The List now comprises only two tables: Table 1: Drugs that contain MSHI in the package insert and/or meet the NIOSH definition of a hazardous drug and are classified by NTP as “known to be a human carcinogen,” or classified by IARC as “carcinogenic” or “probably carcinogenic.”, Table 2: Drugs that meet the NIOSH definition of a hazardous drug, but do not have MSHI and are not classified by NTP as “known to be a human carcinogen,” or classified by IARC as “carcinogenic” or “probably carcinogenic.”. Please provide any additional studies or scientific information that evaluate or validate engineering, work practice or administrative controls to reduce exposures to hazardous drugs in healthcare settings. Director,National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. Please explain. NIOSH created and periodically updates the List to assist employers in providing safe and healthful workplaces by offering a list of drugs that meet the NIOSH definition of a hazardous drug. The documents posted on this site are XML renditions of published Federal Comment: Add a new category for drugs that sublime and offer information about proper handling, including the conditions under which sublimation (transition of a solid substance to a gas) happens as well as the need to filter and exhaust the work area where such drugs are used. Comment: The List should identify those hazardous drugs that are both cytotoxic and cytostatic as well as volatile. Washington — NIOSH has extended until July 30 the comment period on three draft documents pertaining to hazardous drugs in health care. Reproductive toxicity: Cited studies in the package insert demonstrated reproductive toxicity in male and female rates. should verify the contents of the documents against a final, official New Documents Please note that all comments submitted through Beta, both d Section C of the draft Procedures, which includes the evaluation criteria, would be expanded to include new clauses 4 and 5 to allow NIOSH to consider additional factors beyond the intrinsic toxicity of the drug molecule in determining whether to place the drug on the List. In the case of a drug being reevaluated, conclusions about study quality would be discussed in a Federal Register notice. NIOSH has published for comment the long-awaited revised 2020 Hazardous Drug List along with information for managing hazardous drug exposure and the NIOSH procedures for developing the list. NIOSH should clarify the criteria described in the footnote and explain how evidence against these various criteria is evaluated, how each independent line of evidence is systematically and critically appraised, how the quality and risk of bias of individual studies is evaluated, how conflicting information is arbitrated, and how the totality of the data is synthesized. If emailing please type “508 Accommodation PR#9342” without quotes in the subject line of the email. .”. Please provide feedback on the overall document: a. . NIOSH determined that grouping all antineoplastic drugs together in one table is no longer the most useful or informative for the user. This document has been published in the Federal Register. Although there is currently some guidance in the footnotes, it may be worthwhile to consider a more detailed evaluation process of relevant studies and place it in a more prominent location in the document or possibly as an Appendix.”. Accordingly, NIOSH is not proposing to place these two drugs on the List. NIOSH response: NIOSH's rationale for proposing the placement of triazolam on the List was that it mimics the benzodiazepines which are included on the List because they are teratogenic or cause other developmental effects. The draft Procedures is in the docket for this activity. Accordingly, drugs that sublime should be handled using risk management strategies relevant to the conditions of use. 2020 NBA Draft predictions including pick-by-pick analysis from CBS Sports NBA experts. NIOSH response: Because the draft Procedures document only addresses NIOSH's procedure for identifying hazardous drugs, the “Application” section is removed. See https://www.cdc.gov/niosh/docs/2016-161/default.html for all drugs with special handling information added to the 2016 List. If new information becomes available, NIOSH will reevaluate it in a future update to the, This drug was approved by FDA in 2017. All are open for a 60 day comment period. 5. Comment: Botulinum toxins, including abobotulinumtoxinA and onabotulinumtoxinA, should not be placed on the List. . Proposed Location Table 2: No MSHI, not classified as known or probable carcinogen by NTP or IARC. Comment: NIOSH should include the professional qualifications of the NIOSH staff who perform these evaluations. This information is not part of the official Federal Register document. c. What information is redundant, incorrect, missing, or not needed? These changes now reflected in the draft Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings (draft Procedures) include the clarification of some language and streamlining the procedures NIOSH uses to determine the hazard potential of a specific drug. of the issuing agency. Comments may be submitted, 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 the docket numbers (CDC-2020-0046; NIOSH-233-C). 