Federal Register / Vol. 89, No. 245 / Friday, December 20, 2024 / Notices 104163 

FOR FURTHER INFORMATION CONTACT: 

Broderick Yoerg, Division of Global 

Health Protection, Global Health Center, 

Centers for Disease Control and 

Prevention, 1600 Clifton Rd., Atlanta, 

GA 30329, email: DGHPNOFOs@

cdc.gov, telephone: 404–234–0666. 

SUPPLEMENTARY INFORMATION: The sole 

source award will target increased 

capacity at the national and subnational 

level to implement and achieve 

outbreak/epidemic/pandemic control in 

line with US Government (USG) and 

CDC strategy. This collaborative effort 

has led to significant progress in various 

areas under the Global Health Strategic 

Framework, including One Health 

workshops in multiple countries to 

prioritize zoonotic diseases and the 

development of a joint action plan for 

Central America. 

SE–COMISCA is the only entity that 

can carry out this work, as it will 

improve outbreak control capacity, 

better integration between health 

systems, and increased equity in 

healthcare access for all populations, 

especially those historically 

marginalized. 

Summary of the Award 

Recipient: SE–COMISCA 

Purpose of the Award: The purpose of 

this award is to support Global Health 

Security goals in Central America and 

the Dominican Republic by 

collaborating with MOH and other 

partners. Efforts will focus on reaching 

underserved populations, prioritizing 

equity to build resilient health systems 

that protect vulnerable groups. 

Amount of Award: $5,000,000 in 

Federal Fiscal Year (FFY) 2025 funds, 

with a total estimated $25,000,000 for 

the 5-year period of performance, 

subject to availability of funds. 

Authority: This program is authorized 

under section 307 of the Public Health 

Service Act [42 U.S.C. 24l) and Section 

301(a)[42 U.S.C. 24l(a) of the Public 

Health Service Act. 

Period of Performance: September 30, 

2025 through September 29, 2030. 

Dated: December 10, 2024. 

Terrance Perry, 

Acting Director, Office of Grants Services, 

Centers for Disease Control and Prevention. 

[FR Doc. 2024–30223 Filed 12–19–24; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[Docket No. CDC–2020–0046; NIOSH–233– 

C] 

Hazardous Drugs: NIOSH List of 

Hazardous Drugs in Healthcare 

Settings, 2024 and Final Reevaluation 

Determinations for Liraglutide and 

Pertuzumab 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: General notice. 

SUMMARY: 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 (HHS), announces the 

publication of the NIOSH List of 

Hazardous Drugs in Healthcare Settings, 

2024, as well as final reevaluation 

determinations removing the drugs 

liraglutide and pertuzumab from the 

NIOSH List of Hazardous Drugs in 

Healthcare Settings. 

DATES: The documents announced in 

this notice are available on December 

20, 2024. 

ADDRESSES: The documents announced 

in this notice are available in the docket 

at www.regulations.gov and through the 

NIOSH Hazardous Drug Exposures in 

Healthcare website at https://

www.cdc.gov/niosh/healthcare/ 

hazardous-drugs/index.html. 

FOR FURTHER INFORMATION CONTACT: 

Jerald Ovesen, NIOSH, Robert A. Taft 

Laboratories, 1090 Tusculum Avenue, 

MS–C15, Cincinnati, OH 45226, 

telephone: (513)533–8472 (not a toll-free 

number), email: jovesen@cdc.gov. 

SUPPLEMENTARY INFORMATION: This 

notice is organized as follows: 

I. Public Participation 

II. Background 

III. NIOSH Response to Public Comment in 

the May 2020 Federal Register Notice 

and Request for Comment 

A. General Characteristics of the List 

1. Timing of the List 

2. Drugs That Did Not Meet the NIOSH 

Hazardous Drug Criteria 

B. General Drug Descriptors 

1. Unique Identifiers 

2. Use of AHFS Classifications 

3. Use of AHFS Code for Hormone Drug 

Classification 

4. Monoclonal Antibodies as a Class of 

Drugs 

5. Progestins 

6. Additional Information Requested 

C. General Reorganization of the List 

1. Content of Tables 

2. DailyMed and DrugBank Links 

D. Drugs Not on the Draft 2020 List 

1. Drugs Proposed in February 2018 and 

Not Added to the Draft 2020 List 

2. Bacillus Calmette-Guerin (BCG) 

3. Botulinum Toxins 

E. Requests for Specific Drugs To Be 

Removed From the List 

1. Blinatumomab 

2. Carfilzomib 

3. Eslicarbazepine, Lomitapide, 

Mifepristone 

4. Hazardous Drugs Listed for 

Reproductive and Developmental Effects: 

Cabergoline, Clonazepam, Fluconazole, 

Plerixafor, Riociguat, and Ziprasidone 

5. Icatibant 

6. Leuprolide 

7. Olaparib and Teriflunomide 

8. Oxytocin and Other Oxytocic Drugs 

9. Paroxetine 

10. Spironolactone 

11. Topiramate 

12. Ulipristal 

13. Vigabatrin 

F. Placement of Specific Drugs Within the 

List 

1. Carfilzomib 

2. Dasatinib and Imatinib 

3. Eribulin 

4. Exenatide 

5. Ganciclovir and Valganciclovir 

6. Hormonal Agents: Goserelin, Degarelix, 

Leuprolide, Estrogens, and Progesterone 

7. Mycophenolate Mofetil and 

Mycophenolic Acid 

8. Sirolimus and Other Related mTOR 

Targeting Drugs 

9. Thalidomide, Lenalidomide, and 

Pomalidomide 

10. Vandetanib 

G. Specific Drugs Classification/ 

Identification 

1. Triptorelin 

2. Ziv-Aflibercept, Ado-Trastuzumab 

Emtansine, Fam-Trastuzumab 

Deruxtecan 

H. Suggested Copyedits 

IV. NIOSH Response to Public Comment and 

Peer Review in the January 2024 Federal 

Register Notice and Request for 

Comment on Proposed Removal of 

Liraglutide and Pertuzumab From the 

List 

A. Public Comment 

1. General Comments 

2. Liraglutide 

3. Pertuzumab 

a. Is this an appropriate method for 

evaluating the potential for exposure to 

pertuzumab? 

b. Is oligohydramnios the best health effect 

to evaluate? If not, what other health 

effect(s) should be evaluated and why? 

c. Is a needlestick injury the only 

reasonable route of exposure for 

healthcare workers? 

d. Are the assumptions about the amount 

of exposure to pertuzumab in a 

healthcare setting reasonable? 

i. Inhalation 

ii. Percutaneous Exposure 

iii. Oral exposure 

e. What alternatives could be considered to 

this approach for monoclonal antibodies 

to characterize the potential hazard to 

workers? 


ddrumheller on DSK120RN23PROD with NOTICES1
104164 Federal Register / Vol. 89, No. 245 / Friday, December 20, 2024 / Notices 

1NIOSH [2024]. NIOSH List of Hazardous Drugs 

in Healthcare Settings, 2024. By Ovesen JL, 

Sammons D, Connor TH, MacKenzie BA, DeBord 

DG, Trout DB, O’Callaghan JP, Whittaker C. 

Cincinnati, OH: U.S. Department of Health and 

Human Services, Centers for Disease Control and 

Prevention, National Institute for Occupational 

Safety and Health, DHHS (NIOSH) Publication 

Number 2025–103 (Supersedes 2016–161), https:// 

www.cdc.gov/niosh/docs/2025-103. NB: NIOSH has 

periodically updated the List from 2010 through 

2016; prior to the 2024 update to the List, it was 

named the NIOSH List of Antineoplastic and Other 

Hazardous Drugs in Healthcare Settings. 

f. Additional Pertuzumab Comments 

B. Peer Review 

1. Liraglutide Peer Review 

a. Are the evaluated health effects the 

appropriate health effects to consider? If 

not, what other health effect(s) should be 

evaluated and why? 

b. Are the assumptions about the potential 

occupational exposures to liraglutide in 

a healthcare setting reasonable? 

c. Is the determination that the amount of 

exposure to liraglutide in a healthcare 

setting does not constitute a hazard for 

healthcare workers reasonably supported 

by the available scientific information? 

d. What alternative approaches could be 

considered to characterize the potential 

hazard to workers from peptide-based 

drugs? 

e. Is there any additional information that 

NIOSH should consider in its 

reevaluation of liraglutide? 

2. Pertuzumab Peer Review 

a. Reviewer 1 

b. Reviewer 2 

c. Reviewer 3 

V. Summary of Updates and Changes to the 

NIOSH List of Hazardous Drugs in 

Healthcare Settings 

I. Public Participation 

In a Federal Register notice (notice) 

published on May 1, 2020 (85 FR 

25439), NIOSH invited the public to 

participate in the development and 

reorganization of the NIOSH List of 

Hazardous Drugs in Healthcare Settings. 

The NIOSH List of Hazardous Drugs in 

Healthcare Settings (List) assists 

employers in providing safe and healthy 

workplaces by identifying drugs 

approved by the Food and Drug 

Administration (FDA) Center for Drug 

Evaluation and Research (CDER) that 

meet the NIOSH definition of a 

hazardous drug and that may pose 

hazards to healthcare workers who 

handle, prepare, dispense, administer, 

or dispose of these drugs. 

The public was invited to submit 

written comments regarding the draft 

List, as well as views, opinions, 

recommendations, and/or data on any 

topic related to the drugs reviewed by 

NIOSH for possible placement on the 

List. The public comment period for the 

May 2020 notice was initially open until 

June 30, 2020 (85 FR 25439), and later 

extended until July 30, 2020 (85 FR 

37101), to ensure commenters had 

adequate time to comment. 

One hundred thirty-two submissions 

were received from commenters in 

Docket CDC–2020–0046 (NIOSH–233– 

C). Commenters consisted of nurses; 

pharmacists; safety personnel; a 

veterinarian; healthcare, business, and 

government administrators and 

committees; and anonymous and 

unaffiliated individuals. The 

commenters represented a wide range of 

institutions, including academic and 

general medical centers and healthcare 

systems; hospital, commercial drug 

store, and compounding pharmacies; 

manufacturers of pharmaceuticals and 

medical devices; professional, 

healthcare, and veterinary organizations 

and associations; home infusion 

organizations; suppliers of cleanroom 

products; boards of pharmacy; and 

consultant companies for healthcare 

improvement and the performance of 

healthcare facilities, risk assessment, 

and waste management. Public 

comments on the List and two other 

documents discussed in the May 2020 

notice are available in the docket for 

this activity. 

NIOSH carefully considered all public 

comments and peer reviews concerning 

the draft List resulting from the 2020 

notice and determined that some 

clarifications and changes should be 

made to the draft List. Public comments 

on the draft List and specific drugs are 

summarized and answered in section III. 

These changes are summarized in 

section V. of this notice and are 

reflected in the final document 

described in this notice. 

In a January 16, 2024, Federal 

Register notice (89 FR 2614), NIOSH 

sought public comment and peer review 

on the reevaluation of two drugs 

requested to be removed from the List by 

their respective manufacturers: 

liraglutide and pertuzumab. Responses 

to public and peer review comments on 

the reevaluations of the placements of 

liraglutide and pertuzumab on the List 

are in section IV. These changes to the 

List are summarized in section V. 

The NIOSH List of Hazardous Drugs 

in Healthcare Settings, 2024 (2024 List) 1

is published on the NIOSH website and 

is also available in the docket for this 

activity. 

II. Background 

In 2004, NIOSH published the NIOSH 

Alert: Preventing Occupational 

Exposures to Antineoplastic and Other 

Hazardous Drugs in Health Care 

Settings (Alert), which contained a 

compilation of lists of drugs considered 

to be hazardous to workers’ health. 

NIOSH periodically updates this list, 

now named the NIOSH List of 

Hazardous Drugs in Healthcare Settings 

(List), to assist employers in providing 

safe and healthful workplaces by 

identifying drugs that meet the NIOSH 

definition of a hazardous drug. The List 

is informational in nature and confers 

no requirements or legal obligations on 

users. 

In 2017, NIOSH began developing a 

document to make the process used to 

guide the addition of hazardous drugs to 

the List more transparent, entitled the 

Policy and Procedures for Developing 

the NIOSH List of Antineoplastic and 

Other Hazardous Drug in Healthcare 

Settings (Policy and Procedures). The 

Policy and Procedures document was 

created to formalize NIOSH’s 

methodology and establish a process for 

requesting the addition of a drug to, the 

removal of a drug from, or relocation of 

a drug within the List. This document 

was reviewed by four peer reviewers 

and eight interested parties before 

NIOSH made the document available for 

public comment in a February 14, 2018, 

notice (83 FR 6563). The peer reviewers 

and interested parties also provided 

input on the drugs considered for 

placement on the List. 

Consistent with the draft Policy and 

Procedures, NIOSH proposed the 

addition of 20 drugs and one class of 

drugs to the List in the framework for 

the draft List in the February 2018 

notice. Public comments were invited 

regarding any topic related to drugs 

identified in the notice, the draft Policy 

and Procedures, and the framework for 

the February 2018 update to the List, as 

well as the following questions related 

to this activity: 

1. Has NIOSH appropriately identified 

and categorized the drugs considered for 

placement on the NIOSH List of 

Antineoplastic and Other Hazardous 

Drugs in Healthcare Settings, 2018? 

2. Is information available from FDA 

or other Federal agencies or in the 

published, peer-reviewed scientific 

literature about a specific drug or drugs 

identified in this notice that would 

justify the reconsideration of NIOSH’s 

categorization decision? 

3. Does the draft Policy and 

Procedures for Developing the NIOSH 

List of Antineoplastic and Other 

Hazardous Drugs in Healthcare Settings 

include a methodology for reviewing 

toxicity information that is appropriate 

for this activity? 

Fifty-five public comments were 

submitted in response to the February 

2018 notice and summarized with 

NIOSH responses in a May 2020 notice 

(85 FR 25439). Those comments are 

available in Docket CDC–2018–0004. 

The substantive input provided by peer 


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2See www.ahfsdruginformation.com. 

reviewers, interested parties, and public 

commenters on the February 2018 

notice caused NIOSH to reconsider 

certain aspects of the draft Policy and 

Procedures and the draft framework for 

the List. As a result, NIOSH revised and 

updated the draft Policy and 

Procedures, renamed ‘‘Procedures,’’ as 

well as the draft list of drugs proposed 

for placement on the List. This 

collective input also contributed to the 

development of the draft document 

Managing Hazardous Drug Exposures: 

Information for Healthcare Settings 

(Managing Exposures), also announced 

in the May 2020 notice. Comments 

resulting from the May 2020 notice are 

available at www.regulations.gov in 

Docket CDC–2020–0046. 

In April 2023, NIOSH published a 

notice in the Federal Register (88 FR 

25642) that announced the publication 

of the final versions of the ‘‘Procedures’’ 

and ‘‘Managing Exposures’’ documents. 

The April 2023 notice summarized and 

responded to public input on the 

‘‘Procedures’’ and ‘‘Managing 

Exposures’’ documents. Those changes 

were reflected in the finalized 

documents, Procedures for Developing 

the NIOSH List of Hazardous Drugs in 

Healthcare Settings [NIOSH 2023a] and 

Managing Hazardous Drugs Exposures: 

Information for Healthcare Settings 

[NIOSH 2023b], which are available on 

the NIOSH website at https://

www.cdc.gov/niosh/healthcare/ 

hazardous-drugs/publications.html. 

