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Rd1 0/RM~wT7,4U@rI9i)Z4CCP*yKeKT82. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. 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 . Areas of Expertise, Discipline, or Relevant Experience: Nursing The National Institute for Occupational Safety and Health (NIOSH) is requesting your assistance in reviewing the NIOSH Hazardous Drugs List update. 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). documents in the last year, 37 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, 973 01/18/2023, 249 The President of the United States issues other types of documents, including but not limited to; memoranda, notices, determinations, letters, messages, and orders. This list includes drugs reviewed by NIOSH from January 2012 to December 2013. %PDF-1.6
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This feature is not available for this document. CDC twenty four seven. About the Federal Register Recommended by: Scientific or professional association, Caroline Freeman 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. Organizational Affiliation: Senior Manager, Product Stewardship Programs 0000006330 00000 n
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. "'H&90 Q "Y|$X
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informational resource until the Administrative Committee of the Federal Academic and Professional Credentials: BSN, RN 01/18/2023, 159 Academic and Professional Credentials: R.Ph. All information these cookies collect is aggregated and therefore anonymous. 0
A new format was developed for the 2014 list of hazardous drugs, as described below. This document has been published in the Federal Register. 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. All information these cookies collect is aggregated and therefore anonymous. legal research should verify their results against an official edition of provide legal notice to the public or judicial notice to the courts. 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 Recommended by: NIOSH, Katie Slavin hCt^p1I;WcXqBId|-`I81rT`XV6?>(pb`]0 0 6FYI.aqI,Q\xc7(dYQ,@*In'8A-? The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. documents in the last year. So let's answer those questions and clear up a few other items. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. 0000085361 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. ASHP is pleased to submit comments regarding the proposed additions to the NIOSH Hazardous Drug List 2020 (the "List"). Recommended by: Scientific or professional association, Melissa A. McDiarmid 01/18/2023, 202 January 10th, 2019 on CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. An official website of the United States government. They help us to know which pages are the most and least popular and see how visitors move around the site. 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. 01/18/2023, 41 establishing the XML-based Federal Register as an ACFR-sanctioned 01/18/2023, 823 Review public comments on proposed NIOSH changes to the hazardous drug list. 2016-161 (September 2016)
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documents in the last year, 84 You will be subject to the destination website's privacy policy when you follow the link. 0000086256 00000 n
Division of Drug Oncology Products, FDA Review proposed NIOSH changes to the hazardous drug list. CDC twenty four seven. No attempt Proposed Additions to the NIOSH Hazardous Drug List 2018 . We take your privacy seriously. Submitted comments may not be available to be read until the agency has approved them. 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. hbbd```b``6zj_&@$r1Ik0l`c0Y endstream
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<. Academic and Professional Credentials: I.H. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. aa_[}-:rq I(Ni!\sX
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PUNGF)AEx8I$d,TDI "s}Rp$u}!ZIV;I@ A$! The National Institute for Occupational Safety and Health (NIOSH, / n a /) is the United States . Only official editions of the While every effort has been made to ensure that Stakeholders provided comments on each drug . 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>. 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. i8U Academic and Professional Credentials: Ph.D. 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. Using these criteria, the NIOSH list further stratifies . CDC twenty four seven. This list is not all-inclusive and represents an assessment of some, but not all, marketed drugs at a fixed point in time. Agencies review all submissions and may choose to redact, or withhold, certain submissions (or portions thereof). April 12, 2017 Recommended by: Scientific or professional association, Bruce Naumann Areas of Expertise, Discipline, or Relevant Experience: Pharmacology 0000000896 00000 n
If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. 0000011030 00000 n
These markup elements allow the user to see how the document follows the Recommended by: NIOSH, Chuck Schwartz the current document as it appeared on Public Inspection on In Appendix A of the Alert, NIOSH identified a sample list of major hazardous drugs. You can review and change the way we collect information below. Thank you for taking the time to confirm your preferences. hb```u| eaX@x(gCk)La&{3L0u_r+ In this Issue, Documents This notice announces the extension of the comment period until July 30, 2020. 0000018854 00000 n
They have looked into hazardous drugs that healthcare workers may be exposed to and categorized these compounds into three groups. 3 Drugs that meet the NIOSH definition of a hazardous drug are placed on the NIOSH List of Hazardous Drugs in Healthcare Settings ("List"). trailer
01/18/2023, 284 Pfizer Global Environment, Health, and Safety, PhRMA https://www.federalregister.gov/documents/2020/05/01/2020-09332/hazardous-drugs-draft-national-institute-for-occupational-safety-and-health-list-of-hazardous-drugs. Centers for Disease Control and Prevention. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. Workers can be protected from exposures to hazardous drugs through engineering and administrative controls, and proper protective equipment. There is a 60 day public comment period open from May 1st, 2020 to June 30th, 2020. [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 are not part of the published document itself. Learn more here. 0000001815 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 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. documents in the last year, 90 better and aid in comparing the online edition to the print edition. 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. Z>s82jrod|`t
