}l>smnqrC[{{mM ,Hb /h@ r-v{@(N%yH&H#(\,::Db)u,p>\.b1V"E/@,Q`\ cRd2@n#@!$0"fw l#@`GB@ u83.w!Xcb)p$"GL#7:*8d(|? kXcI6?}d(Nu8y4R: Da ~ Division of Drug Oncology Products, FDA 0000069655 00000 n %%EOF corresponding official PDF file on govinfo.gov. on All information these cookies collect is aggregated and therefore anonymous. of the issuing agency. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. 0000085163 00000 n electronic version on GPOs govinfo.gov. Information about this document as published in the Federal Register. documents in the last year, by the International Trade Commission It is not an official legal edition of the Federal The manufacturers of trabectedin (Yondelis), inotuzumab ozogamicin (Besponsa), polatuzumab vedotin (Polivy), enfortumab vedotin (Padcev), trastuzumab deruxtecan (Enhertu), sacituzumab govitecan (Trodelvy), loncastuximab tesirine (Zynlonta), melphalan flufenamide (Pepaxto), belantamab mafodotin (Blenrep), and tisotumab vedotin-tftv (Tivdak) recommend that they be handled as hazardous drugs. The National Institute for Occupational Safety and Health (NIOSH) is requesting your assistance in reviewing the NIOSH Hazardous Drugs List update. documents in the last year, by the Food Safety and Inspection Service trailer 0000001948 00000 n Defining Hazardous Drugs Hazardous drugs include those used for cancer che - motherapy, antiviral drugs, hormones, some bio-engineered drugs, and other miscellaneous drugs. Cookies used to enable you to share pages and content that you find interesting on CDC.gov through third party social networking and other websites. The list was compiled from information provided by four institutions that had generated lists of hazardous drugs for their respective institutions, as well as a list from the Pharmaceutical Research and Manufacturers of America (PhRMA). on 0000069979 00000 n Recommended by: Scientific or professional association, Bruce Naumann Thank you for taking the time to confirm your preferences. No attempt Environment, Health and Safety The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) published this list of hazardous drugs in 2016. on Academic and Professional Credentials: BSN, RN NIOSH has determined it is unlikely that paliperidone (Invega) poses a carcinogenic, reproductive or developmental hazard to workers in a healthcare setting and is no longer considered a hazardous drug by NIOSH. on Centers for Disease Control and Prevention. better and aid in comparing the online edition to the print edition. Organizational Affiliation: Pharmacologist The President of the United States manages the operations of the Executive branch of Government through Executive orders. DHHS (NIOSH) Publication No. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. Recommended by: NIOSH, Marty Polovich Please include the URL of the site in the Subject line of your email request that you would like to access. Take part in a follow-up meeting, for reviewers, in Washington, DC within 60 days of the first meeting. hbbd```b``}" Written comments, identified by CDC-2020-0046 and docket number NIOSH-233-C, may be submitted by any of the following methods: Persons with disabilities experiencing problems accessing this page should contact CDC-INFO at CDC-INFO email form: http://www.cdc.gov/info/, 800-232-4636 or the TTY number at (888) 232-6348 and ask for a 508 Accommodation PR#9342. Genentech, Inc. This count refers to the total comment/submissions received on this document as reported by Regulations.gov (last updated on 08/08/2020 at 11:30 pm). 01/18/2023, 202 Recommended by: NIOSH, Katie Slavin The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services announced that the following draft documents were available for public comment: (1) NIOSH Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings (Procedures); (2) NIOSH List of Hazardous Drugs in Healthcare Settings, 2020 (List), including those drugs proposed for placement on the 2020 List, and (3) Managing Hazardous Drug Exposures: Information for Healthcare Settings. the official SGML-based PDF version on govinfo.gov, those relying on it for This notice announces the extension of the comment period until July 30, 2020. CDC twenty four seven. `# @{3&jb51 QOINAVRpxCVy{j"V$ ->0c, 0000001848 00000 n So let's answer those questions and clear up a . Areas of Expertise, Discipline, or Relevant Experience: 0000006330 00000 n documents in the last year, by the Indian Affairs Bureau Areas of Expertise, Discipline, or Relevant Experience: Occupational health Organizational Affiliation: Duke University Group 1 is antineoplastic drugs (roughly, chemotherapy . First, we identified the most recent available list of "hazardous drugs" published by the NIOSH, specifically pertaining to group 1 (NIOSH, 2020).Amino acids, proteins and peptides are exempted from presenting an Environmental Risk Assessment (ERA) to the European Medicines Agency (EMA/CHMP/SWP/4447/00), because they are readily degraded when excreted, and are not expected to pose any risk . the material on FederalRegister.gov is accurately displayed, consistent with January 10th, 2019 Pfizer Global Environment, Health, and Safety, PhRMA These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. They have looked into hazardous drugs that healthcare workers may be exposed to and categorized these compounds into three groups. Centers for Disease Control and Prevention. }1%o~)FJewD!I;U I5$q$ Rd1 0/RM~wT7,4U@rI9i)Z4CCP*yKeKT82. Submitted comments may not be available to be read until the agency has approved them. i8U 2020-13278 Filed 6-18-20; 8:45 am], updated on 12:35 PM on Wednesday, January 18, 2023, updated on 8:45 AM on Wednesday, January 18, 2023. Thank you for taking the time to confirm your preferences. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. They help us to know which pages are the most and least popular and see how visitors move around the site. 0000051958 00000 n We take your privacy seriously. for better understanding how a document is structured but So let's answer those questions and clear up a few other items. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. This site displays a prototype of a Web 2.0 version of the daily edition of the Federal Register. On May 1, 2020, the National Institute for Occupational Safety and Health (NIOSH), within the Center for Disease Control and Prevention (CDC), opened a docket to obtain public input on the following draft documents: (1) NIOSH Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings (Procedures); (2) NIOSH List of Hazardous Drugs in Healthcare Settings, 2020 Until the ACFR grants it official status, the XML Organizational Affiliation: Office of the Director documents in the last year, 1487 March 23, 2022 This list is not all-inclusive and represents an assessment of some, but not all, marketed drugs at a fixed point in time. 0000022595 00000 n hb```C q|AdXCB>|gq]gWb-WWURuKX[a@@Taa2[CR*4(Mrl0))JA'V&=UX`GIsV3bIOP{Ff`JV-:-nf_1 b# }`p\l{Nxel\N0?(65B ECjH. The tables below provide the stakeholder reviews received regarding NIOSH's proposal to place or not place drugs on the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2018 (List). We take your privacy seriously. Stakeholders provided comments on each drug . endstream endobj startxref documents in the last year, 16 An additional 18 drugs were included from the updated NIH Hazardous Drug List. The National Institute for Occupational Safety and Health (NIOSH) Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings was published in September 2004. These cookies may also be used for advertising purposes by these third parties. As a result, drugs that required different protective measures were grouped together. 2016 NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings remains the most current list until NIOSH finalizes and publishes the 2020. include documents scheduled for later issues, at the request CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. Toxicology, Occupational Health, Industrial Hygiene, Reviewers Selected by: NIOSH, ASHP, ONS, ANA, VA, OSHA, FDA, PhRMA, and BIO, Public Nominations Requested for Reviewers: No, Opportunities for the Public to Comment: Yes, Peer Reviewers Provided with Public Comments Before Their Review: Yes, Cynthia Reilly documents in the last year, 946 Take part in a one-day public meeting in Washington, DC on August 28, 2007. First, any pharmacy that has any type of HD, as identified on the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016, needs to comply with USP <800>. 4762 0 obj <> endobj This prototype edition of the Requests to Add, Remove, or Move a Drug between Tables of the List The Procedures also sets forth procedures for a party to request that NIOSH: (1) add a new drug to the List; (2 . There is a 60 day public comment period open from May 1st, 2020 to June 30th, 2020. NIOSH defines a hazardous drug as any drug that possesses one or more of the following 6 characteristics: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity, organ toxicity at low doses, genotoxicity, or molecular similarity to a known hazardous drug. To view the draft document, visit https://www.federalregister.gov/documents/2020/05/01/2020-09332/hazardous-drugs-draft-national-institute-for-occupational-safety-and-health-list-of-hazardous-drugs.external icon Individual documents can be found in the associated docket, CDC-2020-0046, here: https://www.regulations.gov/docket?D=CDC-2020-0046external icon. 2016-161 (Supersedes 2014-138). A new format was developed for the 2014 list of hazardous drugs, as described below. documents in the last year, 973 Areas of Expertise, Discipline, or Relevant Experience: Pharmacology 06/18/2020 at 8:45 am. &Hc$y@?T&F!. 3|({` ) They help us to know which pages are the most and least popular and see how visitors move around the site. 112 0 obj <> endobj These markup elements allow the user to see how the document follows the If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance. Recommended by: Scientific or professional association, Melissa A. McDiarmid 0000069248 00000 n documents in the last year, 876 Academic and Professional Credentials: MD, MPH Merck & Co., Inc. CDC twenty four seven. You can review and change the way we collect information below. 141 0 obj <>stream Learn more here. Cookies used to make website functionality more relevant to you. 0000000896 00000 n 0000068481 00000 n Health care workers who prepare or administer hazardous drugs (e.g., those used for cancer therapy, and some antiviral drugs, hormone agents, and bioengineered drugs) or who work in areas where these drugs are used may be exposed to these agents in the workplace. documents in the last year, 117 and services, go to ET on July 30, 2020. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. The new drafts, entitled the Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings (Procedures) and the NIOSH List of Hazardous Drugs in Healthcare Settings, 2020 ( List) are found in the Supplemental Materials tab of the docket and are available for public comment, as discussed above. NIOSH is extending the comment period to close on July 30, 2020, to allow stakeholders and other interested parties additional time to respond. Agencies review all submissions and may choose to redact, or withhold, certain submissions (or portions thereof). This feature is not available for this document. documents in the last year. developer tools pages. Organizational Affiliation: Occupational and Environmental Health Sciences ``"v,5Y}p]]E2FGE2^,%~O ,%>2q >o-|E*!/bYDBFJ-2 The term hazardous drug (HD), refers to drugs found on the NIOSH list of Hazardous drugs.These drugs are listed due to being carcinogenic and/or for causing other toxic effects on humans. hWn8>/xN"nZGm5"gC#RjF6XOC` Academic and Professional Credentials: I.H. You will be subject to the destination website's privacy policy when you follow the link. A Notice by the Centers for Disease Control and Prevention on 06/19/2020. are not part of the published document itself. Academic and Professional Credentials: MN, RN, AOCN If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. documents in the last year, 28 0000014615 00000 n NIOSH requests public comment on the updated draft of the NIOSH List of Hazardous Drugs in Healthcare Settings, 2020, as well as the draft NIOSH Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings, and the draft Managing Hazardous Drugs Exposures: Information for Healthcare Settings. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance. In this Issue, Documents Areas of Expertise, Discipline, or Relevant Experience: Pharmacology Question: NIOSH HD list: Once NIOSH list is updated, will new HDs be added that have been FDA approved from 2016 -2020 or will it be added to NIOSH website notice? The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. B. Relevant information about this document from Regulations.gov provides additional context. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day. While NIOSH defines criteria and identifies hazardous drugs, USP developed standards for handling these hazardous drugs to minimize the risk to public health. Additional information for the 2016 update can be found at: Federal Register Notice Notice NIOSH requests public comment on the updated draft of the NIOSH List of Hazardous Drugs in Healthcare Settings, 2020, as well as the draft NIOSH Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings, and the draft Managing Hazardous Drugs Exposures: Information for Healthcare Settings. establishing the XML-based Federal Register as an ACFR-sanctioned This list supersedes the 2004 list in the NIOSH Alert: Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings and the 2014 list of hazardous drugs. These tools are designed to help you understand the official document If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. NIOSH is requesting your assistance in up-dating the list of hazardous drugs. If emailing please type 508 Accommodation PR#9342 without quotes in the subject line of the email. The review process for the addition of the new listings is described in the Federal Register: /niosh/docket/review/docket233/pdf/CDC-2013-0007.pdfpdf icon. 01/18/2023, 41 0 provide legal notice to the public or judicial notice to the courts. publication in the future. These cookies perform functions like remembering presentation options or choices and, in some cases, delivery of web content that based on self-identified area of interests. Cookies used to enable you to share pages and content that you find interesting on CDC.gov through third party social networking and other websites. (List), and (3) Managing Hazardous Drug Exposures: Information for Healthcare Settings. [PDF 32 KB] Required Elements for Initial Public Posting Title: NIOSH Update to the Hazardous Drug List (Appendix A) Subject: NIOSH Hazardous Drug List Purpose: To provide an update of the list of hazardous drugs in the Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance. Therefore, NIOSH considers these drugs to be included in Table 1 of the NIOSH list of hazardous drugs. fairport senior ball 2020 niosh 2021 hazardous . Areas of Expertise, Discipline, or Relevant Experience: Nursing The President of the United States communicates information on holidays, commemorations, special observances, trade, and policy through Proclamations. You can review and change the way we collect information below. They help us to know which pages are the most and least popular and see how visitors move around the site. endstream endobj startxref legal research should verify their results against an official edition of Organizational Affiliation: University of Maryland Register, and does not replace the official print version or the official Recommended by: Scientific or professional association, Vernon Wilkes )1kRM,e@aH:@B!4O84\:BL5eW?WG0/# H[bxqa0 Update on the NIOSH List of Hazardous Drugs in Healthcare Settings 2020, NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016, Closed System Drug-Transfer Device Research, Centers for Disease Control and Prevention.

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