In January 2024, pursuant to the 

Procedures, NIOSH conducted peer 

reviews and sought public comment on 

initial recommendations to change the 

status of the drugs liraglutide and 

pertuzumab, added to the NIOSH List of 

Antineoplastic and Other Hazardous 

Drugs in Healthcare Settings in 2014 

and 2016, respectively. NIOSH 

published its charge to peer reviewers 

and public commenters in a Federal 

Register notice on January 16, 2024 (89 

FR 2614), requesting feedback on 

NIOSH’s initial recommendations to 

remove the drugs liraglutide and 

pertuzumab from the NIOSH List of 

Antineoplastic and Other Hazardous 

Drugs in Healthcare Settings. The two 

initial recommendations and summaries 

of evidence, NIOSH Reevaluation of 

Liraglutide on the NIOSH List of 

Antineoplastic and Other Hazardous 

Drugs in Healthcare Settings and NIOSH 

Reevaluation of Pertuzumab on the 

NIOSH List of Antineoplastic and Other 

Hazardous Drugs in Healthcare Settings, 

were made available to peer reviewers 

and public commenters in the docket for 

this activity. 

III. NIOSH Response to Public 

Comment in the May 2020 Federal 

Register Notice and Request for 

Comment 

The public comments received in 

response to the draft NIOSH List of 

Hazardous Drugs in Healthcare Settings, 

proposed in the May 2020 notice and 

available in the docket, are summarized 

below, followed by NIOSH responses. 

A. General Characteristics of the List 

1. Timing of the List 

Public comment: Several commenters 

mentioned that the NIOSH review has 

created a long gap between List updates 

and would like for NIOSH to have more 

frequent updates. 

NIOSH response: NIOSH received a 

substantial response to its proposed 

revisions of the organization of the List 

in 2018 and has worked diligently to 

provide thorough and transparent 

responses to those comments. This 

notice is the finalization of that process. 

Moving forward, NIOSH intends to 

publish periodic updates to the List 

while maintaining the rigor of review by 

multiple scientists, outside experts, and 

public comment. Because the delay 

between the final date of drugs being 

approved to market and the publication 

of updates to the List is unavoidable, it 

is important for employers to review all 

relevant potential hazard information on 

the drugs being used in their facility, 

especially newly FDA-approved drugs 

that are new to the facility’s formulary 

and which have not yet been publicly 

evaluated by NIOSH. 

2. Drugs That Did Not Meet the NIOSH 

Hazardous Drug Criteria 

Public comment: Two commenters 

requested that NIOSH publish a list of 

which drugs did not meet the NIOSH 

criteria of a hazardous drug, so that 

employers can avoid unnecessary 

reviews of drugs that do not appear on 

the NIOSH List. 

NIOSH response: NIOSH does not 

identify the drugs that have been 

reviewed and have failed to meet the 

NIOSH criteria because doing so might 

be interpreted as indicating those drugs 

are free of potential hazards. In fact, 

even drugs that are not on the List may 

have some hazards associated with 

exposure. In addition, NIOSH 

repeatedly reviews drugs as new 

information and warnings are added to 

their package inserts, so publishing the 

names of reviewed drugs would be 

potentially confusing, as information 

changes. Moreover, some drugs do not 

meet the criteria due to a lack of data. 

Therefore, to be clear that NIOSH is not 

making an affirmative statement that 

drugs reviewed and not added to the 

List have no associated hazards, NIOSH 

does not publish such a list. No change 

to the 2024 List has been made in 

response to this comment. 

B. General Drug Descriptors 

1. Unique Identifiers 

Public comment: In the May 2020 

notice, NIOSH asked ‘‘Which unique 

ingredient identifier is the most useful 

for users of the List?’’ Among the six 

responses NIOSH received, there was 

broad agreement that the most useful 

identifier is the generic name of the 

drug. One reviewer suggested also 

including the brand name(s) of the drug, 

citing recognizability by staff 

unaccustomed to drug names. 

NIOSH response: NIOSH agrees with 

the majority of commenters that generic 

drug names are preferred because of the 

potential volatility of brand names and 

the entry of generics once patents 

expire. No changes were made in 

response to these comments. 

2. Use of AHFS Classifications 

Public comment: Some commenters 

stated that the use of AHFS (formerly 

called the American Hospital Formulary 

Service) classifications on the List leads 

to imprecise or incorrect classification 

of drugs and should be discontinued. 

NIOSH response: NIOSH does not use 

the AHFS classification to determine 

hazard, nor does the AHFS 

classification influence placement of a 

drug on a particular table. The AHFS 

classifications are provided only as 

information for users to aid in 

identifying the drugs and their potential 

therapeutic uses. 

3. Use of AHFS Code for Hormone Drug 

Classification 

Public comment: One commenter on 

the List noted that the use of AHFS 

classification for hormones led to some 

nomenclature concerns. 

NIOSH response: The AHFS identifier 

is provided to give users some 

information on how the listed drugs are 

classified and utilized. Some drugs may 

be classified in more than one category, 

and AHFS may have used the same 

classification codes for drugs that have 

different mechanisms of actions or uses. 

Further information on the drugs may 

be found in their respective AHFS 

monograph.2

4. Monoclonal Antibodies as a Class of 

Drugs 

Public comment: Several commenters 

suggested NIOSH reconsider listing the 

monoclonal antibodies as a class of 


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3U.S. Pharmacopeia [June 2020], Revision 

Bulletin, https://www.uspnf.com/sites/default/files/ 

usp_pdf/EN/USPNF/revisions/gc-800-rb-notice20200626.pdf. 

drugs largely based on the high 

molecular weight of these compounds 

as an exclusionary factor or based on 

data from in vitro systems. 

NIOSH response: NIOSH considers 

each drug based on the potential hazard 

each active pharmaceutical ingredient 

poses. Each is reviewed individually, 

and classes of drugs are not excluded a 

priori. Monoclonal antibodies may 

generally have lower systemic 

availability via inhalation, ingestion, 

and dermal absorption through intact 

skin, but that availability is not zero and 

not all workers have intact skin. NIOSH 

intends to continue reviewing each drug 

individually and considering the 

intrinsic hazard that each drug poses, 

including molecular properties, such as 

molecular weight, which may change 

the likelihood of occupational exposure. 

NIOSH encourages employers to 

examine the potential hazards posed by 

all the therapies handled in their facility 

and evaluate the risk associated with 

occupational exposures. NIOSH 

encourages workplaces to take the 

appropriate risk management strategies 

for the risk related for their specific 

workplace handling of the hazardous 

drugs in their facility. The List is 

informational in nature and confers no 

legal obligations. How facilities 

implement risk management strategies 

should be reflective of the risk they 

identify in their handling scenarios. No 

change to the 2024 List was made in 

response to this comment. 

5. Progestins 

Public comment: One commenter 

suggested that the term ‘‘progestins’’ 

does not provide sufficient information 

about what exactly constitutes a 

progestin. 

NIOSH response: Progestins are 

synthetic hormones that target the 

progesterone receptor. The AHFS 

identifier—AHFS classification code 

‘‘68:32: Progestins’’—is provided in the 

2024 List to give users some information 

on how the listed drugs are classified 

and utilized. 

6. Additional Information Requested 

Public comment: Some commenters 

requested that NIOSH include more 

specific information about the relevant 

hazards posed to healthcare workers in 

the List to provide healthcare workers 

access to more information and improve 

safety. 

NIOSH response: The List identifies 

drugs that meet the criteria specified in 

the Procedures. It is not intended to be 

a comprehensive review of every hazard 

potentially posed by a drug. Drugs are 

repeatedly reviewed as new information 

and warnings are added to their package 

inserts, and some drugs do not meet the 

criteria due to a current lack of data. 

NIOSH suggests that workplaces review 

the potentially hazardous drugs handled 

in their facilities to identify specific 

details on the hazard of those drugs. 

C. General Reorganization of the List 

1. Content of Tables 

Public comment: More than a dozen 

commenters voiced opinions on the 

reorganization of Table 1. Table 1 was 

formerly focused on antineoplastic 

drugs. NIOSH has dropped this 

nomenclature and reorganized Table 1 

in the 2024 List to include only ‘‘[d]rugs 

with MSHI [manufacturer’s special 

handling information] in the package 

insert and/or those that meet the NIOSH 

definition of a hazardous drug and one 

or more of the following criteria: are 

classified by NTP (National Toxicology 

Program) as known to be a human 

carcinogen or are classified by IARC 

(International Agency for Research on 

Cancer) as Group 1 carcinogenic to 

humans or Group 2A probably 

carcinogenic to humans.’’ Eight 

commenters suggested that the 

reorganization of Table 1 was 

appropriate, but some commenters were 

concerned that the change would 

confuse some users and that some drugs 

with shared mechanism of action ended 

up on different tables. In summary, 

commenters expressed agreement with 

the proposal to remove the AHFS 

therapeutic descriptor ‘‘antineoplastic’’ 

as a criterion for placement in Table 1 

and base drug placement in Table 1 on 

drugs with manufacturer’s special 

handling information (MSHI) and/or 

those that are carcinogenic to humans or 

probably carcinogenic to humans. Other 

commenters were less supportive of the 

changes, citing potential end-user 

confusion, and perceived conflict with 

United States Pharmacopeia (USP) 

<800> requirements. 

NIOSH response: NIOSH has 

reorganized the tables with an 

understanding that all antineoplastic 

drugs do not carry the same hazard. As 

discussed above, the new organization 

creates a Table 1 in the 2024 List that 

includes ‘‘[d]rugs that have MSHI in the 

package insert and/or meet the NIOSH 

definition of a hazardous drug and one 

or more of the following criteria: are 

classified by NTP as known to be a 

human carcinogen or are classified by 

IARC as Group 1 carcinogenic to 

humans or Group 2A probably 

carcinogenic to humans.’’ Table 1 does 

not contain all drugs that are used in the 

treatment of cancer, which may carry 

different types of potential occupational 

hazards because of their mechanism of 

action. This aligns more with the 

NIOSH goal of providing a list that 

helps identify potential workplace 

hazards. To alleviate some confusion, 

NIOSH has maintained the AHFS 

classification of drugs so that 

antineoplastic drugs on both tables can 

be identified. In June 2020, USP revised 

Chapter <800> to clarify that the 

chapter’s requirements for 

antineoplastic drugs apply only to those 

antineoplastic drugs found in Table 1 of 

the List.3 Questions concerning the 

language of USP Chapter <800> should 

be directed to USP. 

Public comment: Several commenters 

noted concerns about combining Tables 

2 and 3 into one table. Table 3, included 

in previous iterations of the List but 

removed in the 2020 draft, addressed 

only those non-antineoplastic drugs that 

have adverse reproductive effects. 

Concerned commenters thought that not 

enough was done to identify drugs that 

were only reproductive or 

developmental hazards, citing 

challenges for healthcare workers in 

adequately identifying drugs with 

reproductive and/or developmental 

risks. In addition, a commenter 

expressed concern that the information 

on reproductive and developmental 

hazards was not clearly identified in 

Table 2. 

NIOSH response: NIOSH has 

reorganized Table 2 in the 2024 List to 

include ‘‘[d]rugs that meet the NIOSH 

definition of a hazardous drug and do 

not have MSHI, are not classified by 

NTP as known to be a human 

carcinogen, and are not classified by 

IARC as Group 1, carcinogenic to 

humans, or Group 2A, probably 

carcinogenic to humans. (Some may 

also have adverse developmental and/or 

reproductive effects.)’’ 

NIOSH recognizes that there is an 

important interest in identifying drugs 

that pose a developmental and 

reproductive hazard so that risk 

management strategies can be tailored to 

the situation and has revised Table 2 in 

the 2024 List to include a new column 

to allow readers to find those drugs 

more easily on the List. In addition, 

NIOSH worked with its visual 

information specialists to ensure that 

the information is clear and easy to find. 

With regard to the concern that some 

Table 2 drugs are more toxic than Table 

1 drugs, it is important to note that 

placement of a drug on Table 1 or Table 

2 does not indicate relative potency or 

relative hazard of the drugs. All drugs 


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on the List have been determined by 

NIOSH to meet the definition of a 

hazardous drug. The List is intended to 

identify potential hazards in the 

healthcare workplace so that workplaces 

can further consider what risk 

management strategies are appropriate 

for their specific needs. The drugs are 

separated into two tables based on type 

of hazard. The word ‘‘only’’ in the 

notation regarding reproductive and 

developmental toxicity allows for 

identification of drugs that met just one 

or both of these NIOSH toxicity criteria 

for inclusion on the List. Pointing out 

that a drug met just one or both of these 

criterion helps management tailor 

strategies to the hazard. However, this 

designation does not indicate the 

severity of the hazard. 

2. DailyMed and DrugBank Links 

Public comment: Two commenters 

requested that NIOSH keep the links to 

DailyMed and DrugBank on the NIOSH 

List. 

NIOSH response: Because internet 

links change frequently and links in the 

PDF of the List cannot be updated once 

published, NIOSH has removed the 

DailyMed and DrugBank links. 

However, users are encouraged to access 

these databases to find more 

information about drugs of interest. 

D. Drugs Not on the Draft 2020 List 

1. Drugs Proposed in February 2018 and 

Not Added to the Draft 2020 List 

Public comment: One commenter 

noted some drugs proposed for 

placement on the List in February 2018 

were no longer proposed for placement 

in the May 2020 draft List. 

NIOSH response: In response to 

public and interested party comments to 

the proposals published in the February 

2018 notice, NIOSH clarified the 

Procedures for developing the List and 

reevaluated specific drugs in drafts 

published for public comment in the 

May 2020 notice. After consideration of 

the revised draft Procedures and the 

public comments, NIOSH ultimately 

determined that several drugs proposed 

to be placed on the List in the February 

2018 notice either did not meet the 

NIOSH criteria or were identified as 

needing additional review to be 

considered for future List updates. 

Accordingly, the following drugs 

proposed in 2018 were not included on 

the draft 2020 List: bevacizumab, 

botulinum toxins, darbepoetin alfa, 

interferon beta-1b, osimertinib, 

trastuzumab, and triazolam. 

2. Bacillus Calmette-Guerin (BCG) 

Public comment: Several commenters 

requested that NIOSH relist BCG and 

suggested NIOSH broaden its definition 

of a hazardous drug to include drugs 

approved by FDA Center for Biologics 

Evaluation and Research (CBER). The 

major issue was that by excluding drugs 

approved by CBER, healthcare workers 

would not be apprised of occupational 

hazards that may occur from exposure 

to those drugs. 

NIOSH response: BCG is an infectious 

agent approved for use by the FDA 

CBER. It was included in the 2004 Alert 

as part of the compiled list of drugs 

sourced from other external hazardous 

drug lists. It was maintained on the List 

from that time. While BCG is an 

infectious agent and should be handled 

appropriately, it does not fall under the 

NIOSH definition of a hazardous drug 

for evaluation for placement on the List 

and has thus been removed. Healthcare 

workplaces should review the potential 

hazards of all treatments utilized in 

their facilities, including potentially 

infectious agents, gene therapy 

treatments, radiological treatments, and 

experimental treatments that may not be 

evaluated by NIOSH and identify the 

proper strategies to reduce the risk of 

worker exposure to those hazards. 

3. Botulinum Toxins 

Public comment: NIOSH received four 

comments in response to its request for 

information on botulinum toxins. 

Comments included requests for 

clarification of the criteria to place 

drugs on the List and a request for 

additional information about how 

NIOSH considers balancing the hazard 

with other considerations. 

NIOSH response: In response to 

comments, NIOSH determined that 

additional review of the issues raised by 

commenters on the toxicity data on 

botulinum toxins would be beneficial. 

Therefore, as stated in the May 2020 

notice, NIOSH is not adding botulinum 

toxins to the 2024 List at this time. One 

of the issues with botulinum toxins is 

whether the molecular weight of the 

molecule precludes consideration of the 

drugs as an occupational hazard. NIOSH 

intends to apply those concepts as 

described in the Procedures to the 

botulinum toxins in a future 

reevaluation of the drugs. 

As to the issue of whether NIOSH 

considers balancing the hazard with 

other considerations, NIOSH reminds 

readers that the List is a hazard 

identification tool. It should be used to 

identify drugs that may pose an 

occupational hazard in healthcare 

settings. However, NIOSH does not 

conduct risk assessment for these drugs. 

