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These Authorizations cialis over the counter are applicable can you purchase cialis over the counter on their date of issuance/reissuance. Submit written requests for single copies of an EUA to the Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver can you purchase cialis over the counter Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the Authorization may be sent.

See the SUPPLEMENTARY INFORMATION Start Printed Page 74347section for electronic access to the Authorization. Start Further can you purchase cialis over the counter Info Jennifer J. Ross, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993-0002, 301-796-8510 (this is can you purchase cialis over the counter not a toll free number).

End Further Info End Preamble Start Supplemental Information I. Background Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) allows FDA to strengthen the public health protections can you purchase cialis over the counter against biological, chemical, radiological, or nuclear agent or agents. Among other things, section 564 of the FD&C Act allows FDA to authorize the use of an unapproved medical product or an unapproved use of an approved medical product in certain situations. With this EUA authority, FDA can help ensure that medical countermeasures may be used in emergencies to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by a biological, chemical, radiological, or nuclear agent or agents when there are no adequate, approved, and available alternatives.

Section 564(b)(1) of the FD&C Act provides that, before an EUA may be issued, can you purchase cialis over the counter the Secretary of HHS must declare that circumstances exist justifying the authorization based on one of the following grounds. (1) A determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a biological, chemical, radiological, or nuclear agent or agents. (2) a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to U.S. Military forces, including personnel operating under the authority of title 10 or title 50 of can you purchase cialis over the counter the U.S. Code, of attack with (A) a biological, chemical, radiological, or nuclear agent or agents.

Or (B) an agent or agents that may cause, or are otherwise associated with, an imminently life-threatening and specific risk to U.S. Military forces; [] (3) a determination by the Secretary of HHS that there is a can you purchase cialis over the counter public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of U.S. Citizens living abroad, and that involves a biological, chemical, radiological, or nuclear agent or agents, or a disease or condition that may be attributable to such agent or agents. Or (4) the identification of a material threat by the Secretary of Homeland Security pursuant to section 319F-2 of the Public Health Service (PHS) Act (42 U.S.C. 247d-6b) sufficient to affect national security or the health and security of can you purchase cialis over the counter U.S.

Citizens living abroad. Once the Secretary of HHS has declared that circumstances exist justifying an authorization under section 564 of the FD&C Act, FDA may authorize the emergency use of a drug, device, or biological product if the Agency concludes that the statutory criteria are satisfied. Under section 564(h)(1) of the FD&C Act, FDA is required to publish in can you purchase cialis over the counter the Federal Register a notice of each authorization, and each termination or revocation of an authorization, and an explanation of the reasons for the action. Section 564 of the FD&C Act permits FDA to authorize the introduction into interstate commerce of a drug, device, or biological product intended for use when the Secretary of HHS has declared that circumstances exist justifying the authorization of emergency use. Products appropriate for emergency use may include products and uses that are not approved, cleared, or licensed under section 505, 510(k), 512, or 515 of the FD&C Act (21 U.S.C.

355, 360(k), 360b, or 360e) or section 351 can you purchase cialis over the counter of the PHS Act (42 U.S.C. 262), or conditionally approved under section 571 of the FD&C Act (21 U.S.C. 360ccc). FDA may issue an EUA only if, after consultation with the HHS Assistant Secretary for Preparedness and Response, the Director of the National Institutes of Health, and the Director of the Centers for Disease Control and Prevention (to the extent can you purchase cialis over the counter feasible and appropriate given the applicable circumstances), FDA [] concludes. (1) That an agent referred to in a declaration of emergency or threat can cause a serious or life-threatening disease or condition.

(2) that, based on the totality of scientific evidence available to FDA, including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that (A) the product may be effective in diagnosing, treating, or preventing (i) such disease or condition. Or (ii) a serious or life-threatening disease or condition caused by a product authorized under section 564, approved or cleared under the FD&C Act, or licensed under section 351 of the PHS Act, for diagnosing, treating, or preventing such a disease or condition caused by can you purchase cialis over the counter such an agent. And (B) the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product, taking into consideration the material threat posed by the agent or agents identified in a declaration under section 564(b)(1)(D) of the FD&C Act, if applicable. (3) that there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such disease or condition. (4) in the case of a determination described in can you purchase cialis over the counter section 564(b)(1)(B)(ii), that the request for emergency use is made by the Secretary of Defense.

And (5) that such other criteria as may be prescribed by regulation are satisfied. No other criteria for issuance have been prescribed by regulation under section 564(c)(4) of the FD&C Act. III. Electronic Access An electronic version of this document and the full text of the Authorizations are available on the internet at https://www.fda.gov/​emergency-preparedness-and-response/​mcm-legal-regulatory-and-policy-framework/​emergency-use-authorization. IV.

The Authorizations Having concluded that the criteria for the issuance and, in some cases reissuance, of the following Authorizations under section 564(c) of the FD&C Act are met, FDA has authorized the emergency use of the following products for diagnosing, treating, or preventing erectile dysfunction treatment subject to the terms of each Authorization. The Authorizations in their entirety, including any authorized fact sheets and other written materials, are available on the internet from the FDA web page entitled “Emergency Use Authorization,” available at https://www.fda.gov/​emergency-preparedness-and-response/​mcm-legal-regulatory-and-policy-framework/​emergency-use-authorization. The lists that follow include Authorizations issued, in some cases reissued, from May 16, 2020, through September 14, 2020, and we have included explanations of the reasons for their issuance, as required by section 564(h)(1) of the FD&C Act. FDA is hereby announcing the following Authorizations for molecular diagnostic Start Printed Page 74348and antigen tests for erectile dysfunction treatment, excluding multianalyte tests: [] Color Genomics, Inc.'s Color erectile dysfunction LAMP Diagnostic Assay, issued May 18, 2020, and reissued July 24, 2020. Quidel Corp.'s Lyra Direct erectile dysfunction Assay, issued May 18, 2020.

P23 Labs, LLC's P23 Labs TaqPath SARSd-CoV-2 Assay, issued May 21, 2020, and reissued July 10, 2020. SEASUN BIOMATERIALS, Inc.'s AQ-TOP erectile dysfunction treatment Rapid Detection Kit, issued May 21, 2020. SolGent Co., Ltd.'s DiaPlexQ Novel erectile dysfunction (2019-nCoV) Detection Kit, issued May 21, 2020. BioCore Co., Ltd.'s BioCore 2019-nCoV Real Time PCR Kit, issued May 21, 2020. Exact Sciences Laboratories' SARSd-CoV-2 (N gene detection) Test, issued May 22, 2020, and reissued August 3, 2020.

Dba SpectronRx's Hymon SARSd-CoV-2 Test Kit, issued May 22, 2020. PrivaPath Diagnostics, Inc.'s LetsGetChecked erectile dysfunction (erectile dysfunction treatment) Test, issued May 28, 2020, and reissued August 14, 2020. Gravity Diagnostics, LLC's Gravity Diagnostics erectile dysfunction treatment Assay, issued June 1, 2020. Phosphorus Diagnostics LLC's Phosphorus erectile dysfunction treatment RT-qPCR Test, issued June 4, 2020. Genetron Health (Beijing) Co., Ltd.'s Genetron SARSd-CoV-2 RNA Test, issued June 5, 2020.

Euroimmun US Inc.'s EURORealTime SARSd-CoV-2, issued June 8, 2020. ChromaCode Inc.'s HDPCR SARSd-CoV-2 Assay, issued June 9, 2020. Illumina, Inc.'s Illumina erectile dysfunction treatmentSeq Test, issued June 9, 2020. Tide Laboratories, LLC's DTPM erectile dysfunction treatment RT-PCR Test, issued June 10, 2020. TBG Biotechnology Corp.'s ExProbe SARSd-CoV-2 Testing Kit, issued June 10, 2020.

Cue Health, Inc.'s Cue erectile dysfunction treatment Test, issued June 10, 2020. RTA Laboratories Biological Products Pharmaceutical and Machinery Industry's Diagnovital SARSd-CoV-2 Real-Time PCR Kit, issued June 12, 2020. Kaiser Permanente Mid-Atlantic States's KPMAS erectile dysfunction treatment Test, issued June 13, 2020, and reissued September 9, 2020. Applied BioCode, Inc.'s BioCode SARSd-CoV-2 Assay, issued June 15, 2020. The Ohio State University Wexner Medical Center's OSUWMC erectile dysfunction treatment RT-PCR test, issued June 17, 2020.

Omnipathology Solutions Medical Corp.'s Omni erectile dysfunction treatment Assay by RT-PCR, issued June 17, 2020. Jiangsu Bioperfectus Technologies Co., Ltd.'s erectile dysfunction treatment erectile dysfunction Real Time PCR Kit, issued June 18, 2020. 3B Blackbio Biotech India Ltd., a subsidiary of Kilpest India Ltd.'s TRUPCR SARSd-CoV-2 Kit, issued June 18, 2020. HealthQuest Esoterics's HealthQuest Esoterics TaqPath SARSd-CoV-2 Assay, issued June 23, 2020. University of Alabama at Birmingham Fungal Reference Lab's FRL SARS CoV-2 Test, issued June 23, 2020.

Gencurix, Inc.'s GenePro SARSd-CoV-2 Test, issued June 23, 2020. University of Texas MD Anderson Cancer Center, Molecular Diagnostics Laboratory's MD Anderson High-throughput SARSd-CoV-2 RT-PCR Assay, issued June 24, 2020. Diagnostic Solutions Laboratory, LLC's DSL erectile dysfunction treatment Assay, issued June 25, 2020. PreciGenome LLC's FastPlex Triplex SARSd-CoV-2 detection kit (RT-Digital PCR), issued June 25, 2020. PlexBio Co., Ltd.'s IntelliPlex SARSd-CoV-2 Detection Kit, issued June 25, 2020.

Inform Diagnostics, Inc.'s Inform Diagnostics SARSd-CoV-2 RT-PCR Assay, issued June 26, 2020. Acupath Laboratories, Inc.'s Acupath erectile dysfunction treatment Real-Time (RT-PCR) Assay, issued June 29, 2020. LifeHope Labs' LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic Panel, issued June 29, 2020. Psomagen, Inc.'s Psoma erectile dysfunction treatment RT Test, issued June 30, 2020. TNS Co., Ltd.'s (Bio TNS) erectile dysfunction treatment RT-PCR Peptide Nucleic Acid (PNA) kit, issued June 30, 2020.