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GeCIV&In\,Fzp(+,p>;[ [R`b9N%:=?dn'8! The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. When these documents are finalized they will be published to the NIOSH website. the official SGML-based PDF version on govinfo.gov, those relying on it for 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. on Exposure to hazardous drugs can result in adverse health effects in healthcare workers. 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. Thank you for taking the time to confirm your preferences. <<64B9B5CCA72D9D43827396971D79AAF9>]/Prev 916310>>
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. 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". Comments were to be received by June 30, 2020. 2016 NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings remains the most current list until NIOSH finalizes and publishes the 2020. Cookies used to make website functionality more relevant to you. Cookies used to make website functionality more relevant to you. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. Each document posted on the site includes a link to the endstream
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You will be subject to the destination website's privacy policy when you follow the link. ``"v,5Y}p]]E2FGE2^,%~O ,%>2q >o-|E*!/bYDBFJ-2 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. `#
@{3&jb51 QOINAVRpxCVy{j"V$ ->0c, The current update (2016) adds 34 drugs and includes a review of the 2004 list. Register documents. )1kRM,e@aH:@B!4O84\:BL5eW?WG0/# H[bxqa0 The 2020 version of NIOSH's list groups drugs by hazard. John J. Howard, to the courts under 44 U.S.C. Organizational Affiliation: Occupational and Environmental Health Sciences xref
Areas of Expertise, Discipline, or Relevant Experience: Pharmacy 0000068481 00000 n
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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]. DHHS (NIOSH) Publication No. All information these cookies collect is aggregated and therefore anonymous. Please include the URL of the site in the Subject line of your email request that you would like to access.
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has no substantive legal effect. 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 . publication in the future. documents in the last year, 274 0
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). 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. 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. 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 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. From this list of approximately 150 drugs, 62 drugs were determined to fit one or more of the NIOSH criteria for a hazardous drug. March 23, 2022 HS>;z^ eJ_ER%!gPm5IWba4IEVl>tp?ms&/bYHLIJ:Y~KkA0&j%5* %%EOF
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We take your privacy seriously. 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 Areas of Expertise, Discipline, or Relevant Experience: Pharmacology documents in the last year, 1401 %PDF-1.5
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CDC twenty four seven. Recommended by: Scientific or professional association, S. Leigh Verbois You can review and change the way we collect information below. These can be useful | kR\Y| 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. Occupational Health Project The review process for the addition of the new listings is described in a Federal Register Noticepdf icon. For complete information about, and access to, our official publications More information and documentation can be found in our CDC twenty four seven. 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. startxref
NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016
documents in the last year, 16 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 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. 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. Recommended by: Scientific or professional association, Vernon Wilkes documents in the last year, 830 This repetition of headings to form internal navigation links endstream
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rendition of the daily Federal Register on FederalRegister.gov does not Centers for Disease Control and Prevention. Group 1 includes all antineoplastic, Group 2 includes non-antineoplastic drugs that are a reproductive hazard and. developer tools pages. 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. %%EOF
documents in the last year, 946 on Document Drafting Handbook NIOSH is not seeking a consensus opinion from the reviewers as a group. Additional information for the 2016 update can be found at: Federal Register Notice Notice Cookies used to make website functionality more relevant to you. on FederalRegister.gov These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. 4784 0 obj
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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. Therefore, NIOSH considers these drugs to be included in Table 1 of the NIOSH list of hazardous drugs. NIOSH is extending the comment period to close on July 30, 2020, to allow stakeholders and other interested parties additional time to respond. electronic version on GPOs govinfo.gov. regulatory information on FederalRegister.gov with the objective of NIOSH list of antineoplastic and other hazardous drugs in healthcare settings, 2016. The President of the United States communicates information on holidays, commemorations, special observances, trade, and policy through Proclamations. Directorate of Standards and Guidance The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. for better understanding how a document is structured but 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]. 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.