NIOSH recommends that employers 

familiarize themselves with the toxicity 

of the drugs in their formularies, 

considering factors such as use, dosage 

form, engineering controls, work 

practices, and personal protective 

equipment (PPE) in developing risk 

mitigation strategies for their workplace. 

E. Requests for Specific Drugs To Be 

Removed From the List 

1. Blinatumomab 

Public comment: Some commenters 

suggested that NIOSH remove the 

recombinant therapeutic protein-based 

drug blinatumomab from the List. This 

was primarily based on molecular size 

and related bioavailability. With regard 

to the observed neurological effects of 

blinatumomab, one commenter 

suggested that these effects may be 

caused by a response of lymphoma cells 

present in the brain and may not be 

relevant in healthy people exposed to 

blinatumomab. 

Alternatively, one commenter noted 

that the manufacturer of blinatumomab 

has provided the statements ‘‘[e]nsure 

that personnel are appropriately trained 

in aseptic manipulations and admixing 

of oncology drugs’’ and ‘‘[e]nsure that 

personnel wear appropriate protective 

clothing and gloves.’’ The commenter 

indicated that such warnings are similar 

to MSHI and therefore the drug warrants 

inclusion in Table 1. 

NIOSH response: Blinatumomab has 

been found to have neurological effects 

at low doses. NIOSH intends to review 

the information available on the role of 

lymphoma cells present in the brain and 

is considering reevaluating 

blinatumomab in a future update of the 

List. For now, no change to the 2024 List 

was made in response to these 

comments. 

Regarding the issue of large 

molecules, NIOSH considers each drug 

based on the potential hazard posed 

intrinsically. Each is reviewed 

individually. NIOSH recognizes that 

large molecules may have lower 

systemic availability via inhalation, 

ingestion, and dermal absorption 

through intact skin, and takes that into 

account in its assessment. However, the 

systemic availability of these drugs, 

though low, is not zero, and not all 

workers have intact skin. In response to 

comments, NIOSH has added a column 

to both tables in the 2024 List that 

allows for identification of drugs that 

have been approved by CDER under a 

biologics license application (BLA). 

These drugs are often large protein/ 

peptide-based drugs. Identifying drugs 

that are approved by CDER under BLAs 

will make it easier for users to identify 

drugs that are large peptides and make 

the appropriate risk management 

strategies. 


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With regard to the statements from the 

manufacturer that appear similar to 

MSHI, NIOSH has thus far used 

manufacturers’ identification of 

cytotoxic/genotoxic hazards and 

suggestions that special care be taken 

with these drugs as MSHI. NIOSH 

continues to review how it considers 

MSHI with each List update to ensure 

these criteria are applied consistently 

and appropriately. In any case, NIOSH 

recommends that employers familiarize 

themselves with the potential hazards 

posed by the drugs in their formularies 

and prepare the appropriate strategies to 

reduce the risks of occupational 

exposure. 

2. Carfilzomib 

Public comment: One commenter 

suggested that carfilzomib should be 

removed from the List based on recent 

studies that suggest less than 1 percent 

bioavailability of the drug via oral and 

inhalation bioavailability. 

NIOSH response: This comment 

appears to be based on proprietary data 

that is not currently available to NIOSH, 

but NIOSH will consider evaluating 

carfilzomib again in a future update of 

the List. 

3. Eslicarbazepine, Lomitapide, 

Mifepristone 

Public comment: A commenter 

suggested NIOSH remove 

eslicarbazepine from the List because of 

insufficient human data on the 

reproductive and developmental effects 

and no data about occupational 

exposure and risk. Two commenters 

suggested that lomitapide be removed 

from the List due to a lack of data on 

risk associated with occupational 

exposure. One commenter suggested 

NIOSH remove mifepristone due to a 

lack of data identifying a risk associated 

with occupational exposure. 

NIOSH response: Developmental 

effects were observed in experimental 

animals exposed to eslicarbazepine at 

concentrations lower than the maximum 

recommended human dose (MRHD). 

Results in humans are inconclusive to 

rule out the potential for occupational 

hazard. Therefore, NIOSH is 

maintaining eslicarbazepine on the 2024 

List. Lomitapide was observed to be 

teratogenic in several animal species. 

Mifepristone has been shown to cause 

termination of pregnancy and is listed 

due to potential reproductive and 

developmental effects. Some 

reproductive effects are seen in humans 

and teratogenicity has been observed in 

rabbits. 

NIOSH also notes that sufficient data 

on health effects related to occupational 

exposure to individual drugs are very 

rarely available. The List is intended to 

identify potential hazards to aid 

employers in assessing risks to workers, 

therefore, no change to the 2024 List was 

made in response to these comments. 

4. Hazardous Drugs Listed for 

Reproductive and Developmental 

Effects: Cabergoline, Clonazepam, 

Fluconazole, Plerixafor, Riociguat, and 

Ziprasidone 

Public comment: One commenter 

suggested that NIOSH remove 

cabergoline from the List. They cited 

data suggesting in humans it does not 

cause reproductive or developmental 

harm. They suggested that effects in 

some tested species are secondary to 

maternal toxicity and that the effects 

seen in a rat study on embryo survival 

were species specific. 

Another commenter suggested that 

clonazepam should be removed from 

the List. The commenter noted that the 

manufacturer’s safety data sheet states 

that it is neither teratogenic nor 

embryotoxic. They noted, however, that 

exposure during late stages of pregnancy 

can lead to post-natal dependence and 

withdrawal, while exposures 

immediately prior to childbirth may 

lead to adverse outcomes. They also 

noted some, though inconsistent, 

evidence of adverse developmental 

effects in animals and stated that there 

are no studies of occupational exposures 

to clonazepam. 

Two commenters suggested that 

fluconazole should be removed from the 

NIOSH List. One commenter noted that 

teratogenic risk had only been 

associated with exposures in excess of 

400 mg/day. The commenter also noted 

that data suggested that lower doses 

were not associated with potential 

hazard to reproduction or the 

developing offspring in pregnancy or 

through breastfeeding. Finally, the 

commenter noted that no data were 

available on the health effects of 

occupational exposures. 

One commenter suggested NIOSH 

remove the drug plerixafor from the 

NIOSH List because no data were 

identified on occupational exposures 

leading to reproductive hazards. They 

also noted that reproductive effects in 

animals occurred mainly at a dose 10 

times the MRHD. 

One commenter suggested NIOSH 

remove riociguat. The commenter noted 

that the observed developmental and 

reproductive effects seen in rats and 

rabbits only occurred at doses that 

correlated with doses greater than twice 

the MRHD. 

One commenter suggested that NIOSH 

remove ziprasidone from the List 

because occupational exposures via 

dermal or inhalation routes have not 

been shown to cause teratogenicity. 

However, animal studies have 

demonstrated potential embryofetal 

toxicities without a no-observedadverse-effect level (NOAEL) as low as 

0.2 times the MRHD. The commenter 

also described two case studies of in 

utero exposure, one with no adverse 

outcome and one with cleft palate 

attributed to ziprasidone exposure. 

NIOSH response: In reviewing the 

totality of the evidence, NIOSH believes 

the evidence supports listing 

cabergoline, clonazepam, fluconazole, 

plerixafor, riociguat, and ziprasidone. In 

the case of fluconazole, the teratogenic 

effects observed are consistent with 

effects seen in animals at similar species 

at equivalent doses, and in rats at lower 

doses. In the case of ziprasidone, 

embryofetal toxicity was observed with 

a NOAEL as low as 0.2 times the MRHD 

and at least one case study resulted in 

a cleft palate in the offspring of an 

individual exposed to ziprasidone. 

NIOSH notes that it is not unusual that 

there are no studies of occupational 

exposure to these drugs, as there are few 

occupational studies of hazardous drugs 

exposure. However, NIOSH intends to 

reevaluate the evidence on reproductive 

and developmental hazards for these 

drugs, along with other potential 

reproductive and developmental 

hazards, in a future update of the List to 

assure consistency of application of the 

criteria. No changes to the 2024 List 

were made in response to these 

comments. 

5. Icatibant 

Public comment: One commenter 

suggested that NIOSH remove icatibant 

from the NIOSH List because the limited 

case studies and reports have not shown 

signs of adverse effects in humans. 

NIOSH response: The data indicate 

that in rats, at doses lower than human 

doses, there is fetal death, 

preimplantation loss, and delayed 

parturition. In addition, in rabbits, 

increased abortion rate, increased fetal 

death, increased preimplantation loss, 

and increased preterm births were 

observed at doses lower than MRHD. 

Reproductive effects were also seen in 

dog studies that affected both males and 

females, though these effects were 

reversible 4 weeks after exposure 

ceased. In an occupational setting, 

where a drug is being used on a regular 

basis, repeated exposure to the drug or 

to contaminated surfaces are not 

unexpected. Therefore, NIOSH has 

retained icatibant on the 2024 List. No 

change to the 2024 List was made in 

response to this comment. 


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6. Leuprolide 

Public comment: One commenter 

noted that leuprolide requires 

continuous systemic exposure for 2–3 

weeks to cause the decrease in sex 

hormones that would lead to either fetal 

toxicity or reproductive harm. They 

suggested that occupational exposures 

would not lead to continuous systemic 

exposure, and relevant levels of 

exposure can only occur following 

injection of the extended-release 

formulation. They acknowledged that 

initial exposure may cause a spike in 

gonadotropin release and sex hormones 

levels rather than a decrease. 

Another commenter suggested that 

leuprolide should be removed from the 

List because it can be obtained in a kit 

that decreases the risk of exposure to 

healthcare workers. 

NIOSH response: With regard to 

occupational exposures not being 

equivalent to a sustained systemic 

exposure, NIOSH notes that working in 

areas with contaminated surfaces or 

working regularly with hazardous 

materials may lead to chronic or 

repeated exposures. However, as with 

some of the other drugs identified as 

reproductive or developmental hazards, 

NIOSH intends to consider reevaluating 

leuprolide during a future update to the 

List to ensure consistent application of 

the NIOSH criteria. 

Regarding the distribution of 

leuprolide in a kit that may lower 

occupational exposure, NIOSH notes 

that the List contains active 

pharmaceutical ingredients based on the 

hazards they pose. The List does not 

differentiate based on dosage form. 

Many things may affect the risk 

associated with handling hazardous 

drugs, including drug formulation, 

proper handling technique, and PPE 

utilization. In addition, formulations 

may change, and packaging and delivery 

mechanisms can be damaged. Therefore, 

NIOSH identifies the intrinsic hazards 

of drugs and not the scenario-based 

risks associated with handling each 

drug in a specific way. Healthcare 

workplaces should further consider 

what risk management strategies are 

appropriate for their specific needs, 

given their specific exposure scenarios. 

7. Olaparib and Teriflunomide 

Public comment: One commenter 

suggested that NIOSH remove olaparib 

because the risk of direct occupational 

exposure is likely low when handling 

intact olaparib capsules. One 

commenter noted that while the hazards 

posed by teriflunomide exposure exist, 

the risk of exposure due to formulation 

and packaging means it should not be 

on the NIOSH List. 

NIOSH response: The List is intended 

as a hazard identification tool. The List 

does not differentiate based on dosage 

form. Many things may affect the risk 

associated with handling hazardous 

drugs, including drug formulation, 

proper handling technique, and PPE 

utilization. In addition, formulations 

may change, and packaging and delivery 

mechanisms can be damaged. Therefore, 

NIOSH identifies the hazards of drugs 

and not the scenario-based risks 

associated with handling each drug in a 

specific way. Healthcare workplaces 

should further consider what risk 

management strategies are appropriate 

for their specific needs, given their 

specific exposure scenarios. No change 

to the 2024 List was made in response 

to these comments. 

8. Oxytocin and Other Oxytocic Drugs 

Public comment: Many commenters 

asked NIOSH to remove oxytocin and 

the other oxytocic drugs ergonovine and 

methylergonovine from the List. Most 

commenters stated that there are no 

documented cases where routine 

handling has resulted in occupational 

hazard. In addition, some noted that 

because the mechanism of action of 

ergonovine, methylergonovine, and 

oxytocin differs, they should not be 

treated similarly. 

NIOSH response: NIOSH has 

recognized that the oxytocic drugs were 

added to the List as part of the initial 

compilation in 2004. They have been 

maintained as a class on the List since 

that time. In response to comments on 

the mechanism of action, NIOSH agrees 

that ergonovine, methylergonovine, and 

oxytocin do not appear to have the same 

mechanism of action. Oxytocin and 

methylergonovine have been observed 

to pose a hazard to fetuses in the third 

trimester of pregnancy. Therefore, they 

are retained on the 2024 List. However, 

NIOSH intends to evaluate oxytocin and 

methylergonovine in a future List 

update. Ergonovine has never been 

approved for use in humans by the FDA 

and therefore does not meet NIOSH’s 

definition as a drug. Therefore, 

ergonovine has been removed from the 

2024 List. 

9. Paroxetine 

Public comment: One commenter 

suggested NIOSH remove paroxetine 

from the List, stating that the studies are 

currently inconclusive. The commenter 

also noted that there are no data on 

occupational exposures. 

NIOSH response: Studies indicate that 

therapeutic doses are suspected of 

damaging fertility in males and 

increasing congenital malformations in 

developing fetuses. These effects suggest 

a potential hazard to workers who are 

pregnant, trying to conceive, or males 

who are trying to have children. There 

are also data suggesting that there are 

negative adverse effects on neonates 

exposed during the third trimester of 

pregnancy. These data clearly support 

maintaining paroxetine on the 2024 List. 

With regard to the lack of data from 

occupational exposures, NIOSH notes 

that this is not uncommon, as there are 

few studies of occupational exposure to 

hazardous drugs. However, the totality 

of the evidence supports maintaining 

paroxetine on the 2024 List. No change 

to the 2024 List was made in response 

to this comment. 

10. Spironolactone 

Public comment: Two commenters 

suggested spironolactone be removed 

from the NIOSH List because the health 

effects were only observed after longterm relatively high exposures. 

NIOSH response: Studies have shown 

that long-term (18-month) exposures in 

rats led to significant increases in 

hepatocellular adenomas. There were 

also increases in adenoma of the testes 

in males and proliferative changes in 

the liver in that study. Doses ranged 

from 50 to 200 mg/kg/day. In another 

study, significant increases in 

hepatocellular adenomas and testicular 

interstitial cell tumors were observed in 

rats exposed to 10 mg/kg/day to 100 mg/ 

kg/day; 100 mg/kg/day represents a dose 

five times the human dose of 200 mg/ 

day. 

NIOSH also notes that evidence of 

changes in estrous cycles, retardation of 

follicular development, decreased 

numbers of implanted embryos, and 

increases in stillborn pups were also 

observed in some studies. NIOSH has 

determined that the totality of the 

evidence supports maintaining 

spironolactone on the 2024 List. 

However, as with some of the other 

drugs identified as reproductive and/or 

developmental hazards, NIOSH intends 

to consider evaluating spironolactone 

again in a future List update to ensure 

consistent application of the NIOSH 

criteria. No change to the 2024 List was 

made in response to these comments. 

11. Topiramate 

Public comment: One commenter 

recommended that topiramate be 

removed from the List and noted that no 

data were identified describing 

reproductive risk of associated with 

occupational exposure to topiramate. 

NIOSH response: The lack of 

occupational exposure studies is not 

unusual. In evaluating the totality of the 


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available evidence, NIOSH notes that 

studies have shown limb malformations 

and reduced fetal body weights in rats 

exposed to doses half the recommended 

human dose. In addition, the NOAEL for 

rats in that study was less than the 

MRHD. In rabbits, embryofetal effects 

were seen only at doses greater than 

human recommended doses. 

In a different rat developmental study 

with administration through the later 

part of gestation and throughout 

lactation, it was observed that doses as 

low as 2 mg/kg/day led to decreased 

pre- and/or post-weaning body weights. 

