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confidential by the respondent (5 U.S.C. schedules. Other than examination DEPARTMENT OF HEALTH AND 552(b)(4)). reports, it provides the only financial HUMAN SERVICES Current actions: The Board has data available for these corporations. temporarily revised the instructions to The Federal Reserve is solely Centers for Disease Control and the FR Y–9C report to accurately reflect responsible for authorizing, supervising, Prevention the revised definition of ‘‘savings and assigning ratings to Edges. The [CDC–2020–0046; NIOSH–233–C] deposits’’ in accordance with the Federal Reserve uses the data collected amendments to Regulation D in the on the FR 2886b to identify present and Hazardous Drugs: Draft NIOSH List of interim final rule published on April 28, potential problems and monitor and Hazardous Drugs in Healthcare 2020 (85 FR 23445). Specifically, the develop a better understanding of Settings, 2020; Procedures; and Risk Board has temporarily revised the activities within the industry. Management Information instructions on the FR Y–9C, Schedule HC–E, items 1(b), 1(c), 2(c) and glossary Legal authorization and AGENCY: Centers for Disease Control and content to remove the transfer or confidentiality: Sections 25 and 25A of Prevention, HHS. withdrawal limit. As a result of the the Federal Reserve Act authorize the ACTION: Notice and request for comment. revision, if a depository institution Federal Reserve to collect the FR 2886b chooses to suspend enforcement of the (12 U.S.C. 602, 625). The obligation to SUMMARY: The National Institute for six transfer limit on a ‘‘savings deposit,’’ report this information is mandatory. Occupational Safety and Health the depository institution may continue The information collected on the FR (NIOSH) of the Centers for Disease to report that account as a ‘‘savings 2886b is generally not considered Control and Prevention (CDC), in the deposit’’ or may instead choose to report confidential, but certain data may be Department of Health and Human that account as a ‘‘transaction account.’’ exempt from disclosure pursuant to Services announces that the following draft documents are available for public (3) Report title: Consolidated Report exemptions (b)(4) and (b)(7)(C) of FOIA, comment: (1) NIOSH Procedures for of Condition and Income for Edge and (5 U.S.C. 552(b)(4) and (b)(7)(C)). The Developing the NIOSH List of Agreement Corporations. information exempt from disclosure Agency form number: FR 2886b. Hazardous Drugs in Healthcare Settings OMB control number: 7100–0086. pursuant to (b)(4) consists of (Procedures); (2) NIOSH List of Applicable date: May 1, 2020. information provided on Schedule RC– Hazardous Drugs in Healthcare Settings, Frequency: Quarterly and annually. M (with the exception for item 3) and 2020 (List), including those drugs Respondents: Banking Edge and on Schedule RC–V, both of which proposed for placement on the 2020 agreement corporations and investment pertain to claims on and liabilities to List, and (3) Managing Hazardous Drug (nonbanking) Edge and agreement related organizations. The information Exposures: Information for Healthcare corporations. exempt from disclosure pursuant to Settings. Estimated number of respondents: exemption (b)(7)(C) is information DATES: Comments must be received by Banking Edge and agreement provided in the Patriot Act Contact June 30, 2020. corporations (quarterly): 9; banking Information section of the reporting ADDRESSES: Edge and agreement corporations form. Comments may be (annually): 1; investment Edge and submitted, identified by docket numbers agreement corporations (quarterly): 21; Current actions: The Board has CDC–2020–0046 and NIOSH–233–C, by investment Edge and agreement temporarily revised the instructions to either of the following two methods: corporations (annually): 7. the FR 2886b to update the definition of • Federal eRulemaking Portal: Estimated average hours per response: ‘‘savings deposits’’ in accordance with www.regulations.gov Follow the Banking Edge and agreement the amendments to Regulation D in the instructions for submitting comments. corporations (quarterly): 15.77 hours; interim final rule published on April 28, • Mail: NIOSH Docket Office, Robert banking Edge and agreement 2020 (85 FR 23445). Specifically, the A. Taft Laboratories, MS–C34, 1090 corporations (annually): 15.87; Board has temporarily revised the Tusculum Avenue, Cincinnati, OH investment Edge and agreement instructions on Schedule RC–E to 45226–1998. corporations (quarterly): 11.81; remove the transfer and withdrawal Instructions: All information received investment Edge and agreement limit from the definition of a savings in response to this notice must include corporations (annually): 10.82. deposit. Please note that this revision the agency name and the docket Estimated annual burden hours: does not require any changes to the form numbers (CDC–2020–0046; NIOSH– Banking Edge and agreement itself. As a result of the revision, if a 233–C). All relevant comments received corporations (quarterly): 568; banking depository institution chooses to will be posted without change to Edge and agreement corporations suspend enforcement of the six transfer www.regulations.gov, including any (annually): 16; investment Edge and limit on a ‘‘savings deposit,’’ the personal information provided. agreement corporations (quarterly): 992; depository institution may continue to FOR FURTHER INFORMATION CONTACT: investment Edge and agreement report that account as a ‘‘savings Barbara MacKenzie, NIOSH, Robert A. corporations (annually): 76. deposit’’ or may instead choose to report Taft Laboratories, 1090 Tusculum General description of report: The FR that account as a ‘‘transaction account.’’ Avenue, MS–C26, Cincinnati, OH 2886b reporting form is filed quarterly 45226, telephone (513) 533–8132 (not a and annually by banking Edge and Board of Governors of the Federal Reserve toll free number), email:bmackenzie@ agreement corporations and investment System, April 28, 2020. cdc.gov. (nonbanking) Edge and agreement Michele Taylor Fennell, SUPPLEMENTARY INFORMATION: corporations (collectively, Edges or Edge Assistant Secretary of the Board. corporations). The mandatory FR 2886b [FR Doc. 2020–09342 Filed 4–30–20; 8:45 am] I. Public Participation comprises an income statement with two schedules reconciling changes in BILLING CODE 6210–01–P A. Request for Comments capital and reserve accounts and a Interested parties are invited to balance sheet with 11 supporting participate in this activity by submitting

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written views, opinions, medical school professor, a neurologist, • Does the draft policy and recommendations, and/or data. and an anonymous commenter. NIOSH procedures clearly describe the process Comments are invited on any topic also conducted a peer review, with four used by NIOSH to screen and evaluate related to the procedures and drugs independent reviewers, of the draft drugs? identified in this notice, including three Policy and Procedures.2 • Are the screening and evaluation draft documents: (1) NIOSH Procedures Significant peer review and public categorization processes described by for Developing the NIOSH List of comments on the draft Policy and the draft policy and procedures Hazardous Drugs in Healthcare Settings Procedures are summarized and scientifically sound? (Procedures); (2) NIOSH List of answered below in Section II; public • Is the set of information sources Hazardous Drugs in Healthcare Settings, comments on specific drugs are used for classifying drugs sufficient to 2020 (List), including those drugs summarized and answered below in identify relevant hazards? Are there identified in this notice as being Section III. other information sources that should be proposed for placement on the List; and NIOSH carefully considered all of the included? (3) Managing Hazardous Drug peer reviews and public comments and • Is the threshold of information Exposures: Information for Healthcare determined that significant, substantial required to move from the screening Settings. All three draft documents are changes should be made to the draft process to the full evaluation process available in the docket for this activity. Policy and Procedures, the list of drugs clearly described? Is the information NIOSH also invites comments proposed for placement on the List, and threshold scientifically sound? specifically on the following questions also to the organization of the List itself. • Is the reconsideration process for related to this activity: The new drafts, entitled the Procedures addition or deletion of a drug to/from 1. Which unique ingredient identifier for Developing the NIOSH List of the hazardous drug list adequately is the most useful for users of the List? Hazardous Drugs in Healthcare Settings described? • 2. Because there is conflicting (Procedures) and the NIOSH List of Are there any issues not considered evidence about the hazard posed by Hazardous Drugs in Healthcare Settings, by the charge questions that should be botulinum toxins to the workers who 2020 (List) are found in the addressed? handle these drugs, NIOSH is not Supplemental Materials tab of the Overall, the independent peer proposing the placement of botulinum docket and are available for public reviewers found the draft Policy and toxins on the List at this time and comment, as discussed above. Procedures to be clearly written and invites additional studies, data, and Public comments on the draft Policy supported by the available science and expert opinions pertinent to this issue and Procedures and the drugs proposed the reconsideration process (now in order to evaluate the botulinum for placement on the List and peer referred to as ‘‘reevaluation’’) to be toxins more fully. review summaries on specific drugs adequate. Two reviewers had questions about the information thresholds B. February 2018 Federal Register proposed for placement on the List are Notice available in dockets CDC–2018–0004 required to evaluate drugs, and all and NIOSH–233–B. reviewers had editorial suggestions for In a Federal Register notice (FRN) improving the clarity of the draft. Peer published on February 14, 2018 (83 FR II. Procedures for Developing the reviews on the draft Policy and 6563), NIOSH invited the public to NIOSH List of Hazardous Drugs in Procedures, as well as NIOSH’s participate in the development of the Healthcare Settings responses, are discussed below. List and the procedures used to develop NIOSH created and periodically the List by submitting written views, Scientific Approach updates the List to assist employers in opinions, recommendations, and/or providing safe and healthful workplaces Peer review comment: Some data. Comments were invited on any by offering a list of drugs that meet the paragraphs in the section entitled, topic related to the drugs reviewed by NIOSH definition of a hazardous drug. ‘‘Evidence of Health Effects in Workers NIOSH for possible placement on the In the February 2018 Request for from Handling Hazardous Drugs’’ do not planned 2018 version of the List. NIOSH Comment, NIOSH requested comment belong in the scientific approach section also sought comment on a draft Policy and should be moved to be part of and Procedures for Developing the on a draft Policy and Procedures for developing the List. The draft Policy and section B ‘‘Systematic and Sequential NIOSH List of Antineoplastic and Other Methodology’’ section. Hazardous Drugs in Healthcare Settings Procedures document was developed to formalize the methodology NIOSH uses Peer review comment: The frequency (Policy and Procedures).1 of review of the FDA database should be Fifty-seven submissions were to guide the addition of hazardous drugs to the List and create a process for specified earlier in the draft. received in docket CDC–2018–0004 NIOSH response: Although NIOSH requesting the removal from or (NIOSH–233–B) from 55 commenters typically reviews the FDA database on placement of drugs on the List. Four (one commenter sent three separate a monthly basis, the draft Procedures no independent peer reviewers and 55 submissions to the docket). Commenters longer specifies or indicates a frequency public commenters offered input on the included pharmacists, professional of database review to allow for draft Policy and Procedures; their organizations and associations, flexibility in the event of unforeseen substantive comments are summarized pharmaceutical manufacturers, medical circumstances. centers and/or health systems, below, followed by NIOSH responses. Peer review comment: NIOSH’s individuals who provided their names A. Peer Review Summaries and NIOSH discussion of an employer-performed but not their affiliations, a company that Responses site-based risk assessment to control the provides risk assessments, a drug risk of exposure is confusing when database, an insurance company, a NIOSH consulted four independent peer reviewers, who were asked to placed in a document describing consider the following questions: NIOSH’s hazard identification 1 As discussed later in this notice, NIOSH has procedures. The Procedures should state revised the draft Policy and Procedures based on peer reviews and public comments. The new 2 See https://www.cdc.gov/niosh/topics/hazdrug/ ‘‘that this list is [a] hazard identification iteration is now referred to as ‘‘draft Procedures’’ peer-review-plan.html for the peer review plan for and not a risk assessment exercise. The throughout this notice. the draft Policy and Procedures. subsequent description of a site risk

