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Trains take a toll on wildlife, especially when they pass through the more remote areas of northwestern Montana that still harbors a wide range of species.

Center for Biologics Evaluation and Research Under section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379k-1(a)), beginning no earlier than 24 months after the issuance of this final guidance in which the Food and Drug Administration (FDA or Agency) has specified the electronic format for submitting certain submission types to the Agency, the content of such submission types must be submitted electronically and in the format specified by FDA. This guidance describ...

December 18, 2020 NJT PTC Arrives JIT Written by William C. Vantuono, Editor-in-Chief New Jersey Gov. Phil Murphy announces that NJ Transit has completed all the requirements for the installation, testing, and training of Positive Train Control at the Meadows Maintenance Complex in Kearny, N.J., Dec. 18, 2020. In New Jersey Transit’s epic struggle with implementing Positive Train Control by the Dec. 31, 2020 federal deadline, the agency came i...

consolidation and expedited consideration of two related filings, submitted December 11, 2020, that concern the November 3, 2020, presidential election. These filings have direct implications for the outcome of the election nationwide. The first of the filings concerns the presidential election conducted in the State of Michigan and was assigned Docket Number 20-815 (the “Michigan Petition”). The Michigan Petition seeks emergency declaratory relief avowing that the presidential election res...

consolidation and expedited consideration of two related filings, submitted December 11, 2020, that concern the November 3, 2020, presidential election. These filings have direct implications for the outcome of the election nationwide. The first of the filings concerns the presidential election conducted in the State of Michigan and was assigned Docket Number 20-815 (the “Michigan Petition”). The Michigan Petition seeks emergency declaratory relief avowing that the presidential election res...

December 2020 The purpose of this guidance is to advise food manufacturers of our intent to exercise enforcement discretion for declaration of the name “potassium salt” in the ingredient statement on food labels as an alternative to the common or usual name “potassium chloride.” FDA intends to exercise this enforcement discretion to provide industry with greater flexibility when labeling their food products, including those that are formulated to reduce sodium content. This enforcement...

Center for Drug Evaluation and Research This guidance provides information regarding the process by which generic drug manufacturers and related industry or their representatives can submit to FDA controlled correspondence requesting information related to generic drug development. This guidance also describes the Agency’s process for providing communications related to such correspondence. This guidance replaces the September 2015 guidance for industry Controlled Correspondence Related to Ge...

Center for Devices and Radiological Health This guidance provides performance criteria for magnetic resonance (MR) receive-only coils in support of the Safety and Performance Based Pathway. Under this framework, submitters (you) planning to submit a 510(k) using the Safety and Performance Based Pathway for MR receive-only coils will have the option to use the performance criteria proposed in this guidance to support substantial equivalence, rather than a direct comparison of the performance of ...

Adjoining courthouse. a few days earlier, sobel was here for a bail hearing with his co-defendant and girlfriend ariel potter. he attempted to get an envelope to her by pretending she dropped it, and then handing it to a deputy to give to her. >> im going to try to give it to one of the deputies down there saying she forget it in the courtroom and hopefully it gets into her hands. >> but not only did the deputy apparently leave it behind, its just been discovered by another. >> i think this is a...

20 miles away at sacramento countys downtown jail inmates make their way to and from the adjoining courthouse. a few days earlier, sobel was here for a bail hearing with his co-defendant and girlfriend, ariel potter. he attempted to get an envelope to her by pretending she dropped it and handing it to a deputy to give to her. >> im going to try to give it to one of the deputies down there, saying she forgot it in the courtroom and hopefully it gets into her hands. >> but not only did the deputy ...