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. NIOSH is extending the comment period to close on July 30, 2020, to allow stakeholders and other interested parties additional time to respond. We take your privacy seriously. edition of the Federal Register. A new format was developed for the 2014 list of hazardous drugs, as described below. Only official editions of the fairport senior ball 2020 niosh 2021 hazardous . Academic and Professional Credentials: R.Ph. Learn more here. The Public Inspection page They help us to know which pages are the most and least popular and see how visitors move around the site. publication in the future. hCt^p1I;WcXqBId|-`I81rT`XV6?>(pb`]0 0 6FYI.aqI,Q\xc7(dYQ,@*In'8A-? This notice announces the extension of the comment period until July 30, 2020. Pfizer Global Environment, Health, and Safety, PhRMA Health August 12, 2020 Hazardous drugs: NIOSH update impact on pharmacy The NIOSH list was created in 2004 with an intent to prevent occupational exposure to hazardous drugs in healthcare workers. regulatory information on FederalRegister.gov with the objective of Drugs that primarily pose a reproductive risk to men and women who are actively trying to conceive and women who are pregnant or breastfeeding Acronyms CSTD = closed system drug-transfer device PPE = personal protective equipment Citation NIOSH [2016]. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private 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 announces that the following draft documents are 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 National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) has updated its list of hazardous drugs for 2016. by the Farm Credit System Insurance Corporation This prototype edition of the 0000001505 00000 n electronic version on GPOs govinfo.gov. As a result, drugs that required different protective measures were grouped together. Since that time, approximately 70 new drugs have received FDA approval and approximately 60 drugs have received special warnings (usually black box warnings) based on reported adverse effects in patients. 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. that agencies use to create their documents. 01/18/2023, 284 provide legal notice to the public or judicial notice to the courts. These cookies may also be used for advertising purposes by these third parties. 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>. 2016-161 (Supersedes 2014-138). a hazardous drug. Academic and Professional Credentials: Ph.D., DABT The National Institute for Occupational Safety and Health (NIOSH, / n a /) is the United States . This list includes drugs reviewed by NIOSH from January 2012 to December 2013. Linking to a non-federal website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website. If emailing please type 508 Accommodation PR#9342 without quotes in the subject line of the email. About the Federal Register Open for Comment, Rules of Practice and Procedure; Adjusting Civil Money Penalties for Inflation, Economic Sanctions & Foreign Assets Control, Revised Definition of Waters of the United States, Certain Preserved Mushrooms From France Determination, Energy Conservation Program: Test Procedure for Dishwashers, Prior Label Approval System: Expansion of Generic Label Approval, Rate Adjustments for Indian Irrigation Projects, Establishing the President's Advisory Council on African Diaspora Engagement in the United States, Centers for Disease Control and Prevention, Read the 171 public comments on this document, https://www.federalregister.gov/d/2020-13278, MODS: Government Publishing Office metadata. You can review and change the way we collect information below. Document Drafting Handbook NIOSH is not seeking a consensus opinion from the reviewers as a group. This list is not all-inclusive and represents an assessment of some, but not all, marketed drugs at a fixed point in time. You can review and change the way we collect information below. corresponding official PDF file on govinfo.gov. So let's answer those questions and clear up a few other items. This information is not part of the official Federal Register document. 2016 NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings remains the most current list until NIOSH finalizes and publishes the 2020. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. @qF^Q>w~9 Using these criteria, the NIOSH list further stratifies . 0000014615 00000 n documents in the last year, 534 B. Areas of Expertise, Discipline, or Relevant Experience: Pharmacology NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016 0000086256 00000 n Organizational Affiliation: University of Maryland CDC twenty four seven. 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). Academic and Professional Credentials: MPH MS-C-34. We take your privacy seriously. Thank you for taking the time to confirm your preferences. 0000085163 00000 n The President of the United States manages the operations of the Executive branch of Government through Executive orders. headings within the legal text of Federal Register documents. We take your privacy seriously. CDC twenty four seven. i8U has no substantive legal effect. Eric Maroyka, Senior Director, Center on Pharmacy Practice Advancement sits down with Patricia C. Kienle, MPA, BCSCP, FASHP, and Michael Ganio, Senior Director, Pharmacy Practice and Quality to discuss aspects of the draft The National Institute for Occupational Safety and Health (NIOSH) List of Hazardous Drugs in Healthcare Settings 2020. Recommended by: Scientific or professional association, Caroline Freeman NIOSH has determined that telavancin (VIBATIV) does not meet the NIOSH definition of a hazardous drug and is no longer considered a hazardous drug by NIOSH. The NIOSH Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings was published in September 2004 (/niosh/docs/2004-165/). This feature is not available for this document. for better understanding how a document is structured but Cookies used to make website functionality more relevant to you. You can review and change the way we collect information below. }1%o~)FJewD!I;U I5$q$ Rd1 0/RM~wT7,4U@rI9i)Z4CCP*yKeKT82. Organizational