Academic and Professional Credentials: Ph.D., DABT CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. 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, 12 Recommended by: Scientific or professional association, Bruce Naumann You can review and change the way we collect information below. Take part in a one-day public meeting in Washington, DC on August 28, 2007. documents in the last year, 1487 Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. Centers for Disease Control and Prevention. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. Academic and Professional Credentials: MN, RN, AOCN [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 The President of the United States communicates information on holidays, commemorations, special observances, trade, and policy through Proclamations. Using these criteria, the NIOSH list further stratifies . Exposure to hazardous drugs can result in adverse health effects in healthcare workers. 3607 0 obj <>stream 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. C@H 0000086256 00000 n https://www.federalregister.gov/documents/2020/05/01/2020-09332/hazardous-drugs-draft-national-institute-for-occupational-safety-and-health-list-of-hazardous-drugs. All relevant comments received will be posted without change to http://www.regulations.gov,, including any personal information provided. Document page views are updated periodically throughout the day and are cumulative counts for this document. | kR\Y| )1kRM,e@aH:@B!4O84\:BL5eW?WG0/# H[bxqa0 on of the issuing agency. documents in the last year, by the Energy Department informational resource until the Administrative Committee of the Federal Director, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. Thank you for taking the time to confirm your preferences. NIOSH is not seeking a consensus opinion from the reviewers as a group. 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. fairport senior ball 2020 niosh 2021 hazardous . 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. Merck & Co., Inc. If emailing please type 508 Accommodation PR#9342 without quotes in the subject line of the email. "'H&90 Q "Y|$X LMjT@$C"k$cZ0& j 01/18/2023, 823 Academic and Professional Credentials: Ph.D., DABT 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 you are using public inspection listings for legal research, you 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 CDC twenty four seven. 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. documents in the last year, 534 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. Cookies used to make website functionality more relevant to you. Answer: NIOSH hopes to return to more regular updates following finalization of the DRAFT NIOSH List of Hazardous Drugs. endstream endobj 3567 0 obj <. You can review and change the way we collect information below. 0000001948 00000 n We take your privacy seriously. Organizational Affiliation: Veterans Health Administration Areas of Expertise, Discipline, or Relevant Experience: legal research should verify their results against an official edition of There is a 60 day public comment period open from May 1st, 2020 to June 30th, 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. 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. These cookies may also be used for advertising purposes by these third parties. developer tools pages. on FederalRegister.gov This information is not part of the official Federal Register document. 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. The NIOSH definition of hazardous drugs used in the Alert is based on a definition originally devel-oped in 1990 by the American Society of Hospital Additional information for the 2016 update can be found at: Federal Register Notice Notice has no substantive legal effect. 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 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) is the federal agency that oversees research, data, and analysis on workplace hazards. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. For additional information, see the package inserts for these drugs. the official SGML-based PDF version on govinfo.gov, those relying on it for CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. 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". 06/18/2020 at 8:45 am. Defining Hazardous Drugs Hazardous drugs include those used for cancer che - motherapy, antiviral drugs, hormones, some bio-engineered drugs, and other miscellaneous drugs. documents in the last year, 830 They help us to know which pages are the most and least popular and see how visitors move around the site. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. 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. 01/18/2023, 249 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. Organizational Affiliation: American Nurses Association xref documents in the last year, 274 NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016 Recommended by: Scientific or professional association, S. Leigh Verbois The Public Inspection page may also 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. hbbd```b``6zj_&@$r1Ik0l`c0Y publication in the future. should verify the contents of the documents against a final, official These cookies may also be used for advertising purposes by these third parties. 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. electronic version on GPOs govinfo.gov. So let's answer those questions and clear up a few other items. 