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assessment does not seem appropriate Although such drugs are not in patient safety when seeking approval for here. The last paragraph of this section widespread clinical use, personnel in their drugs. The FDA requirements for is particularly confusing to the academic and research-oriented tested and reported endpoints generally reader. . .’’ facilities are potentially at risk from overlap with the NIOSH definition of a NIOSH response: NIOSH is exposure to these drugs. . . . the hazardous drug. The fact that FDA has reorganizing and streamlining the document speaks to the need for requirements for reporting of relevant document to make it more easily individual healthcare workplaces to safety related data supports the NIOSH understood and to move information on create their own lists of hazardous presumption that a lack of information site risk assessment to a separate draft drugs, but this places the burden of on an endpoint indicates a lack of document, Managing Hazardous Drug regulation on these institutions concern for a specific type of hazard. Exposures: Information for Healthcare themselves, or more likely individuals Peer review comment: A statement Settings. The draft Procedures within these institutions. I wonder about the evaluation procedures in the document is now focused on NIOSH’s whether the current regulatory climate draft Policy and Procedures indicates procedure for identifying hazardous permits NIOSH any level of control over that NIOSH would only consider human drugs and no longer discusses managing the handling of drugs in this category.’’ studies. ‘‘’When available, published, the risk of exposure. NIOSH response: Drugs still under peer-reviewed scientific literature about Peer review comment: NIOSH should investigation are not included on the the hazard potential of a particular drug, add ‘‘administrative controls’’ when List because no scientific information, including any studies cited in the discussing engineering controls, including information normally package insert that are relevant to personal protective equipment, and provided in package inserts, is available workers in a health care setting.’ This other steps to manage the risk of for NIOSH review. Accordingly, the List clearly infers human studies only. exposure, because of their significance is derived only from drugs approved by However, the remaining parts of the ‘‘in the well-accepted hierarchy of FDA’s Center for Drug Evaluation and draft policy and procedures mentions controls for minimizing exposure to Research. For this reason, NIOSH that animal studies should be reviewed workplace hazards.’’ encourages individual healthcare . . . . It is unclear why animal studies Peer review comment: NIOSH should settings to develop their own formulary- were not included as a source of list further tools to aid employers to specific lists of hazardous drugs, which evaluating potentially hazardous drugs. protect workers. could include investigational drugs that In my opinion, a review of any animal NIOSH response: In streamlining the have not yet been approved by FDA. studies should be conducted as they may offer insight regarding the potential document to make it more focused on Identifying, Screening, Evaluating, and risk posed by a drug. As such, the use NIOSH’s procedures for identifying Reviewing a Drug for Placement on the of animal studies to evaluate the hazardous drugs, information on List: Screening Potentially Hazardous hazardous nature of a drug should be controlling the risk of hazardous drug Drugs exposure in the workplace was moved explicitly stated.’’ to the draft NIOSH document Managing Peer review comment: It may be NIOSH response: The reviewer has Hazardous Drug Exposures: Information inappropriate for NIOSH not to place interpreted the NIOSH statement for Healthcare Settings. drugs on the List when NIOSH has differently than what the agency determined there is insufficient intended. Animal studies, where Application information to support the placement. available, are also used in our Peer review comment: NIOSH should According to the reviewer, ‘‘[t]his evaluations. The draft Procedures mention ‘‘some other common approach may not be appropriate if document is being reorganized to clarify healthcare job categories that are likely indeed the purpose of the screening is the information NIOSH considers in its to be exposed . . . From my to protect the health and well-being of evaluations, including relevant animal perspective, as a minimum, this should workers who may be exposed to studies. include porters, ward aides and unit hazardous drugs. From an occupational Peer review comment: NIOSH should clerks.’’ hygiene perspective, if there is no consider a more detailed process when NIOSH response: Because the draft existing occupational exposure limit or evaluating study quality because ‘‘[t]he Procedures document only addresses threshold limit value for a chemical issue related to the quality of a study NIOSH’s procedure for identifying hazard, the best practice is to ensure and, in turn, the strength of data i.e. hazardous drugs, the ‘‘Application’’ that worker exposure to the chemical relative risk, odds ratios, etc. is not section is removed. Information about remains As Low As Reasonably clearly outlined with respect to the the application of the List can be found Achievable (ALARA). This is because evaluation process. Drawing in the introduction of the draft there is insufficient information to conclusions from a methodologically Managing Hazardous Drug Exposures: establish an exposure limit and, flawed paper can lead to Information for Healthcare Settings. therefore, one should err on the side of misclassification of a drug. In addition, However, rather than identifying job- caution and apply the ALARA having an algorithm to determine the specific titles, the document focuses on principle. Employing this same train of strength of a paper will also aid in workplace activities. thought to the draft policy and minimizing any potential inter- and procedures, it would, in my opinion, be intra-reviewer differences. Although Definitions a best practice to add the drug that has there is currently some guidance in the Peer review comment: NIOSH did not insufficient information to the List until footnotes, it may be worthwhile to include a mechanism to place suitable scientific evidence consider a more detailed evaluation investigational drugs on the List. There demonstrates that it should not be process of relevant studies and place it seems to be no ‘‘mechanism in place for included.’’ in a more prominent location in the labeling investigational (i.e., non-FDA NIOSH response: FDA-approved document or possibly as an Appendix.’’ approved drugs used in preclinical and drugs generally have a reasonable body NIOSH response: The majority of drug clinical research prior to submission of of toxicity information because the evaluations are based on information an NDA [new drug approval]) drugs as manufacturers are required by FDA to provided in the drug package insert; potential human health hazards. provide this information to ensure NIOSH relies on the quality of science