The Kroger Co.'s Kroger Health erectile dysfunction treatment Test Home Collection Kit, issued June 30, 2020. CENTOGENE US, LLC's CentoFast-SARSd-CoV-2 RT-PCR Assay, issued July 1, 2020. Becton, Dickinson and Co.'s BD Veritor System for Rapid Detection of SARSd-CoV-2, issued July 2, 2020. Laboratorio Clinico Toledo's Laboratorio Clinico Toledo SARSd-CoV-2 Assay, issued July 6, 2020. Gene By Gene's Gene By Gene SARSd-CoV-2 Detection Test, issued July 7, 2020.

Access Bio, Inc.'s CareStart erectile dysfunction treatment MDx RT-PCR, issued July 7, 2020. Enzo Life Sciences, Inc.'s AMPIPROBE SARSd-CoV-2 Test System, issued July 7, 2020. Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and Harvard's CRSP SARSd-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay, issued July 8, 2020. BioSewoom, Inc.'s Real-Q 2019-nCoV Detection Kit, issued July 9, 2020. UCSF Health Clinical Laboratories, UCSF Clinical Labs at China Basin's SARSd-CoV-2 RNA DETECTR Assay, issued July 9, 2020.

Boston Medical Center's BMC-CReM erectile dysfunction treatment Test, issued July 10, 2020. KogeneBiotech Co., Ltd.'s PowerChek 2019-nCoV Real-time PCR Kit, issued July 13, 2020. Trax Management Services Inc.'s PhoenixDx SARSd-CoV-2 Multiplex, issued July 13, 2020. Compass Laboratory Services, LLC's Compass Laboratory Services SARSd-CoV2 Assay, issued July 13, 2020. Quest Diagnostics Infectious Disease, Inc.'s Quest Diagnostics PF SARSd-CoV-2 Assay, issued July 15, 2020, and reissued August 21, 2020.

Quest Diagnostics Infectious Disease, Inc.'s Quest Diagnostics RC SARSd-CoV-2 Assay, issued July 15, 2020, and reissued August 21, 2020. Quest Diagnostics Infectious Disease, Inc.'s Quest Diagnostics HA SARSd-CoV-2 Assay, issued July 15, 2020, and reissued August 21, 2020. Boston Heart Diagnostics' Boston Heart erectile dysfunction treatment RT-PCR Test, issued July 16, 2020. Access Genetics, LLC's OraRisk erectile dysfunction treatment RT-PCR, issued July 17, 2020. DiaCarta, Inc.'s Quanticialis SARSd-CoV-2 Multiplex Test Kit, issued July 21, 2020.

Helix OpCo LLC's (dba Helix's) Helix erectile dysfunction treatment Test, issued July 23, 2020. Jiangsu CoWin Biotech Co., Ltd.'s Novel erectile dysfunction (SARSd-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluorescence Probing), issued July 24, 2020. LabCorp's erectile dysfunction treatment RT-PCR Test, reissued July 24, 2020 (original issuance March 16, 2020). Eli Lilly and Co.'s Lilly SARSd-CoV-2 Assay, issued July 27, 2020;Start Printed Page 74349 Sandia National Laboratories' SNL-NM 2019 nCoV Real-Time RT-PCR Diagnostic Assay, issued July 27, 2020. Clinical Reference Laboratory, Inc.'s CRL Rapid Response, issued July 30, 2020.

University of California San Diego Health's UCSD RC SARSd-CoV-2 Assay, issued July 31, 2020. Xiamen Zeesan Biotech Co., Ltd.'s SARSd-CoV-2 Test Kit (Real-time PCR), issued July 31, 2020. ISPM Labs, LLC dba Capstone Healthcare's Genus SARSd-CoV-2 Assay, issued August 3, 2020. Poplar Healthcare's Poplar SARSd-CoV-2 TMA Pooling assay, issued August 3, 2020. Cleveland Clinic Robert J.

Tomsich Pathology and Laboratory Medicine Institute's Cleveland Clinic SARSd-CoV-2 Assay, issued August 3, 2020. Ethos Laboratories' Ethos Laboratories SARSd-CoV-2 MALDI-TOF Assay, issued August 3, 2020. Wren Laboratories LLC's Wren Laboratories erectile dysfunction treatment PCR Test, issued August 3, 2020. Vela Operations Singapore Pte Ltd.'s ViroKey SARSd-CoV-2 RT-PCR Test, issued August 5, 2020. Helix OpCo LLC's (dba Helix) Helix erectile dysfunction treatment NGS Test, issued August 6, 2020.

George Washington University Public Health Laboratory's GWU SARSd-CoV-2 RT-PCR Test, issued August 7, 2020. Quest Diagnostics Infectious Disease, Inc.'s SARSd-CoV-2 RNA, Qualitative Real-Time RT-PCR, reissued August 7, 2020 (original issuance March 17, 2020). Alpha Genomix Laboratories' Alpha Genomix TaqPath SARSd-CoV-2 Combo Assay, issued August 10, 2020. Solaris Diagnostics' Solaris Multiplex SARSd-CoV-2 Assay, issued August 10, 2020. Biomeme, Inc.'s Biomeme SARSd-CoV-2 Real-Time RT-PCR Test, issued August 11, 2020.

LumiraDx UK Ltd.'s LumiraDx erectile dysfunction RNA STAR, issued August 11, 2020. Pro-Lab Diagnostics' Pro-AmpRT SARSd-CoV-2 Test, issued August 13, 2020. Yale School of Public Health, Department of Epidemiology of Microbial Diseases' SalivaDirect, issued August 15, 2020, and reissued August 28, 2020. ZhuHai Sinochips Bioscience Co., Ltd.'s erectile dysfunction treatment Nucleic Acid RT-PCR Test Kit, issued August 17, 2020. LumiraDx UK Ltd.'s LumiraDx SARSd-CoV-2 Ag Test, issued August 18, 2020.

Assurance Scientific Laboratories' Assurance SARSd-CoV-2 Panel, reissued August 19, 2020 (original issuance May 15, 2020). Guardant Health, Inc.'s Guardant-19, issued August 21, 2020. DxTerity Diagnostics, Inc.'s DxTerity SARSd-CoV-2 RT-PCR Test, issued August 21, 2020. Texas Department of State Health Services, Laboratory Services Section's Texas Department of State Health Services SARSd-CoV-2 Assay, issued August 21, 2020. Fluidigm Corp.'s Advanta Dx SARSd-CoV-2 RT-PCR Assay, issued August 25, 2020.

QDx Pathology Services' QDX SARSd-CoV-2 Assay, issued August 25, 2020. Cuur Diagnostics' Cuur Diagnostics SARSd-CoV-2 Molecular Assay, issued August 26, 2020. Abbott Diagnostics Scarborough, Inc.'s BinaxNOW erectile dysfunction treatment Ag Card, issued August 26, 2020. Patients Choice Laboratories, LLC's PCL SARSd-CoV-2 Real-Time RT-PCR Assay, issued August 28, 2020. DxTerity Diagnostics, Inc.'s DxTerity SARSd-CoV-2 RT PCR CE Test, issued August 28, 2020.

T2 Biosystems, Inc.'s T2SARSd-CoV-2 Panel, issued August 31, 2020. MiraDx's MiraDx SARSd-CoV-2 RT-PCR assay, issued August 31, 2020. Mammoth Biosciences, Inc.'s SARSd-CoV-2 DETECTR Reagent Kit, issued August 31, 2020. BayCare Laboratories, LLC's BayCare SARSd-CoV-2 RT PCR Assay, issued August 31, 2020. Detectachem Inc.'s MobileDetect Bio BCC19 (MD-Bio BCC19) Test Kit, issued September 1, 2020.

OPTOLANE Technologies, Inc.'s Kaira 2019-nCoV Detection Kit, issued September 1, 2020. Bioeksen R&D Technologies Ltd.'s Bio-Speedy Direct RT-qPCR SARSd-CoV-2, issued September 2, 2020. BillionToOne, Inc.'s qSanger-erectile dysfunction treatment Assay, issued September 4, 2020. Verily Life Sciences' Verily erectile dysfunction treatment RT-PCR Test, issued September 8, 2020. And Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.'s Wantai SARSd-CoV-2 RT-PCR Kit, issued September 9, 2020.

FDA is hereby announcing the following Authorizations for serology tests: [] Healgen Scientific LLC's erectile dysfunction treatment IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma), issued May 29, 2020. Siemens Healthcare Diagnostics Inc.'s Atellica IM SARSd-CoV-2 Total (COV2T), issued May 29, 2020. Siemens Healthcare Diagnostics Inc.'s ADVIA Centaur SARSd-CoV-2 Total (COV2T), issued May 29, 2020. Hangzhou Biotest Biotech Co., Ltd.'s RightSign erectile dysfunction treatment IgG/IgM Rapid Test Cassette, issued June 4, 2020. Vibrant America Clinical Labs' Vibrant erectile dysfunction treatment Ab Assay, issued June 4, 2020.

Siemens Healthcare Diagnostics Inc.'s Dimension Vista SARSd-CoV-2 Total antibody assay (COV2T), issued June 8, 2020. Siemens Healthcare Diagnostics Inc.'s Dimension EXL SARSd-CoV-2 Total antibody assay (CV2T), issued June 8, 2020. InBios International, Inc.'s SCoV-2 Detect IgG ELISA [enzyme-linked immunosorbent assay], issued June 10, 2020. Cellex Inc.'s qSARSd-CoV-2 IgG/IgM Rapid Test, reissued June 12, 2020 (original issuance April 1, 2020). Emory Medical Laboratories' SARSd-CoV-2 RBD IgG test, issued June 15, 2020.

Biohit Healthcare (Hefei) Co. Ltd.'s Biohit SARSd-CoV-2 IgM/IgG Antibody Test Kit, issued June 18, 2020. Hangzhou Laihe Biotech Co., Ltd.'s LYHER Novel erectile dysfunction (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold), issued June 19, 2020. Babson Diagnostics, Inc.'s Babson Diagnostics aC19G1, issued June 23, 2020. Beckman Coulter, Inc.'s Access SARSd-CoV-2 IgG, issued June 26, 2020.