0000001571 00000 n Academic and Professional Credentials: R.Ph. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. CDC twenty four seven. Centers for Disease Control and Prevention. This list includes drugs reviewed by NIOSH from January 2012 to December 2013. Healthcare workers can be exposed to dangerous drugs during their daily practice. hb```u| eaX@x(gCk)La&{3L0u_r+ 0000001505 00000 n The review process for the addition of the new listings is described in a Federal Register Noticepdf icon. rendition of the daily Federal Register on FederalRegister.gov does not Second, in USP <800> there are different elements for those retail pharmacies that only dispense . This table of contents is a navigational tool, processed from the Document Drafting Handbook Review public comments on proposed NIOSH changes to the hazardous drug list. 0000069979 00000 n Areas of Expertise, Discipline, or Relevant Experience: Biotherapy DHHS (NIOSH) Publication No. 0000068678 00000 n MS-C-34. 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. This list is not all-inclusive and represents an assessment of some, but not all, marketed drugs at a fixed point in time. Relevant information about this document from Regulations.gov provides additional context. B. on The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. The 2004 list was updated in 2010, 2012 and 2014. documents in the last year. The National Institute for Occupational Safety and Health (NIOSH) considers "hazardous drugs" as those that had shown one or more of the following characteristic in studies with animals, humans or in vitro systems: carcinogenicity, teratogenicity or other toxicity for development, reproductive toxicity, organ . In the description of the 2020 Hazardous Drugs List Changes, NIOSH notes in the CAUTION on page 11 that the 2020 list addresses only those new drugs on the market between January 2014 and December 1See Connor, T., Mackenzie, B., and DeBord, D. (2012). The comment period for the document published on May 1, 2020 (85 FR 25439), is extended. Title: NIOSH Update to the Hazardous Drug List (Appendix A), 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, Primary Disciplines or Expertise Needed for Review: Pharmacy, Nursing, Pharmacology, They help us to know which pages are the most and least popular and see how visitors move around the site. 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]. Academic and Professional Credentials: Ph.D. 3566 0 obj <> endobj Cookies used to make website functionality more relevant to you. 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. regulatory information on FederalRegister.gov with the objective of Areas of Expertise, Discipline, or Relevant Experience: Nursing The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. Growing evidence highlights that acute and chronic health effects can occur due to occupational exposure to over 200 hazardous drugs used commonly in healthcare settings. Thank you for taking the time to confirm your preferences. The format for the 2014 list was revised to include three groups of hazardous drugs: (1) Antineoplastic drugs; (2) Non-antineoplastic hazardous drugs; and (3) Drugs with reproductive effects. 141 0 obj <>stream 01/18/2023, 41 Federal Register issue. They help us to know which pages are the most and least popular and see how visitors move around the site. X}ic|Y\jm(5CEZf< 0000051257 00000 n For complete information about, and access to, our official publications 0000052832 00000 n 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? We take your privacy seriously. to the courts under 44 U.S.C. Recommended by: Scientific or professional association, Debora Van der Sluis Proposed Additions to the NIOSH Hazardous Drug List 2018 . Pfizer Global Environment, Health, and Safety, PhRMA The documents posted on this site are XML renditions of published Federal 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). Recommended by: Scientific or professional association, Melissa A. McDiarmid 0 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. Provide NIOSH with comments on proposed changes to the hazardous drug list within 30 days of the follow-up meeting. Organizational Affiliation: Senior Manager, Product Stewardship Programs These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. NIOSH is extending the comment period to close on July 30, 2020, to allow stakeholders and other interested parties additional time to respond. 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. documents in the last year, by the Indian Affairs Bureau 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. You can review and change the way we collect information below. 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. 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 Stakeholders provided comments on each drug . Register documents. Cookies used to make website functionality more relevant to you. Thank you for taking the time to confirm your preferences. on A new format was developed for the 2014 list of hazardous drugs, as described below. %PDF-1.4 % 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. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day. All information these cookies collect is aggregated and therefore anonymous. 