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generated by a drug manufacturer, dose’ exposure? Is there a scientific package insert, ‘‘or if written requests subsequently reviewed by FDA during justification for them? If so, perhaps this from interested parties to the NIOSH the drug approval process, and then could be referenced with a footnote.’’ Director are the only mechanism for published in the drug package insert. NIOSH response: The daily consideration of a drug for deletion from Peer-reviewed, published studies are therapeutic dose at which serious organ the List (the reconsideration process as usually not available and therefore toxicity, developmental toxicity, or described). If the latter is the case, could evaluating the quality of studies is not reproductive toxicity occurs (10 mg/day a sentence be added to clarify that?’’ typically possible. When studies are in human adults and 1 mg/kg per day NIOSH response: A drug may be available for review of a drug being in laboratory animals) has long been removed from the List based on either a considered for placement on the List or used by the pharmaceutical industry to written request from an interested party for the reevaluation of a drug already on develop occupational exposure limits or a change to the package insert. the List, quality may be evaluated by (OELs) of less than 10 mg/m3 after Although rare, NIOSH notes any NIOSH scientists and independent peer applying appropriate uncertainty labeling changes that could affect the reviewers on a case-by-case basis. In the factors.3 OELs in this range are typically status of a drug that has been previously case of a drug being reevaluated, established for potent or toxic drugs in classified as hazardous. No labeling conclusions about study quality would the pharmaceutical industry. NIOSH is change has ever resulted in the removal be discussed in a notice published in adding text in footnote 16 of the draft of a drug from the List, but labeling the Federal Register. Procedures to clarify and emphasize the changes that demonstrate a lack of Peer review comment: NIOSH should derivation. evidence of toxicity would be dealt with provide ‘‘a more robust description of Peer review comment: NIOSH should in the regular List updates. the evaluation criteria to include that clarify a sentence concerning NIOSH’s Only when a labeling change results these are shared across a number of preference for human genotoxicity data in the addition of MSHI to a package other professional organizations and which states: ‘‘If available, NIOSH gives insert will NIOSH automatically panels which also endorsed these same preference to those studies. . .’’ consider the drug to be a hazardous criteria.’’ NIOSH response: This refers to drug and add it to the List. NIOSH response: The NIOSH List is human genotoxicity studies, which are adopted, endorsed, and/or referenced by rarely available. If available, NIOSH B. Public Comment Summaries and a number of non-governmental would give preference to them over NIOSH Responses organizations, including the American animal and in vitro studies. NIOSH is The public comments have been Society of Health-System Pharmacists adding text to clarify the agency’s organized into the following topic areas: (ASHP), The Joint Commission, and the intent. organization of the List and impact of Oncology Nursing Society. Peer review comment: ‘‘Following the United States Pharmacopeia (USP) Because the organizations that may 60-day period to allow for public and Compounding Compendium chapter endorse the evaluation criteria may stakeholder consultations, it is unclear <800≤ Hazardous Drugs—Handling in change, NIOSH declines to identify if NIOSH will be responding to any Healthcare Settings; the nature of the them in the Procedures document. parties that have provided comments. List—exposure/hazard characterization; Peer review comment: NIOSH should On the contrary, if a party submits a monoclonal antibodies; periodicity; offer an example of why a drug written request for reconsideration, methodology/process; criteria identified as a hazardous drug because NIOSH will be responding in these clarification; and editorial suggestions. it poses as carcinogenic hazard might instances. One would assume that, in Organization of the List and Impact of not be a classified as a carcinogen both instances, a great deal of time and ≤ pursuant to the NIOSH Chemical thought is expected to provide feedback USP <800 Hazardous Drugs—Handling Carcinogen Policy. to NIOSH. It would presumably be in Healthcare Settings NIOSH response: A drug may be courteous to respond to any party that Seven commenters expressed concern considered a hazardous drug but not a has provided comments for about the impact of USP <800≤ on the chemical carcinogen if, for example, a consideration.’’ NIOSH List, and, in turn, the effect on drug manufacturer includes a NIOSH response: It is NIOSH practice small pharmacies that compound carcinogenicity warning in the drug’s to respond to all stakeholder and public pharmaceutical drugs. USP <800≤ package insert but the evidence for comments and peer reviews in a Federal incorporates by reference the NIOSH carcinogenicity has not been reviewed Register notice or in a document posted List and imposes certain requirements by the International Agency for in the relevant NIOSH docket, to on its users when handling certain Research on Cancer (IARC); the National maintain a transparent and thorough drugs on the List. The individuals and Toxicology Program (NTP), within the administrative record. organizations who commented on this U.S. Department of Health and Human issue felt that USP’s use of the NIOSH Reconsideration (Reevaluation) of Services; the U.S. Environmental List raises the List to the level of a NIOSH Decisions to Place and Remove Protection Agency (EPA); or regulatory action, and should include Drugs independently by NIOSH. In that case, only antineoplastic drugs on Table 1. NIOSH may consider it to be Peer review comment: NIOSH should Comment: Prior to USP <800≤, the appropriately grouped with clarify whether a drug may be removed NIOSH List was considered a carcinogenic drugs, although it would from the List based on changes to the ‘‘precautionary recommendation.’’ But not necessarily meet the criteria for an the USP <800≤ standards are too occupational carcinogen according to 3 Sargent EV and Kirk GD [1988], Establishing restrictive and overreaching, and the Airborne Exposure Control Limits in the the NIOSH Chemical Carcinogen Policy. Pharmaceutical Industry, Am Ind Hyg Assoc J chapter’s incorporation into state law Peer review comment: NIOSH should 49(6):309–13; Naumann BD and Sargent EV [1997], places facilities at legal risk if they fail clarify ‘‘how the threshold dosages (10 Setting Occupational Exposure Limits for to comply. The ordering of the tables in mg/day or 1 mg/kg/day) for defining Pharmaceuticals, Occup Med 12(1):67–80; Sargent the List implies risk stratification; USP EV, Naumann BD, Dolan DG, Faria EC, Schulman ≤ organ toxicity at ’low doses’ . . . were L [2002], The Importance of Human Data in the <800 supports this impression by derived. . . . Are these standard or Establishment of Occupational Exposure Limits, requiring heightened handling commonly accepted definitions of ’low Hum Ecol Risk Assess 8(4):805–822. requirements for Table 1 drugs. Because

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Table 1 includes drugs identified as developmental and/or reproductive specific circumstances dictate antineoplastic, NIOSH should clarify developmental toxins but are not drugs otherwise.’’ the rationale and intent of Table 1, since which have MSHI or are classified as Comment: Monoclonal antibodies drugs used as antineoplastics, but which carcinogens or probable carcinogens by (i.e., therapeutic proteins) are of such a are not cytotoxic or genotoxic, as NTP or IARC. Table 3 would be large molecular weight that they do not traditional antineoplastics are, have removed and the drugs formerly placed pose a realistic risk to healthcare been included. Moreover, USP <800≤ in that table placed into Table 1 or 2, workers. For example, monoclonal requires the use of personal protective accordingly. antibodies ‘‘are too large to be absorbed equipment for Table 1 drugs, which may Realistic Risk of Occupational Exposure through skin contact, and if ingested, delay care or undermine patient safety. they would be destroyed by digestion; if NIOSH should collaborate with Nine commenters expressed the inhaled, the pulmonary system would healthcare to better understand the sentiment that the List would be more prevent absorption. Consequently, these implications of identifying certain drugs useful if it identified drugs that pose a drugs are all administered by injection. as hazardous and the cost to implement realistic risk to healthcare workers. The only potential risk to healthcare USP <800≤. Comment: NIOSH should identify workers is of an accidental needle stick, NIOSH response: The NIOSH List those drugs that pose a realistic risk to which would not inject a creates no legal obligation for its users; healthcare workers by considering such pharmacologically active dose.’’ it is informational, not regulatory, in occupation exposure factors as drug Accordingly, the monoclonal antibodies content. USP added clarification about type (e.g., small molecule, biologic), bevacizumab, blintumomab, and the application of chapter <800≤ to stability, dosage form, and route of trastuzumab should not be placed on hazardous drugs, which can be found on exposure, and then evaluating them the List, and pertuzumab should be its FAQ page.4 against the toxicity criteria. Not refining removed from Table 1. In response to peer reviews and the List to identify real risks of Comment: The draft Policy and public comments, NIOSH proposes a occupational exposure could lead to Procedures should include a reorganization of the tables in the draft ‘‘overwarning’’ for drugs that present methodology describing how NIOSH 2020 List in a manner that may address little or no workplace risk. evaluates monoclonal antibodies. NIOSH response: Compilation of the at least some of the concerns expressed. NIOSH response: NIOSH applies the List is a hazard identification and Because the way cancer is treated same methodology for evaluating each hazard characterization process, as therapeutically has changed, and the drug approved by the FDA Center for described in the draft Procedures. The classes of drugs used to fight cancer Drug Evaluation and Research, draft Procedures considers the toxicity have changed, antineoplastic drugs are regardless of class. The definition of a criteria in the definition of a hazardous no longer all cytotoxic or genotoxic. hazardous drug in the draft Procedures drug to identify the hazard and some Furthermore, some drugs carry multiple recognizes that the molecular properties intrinsic molecular properties to American Hospital Formulary Service of a drug, such as the molecular weight, characterize the hazard 5 when (AHFS) code classifications and are not may substantially limit the potential for determining the potential for adverse solely used as antineoplastic drugs. adverse health effects. NIOSH may health effects of hazardous drugs in Therefore, when antineoplastic drugs consider molecular weight along with healthcare workers. Risks associated are grouped as they were in earlier the other intrinsic molecular properties with how and how often a hazardous versions of Table 1 of the List, an of a drug that affect the hazard a drug drug is used in a particular setting, and appearance that these drugs pose the poses. While some large molecular evaluation of exposure factors for all same hazard was inadvertently created weight drugs may have low occupational exposures is beyond the (i.e., non-cytotoxic drugs with cytotoxic bioavailability by relevant routes of scope of the List. The draft Managing drugs). NIOSH determined that exposure, other factors in the Hazardous Drug Exposures: Information grouping all antineoplastic drugs characterization of the hazard are for Healthcare Settings, which is in the together in one table is no longer the considered as well. Therefore, in docket for this activity, is intended to most useful or informative for the user. accordance with the draft Procedures assist employers in establishing their In light of these changes, NIOSH some monoclonal antibodies may not own hazardous drugs management proposes a new List structure, described meet the NIOSH definition of the term procedures specific to their workplace. in the preamble to the draft List, which ‘‘hazardous drug.’’ Because the list of is available for review in the docket for Monoclonal Antibodies drugs proposed for placement on the this activity. Changes to the List Seven commenters opposed the List has been updated based on the draft structure would place all drugs that Procedures, the monoclonal antibodies meet the NIOSH definition of a inclusion of biological drug products (monoclonal antibodies) on the List. bevacizumab and trastuzumab are no hazardous drug and contain MSHI in longer proposed for placement on the the package insert and/or are classified Comment: The language in the section titled ‘‘Application’’ indicates that the List. Blinatumomab continues to be by the National Toxicology Program proposed for placement and other (NTP) as ‘‘known to be a human draft Policy and Procedures do not apply to healthcare workers who handle monoclonal antibodies that have carcinogen,’’ or classified by the properties meeting the NIOSH International Agency for Research on recombinant therapeutic proteins. Therefore, all recombinant therapeutic definition of a hazardous drug will Cancer (IARC) as ‘‘carcinogenic’’ or remain on the List. ‘‘probably carcinogenic’’ on Table 1. proteins should be excluded from the Table 2 would now contain drugs that List unless ‘‘science-based or product- Periodicity meet one or more of the NIOSH 5 See draft Procedures footnote 18, ‘‘Properties of Three commenters offered opinions hazardous drug criteria and may be a drug molecule that may limit adverse effects in on the timeliness of the List, which healthcare workers are typically chemical, physical NIOSH has attempted to publish every 4 ≤ See USP, FAQs: <800 Hazardous Drugs— and structural properties that affect its absorption 2 years since 2010. Handling in Healthcare Settings, https:// (ability to enter the cells of the body), distribution, www.usp.org/frequently-asked-questions/ metabolism, and/or elimination e.g., chemical Comment: The List seems to be hazardous-drugs-handling-healthcare-settings. structure, molecular weight or mass.’’ heavily weighted toward older drugs.