InBios International, Inc.'s SCoV-2 Detect IgM ELISA, issued June 30, 2020. Assure Tech.'s (Hangzhou Co., Ltd.) Assure erectile dysfunction treatment IgG/IgM Rapid Test Device, issued July 6, 2020. Diazyme Laboratories, Inc.'s Diazyme DZ-Lite SARSd-CoV-2 IgG CLIA Kit, issued July 8, 2020. Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.'s WANTAI SARSd-CoV-2 Ab Rapid Test, July 10, 2020;Start Printed Page 74350 Salofa Oy's Sienna-Clarity COVIBLOCK erectile dysfunction treatment IgG/IgM Rapid Test Cassette, issued July 13, 2020. Luminex Corp.'s xMAP SARSd-CoV-2 Multi-Antigen IgG Assay, issued July 16, 2020.

Megna Health, Inc.'s Rapid erectile dysfunction treatment IgM/IgG Combo Test Kit, issued July 17, 2020. Access Bio, Inc.'s CareStart erectile dysfunction treatment IgM/IgG, issued July 24, 2020. Xiamen Biotime Biotechnology Co., Ltd.'s BIOTIME SARSd-CoV-2 IgG/IgM Rapid Qualitative Test, issued July 24, 2020. Siemens Healthcare Diagnostics Inc.'s ADVIA Centaur SARSd-CoV-2 IgG (COV2G), issued July 31, 2020. Siemens Healthcare Diagnostics Inc.'s Atellica IM SARSd-CoV-2 IgG (COV2G), issued July 31, 2020.

Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.'s WANTAI SARSd-CoV-2 Ab ELISA, issued August 5, 2020. BioMérieux SA's VIDAS SARSd-CoV-2 IgM, issued August 6, 2020. BioMérieux SA's VIDAS SARSd-CoV-2 IgG, issued August 6, 2020. Diazyme Laboratories, Inc.'s Diazyme DZ-Lite SARSd-CoV-2 IgM CLIA Kit, issued August 17, 2020. BioCheck, Inc.'s BioCheck SARSd-CoV-2 IgG and IgM Combo Test, issued August 17, 2020.

Biocan Diagnostics Inc.'s Tell Me Fast Novel erectile dysfunction (erectile dysfunction treatment) IgG/IgM Antibody Test, issued August 25, 2020. TBG Biotechnology Corp.'s TBG SARSd-CoV-2 IgG/IgM Rapid Test Kit, issued August 31, 2020. University of Arizona Genetics Core for Clinical Services' erectile dysfunction treatment ELISA pan-Ig Antibody Test, issued August 31, 2020. Sugentech, Inc.'s SGTi-flex erectile dysfunction treatment IgG, issued September 3, 2020. BioCheck, Inc.'s BioCheck erectile dysfunction IgG Antibody Test Kit, issued September 9, 2020.

BioCheck, Inc.'s BioCheck erectile dysfunction IgM Antibody Test Kit, issued September 9, 2020. And Shenzhen New Industries Biomedical Engineering Co., Ltd.'s MAGLUMI 2019-nCoV IgM/IgG, issued September 14, 2020. FDA is hereby announcing the following Authorizations for multianalyte in vitro diagnostics: [] Centers for Disease Control and Prevention's Influenza erectile dysfunction (Flu SC2) Multiplex Assay, issued July 2, 2020. Roche Molecular Systems, Inc.'s cobas erectile dysfunction &. Influenza A/B, issued September 3, 2020.

And Roche Molecular Systems, Inc.'s cobas erectile dysfunction &. Influenza A/B Nucleic Acid Test for use on the cobas Liat System, issued September 14, 2020. FDA is hereby announcing the following Authorizations for personal respiratory protective devices: [] FDA is hereby announcing the following Authorizations for other medical devices. Baxter Healthcare Corp.'s Prismaflex ST Set, issued May 20, 2020; [] STERIS Corp.'s AMSCO Medium Steam Sterilizers + the STERIS STEAM Decon Cycle, issued May 21, 2020; [] Certain Gowns and Other Apparel, issued May 22, 2020; [] CLEW Medical Ltd.'s CLEWICU System, issued May 26, 2020; [] Abiomed, Inc.'s Impella RP System, issued May 29, 2020; [] Start Printed Page 74351 Roche Diagnostics' Elecsys IL-6, issued on June 2, 2020; [] Battelle Memorial Institute's Battelle CCDS Critical Care Decontamination System (“Batelle Decontamination System”), reissued June 6, 2020 [] (original issuance March 29, 2020). STERIS Corp.'s STERIS Sterilization System, reissued June 6, 2020 [] (original issuance April 9, 2020).

Stryker Instruments' STERIZONE VP4 N95 Respirator Decontamination Cycle, reissued June 6, 2020 [] (original issuance on April 14, 2020). Advanced Sterilization Products, Inc.'s (ASP) STERRAD 100S, NX, and 100NX Sterilization Systems (“ASP STERRAD Sterilization Systems”), reissued June 6, 2020 [] (original issuance April 11, 2020). Stryker Sustainability Solutions' (SSS) SSS VHP N95 Respirator Decontamination System, issued May 27, 2020, reissued June 6, 2020; [] Sterilucent, Inc.'s Sterilucent HC 80TT Hydrogen Peroxide Sterilizer (“Sterilucent Sterilization System”), reissued June 6, 2020 [] (original issuance April 20, 2020). Duke University Health System's Duke Decontamination System for Decontamination and Reuse of N95 Respirators with Hydrogen Peroxide Vapor (“Duke Decontamination System”), reissued June 6, 2020 [] (original issuance May 7, 2020). Technical Safety Services LLC's 20-CS Decontamination System, issued June 13, 2020; [] Oceanetics, Inc.'s Negative-pressure Respiratory System with Advanced Ventilation Return (“NRSAVR-100”), issued June 13, 2020; [] US Army and MHS's erectile dysfunction treatment Airway Management Isolation Chamber (CAMIC), issued May 19, 2020 and reissued to US Army Medical Research Development Command June 22, 2020; [] Start Printed Page 74352 electroCore, Inc.'s gammaCore Sapphire CV, issued July 10, 2020; [] Michigan State University Animal Care Program's MSU Decontamination System, issued July 24, 2020; [] IkonX, Inc.'s Airway Dome, issued July 24, 2020; [] Abiomed, Inc.'s Impella Left Ventricular (LV) Support Systems, issued August 3, 2020; [] Baxter Healthcare Corp.'s Prismaflex HF20 Set, issued August 10, 2020; [] NovaSterilis, Inc.'s Nova2200 using the NovaClean decontamination process for decontaminating compatible N95 respirators, issued August 20, 2020; [] and Color Genomics, Inc.'s Color erectile dysfunction treatment Self-Swab Collection Kit, issued August 31, 2020.[] Start Signature Dated.

November 13, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. End Signature End Supplemental Information [FR Doc. 2020-25603 Filed 11-19-20.

8:45 am]BILLING CODE 4164-01-PBy Kelsie George Rural residents across the U.S. May be at higher risk for severe illness from erectile dysfunction treatment due to the aging population, higher rates of underlying chronic disease, and higher likelihood of having a disability. Combined with limited health care infrastructure and greater travel times to access in-person care, these challenges limit access to critical health care for the approximately 20% of Americans that live in rural communities. Today, Nov. 19, is National Rural Health Day, an annual celebration of rural communities and their success in addressing their unique challenges in accessing and delivering health care services.

This day is an opportunity to recognize the positive things that are taking place in rural health. For example, amid the erectile dysfunction treatment cialis, states are ensuring access to quality health care for rural residents through several policy strategies—such as bolstering telehealth services and supporting rural hospitals and health facilities. Bolstering Telehealth Access and Coverage Patients and providers are seeking opportunities to access and deliver health care services during the erectile dysfunction treatment public health crisis. Bolstering telehealth access and coverage is one way states are enhancing access to care, especially for large rural populations. On the payment front.

Colorado required Medicaid reimbursement for telehealth services at the same rate as in-person services for Rural Health Clinics, federal Indian Health Service facilities, and Federally Qualified Health Centers. Florida appropriated $4 million to implement a pilot project to provide behavioral telehealth services to children in public schools, with a focus on rural communities. Michigan expanded originating sites (the patient’s location during a telehealth visit) to include in-home and in-school settings. In part to ensure access to telehealth services, Mississippi authorized grant funding for the erectile dysfunction treatment Broadband Provider Grant Program Fund to expand rural broadband capacity and facilitate telemedicine, remote work and distance learning. Supporting Rural Hospitals and Health Facilities Health care infrastructure presents a challenge for rural communities given the potentially long distances to health facilities, the large geographic areas health facilities serve, and the shortage of health professionals in rural regions.

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COMING IN April 2021 - In the NYS Budget enacted in April 2020, the pharmacy benefit cialis 10mg price was "carved out" of "mainstream" Medicaid managed care plans. That means that members of managed care plans will access their drugs outside their plan, unlike the rest of their medical care, which is accessed from in-network providers. How Prescription Drugs are Obtained through Managed Care plans No - Until April 2020 HOW DO MANAGED CARE PLANS DEFINE THE PHARMACY BENEFIT FOR CONSUMERS?. The Medicaid pharmacy benefit includes all FDA approved prescription drugs, as well as some over-the-counter drugs and medical supplies cialis 10mg price.

Under Medicaid managed care. Plan formularies will be comparable to but not the same as the Medicaid formulary. Managed care plans are cialis 10mg price required to have drug formularies that are “comparable” to the Medicaid fee for service formulary. Plan formularies do not have to include all drugs covered listed on the fee for service formulary, but they must include generic or therapeutic equivalents of all Medicaid covered drugs.

The Pharmacy Benefit will vary by plan. Each plan will have its own formulary and drug coverage policies like prior authorization and cialis 10mg price step therapy. Pharmacy networks can also differ from plan to plan. Prescriber Prevails applies in certain drug classes.

Prescriber prevails applys to medically cialis 10mg price necessary precription drugs in the following classes. atypical antipsychotics, anti-depressants, anti-retrovirals, anti-rejection, seizure, epilepsy, endocrine, hemotologic and immunologic therapeutics. Prescribers will need to demonstrate reasonable profession judgment and supply plans witht requested information and/or clinical documentation. Pharmacy Benefit Information Website -- http://mmcdruginformation.nysdoh.suny.edu/-- This website provides very helpful information on a plan cialis 10mg price by plan basis regarding pharmacy networks and drug formularies.