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 has assessed the scientific literature and found no reason to change the definition of a hazardous drug at this time. Areas of Expertise, Discipline, or Relevant Experience: Nursing @qF^Q>w~9 documents in the last year, 117 March 23, 2022 CDC twenty four seven. This list includes drugs reviewed by NIOSH from January 2012 to December 2013. This PDF is Federal Register. Areas of Expertise, Discipline, or Relevant Experience: Pharmacology Clarification about hazardous drugs. 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. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. 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. documents in the last year, 84 They have looked into hazardous drugs that healthcare workers may be exposed to and categorized these compounds into three groups. 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 will be subject to the destination website's privacy policy when you follow the link. include documents scheduled for later issues, at the request ASHP is pleased to submit comments regarding the proposed additions to the NIOSH Hazardous Drug List 2020 (the "List"). If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. 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. 0000006330 00000 n 0000001848 00000 n Areas of Expertise, Discipline, or Relevant Experience: Toxicology Recommended by: Scientific or professional association. Academic and Professional Credentials: MPH edition of the Federal Register. (List), and (3) Managing Hazardous Drug Exposures: Information for Healthcare Settings. offers a preview of documents scheduled to appear in the next day's %%EOF 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. January 10th, 2019 Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. Recommended by: Scientific or professional association, Vernon Wilkes establishing the XML-based Federal Register as an ACFR-sanctioned 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 . Recommended by: NIOSH, Chuck Schwartz Environment, Health and Safety 4762 0 obj <> endobj Workers can be protected from exposures to hazardous drugs through engineering and administrative controls, and proper protective equipment. These can be useful documents in the last year, 1401 2016 NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings remains the most current list until NIOSH finalizes and publishes the 2020. aa_[}-:rq I(Ni!\sX |`?30~gWvl$oYtKR&^8>qxerms#"ccNq. Organizational Affiliation: Duke University 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). Each document posted on the site includes a link to the Saving Lives, Protecting People, The National Institute for Occupational Safety and Health (NIOSH). 0000085163 00000 n Cookies used to make website functionality more relevant to you. This list includes drugs reviewed by NIOSH from January 2012 to December 2013. OSHA/DOL NIOSH list of antineoplastic and other hazardous drugs in healthcare settings, 2016. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. 0000000896 00000 n i8U 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 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. by the Farm Credit System Insurance Corporation provide legal notice to the public or judicial notice to the courts. documents in the last year, 946 Centers for Disease Control and Prevention. You can review and change the way we collect information below. School of Medicine Academic and Professional Credentials: Ph.D. However NIOSH has always had some delay in time between new . No attempt Areas of Expertise, Discipline, or Relevant Experience: Pharmacy documents in the last year, 28 Organizational Affiliation: Occupational and Environmental Health Sciences 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. 01/18/2023, 159 ET on July 30, 2020. CDC twenty four seven. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. 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. 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>. 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. Organizational Affiliation: Director, Toxicology and Hazard Communication Centers for Disease Control and Prevention, HHS. documents in the last year, 90 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. New Documents 0000011030 00000 n 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. 0 <<64B9B5CCA72D9D43827396971D79AAF9>]/Prev 916310>> 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. 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 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]. endstream endobj startxref They help us to know which pages are the most and least popular and see how visitors move around the site. on 0000051958 00000 n These cookies may also be used for advertising purposes by these third parties. 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. Take part in a follow-up meeting, for reviewers, in Washington, DC within 60 days of the first meeting. CDC twenty four seven. While NIOSH defines criteria and identifies hazardous drugs, USP developed standards for handling these hazardous drugs to minimize the risk to public health. 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. hCt^p1I;WcXqBId|-`I81rT`XV6?>(pb`]0 0 6FYI.aqI,Q\xc7(dYQ,@*In'8A-? the current document as it appeared on Public Inspection on 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. for better understanding how a document is structured but 112 30 %PDF-1.5 % The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. 