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NIOSH response: The List is about 4 NIOSH response: A systematic review Comment: The draft Policy and years behind the introduction of new is a significant undertaking requiring Procedures should provide the drug drugs when it is periodically updated the prior publication or dissemination manufacturer with ‘‘transparent because there are several steps in the of multiple studies relating to a specific documentation as to the basis of adding review process. NIOSH appreciates that drug. In very few cases, if any, would a drug to the List.’’ Without a thorough a timelier List might be helpful and is sufficient studies be available to understanding of the basis for adding a working toward that end. The current conduct a formal meta-analysis relating drug, the drug manufacturer may not be List created by NIOSH requires an to a specific drug. NIOSH will consider able to formulate a request for extensive review process that does not conducting a systematic review if such reconsideration of the drug. readily allow more frequent publication. studies become available relating to the NIOSH response: The rationale for That said, when NIOSH becomes aware hazard that a specific drug may pose in proposing the placement of each drug to of new drugs with MSHI, NIOSH healthcare settings. the List is provided in the Federal identifies such drugs on the web page Comment: What is the mechanism for Register notice preceding the final List for the current List to immediately alert evaluating investigational new drugs publication. The manufacturer or any stakeholders. The inclusion of MSHI (i.e., drugs used in preclinical and other stakeholder is invited to comment makes such drugs automatically clinical research but not yet FDA- on the sufficiency of the explanation of hazardous under the NIOSH definition approved)? the basis for adding a drug to the List. and thus, the extensive review process NIOSH response: Drugs still under Comment: Providing sufficient is not required. investigation are not included on the information to rebut a NIOSH Comment: FDA-approved drugs List because no scientific information, determination to add or not add a drug should be reviewed in real time or including information normally to the List is difficult for healthcare NIOSH should provide ‘‘off-cycle’’ provided in package inserts, is available organizations. NIOSH response: For reevaluation of updates to the List. for NIOSH review. Accordingly, the List NIOSH response: The List is updated a listed drug, NIOSH does not require is derived only from drugs approved by any time NIOSH is aware that a drug requestors to provide a complete FDA’s Center for Drug Evaluation and manufacturer has added special analysis of the available evidence. The Research. NIOSH does not review drugs handling information to the patient requestor need only provide some new that are not yet approved for use in information for a specific drug. For information that is relevant to the issue humans. NIOSH does not review example, three drugs were added to the of whether the drug does or does not biologics reviewed by the FDA Center 2016 List after it was initially published; meet the NIOSH definition of a for Biologics Evaluation and Research. they are identified on the NIOSH List of hazardous drug or the decision to place Comment: Peer reviews should be Antineoplastic and Other Hazardous a drug on a particular table in the List. conducted before the close of the public Drugs in Healthcare Settings, 2016 web NIOSH will begin the reevaluation comment period to allow public page, https://www.cdc.gov/niosh/docs/ process for any request to add or remove commenters time to review them. Not 2016–161/default.html. NIOSH’s a drug that provides some new allowing public commenters to review extensive review process only allows for supporting evidence by searching for peer reviews before submitting their periodic updates of hazardous drugs additional hazard identification own comments to the docket is ‘‘in that do not have MSHI. (toxicity) and hazard characterization conflict with the principle of information about the drug that is Methodology/Process transparency’’ established in the OMB relevant to the criteria set out in the Seven commenters asked questions Final Information Quality Bulletin for NIOSH definition of a hazardous drug. and offered suggestions about the Peer Review (70 FR 2664, Jan. 14, 2005). procedures themselves. NIOSH response: NIOSH views peer Criteria Clarification Comment: The methodology used to review and public comment as two Six commenters were critical of the develop the list of drugs proposed for distinct, often complementary, tools in methodology NIOSH described for placement on the List was not the same ensuring both quality and transparency adding drugs to the List and asked that as the methodology used in previous in influential scientific information NIOSH clarify the language in certain years. products. As stated in the OMB Final sections of the draft Policy and NIOSH response: In 2004, NIOSH Information Quality Bulletin for Peer Procedures. used lists from several organizations as Review (Bulletin), ‘‘[p]eer reviewers Comment: NIOSH should include the examples of hazardous drugs. In 2010, shall be charged with reviewing professional qualifications of the NIOSH NIOSH first updated the List based on scientific and technical matters. . .’’ staff who perform these evaluations. the NIOSH definition of a hazardous whereas public comment, including NIOSH response: NIOSH relies on a drug. The draft Policy and Procedures stakeholder review, often provides range of knowledge, experience, and used to develop the drugs proposed for NIOSH with crucial feedback on how a skills to evaluate drugs for placement on placement on the List in the February project or publication may impact the the List, including but not limited to 2018 FRN described the methodology interests of employees, stakeholder pharmacology, toxicology, medicine, used by NIOSH since 2010. The draft organizations, or other parties. While and risk evaluation. The specific Procedures reflects peer review and the Bulletin recognizes the benefit of backgrounds of the professional staff public comment; the list of drugs both forms of input to agencies, it engaged in the evaluation process may proposed for placement on the List has provides agencies with broad discretion change over time, but NIOSH is been updated based on the revised draft in determining how to implement peer committed to a high-quality process Procedures. review, including timing as it relates to conducted by a team of professionals Comment: NIOSH should conduct or public comment, if applicable. NIOSH with the needed knowledge and commission a meta-analysis or does not offer peer reviews for public experience. Additionally, peer reviews systematic review, ‘‘[i]n the absence of comment for any scientific publications provide the Agency with a review of its published literature synthesizing the because the technical and scientific science; peer reviewers and their body of clinical knowledge’’ about a review conducted by independent peer credentials are identified in the NIOSH specific drug. reviewers are not NIOSH products. Peer Review Agenda.