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… This drug is administered as a coated tablet, self-administered by the patient at home; as such, ivabradine poses no risk to healthcare workers. headings within the legal text of Federal Register documents. . Formerly the “NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings,” the list will be called more simply the “NIOSH List of Hazardous Drugs in Healthcare Settings, 2020.” The list, which is a basic reference document for OSHA, USP and other standard-setting organizations, has not been updated since 2016. The following seven drugs that were proposed for placement on the List in the February 2018 FRN are no longer proposed for placement on the List, for the reasons discussed above in Sections II.B. Open for Comment, Economic Sanctions & Foreign Assets Control, Threatened Species Status for Whitebark Pine, Animal and Plant Health Inspection Service, Organization and functions (Government agencies), Addressing the Threat From Securities Investments That Finance Communist Chinese Military Companies, Establishing the President's Advisory 1776 Commission, Centers for Disease Control and Prevention, II. . 3. Reproductive toxicity/teratogenicity: The FDA classifies lapatinib as pregnancy category D indicating positive evidence of human fetal risk. . Public comments on the draft Policy and Proceduresand the drugs proposed for The manufacturer or any other stakeholder is invited to comment on the sufficiency of the explanation of the basis for adding a drug to the List. For complete information about, and access to, our official publications 12/02/2020, 201 The Public Inspection page documents in the last year, 929 Therefore, when drugs are grouped by their function (i.e., antineoplastic), as they were in earlier versions of Table 1, drugs that required different protective measures were grouped together (non-cytotoxic drugs with cytotoxic drugs). In very few cases, if any, would sufficient studies be available to conduct a formal meta-analysis relating to a specific drug. If a meta-analysis or systematic review is warranted for a reevaluation, NIOSH would consider these criteria on a case-by-case basis. NIOSH may conduct a meta-analysis or systematic review when reevaluating the placement of a drug already on the List, if the available evidence warrants such a review. Peer review comment: NIOSH should add “administrative controls” when discussing engineering controls, personal protective equipment, and other steps to manage the risk of exposure, because of their significance “in the well-accepted hierarchy of controls for minimizing exposure to workplace hazards.”. 4. [3] .”. The size of the molecule limits dermal absorption and aerosolization. There are no human studies relating to the developmental effects of daratumumab or dinutuximab. For some of these drugs, no drug-specific data were available in the package inserts to support warnings in the inserts regarding developmental or reproductive effects; for other drugs, the toxic effects occurred at doses higher than human recommended doses. NIOSH also sought comment on a draft Policy and Procedures for Developing the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings (Policy and Procedures). Therefore, at this time NIOSH is no longer proposing to place the class of botulinum toxins on the 2020 List. Peer review comment: NIOSH should clarify “how the threshold dosages (10 mg/day or 1 mg/kg/day) for defining organ toxicity at 'low doses' . Washington — NIOSH is asking for stakeholder comment on three draft documents pertaining to hazardous drugs in health care settings. the current document as it appeared on Public Inspection on on 2. Also available for comments are the “NIOSH Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings” and “Managing Hazardous Drug Exposures: Information for Healthcare Settings”. The Federal Register Notice for the Draft of the 2020 NIOSH List of Hazardous Drugs is now available. Comment: The draft Policy and Procedures should include a methodology describing how NIOSH evaluates monoclonal antibodies. Comment: Azole antifungal drugs are being treated inconsistently. To learn more about the list visit … Information of particular interest includes considerations for design and implementation of a medical surveillance program, data analysis, and communication of results to participants. Is the threshold of information required to move from the screening process to the full evaluation process clearly described? when determining the potential for adverse health effects of hazardous drugs in healthcare workers. documents in the last year, 73 documents in the last year, 22 NIOSH response: The List is about 4 years behind the introduction of new drugs when it is periodically updated because there are several steps in the review process. The Federal Docket folder of supporting information behind the NIOSH proposal includes not only a draft of the actual 2020 list and the document on managing drug exposures, but also a draft of the procedures NIOSH used to develop the 2020 list. Comment: Triazolam should not be placed on the List. NIOSH response: The daily therapeutic dose at which serious organ toxicity, developmental toxicity, or reproductive toxicity occurs (10 mg/day in human adults and 1 mg/kg per day in laboratory animals) has long been used by the pharmaceutical industry to develop occupational exposure limits (OELs) of less than 10 μg/m[3] after applying appropriate uncertainty factors. . Comment: In the draft Policy and Procedures footnote 45, NIOSH lists criteria used to evaluate information from animal studies. Is the information threshold scientifically sound? NIOSH response: NIOSH has not conducted a formal meta-analysis or systematic review for any drug currently on the List. on The 60-day window for public comments is May 1st, 2020 – June 1st, 2020. Similar questions were raised