The NOAEL for these studies, 0.2 mg/ 

kg/day, was also below the MRHD. In 

mice, when topiramate was 

administered during organogenesis fetal 

malformations, primarily craniofacial 

were seen at all tested doses (0, 20, 100, 

or 500 mg/kg/day) with no NOAEL. The 

lowest dose tested in this study was 

lower than the MRHD. Human data from 

the pregnancy registries suggest that 

infants exposed in utero are at increased 

risk for cleft palate and being small at 

gestational age, the latter seen at all 

tested doses and appearing to be dose 

dependent. From this evidence, NIOSH 

determined that topiramate poses a 

potential hazard to the development of 

offspring of workers exposed while 

pregnant and has maintained it on the 

2024 List. No change to the 2024 List 

was made in response to these 

comments. 

12. Ulipristal 

Public comment: One commenter 

suggested NIOSH remove ulipristal from 

the List. The commenter noted that the 

effects after pregnancy are established 

are insufficient to determine if ulipristal 

poses a teratogenic/developmental 

hazard at that time. 

NIOSH response: Ulipristal is a 

progesterone agonist/antagonist 

indicated for pregnancy prevention 

within 5 days of unprotected 

intercourse or contraception failure. 

Workers may be trying to become 

pregnant or be pregnant potentially at 

any time, and the data indicate that 

there may be a hazard that affects 

reproductive ability within the first 5 

days of attempted conception. 

Therefore, NIOSH has maintained 

ulipristal on the 2024 List. 

13. Vigabatrin 

Public comment: One commenter 

suggested that vigabatrin should be 

removed from the NIOSH List because 

no adverse effects on fertility have been 

reported in rats up to a dose of 1⁄2 the 

MRHD. They also stated that the 

manufacturer notes that changes in postnatal development and male fertility in 

rats may be related to the drug-related 

effects on food intake and weight. When 

exposed to vigabatrin during 

development, there was an increase in 

cleft palate and embryofetal deaths for 

rabbits but not for rats. In rabbits, the no 

effect level for development was 

approximately 1⁄2 of the MRHD, and the 

effects in rabbits were repeated in two 

studies. 

NIOSH response: The manufacturer’s 

package insert notes that exposure 

throughout organogenesis in rats led to 

decreased fetal weights and increased 

fetal anatomical variations with an 

embryo-fetal NOAEL approximately 

equivalent to 1⁄5 of the MRHD. 

Additionally, when rats were exposed 

through the later part of pregnancy 

throughout lactation, long-term neurohistopathological changes and 

neurobehavioral effects were observed. 

These effects had no NOAEL and a 

lowest-observed effect level of 1⁄5 of the 

MRHD. Exposure during early post-natal 

period in rats, a period that is generally 

thought to correspond with late 

pregnancy in humans, also resulted in 

neurobehavioral and neurohistopathological with a NOAEL that 

was 1⁄30 of the measured plasma 

exposures in pediatric patients receiving 

a 50 mg/kg dose. Therefore, NIOSH 

determined that vigabatrin may pose a 

potential hazard to the development of 

unborn offspring when the mother is 

exposed during pregnancy and has 

maintained it on the 2024 List. 

F. Placement of Specific Drugs Within 

the List 

1. Carfilzomib 

Public comment: Some commenters 

noted that carfilzomib is on Table 2 

while a similar proteosome inhibitor 

bortezomib appears on Table 1. One 

noted that while the manufacturers of 

bortezomib provide ample identification 

of bortezomib as a cytotoxic agent and 

suggest appropriate handling for the 

protection of healthcare workers, the 

manufacturers of carfilzomib do not. 

NIOSH response: Table 1 of the 2024 

List includes ‘‘[d]rugs that have MSHI in 

the package insert and/or meet the 

NIOSH definition of a hazardous drug 

and one or more of the following 

criteria: are classified by NTP as known 

to be a human carcinogen or are 

classified by IARC as Group 1 

carcinogenic to humans or Group 2A 

probably carcinogenic to humans.’’ The 

manufacturers of carfilzomib did not 

provide MSHI. Nor was carfilzomib 

evaluated by NTP or IARC. Therefore, it 

was not included on Table 1. 

Table 2 of the 2024 List includes 

‘‘[d]rugs that meet the NIOSH definition 

of a hazardous drug and do not have 

MSHI, are not classified by NTP as 

known to be a human carcinogen, and 

are not classified by IARC as Group 1 

carcinogenic to humans or Group 2A 

probably carcinogenic to humans. 

(Some may also have adverse 

developmental and/or reproductive 

effects.)’’ However, NIOSH notes that 

the tables in the List are not 

hierarchical; Table 1 does not contain 

inherently more hazardous drugs than 

Table 2. It is expected that in some 

cases, drugs in the same class with 

similar activity could be on different 

tables because of the information 

available. 

2. Dasatinib and Imatinib 

Public comment: One commenter 

suggested dasatinib and imatinib should 

be moved to Table 2. They noted similar 

kinase inhibitors, bosutinib, nilotinib, 

and ponatinib, are on Table 2. 

NIOSH response: In reviewing the 

package insert, some data suggest that 

dasatinib and imatinib may be 

carcinogenic, clastogenic, or genotoxic. 

The manufacturers of dasatinib and 

imatinib include MSHI, which provides 

guidance on appropriately handling 

these clastogenic and/or genotoxic 

compounds to protect healthcare 

workers. At this time, all evaluated 

drugs with this information are 

included on Table 1 of the 2024 List. 

However, NIOSH notes that the tables in 

the List are not hierarchical; Table 1 

does not contain inherently more 

hazardous drugs than Table 2. It is 

expected that in some cases, drugs in 

the same class with similar activity 

could be on different tables because of 

the information available. No change to 

the 2024 List was made in response to 

this comment. 

3. Eribulin 

Public comment: One commenter 

suggested that NIOSH include eribulin 

on Table 1 because the mechanism of 

action, mitotic inhibition by 

suppression of microtubule growth, is 

similar to those of several other 

cytotoxic drugs such as vinblastine and 

paclitaxel, which are located on Table 1. 

NIOSH response: Table 1 of the 2024 

List includes ‘‘[d]rugs that have MSHI in 

the package insert and/or meet the 

NIOSH definition of a hazardous drug 

and one or more of the following 

criteria: are classified by NTP as known 

to be a human carcinogen or by IARC 

as Group 1 carcinogenic to humans or 

Group 2A probably carcinogenic to 

humans.’’ NIOSH agrees that 

manufacturers of other genotoxic/ 

cytotoxic drugs that inhibit mitosis via 

microtubule inhibition have included 


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MSHI for healthcare workers to handle 

them appropriately. In 2021 the 

manufacturers of eribulin updated the 

eribulin prescribing information noting 

that it is a cytotoxic drug with the 

instructions that special handling and 

disposal procedures should be followed. 

Because the manufacturer of eribulin 

suggests special handling it has been 

placed on Table 1 in the NIOSH List of 

Hazardous Drugs, 2024. 

4. Exenatide 

Public comment: One commenter 

suggested that exenatide should be 

listed on Table 1 because it meets 

NIOSH criteria as carcinogenic. 

NIOSH response: Table 1 of the 2024 

List includes ‘‘[d]rugs that have MSHI in 

the package insert and/or meet the 

NIOSH definition of a hazardous drug 

and one or more of the following 

criteria: are classified by NTP as known 

to be a human carcinogen or are 

classified by IARC as Group 1 

carcinogenic to humans or Group 2A 

probably carcinogenic to humans.’’ 

However, NIOSH notes that the tables in 

the List are not hierarchical; Table 1 

does not contain inherently more 

hazardous drugs than Table 2. It is 

expected that in some cases, drugs in 

the same class with similar activity 

could be on different tables because of 

the information available. In the 2024 

List, Table 2 includes ‘‘[d]rugs that meet 

the NIOSH definition of a hazardous 

drug and do not have MSHI, are not 

classified by NTP as known to be a 

human carcinogen and are not classified 

by IARC as Group 1 carcinogenic to 

humans or Group 2A probably 

carcinogenic to humans. (Some may 

also have adverse developmental and/or 

reproductive effects.)’’ 

5. Ganciclovir and Valganciclovir 

Public comment: One commenter 

suggested NIOSH move these antiviral 

drugs to Table 2 from Table 1 because 

of confusion regarding the application 

of USP <800>. 

NIOSH response: Ganciclovir and 

valganciclovir are listed on Table 1 

because these nucleoside drugs have 

been identified by the manufacturers to 

pose a hazard to workers handling them 

and they both have MSHI. According to 

NIOSH criteria, this warrants placement 

on Table 1. Table 1 of the 2024 List 

includes ‘‘[d]rugs that have MSHI in the 

package insert and/or meet the NIOSH 

definition of a hazardous drug and one 

or more of the following criteria: are 

classified by NTP as known to be a 

human carcinogen or are classified by 

IARC as Group 1 carcinogenic to 

humans or Group 2A probably 

carcinogenic to humans.’’ This means 

some drugs listed on Table 1 may not 

be antineoplastic drugs. The tables 

comprising the List are not intended to 

stratify levels of hazard, and neither are 

the inclusion of AHFS classification. 

The AHFS classifications are included 

as helpful information for users. NIOSH 

suggests that concerns with USP <800> 

standard be addressed with USP. No 

change to the 2024 List was made in 

response to this comment. 

6. Hormonal Agents: Goserelin, 

Degarelix, Leuprolide, Estrogens, and 

Progesterone 

Public comment: One commenter 

suggested NIOSH moving the hormonal 

agents goserelin, degarelix, and 

leuprolide to Table 3 as they were 

previously listed under Table 1— 

Antineoplastic Drugs. Two commenters 

asked NIOSH to move the estrogens and 

progesterone drugs from Table 1 to 

Table 2. 

NIOSH response: In the current List, 

leuprolide, goserelin, and degarelix are 

listed on Table 2. There is no longer a 

Table 3, and all of these drugs on Table 

2 are now described as only having met 

NIOSH criteria as a developmental or 

reproductive hazard. 

For the estrogens and progesterone, 

Table 1 of the 2024 List includes 

‘‘[d]rugs that have MSHI in the package 

insert and/or meet the NIOSH definition 

of a hazardous drug and one or more of 

the following criteria: are classified by 

NTP as known to be a human 

carcinogen or are classified by IARC as 

Group 1 carcinogenic to humans or 

Group 2A probably carcinogenic to 

humans.’’ This means some drugs that 

are potential carcinogens via different 

mechanisms may be listed on Table 1 

because they met one of the criteria for 

placement on Table 1. The tables 

comprising the List are not intended to 

stratify risk and NIOSH recommends 

that facilities evaluate the potential 

hazards of the drugs in their formulary 

so they can make the appropriate 

exposure control management strategies. 

Specifically, for the estrogens and 

progesterone, IARC classifies the 

estrogen/progesterone combination 

drugs as carcinogenic to humans (Group 

1) with sufficient evidence that they 

cause cancer of the breast and 

endometrium. . While as one 

commenter noted, the increased risk for 

estrogen-related endometrial cancer is 

decreased depending on the number of 

days that progesterone is included in 

the treatment, the drugs are still 

classified as IARC Group 1 and are 

therefore the appropriate placement 

according to the NIOSH criteria is on 

Table 1. No change to the 2024 List was 

made in response to these comments. 

7. Mycophenolate Mofetil and 

Mycophenolic Acid 

Public comment: Two commenters 

requested NIOSH move mycophenolate 

mofetil and mycophenolic acid to Table 

1 because of the potential carcinogenic 

hazard and because most facilities 

currently treat them as hazardous 

antineoplastic drugs. 

NIOSH response: Table 1 in the 2024 

List includes ‘‘[d]rugs that have MSHI in 

the package insert and/or meet the 

NIOSH definition of a hazardous drug 

and one or more of the following 

criteria: are classified by NTP as known 

to be a human carcinogen or are 

classified by IARC as Group 1 

carcinogenic to humans or Group 2A 

probably carcinogenic to humans.’’ This 

means some drugs that are potential 

carcinogens and are potential genotoxic/ 

cytotoxic compounds may be on Table 

2 because they had not yet been 

evaluated by IARC or NTP or because 

the manufacturer has not identified the 

need for safe handling to protect 

healthcare workers who may handle the 

drug. The tables comprising the List are 

not intended to stratify hazard. Some 

drugs on Table 2 may be more 

hazardous than those on Table 1. In 

general, NIOSH recommends that 

facilities evaluate the potential hazards 

of the drugs in their formulary so they 

can make the appropriate exposure 

control management strategies. 

Mycophenolate mofetil, while not an 

antineoplastic, had MSHI added to the 

prescribing information in 2019 and has 

been moved to Table 1 in response to 

this comment. 

8. Sirolimus and Other Related mTOR 

Targeting Drugs 

Public comment: One commenter 

requested NIOSH move sirolimus to 

Table 1 because of the potential 

carcinogenic hazard and because the 

similar drug, tacrolimus, is on Table 1. 

Another reviewer asked that everolimus 

and temsirolimus be moved to Table 2 

because they are a similar class as 

sirolimus, which is on Table 2. 

NIOSH response: Table 1 in the 2024 

List includes ‘‘[d]rugs that have MSHI in 

the package insert and/or meet the 

NIOSH definition of a hazardous drug 

and one or more of the following 

criteria: are classified by NTP as known 

to be a human carcinogen or are 

classified by IARC as Group 1 

carcinogenic to humans or Group 2A 

probably carcinogenic to humans.’’ This 

means some drugs that are in the same 

class and may carry similar hazards may 

be listed on different tables because of 

differences in MSHI and evaluation of 

the drugs by IARC or NTP. The tables 


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comprising the List are not intended to 

stratify hazard and NIOSH recommends 

that facilities evaluate the potential 

hazards of the drugs in their formulary 

so they can make the appropriate 

exposure control management strategies. 

No change to the 2024 List was made in 

response to these comments. 

9. Thalidomide, Lenalidomide, and 

Pomalidomide 

Public comment: One commenter 

suggested thalidomide and the related 

analogs lenalidomide and 

pomalidomide should not be listed on 

Table 1 because they have only 

reproductive and developmental effects 

and have not demonstrated genotoxicity 

or carcinogenicity. 

NIOSH response: Table 1 in the 2024 

List includes ‘‘[d]rugs that have MSHI in 

the package insert and/or meet the 

NIOSH definition of a hazardous drug 

and one or more of the following 

criteria: are classified by the NTP as 

known to be a human carcinogen or are 

classified by IARC as Group 1 

carcinogenic to humans or Group 2A 

probably carcinogenic to humans.’’ 

Thalidomide, lenalidomide, and 

pomalidomide include MSHI with 

guidance on handling these drugs in a 

way that protects workers. In the 2024 

List, not all drugs on Table 1 are 

genotoxic or carcinogenic. Additionally, 

drugs that are carcinogenic on Table 1 

may not be genotoxic but act through a 

different mechanism of carcinogenicity. 

It is important that workplaces identify 

what the specific hazards are related to 

the drugs in their facility’s formulary 

and use the appropriate exposure 

management strategies for those 

hazards. No change to the 2024 List was 

made in response to these comments. 

10. Vandetanib 

Public comment: One commenter 

suggested that vandetanib should be 

placed in Table 2 similar to other EGFR 

tyrosine kinase inhibitors. 

NIOSH response: The vandetanib 

package insert includes MSHI indicating 

that it be handled and disposed of in a 

way that protects the healthcare 

workers. All evaluated drugs with this 

information are included on Table 1 of 

2024 List. However, NIOSH notes that 

the tables in the List are not 

hierarchical; Table 1 does not contain 

inherently more hazardous drugs than 

Table 2. It is expected that in some 

cases, drugs in the same class with 

similar activity could be on different 

tables because of the information 

available. No change to the 2024 List 

was made in response to this comment. 

G. Specific Drug Classification/ 

Identification 

1. Triptorelin 

Public comment: One commenter 

suggested that noting the antineoplastic 

designation for the drug triptorelin will 

confuse some healthcare professionals 

and lead them to deny patients needed 

therapy due to special handling of 

neoplastic agents. 