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Commenters: NIOSH should identify and how the totality of the data is NIOSH conducts categorical regression the criteria used to evaluate study synthesized. analyses to evaluate dose-response data quality and strength, and describe how NIOSH response: NIOSH uses the for severity. The value for ‘‘low dose’’ they are used to critically appraise the subset of Bradford Hill criteria which should be drug-specific and a function quality and risk of bias and other are most useful for evaluating human of several factors such as normal limitations of individual studies; study results on hazardous drugs. The therapeutic doses, body weight, and arbitrate conflicting information; and most important criteria for the review of length of exposure. synthesize the totality of animal and human studies are strength of NIOSH response: The daily human studies data in support of, or association, temporality, plausibility, therapeutic dose at which serious organ opposition to, the listing of a drug as and biological gradient. toxicity, developmental toxicity, or ‘‘hazardous.’’ Comment: In the draft Policy and reproductive toxicity occurs (10 mg/day Procedures footnote 45, NIOSH lists in human adults and 1 mg/kg per day NIOSH response: The majority of criteria used to evaluate information in laboratory animals) has long been these evaluations are based on the from animal studies. It is unclear if used by the pharmaceutical industry to information provided in the drug NIOSH will conduct meta-analyses to develop occupational exposure limits package insert; thus, NIOSH relies on test for consistency of results; how (OELs) of less than 10 mg/m3 after the quality of science generated by a NIOSH will interpret evidence for, or applying appropriate uncertainty drug manufacturer, subsequently absence of, concordance across species factors.7 OELs in this range are typically reviewed by FDA during the drug or between structural analogs of the established for potent or toxic drugs in approval process, and then published in drug; whether NIOSH will conduct the pharmaceutical industry. NIOSH is the drug package insert. When studies categorical regression analyses to adding text in footnote 16 of the draft are available for review of a drug being evaluate dose-response data; and how Procedures to clarify and emphasize the considered for placement on the List or NIOSH evaluates routes of exposures. derivation. Furthermore, animal studies must be for the reevaluation of a drug already on Comment: NIOSH should clarify how evaluated for the recovery/reversibility the List, quality may be evaluated by close chemical analogs are identified, of effects and the pharmacological NIOSH scientists and independent peer and whether NIOSH establishes site relevance of the species studied. NIOSH reviewers on a case-by-case basis. In the concordance across analogs and how must add criteria for animal studies to case of a drug being reevaluated, evidence for and against the absence of include the recovery/reversibility of conclusions about study quality would concordance is interpreted. Similar adverse effects and the pharmacological be discussed in a Federal Register questions were raised about animal notice. relevance of the test species. NIOSH response: NIOSH has not studies. Comment: While NIOSH describes conducted a formal meta-analysis or NIOSH response: NIOSH examines several Bradford Hill criteria 6 used to systematic review for any drug currently chemical analogs based on similarities evaluate information from human on the List. In very few cases, if any, in a drug’s structure and toxicity profile studies in footnote 44 of the draft Policy would sufficient studies be available to compared with other drugs on the List. and Procedures, no rationale is offered conduct a formal meta-analysis relating Often the mechanism of action for the to explain why many of the original to a specific drug. Accordingly, NIOSH drug being assessed is known and can nine Bradford Hill criteria are not used. primarily uses information available in be compared to other drugs of a similar Moreover, caution should be taken the package inserts to make structure/activity. This criterion is when making determinations about determinations about whether to place a typically only used when toxicity potentially hazardous drugs because drug on the List. NIOSH may conduct a information specific to the drug under causality is not necessarily meta-analysis or systematic review evaluation is insufficient or unavailable demonstrated by a strong association when reevaluating the placement of a but is available for the chemical analog. just as absence of causality is not drug already on the List, if the available Comment: Hazardous drugs should necessarily demonstrated by weak evidence warrants such a review. In that also be identified by UNII code (the associations; associations that case, important criteria for animal unique ingredient identifier used by demonstrate a monotonic trend in studies include strength of association; FDA and USP) on the List. health outcome frequency (steadily consistency between studies; relevance NIOSH response: There are several increasing or decreasing without ever of the model system and routes of methods for identifying active changing direction) are not necessarily exposure; the duration, reversibility, pharmaceutical ingredient compounds, causal if a confounding factor and recoverability of the observed including Chemical Abstract Service demonstrates a dose-response effects; and concordance of those effects Registry number (CAS) and UNII. At relationship with the health outcome; with effects in humans. If a meta- this time, NIOSH has chosen not to list and prior beliefs should not be allowed analysis or systematic review is any of the identification numbers but is to cloud judgment with regard to warranted for a reevaluation, NIOSH considering doing so in the future. plausibility. NIOSH should clarify the would consider these criteria on a case- NIOSH encourages public input on the criteria described in the footnote and by-case basis. Under the draft question of which ingredient identifier explain how evidence against these Procedures, NIOSH’s rationale, may be the most useful for the List. various criteria is evaluated, how each including a description of any meta- Editorial Suggestions independent line of evidence is analysis or systematic review if systematically and critically appraised, performed, and final determination Two commenters offered editorial how the quality and risk of bias of would be described in a notice suggestions for clarifying language in individual studies is evaluated, how published in the Federal Register. the draft; although the comments are not conflicting information is arbitrated, Comment: It is unclear how NIOSH summarized here, changes were made to interprets evidence of increasing the revised draft Procedures as appropriate. 6 Aschengrau A, Seage GR [2018], Essentials of progression or severity with increased Epidemiology in Public Health. 4th Edition, dose, and how the value for ‘‘low dose’’ (Burlington, MA: Jones & Bartlett). was derived. Specifically, whether 7 See supra note 3.

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C. Draft Procedures: Summary of Do Not Place Drug on the List NIOSH response: NIOSH has Changes Comment: Botulinum toxins, determined that dihydroergotamine has including abobotulinumtoxinA and demonstrated reproductive toxicity in NIOSH considered peer review and experimental animals. In embryo-fetal public comment received in response to onabotulinumtoxinA, should not be placed on the List. Botulinum toxins do development studies of the February 2018 FRN, and not meet the criteria for placement on dihydroergotamine mesylate nasal significantly revised the draft Policy and the List; abotulinumtoxinA and spray, intranasal administration to Procedures; that document is now rimabotulinumtoxinB did not have pregnant rats throughout the period of called Procedures. These changes now labeling changes during the search organogenesis resulted in decreased fetal body weights and/or skeletal reflected in the draft Procedures for period January 2014 through December ossification at doses approximately 0.4– Developing the NIOSH List of 2015, and changes to the labels for 1.2 times the exposures in humans Hazardous Drugs in Healthcare Settings onabotulinumtoxinA and receiving the maximum recommended (draft Procedures) include the incobotulinumtoxinA do not meet the daily dose of 4 mg or greater. clarification of some language and criteria for organ toxicity at low doses Accordingly, NIOSH proposes to place streamlining the procedures NIOSH or teratogenicity or other developmental uses to determine the hazard potential dihydroergotamine on the List. toxicity. Moreover, NIOSH is not Comment: Exenatide should not be of a specific drug. Most importantly, the properly weighing the low therapeutic definition of the term ‘‘hazardous drug’’ placed on the List. NIOSH did not take index of the drug against the relatively into account the real risk of would now acknowledge that ‘‘hazard low risk of handling the drug by occupational exposure or the characterization’’ is an important factor healthcare workers who are mechanism of action of this relatively for drugs under consideration. Section C knowledgeable about safe handling. large molecule. The size of the molecule of the draft Procedures, which includes According to the safety data sheets for limits dermal absorption and the evaluation criteria, would be botulinum toxins, no engineering aerosolization. expanded to include new clauses 4 and controls or respiratory protective NIOSH response: While some drugs 5 to allow NIOSH to consider additional devices are required for safe handling. may have low bioavailability by relevant factors beyond the intrinsic toxicity of NIOSH response: NIOSH reviews the routes of exposure due to molecular the drug molecule in determining relevant data on a drug when a label weight, other factors in the whether to place the drug on the List. change is made, not just the data characterization of the hazard are The draft Procedures is in the docket for relating to the label change. However, considered as well. NIOSH has this activity. after consideration of input from the determined that exenatide extended- public and stakeholders, NIOSH has release caused a dose-related and III. The NIOSH List of Hazardous Drugs decided to review the toxicity and the treatment-duration–dependent increase in Healthcare Settings, 2020 hazards related to occupational in the incidence of thyroid C-cell A. Public Comment Summaries and exposure to botulinum toxins. tumors (adenomas and/or carcinomas) NIOSH Responses Therefore, at this time NIOSH is no at clinically relevant exposures in both longer proposing to place the class of genders of rats. In mice, doses near the As discussed extensively in the notice botulinum toxins on the 2020 List. Any maximum recommended human dose published February 14, 2018, NIOSH additional information from any lead to increased neonatal death. In rats, identified 275 potentially hazardous interested party that will assist with exenatide administered during the drugs between January 2014 and further reviews of the botulinum toxins period of organogenesis reduced fetal December 2015 (83 FR 6563). Of the 275 will be reviewed for potential placement growth and produced skeletal drugs identified during that timeframe, on the List in the future. ossification deficits at doses that two had special handling information Comment. Darbepoetin alfa should approximate the maximum specified by the manufacturer (MSHI) not be placed on the List. This drug recommended human dose. and were automatically placed on the poses no risk to healthcare workers; the Accordingly, NIOSH proposes to place evidence supporting its addition is not List. The other 273 were screened and exenatide on the List. Polypeptides of based on occupational exposure. The the information available for 44 drugs this size and larger have been shown to large molecular size limits dermal suggested one or more toxic effects; have bioavailability through relevant absorption and aerosolization. The routes of exposure. Because dosage those drugs were evaluated by NIOSH drug’s mechanism of action does not forms can change and new dosage forms and shared with peer reviewers and indicate DNA damage. may be approved, dosage form is not stakeholders. After considering the peer NIOSH response: NIOSH concurs considered in making List placement and stakeholder reviews, NIOSH with commenters that the evidence of determinations. determined that 20 drugs and one class carcinogenicity for darbepoetin alfa in Comment: Interferon beta-1b should of drugs exhibit toxicity that meets the patients who did not already have not be placed on the List, or, in the NIOSH definition of a hazardous drug cancer was insufficient to support a alternative, it should only be placed on and proposed them for placement on the NIOSH finding of carcinogenicity. In Table 3. The rationale for placing List. The two drugs with MSHI that were addition, darbepoetin alfa did not meet interferon beta-1b on the List is that placed on the List and the 20 drugs and the NIOSH criteria for a hazardous drug information from the package insert one drug class proposed for placement based on any other toxicity endpoint. indicated reproductive toxicity: on the List were identified in the Accordingly, darbepoetin alfa is no spontaneous abortion in human clinical February 14, 2018 notice, along with longer proposed for placement on the trials. Data evaluation submitted to the NIOSH’s rationale for each proposed 2020 List. docket by the manufacturer addition. A new peer review was not Comment: Dihydroergotamine should demonstrates that interferon beta-1b is conducted. Public comments on the not be placed on the List. The safety not causally associated with drugs and drug class proposed for data sheet for this drug indicates that it spontaneous abortion or with any placement on the List in 2018 are does not pose a heightened risk to ‘‘patterns or signals suggesting summarized and answered below. healthcare workers. pregnancy outcomes.’’ Research on

