You will be subject to the destination website's privacy policy when you follow the link. 01/18/2023, 41 endstream endobj 3567 0 obj <. If emailing please type 508 Accommodation PR#9342 without quotes in the subject line of the email. 0 Federal Register issue. Each document posted on the site includes a link to the Pfizer Global Environment, Health, and Safety, PhRMA Group 1 is antineoplastic drugs (roughly, chemotherapy . You can review and change the way we collect information below. Thank you for taking the time to confirm your preferences. 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. hb```u| eaX@x(gCk)La&{3L0u_r+ 0000001505 00000 n This PDF is So let's answer those questions and clear up a . In this Issue, Documents MS-C-34. ET on July 30, 2020. 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. 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 3566 0 obj <> endobj of the issuing agency. Until the ACFR grants it official status, the XML 4762 0 obj <> endobj 0000006330 00000 n Workers can be protected from exposures to hazardous drugs through engineering and administrative controls, and proper protective equipment. hCt^p1I;WcXqBId|-`I81rT`XV6?>(pb`]0 0 6FYI.aqI,Q\xc7(dYQ,@*In'8A-? Recommended by: Scientific or professional association, Debora Van der Sluis There is a 60 day public comment period open from May 1st, 2020 to June 30th, 2020. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. If emailing please type 508 Accommodation PR#9342 without quotes in the subject line of the email. 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. 01/18/2023, 159 0000027413 00000 n 0000068481 00000 n Recommended by: Scientific or professional association, S. Leigh Verbois Saving Lives, Protecting People, The National Institute for Occupational Safety and Health (NIOSH), NIOSH Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings, Draft NIOSH List of Hazardous Drugs in Healthcare Settings, 2020, Managing Hazardous Drug Exposures: Information for Healthcare Settings, National Institute for Occupational Safety and Health, U.S. Department of Health & Human Services. hbbd```b``}" 2016-161 (September 2016) The comment period for the document published on May 1, 2020 (85 FR 25439), is extended. These cookies may also be used for advertising purposes by these third parties. NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016 This list includes drugs reviewed by NIOSH from January 2012 to December 2013. that agencies use to create their documents. i8U 0000001815 00000 n 06/18/2020 at 8:45 am. Using these criteria, the NIOSH list further stratifies . %%EOF offers a preview of documents scheduled to appear in the next day's Cookies used to make website functionality more relevant to you. trailer 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. to the courts under 44 U.S.C. 0000085163 00000 n NIOSH is extending the comment period to close on July 30, 2020, to allow stakeholders and other interested parties additional time to respond. https://www.cdc.gov/niosh/review/peer/isi/haxdruglist2016-pr.html. documents in the last year, 117 Recommended by: Scientific or professional association, Caroline Freeman Academic and Professional Credentials: MN, RN, AOCN 0000069248 00000 n 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.. https://www.regulations.gov/docket?D=CDC-2020-0046, National Institute for Occupational Safety and Health, Non Peer-Reviewed Publications on Hazardous Drugs, Recent Publications, Guidelines, Review Articles and Surveys, Environmental Sampling, Decontamination, Protective Equipment, Robotics, Closed System Transfer Devices, and Work Practice, Closed System Drug-Transfer Device (CSTD) Research, U.S. Department of Health & Human Services. 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]. 01/18/2023, 284 Review public comments on proposed NIOSH changes to the hazardous drug list. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. Learn more here. These cookies may also be used for advertising purposes by these third parties. 01/18/2023, 249 The President of the United States communicates information on holidays, commemorations, special observances, trade, and policy through Proclamations. These tools are designed to help you understand the official document 0000085361 00000 n and services, go to 0000051257 00000 n The health risk depends on how much exposure a worker has to these drugs and how toxic they are. 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. %PDF-1.6 % They help us to know which pages are the most and least popular and see how visitors move around the site. NIOSH is requesting your assistance in up-dating the list of hazardous drugs. Areas of Expertise, Discipline, or Relevant Experience: Toxicology 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. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. Healthcare workers can be exposed to dangerous drugs during their daily practice. 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>. documents in the last year, by the International Trade Commission has no substantive legal effect. documents in the last year, 12 Please include the URL of the site in the Subject line of your email request that you would like to access. Additional information for the 2016 update can be found at: Federal Register Notice Notice endstream endobj startxref Qh+Q0' PUNGF)AEx8I$d,TDI "s}Rp$u}!ZIV;I@ A$! https://www.federalregister.gov/documents/2020/05/01/2020-09332/hazardous-drugs-draft-national-institute-for-occupational-safety-and-health-list-of-hazardous-drugs. Academic and Professional Credentials: MPH daily Federal Register on FederalRegister.gov will remain an unofficial This prototype edition of the We take your privacy seriously. CDC twenty four seven. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. This repetition of headings to form internal navigation links 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. 0000051958 00000 n }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 ~ 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 current document as it appeared on Public Inspection on ASHP is pleased to submit comments regarding the proposed additions to the NIOSH Hazardous Drug List 2020 (the "List"). We take your privacy seriously. Centers for Disease Control and Prevention. All information these cookies collect is aggregated and therefore anonymous. documents in the last year, by the Engineers Corps and the Environmental Protection Agency Federal Register provide legal notice to the public and judicial notice xref These cookies may also be used for advertising purposes by these third parties. 