NIOSH response: Triptorelin is 

identified on the List in Table 2 as 

having both AHFS classifications 

‘‘68:18:08 Gonadotropin Agonist/ 

Antagonist’’ and ‘‘10:00 

Antineoplastic.’’ These are offered as 

information to aid the user. NIOSH 

suggests that facilities evaluate all the 

hazards that may be present in their 

formulary. A designation of 

antineoplastic by AHFS does not 

identify some special hazard. Cancer 

treatments have changed over time and 

not all drugs utilized in the treatment of 

cancer have the same hazards. Because 

of this, NIOSH no longer groups all 

antineoplastic drugs together on a single 

table. The tables comprising the List are 

not intended to rank levels of hazard, 

and neither are the identification of 

AHFS classifications. These are only 

intended as potentially useful 

information for users. No change to the 

2024 List was made in response to this 

comment. 

2. Ziv-Aflibercept, Ado-Trastuzumab 

Emtansine, Fam-Trastuzumab 

Deruxtecan 

Public comment: In the draft List 

published in the docket for the May 

2020 notice, NIOSH removed the 

prefixes that are part of several generic 

drug names in an attempt to focus on 

identifying the active pharmaceutical 

ingredient. NIOSH was alerted by 

several commenters that in doing so 

NIOSH had listed names that were not 

actual products or were different 

products than originally intended. 

NIOSH response: NIOSH appreciates 

the commenters who brought up this 

issue and regrets the confusion that this 

caused. NIOSH has revised the 2024 List 

to include the FDA assigned prefixes 

(i.e., ziv-, ado-, and fam-) in the 

appropriate generic drugs names (zivaflibercept, ado-trastuzumab emtansine, 

fam-trastuzumab deruxtecan) to correct 

the issue and refer to the appropriate 

pharmaceutical products. 

H. Suggested Copyedits 

Public comment: Several commenters 

noted spelling mistakes, errors in tables, 

and other editorial improvements. 

NIOSH response: NIOSH accepted all 

editorial, spelling, and correction 

comments in the 2024 List, as 

appropriate. 

IV. NIOSH Response to Public 

Comment and Peer Review in the 

January 2024 Federal Register Notice 

and Request for Comment on Proposed 

Removal of Liraglutide and Pertuzumab 

From the List 

As described above, on January 16, 

2024, NIOSH published a request for 

public comment in the Federal Register, 

charging peer reviewers and public 

commenters with considering five 

questions about the liraglutide initial 

recommendation and summary of 

evidence: 

1. Are the evaluated health effects the 

appropriate health effects to evaluate? If 

not, what other health effect(s) should 

be evaluated and why? 

2. Are the assumptions about the 

potential exposures to liraglutide in a 

healthcare setting reasonable? Please 

explain. 

3. Is the determination that the 

amount of exposure to liraglutide in a 

healthcare setting does not constitute a 

hazard for healthcare workers 

reasonably supported by the available 

scientific information? Please explain. 

4. What alternative approaches could 

be considered to characterize the 

potential hazard to workers from 

peptide-based drugs? 

5. Is there any additional information 

that NIOSH should consider in its 

reevaluation of liraglutide? 

Peer reviewers and public 

commenters were also charged with 

considering six questions about the 

pertuzumab initial recommendation and 

summary of evidence: 

1. Is this an appropriate method for 

evaluating the potential for exposure to 

pertuzumab? 

2. Is oligohydramnios the best health 

effect to evaluate? If not, what other 

health effect(s) should be evaluated and 

why? 

3. Is a needlestick injury the only 

reasonable route of exposure for 

healthcare workers? Please explain. 

4. Are the assumptions about the 

amount of exposure to pertuzumab in a 

healthcare setting reasonable? Please 

explain. 

5. Is the determination that the 

amount of exposure to pertuzumab in a 

healthcare setting does not constitute a 

hazard for healthcare workers 

reasonably supported by the available 

scientific information? Please explain. 

6. What alternatives could be 

considered to this approach for 

monoclonal antibodies to characterize 

the potential hazard to workers? 

NIOSH received comments from three 

public commenters on the January 2024 


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4The NIOSH definition of a hazardous drug is 

established in sec. IV of the Procedures for 

Developing the NIOSH List of Hazardous Drugs in 

Healthcare Settings [2023]. 

notice, including a trade association, a 

pharmaceutical manufacturer, and a 

private individual. One commenter 

addressed liraglutide and pertuzumab, 

as well as the process NIOSH used to 

reevaluate placing liraglutide and 

pertuzumab on the List. Two 

commenters addressed just pertuzumab. 

NIOSH received two peer reviews of the 

proposal to remove liraglutide from the 

List and three peer reviews of the 

proposal to remove pertuzumab from 

the List. 

Following review and consideration 

of the peer reviews and public 

comments, and as discussed below, 

NIOSH has agreed to clarify some points 

in the initial recommendations and 

summaries of evidence, NIOSH 

Reevaluation of Liraglutide on the 

NIOSH List of Antineoplastic and Other 

Hazardous Drugs in Healthcare Settings 

and NIOSH Reevaluation of Pertuzumab 

on the NIOSH List of Antineoplastic and 

Other Hazardous Drugs in Healthcare 

Settings. Those changes are reflected in 

the NIOSH Final Reevaluation 

Determination of Liraglutide on the 

NIOSH List of Hazardous Drugs in 

Healthcare Settings and NIOSH Final 

Reevaluation Determination of 

Pertuzumab on the NIOSH List of 

Hazardous Drugs in Healthcare Settings, 

available in the docket for this activity. 

Based on the evaluations described in 

the initial recommendations and on 

peer reviews and public comments 

discussed below, NIOSH has made final 

determinations to remove both 

liraglutide and pertuzumab from the 

List. 

A. Public Comment 

1. General Comments 

Public comment: The commenter 

‘‘expresses concern that the methods 

used to reevaluate liraglutide and 

pertuzumab for inclusion in the List 

represent risk assessment, not hazard 

identification. The physical properties 

of a drug molecule are not among the six 

characteristics considered for hazard 

determination. The purpose of the 

NIOSH List should be to identify 

hazards so that healthcare settings can 

assess and mitigate risk. If NIOSH 

removes these drugs based on risk 

assessment, healthcare settings may 

incorrectly think that a hazard does not 

exist. 

While [we] agree[ ] that a drug’s 

physical properties may reduce the risk 

of absorption through common methods 

of occupational exposure, NIOSH 

should not assume that all healthcare 

staff and healthcare environments are 

the same. Exposure through mucous 

membranes or other routes may be rare, 

but they are still important 

considerations that healthcare settings 

should evaluate when performing a risk 

assessment specific to their 

environment and to their employees.’’ 

NIOSH response: NIOSH evaluates 

the hazard to healthcare workers posed 

by exposure to FDA Center for Drug 

Evaluation and Research (CDER) 

approved drugs. NIOSH considers 

hazards at maximum human 

recommended dose via all relevant 

routes of exposure. NIOSH considers the 

molecular properties as they relate to 

the specific adverse effects posed by the 

drug via all relevant routes of exposure. 

The NIOSH hazardous drugs definition 4

clarifies that NIOSH considers 

molecular properties when 

characterizing the hazard a drug 

actually poses to healthcare worker after 

exposure. It recognizes that although a 

drug may meet the definition of a 

hazardous drug, the drug may be 

excluded from the List if NIOSH 

determines that occupational hazards 

are limited due to the molecular 

properties of the drug. The purpose of 

this exclusion is to focus the List on 

drugs that have a potential for toxicity 

due to occupational exposure, so that 

workers’ attention is focused on drugs 

that are likely to be hazardous in 

occupational settings. This is a way for 

NIOSH to more specifically characterize 

the hazard posed by the pharmaceutical 

ingredients; it is important to note that 

this is not an automatic exclusion. 

NIOSH has not established specific 

molecular properties for which drugs 

are automatically excluded from the 

List. Instead, NIOSH reviewers look at 

the totality of the evidence and evaluate 

whether there is a hazard to healthcare 

workers. NIOSH considers molecular 

properties as they relate to the specific 

adverse effects to characterize those 

hazards posed by the drug being 

evaluated. 

Public comment: The commenter 

‘‘also urges caution when making 

assumptions about occupational 

exposure based on commercially 

available dosage forms of a drug. NIOSH 

should not base hazard identification on 

a specific route of exposure, such as 

needlestick injuries. Splashes, leaks, 

and spills all occur in healthcare 

settings. While a currently available 

dosage form (e.g., prefilled syringe or 

pen) may limit the risk of a splash, leak, 

or spill, dosage forms available at some 

time in the future may not offer the 

same protection. 

Pharmacy employees may handle 

bulk active pharmaceutical ingredients 

when compounding various 

preparations. In the case of 503B 

registered outsourcing facilities [FDA 

2022], workers may handle a hazardous 

drug in bulk powder form in higher 

quantities and with more frequency 

than a typical healthcare worker might 

handle a commercial preparation. 

Duration and intensity of exposure are 

important factors to consider when 

assessing and mitigating exposure risk. 

Individual healthcare settings can 

evaluate exposure duration and 

intensity when assessing risk, but that 

evaluation is unlikely to occur if the 

hazard has not been recognized.’’ 

NIOSH response: NIOSH agrees that 

evaluating the hazards of potentially 

hazardous drugs should not be limited 

to currently commercially available 

formulations. NIOSH evaluates how the 

molecular properties influence hazard 

potential at occupational exposures to 

doses equivalent to therapeutic human 

recommended doses via occupationally 

relevant routes of exposure. This is true 

even if a route of exposure is unlikely 

given currently available formulations. 

NIOSH understands that formulations 

may change, and handling needs may be 

different across facilities. For liraglutide 

and pertuzumab, NIOSH evaluated how 

the molecular properties influence 

bioavailability after exposures via 

needlesticks, dermal exposure, 

ingestion, and inhalation. A large 

peptide molecule, currently only 

available in liquid formulations, may 

not lead to exposure equal to a human 

recommended dose via inhalation of 

dust or droplets, but NIOSH still 

considered that potential exposure route 

in its reevaluations. NIOSH noted in 

both reevaluations that inhalation of a 

full therapeutic dose is unlikely to 

result in systemic exposures that would 

cause the relevant adverse effects. This 

is not based on any formulation, but 

rather on intrinsic molecular properties 

of the reevaluated pharmaceutical 

ingredients. The formulations and 

marketed products that include the 

pharmaceutical ingredients may 

decrease the risk of exposure, but they 

were not part of NIOSH’s 

characterization of the hazard posed by 

the active pharmaceutical ingredients, 

pertuzumab and liraglutide. 

NIOSH uses a recommended human 

dose as a benchmark to indicate the 

high end of doses of concern. NIOSH 

would be typically concerned with toxic 

effects that occurred below this level. 

NIOSH considers exposures at the 

human recommended doses to be 

greater than the expected dose for 

healthcare workers. In situations where 


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5HER2 inhibition refers to the inhibition of the 

activation of the Human Epidermal growth factor 

Receptor 2. Oligohydramnios is the disorder during 

pregnancy of having a low level of amniotic fluid 

for gestational age. HER2 inhibitory monoclonal 

antibodies cause oligohydramnios by causing a 

delayed development of the urinary tract 

development of the embryo, leading to decreased 

amniotic fluid production. 

healthcare workers may be exposed to 

therapeutic agents at levels greater than 

what patients are exposed to, then 

pharmacological effects may occur. 

Based on this comment, NIOSH made 

changes in the NIOSH Final 

Reevaluation Determination of 

Liraglutide on the NIOSH List of 

Hazardous Drugs in Healthcare Settings 

and NIOSH Final Reevaluation 

Determination of Pertuzumab on the 

NIOSH List of Hazardous Drugs in 

Healthcare Settings. 

2. Liraglutide 

Public comment: The commenter 

‘‘agrees that repeated exposure and 

absorption to peptide-based drugs is not 

likely in many clinical settings. 

However, we again stress concern about 

using physical properties for hazard 

identification for reasons already 

mentioned. Since carcinogenic effects 

and fetal abnormalities cannot be ruled 

out in humans, liraglutide meets the 

existing criteria for hazard 

identification. The duration, intensity, 

and routes of exposure should be part of 

a healthcare setting’s risk assessment. 

[We] disagree[ ] with removal of 

liraglutide from the NIOSH List.’’ 

NIOSH response: Consideration of 

intrinsic molecular properties of 

potentially hazardous drugs is 

important to characterizing if they pose 

a hazard to healthcare workers in the 

workplace. The NIOSH hazardous drugs 

definition [NIOSH 2023] considers the 

molecular properties of hazardous drugs 

because although a drug may meet some 

criteria as a hazardous drug, those 

occupational hazards may not be 

significant due to intrinsic molecular 

properties of the drug and therefore that 

drug may be excluded from the List. The 

purpose of this exclusion is to focus the 

List on drugs that have a potential for 

toxicity due to occupational exposure, 

so that workers’ attention is focused on 

drugs that are likely to be hazardous in 

occupational settings. This is a way for 

NIOSH to more specifically characterize 

the hazard posed by the pharmaceutical 

ingredients; it is important to note that 

this is not an automatic exclusion. 

Occupational exposure to liraglutide is 

unlikely to reach systemic exposure 

levels that pose a hazard to workers. No 

changes were made to the NIOSH Final 

Reevaluation Determination of 

Liraglutide on the NIOSH List of 

Hazardous Drugs in Healthcare Settings 

and NIOSH Final Reevaluation 

Determination of Pertuzumab on the 

NIOSH List of Hazardous Drugs in 

Healthcare Settings as a result of this 

comment. 

3. Pertuzumab 

Public comment: While the 

commenter ‘‘agrees that repeated 

exposure and absorption of a 

monoclonal antibody is not likely in 

many clinical scenarios, we again 

express concern about assumptions 

made about healthcare workers and 

environments when defining a hazard. 

[We] also [have] concerns with 

consideration about whether a condition 

is reversible or not when performing 

hazard identification. While 

oligohydramnios may be reversible, the 

condition can lead to fetal 

complications [Keilman and Shanks 

2022]. [We] question[ ] whether NIOSH 

will begin considering whether an 

adverse effect is reversible when 

determining other hazard assessments. 

[We] disagree[ ] with removal of 

pertuzumab from the NIOSH list.’’ 

Public comment: ‘‘I think the biggest 

issue is whatever is the most fatal or can 

cause the most damage or permanent 

damage. While this sounds reversible, I 

still would not want to risk my fetus 

through the possibility of exposure.’’ 

NIOSH response: NIOSH agrees that 

whether a hazard is reversible alone is 

not enough to determine if a drug is 

hazardous to healthcare workers. In the 

case of pertuzumab, data for the related 

drug trastuzumab show that continuous 

exposures at therapeutic levels causes 

delayed-genitourinary developmentrelated oligohydramnios.5 If systemic 

exposure is continuous, that will lead to 

further fetal complications. However, if 

treatment is ceased, and 

oligohydramnios is resolved in the first 

trimester, further fetal complications are 

avoided. Oligohydramnios requires 

continuous systemic exposure to 

pertuzumab, and continued HER2 

inhibition, to occur. As noted in the 

reevaluation, for the related HER2 

inhibitor monoclonal antibody 

trastuzumab, use during pregnancy 

showed that patients who had exposure 

during just the first trimester had babies 

born with no complications, deaths, or 

oligohydramnios. There was a trend of 

increased incidence in oligohydramnios 

with increased exposure to trastuzumab. 

In the available studies, it appears that 

trastuzumab-related oligohydramnios 

was reversible following cessation of 

treatment with generally good outcomes 

for the fetus, as seen in the Watson 

[2005] case. 