about animal studies. Accordingly, NIOSH proposes to place exenatide on the List. Polypeptides of this size and larger have been shown to have bioavailability through relevant routes of exposure. Each document posted on the site includes a link to the 6. NIOSH carefully considered all of the peer reviews and public comments and determined that significant, substantial changes should be made to the draft Policy and Procedures, the list of drugs proposed for placement on the List, and also to the organization of the List itself. NIOSH response: For reevaluation of a listed drug, NIOSH does not require requestors to provide a complete analysis of the available evidence. developer tools pages. We're less than a week away from the 2020 NFL draft, which means it's time to unveil my annual list of favorite prospects at every position. NIOSH Docket Number 233-C, CDC-2020-0046. In this Issue, Documents The requestor need only provide some new information that is relevant to the issue of whether the drug does or does not meet the NIOSH definition of a hazardous drug or the decision to place a drug on a particular table in the List. You will be subject to the destination website's privacy policy when you follow the link. In the case of a drug being reevaluated, conclusions about study quality would be discussed in a notice published in the Federal Register. Comment: Osimertinib should not be placed on the List. NIOSH response: FDA-approved drugs generally have a reasonable body of toxicity information because the manufacturers are required by FDA to provide this information to ensure patient safety when seeking approval for their drugs. Peer review comment: NIOSH should mention “some other common healthcare job categories that are likely to be exposed . On the contrary, if a party submits a written request for reconsideration, NIOSH will be responding in these instances. the material on FederalRegister.gov is accurately displayed, consistent with NIOSH has provided its proposed recommendations and related information about controlling hazardous drugs in the Table of Control Approaches in Chapter 8. a. As stated in the OMB Final Information Quality Bulletin for Peer Review (Bulletin), “[p]eer reviewers shall be charged with reviewing scientific and technical matters. CDC twenty four seven. What structural or format changes could be made to improve the utility of this table? Two reviewers had questions about the information thresholds required to evaluate drugs, and all reviewers had editorial suggestions for improving the clarity of the draft. Carcinogenicity/genotoxicity: Cited studies in the package insert demonstrated an increased incidence of tumors in hamsters and rats. Does the draft policy and procedures clearly describe the process used by NIOSH to screen and evaluate drugs? were derived. is not clearly outlined with respect to the evaluation process. Often the mechanism of action for the drug being assessed is known and can be compared to other drugs of a similar structure/activity. In order to clarify that the List is a hazard identification tool, NIOSH has removed this table from the document. Information about this document as published in the Federal Register. Centers for Disease Control and Prevention. It would presumably be courteous to respond to any party that has provided comments for consideration.”. Only when a labeling change results in the addition of MSHI to a package insert will NIOSH automatically consider the drug to be a hazardous drug and add it to the List. After evaluating public comments, NIOSH made the following determination: 13 drugs are proposed for placement on the List, 3 drugs are automatically added to the List because they have MSHI in the package insert (2 drugs identified in the 2018 FRN and another recently-approved by FDA), 7 drugs proposed for placement on the List in the 2018 FRN are no longer considered in this action. documents in the last year, 302 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.”. As such, the use of animal studies to evaluate the hazardous nature of a drug should be explicitly stated.”. The ordering of the tables in the List implies risk stratification; USP <800> supports this impression by requiring heightened handling requirements for Table 1 drugs. Submitted comments may not be available to be read until the agency has approved them. Please provide specific examples. It is not an official legal edition of the Federal Peer review comment: NIOSH should offer an example of why a drug identified as a hazardous drug because it poses as carcinogenic hazard might not be a classified as a carcinogen pursuant to the NIOSH Chemical Carcinogen Policy. Many of the drugs currently used to fight cancer function differently than those previously used. Animal studies, where available, are also used in our evaluations. Commenters included pharmacists, professional organizations and associations, pharmaceutical manufacturers, medical centers and/or health systems, individuals who provided their names but not their affiliations, a company that provides risk assessments, a drug database, an insurance company, a medical school professor, a neurologist, and an anonymous commenter. 2. 