The Department of Health plans to build capacity for interactive searches allowing for comparison of coverage across plans in the near future. Standardized Prior Autorization (PA) Form -- The Department of Health worked with managed care plans, provider organizations and other state agencies to develop a standard prior authorization form for the pharmacy benefit in Medicaid managed care. The form will be cialis 10mg price posted on the Pharmacy Information Website in July of 2013. Mail Order Drugs -- Medicaid managed care members can obtain mail order/specialty drugs at any retail network pharmacy, as long as that retail network pharmacy agrees to a price that is comparable to the mail order/specialty pharmacy price.

CAN CONSUMERS SWITCH PLANS IN ORDER TO GAIN ACCESS TO DRUGS?. Changing plans is often an effective strategy for consumers eligible for both Medicaid and Medicare (dual eligibles) who receive their pharmacy service through Medicare Part D, because cialis 10mg price dual eligibles are allowed to switch plans at any time. Medicaid consumers will have this option only in the limited circumstances during the first year of enrollment in managed care. Medicaid managed care enrollees can only leave and join another plan within the first 90 days of joining a health plan.

After the 90 days has cialis 10mg price expired, enrollees are “locked in” to the plan for the rest of the year. Consumers can switch plans during the “lock in” period only for good cause. The pharmacy benefit changes are not considered good cause. After the first 12 months of enrollment, Medicaid managed care enrollees cialis 10mg price can switch plans at any time.

STEPS CONSUMERS CAN TAKE WHEN A MANAGED CARE PLAM DENIES ACCESS TO A NECESSARY DRUG As a first step, consumers should try to work with their providers to satisfy plan requirements for prior authorization or step therapy or any other utilization control requirements. If the plan still denies access, consumers can pursue review processes specific to managed care while at the same time pursuing a fair hearing. All plans are required to cialis 10mg price maintain an internal and external review process for complaints and appeals of service denials. Some plans may develop special procedures for drug denials.

Information on these procedures should be provided in member handbooks. Beginning April 1, 2018, Medicaid managed care enrollees whose plan denies prior approval of a prescription drug, or discontinues a drug that had been approved, will receive an Initial Adverse Determination notice from the cialis 10mg price plan - See Model Denial IAD Notice and IAD Notice to Reduce, Suspend or Stop Services The enrollee must first request an internal Plan Appeal and wait for the Plan's decision. An adverse decision is called a 'FInal Adverse Determination" or FAD. See model Denial FAD Notice and FAD Notice to Reduce, Suspend or Stop Services.

The enroll has the right to request a cialis 10mg price fair hearing to appeal an FAD. The enrollee may only request a fair hearing BEFORE receiving the FAD if the plan fails to send the FAD in the required time limit, which is 30 calendar days in standard appeals, and 72 hours in expedited appeals. The plan may extend the time to decide both standard and expedited appeals by up to 14 days if more information is needed and it is in the enrollee's interest. AID CONTINUING -- If an enrollee requests a Plan Appeal and then a fair hearing because access to a drug has been reduced or terminated, the enrollee has the right to aid cialis 10mg price continuing (continued access to the drug in question) while waiting for the Plan Appeal and then the fair hearing.

The enrollee must request the Plan Appeal and then the Fair Hearing before the effective date of the IAD and FAD notices, which is a very short time - only 10 days including mailing time. See more about the changes in Managed Care appeals here. Even though cialis 10mg price that article is focused on Managed Long Term Care, the new appeals requirements also apply to Mainstream Medicaid managed care. Enrollees who are in the first 90 days of enrollment, or past the first 12 months of enrollment also have the option of switching plans to improve access to their medications.

Consumers who experience problems with access to prescription drugs should always file a complaint with the State Department of Health’s Managed Care Hotline, number listed below. ACCESSING MEDICAID'S PHARMACY BENEFIT IN FEE FOR SERVICE MEDICAID For those Medicaid recipients who are not yet in a Medicaid Managed Care program, and who do not have Medicare Part D, the Medicaid Pharmacy program covers most of their prescription drugs and select non-prescription drugs cialis 10mg price and medical supplies for Family Health Plus enrollees. Certain drugs/drug categories require the prescribers to obtain prior authorization. These include brand name drugs that have a generic alternative under New York's mandatory generic drug program or prescribed drugs that are not on New York's preferred drug list.

The full cialis 10mg price Medicaid formulary can be searched on the eMedNY website. Even in fee for service Medicaid, prescribers must obtain prior authorization before prescribing non-preferred drugs unless otherwise indicated. Prior authorization is required for original prescriptions, not refills. A prior authorization is effective for the original dispensing and up to five refills cialis 10mg price of that prescription within the next six months.

Click here for more information on NY's prior authorization process. The New York State Board of Pharmacy publishes an annual list of the 150 most frequently prescribed drugs, in the most common quantities. The State Department of Health collects retail price information on these cialis 10mg price drugs from pharmacies that participate in the Medicaid program. Click here to search for a specific drug from the most frequently prescribed drug list and this site can also provide you with the locations of pharmacies that provide this drug as well as their costs.

Click here to view New York State Medicaid’s Pharmacy Provider Manual. WHO YOU CAN CALL FOR HELP cialis 10mg price Community Health Advocates Hotline. 1-888-614-5400 NY State Department of Health's Managed Care Hotline. 1-800-206-8125 (Mon.

- Fri cialis 10mg price. 8:30 am - 4:30 pm) NY State Department of Insurance. 1-800-400-8882 NY State Attorney General's Health Care Bureau. 1-800-771-7755Haitian individuals and immigrants from some other countries who have applied for Temporary Protected Status (TPS) may be eligible for public health insurance in cialis 10mg price New York State.

2019 updates - The Trump administration has taken steps to end TPS status. Two courts have temporarily enjoined the termination of TPS, one in New York State in April 2019 and one in California in October 2018. The California cialis 10mg price case was argued in an appeals court on August 14, 2019, which the LA Times reported looked likely to uphold the federal action ending TPS. See US Immigration Website on TPS - General TPS website with links to status in all countries, including HAITI.

See also Pew Research March 2019 article. Courts Block Changes in Public charge rule- See updates on the Public cialis 10mg price Charge rule here, blocked by federal court injunctions in October 2019. Read more about this change in public charge rules here. What is Temporary Protected Status?.

TPS is a temporary immigration status granted to eligible individuals of a certain country designated by the Department of Homeland cialis 10mg price Security because serious temporary conditions in that country, such as armed conflict or environmental disaster, prevents people from that country to return safely. On January 21, 2010 the United States determined that individuals from Haiti warranted TPS because of the devastating earthquake that occurred there on January 12. TPS gives undocumented Haitian residents, who were living in the U.S. On January 12, 2010, protection from forcible deportation and allows them to work cialis 10mg price legally.

It is important to note that the U.S. Grants TPS to individuals from other countries, as well, including individuals from El Salvador, Honduras, Nicaragua, Somalia and Sudan. TPS and Public Health Insurance TPS applicants residing in New York are eligible for Medicaid and Family Health Plus as long as they also meet the income cialis 10mg price requirements for these programs. In New York, applicants for TPS are considered PRUCOL immigrants (Permanently Residing Under Color of Law) for purposes of medical assistance eligibility and thus meet the immigration status requirements for Medicaid, Family Health Plus, and the Family Planning Benefit Program.

Nearly all children in New York remain eligible for Child Health Plus including TPS applicants and children who lack immigration status. For more information on immigrant eligibility for public health insurance in New York see 08 GIS MA/009 and cialis 10mg price the attached chart. Where to Apply What to BringIndividuals who have applied for TPS will need to bring several documents to prove their eligibility for public health insurance. Individuals will need to bring.

1) Proof of identity cialis 10mg price. 2) Proof of residence in New York. 3) Proof of income. 4) Proof cialis 10mg price of application for TPS.

5) Proof that U.S. Citizenship and Immigration Services (USCIS) has received the application for TPS. Free Communication cialis 10mg price Assistance All applicants for public health insurance, including Haitian Creole speakers, have a right to get help in a language they can understand. All Medicaid offices and enrollers are required to offer free translation and interpretation services to anyone who cannot communicate effectively in English.

A bilingual worker or an interpreter, whether in-person or over the telephone, must be provided in all interactions with the office. Important documents, such as Medicaid applications, should be cialis 10mg price translated either orally or in writing. Interpreter services must be offered free of charge, and applicants requiring interpreter services must not be made to wait unreasonably longer than English speaking applicants. An applicant must never be asked to bring their own interpreter.

Related Resources on TPS and Public Health Insurance o The New York Immigration Coalition (NYIC) has compiled a list of agencies, law firms, and law schools responding to the tragedy in Haiti and the designation of Haiti for Temporary Protected Status. A copy of the list is posted at the NYIC’s website at http://www.thenyic.org. o USCIS TPS website with links to status in all countries, including HAITI. O For information on eligibility for public health insurance programs call The Legal Aid Society’s Benefits Hotline 1-888-663-6880 Tuesdays, Wednesdays and Thursdays.

9:30 am - 12:30 pm FOR IMMIGRATION HELP. CONTACT THE New York State New Americans Hotline for a referral to an organization to advise you. 212-419-3737 Monday-Friday, from 9:00 a.m. To 8:00 p.m.Saturday-Sunday, from 9:00 a.m.

To 5:00 p.m. Or call toll-free in New York State at 1-800-566-7636 Please see these fact sheets and web sites of national organizations for more information about the new PUBLIC CHARGE rules. Printable Fact Sheets for Distribution This article was co-authored by the New York Immigration Coalition, Empire Justice Center and the Health Law Unit of the Legal Aid Society. 1/29/10, updated 3/1/10, updated 8/15/19 by NY Legal Assistance Group.

At that can you purchase cialis over the counter time, this drug benefit was "carved into" the Medicaid managed care benefit package. Before that date, people enrolled in a Medicaid managed care plan obtained all of their health care through the plan, but used their regular Medicaid card to access any drug available on the state formulary on a "fee for service" basis without needing to utilize a restricted pharmacy network or comply with managed care plan rules. COMING IN April 2021 - In the NYS Budget enacted in April 2020, the pharmacy benefit was "carved out" of "mainstream" Medicaid managed care plans. That means that members of managed care plans can you purchase cialis over the counter will access their drugs outside their plan, unlike the rest of their medical care, which is accessed from in-network providers. How Prescription Drugs are Obtained through Managed Care plans No - Until April 2020 HOW DO MANAGED CARE PLANS DEFINE THE PHARMACY BENEFIT FOR CONSUMERS?.