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populations who have received be exposed to osimertinib during insufficient to support placement on the interferon beta-1b throughout pregnancy handling at levels found to cause List. There are no human studies have demonstrated no difference in embryo-fetal harm. In addition, there are relating to the developmental effects of spontaneous abortions or birth weight no reports of teratogenicity, daratumumab or dinutuximab. No compared to population comparators. developmental toxicity, embryo-fetal animal studies have been performed NIOSH response: The manufacturer toxicity, lethality, or reduced growth in regarding developmental effects of provided information indicating that clinical trials conducted in humans, or daratumumab or dinutuximab. multiple evaluations of pregnancy in real world use since FDA approval in Accordingly, NIOSH is not proposing to registries did not provide any signals 2015. place these two drugs on the List. suggesting negative pregnancy outcomes NIOSH response: NIOSH has associated with interferon beta-1b. determined that teratogenicity or other Comment: NIOSH indicated that 10 Accordingly, NIOSH has determined developmental toxicity after exposure to drugs—cetuximab, ibrutinib, that interferon beta-1b does not meet the osimertinib were observed at doses ipilmumab, necitumumab, nintedanib, criteria for a hazardous drug and is no higher than the maximum nivolumab, palbociclib, panitumumab, longer proposing to place it on the List. recommended human dose and ramucirumab, and ruxolitinib— Comment: Ivabradine should not be reproductive effects at doses lower than demonstrated available information that placed on the List. This drug is the maximum recommended human shows a toxic effect that does not meet administered as a coated tablet, self- doses were equivocal. Therefore, NIOSH the NIOSH definition of a hazardous administered by the patient at home; as no longer proposes to place osimertinib drug. These drugs should be placed on such, ivabradine poses no risk to on the List. the List because of their teratogenic and/ healthcare workers. Comment: Triazolam should not be or reproductive effects or the rationale NIOSH response: NIOSH has placed on the List. for not proposing their placement on the determined that reproductive effects NIOSH response: NIOSH’s rationale List should be further explained. were observed in pregnant rats at doses for proposing the placement of NIOSH response: As presented in the near the equivalent maximum triazolam on the List was that it mimics 2018 FRN, NIOSH reviewed cetuximab, recommended human dose. Drugs are the benzodiazepines which are included ibrutinib, ipilimumab, necitumumab, placed on the List based on their on the List because they are teratogenic nintedanib, nivolumab, palbociclib, intrinsic properties. Because dosage or cause other developmental effects. panitumumab, ramucirumab, and forms can change and new dosage forms However, NIOSH did not independently ruxolitinib for placement on the List may be approved, dosage form is not evaluate triazolam. After review, NIOSH and, for each, the available information considered in making List placement now finds that the information in the showed a toxic effect that does not meet determinations. Accordingly, NIOSH package insert for this drug does not the NIOSH definition of a hazardous continues to propose placing ivabradine support a determination that it presents drug. For some of these drugs, no drug- on the List. a hazard to healthcare workers and is no specific data were available in the Comment: Olaparib should not be longer proposing to place it on the List. package inserts to support warnings in placed on the List because the risk to the inserts regarding developmental or direct occupational healthcare worker Place Drug on the List reproductive effects; for other drugs, the exposure is anticipated to be minimal Comment: NIOSH indicated that two toxic effects occurred at doses higher when handling intact olaparib capsules. drugs—daratumumab and NIOSH response: NIOSH has dinutuximab—demonstrated than human recommended doses. For determined that teratogenicity occurred insufficient toxicity information example, NIOSH found that ibrutinib in rats at doses approximately 0.3 available to meet the NIOSH definition had developmental effects in animals percent of therapeutic doses in humans. of a hazardous drug. Both drugs should but only at doses twice the maximum Accordingly, NIOSH proposes to place be placed on the List because recommended human dose of 560 mg/ olaparib on the List. Because dosage information available in the respective day. If new information becomes forms can change and new dosage forms package inserts indicates that both drugs available about any of these drugs, may be approved, dosage form is not may cause teratogenic effects. NIOSH NIOSH will reevaluate them in a future considered in making List placement should provide the rationale for not update to the List. determinations. proposing their placement on the List. Comment: Eight drugs were approved Comment: Osimertinib should not be NIOSH response: As presented in the by FDA prior to December 2015, but do placed on the List. Embryo-fetal toxicity 2018 FRN, daratumumab and not appear on the 2016 List and were is shown to happen at dose exposure 1.5 dinutuximab were reviewed and did not not proposed for placement on the List times the recommended ingested human meet the NIOSH criteria for a hazardous in the February 2018 FRN. The drugs dose of 80 mg; it is unlikely that a drug because the available information and rationales for each of them include healthcare worker would accidentally about each drug’s toxicity was the following:

Fosamprenavir ...... Carcinogenicity: Cited studies demonstrated an increased incidence of various oncologic presentations (hepatocellular adenoma/carcinoma, interstitial cell hyperplasia, and uterine endometrial adenocar- cinoma), in multiple animal species (rat and mice) at exposure lower than human doses (0.7–1.4 fold in rats and 0.3–0.7 fold in mice compared to a human dosing). Gefitinib ...... Carcinogenicity/teratogenicity: Cited studies demonstrated an increased incidence of hepatocellular adeno- mas in mice. The package insert also cites gefitinib as exhibiting teratogenicity. Idelalisib ...... Genotoxicity: Cited studies demonstrated genotoxicity in male rats at high doses (2 grams/kilogram). Lapatinib ...... Reproductive toxicity/teratogenicity: The FDA classifies lapatinib as pregnancy category D indicating posi- tive evidence of human fetal risk. Cited studies in the package insert also demonstrate impaired fertility in rats. Midostaurin ...... Reproductive toxicity: Cited studies in the package insert demonstrated reproductive toxicity in male and female rates. Nicotine ...... Carcinogenicity/genotoxicity: Cited studies in the package insert demonstrated an increased incidence of tumors in hamsters and rats. Genotoxicity has been noted in Chinese hamster ovary cells.

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Pembrolizumab ...... Teratogenicity: The package insert contains a warning of embryofetal toxicity when administered to preg- nant women. Manufacturer recommendation: that females of reproduction potential use effective contra- ception during and for four months after completing therapy. Talimogene laherparepvec ...... Reproductive toxicity: The package insert contains MSHI stating, ‘‘Healthcare providers who are immunocompromised or pregnant should not prepare or administer IMLYGIC and should not come into direct contact with the IMLYGIC injection sites, dressings, or body fluids of treated patients’’ due to the risk of transmission of talimogene laherparepvec and herpetic infection.

NIOSH response: Each of these drugs of a hazardous drug, falls outside the in the future. NIOSH’s findings about has either been previously reviewed and scope of the List, or is slated for review each drug are as follows: found not to meet the NIOSH definition

Fosamprenavir ...... This drug was reviewed by NIOSH for a previous update to the List and it did not meet the criteria for a hazardous drug. The available information showed this drug has a toxic effect that does not meet the NIOSH definition of hazardous drug. No new information has been reported that would meet the NIOSH criteria for a hazardous drug. If new information becomes available, NIOSH will reevaluate it in a future update to the List. Gefitinib ...... This drug was reviewed by NIOSH for a previous update to the List and it did not meet the criteria for a hazardous drug. However, because new safety information was recently added to the package insert, this drug is scheduled to be reviewed for the update after the 2020 List update. Idelalisib ...... This drug was reviewed by NIOSH and presented in the 2018 FRN; it did not meet the criteria for a haz- ardous drug. The available information does not demonstrate or support a determination that the drug meets the NIOSH definition of hazardous drug. No new information has been reported that would meet the NIOSH criteria for a hazardous drug. If new information becomes available, NIOSH will reevaluate it in a future update to the List. Lapatinib ...... This drug was reviewed by NIOSH for a previous update to the List. The available information showed this drug has a toxic effect that does not meet the NIOSH definition of hazardous drug. No new information has been reported that would meet the NIOSH criteria for a hazardous drug. If new information becomes available, NIOSH will reevaluate it in a future update to the List. Midostaurin ...... This drug was approved by FDA in 2017. This drug is scheduled to be reviewed for the next List update. Nicotine ...... Because drugs sold over the counter are not contemplated in this activity, this drug has not been and will not be reviewed for placement on the List. Pembrolizumab ...... This drug was reviewed by NIOSH and presented in the 2018 FRN; the available information shows a toxic effect that does not meet the NIOSH definition of hazardous drug. It is scheduled to be re-reviewed for the next update to the List, because new information has been added to the package insert. Talimogene laherparepvec ...... This oncolytic viral therapy product is outside the scope of NIOSH’s definition of a hazardous drug be- cause it is approved by FDA’s Center for Biologics Evaluation and Research. NIOSH’s definition of a hazardous drug only covers drugs approved by FDA’s Center for Drug Evaluation and Research and is not considered for inclusion on the List.