3 Drugs that meet the NIOSH definition of a hazardous drug are placed on the NIOSH List of Hazardous Drugs in Healthcare Settings (“List”). Accordingly, the List is derived only from drugs approved by FDA's Center for Drug Evaluation and Research. NIOSH response: NIOSH has determined that teratogenicity or other developmental toxicity after exposure to osimertinib were observed at doses higher than the maximum recommended human dose and reproductive effects at doses lower than the maximum recommended human doses were equivocal. Accessed July 16, 2020. Comment: Peer reviews should be conducted before the close of the public comment period to allow public commenters time to review them. Comment: NIOSH should identify those drugs that pose a realistic risk to healthcare workers by considering such occupation exposure factors as drug type (e.g., small molecule, biologic), stability, dosage form, and route of exposure, and then evaluating them against the toxicity criteria. Additional changes to the List, including those drugs proposed for removal from the List, are described in detail in the draft NIOSH List of Hazardous Drugs in Healthcare Settings, 2020, which is available for review in the docket for this activity. 12/02/2020, 382 “'When available, published, peer-reviewed scientific literature about the hazard potential of a particular drug, including any studies cited in the package insert that are relevant to workers in a health care setting.' OELs in this range are typically established for potent or toxic drugs in the pharmaceutical industry. Most importantly, the definition of the term “hazardous drug” would now acknowledge that “hazard characterization” is an important factor for drugs under consideration. Comment: What is the mechanism for evaluating investigational new drugs (i.e., drugs used in preclinical and clinical research but not yet FDA-approved)? Sargent EV and Kirk GD [1988], Establishing Airborne Exposure Control Limits in the Pharmaceutical Industry, Am Ind Hyg Assoc J 49(6):309-13; Naumann BD and Sargent EV [1997], Setting Occupational Exposure Limits for Pharmaceuticals, Occup Med 12(1):67-80; Sargent EV, Naumann BD, Dolan DG, Faria EC, Schulman L [2002], The Importance of Human Data in the Establishment of Occupational Exposure Limits, Hum Ecol Risk Assess 8(4):805-822. NIOSH is adding text to clarify the agency's intent. Aschengrau A, Seage GR [2018], Essentials of Epidemiology in Public Health. documents in the last year, by the Centers for Medicare & Medicaid Services NIOSH response: In 2004, NIOSH used lists from several organizations as examples of hazardous drugs. Table 2 would now contain drugs that meet one or more of the NIOSH hazardous drug criteria and may be developmental and/or reproductive developmental toxins but are not drugs which have MSHI or are classified as carcinogens or probable carcinogens by NTP or IARC. By Connor TH, MacKenzieBA, DeBordDG, Trout DB, O’Callaghan JP, OvesenJL, Whittaker C. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safe ty and Health, DHHS (NIOSH) Publication Number 2020 -xxx See draft Procedures footnote 18, “Properties of a drug molecule that may limit adverse effects in healthcare workers are typically chemical, physical and structural properties that affect its absorption (ability to enter the cells of the body), distribution, metabolism, and/or elimination e.g., chemical structure, molecular weight or mass.”. In that case, NIOSH may consider it to be appropriately grouped with carcinogenic drugs, although it would not necessarily meet the criteria for an occupational carcinogen according to the NIOSH Chemical Carcinogen Policy. Accordingly, NIOSH proposes to place dihydroergotamine on the List. Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings, A. NIOSH List of Hazardous Drugs in Healthcare Settings (Procedures) and theNIOSH 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. documents in the last year, 64 This table of contents is a navigational tool, processed from the All are open for a 60 day comment period. Document Drafting Handbook It is unclear why animal studies were not included as a source of evaluating potentially hazardous drugs. Significant peer review and public comments on the draft Policy and Procedures are summarized and answered below in Section II; public comments on specific drugs are summarized and answered below in Section III. Comment: NIOSH indicated that 10 drugs—cetuximab, ibrutinib, ipilmumab, necitumumab, nintedanib, nivolumab, palbociclib, panitumumab, ramucirumab, and ruxolitinib—demonstrated available information that shows a toxic effect that does not meet the NIOSH definition of a hazardous drug. Peer review comment: NIOSH should list further tools to aid employers to protect workers. Are there other information sources that should be included? NIOSH response: NIOSH relies on a range of knowledge, experience, and skills to evaluate drugs for placement on the List, including but not limited to pharmacology, toxicology, medicine, and risk evaluation. The President of the United States issues other types of documents, including but not limited to; memoranda, notices, determinations, letters, messages, and orders. Furthermore, some drugs carry multiple AHFS code classifications and are not just antineoplastic drugs. What changes could be made to improve the utility of the information? Additionally, peer reviews provide the Agency with a review of its science; peer reviewers and their credentials are identified in the NIOSH Peer Review Agenda.Start Printed Page 25445, Commenters: NIOSH should identify the criteria used to evaluate study quality and strength, and describe how they are used to critically appraise the quality and risk of bias and other limitations of individual studies; arbitrate conflicting information; and synthesize the totality of animal and human studies data in support of, or opposition to, the listing of a drug as “hazardous.”. 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