The Medicaid pharmacy benefit includes all FDA approved prescription drugs, as well as some over-the-counter drugs and medical supplies. Under Medicaid can you purchase cialis over the counter managed care. Plan formularies will be comparable to but not the same as the Medicaid formulary. Managed care plans are required to have drug formularies that are “comparable” to the Medicaid fee for service formulary. Plan formularies do not have to include all drugs covered listed on the fee can you purchase cialis over the counter for service formulary, but they must include generic or therapeutic equivalents of all Medicaid covered drugs.

The Pharmacy Benefit will vary by plan. Each plan will have its own formulary and drug coverage policies like prior authorization and step therapy. Pharmacy networks can also differ from plan to can you purchase cialis over the counter plan. Prescriber Prevails applies in certain drug classes. Prescriber prevails applys to medically necessary precription drugs in the following classes.

atypical antipsychotics, can you purchase cialis over the counter anti-depressants, anti-retrovirals, anti-rejection, seizure, epilepsy, endocrine, hemotologic and immunologic therapeutics. Prescribers will need to demonstrate reasonable profession judgment and supply plans witht requested information and/or clinical documentation. Pharmacy Benefit Information Website -- http://mmcdruginformation.nysdoh.suny.edu/-- This website provides very helpful information on a plan by plan basis regarding pharmacy networks and drug formularies. The Department of Health plans to build capacity for interactive searches allowing for comparison of coverage across plans in the near future can you purchase cialis over the counter. Standardized Prior Autorization (PA) Form -- The Department of Health worked with managed care plans, provider organizations and other state agencies to develop a standard prior authorization form for the pharmacy benefit in Medicaid managed care.

The form will be posted on the Pharmacy Information Website in July of 2013. Mail Order Drugs -- Medicaid managed care members can obtain mail order/specialty drugs at any retail network pharmacy, as long as that retail network pharmacy agrees to a price that is comparable to the mail order/specialty pharmacy price can you purchase cialis over the counter. CAN CONSUMERS SWITCH PLANS IN ORDER TO GAIN ACCESS TO DRUGS?. Changing plans is often an effective strategy for consumers eligible for both Medicaid and Medicare (dual eligibles) who receive their pharmacy service through Medicare Part D, because dual eligibles are allowed to switch plans at any time. Medicaid consumers will have this option only in the limited circumstances during the first can you purchase cialis over the counter year of enrollment in managed care.

Medicaid managed care enrollees can only leave and join another plan within the first 90 days of joining a health plan. After the 90 days has expired, enrollees are “locked in” to the plan for the rest of the year. Consumers can switch plans during the “lock in” period only for good can you purchase cialis over the counter cause. The pharmacy benefit changes are not considered good cause. After the first 12 months of enrollment, Medicaid managed care enrollees can switch plans at any time.

STEPS CONSUMERS CAN TAKE WHEN A MANAGED CARE PLAM DENIES ACCESS TO A NECESSARY DRUG As a first step, consumers should try to work with their providers to satisfy plan requirements can you purchase cialis over the counter for prior authorization or step therapy or any other utilization control requirements. If the plan still denies access, consumers can pursue review processes specific to managed care while at the same time pursuing a fair hearing. All plans are required to maintain an internal and external review process for complaints and appeals of service denials. Some plans may develop special procedures for can you purchase cialis over the counter drug denials. Information on these procedures should be provided in member handbooks.

Beginning April 1, 2018, Medicaid managed care enrollees whose plan denies prior approval of a prescription drug, or discontinues a drug that had been approved, will receive an Initial Adverse Determination notice from the plan - See Model Denial IAD Notice and IAD Notice to Reduce, Suspend or Stop Services The enrollee must first request an internal Plan Appeal and wait for the Plan's decision. An adverse decision is called a 'FInal can you purchase cialis over the counter Adverse Determination" or FAD. See model Denial FAD Notice and FAD Notice to Reduce, Suspend or Stop Services. The enroll has the right to request a fair hearing to appeal an FAD. The enrollee may only request a fair hearing BEFORE receiving the FAD if the plan fails to send the FAD in the required time limit, which is 30 can you purchase cialis over the counter calendar days in standard appeals, and 72 hours in expedited appeals.

The plan may extend the time to decide both standard and expedited appeals by up to 14 days if more information is needed and it is in the enrollee's interest. AID CONTINUING -- If an enrollee requests a Plan Appeal and then a fair hearing because access to a drug has been reduced or terminated, the enrollee has the right to aid continuing (continued access to the drug in question) while waiting for the Plan Appeal and then the fair hearing. The enrollee can you purchase cialis over the counter must request the Plan Appeal and then the Fair Hearing before the effective date of the IAD and FAD notices, which is a very short time - only 10 days including mailing time. See more about the changes in Managed Care appeals here. Even though that article is focused on Managed Long Term Care, the new appeals requirements also apply to Mainstream Medicaid managed care.

Enrollees who are can you purchase cialis over the counter in the first 90 days of enrollment, or past the first 12 months of enrollment also have the option of switching plans to improve access to their medications. Consumers who experience problems with access to prescription drugs should always file a complaint with the State Department of Health’s Managed Care Hotline, number listed below. ACCESSING MEDICAID'S PHARMACY BENEFIT IN FEE FOR SERVICE MEDICAID For those Medicaid recipients who are not yet in a Medicaid Managed Care program, and who do not have Medicare Part D, the Medicaid Pharmacy program covers most of their prescription drugs and select non-prescription drugs and medical supplies for Family Health Plus enrollees. Certain drugs/drug can you purchase cialis over the counter categories require the prescribers to obtain prior authorization. These include brand name drugs that have a generic alternative under New York's mandatory generic drug program or prescribed drugs that are not on New York's preferred drug list.

The full Medicaid formulary can be searched on the eMedNY website. Even in fee for service Medicaid, can you purchase cialis over the counter prescribers must obtain prior authorization before prescribing non-preferred drugs unless otherwise indicated. Prior authorization is required for original prescriptions, not refills. A prior authorization is effective for the original dispensing and up to five refills of that prescription within the next six months. Click here for can you purchase cialis over the counter more information on NY's prior authorization process.

The New York State Board of Pharmacy publishes an annual list of the 150 most frequently prescribed drugs, in the most common quantities. The State Department of Health collects retail price information on these drugs from pharmacies that participate in the Medicaid program. Click here to search for a specific drug from the most frequently prescribed drug list and this site can also provide can you purchase cialis over the counter you with the locations of pharmacies that provide this drug as well as their costs. Click here to view New York State Medicaid’s Pharmacy Provider Manual. WHO YOU CAN CALL FOR HELP Community Health Advocates Hotline.

1-888-614-5400 NY State can you purchase cialis over the counter Department of Health's Managed Care Hotline. 1-800-206-8125 (Mon. - Fri. 8:30 am - 4:30 pm) NY can you purchase cialis over the counter State Department of Insurance. 1-800-400-8882 NY State Attorney General's Health Care Bureau.

1-800-771-7755Haitian individuals and immigrants from some other countries who have applied for Temporary Protected Status (TPS) may be eligible for public health insurance in New York State. 2019 updates - The Trump can you purchase cialis over the counter administration has taken steps to end TPS status. Two courts have temporarily enjoined the termination of TPS, one in New York State in April 2019 and one in California in October 2018. The California case was argued in an appeals court on August 14, 2019, which the LA Times reported looked likely to uphold the federal action ending TPS. See US Immigration Website on TPS - General TPS website with links can you purchase cialis over the counter to status in all countries, including HAITI.

See also Pew Research March 2019 article. Courts Block Changes in Public charge rule- See updates on the Public Charge rule here, blocked by federal court injunctions in October 2019. Read more about can you purchase cialis over the counter this change in public charge rules here. What is Temporary Protected Status?. TPS is a temporary immigration status granted to eligible individuals of a certain country designated by the Department of Homeland Security because serious temporary conditions in that country, such as armed conflict or environmental disaster, prevents people from that country to return safely.

On January 21, 2010 the United States determined that individuals from Haiti can you purchase cialis over the counter warranted TPS because of the devastating earthquake that occurred there on January 12. TPS gives undocumented Haitian residents, who were living in the U.S. On January 12, 2010, protection from forcible deportation and allows them to work legally. It is important to note that the can you purchase cialis over the counter U.S. Grants TPS to individuals from other countries, as well, including individuals from El Salvador, Honduras, Nicaragua, Somalia and Sudan.

TPS and Public Health Insurance TPS applicants residing in New York are eligible for Medicaid and Family Health Plus as long as they also meet the income requirements for these programs. In New York, applicants for TPS are considered PRUCOL immigrants (Permanently Residing Under Color of Law) for purposes of medical assistance eligibility and thus meet the immigration status requirements can you purchase cialis over the counter for Medicaid, Family Health Plus, and the Family Planning Benefit Program. Nearly all children in New York remain eligible for Child Health Plus including TPS applicants and children who lack immigration status. For more information on immigrant eligibility for public health insurance in New York see 08 GIS MA/009 and the attached chart. Where to Apply What to BringIndividuals who can you purchase cialis over the counter have applied for TPS will need to bring several documents to prove their eligibility for public health insurance.

Individuals will need to bring. 1) Proof of identity. 2) Proof of residence in New York. 3) Proof of income. 4) Proof of application for TPS.

5) Proof that U.S. Citizenship and Immigration Services (USCIS) has received the application for TPS. Free Communication Assistance All applicants for public health insurance, including Haitian Creole speakers, have a right to get help in a language they can understand. All Medicaid offices and enrollers are required to offer free translation and interpretation services to anyone who cannot communicate effectively in English. A bilingual worker or an interpreter, whether in-person or over the telephone, must be provided in all interactions with the office.

Important documents, such as Medicaid applications, should be translated either orally or in writing. Interpreter services must be offered free of charge, and applicants requiring interpreter services must not be made to wait unreasonably longer than English speaking applicants. An applicant must never be asked to bring their own interpreter. Related Resources on TPS and Public Health Insurance o The New York Immigration Coalition (NYIC) has compiled a list of agencies, law firms, and law schools responding to the tragedy in Haiti and the designation of Haiti for Temporary Protected Status. A copy of the list is posted at the NYIC’s website at http://www.thenyic.org.

o USCIS TPS website with links to status in all countries, including HAITI. O For information on eligibility for public health insurance programs call The Legal Aid Society’s Benefits Hotline 1-888-663-6880 Tuesdays, Wednesdays and Thursdays. 9:30 am - 12:30 pm FOR IMMIGRATION HELP. CONTACT THE New York State New Americans Hotline for a referral to an organization to advise you. 212-419-3737 Monday-Friday, from 9:00 a.m.

