Strengthen Security Coordination at Northern Border Included in Defense Authorization Bill
WASHINGTON, Dec. 12 -- Rep. Chris Pappas, D-New Hampshire, issued the following news release:
Congressman Chris Pappas's (NH-01) Securing Our Northern Border Act was included in the National Defense Authorization Act for fiscal year 2025 that the House passed yesterday. This bipartisan legislation would require the Department of Homeland Security (DHS) to establish the Northern Border Mission Center to strengthen implementation and coordination of the Northern Border Strategy, which includes tr
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Sens. Grassley, Hassan Seek to Shine Light on Opioid Makers' Financial Conflicts of Interest
WASHINGTON, Dec. 13 -- Sen. Maggie Hassan, D-New Hampshire, issued the following news release on Dec. 12, 2024:
Sen. Chuck Grassley (R-Iowa), a senior member and former chairman of the Senate Finance Committee, and Sen. Maggie Hassan (D-N.H.) today introduced bipartisan legislation to make public pharmaceutical and device manufacturers' financial relationships with tax-exempt patient advocacy groups. The Open Payments Expansion Act builds on Grassley's 2020 investigative report, which found opi
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Sens. Grassley, Hassan Seek to Shine Light on Opioid Makers' Financial Conflicts of Interest
WASHINGTON, Dec. 13 -- Sen. Maggie Hassan, D-New Hampshire, issued the following news release on Dec. 12, 2024:
Sen. Chuck Grassley (R-Iowa), a senior member and former chairman of the Senate Finance Committee, and Sen. Maggie Hassan (D-N.H.) today introduced bipartisan legislation to make public pharmaceutical and device manufacturers' financial relationships with tax-exempt patient advocacy groups.
The Open Payments Expansion Act builds on Grassley's 2020 investigative report (https://www.f
more
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