Registration and Reregistration Fees: Controlled Substance and List I Chemical Registrants
2020-05-13 2020-05-15 2020-03-17 2020-05-11 2020-04-13 2020-03-17 2020-03-17
DEA-2020-0007-0009 DEA-2020-0007-0013 DEA-2020-0007-0004 DEA-2020-0007-0007 DEA-2020-0007-0006 DEA-2020-0007-0002 DEA-2020-0007-0003
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https://api.regulations.gov/v4/comments/DEA-2020-0007-0009 https://api.regulations.gov/v4/comments/DEA-2020-0007-0013 https://api.regulations.gov/v4/comments/DEA-2020-0007-0004 https://api.regulations.gov/v4/comments/DEA-2020-0007-0007 https://api.regulations.gov/v4/comments/DEA-2020-0007-0006 https://api.regulations.gov/v4/comments/DEA-2020-0007-0002 https://api.regulations.gov/v4/comments/DEA-2020-0007-0003
Anonymous Anonymous Mendy Tim Anonymous Mendy Mendy
Anonymous Anonymous West Lenzi Anonymous West West
My pharmaceutical company has ended contracts with the Department of the Treasury Internal Affairs Revenue Division. IRS With President Trump it always comes down to numbers. Polls! Electoral college votes! Inauguration crowds! Stock market highs! Unemployment rates!Due to the Covid-19 pandemic this has become more challenging. But Trump has continued looking for a number he could brag about. First he bragged about Americas low number of cases... which is now the highest in the world, in fact higher than the next six countries combined. Then he boasted about our relatively low mortality rate. Not only is this a bizarre statistic to crow over, the US now has more deaths than the next two countries (soon to be three) - and one of the worst deaths per population ratio on the planet. Lately Trump has bragged about how many tests weve conducted. Brilliant. Its like saying After the horse left the barn we installed the worlds best padlock.Since all of these numbers have exploded in Trumps fat face, hes shifted to attacking the numbers. Maybe were over counting Covid-19 deaths, while other countries are under counting. Maybe were doing too many tests. Maybe the worst case scenario was too low, so Trump should be given credit for saving millions of lives rather than causing over 87,000 deaths. Maybe the bad numbers are all Obamas fault.There is one number that says it all: 45. Thats the number of the Worst. President. Ever. DEA 501 A RIN 1117-AB51/Docket No. DEA-501MGP Response to DEA Proposed Registration Fees Increase 05-07-2020Morton Grove Pharmaceuticals, Inc. (MGP) is a small pharmaceutical manufacturer bordering the northwest side of Chicago that employs 177 people.  In addition to our manufacturer registration, MGP has the following registrations:Analytical LabImporterExporterList I Chemical ImporterMGP has a commitment to a vibrant DEA compliance program ensuring all MGP registrations adhere to the laws/regulations of the Controlled Substances Act (CSA).  MGP Standard Operating Procedures (SOPs) for DEA compliance are the cornerstone of that commitment, and we continually enhance those SOPs.  As a registrant who takes controlled substance compliance very seriously, MGP appreciates this opportunity to express concerns over the proposed increase in registrations fees published on March 16, 2020 in the Federal Register.   The publishing in the Federal Register of a proposed fee increase in the midst of a worldwide Covid-19 Pandemic seriously affecting both public health/safety and the economy was poorly timed.  Proposing increased registration fees, especially to small businesses like MGP, during an unprecedented worldwide health pandemic with looming economic uncertainties is not wise in these circumstances.  We recommend tabling these proposed fee increases and the comment period until January 2021 at the earliest.    In the interim, MGP proposes two alternative avenues for assessing registration fees: assessing fees based on the size of the business or having registrants with a significant history of CSA violations pay much higher registration fees.  Both proposals are discussed in more detail below.In the first proposal, registration fees would be assessed based on the size of the business (number of employees, annual earnings, etc.) for Type B registrants.  As a manufacturer, MGP competes with much larger corporate entities that have multiple facilities and more employees.  The proposed annual fee increases for MGP in the following categories amount to substantial increases for a small business:Manufacturer $3,699.00 from $3,047.00  *$652.00 increaseAnalytical Lab $296.00 from $244.00*$52.00 increase Importer $1,850.00 from $1,523.00*$327.00 increaseExporter $1,850.00 from $1,523.00*$327.00 increaseList I Importer $1,850.00 from $1,523.00  *$327.00 increaseMGP would pay an extra $1,685.00 annually.  Small businesses have to forecast sales revenue and subsequently plan operating costs in advance of their fiscal year.  While MGP can modify its operating budget for the increased registration fees, it places a financial burden on a small employer serving an important function manufacturing oral liquid and topical pharmaceutical products.  The second pathway proposed having registrants with a significant history of CSA violations pay dramatically increased registration fees is a viable option worth exploring.  Our nation has struggled with an ongoing opioid epidemic for over a decade resulting in thousands of lives lost, many people suffering from their addiction to opiates, heavy burdens on the nations healthcare system, and significant financial costs to state, county and local governments.  It is well documented that specific manufacturers and wholesale distributors contributed to this epidemic by turning a blind eye to CSA laws/regulations allured by sales of opioid medications and profits over their responsibilities as DEA registrants.  DEA registrations are issued with the understanding that any registrant must act responsibly with controlled substances.  Thus, these registrants could be assessed the significantly higher registration fees.  This format rewards compliance for both large scale business model registrants and small business registrants like MGP.   In conclusion, MGP asks that the DEA table the proposed increase in registration fees and its comment period until January 2021 as our nations priority now is to focus numerous resources on public health/safety measures to fight the Covid-19 Pandemic.  At that time, MGP would welcome discussion on the two alternative avenues for assessing registration fees: assessing fees based on the size of the business for Type B registrants and/or having registrants with a significant history of CSA violations pay much higher registration fees.   I am writing against the increased fees. I think the Agency needs to show where and how the money is going in some sort of spreadsheet or that some sort of OIG audit should be done on the DEA fee account, because some of the numbers that are cited in the NPRM seem a bit fishy.Hiring more people does not seem to be the answer. Enforcement clearly isnt working on the opioid epidemic; policy doesnt seem to be working either, because DEA has made very few of the deadlines Congress set for them, or because they have certain documents floating in the ether that the public needs answers to. The Agency seems to be very reactive instead of proactive, and the agency seems to think that by giving it more money to hire these additional people to carry out these essential functions the opioid epidemic will be magically solved. DEA 501 A Docket Number DEA 501A