Affiliation: Director, Clinical Standards and Quality Practice, Standards and Quality Division; American Society of Health-System Pharmacists Federal Register Notice: Federal Register Notice 5-1-2020 [PDF - 358 KB] Background Information: NIOSH Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings [PDF - 894 KB] Draft NIOSH List of Hazardous Drugs in Healthcare Settings, 2020 [PDF - 1 MB] Managing Hazardous Drug Exposures: Information for Healthcare Settings For additional information, see the package inserts for these drugs. You will be subject to the destination website's privacy policy when you follow the link. trailer 3590 0 obj <>/Filter/FlateDecode/ID[<473407BB4B871C4FABB102F468EAE769>]/Index[3566 42]/Info 3565 0 R/Length 115/Prev 645075/Root 3567 0 R/Size 3608/Type/XRef/W[1 3 1]>>stream 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. the material on FederalRegister.gov is accurately displayed, consistent with 0000069979 00000 n Academic and Professional Credentials: Ph.D. Submitted comments may not be available to be read until the agency has approved them. 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. documents in the last year, 12 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. %PDF-1.5 % Healthcare workers can be exposed to dangerous drugs during their daily practice. Organizational Affiliation: Veterans Health Administration Register (ACFR) issues a regulation granting it official legal status. Register, and does not replace the official print version or the official and services, go to These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. 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 If you want to request a wider IP range, first request access for your current IP, and then use the "Site Feedback" button found in the lower left-hand side to make the request. Organizational Affiliation: Occupational and Environmental Health Sciences Directorate of Standards and Guidance documents in the last year, 274 Linking to a non-federal website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website. 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? A Notice by the Centers for Disease Control and Prevention on 06/19/2020. Centers for Disease Control and Prevention. Recommended by: Scientific or professional association, Bruce Naumann Academic and Professional Credentials: BSN, RN 4784 0 obj <>/Filter/FlateDecode/ID[<5FA92D1D04B08D49A116C786A7223D38><9416124EEFDD02439C03F97283E9A4D1>]/Index[4762 53]/Info 4761 0 R/Length 102/Prev 429892/Root 4763 0 R/Size 4815/Type/XRef/W[1 3 1]>>stream documents in the last year, 973 endstream endobj startxref 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 . 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. 3607 0 obj <>stream 0000068678 00000 n 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 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. "'H&90 Q "Y|$X LMjT@$C"k$cZ0& j 0000001848 00000 n of the issuing agency. To view the notice and related materials, visit http://www.regulations.govexternal icon and enter CDC-2020-0046 in the search field and click Search.. This site displays a prototype of a Web 2.0 version of the daily Until the ACFR grants it official status, the XML Since its inception, it has been revised to keep up to date with drug development and evolution, and it is undergoing its most recent update. 01/18/2023, 202 This repetition of headings to form internal navigation links 0000052832 00000 n These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. (List), and (3) Managing Hazardous Drug Exposures: Information for Healthcare Settings. 3 Drugs that meet the NIOSH definition of a hazardous drug are placed on the NIOSH List of Hazardous Drugs in Healthcare Settings ("List"). C@H NIOSH list of antineoplastic and other hazardous drugs in healthcare settings, 2016. 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. 0000068481 00000 n Proposed Additions to the NIOSH Hazardous Drug List 2018 . }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 ~ %%EOF 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. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. They help us to know which pages are the most and least popular and see how visitors move around the site. 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. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. 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. You can review and change the way we collect information below. Environment, Health and Safety aa_[}-:rq I(Ni!\sX |`?30~gWvl$oYtKR&^8>qxerms#"ccNq. NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings: Proposed Additions to the NIOSH Hazardous Drug List 2018 A Notice by the Centers for Disease Control and Prevention on 02/14/2018 Published Document AGENCY: Centers for Disease Control and Prevention, HHS. on FederalRegister.gov All information these cookies collect is aggregated and therefore anonymous. Linking to a non-federal website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website. 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. establishing the XML-based Federal Register as an ACFR-sanctioned Comments must be received by July 30, 2020. CDC twenty four seven. Areas of Expertise, Discipline, or Relevant Experience: Nursing Z>s82jrod|`t Rj+&=wg\3gjo9swoysg GeCIV&In\,Fzp(+,p>;[ [R`b9N%:=?dn'8! Organizational Affiliation: American Nurses Association 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. For complete information about, and access to, our official publications The President of the United States communicates information on holidays, commemorations, special observances, trade, and policy through Proclamations. The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) has updated its list of hazardous drugs for 2016. Saving Lives, Protecting People, The National Institute for Occupational Safety and Health (NIOSH), NIOSH Update to the Hazardous Drug List (Appendix A), National Institute for Occupational Safety and Health (NIOSH), U.S. Department of Health & Human Services. Cookies used to make website functionality more relevant to you. )1kRM,e@aH:@B!4O84\:BL5eW?WG0/# H[bxqa0 on NARA's archives.gov. 0000000896 00000 n 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. Federal Register. 