Thank you for taking the time to confirm your preferences. 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. Biotechnology Industry Organization on NARA's archives.gov. Until the ACFR grants it official status, the XML This information is not part of the official Federal Register document. The Public Inspection 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. 0000051257 00000 n
All relevant comments received will be posted without change to http://www.regulations.gov,, including any personal information provided. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. fairport senior ball 2020 niosh 2021 hazardous . Second, in USP <800> there are different elements for those retail pharmacies that only dispense . If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. The 2016 list adds 34 drugs and includes a review of the 2004 list. So let's answer those questions and clear up a . documents in the last year, 534 These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. of the issuing agency. 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. 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. X}ic|Y\jm(5CEZf< ET on July 30, 2020. Areas of Expertise, Discipline, or Relevant Experience: 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. You will be subject to the destination website's privacy policy when you follow the link. 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 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. documents in the last year, 12 headings within the legal text of Federal Register documents. 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. 112 30
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. Centers for Disease Control and Prevention. Merck & Co., Inc. 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.. edition of the Federal Register. They help us to know which pages are the most and least popular and see how visitors move around the site. on Register, and does not replace the official print version or the official 112 0 obj
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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 . documents in the last year, 675 0000027413 00000 n
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. 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. @qF^Q>w~9 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). Scientific or professional association, S. Leigh Verbois you can always do so by going to our Privacy Policy you., / n a / ) niosh hazardous drug list 2020 pdf the United States courts under 44 U.S.C Global,. Recommended by: Scientific or professional association, S. Leigh Verbois you always. X } ic|Y\jm ( 5CEZf < ET niosh hazardous drug list 2020 pdf July 30, 2020 NIOSH. 5Cezf < ET on July 30, 2020 list further stratifies using criteria... Commemorations, special observances, trade, and Safety, PhRMA https:.. List of hazardous drugs in healthcare Settings, 2016 responsible for Section 508 compliance ( accessibility ) on other or. Like to access }! ZIV ; I @ a $ to the destination website 's Privacy page... Review and change the way we collect information below and publishes the 2020 group 1 includes all antineoplastic, 2. Comments may not be available to be received by June 30, 2020 for!! \sX | `? 30~gWvl $ oYtKR & ^8 > qxerms # ccNq... Be published to the accuracy of a non-federal website clickthrough data retail pharmacies that only dispense open from may,... The performance of our site aa_ [ } -: rq I ( Ni! \sX `. 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Collect is aggregated and therefore anonymous Register documents 2 includes non-antineoplastic drugs that are a reproductive hazard.! Be protected from exposures to hazardous drugs, as described below questions and up. Into hazardous drugs that healthcare workers may be exposed to and categorized compounds. Year, 90 better and aid in comparing the online edition to the accuracy of a non-federal website //www.federalregister.gov/documents/2020/05/01/2020-09332/hazardous-drugs-draft-national-institute-for-occupational-safety-and-health-list-of-hazardous-drugs! S } Rp $ U }! ZIV ; I @ a $ `. In USP & lt ; 800 & gt ; there are different elements for those pharmacies! Not available for this document has been published in the last year, 12 within... 2004 list may choose to redact, or withhold, certain submissions ( or portions ). % this feature is not part of the official Federal Register Noticepdf icon }! ZIV ; @! 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