Healthcare workers are unlikely to 

experience prolonged and consistent 

exposure to pertuzumab in the 

workplace that would lead to high 

levels of systemic exposure. This is due 

to various factors, such as limited 

availability of systemic exposure and 

the rarity of incidental needlestick 

injuries with significant volumes, which 

are necessary for sustained high 

systemic exposures. As a result, the 

development of oligohydramnios that 

goes unresolved beyond the first 

trimester is not expected in healthcare 

workers. No changes were made in the 

document based on these comments. 

a. Is this an appropriate method for 

evaluating the potential for exposure to 

pertuzumab? 

Public comment: This commenter 

‘‘agrees it is appropriate to consider the 

physicochemical properties of 

pertuzumab that minimize the potential 

for adverse health effects from 

inhalation, dermal, or oral exposure. 

With regard to potential exposures via 

inhalation, [We] agree[ ] there is no 

scenario in which substantial air 

concentrations of pertuzumab could be 

generated while preparing or 

administering Perjeta® in a healthcare 

setting. In addition, [We] agree[ ] it is 

appropriate to consider the minimal 

volume that could be delivered to a 

healthcare worker when evaluating the 

potential exposure to pertuzumab in a 

needlestick scenario. 

NIOSH response: No changes were 

made to the NIOSH Final Reevaluation 

Determination of Pertuzumab on the 

NIOSH List of Hazardous Drugs in 

Healthcare Settings based on these 

comments. 

b. Is oligohydramnios the best health 

effect to evaluate? If not, what other 

health effect(s) should be evaluated and 

why? 

Public comment: ‘‘The notable 

potential health effects in patients 

treated with Perjeta® (i.e., those 

described in the Warnings and 

Precautions section of the prescribing 

information) include embryo-fetal 

toxicity, left ventricular dysfunction, 

infusion-related reactions, and 

hypersensitivity reactions/anaphylaxis. 

Embryo-fetal toxicity and left 

ventricular dysfunction are recognized 

as pharmacologically mediated class 

effects of therapies that target HER–2. In 

addition to being over-expressed in 

some tumors, HER2 is expressed in 

normal renal epithelium and 

cardiomyocytes. The embryo-fetal 

effects of HER2 inhibitors are secondary 


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to delayed fetal kidney development 

that can result in oligohydramnios and 

related effects (oligohydramnios 

sequence). In cardiomyocytes, HER2 

activation results in a protective effect 

that may be inhibited in patients treated 

with HER2 antagonists [Perez et al. 

2008]. In contrast to anthracyclineinduced cardiac toxicity, HER2-related 

cardiac dysfunction does not appear to 

increase with cumulative dose or to be 

associated with ultrastructural changes 

in the myocardium; it is also generally 

reversible. Both oligohydramnios and 

left ventricular dysfunction are nonacute effects that would require 

sustained, biologically significant 

inhibition of HER2 to manifest. Such 

exposures can only be reasonably 

expected to occur via intentional 

intravenous administration of 

pertuzumab in a therapeutic context. 

Consequently, Genentech does not 

consider oligohydramnios or left 

ventricular dysfunction to be relevant 

health effects for the purpose of 

evaluating potential risks to healthcare 

workers. 

Other notable adverse reactions 

observed in patients receiving 

pertuzumab include infusion-related 

reactions and hypersensitivity 

reactions/anaphylaxis. Both are 

common risks of intravenous 

monoclonal antibody therapies and are 

not specific to pertuzumab. In addition, 

the risk of infusion-related reactions is 

only relevant to patients being treated 

with pertuzumab via intravenous 

infusion. Neither of these endpoints 

would therefore be appropriate to 

evaluate for the purposes of the List. 

Because none of the notable adverse 

reactions associated with therapeutic 

uses of pertuzumab are considered 

relevant to healthcare exposure 

scenarios, it would not be meaningful to 

consider any of these hazards to be 

better suited for evaluation for the 

purpose of the List.’’ 

NIOSH response: NIOSH agrees that 

none of these effects posed a hazard to 

healthcare workers. No changes were 

made to the NIOSH Final Reevaluation 

Determination of Pertuzumab on the 

NIOSH List of Hazardous Drugs in 

Healthcare Settings based on these 

comments. 

Public comment: ‘‘We might however, 

want to think about allergic reactions 

from exposure? Utilizing less measures 

than chemo with tubing, gear, and 

gloving exposes nursing and pharmacy 

teams to the drugs more because of less 

need for precautions.’’ 

NIOSH response: Sensitization and 

allergic reaction are not criteria under 

the Procedures for Developing the 

NIOSH List of Hazardous Drugs in 

Healthcare Settings. No changes were 

made to the NIOSH Final Reevaluation 

Determination of Pertuzumab on the 

NIOSH List of Hazardous Drugs in 

Healthcare Settings based on this 

comment. 

c. Is a needlestick injury the only 

reasonable route of exposure for 

healthcare workers? Please explain. 

Public comment: ‘‘There is no 

scenario in which inhalation, dermal, or 

oral exposure could be expected to 

result in a pharmacologically active 

dose of pertuzumab. [We] therefore 

agree[ ] that a needlestick injury is the 

only relevant route of exposure for 

Perjeta® for healthcare providers.’’ 

NIOSH response: No changes were 

made to the NIOSH Final Reevaluation 

Determination of Pertuzumab on the 

NIOSH List of Hazardous Drugs in 

Healthcare Settings based on this 

comment. 

d. Are the assumptions about the 

amount of exposure to pertuzumab in a 

healthcare setting reasonable? Please 

explain. 

One commenter stated their 

agreement with the general approach 

and conclusions described for each 

route. 

i. Inhalation 

Public comment: ‘‘The peer-reviewed 

publications support the statement that 

the inhalation bioavailability of 

monoclonal antibodies such as 

pertuzumab is minimal. The 5% value 

utilized in the review is considered to 

be a conservative, upper-limit estimate 

for the inhalation bioavailability of an 

IgG antibody, and the systemically 

available fraction is more likely <1% 

[Gould et al. 2018; Pfister et al. 2014]; 

Perjeta® is supplied as a liquid in vial, 

is prepared using aseptic techniques, 

and is not administered as a powder or 

aerosol. [We] agree[ ] there is no 

mechanism by which volumes of 

pertuzumab dusts or aerosols sufficient 

to achieve systemic exposures 

associated with adverse effects could be 

generated in a healthcare setting.’’ 

NIOSH response: When evaluating the 

potential hazard to healthcare workers, 

NIOSH does not limit evaluation to just 

the currently produced commercially 

available formulations and therefore 

also considers powders or aerosol 

exposures. NIOSH based the evaluation 

on assumptions for exposures that are 

unlikely in commercially available 

formulations and on intrinsic properties 

of the active pharmaceutical 

ingredients, not on any particular 

formulation or treatment product. No 

changes were made to the NIOSH Final 

Reevaluation Determination of 

Pertuzumab on the NIOSH List of 

Hazardous Drugs in Healthcare Settings 

based on this comment. 

Public comment: ‘‘[P]harmacy 

compounds the medication and moving 

drugs to the nonhazardous list means 

we use more needles than safety 

features. Hazardous medications we use 

items such as chemolock to protect us 

from needle sticks, we do not with the 

nonhazardous medications. My concern 

with medications like this is we can 

compound these for prolonged times 

and over days, months, and years. We 

could expose technicians to the amount 

listed and harm them and if they were 

to not know they were pregnant yet or 

whatever the case this could be an 

issue.’’ 

NIOSH response: NIOSH evaluated 

how the molecular properties affected 

bioavailability after exposures via 

needlesticks, dermal exposure, 

ingestion, and inhalation. A large 

molecule currently only available in 

liquid formulations may not lead to 

exposure equal to a human 

recommended dose via inhalation of 

dust or droplets, but that potential route 

of exposure was considered. 

NIOSH has used the recommended 

human dose as a benchmark to indicate 

the high end of doses of concern. 

NIOSH is typically only concerned with 

toxic effects that occurred below this 

level. NIOSH considers exposures at the 

human recommended doses to be 

greater than the expected dose for 

healthcare workers. In situations where 

healthcare workers may be exposed to 

therapeutic agents at levels greater than 

the levels that patients are exposed to, 

then the pharmacological effects may 

occur. Some changes were made to the 

NIOSH Final Reevaluation 

Determination of Pertuzumab on the 

NIOSH List of Hazardous Drugs in 

Healthcare Settings to clarify. 

ii. Percutaneous Exposure 

Public comment: ‘‘The published 

literature on needlestick injuries 

supports the statement that the volume 

of Perjeta® delivered from an 

inadvertent percutaneous exposure is 

expected to be minimal (e.g., <1 

microliter) and would be insufficient to 

deliver a toxicologically relevant dose. 

However, the 670 microliter ‘human 

dose,’ because needlestick exposures are 

expected to occur infrequently, it would 

be more appropriate to compare the <1 

microliter needlestick volume to the 

volume of Perjeta® that would be 

required to deliver a therapeutic dose 

(30 mL).’’ 

NIOSH response: NIOSH agrees that 

the use of a relevant human dose is 


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highly protective, and an incidental 

percutaneous exposure is unlikely to 

result in such a high exposure; however, 

NIOSH evaluated what was certainly a 

worst-case scenario. No changes were 

made to the NIOSH Final Reevaluation 

Determination of Pertuzumab on the 

NIOSH List of Hazardous Drugs in 

Healthcare Settings in response to this 

comment. 

iii. Oral Exposure 

Public comment: ‘‘The peer-reviewed 

publications support the statement that 

the oral bioavailability of monoclonal 

antibodies such as pertuzumab is 

negligible. In addition, the sterile 

preparation and administration 

procedures used to administer 

pertuzumab further reduce any potential 

for oral exposure.’’ 

NIOSH response: When evaluating the 

potential hazard to healthcare workers, 

NIOSH does not limit its evaluation to 

just the currently produced 

commercially available formulations, 

therefore it also considers powders or 

aerosol exposures. NIOSH based the 

evaluation on assuming unlikely 

exposures in commercially available 

formulations and considering intrinsic 

properties of the active pharmaceutical 

ingredients, rather than focusing on any 

particular formulation or treatment 

product. No changes were made to the 

NIOSH Final Reevaluation 

Determination of Pertuzumab on the 

NIOSH List of Hazardous Drugs in 

Healthcare Settings in response to this 

comment. 

e. What alternatives could be considered 

to this approach for monoclonal 

antibodies to characterize the potential 

hazard to workers? 

Public comment: ‘‘Monoclonal 

antibodies have been approved for use 

to treat humans for more than 25 years 

and have been safely prepared and 

administered using routine aseptic 

procedures. Although they were still 

relatively novel when the List was first 

developed, monoclonal antibody-based 

products are now mainstream therapies 

for cancer and other conditions in 

humans, and their molecular and 

physiological properties are well 

characterized. The properties of 

monoclonal antibodies and other high 

molecular weight molecules result in 

occupational risk profiles that are 

clearly distinct from that of traditional, 

small molecule ‘chemotherapies’ that 

drove the original 2004 NIOSH Alert 

[2004] and subsequent publication of 

the List. 

The current process for evaluating 

monoclonal antibodies for potential 

inclusion on the List is initially based 

on hazard (i.e., any potential effect 

associated with a molecule). The 

various exposure-related factors that 

determine that the potential risk to a 

healthcare worker are secondary 

considerations. 

An alternative approach to 

characterizing the potential hazard that 

a monoclonal antibody-based product 

poses to healthcare workers would be a 

risk-based paradigm that initially 

considers exposure potential. Based on 

the properties of monoclonal antibodies 

that minimize the potential for systemic 

exposure, nearly all monoclonal 

antibody-based pharmaceuticals could 

be excluded from consideration without 

the need for a comprehensive review of 

all hazards that are considered to be 

relevant to patients in a therapeutic 

context. Eliminating products with little 

potential to cause health effects in 

workers would greatly streamline the 

nomination and review process for the 

List. 

Potential exceptions to this approach 

may include immunoglobulin-based 

products with usually high potency 

(e.g., a monoclonal antibody with a 

therapeutic maintenance dose <1 mg) or 

immunoglobulin-based products that 

are conjugated to a low-molecular 

weight component that may meet the 

criteria for the List (e.g., a product 

consisting of a monoclonal antibody 

conjugated to a small molecule antimitotic agent). However, such examples 

are relatively rare and can be readily 

identified based on the description in 

the prescribing information (Section 

11).’’ 

NIOSH response: NIOSH considers 

each drug based on the potential hazard 

posed intrinsically. Each is reviewed 

individually, and classes of drugs are 

not excluded. Monoclonal antibodies 

may generally have lower systemic 

availability via inhalation, ingestion, 

and dermal absorption through intact 

skin, but that availability is not zero and 

not all workers have intact skin. NIOSH 

intends to continue reviewing each drug 

individually and will consider the 

intrinsic hazard that each drug poses, 

including molecular properties, such as 

molecular weight, which may change 

the likelihood of occupational exposure. 

The process of excluding a whole class 

of drugs proposed by the commenter 

may miss some hazards for some 

healthcare workplaces. The NIOSH List 

of Hazardous Drugs in Healthcare 

Settings is a hazard identification tool, 

and using a risk-based paradigm that 

considers exposure potential first may 

not be sufficient to identify hazards that 

many drugs may potentially pose in a 

wide variety of healthcare settings. 

Public comment: ‘‘For compounding, 

could there possibly be the 

consideration of an adapter that goes 

with it? This would prevent a needle 

from technically being used at all as we 

often use a bag spike to inject the 

medications in the bags on either side.’’ 

NIOSH response: The List does not 

take into consideration the specific 

practices used when handling different 

formulations of the potentially 

hazardous drugs used by each facility. 

No changes were made to the NIOSH 

Final Reevaluation Determination of 

Pertuzumab on the NIOSH List of 

Hazardous Drugs in Healthcare Settings 

based on this comment. 

f. Additional Pertuzumab Comments 

Public comment: The commenter 

‘‘requests clarification of the statement 

that ‘No oral, inhalation, or dermal 

exposure studies of therapeutic 

monoclonal antibodies have been 

conducted’ (on Page 4 of the 

reevaluation). This statement suggests 

that there is a large degree of 

uncertainty related to these key 

presumptions related to the evaluation 

of the risk posed by pertuzumab to 

healthcare workers.’’ 

NIOSH response: NIOSH agrees and 

has clarified NIOSH Final Reevaluation 

Determination of Pertuzumab on the 

NIOSH List of Hazardous Drugs in 

Healthcare Settings that these studies 

were not performed because those 

therapies are not typically delivered via 

these routes. 

Public comment: The commenter 

‘‘requests clarification of the statement 

that ‘The toxicity profile of pertuzumab 

shows it is a potent developmental 

hazard.’ There is no regulatory or other 

consensus definition for a ‘potent’ 

hazard in a pharmaceutical context. The 

use of this term in policy or regulatory 

documents is therefore likely to cause 

confusion and/or an unwarranted 

degree of concern among the intended 

audiences. The doses of pertuzumab 

that have been associated with adverse 

developmental outcomes in a 

therapeutic context are relatively high 

when compared with many other 

pharmaceuticals or chemicals, so its 

characterization as a potent 

developmental hazard is potentially 

misleading. In addition, the available 

data from nonclinical studies and 

human experience provide evidence of 

a dose-responsive effect that is unlikely 

to occur at far sub-therapeutic 

exposures. The description of 

pertuzumab as a potent developmental 

hazard therefore overstates the risk of 

Perjeta® to healthcare workers.’’ 

NIOSH response: NIOSH agrees and 

has rephrased this sentence in NIOSH 


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Final Reevaluation Determination of 

Pertuzumab on the NIOSH List of 

Hazardous Drugs in Healthcare Settings 

to note that pertuzumab caused 

oligohydramnios which is a clear 

developmental hazard. The word 

‘‘potent’’ has been removed. 

Public comment: In relation to the 

results of a study included in the 

reevaluation, in the table form on Page 

7, the commenter states, ‘‘[t]he findings 

from the embryo-fetal development 

toxicity study support the expectation 

that the adverse developmental effects 

of pertuzumab are dose-related and are 

not expected to occur at the far subtherapeutic exposure scenarios relevant 

to healthcare workers. The evidence of 

a dose-responsive relationship between 

maternal pertuzumab doses and adverse 

outcomes can be leveraged to support 

many of the presumptions in the 

external review.’’ 

