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Customer Service Satisfaction Survey Collection
The FDA is seeking public comments on a proposed information collection for customer service satisfaction surveys. Under the Paperwork Reduction Act of 1995, federal agencies must publish notice and allow 60 days for public comment on proposed collections. Comments are due by June 2, 2026.
Determination of Regulatory Review Period for HYMPAVZI Patent Extension
The FDA has determined the regulatory review period for HYMPAVZI, a human biological product, and published this notice as required by law. The determination was made in connection with an application to the USPTO for extension of a patent claiming the product. Interested parties may submit comments or petitions regarding the determination.
Determination of Regulatory Review Period for Purposes of Patent Extension; EMRELIS
The FDA has determined the regulatory review period for EMRELIS, a human biological product, and published this notice as required by law for patent extension purposes. The determination affects the calculation of patent term extension under federal law. Comments on the determination may be submitted until June 2, 2026, and petitions regarding due diligence may be filed until September 30, 2026.
Determination of Regulatory Review Period for Patent Extension; ENFLONSIA
The FDA has determined the regulatory review period for ENFLONSIA, a human biological product, and published this notice as required by 21 CFR Part 60. The notice allows any person to submit comments correcting dates by June 2, 2026, and any interested party may petition FDA by September 30, 2026 regarding due diligence during the review period.
Determination of Regulatory Review Period for VYLOY Patent Extension
The FDA has determined the regulatory review period for VYLOY, a human biological product, for patent extension purposes. The Agency is publishing this notice as required by law due to patent extension applications submitted to the USPTO. Comments regarding date corrections must be submitted by June 2, 2026, and petitions for due diligence determinations may be filed by September 30, 2026.
Determination of Regulatory Review Period for ENCELTO Patent Extension
The FDA has determined the regulatory review period for ENCELTO, a human biological product, and published this notice as required by law for patent extension purposes under 35 U.S.C. 156. The determination opens a public comment period through June 2, 2026, and allows petitions regarding due diligence through September 30, 2026.
ZIIHERA Regulatory Review Period Determination for Patent Extension
The FDA has determined the regulatory review period for ZIIHERA, a human biological product, and is publishing this notice as required by law for patent extension purposes under 21 USC 356. The determination is being forwarded to the USPTO for use in processing the patent extension application. Interested parties may submit comments on the accuracy of published dates or petition FDA regarding due diligence during the review period.
Lakes Parkway Lithium Battery Fire Superfund Site Settlement
EPA Region 4 Southeast proposes an Administrative Settlement Agreement with Corporate Lakes Atlanta, LLC for the Lakes Parkway Lithium Battery Fire Superfund Site in Lawrenceville, Georgia. The settlement addresses EPA's recovery of CERCLA costs for cleanup performed at the site. Public comments on the proposed settlement will be accepted until May 4, 2026.
E-Rate Program Debarment Notice
The FCC Enforcement Bureau has debarred Susan Klein from the federal E-Rate program (schools and libraries universal service support mechanism) and all federal universal service support mechanisms for three years. The debarment commences on April 3, 2026 or when she receives the debarment letter, whichever is first. This action was taken pursuant to 47 CFR 54.8.
Peretz Klein Debarred from E-Rate Program
The FCC Enforcement Bureau has debarred Peretz Klein from the E-Rate program and all federal universal service support mechanisms for three years. The debarment takes effect April 3, 2026 or upon receipt of the debarment letter, whichever is first, pursuant to 47 CFR 54.8. This enforcement action prohibits Klein from participating in these programs through approximately April 2029.
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