To 8:00 p.m.Saturday-Sunday, from 9:00 a.m. To 5:00 p.m. Or call toll-free in New York State at 1-800-566-7636 Please see these fact sheets and web sites of national organizations for more information about the new PUBLIC CHARGE rules.

What should I watch for while using Cialis?

If you notice any changes in your vision while taking this drug, call your doctor or health care professional as soon as possible. Stop using Cialis and call your health care provider right away if you have a loss of sight in one or both eyes.

Contact you doctor or health care professional right away if the erection lasts longer than 4 hours or if it becomes painful. This may be a sign of serious problem and must be treated right away to prevent permanent damage.

If you experience symptoms of nausea, dizziness, chest pain or arm pain upon initiation of sexual activity after taking Cialis, you should refrain from further activity and call your doctor or health care professional as soon as possible.

Do not drink alcohol to excess (examples, 5 glasses of wine or 5 shots of whiskey) when taking Cialis. When taken in excess, alcohol can increase your chances of getting a headache or getting dizzy, increasing your heart rate or lowering your blood pressure.

Using Cialis does not protect you or your partner against HIV (the cialis that causes AIDS) or other sexually transmitted diseases.

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No Supplementary Data.No taking cialis Article http://mtvernontree.com/get-levitra-prescription MediaNo MetricsDocument Type. EditorialAffiliations:1. London School of Hygiene &. Tropical Medicine, London, UK taking cialis 2. Oxford University Clinical Research Unit, Ho Chi Minh City, VietnamPublication date:01 August 2021More about this publication?.

The International Journal of Tuberculosis and Lung Disease (IJTLD) is for clinical research and epidemiological studies on lung health, including articles on TB, TB-HIV and respiratory diseases such as erectile dysfunction treatment, asthma, COPD, child lung health and the hazards of tobacco and air pollution. Individuals and institutes can subscribe to the IJTLD online or in print – simply email us at [email protected] for taking cialis details. The IJTLD is dedicated to understanding lung disease and to the dissemination of knowledge leading to better lung health. To allow us to share scientific research as rapidly as possible, the IJTLD is fast-tracking the publication of certain articles as preprints prior to their publication. Read fast-track articles.Editorial BoardInformation for AuthorsSubscribe to this TitleInternational Journal of Tuberculosis and Lung taking cialis DiseasePublic Health ActionIngenta Connect is not responsible for the content or availability of external websitesDownload Article.

Download (PDF 41.2 kb) No AbstractNo Reference information available - sign in for access. No Supplementary Data.No Article MediaNo MetricsDocument Type. EditorialAffiliations:1. Research Institute of the McGill University Health Centre, Montréal, QC, Faculty of Medicine, McGill University, Montréal, QC, McGill International TB Centre, Montréal, QC, Canada 2. Clinical Epidemiology &.

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No Supplementary can you purchase cialis over the counter Data.No Article MediaNo MetricsDocument http://mtvernontree.com/get-levitra-prescription Type. EditorialAffiliations:1. London School of Hygiene &. Tropical Medicine, London, UK 2 can you purchase cialis over the counter.

Oxford University Clinical Research Unit, Ho Chi Minh City, VietnamPublication date:01 August 2021More about this publication?. The International Journal of Tuberculosis and Lung Disease (IJTLD) is for clinical research and epidemiological studies on lung health, including articles on TB, TB-HIV and respiratory diseases such as erectile dysfunction treatment, asthma, COPD, child lung health and the hazards of tobacco and air pollution. Individuals and institutes can subscribe to the IJTLD online or in print – simply email us at [email protected] can you purchase cialis over the counter for details. The IJTLD is dedicated to understanding lung disease and to the dissemination of knowledge leading to better lung health.

To allow us to share scientific research as rapidly as possible, the IJTLD is fast-tracking the publication of certain articles as preprints prior to their publication. Read fast-track articles.Editorial BoardInformation for AuthorsSubscribe to this TitleInternational Journal of Tuberculosis and Lung DiseasePublic Health ActionIngenta Connect is not responsible for the content or availability can you purchase cialis over the counter of external websitesDownload Article. Download (PDF 41.2 kb) No AbstractNo Reference information available - sign in for access. No Supplementary Data.No Article MediaNo MetricsDocument Type.

EditorialAffiliations:1. Research Institute of the McGill University Health Centre, Montréal, QC, Faculty of Medicine, McGill University, Montréal, QC, McGill International TB Centre, Montréal, QC, Canada 2. Clinical Epidemiology &. Biostatistics Unit, Department of Medicine Makerere University College of Health Sciences and Uganda Tuberculosis Implementation Research Consortium, Kampala, Uganda 3.

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NSW recorded 644 new cialis patent expiration locally acquired cases of erectile dysfunction treatment in the 24 hours to 8pm last night. Of these locally acquired cases, 134 are linked to a known case or cluster – 107 are household contacts and 27 are close contacts – cialis patent expiration and the source of for 508 cases is under investigation.Sixty-five cases were in isolation throughout their infectious period and 30 were in isolation for part of their infectious period. Forty-one cases were infectious in the community, and the isolation status of 506 cases remains under investigation.Two cases acquired their in the ACT and are in isolation in southern NSW.Two new cases were acquired overseas in the 24 hours to 8pm last night. The total number of cases in cialis patent expiration NSW since the beginning of the cialis now stands at 16,164.Sadly, NSW Health has been notified of the deaths of four people who had erectile dysfunction treatment in the 24 hours to 8pm last night.A woman in her 80s from Sydney’s inner west died at Royal North Shore Hospital.

She was a resident at Wyoming Aged Care Facility and is the fourth death linked to this cluster cialis patent expiration. A man in his 70s from south-east Sydney died at St George Hospital, where he acquired his .A man in his 80s from western Sydney died at Nepean Hospital, where he acquired his .There have now been two deaths linked to the outbreak at Nepean Hospital. A previously cialis patent expiration reported erectile dysfunction treatment death – a man in his 70s from western Sydney who died on 17 August at Nepean Hospital – is now also linked to this outbreak.A woman in her 80s from south-west Sydney died at Campbelltown Hospital. NSW Health extends its deepest sympathies to their loved ones.This brings the number of erectile dysfunction treatment-related deaths to 65 since 16 June, and the number of lives lost to 121 since the beginning of the cialis.There have been 10,582 locally cialis patent expiration acquired cases reported since 16 June 2021, when the first case in this outbreak was reported.

There are currently 470 erectile dysfunction treatment cases admitted to hospital, with 80 people in intensive care, 27 of whom require ventilation.There were 127,590 erectile dysfunction treatment tests reported to 8pm last night, compared with the previous day’s total of 119,310. Confirmed cases (including interstate residents in NSW health care facilities) 16,164 Deaths (in NSW from confirmed cialis patent expiration cases) 121 Total tests carried out 11,472,375 Total vaccinations administered in NSW5,606,572 NSW Health administered a record 46,645 erectile dysfunction treatments in the 24 hours to 8pm last night, including 9,823 at the vaccination centre at Sydney Olympic Park. The total number of treatments administered in NSW is now 5,606,572, with 2,021,684 doses administered by NSW Health to 8pm last night and 3,584,888 administered by the GP network and other providers to 11.59pm on Wednesday 18 August.Of the 644 locally acquired cases reported to 8pm last night, 256 are from Western Sydney Local Health District (LHD), 222 are from South Western Sydney LHD, 47 are from Sydney LHD, 35 are from Nepean Blue Mountains LHD, 27 are from Western NSW LHD, 25 are from South Eastern Sydney LHD, eight are from Northern Sydney LHD, three are from Hunter New England LHD, three are from Far West LHD, three are from Central Coast LHD, two are from Southern NSW LHD, one is from Mid North Coast LHD, and 12 cases are yet to be assigned to an LHD.NSW Health's ongoing sewage surveillance program has detected fragments of the cialis that causes erectile dysfunction treatment at the Cobar, Port Macquarie, Parkes, Coonamble and Bellambi sewage treatment plants in recent days.The Cobar sewage treatment plant serves around 4,000 people, the Port cialis patent expiration Macquarie sewage treatment plant serves around 54,000 people, the Parkes sewage treatment plant serves about 11,600 people, the Coonamble sewage treatment plant serves about 2,700 people and the Bellambi sewage treatment plant serves about 82,000 people.These detections are of particular concern and everyone in these areas is urged to monitor for the onset of symptoms, and if they appear, to immediately be tested and isolate until a negative result is received.If you are directed to get tested for erectile dysfunction treatment‑19 or self-isolate at any time, you must follow the rules whether or not the venue or exposure setting is listed on the NSW Health website.It remains vital that anyone who has any symptoms or is a close or casual contact of a person with erectile dysfunction treatment, isolates and is tested immediately. When testing clinics are busy, please ensure you stay in line, identify yourself to staff and tell them that you have symptoms or are a contact of a case.Please check the NSW Government website regularly, and follow the relevant health advice if you have attended a venue of concern or travelled on a public transport route at the same time as a confirmed case of erectile dysfunction treatment.

This list is being updated regularly as case cialis patent expiration investigations proceed.There are more than 450 erectile dysfunction treatment testing locations across NSW, many of which are open seven days a week. To find your nearest clinic cialis patent expiration visit. erectile dysfunction treatment clinics or contact your GP. Likely source of confirmed erectile dysfunction treatment cases in NSWOverseas 2 12 3,393 Interstate 2 3 94 Locally acquired – linked to known case or cluster 134 1,477 7,622 Locally acquired cialis patent expiration – no links to known case or cluster0 13 495 Locally acquired – investigation ongoing 508 2,174 4,560 Under initial investigation0 0 0 Note.

Case counts reported for a particular day may vary over time cialis patent expiration due to ongoing investigations and case review. *notified from 8pm 18 August 2021 to 8pm 19 August 2021 **from 8pm 13 August 2021 to 8pm 19 August 2021 erectile dysfunction treatment vaccination updateNSW Health – first doses32,3071,251,875NSW Health – second doses 14,338769,809*notified from 8pm 18 August 2021 to 8pm 19 August 2021 Video of today's press conference will be uploaded to erectile dysfunction treatment (erectile dysfunction) - press conferences and video updates..