Move From One Table on the List to As such, they should be moved from NIOSH response: BCG, a vaccine Another Table 1 to another place on the List. approved by the FDA Center for Comment: The hormonal agents in NIOSH response: After scientific Biologics Evaluation and Research, was Table 1 of the 2016 List that are review and consideration of input from included in the original 2004 Alert and exclusively reproductive risks, peer reviewers and public commenters, ‘grandfathered’ into the List. However, including estrogens (estrogen agonist- NIOSH is proposing a reorganization of because NIOSH has reaffirmed in the antagonists such as tamoxifen and the List. As cancer therapy has changed draft Procedures that only those drugs antiestrogens such as anastrozole, from primarily cytotoxic drugs to non- approved by the FDA Center for Drug exemestane, and letrozole), cytotoxic and targeted therapies, there is Evaluation and Research are included in gonadotropins (leuprolide and sometimes a mismatch in general the List, BCG is no longer included in triptorelin), antigonadotrophins recommendations for safe handling and the List. (degarelix), and progestins (megestrol) the hazardous nature of the drugs. In should be moved to Table 2 or 3. light of these changes, NIOSH proposes Drugs Handled Inconsistently Comment: Monoclonal antibodies do a new List structure, described in the Comment: The drugs ibrutinib and not have a cytotoxic mechanism of preamble to the List, which is available blinatumomab, both antineoplastic action and, as such, do not pose the for review in the docket for this activity. same level of occupational risk or In accordance with the new structure, monoclonal antibodies, are treated toxicity as conventional antineoplastic many of the hormonal agents on the inconsistently in the February 2018 drugs. Those monoclonal antibodies 2016 List have been moved to Table 2. FRN. Ibrutinib was identified as a drug that are not directly cytotoxic or Hormonal agents that are classified by for which the available information conjugated with a cytotoxic agent NTP as ‘‘known to be a human shows a toxic effect that does not meet should be moved from Table 1 to carcinogen’’ or by IARC as the NIOSH definition of a hazardous another place on the List. ‘‘carcinogenic’’ or ‘‘probably drug; blinatumomab was proposed for Similarly, small-molecule kinase carcinogenic’’ will be identified in Table placement on the List on the basis of inhibitors, such as afatinib, crizotinib, 1. evidence which shows the drug is a dabrafenib, and imatinib, act through a neurotoxin at low doses. NIOSH should targeted mechanism of action and are Remove Drug From List consider whether reliance on the AHFS not directly cytotoxic; they primarily Comment: Bacillus Calmette-Guerin Class 10:00 (antineoplastic agents) alone pose a reproductive and teratogenic risk. (BCG) should be removed from the List. ‘‘is enough to necessitate Table 1

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inclusion even if a drug does need to be human recommended dose of 400 mg/ inherent toxicity, it is currently beyond on the NIOSH list.’’ day. In humans receiving 400 mg/day or the scope of the List. NIOSH will NIOSH response: In response to input higher developmental effects consistent consider identifying hazardous drugs from peer reviewers and external with animal data have been observed that are known to be volatile in future comments and following scientific and epidemiological data suggest a risk updates to the List. review, NIOSH proposes a of spontaneous abortions and congenital B. Draft NIOSH List of Hazardous Drugs reorganization of the tables in the draft abnormalities in infants whose mothers in Healthcare Settings, 2020: Summary 2020 List in a manner that may address were treated with 150 mg/day of Changes at least some of the concerns expressed. fluconazole. Data on the developmental Because the way cancer is treated effects of itraconazole and ketoconazole In February 2018, NIOSH proposed therapeutically has changed, and the suggest developmental toxicity has only adding 21 drugs (including one class of types of drugs used to fight cancer have been observed in doses greater than the drugs) to the List. After evaluating changed, antineoplastic drugs are no maximum human recommended dose. public comments, NIOSH made the longer all cytotoxic, genotoxic, and following determination: Add New Category of Drugs highly hazardous chemicals. D 13 drugs are proposed for Furthermore, some drugs carry multiple Comment: Add a new category for placement on the List AHFS code classifications and are not drugs that sublime and offer information D 3 drugs are automatically added to just antineoplastic drugs. Therefore, about proper handling, including the the List because they have MSHI in the when antineoplastic drugs are grouped, conditions under which sublimation package insert (2 drugs identified in the as they were in earlier versions of Table (transition of a solid substance to a gas) 2018 FRN and another recently- 1, drugs that required different levels of happens as well as the need to filter and approved by FDA) protection were grouped together (non- exhaust the work area where such drugs D 7 drugs proposed for placement on cytotoxic drugs with cytotoxic drugs). are used. The List should also indicate the List in the 2018 FRN are no longer NIOSH determined that grouping all that hazardous drugs that do not considered in this action antineoplastic drugs together in one sublime may be exhausted through a table is no longer the most useful or HEPA filter back into the work area. The 13 drugs proposed for placement informative for the user. In light of these NIOSH response: Sublimation on the List are presented for public changes, NIOSH proposes a new List depends on the drug form and is not an comment in the table below, along with structure, described in the preamble to inherent toxicity property of the drug. the rationale for their placement on the the draft List, which is available for Accordingly, drugs that sublime should List. review in the docket for this activity. be handled using risk management Two drugs included in the 2018 FRN, Comment: Azole antifungal drugs are strategies relevant to the conditions of inotuzumab ozogamicin and being treated inconsistently. use. Although assessing specific trabectedin, have MSHI and are Fluconazole is included in the List on controls for specific exposure situations automatically added to the 2016 List. Table 3, but for two newer azole is beyond the scope of the List, One additional drug, polatuzumab antifungals, the available information information about the use of respiratory vedotin, was approved by FDA’s Center showed a toxic effect that does not meet protection in the handling of hazardous for Drug Evaluation and Research in the NIOSH definition of a hazardous drugs is found in the draft risk July/August 2019 and its package insert drug (ketoconazole) and information management document, Managing includes MSHI provided by the drug’s does not demonstrate or support that the Hazardous Drug Exposures: Information manufacturer. Because drugs with MSHI drug meets the NIOSH definition for Healthcare Settings, which is are automatically placed on the List and (itraconazole) in the FRN. Thus, neither available in the docket for this activity. are not subject to public or peer review, was proposed for placement on the List Comment: The List should identify polatuzumab vedotin was added to the in the February 2018 FRN. those hazardous drugs that are both 2016 List in September 2019 and will NIOSH response: NIOSH has cytotoxic and cytostatic as well as appear in the 2020 List.8 These three evaluated each drug individually and volatile. The drugs pose the greatest risk drugs do not appear below because they not by class of drug. Two very similar to healthcare workers, ‘‘based on a are not subject to public comment. drugs may have substantially different combination of volatility and dose- The following seven drugs that were toxicities and at different doses. related toxic potential of those vapors.’’ proposed for placement on the List in Fluconazole meets the NIOSH criteria NIOSH response: Only a few of the the February 2018 FRN are no longer for a hazardous drug while the other drugs on the List are known to have an proposed for placement on the List, for two, ketoconazol and itraconazole, do appreciable vapor pressure; reliable the reasons discussed above in Sections not. Animal data on the developmental information concerning the vapor II.B. and III.B: bevacizumab, botulinum effects of fluconazole suggest pressure of most drugs can be difficult toxins, darbepoetin alfa, interferon beta- developmental changes in rats at doses to identify. Because this issue is a 1b, osimertinib, trastuzumab, and less than the equivalent maximum matter of delivery form, rather than triazolam.

DRUGS PROPOSED FOR PLACEMENT ON THE NIOSH LIST OF HAZARDOUS DRUGS IN HEALTHCARE SETTINGS, 2020

Generic drug name a and AHFS class b Rationale c and proposed location d on the List

Blinatumomab ...... Rationale AHFS Class: Antineoplastic ...... Organ toxicity at low doses: neurotoxicity at low doses in patients in clinical studies. Proposed Location Table 2: No MSHI, not classified as known or probable carcinogen by NTP or IARC.

8 See https://www.cdc.gov/niosh/docs/2016-161/ default.html for all drugs with special handling information added to the 2016 List.