NIOSH response: The evidence in this 

study does not provide a dose at which 

developmental effects are not seen. The 

commenter is correct that it does 

support a dose-response relationship 

between pertuzumab and 

developmental effects, supporting the 

conclusion that lower systemic doses 

resulting from occupational exposures 

are less likely to cause developmental 

effects. No changes were made to the 

NIOSH Final Reevaluation 

Determination of Pertuzumab on the 

NIOSH List of Hazardous Drugs in 

Healthcare Settings based on this 

comment. 

B. Peer Review 

1. Liraglutide Peer Review 

Two external peer reviewers 

submitted responses to NIOSH, which 

are marked as ‘‘Reviewer comment’’ 

below. In general, both peer reviewers 

agreed with the approach NIOSH used 

to determine if liraglutide posed a 

hazard to workers in healthcare settings. 

Both peer reviewers also agreed with 

NIOSH that thyroid tumors and adverse 

developmental effects were appropriate 

health outcomes to consider. Lastly, 

both peer reviewers agreed that the 

systemic and occupational exposure 

assumptions NIOSH used in the 

evaluation were appropriate, and the 

resulting determination that liraglutide 

does not constitute a hazard for 

healthcare workers is correct. 

a. Are the evaluated health effects the 

appropriate health effects to consider? If 

not, what other health effect(s) should 

be evaluated and why? 

Reviewer 1 comment: ‘‘Yes, the 

evaluated health effects are the 

appropriate health effects to consider.’’ 

NIOSH response: No changes were 

made to the NIOSH Final Reevaluation 

Determination of Liraglutide on the 

NIOSH List of Hazardous Drugs in 

Healthcare Settings based on this 

comment. 

Reviewer 2 comment: ‘‘Yes. Thyroid 

tumors as indicated in the black box 

warning and developmental effects, as 

indicated by the Pregnancy Category C 

determination, and are the most relevant 

adverse health effects to be considered. 

The assertions made concerning a 

causal association between incretinbased drugs like liraglutide and 

pancreatitis or pancreatic tumors, as 

expressed currently in the scientific 

literature and in the media, are 

inconsistent with the current data. In 

the NIOSH review, concerns about the 

potential effects, including thyroid 

cancer and developmental effects, 

should be reduced in light of more 

recent data. There are no other potential 

health effects to be considered that are 

supported by current data. Other 

nonspecific effects noted in the package 

insert, such as nausea, injection site 

pain, and low blood sugar, are 

manageable and not serious.’’ 

NIOSH response: No changes were 

made to the NIOSH Final Reevaluation 

Determination of Liraglutide on the 

NIOSH List of Hazardous Drugs in 

Healthcare Settings based on this 

comment. 

b. Are the assumptions about the 

potential occupational exposures to 

liraglutide in a healthcare setting 

reasonable? Please explain. 

Reviewer 1 comment: ‘‘The 

assumptions about the potential 

occupational exposures to liraglutide in 

a healthcare setting are reasonable. 

Given the formulation and packaging of 

liraglutide, it would be expected that 

occupational exposure may occur if a 

vial leaks or breaks, which would lead 

to inhalation or dermal exposure, 

neither of which produce significant 

systemic bioavailability; or if a 

needlestick injury occurs, in which the 

quantity of drug actually injected would 

also be insignificant in the majority of 

cases.’’ 

NIOSH response: No changes were 

made to the NIOSH Final Reevaluation 

Determination of Liraglutide on the 

NIOSH List of Hazardous Drugs in 

Healthcare Settings based on this 

comment. 

Reviewer 2 comment: ‘‘Yes. This is a 

peptide with approximately 3750 

molecular weight. Substances with 

molecular weights greater than 1000 

Daltons show nil to poor absorption 

(less than 0.1%). Thus, dermal 

absorption in a healthcare workplace 

exposure would be nil, as the skin is a 

barrier for substances of this molecular 

weight. Normally (in clinical use) this 

substance is injected. The substance 

would also be expected to be degraded 

in oral exposure scenarios. Inhalation 

exposure scenarios can also be ruled out 

as this substance is in aqueous form in 

prefilled syringes and thus 

aerosolization is not expected. 

Absorption through this route would 

also be expected to be nil to poor. 

Needlestick exposures do occur in 

healthcare situations, but the 

mechanism of action for a chronic 

carcinogenic mechanism of action 

would not be triggered by needlestick 

exposures because of the toxicokinetics 

of peptides. A sufficient peak 

concentration would not be sustained 

for a sufficient duration to produce 

chronic effects. In short, exposures to 

this drug in the occupational exposure 

scenarios are exceedingly low . . . de 

minimis, in my opinion.’’ 

NIOSH response: While inhalation of 

liraglutide in current formulations can 

be ruled out, NIOSH still evaluated 

inhalation routes of exposure. NIOSH 

does not limit the evaluation to current 

formulations. NIOSH determined that 

liraglutide would not pose a hazard to 

workers even via the inhalation route. 

No changes were made to the NIOSH 

Final Reevaluation Determination of 

Liraglutide on the NIOSH List of 

Hazardous Drugs in Healthcare Settings 

based on this comment. 

c. Is the determination that the 

amount of exposure to liraglutide in a 

healthcare setting does not constitute a 

hazard for healthcare workers 

reasonably supported by the available 

scientific information? Please explain. 

Reviewer 1 comment: ‘‘Yes, the 

determination that the amount of 

exposure to liraglutide in a healthcare 

setting does not constitute a hazard for 

healthcare workers is reasonably 

supported by the available scientific 

information. Given the mechanisms of 

action of liraglutide, sustained exposure 

is required for significant effect, which 

would not likely be encountered in the 

occupational setting if medication is 

prepared, transported and administered 

as indicated (i.e., in sealed vials).’’ 

NIOSH response: No changes were 

made to the NIOSH Final Reevaluation 

Determination of Liraglutide on the 

NIOSH List of Hazardous Drugs in 

Healthcare Settings based on this 

comment. 

Reviewer 2 comment: ‘‘Yes. In my 

review of the literature, the hazard to 

humans due to the ‘‘black box’’ warning 

about thyroid tumors is low. In the 

study, at least some of the cases of 

thyroid tumors occurred in subjects 

with existing thyroid disease, and 


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should have been excluded. Secondly, a 

mitogenic mode of action is suggested, 

which would require continuous 

exposures, which are unlikely. Evidence 

suggests species-specific effects due to 

elevated GLP–1R receptor levels and 

downstream signaling. The knockout 

mouse study seems compelling in 

suggesting that the effects observed in 

rodents should not be directly 

extrapolated to humans. Thus, in 

addition to having a de minimis 

exposure, the potential of adverse 

effects is less than previously 

recognized. While the developmental 

effects in rats/rabbits cannot be ruled 

out, the statistical significance/ 

magnitude of these hazards was not 

identified. For example, while it was 

stated that doses in the same range as 

human caused developmental effects, it 

was not clear that this was a ‘human 

equivalent dose’ . . . some sort of body 

weight 3⁄4 calculation. That lack of 

significance/magnitude of these 

potential hazards also raise concerns 

about the potential over-interpretation 

of these developmental effects. Thus, de 

minimis exposures coupled with lower 

than previously recognized hazards 

combine to lower the risks to healthcare 

workers in clinical settings. NIOSH has 

evaluated data and estimated exposures 

and has come to the correct conclusion. 

I fully agree.’’ 

NIOSH response: No changes were 

made to the NIOSH Final Reevaluation 

Determination of Liraglutide on the 

NIOSH List of Hazardous Drugs in 

Healthcare Settings based on this 

comment. 

d. What alternative approaches could 

be considered to characterize the 

potential hazard to workers from 

peptide-based drugs? 

Reviewer 1 comment: ‘‘The alternative 

approaches that could be considered to 

characterize the potential hazard to 

workers from peptide-based drugs 

include surveillance regarding OSHA 

reportable injuries or illness related to 

occupational exposure to liraglutide and 

periodic review of the Medullary 

Thyroid Carcinoma (MTC) Surveillance 

Study [Hale et al. 2020].’’ 

NIOSH response: The Medullary 

Thyroid Carcinoma (MTC) registry 

could provide data that could affect 

future evaluations of liraglutide. NIOSH 

evaluates drugs when a safety related 

labeling change is posted regarding the 

drugs [NIOSH 2023]. Further, if new 

data related to the MTC surveillance 

study were brought to NIOSH’s 

attention, NIOSH could further evaluate 

the potential hazards of liraglutide 

exposures to healthcare workers as 

indicated in the NIOSH Procedures for 

Developing the NIOSH List of 

Hazardous Drugs in Healthcare Settings 

[NIOSH 2023]. 

Reviewer 2 comment: ‘‘It might be 

possible to do a literature search on 

studies for adverse effects in 

occupational exposures to insulin. This 

is a common peptide hormone with 100 

years of clinical experience. I’d imagine 

that the exposures to healthcare workers 

to insulin (by all routes) would be 

similar to liraglutide. As liraglutide had 

a molecular weight about 7-fold higher 

than that of insulin, it would be more 

poorly absorbed and less of a risk. The 

incidence of adverse effects in worker 

exposures in health care settings for 

insulin could be used as a ‘worst-case’ 

analogue to estimate of the incidence of 

liraglutide exposures and potential 

risk.’’ 

NIOSH response: Due to the rapid 

acute effects of insulin, NIOSH agrees it 

would likely serve as a worst-case 

scenario and overestimate the effects of 

exposure to liraglutide. Also, as the 

reviewer notes, any use of insulin as a 

surrogate would involve consideration 

of many caveats, including absorption, 

effect intensity/duration, and different 

specific mechanisms of action. These 

uncertainties would make the resulting 

evaluation less useful for the purpose of 

NIOSH’s hazard identification for 

placement on the List. Therefore, 

NIOSH would not use insulin as a 

surrogate for evaluation of the hazard of 

liraglutide or other GLP–1 agonist drugs 

since only hazard identification is the 

basis for placement on the List. No 

changes were made to the NIOSH Final 

Reevaluation Determination of 

Liraglutide on the NIOSH List of 

Hazardous Drugs in Healthcare Settings 

based on this comment. 

e. Is there any additional information 

that NIOSH should consider in its 

reevaluation of liraglutide? 

Reviewer 1 comment: ‘‘There is no 

additional information that NIOSH 

should consider in its reevaluation of 

liraglutide at this time.’’ 

NIOSH response: No changes were 

made to the NIOSH Final Reevaluation 

Determination of Liraglutide on the 

NIOSH List of Hazardous Drugs in 

Healthcare Settings based on this 

comment. 

Reviewer 2 comment: ‘‘As with all 

things, decisions are based on the best 

available data. As the availability of data 

will change with time, a further 

reevaluation in the decades that come 

will be appropriate should new data 

become available about any of the 

potential health effects or new ones that 

emerge.’’ 

NIOSH response: No changes were 

made to the NIOSH Final Reevaluation 

Determination of Liraglutide on the 

NIOSH List of Hazardous Drugs in 

Healthcare Settings based on this 

comment. 

2. Pertuzumab Peer Review 

Three external peer reviewers 

submitted responses to NIOSH. Overall, 

all agreed with the general approach 

NIOSH used to determine if the 

molecular properties, molecular size in 

this case, of pertuzumab would limit the 

hazard it poses in healthcare settings. 

Two of the reviewers agreed with the 

conclusion that NIOSH proposed, which 

was that pertuzumab would not be able 

to pose a developmental hazard in 

healthcare settings. They did however 

believe that the NIOSH inhalation 

exposure scenario overestimated the 

potential systemic exposure and that an 

incidental needlestick would pose the 

most relevant exposure. Both expressed 

an interest in other potential hazards. 

One expressed an interest in cardiac 

hazards and one in sensitization. 

The third reviewer, while agreeing 

that the approach was sound and the 

assumptions reasonable, disagreed with 

NIOSH on some points and felt that 

pertuzumab should remain on the List. 

This reviewer stated that there was not 

enough quantitative data to rule out 

potentially relevant levels of exposures 

via the dermal and oral routes. They 

stated that without quantitative data to 

support the assumptions made that the 

lack of a NOAEL and the severity of 

effects in the animal study in the FDA 

review supported leaving pertuzumab 

on the List. This reviewer expressed a 

concern that while the observed effect, 

oligohydramnios, was reversible that 

did not rule out that there are no 

adverse effects to the fetus, including 

potential upstream and downstream 

effects. They also expressed concerns 

that using trastuzumab as a model for 

pertuzumab effects might not be 

appropriate. There may be some 

differences in their effects, as some 

differences in molecular signaling have 

been identified in a cell system model. 

a. Reviewer 1 

Reviewer 1 comment 1: ‘‘More 

quantitative information is needed, 

quantitative gaps need to be addressed, 

and justification in the face of the gaps 

need to be outlined. The examination of 

routes of exposure seems to be limited 

to the molecular properties of the drug. 

Workplace exposure scenarios are not 

described (e.g., opportunities of 

splashing, use of PPE such as gloves, 

potential for hand to mouth activity, 

etc.). Inclusion of these exposure 

scenarios would be informative, but if 

they are not described the rationale for 


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6Pertuzumab, but not trastuzumab, blocks the 

activation of a cell survival pathway in cultured cell 

lines in an in vitro assay. 

not providing a set of exposure 

scenarios, should be explained.’’ 

NIOSH response: Evaluation of 

workplace exposure scenarios are 

outside of the scope of the List. Because 

the large variety of scenarios that may 

take place in healthcare workplaces and 

the different properties of hazardous 

drugs, NIOSH does not take into 

account all of the possible workplace 

exposure scenarios. Therefore, for 

pertuzumab, NIOSH considered 

maximum occupational systematic 

exposure via all available routes to be 

less than a full therapeutic dose. In this 

case, NIOSH considered if the 

properties of the drug might limit the 

systemic availability via worst-case 

relevant routes of occupational 

exposure. Individual scenario analysis 

would not add significantly to these 

findings, as the resultant exposures 

would likely be much less than the 

worst-case scenarios. This is why the 

examination is limited to molecular 

properties of the drug and an evaluation 

of worst-case workplace exposures. 

Reviewer 1 comment 2: ‘‘The 

assumptions are reasonable, but the 

evidence to support them is very 

limited. Research gaps should be 

identified and described. An example is 

the lack of quantitative data on the 

absorption of pertuzumab following oral 

exposure. The statement that 

bioavailability as ‘low’ lacks clarity. The 

studies cited to back up the qualitative 

statement do not present quantitative 

data or reference other studies to 

support the claims regarding oral 

bioavailability.’’ 

NIOSH response: No quantitative data 

on the oral bioavailability of 

pertuzumab exist. The bioavailability of 

monoclonal antibodies and proteins are 

low because they are degraded in the 

gastrointestinal tract and are poorly 

absorbed through the gastrointestinal 

epithelium [Keizer et al. 2010; Wang et 

al. 2008]. This severely limits the 

bioavailability of intact proteins passing 

through the GI tract. Because of this, 

systemic exposure via the oral route is 

likely much lower when compared with 

the inhalation worst-case scenario 

NIOSH considered. The same is true for 

dermal exposures. The worst-case 

scenario NIOSH addressed in the 

inhalation scenario is likely the worstcase scenario overall. Some clarifying 

language has been added to the 

appropriate sections of the document. 

Reviewer 1 comment 3: 

‘‘Oligohydramnios being reversible does 

not necessarily indicate no adverse 

effect on the fetus. Downstream and 

upstream effects should be considered.’’ 