NSW recorded 644 new locally acquired cases of erectile dysfunction treatment in can you purchase cialis over the counter the 24 hours to 8pm last night. Of these can you purchase cialis over the counter locally acquired cases, 134 are linked to a known case or cluster – 107 are household contacts and 27 are close contacts – and the source of for 508 cases is under investigation.Sixty-five cases were in isolation throughout their infectious period and 30 were in isolation for part of their infectious period. Forty-one cases were infectious in the community, and the isolation status of 506 cases remains under investigation.Two cases acquired their in the ACT and are in isolation in southern NSW.Two new cases were acquired overseas in the 24 hours to 8pm last night.

The total number of cases in NSW since the beginning of the can you purchase cialis over the counter cialis now stands at 16,164.Sadly, NSW Health has been notified of the deaths of four people who had erectile dysfunction treatment in the 24 hours to 8pm last night.A woman in her 80s from Sydney’s inner west died at Royal North Shore Hospital. She was a resident at Wyoming Aged Care Facility and is the fourth death linked can you purchase cialis over the counter to this cluster. A man in his 70s from south-east Sydney died at St George Hospital, where he acquired his .A man in his 80s from western Sydney died at Nepean Hospital, where he acquired his .There have now been two deaths linked to the outbreak at Nepean Hospital.

A previously reported erectile dysfunction treatment death – a man in his 70s from western Sydney who died on 17 August at Nepean Hospital – is now also linked to this outbreak.A woman in her can you purchase cialis over the counter 80s from south-west Sydney died at Campbelltown Hospital. NSW Health extends its deepest sympathies to their loved ones.This brings the number of erectile dysfunction treatment-related deaths to 65 since 16 June, and the number of lives lost to 121 since the beginning of the cialis.There have been can you purchase cialis over the counter 10,582 locally acquired cases reported since 16 June 2021, when the first case in this outbreak was reported. There are currently 470 erectile dysfunction treatment cases admitted to hospital, with 80 people in intensive care, 27 of whom require ventilation.There were 127,590 erectile dysfunction treatment tests reported to 8pm last night, compared with the previous day’s total of 119,310.

Confirmed cases (including interstate residents in NSW health care facilities) 16,164 Deaths (in NSW from confirmed cases) 121 Total tests carried out 11,472,375 Total vaccinations administered in NSW5,606,572 NSW Health administered a record 46,645 erectile dysfunction treatments in the 24 hours to 8pm last night, including 9,823 at the vaccination centre can you purchase cialis over the counter at Sydney Olympic Park. The total number of treatments administered in NSW is now 5,606,572, with 2,021,684 doses administered by NSW Health to 8pm last night and 3,584,888 administered by the GP network and other providers to 11.59pm on Wednesday 18 August.Of the 644 locally acquired cases reported to 8pm last night, 256 are from Western Sydney Local Health District (LHD), 222 are from South Western Sydney LHD, 47 are from Sydney LHD, 35 are from Nepean Blue Mountains LHD, 27 are from Western NSW LHD, 25 are from South Eastern Sydney LHD, eight are from Northern Sydney LHD, three are from Hunter New England LHD, three are from Far West LHD, three are from Central Coast LHD, two are from Southern NSW LHD, one is from Mid North Coast LHD, and 12 cases are yet to be assigned to an LHD.NSW Health's ongoing sewage surveillance program has detected fragments of the cialis that causes erectile dysfunction treatment at the Cobar, Port Macquarie, Parkes, Coonamble and Bellambi sewage treatment plants in recent days.The Cobar sewage treatment plant serves around 4,000 people, the Port Macquarie sewage treatment plant serves around 54,000 people, the Parkes sewage treatment plant serves about 11,600 people, the Coonamble sewage treatment plant serves about 2,700 people and the Bellambi sewage treatment plant serves about 82,000 people.These detections are of particular concern and everyone in these areas is urged to monitor for can you purchase cialis over the counter the onset of symptoms, and if they appear, to immediately be tested and isolate until a negative result is received.If you are directed to get tested for erectile dysfunction treatment‑19 or self-isolate at any time, you must follow the rules whether or not the venue or exposure setting is listed on the NSW Health website.It remains vital that anyone who has any symptoms or is a close or casual contact of a person with erectile dysfunction treatment, isolates and is tested immediately. When testing clinics are busy, please ensure you stay in line, identify yourself to staff and tell them that you have symptoms or are a contact of a case.Please check the NSW Government website regularly, and follow the relevant health advice if you have attended a venue of concern or travelled on a public transport route at the same time as a confirmed case of erectile dysfunction treatment.

This list is being updated regularly as case investigations proceed.There are more than 450 erectile dysfunction treatment testing locations across NSW, many can you purchase cialis over the counter of which are open seven days a week. To find your nearest can you purchase cialis over the counter clinic visit. erectile dysfunction treatment clinics or contact your GP.

Likely source can you purchase cialis over the counter of confirmed erectile dysfunction treatment cases in NSWOverseas 2 12 3,393 Interstate 2 3 94 Locally acquired – linked to known case or cluster 134 1,477 7,622 Locally acquired – no links to known case or cluster0 13 495 Locally acquired – investigation ongoing 508 2,174 4,560 Under initial investigation0 0 0 Note. Case counts reported for a can you purchase cialis over the counter particular day may vary over time due to ongoing investigations and case review. *notified from 8pm 18 August 2021 to 8pm 19 August 2021 **from 8pm 13 August 2021 to 8pm 19 August 2021 erectile dysfunction treatment vaccination updateNSW Health – first doses32,3071,251,875NSW Health – second doses 14,338769,809*notified from 8pm 18 August 2021 to 8pm 19 August 2021 Video of today's press conference will be uploaded to erectile dysfunction treatment (erectile dysfunction) - press conferences and video updates..

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These simple acts of kindness generic cialis price will help reduce community spread of erectile dysfunction treatment and ensure businesses, dangers of cialis schools and hospitals can remain open to serve you!. Wear A Mask Protect yourself and others by properly wearing a mask that covers your nose and mouth at all times when in public. Learn more at MaskUpMichigan. Stay Home Right now, staying home unless you absolutely dangers of cialis need to go out is one of the best ways to help flatten the curve.

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These simple acts of kindness will help reduce community spread can you purchase cialis over the counter of you can try these out erectile dysfunction treatment and ensure businesses, schools and hospitals can remain open to serve you!. Wear A Mask Protect yourself and others by properly wearing a mask that covers your nose and mouth at all times when in public. Learn more at MaskUpMichigan. Stay Home can you purchase cialis over the counter Right now, staying home unless you absolutely need to go out is one of the best ways to help flatten the curve. When you do go out for work, groceries or exercise, stay 6 feet apart, wear a mask and wash your hands.

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Call Ahead for Health Care Don’t neglect your health, but do call ahead to your doctor’s office or Urgent Care so they can prepare for your visit and safely accommodate you. Or call your primary care provider to schedule a video visit. Thank Essential WorkersIt seems simple, but a colorful sign in your yard or window, or a note of encouragement and gratitude on social media can go a long way to remind essential workers of your support.Make a DonationConsider supporting non-profit organizations that are providing erectile dysfunction treatment relief, such as securing needed medical supplies or assisting vulnerable populations..

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Autodesk deployed it’s Octo-Copter in Africa for high resolution reality capture.  This was done in support of Louis Leakey in Kenya in search of our ancestral trails


Additonally, they deployed it on their head quarters in San Rafael.

From the Gizmag Website:

The Mikrokopter Octocopter is an 8-rotor flying platform which has a 2 kg (4.4 lbs) capacity to carry cameras. It can be flown using an internal camera to give the operator a copter-based vantage point on video glasses, or can be programmed to follow a GPS-controlled flight path. An Octocopter can fly autonomously at altitudes up to 1000 meters (3280 feet), or can be manually flown as high as 3500 meters (11,480 feet). In the Autodesk tests video was captured using a GOPro Hero 2 camera, and the still pictures from which the 3D model was later built were taken by a remotely triggered Canon SLR camera.

Autodesk 123D is a suite of programs which allow a user to create, manipulate, and construct 3D objects using a 3D printer. Catch is part of the 123D suite, and offers a standalone software package that helps you create 3D models from a series of 2D digital images of an object or a scene. The spatial resolution available using 123D Catch is about 1 part in 600, or 0.167% of the total size of the object pictured, so you would be able to accurately place individual windows on a 3D model of a Boeing 747.

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Get to the Beach and then Treat Yourself

Cranes Beach & Wingaersheek Beech, Head north on 128.  Enjoy the water, and then take the short drive to Essex and go get fried clams and soft serve, call in your fried clam order if you can.  Try Woodman’s, Farnham’s (they got picnic tables over looking the tidal marsh) or try the Village, and Essex Seafood, which has always been a solid go to.

Horseneck Beach, terrific beach going south on 24, Westport, MA almost always less traffic, then go to the Back Eddy for something to cold to drink and a snack.

You’re in and around the city.

Find a Roof Deck and/or Pool, a variety of posts on the subject from Boston.com, but it seems the Colonade for a pool stop is always mentioned. And outside of the city, Indigo in Newton is pretty nice stop.

Walk the Greenway, play in the fountains, get gelatto, try the Gelateria  in the North End.

Have a cold drink in a well air conditioned bar by the Garden, then walk over the river, across the locks into Charlestown and do the same thing there.  Your choice for locations, there are many.  But go ahead and stop at Emack and Bolio’s on the walk back.

Play in the Fountain at the Christian Science Center, walk into the Pru and Copley to soak in the air conditioning, play “how much are these shoes” at Nordstrom.  Have a friend stand back from the shoe tables, have them guess.  Most likely off by a factor of 10, go get a coolata at Dunkin.

If you are feeling particularly flush and it’s after 5, go get a martini at the Oak Room, used to come with side car sitting in ice.  That will frame the rest of your day.  Air Conditioning set on igloo.

Take your dog for a walk at the Middlesex Fells Reservation, or bring him/her to a pond, throw a stick. Jamaica Pond, Spy Pond, Fresh Pond, etc.  You might not get cool, but look at the dog, so happy.  And now I’ve seen Canoe and Kayak Rentals at Spy Pond.

So there’s a start, generally, a cold drink, cone or a slush, water, you get the idea.