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DRUGS PROPOSED FOR PLACEMENT ON THE NIOSH LIST OF HAZARDOUS DRUGS IN HEALTHCARE SETTINGS, 2020— Continued

Generic drug name a and AHFS class b Rationale c and proposed location d on the List

Ceritinib ...... Rationale AHFS Class: Antineoplastic ...... Developmental toxicity: embryo-fetal toxicity at low doses in rats and rabbits. Proposed Location Table 2: No MSHI, not classified as known or probable carcinogen by NTP or IARC. Clobazam ...... Rationale AHFS Class: Antiepileptic ...... Reproductive toxicity and Developmental toxicity: embryo-fetal mortality and other harm at low doses in rats and rabbits, present in human breast milk. Proposed Location Table 2: No MSHI, not classified as known or probable carcinogen by NTP or IARC. Cobimetinib ...... Rationale AHFS Class: Antineoplastic ...... Reproductive toxicity and Developmental toxicity: increased post-implantation loss, including total litter loss in rats at low doses; post-implantation loss and fetal malformations in humans. Proposed Location Table 2: No MSHI, not classified as known or probable carcinogen by NTP or IARC. Dihydroergotamine ...... Rationale AHFS Class: 5-hydroxytryptamine (HT) Reproductive toxicity: oxytocic properties at low doses in humans. receptor binder. Proposed Location Table 2: No MSHI, not classified as known or probable carcinogen by NTP or IARC. Exenatide ...... Rationale AHFS Class: Antidiabetic ...... Carcinogenicity and Developmental toxicity: thyroid C-cell tumors in rat studies; adverse fetal effects in rats and mice. Proposed Location Table 2: No MSHI, not classified as known or probable carcinogen by NTP or IARC. Isotretinoin ...... Rationale AHFS Class: Retinoid ...... Developmental toxicity: severe fetal malformations at any dose in humans. Proposed Location Table 2: No MSHI, not classified as known or probable carcinogen by NTP or IARC. Ivabradine ...... Rationale AHFS Class: Hyperpolarization-acti- Developmental toxicity: embryo-fetal toxicity and teratogenicity at low doses in rats. vated cyclic nucleotide-gated (HCN) blocker. Proposed Location Table 2: No MSHI, not classified as known or probable carcinogen by NTP or IARC. Lenvatinib ...... Rationale AHFS Class: Antineoplastic ...... Developmental toxicity: embryo-fetal toxicity at low doses in rats and rabbits; abortifacient in rabbits at low doses. Proposed Location Table 2: No MSHI, not classified as known or probable carcinogen by NTP or IARC. Miltefosine ...... Rationale AHFS Class: Antibiotic ...... Developmental toxicity: fetal death and teratogenicity at low doses in rats and rabbits. Proposed Location Table 2: No MSHI, not classified as known or probable carcinogen by NTP or IARC. Olaparib ...... Rationale AHFS Class: Antineoplastic ...... Carcinogenicity and Developmental toxicity: myelodysplastic syndrome/acute myeloid leukemia in pa- tients in clinical studies; embryo-fetal toxicity, post implantation loss, malformations at low doses in rats. Proposed Location Table 2: No MSHI, not classified as known or probable carcinogen by NTP or IARC. Sonidegib ...... Rationale AHFS Class: Antineoplastic ...... Reproductive toxicity and Developmental toxicity: embryo-fetal toxicity, teratogenesis, and spontaneous abortions at low doses in rabbits. Proposed Location Table 2: No MSHI, not classified as known or probable carcinogen by NTP or IARC. Urofollitropin ...... Rationale AHFS Class: Ovulation stimulator ...... Developmental toxicity: drug is known to cause fetal harm in patients. Proposed Location Table 2: No MSHI, not classified as known or probable carcinogen by NTP or IARC. a FDA-approved drug (January 2014–December 2015). b AHFS (American Hospital Formulary Service) Pharmacologic-Therapeutic Classification system. c See Procedures section IV. d NIOSH proposes that the List include only two tables. Table 1 includes only those drugs that contain MSHI in the package insert; and/or meet the NIOSH definition of a hazardous drug and are classified by the NTP as ‘‘known to be a human carcinogen,’’ or classified by the IARC as ‘‘carcinogenic’’ or ‘‘probably carcinogenic.’’ Table 2 includes those drugs that meet the NIOSH definition of a hazardous drug but are not drugs that have MSHI or are classified by the NTP as ‘‘known to be a human carcinogen,’’ or classified by the IARC as ‘‘carcinogenic’’ or ‘‘prob- ably carcinogenic.’’

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C. NIOSH List of Hazardous Drugs in website 9 and includes the following implementation of a medical Healthcare Settings, 2020—Title, questions. NIOSH encourages public surveillance program, data analysis, and Reorganization, and Removals comment on these questions. communication of results to NIOSH has retitled and reorganized 1. Please provide feedback on the participants. the List in response to comments overall document: a. What additional information would John J. Howard, received. Many of the drugs currently Director,National Institute for Occupational used to fight cancer function differently improve its usefulness and why? b. What changes could be made to Safety and Health, Centers for Disease Control than those previously used. and Prevention. Antineoplastic drugs are no longer all improve the utility of the information? c. What information is redundant, [FR Doc. 2020–09332 Filed 4–30–20; 8:45 am] cytotoxic, genotoxic, and highly BILLING CODE 4163–18–P hazardous chemicals. Therefore, when incorrect, missing, or not needed? drugs are grouped by their function (i.e., Please explain. 2. Please provide any additional antineoplastic), as they were in earlier DEPARTMENT OF HEALTH AND studies or scientific information that versions of Table 1, drugs that required HUMAN SERVICES different protective measures were evaluate or validate engineering, work grouped together (non-cytotoxic drugs practice or administrative controls to Centers for Disease Control and with cytotoxic drugs). NIOSH has reduce exposures to hazardous drugs in Prevention determined that grouping all healthcare settings. antineoplastic drugs together in one 3. Please provide any additional Mine Safety and Health Research table is no longer the most useful or studies or scientific information that Advisory Committee (MSHRAC) informative for users. Therefore, NIOSH support or validate the use of the NIOSH recommended control strategies AGENCY: Centers for Disease Control and has regrouped the tables by hazard. The Prevention (CDC), Department of Health List now comprises only two tables: or alternative strategies to control exposures to hazardous drugs. and Human Services (HHS). Table 1: Drugs that contain MSHI in the 4. Please provide any additional ACTION: Notice of meeting. package insert and/or meet the NIOSH studies or scientific information that definition of a hazardous drug and are support or validate evidence-based SUMMARY: In accordance with the classified by NTP as ‘‘known to be a human Federal Advisory Committee Act, the carcinogen,’’ or classified by IARC as strategies or approaches for controlling ‘‘carcinogenic’’ or ‘‘probably carcinogenic.’’ exposures to hazardous drugs that are CDC announces the following meeting Table 2: Drugs that meet the NIOSH different from those that NIOSH has for the Mine Safety and Health Research definition of a hazardous drug, but do not proposed. Advisory Committee (MSHRAC). This is have MSHI and are not classified by NTP as 5. NIOSH has provided its proposed a virtual meeting. It is open to the ‘‘known to be a human carcinogen,’’ or recommendations and related public, limited only by web conference classified by IARC as ‘‘carcinogenic’’ or lines (500 web conference lines are ‘‘probably carcinogenic.’’ information about controlling hazardous drugs in the Table of Control available). If you wish to attend, please Additional changes to the List, Approaches in Chapter 8. contact Marie Chovanec by email at including those drugs proposed for a. What additional information would [email protected] or by telephone at removal from the List, are described in improve the usefulness of this table and 412–386–5302 at least 5 business days detail in the draft NIOSH List of why? in advance of the meeting. She will Hazardous Drugs in Healthcare Settings, b. What structural or format changes provide you the Zoom web conference 2020, which is available for review in could be made to improve the utility of access. the docket for this activity. this table? DATES: The meeting will be held on June IV. Risk Management for Hazardous c. What information is redundant, 2, 2020, 10:00 a.m.–2:30 p.m., EDT. Drugs in Healthcare Settings incorrect, missing, or not needed? ADDRESSES: The Zoom web conference Please explain. access can be obtained via email at In the 2016 List, Table 5 provided 6. What improvements could be made information on recommended exposure [email protected] or by telephone at to this risk management information to 412–386–5302. controls for hazardous drugs based on make it more useful to employers and formulations. In order to clarify that the FOR FURTHER INFORMATION CONTACT: healthcare workers? Please provide Jeffrey H. Welsh, Designated Federal List is a hazard identification tool, specific examples. NIOSH has removed this table from the Officer, MSHRAC, NIOSH, CDC, 626 7. Please provide information about Cochrans Mill Road, Pittsburgh, PA document. In its place, NIOSH has your professional experience, if any, of developed a new, comprehensive 15236, telephone 412–386–4040; email implementing control strategies for [email protected]. document on risk management exposures to hazardous drugs in SUPPLEMENTARY INFORMATION: strategies entitled, Managing Hazardous healthcare or similar settings. Please Purpose: This committee is charged Drug Exposures: Information for describe what you found to be most or with providing advice to the Secretary, Healthcare Settings, which includes a least effective and why. Include relevant Department of Health and Human revision of this table on control publications if available. approaches to safe handling of 8. Please provide any additional Services; the Director, CDC; and the hazardous drugs. The new risk studies or scientific information related Director, NIOSH, on priorities in mine management document is available for to the use of a medical surveillance safety and health research, including review in the docket for this activity. program as an additional approach to grants and contracts for such research, NIOSH is seeking input from the protect workers in healthcare settings. 30 U.S.C. 812(b)(2), Section 102(b)(2). public on the draft risk management Information of particular interest Matters to be Considered: The agenda strategies document and table to ensure includes considerations for design and will include discussions on mining that they contain accurate and helpful safety and health research projects and information. Independent peer 9 NIOSH Peer Review Agenda, https:// outcomes, including updates from one reviewers are being consulted as well; www.cdc.gov/niosh/review/peer/isi/ MSHRAC Workgroup, the Health their charge is available on the NIOSH healthsafetyrisks.html. Advisory in the Mining Program

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