NIOSH response: Only one case study 

of exposure to pertuzumab during 

pregnancy in a human was identified 

and that exposure included co-exposure 

with trastuzumab. Information was 

available on exposure to trastuzumab, 

the similar monoclonal antibody 

targeting the same HER2 mechanism. No 

long-term follow-up on the exposed 

children was identified, but the Zagouri 

et al. [2013] review noted that all 

children with only first trimester 

exposure, when treatment was ceased, 

had good outcomes, and all babies born 

healthy were still healthy at nine 

months after birth. However, this is the 

only follow-up identified. 

Reviewer 1 comment 4: ‘‘Given the 

severity of the renal effects seen in 

cynomolgus monkey offspring, removal 

of pertuzumab from the List based on its 

molecular properties related to exposure 

should be based on a strong evidence 

base (e.g., direct evidence in humans 

that a single low exposure dose does not 

carry risk of renal effects in the fetus).’’ 

NIOSH response: Only one case study 

identifying human pregnancy exposure 

to pertuzumab was identified and that 

patient was also receiving trastuzumab. 

In the cynomolgus monkey study, the 

effects did appear to be dose-related and 

treatment was continued throughout 

gestation. Data in humans with in utero 

exposure to the monoclonal antibody 

trastuzumab, which targets the same 

mechanism, suggest that the effects are 

reversible, and when exposure is 

ceased, outcomes improve with healthy 

babies being born. Lambertini et al. 

[2019] found 12 cases of potential in 

utero exposure to trastuzumab and/or 

the HER2 targeting small molecule drug 

lapatinib, seven had elective abortions 

and five continued the pregnancy. In all 

cases where the child was born, 

exposure was only during the first 

trimester. Outcomes at birth were 

normal for four. In the fifth, the baby 

was delivered via caesarian at 34 weeks 

due to growth retardation. In that case, 

the mother had received radiation 

therapy for brain metastasis and died 17 

days following delivery. The 

mechanism of action of pertuzumab 

appears to lead to reversible effects 

when exposure is not continuous. 

Reviewer 1 comment 5: ‘‘The use of 

another drug, trastuzumab, as a model 

for pertuzumab, may provide some 

insights, but this evidence must be 

interpreted with caution because small 

differences between substances with 

similar structures or mechanisms of 

action can significantly impact their 

biological activity, as exemplified by 

(but not limited to) the ability of 

pertuzumab, but not trastuzumab to 

induce activation of the PI3K cell 

survival pathway [FDA 2012].’’ 

NIOSH response: In cell lines, 

pertuzumab does block activation of the 

PI3K survival pathway as indicated by 

decreased phosphorylation of AKT in a 

cancer cell line.6 Physiological effects 

appear similar between the two 

monoclonal antibodies. There are no 

available reports of fetal effects of 

pertuzumab without concurrent 

trastuzumab exposure in humans during 

pregnancy. Trastuzumab was used as a 

model of human exposure during 

pregnancy because the primary target 

pathway for the two molecules is the 

same, and the effect in humans and the 

cynomolgus monkeys are the same. This 

indicates that the mechanism of action 

is related to the similar HER2 inhibition 

of the two molecules. 

Reviewer 1 comment 6: ‘‘The lack of 

a NOAEL suggests that a strong case is 

needed for this drug to be exempt based 

on the ‘molecular properties’ 

argument.’’ 

NIOSH response: While there is no 

identified NOAEL stated in the available 

monkey studies, the effects do appear to 

increase in severity with dose. For 

trastuzumab, which targets the same 

molecular mechanism, it also appears 

that continued exposure in the later 

trimesters of pregnancy is required to 

initiate the effects that lead to 

oligohydramnios. The molecular 

properties of monoclonal antibodies 

mean the bioavailability to a single 

exposure is lower. Repeated exposure to 

a level that might lead to systemic 

exposures that could lead to continued 

reversible effects are also unlikely. 

Reviewer 1 comment 7: ‘‘Would this 

section [the section called Hazard 

Characterization] be more appropriately 

named something related to exposure 

rather than hazard?’’ 

NIOSH response: Under the heading 

Integrated Toxicity and Molecular 

Property Hazard Characterization of the 

NIOSH Reevaluation of Pertuzumab on 

the NIOSH List of Antineoplastic and 

Other Hazardous Drugs in Healthcare 

Settings, NIOSH discussed how the 

relevant molecular properties, in this 

case, molecular weight, affect the hazard 

of the drug. In this case, consideration 

of relevant potential exposures 

influence how the potential hazard is 

characterized. This information is about 

hazard characterization rather than 

exposure. No change was made to the 

NIOSH Final Reevaluation 

Determination of Pertuzumab on the 

NIOSH List of Hazardous Drugs in 

Healthcare Settings in response to this 

comment. 


ddrumheller on DSK120RN23PROD with NOTICES1
104180 Federal Register / Vol. 89, No. 245 / Friday, December 20, 2024 / Notices 

b. Reviewer 2 

Reviewer 2 comment 1: ‘‘An 

accidental needle stick is the only 

reasonable route of exposure for 

healthcare workers. The skin serves as 

an effective barrier to penetration of 

most environmental sources of 

chemicals, including large molecules 

such as pertuzumab. Orally, pertuzumab 

will be degraded by intestinal proteases. 

Since pertuzumab is provided as a 

solution in a single use vial to be mixed 

with saline prior to infusion, inhalation 

of droplets will not provide sufficient 

exposure to result in risks to the fetus 

of a healthcare worker.’’ 

NIOSH response: NIOSH does not 

limit the consideration to the currently 

available formulation. Formulations 

may change over time, so inhalation was 

considered. 

Reviewer 2 comment 2: ‘‘The estimate 

for inhalation exposure of 5% was 

developed for workers in a 

manufacturing setting to derive 

occupational exposure limits but is 

likely an overestimate of potential 

exposure of pertuzumab in a healthcare 

setting. According to the data and 

discussion in Pfister et al. [2014], the 

5% value represents a maximum 

bioavailability for proteins >40 kDa; 

1.7% was the median. According to the 

package insert, pertuzumab has an 

approximate molecular weight of 148 

kDa. Proteins >40 kDa were applied by 

intratracheal instillation (Table 1). This 

is not a likely route of exposure for 

pertuzumab in a healthcare setting.’’ 

NIOSH response: While intratracheal 

instillation is not a likely route of 

exposure for a drug in a healthcare 

setting, it provided the only data to 

consider bioavailability through the 

respiratory tract tissues. The studies 

reviewed by Pfister et al. [2014] did 

include studies that looked at 

intratracheal instillation of monoclonal 

antibodies like pertuzumab. 

Reviewer 2 comment 3: ‘‘Another 

sensitive endpoint could be assessing 

respiratory sensitization in workers 

though workplace monitoring, but this 

should be applied only if there is a 

hazard identified in a clinical trial or 

post marketing setting. According to 

Pfister et al., respiratory sensitization 

has not been observed in a 

manufacturing setting to date.’’ 

NIOSH response: The NIOSH List 

does not consider respiratory 

sensitization as a criterion for 

identifying potential drug hazards. 

c. Reviewer 3 

Reviewer 3 comment 1: ‘‘[A]nother 

potential health effect could be heart 

problems associated with Perjeta 

treatment [Shrim et al. 2007; Swain et 

al. 2014]. The decreased left ventricular 

ejection fraction resulting in cardiac 

failure and congestive heart failure has 

been listed as possible side effects of the 

treatment and should be reversible 

when the treatment is stopped. To the 

best of my knowledge, there were no 

reported heart related issues with the 

offsprings from the in vivo studies. 

Whether the occupational exposure 

concentrations would be high enough to 

cause the potential heart problems or 

not, this should be considered as a 

probable hazard to healthcare workers 

in occupational exposure settings.’’ 

NIOSH response: Cardiac effects may 

occur at treatment levels, but these do 

not meet NIOSH criteria. Even in the 

worst-case scenario, systemic exposures 

in healthcare workplaces are unlikely to 

reach levels near treatment levels. The 

cardiac effects are unlikely to be of 

relevance in occupational exposures in 

healthcare settings because they are 

associated with exposures only at 

treatment levels. 

Reviewer 3 comment 2: ‘‘Based on the 

highest concentration provided (30 mg/ 

mL), an accidental needle stick delivery 

based on the different needle properties 

[Foster et al. 2010; Gaughwin et al. 

1991; Krikorian et al. 2007; Mast et al. 

1993; Napoli and McGowan 1987] 

would be negligible (<1 mL) to achieve 

the human dose. Since pertuzumab is 

not volatile, an inhalation route would 

pose negligible hazard. As mentioned 

above, the accidental needle stick 

delivery would be extremely low to 

achieve the human dose.’’ 

NIOSH response: NIOSH evaluated a 

scenario for needlestick that went 

beyond the worst case. NIOSH agrees 

that an incidental needlestick would not 

deliver a human dose, but even if it did, 

multiple needle sticks providing the 

relevant exposures are not considered to 

be likely. The effect of concern is 

reversible and requires repeated 

exposure to maintain the systemic 

exposure levels that would cause 

oligohydramnios, which would not 

happen even in the NIOSH evaluated 

worst-case scenario. 

V. Summary of Updates and Changes to 

NIOSH List of Hazardous Drugs in 

Healthcare Settings 

In this update, 25 drugs have been 

added to the List since the publication 

of the NIOSH List of Antineoplastics 

and Other Hazardous Drugs, 2016. 

Twelve of those newly added drugs 

have special handling information from 

the manufacturers. Seven drugs have 

been removed from the List, including 

liraglutide and pertuzumab. These 

additions and removals, as well as the 

reorganization discussed below, are now 

reflected in the NIOSH List of 

Hazardous Drugs in Healthcare Settings, 

2024, available on the NIOSH website 

(see https://www.cdc.gov/niosh/ 

healthcare/hazardous-drugs/ 

index.html) and in the docket for this 

activity. 

Drugs reviewed for this update were 

either new drug approvals or those 

drugs that received new safety-related 

warnings from FDA in the period 

between January 2014 and December 

2015. In addition to these updates, the 

tables categorizing hazardous drugs 

have been reorganized. 

Table 1 now includes 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 and/or by IARC 

as carcinogenic to humans (Group 1) or 

probably carcinogenic to humans 

(Group 2A). 

In the 2016 List, Table 1 focused on 

antineoplastic drugs. However, in the 

2024 List, NIOSH has removed the 

identifier ‘‘antineoplastic’’ because of 

advances in cancer treatment, the 

therapeutic designation 

‘‘antineoplastic’’ no longer indicates 

drugs of high toxicity. Therefore, Table 

1 focuses on the toxicity and 

carcinogenicity of drugs, regardless of 

their therapeutic use. 

Table 2 now contains drugs that: 

• Meet one or more of the NIOSH 

definitions of a hazardous drug, and 

• Are not drugs with MSHI, and 

• Are not classified by NTP as known 

to be a human carcinogen or by IARC as 

carcinogenic to humans (Group 1) or 

probably carcinogenic to humans 

(Group 2A). 

Some of the drugs in Table 2 have 

adverse reproductive effects for 

populations at risk. 

This table includes those drugs that 

only meet the NIOSH criteria as a 

developmental (including 

teratogenicity) and/or reproductive 

hazard. In the 2016 update of the List, 

such drugs were included in a separate 

table (Table 3), which has been 

combined with Table 2. Drugs that only 

meet the NIOSH criteria as a 

reproductive and/or developmental 

hazard are identified in a column 

labeled ‘‘Only Developmental and/or 

Reproductive Hazard’’ in the 2024 List. 

Changes to the placement of drugs on 

the List, including drugs that are no 

longer considered hazardous and those 

that have been moved from one table to 

another, are described in a new section 

in the 2024 List and not called out in a 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 245 / Friday, December 20, 2024 / Notices 104181 

7https://www.cdc.gov/niosh/healthcare/ 

hazardous-drugs/?CDC_AAref_Val=https://

www.cdc.gov/niosh/topics/hazdrug/default.html. 

separate table as in the 2016 update 

(former Table 4). 

In the 2016 update, Table 5 provided 

information on recommended exposure 

controls for hazardous drugs based on 

formulations. NIOSH moved and 

expanded the risk management 

information formerly provided in Table 

5 and developed a new document, 

Managing Exposures. This document 

includes information on engineering 

controls, administrative controls, and 

PPE for working with hazardous drugs 

in healthcare settings. It is available on 

the NIOSH Hazardous Drug Exposures 

in Healthcare website.7

In previous updates, NIOSH included 

a supplemental information column that 

contained additional information about 

individual drugs, including pregnancy 

categories. However, as of 2015, FDA no 

longer uses the pregnancy categories for 

drugs and this information was not 

necessarily related to the NIOSH 

decision to place the drug on the List. 

Therefore, NIOSH has removed the 

supplemental information column from 

the 2024 List. 

Finally, in the 2024 List, NIOSH has 

added a column to identify drugs that 

were approved by CDER under a BLA. 

These drugs tend to be large, proteinbased molecules. The properties of these 

drugs may affect the strategies used to 

address the hazards they pose. 

Identifying them would aid in hazard 

identification for risk management in 

healthcare settings. NIOSH notes that 

some of the drugs that were approved 

under a BLA may include conjugates 

with their own separate hazards, which 

should also be taken into account. 

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[2014]. Pertuzumab, trastuzumab, and 

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Papadimitriou CA, Dimopoulos M–A, 

Bartsch R [2013]. Trastuzumab 

administration during pregnancy: a 

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2368-y. 

John Howard, 

Director, National Institute for Occupational 

Safety and Health, Centers for Disease Control 

and Prevention, Department of Health and 

Human Services. 

[FR Doc. 2024–30456 Filed 12–19–24; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Centers for Disease Control and 

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Advisory Committee on HIV, Viral 

Hepatitis and STD Prevention and 

Treatment; Notice of Charter Renewal 

AGENCY: Centers for Disease Control and 

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and Human Services (HHS). 

ACTION: Notice of charter renewal. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC), within 

the Department of Health and Human 

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of the charter of the Centers for Disease 

Control and Prevention (CDC)/Health 

Resources and Services Administration 

(HRSA) Advisory Committee on HIV, 

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Treatment (CHAC). 

FOR FURTHER INFORMATION CONTACT: 

Jonathan Mermin, M.D., M.P.H., 

Designated Federal Officer, CDC/HRSA 

Advisory Committee on HIV, Viral 

Hepatitis and STD Prevention and 

Treatment, Centers for Disease Control 

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and Human Services, 1600 Clifton Road 

NE, Mailstop H24–6, Atlanta, Georgia 

30329–4027. Telephone: (404) 639– 

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SUPPLEMENTARY INFORMATION: CDC is 

providing notice under 5 U.S.C. 1001– 

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Centers for Disease Control and 

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Advisory Committee on HIV, Viral 

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The Director, Office of Strategic 

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Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Kalwant Smagh, 

Director, Office of Strategic Business 

Initiatives, Office of the Chief Operating 

Officer, Centers for Disease Control and 

Prevention. 

[FR Doc. 2024–30414 Filed 12–19–24; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Mine Safety and Health Research 

Advisory Committee; Notice of Charter 

Renewal 

AGENCY: Centers for Disease Control and 

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ACTION: Notice of charter renewal. 

SUMMARY: The Centers for Disease 

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FOR FURTHER INFORMATION CONTACT: 

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Telephone: (412) 386–4660; email: 

RRandolph@cdc.gov. 

SUPPLEMENTARY INFORMATION: CDC is 

providing notice under 5 U.S.C. 1001– 

1014 of the renewal of the charter of the 

Mine Safety and Health Research 

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Department of Health and Human 

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for a two-year period through November 

30, 2026. 

The Director, Office of Strategic 

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Operating Officer, Centers for Disease 

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delegated the authority to sign Federal 

Register notices pertaining to 

announcements of meetings and other 

committee management activities, for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Kalwant Smagh, 

Director, Office of Strategic Business 

Initiatives, Office of the Chief Operating 

Officer, Centers for Disease Control and 

Prevention. 

[FR Doc. 2024–30408 Filed 12–19–24; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

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[Document Identifier: CMS–R–65 and CMS– 

10142] 

Agency Information Collection 

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