 

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With Microsoft’s announcement of Windows 8, and the unveiling of the Surface Tablet, it finally appears there will be a tablet form factor that will run Revit in the field.  According to the press release there will be two versions, one based on the ARM chip and another based on the Intel i5 chip running Windows 8 Pro.  The iPad, as much it is great for so many tasks, simply does not have the horsepower to run Revit in the field, and delivering the type of user experience one would want with heavyweight programs is a real limitation in the ‘cloud.’  I understand Autodesk is now counting solely on Citrix to provide its remote platform but even if you are driving Revit remotely would you want to rely on whatever internet connection you have?  That’s just not a funnel I would want to count on in the field.

At first glance you might say so what, not a big deal.  However, if I can have a device that toggles between my heavyweight AEC programs, and delivers content the way my my iPad does then I might have an iPad to sell you; because frankly I am sick of devices, I live between the Mac and Windows camp, I’m tired of it.  I used to be an Apple fanatic, even being the only kid in business school with a Mac, the disastrous PowerPC model, but what was not to like about Apple.  Now, how did we get to the point where Microsoft is the little guy, relatively speaking.  Now if they could get their content management into a spot that works the way you want.  Imagine the central Revit model up on the sky drive, you check it out in the field, do your work, update it, booyah.

I think single purpose, highly specific apps are great to digest data,  not for the creation of it so I am real interested in the melding of tablet like functionality with horsepower.  I’m rooting for the little guy, I’m rooting for Microsoft.

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BTW anyone else bother to notice the blending and vertical integration of software/hardware.  Apple, obviously.  Google buys Motorola. Microsoft with multiple attempts, Zune, XBox, etc.  and now Surface. And more germane to AEC Trimble buys Tekla and SketchUp.  Seems to be the biz strategy du jour, watch for more.

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Tweet about PKNail Pro’s Proven Field to BIM Technology, Get Entered Automatically

PointKnown is giving away a free Apple iPad to one lucky Twitterer…er, tweeter, i.e.  one who uses the service twitter to disseminate clever, witty, informative text burst in 140 characters or less.  PointKnown does not claim to be clever, witty or informative, but will claim producing kick ahh…whup ahh…Excellent productivity software tools for documenting existing buildings.

 

 

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To participate, simply tweet using the hash tags below:

#pknail #revit #bim and mention ‘PKNail Pro’

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PKNail Pro turbo charges Revit and modeling existing buildings #pknail #revit #bim

or “Capture Existing Buildings Directly In Revit with PKNail Pro, 5x-10x faster #pknail #revit #bim

less pertinent but still acceptable “We came, we saw, we conquered with PKNail Pro, #pknail, #bim , #revit

less pertinent verging to the non-sequitur but still acceptable…

beautiful software for happy people PKNail Pro, #pknail, #bim, #revit

or certainly and you are most welcome and encouraged to tweet your own stuff; as we will have a separate drawing of $100 VISA Card for best/most creative tweet as judged by anyone at our next BBQ.

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We are on the road with Microcad and have other excellent resellers including,  Seiler Instrument (ask for Harvey) and CADDFX

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1. This giveaway is offered by PointKnown LLC and is open to anyone with a Twitter account who is at least 16 years of age. Employees of PointKnown, LLC. and/or its affiliated companies and family members of such employees may enter the contest but are not eligible to win.

2. The giveaway will begin at the time of this post and end 62 days after initial post, a winner will be randomly chosen, much like the number 62, and announced via twitter through @pointknown

3. One giveaway will be available: a 16GB Wi-Fi Apple iPad or $499 Apple Store Credit, winner’s choice.

4. You must prove ownership of the winning entry and provide your email address to collect the prize.

5. To enter the giveaway you must send out a tweet from your own Twitter account that includes the #hash tags above in your message.

6. Entries using automated tweets will be disqualified, however there is no limit on the number of tweets you may enter.

7. PointKnown LLC will choose a winner randomly from all the entries within the specified period. The winner will be announced from our twitter account (@pointknown) once the contest ends.

8. Entrants agree to allow @pointknown to use their twitter handles and entry tweets for marketing purposes.

9. Neither PointKnown LLC. nor its affiliated companies shall have any liability for (i) any technical failures of any kind, including but not limited to malfunctions, interruptions or disconnections in phone lines or network hardware or software; (ii) technical or human error which may occur in the administration of the giveaway; (iii) any malfunction of or damage to the prize; (iv) any corruption, typos or hacking of prize winners email accounts; or (v) any restrictions or delays imposed by any customs authorities or any import or other taxes of any kind imposed by any taxation authority in respect of the prizes.

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Announced today, Autodesk Acquires Vela Systems.  If you are developing products within the Building Life Cycle somewhere between and including design to demolition, you are in play.  Trimble has been going on an acquisition rampage with its acquisition of Tekla and Sketch Up and Autodesk never one to be a wallflower has just acquired Vela.  This is almost 2 years to the date that Vela was unveiled publicly.  No idea of their market size but their own press releases state that they are more than ‘twice as big’ as any competitive Field BIM Systems.  Regardless, market penetration means little at this point now that the Autodesk marketing/sales system is behind it.  How big was Revit in 2006 when they were purchased.  A primer of Vela’s Key Features below.  Congrats Vela folks, job well done.

Vela Field Management Suite Key Features
The Vela Field Management Suite of Web, Mobile and Reports enables everyone throughout the enterprise to access documents, field activities and reports in the office and in the field. Since its release a year ago, and to further broaden the usability throughout the enterprise, Vela Systems has expanded upon the following features:

  • Field BIM® for commissioning and handover that ties BIM to the field for data and document exchange
  • Company-level checklist and issue template capabilities to implement and enforce quality and safety programs
  • Increased accessibility via the Internet on multiple devices like iPads and Smart Phones
  • Better web-based reporting that turns field data into powerful information for managing quality, safety and risk at the project and company level
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As reported by Industry Week, ‘The world’s most sophisticated malware had a ‘high interest in AutoCAD drawings,’ Kaspersky Lab said.  The Flame Virus, which mainly affected computers in the Middle East used a loophole in Microsoft software tricking computers into thinking they are downloading a legitimate Windows update.  This fact, being reported by Reuters, The Times, CNET, and others. CNN reported that Flame can turn on your microphone, webcam, log e-mails, etc.  I have not read if it can do anything malicious itself as the Stuxnet Virus did to Iran Uranium enrichment facilities by having centrifuges essentially tear themselves apart.  However, going after CAD, essentially engineering and building documents can let whoever is collecting this information know what you are designing and building, and possibly have the blueprints of the building you are designing and building in.  And you thought google knowing that you smoke cigars and eat ice cream on your back porch at 5:23 PM was intrusive.

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File under cool.   The City of New York has unveiled an initiative for the electronic submission of BIM safety plans; you can learn more here; and a  Turner Press Release yesterday stated they used both 2D and 3D BIM submissions to get approval for their construction project at the Energy Building at NYU Langone Medical Center.

“The digital submission of 3D, BIM-based site safety plans reduced the approval times from weeks to days,” said Di Fillipo, Turner Senior Vice President.

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The more demos I go on, the more I get asked about our field kit, so I wanted to post what’s in my bag and what we use on a day to day basis when surveying/modeling in the field with PKNail Pro.  Those of you not interested in the day-in day-out particulars of surveying buildings may want to hit your back button now… Anyway an individual equally equipped will be ready for knocking out BIM Building Surveys, and this kit, all in, costs a fraction of most other technology solutions, plus the added benefit of surveying/modeling directly in the platform you or your clients are most likely working in.  However, always choose the tool/service that fits your needs.  In fact, we’ll be posting shortly where we combined workflows of PKNail Pro and pointclouds.  But here you go, what’s in my bag or my complete kit.

So it might seem like a lot but all fits in the bag except for the tripods.  The laptop tripod is excellent when mobility/portability with your gear is at a premium but I will use a laptop cart with wheels if the space allows;  it is easier with wheels and has more surface area to put stuff.

The real minimum you need to have with you is a laptop/tablet PC running the appropriate software, a Disto D8 or 330i, a measuring tape, and something to use for a target when needed, like an outside corner.  Stickynotes (larger size) are excellent for shorter distances, a reflective Leica Target attached with Painter’s Tape is better for longer ones.  Rechargeable batteries for both the laptop and Disto.  I prefer an external battery pack for the laptop as it can be used on any laptop and it is self contained unlike an extra battery for a specific laptop.

I  like Eneloop rechargeables for devices, my preference, they come preloaded with a charge, and seem to carry it longer when not being used.  You need a measuring tape on occasion for distances to short or sometimes nice to hook something with a tape when finding a distance manually.  I like thick banded measuring tapes because they will extend longer without ‘breaking’ but find they are just as prone to wear down as any other so sometimes not worth the expense.  LED flashlight because they are bright and do not use as much juice as others, and are always nice to have.  I also have an LED light that you can wear on your head, which is my preferred.  Diameter tape is a luxury but one side is graduated the other will measure the diameter of any round column which is helpful.

The tripod attachment from Leica allows it to pivot properly on the its axis so the measurements stay as accurate as possible.  This is great to have for exterior work  when you might not have access to the interior of the building.  Building chalk or a marking crayon can be helpful but usually would want to mark with painters tape or sticky pad because they are easily removed, however, the former comes in handy sometimes, especially in basements.

And bring food and drink, nothing clouds your mind like being hungry, so eat.

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Interioreview, utilized PKNail Pro, an add in to Revit, combined with Leica Disto D8 laser range finders as the main surveying tool and software for capturing and modeling the 28 Story DuBois Library at UMass Amherst.  The structure designed by Durell Stone in 1966 is tallest library in the United States.  While intially considering combining LIDAR and creating a pointcloud for the exterior and utilizing PKNail Pro for the interior it turned out the exterior was the easiest part of the job and it was interior that was the most difficult.  Every 3rd floor contained  90+ rooms  with study carrels combined with classrooms where very few technologies would work well.  Nico Martinez, a Project Manager with Interioreview, commented,”Without PKNail the survey work could have taken  5 times, 10 times what it was.”

The project was completed to support the design and retrofitting a fire protection system.

Interioreview, an architecural surveying firm founded in 2003 specialzies in documenting the built environment in both 2D CAD and 3D Revit formats.

PointKnown, a software firm, founded in 2008 develops productivity tools for the built environment / AEC (Architectural, Engineering, and Construction) Industry

PKNail Pro, allows a user to measure and model objects in real time directly in Revit.

Autodesk® Revit® software is specifically built for Building Information Modeling (BIM), helping building professionals design, build, and maintain higher-quality, more energy-efficient buildings.

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