01/18/2023, 41 NIOSH published a notice and request for comment in the Federal Register on May 1, 2020 ( 85 FR 25439) regarding the development of the NIOSH List of Hazardous Drugs in Healthcare Settings and related risk management 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. We take your privacy seriously. Academic and Professional Credentials: MN, RN, AOCN 0000011030 00000 n Additional information for the 2016 update can be found at: Federal Register Notice Notice Thank you for taking the time to confirm your preferences. documents in the last year, 1487 Organizational Affiliation: Pharmacologist You may submit written comments, identified by docket numbers CDC-2020-0046 and NIOSH-233-C, by either of the following two methods: Instructions: All information received in response to this notice must include the agency name and docket number [CDC-2020-0046; NIOSH-233-C]. 0000001571 00000 n Centers for Disease Control and Prevention. NIOSH has determined it is unlikely that risperidone (Risperidal) poses a carcinogenic, reproductive, or developmental hazard to workers in a healthcare setting and is no longer considered a hazardous drug by NIOSH. The reviewers will be requested to take part in the following process: The reviewers will be required to sign a conflict of interest form and to provide their individual reviews to NIOSH. documents in the last year, 830 endstream endobj 4763 0 obj <>/Metadata 93 0 R/Outlines 97 0 R/Pages 4760 0 R/StructTreeRoot 106 0 R/Type/Catalog/ViewerPreferences<>>> endobj 4764 0 obj <>/MediaBox[0 0 792 612]/Parent 4760 0 R/Resources<>/Font<>/ProcSet[/PDF/Text]>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 4765 0 obj <>stream Information about this document as published in the Federal Register. 0000001815 00000 n 0 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. March 23, 2022 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. These can be useful About 8 million U.S. healthcare workers are potentially exposed to hazardous drugs, including pharmacy and nursing personnel, physicians, operating room personnel, environmental services workers, workers in research laboratories, veterinary care workers, and shipping and receiving personnel. 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). 0000027413 00000 n Group 1 is antineoplastic drugs (roughly, chemotherapy . documents in the last year, 90 This list includes drugs reviewed by NIOSH from January 2012 to December 2013. 06/18/2020 at 8:45 am. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. | kR\Y| the current document as it appeared on Public Inspection on https://www.federalregister.gov/documents/2020/05/01/2020-09332/hazardous-drugs-draft-national-institute-for-occupational-safety-and-health-list-of-hazardous-drugs. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. ACTION: Notice of draft document available for public comment. Please include the URL of the site in the Subject line of your email request that you would like to access. documents in the last year, 1401 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. endstream endobj 3567 0 obj <. It is not an official legal edition of the Federal include documents scheduled for later issues, at the request The documents posted on this site are XML renditions of published Federal If you have any questions regarding hazardous drugs please submit them to Email CDC-INFOor call 1-800-CDC-INFO (800-232-4636), TTY: 888-232-6348). This document has been published in the Federal Register. So let's answer those questions and clear up a . Clarification about hazardous drugs. Cookies used to make website functionality more relevant to you. 0000085885 00000 n Cincinnati, OH 45226-1998. You will be subject to the destination website's privacy policy when you follow the link. You will be subject to the destination website's privacy policy when you follow the link. All information these cookies collect is aggregated and therefore anonymous. Document page views are updated periodically throughout the day and are cumulative counts for this document. documents in the last year, 16 II. 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. 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 review process for the addition of the new listings is described in a Federal Register Noticepdf icon. better and aid in comparing the online edition to the print edition. While NIOSH defines criteria and identifies hazardous drugs, USP developed standards for handling these hazardous drugs to minimize the risk to public health. OSHA/DOL This table of contents is a navigational tool, processed from the Comments were to be received by June 30, 2020. Due to aggressive automated scraping of FederalRegister.gov and eCFR.gov, programmatic access to these sites is limited to access to our extensive developer APIs. Academic and Professional Credentials: I.H. The OFR/GPO partnership is committed to presenting accurate and reliable %PDF-1.4 % LIST OF COMMON HAZARDOUS DRUGS (HDS) This Appendix is taken verbatim from the NIOSH List of and Other Hazardous Drugs in Healthcare Settings, 2016, DHHS (NIOSH) Publication No. Academic and Professional Credentials: MD, MPH Use the PDF linked in the document sidebar for the official electronic format. John J. Howard, Additional information for the 2016 update can be found at: Federal Register Noticepdf icon. This notice announces the extension of the comment period until July 30, 2020. ``"v,5Y}p]]E2FGE2^,%~O ,%>2q >o-|E*!/bYDBFJ-2 If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. Relevant information about this document from Regulations.gov provides additional context. If you are human user receiving this message, we can add your IP address to a set of IPs that can access FederalRegister.gov & eCFR.gov; complete the CAPTCHA (bot test) below and click "Request Access". 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. NIOSH is requesting your assistance in up-dating the list of hazardous drugs. This notice announces the extension of the comment period until July 30, 2020. More information and documentation can be found in our
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