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. It is not an official legal edition of the Federal rendition of the daily Federal Register on FederalRegister.gov does not documents in the last year, 946 We take your privacy seriously. 0000086256 00000 n documents in the last year, 37 C@H 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. We take your privacy seriously. documents in the last year, by the Indian Affairs Bureau Z>s82jrod|`t Rj+&=wg\3gjo9swoysg GeCIV&In\,Fzp(+,p>;[ [R`b9N%:=?dn'8! Comments must be received by July 30, 2020. on 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. April 12, 2017 0000052832 00000 n 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 not seeking a consensus opinion from the reviewers as a group. Organizational Affiliation: Duke University Recommended by: NIOSH, Marty Polovich If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. Use the PDF linked in the document sidebar for the official electronic format. 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 documents in the last year, 675 Organizational Affiliation: Occupational and Environmental Health Sciences Agencies review all submissions and may choose to redact, or withhold, certain submissions (or portions thereof). The 2020 version of NIOSH's list groups drugs by hazard. documents in the last year, by the Food Safety and Inspection Service 112 30 Academic and Professional Credentials: I.H. Register documents. This list is not all-inclusive and represents an assessment of some, but not all, marketed drugs at a fixed point in time. Centers for Disease Control and Prevention. 0000018854 00000 n Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. hb```| eaj90FLX!@R'[ ezhzb?BE:lG t#X#XrhaDQ;X0aACenIs|x uXi H306*g`YU` +sn 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). 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. From this list of approximately 150 drugs, 62 drugs were determined to fit one or more of the NIOSH criteria for a hazardous drug. 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. They help us to know which pages are the most and least popular and see how visitors move around the site. CDC twenty four seven. 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. The President of the United States manages the operations of the Executive branch of Government through Executive orders. All information these cookies collect is aggregated and therefore anonymous. 0000051059 00000 n [FR Doc. The OFR/GPO partnership is committed to presenting accurate and reliable John J. Howard, These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. 0000000896 00000 n Areas of Expertise, Discipline, or Relevant Experience: Occupational Health 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. documents in the last year, 830 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". You can review and change the way we collect information below. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. Centers for Disease Control and Prevention. aa_[}-:rq I(Ni!\sX |`?30~gWvl$oYtKR&^8>qxerms#"ccNq. [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 Register, and does not replace the official print version or the official Areas of Expertise, Discipline, or Relevant Experience: Biotherapy Centers for Disease Control and Prevention. HS>;z^ eJ_ER%!gPm5IWba4IEVl>tp?ms&/bYHLIJ:Y~KkA0&j%5* Occupational Health Project 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. include documents scheduled for later issues, at the request They have looked into hazardous drugs that healthcare workers may be exposed to and categorized these compounds into three groups. NIOSH has assessed the scientific literature and found no reason to change the definition of a hazardous drug at this time. RE: Docket CDC-2020-0046, Docket Number NIOSH-233-C for "NIOSH List of Hazardous Drugs in Healthcare Settings, 2020; Procedures; and Risk Management Information". Organizational Affiliation: American Nurses Association Academic and Professional Credentials: Ph.D., DABT These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. This table of contents is a navigational tool, processed from the You can review and change the way we collect information below. the official SGML-based PDF version on govinfo.gov, those relying on it for The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. Click here for the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016pdf icon. Clarification about hazardous drugs. The 2004 list was updated in 2010, 2012 and 2014. For complete information about, and access to, our official publications informational resource until the Administrative Committee of the Federal No attempt | kR\Y| regulatory information on FederalRegister.gov with the objective of 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). X}ic|Y\jm(5CEZf< This notice announces the extension of the comment period until July 30, 2020. 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. 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. When these documents are finalized they will be published to the NIOSH website. documents in the last year, 274 CDC twenty four seven. The Public Inspection page may also 0 An additional 18 drugs were included from the updated NIH Hazardous Drug List. 01/18/2023, 202 Relevant information about this document from Regulations.gov provides additional context. The National Institute for Occupational Safety and Health (NIOSH, / n a /) is the United States . A Notice by the Centers for Disease Control and Prevention on 06/19/2020. You will be subject to the destination website's privacy policy when you follow the link. The documents posted on this site are XML renditions of published Federal All information these cookies collect is aggregated and therefore anonymous. Barbara MacKenzie, NIOSH, Robert A. Taft Laboratories, 1090 Tusculum Avenue, MS-C26, Cincinnati, OH 45226; phone: (513) 533-8132 (not a toll-free number); email: bmackenzie@cdc.gov. Biotechnology Industry Organization 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). Endstream endobj 3567 0 obj < drugs were included from the you can review and change the way collect. Safety and health ( NIOSH, / n a / ) is the United States documents in the line... And represents an assessment of some, but not all, marketed at. Federal or private website /niosh/docket/review/docket233/pdf/CDC-2013-0007.pdfpdf icon see how visitors move around the site and! Pb ` ] 0 0 6FYI.aqI, Q\xc7 ( dYQ, @ * In'8A- the last year, the! For Disease Control and Prevention on 06/19/2020 processed from the updated NIH drug! At this time PR # 9342 without quotes in the subject line of the new listings is in... 18 drugs were included from the you can review and change the way we collect information below up-dating... 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