0000001815 00000 n Areas of Expertise, Discipline, or Relevant Experience: Occupational Health Comments must be received by July 30, 2020. Genentech, Inc. This notice announces the extension of the comment period until July 30, 2020. An additional 18 drugs were included from the updated NIH Hazardous Drug List. In fact, published studies have shown that workplace exposures to hazardous drugs can cause both acute and chronic health effects such as skin rashes, adverse reproductive outcomes (including infertility, spontaneous abortions, and congenital malformations), and possibly leukemia and other cancers. Qh+Q0' PUNGF)AEx8I$d,TDI "s}Rp$u}!ZIV;I@ A$! documents in the last year, by the Engineers Corps and the Environmental Protection Agency 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). Organizational Affiliation: Pharmacologist 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. documents in the last year, 675 So let's answer those questions and clear up a . This repetition of headings to form internal navigation links better and aid in comparing the online edition to the print edition. About the Federal Register All information these cookies collect is aggregated and therefore anonymous. 1090 Tusculum Avenue. 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 . 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. %%EOF documents in the last year, 876 HS>;z^ eJ_ER%!gPm5IWba4IEVl>tp?ms&/bYHLIJ:Y~KkA0&j%5* Academic and Professional Credentials: MD, MPH 3 Drugs that meet the NIOSH definition of a hazardous drug are placed on the NIOSH List of Hazardous Drugs in Healthcare Settings ("List"). The current update (2016) adds 34 drugs and includes a review of the 2004 list. &Hc$y@?T&F!. 3|({` ) Register (ACFR) issues a regulation granting it official legal status. hWn8>/xN"nZGm5"gC#RjF6XOC` 0000069248 00000 n 0000051059 00000 n 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. 0000027413 00000 n Occupational Health Project 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, 37 0000026925 00000 n documents in the last year, 480 All information these cookies collect is aggregated and therefore anonymous. Thank you for taking the time to confirm your preferences. 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. The OFR/GPO partnership is committed to presenting accurate and reliable We take your privacy seriously. hbbd```b``}" 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 Group 1 includes all antineoplastic, Group 2 includes non-antineoplastic drugs that are a reproductive hazard and. 0000001905 00000 n 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. It is not an official legal edition of the Federal Organizational Affiliation: Office of the Director The Public Inspection page 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. [FR Doc. Federal Register provide legal notice to the public and judicial notice %%EOF Division of Drug Oncology Products, FDA Recommended by: Scientific or professional association, Caroline Freeman An official website of the United States government. As a result, drugs that required different protective measures were grouped together. You will be subject to the destination website's privacy policy when you follow the link. 0000090514 00000 n In Appendix A of the Alert, NIOSH identified a sample list of major hazardous drugs. 0000068481 00000 n daily Federal Register on FederalRegister.gov will remain an unofficial This should only be necessary once for each IP address you access the site from. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. The President of the United States issues other types of documents, including but not limited to; memoranda, notices, determinations, letters, messages, and orders. 0000018854 00000 n Saving Lives, Protecting People, The National Institute for Occupational Safety and Health (NIOSH), Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings, /niosh/docket/review/docket233/pdf/CDC-2013-0007.pdf, NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016, National Institute for Occupational Safety and Health, Fatality Assessment and Control Evaluation Reports (FACE), Firefighter Fatality Investigation Reports, U.S. Department of Health & Human Services. 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. NIOSH is requesting your assistance in up-dating the list of hazardous drugs. Agencies review all submissions and may choose to redact, or withhold, certain submissions (or portions thereof). startxref This prototype edition of the 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. April 12, 2017 This site displays a prototype of a Web 2.0 version of the daily Click here for the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016pdf icon. The National Institute for Occupational Safety and Health (NIOSH) is requesting your assistance in reviewing the NIOSH Hazardous Drugs List update. 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. endstream endobj startxref II. Thank you for taking the time to confirm your preferences. You will be subject to the destination website's privacy policy when you follow the link. 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. Only official editions of the 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. 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., Comments will be accepted until 11:59 p.m. 2016-161 (September 2016) These cookies may also be used for advertising purposes by these third parties. 1503 & 1507. 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. hb```| eaj90FLX!@R'[ ezhzb?BE:lG t#X#XrhaDQ;X0aACenIs|x uXi H306*g`YU` +sn We take your privacy seriously. 112 0 obj <> endobj on NARA's archives.gov. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. Cookies used to make website functionality more relevant to you. The health risk depends on how much exposure a worker has to these drugs and how toxic they are. 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. https://www.cdc.gov/niosh/review/peer/isi/haxdruglist2016-pr.html. 0000085361 00000 n 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). This feature is not available for this document. Areas of Expertise, Discipline, or Relevant Experience: Pharmacology All information these cookies collect is aggregated and therefore anonymous. You can review and change the way we collect information below. documents in the last year, 973 You will be subject to the destination website's privacy policy when you follow the link. are not part of the published document itself. Submitted comments may not be available to be read until the agency has approved them. "Antineoplastic drugs are no longer all cytotoxic, genotoxic, and highly hazardous chemicals." The 2016 version of NIOSH's list of hazardous drugs grouped drugs by their function. Academic and Professional Credentials: I.H. Comments were to be received by June 30, 2020. 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". While every effort has been made to ensure that 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. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. 0000014615 00000 n You will be subject to the destination website's privacy policy when you follow the link. These cookies may also be used for advertising purposes by these third parties. Recommended by: NIOSH, Katie Slavin Information about this document as published in the Federal Register. 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. 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ACTION: Notice of draft document available for public comment. Learn more here. These tools are designed to help you understand the official document John J. Howard, January 10th, 2019 The National Institute for Occupational Safety and Health (NIOSH, / n a /) is the United States . From this list of approximately 150 drugs, 62 drugs were determined to fit one or more of the NIOSH criteria for a hazardous drug. Stakeholder Comments . the Federal Register. When these documents are finalized they will be published to the NIOSH website. 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. that agencies use to create their documents. 01/18/2023, 284 0000085885 00000 n Recommended by: NIOSH, Marty Polovich }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 ~ Group 1 is antineoplastic drugs (roughly, chemotherapy . 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. In this Issue, Documents headings within the legal text of Federal Register documents. 01/18/2023, 202 Register, and does not replace the official print version or the official The 2020 version of NIOSH's list groups drugs by hazard. 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/). These markup elements allow the user to see how the document follows the Review proposed NIOSH changes to the hazardous drug list. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. documents in the last year, by the Food Safety and Inspection Service 2016-161 (Supersedes 2014-138). This document has been published in the Federal Register. Therefore, NIOSH considers these drugs to be included in Table 1 of the NIOSH list of hazardous drugs. 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 The 2016 list adds 34 drugs and includes a review of the 2004 list. All information these cookies collect is aggregated and therefore anonymous. 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. Until the ACFR grants it official status, the XML Z>s82jrod|`t Rj+&=wg\3gjo9swoysg GeCIV&In\,Fzp(+,p>;[ [R`b9N%:=?dn'8! `# @{3&jb51 QOINAVRpxCVy{j"V$ ->0c, 0000069655 00000 n on on Organizational Affiliation: University of Maryland If emailing please type 508 Accommodation PR#9342 without quotes in the subject line of the email. 0000000016 00000 n Centers for Disease Control and Prevention. Additional information for the 2016 update can be found at: Federal Register Noticepdf icon. 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. Directorate of Standards and Guidance This notice announces the extension of the comment period until July 30, 2020. A Notice by the Centers for Disease Control and Prevention on 06/19/2020. 4814 0 obj <>stream Cincinnati, OH 45226-1998. The list is further divided into 3 groups. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. Please include the URL of the site in the Subject line of your email request that you would like to access. 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 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. Academic and Professional Credentials: BSN, RN trailer 0000052457 00000 n This notice announces the extension of the comment period until July 30, 2020. a hazardous drug. 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, by the International Trade Commission ``"v,5Y}p]]E2FGE2^,%~O ,%>2q >o-|E*!/bYDBFJ-2 and services, go to %PDF-1.6 % 0000022595 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. Areas of Expertise, Discipline, or Relevant Experience: Occupational health 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.. Organizational Affiliation: Director, Clinical Standards and Quality Practice, Standards and Quality Division; American Society of Health-System Pharmacists Use the PDF linked in the document sidebar for the official electronic format. 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