2614 Federal Register / Vol. 89, No. 10 / Tuesday, January 16, 2024 / Notices 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Public Health Ethics and 

Regulations, Office of Science, Centers for 

Disease Control and Prevention. 

[FR Doc. 2024–00652 Filed 1–12–24; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[Docket Number CDC–2020–0046, NIOSH– 

233–C] 

Request for Public Comment on NIOSH 

Initial Recommendations To Change 

the Status of Liraglutide and 

Pertuzumab on the NIOSH List of 

Antineoplastic and Other Hazardous 

Drugs in Healthcare Settings 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Request for comment. 

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), requests public 

comment on two draft reevaluations 

with initial recommendations to change 

the status of two drugs, liraglutide and 

pertuzumab, on the NIOSH List of 

Antineoplastics and Other Hazardous 

Drugs in Healthcare Settings (List). The 

reevaluations were developed based on 

the process described in the NIOSH 

Procedures for Developing the NIOSH 

List of Hazardous Drugs in Healthcare 

Settings. Based on the reevaluations, the 

NIOSH initial recommendations are to 

remove liraglutide and pertuzumab from 

the List. 

DATES: Electronic or written comments 

must be received by February 15, 2024. 

ADDRESSES: You may submit comments, 

identified by CDC–2020–0046 and 

docket number NIOSH–233–C, by either 

of the following methods: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: National Institute for 

Occupational Safety and Health, NIOSH 

Docket Office, 1090 Tusculum Avenue, 

MS C–34, Cincinnati, Ohio 45226–1998. 

Instructions: All information received 

in response to this notice must include 

the agency name and docket number 

(CDC–2020–0046; NIOSH–233–C). All 

relevant comments, including any 

personal information provided, will be 

posted without change to https://

www.regulations.gov. Do not submit 

comments by email. CDC does not 

accept comments by email. For access to 

the docket to read background 

documents or comments received, go to 

https://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: R. 

Todd Niemeier, Ph.D., National Institute 

for Occupational Safety and Health, 

MS–C15, 1090 Tusculum Avenue, 

Cincinnati, OH 45226. Telephone: (513) 

533–8166. 

SUPPLEMENTARY INFORMATION: NIOSH 

seeks public comments on its 

reevaluations with initial 

recommendations to change the status 

of two drugs, pertuzumab and 

liraglutide, on the NIOSH List of 

Antineoplastic and Other Hazardous 

Drugs in Healthcare Settings (the List). 

The NIOSH reevaluations were 

conducted based on the process 

described in the NIOSH Procedures for 

Developing the NIOSH List of 

Hazardous Drugs in Healthcare Settings, 

available at https://www.cdc.gov/niosh/ 

docs/2016-161/. 

NIOSH reevaluated the placement of 

pertuzumab on the NIOSH List in 

response to a request for reevaluation 

from the manufacturer. Based on this 

reevaluation, the initial NIOSH 

recommendation is to remove 

pertuzumab from the NIOSH List. In its 

reevaluation NIOSH determined that, 

due to the intrinsic molecular properties 

of pertuzumab and the nature of the 

specific hazard posed by exposure to 

pertuzumab, it is not likely to pose a 

hazard to workers in healthcare settings. 

The potential adverse health effect 

relevant to pertuzumab occupational 

exposure is the increased potential for 

fetal developmental abnormalities due 

to oligohydramnios during pregnancy 

[FDA 2012]. However, the development 

of oligohydramnios during pregnancy is 

reversible and would require repeated 

exposures to pertuzumab that are high 

enough to cause oligohydramnios 

through the relevant period of 

development. Pertuzumab has limited 

dermal, oral, and inhalation 

bioavailability due to its intrinsic 

molecular properties. Repeated 

unintended exposures resulting from 

needlestick injuries at levels high 

enough to result in sustained 

oligohydramnios is unlikely. For these 

reasons, pertuzumab is not expected to 

pose a hazard to workers in healthcare 

workplaces. 

NIOSH reevaluated the placement of 

liraglutide on the NIOSH List in 

response to a request for reevaluation 

from the manufacturer. Based on this 

reevaluation, the initial NIOSH 

recommendation is to remove 

liraglutide from the NIOSH List. In its 

reevaluation NIOSH determined that, 

due to the intrinsic molecular properties 

of liraglutide and the nature of the 

specific hazard posed by exposure to 

liraglutide, it is not likely to pose a 

hazard to workers in healthcare settings. 

In animal studies liraglutide was 

reported to cause C-cell specific thyroid 

tumors [FDA 2009]. This carcinogenic 

effect was due to mitogenic activity, and 

the progression required continued 

liraglutide exposure. The relevance of Ccell specific thyroid tumor formation in 

response to liraglutide exposure to 

humans is unknown but cannot be ruled 

out. Potential fetal developmental 

abnormalities are also seen in some 

animal studies, and there may be risk to 

the fetus in pregnant patients. However, 

the intrinsic molecular properties of the 

liraglutide peptide greatly decrease 

dermal, oral, and inhalation 

bioavailability, and the hazards related 

to liraglutide exposure would require 

repeated needlestick injuries. Systemic 

exposures in workplaces are not likely 

to reach levels required for the potential 

adverse effects to pose a hazard. 

In addition to providing the 

opportunity for public comment, NIOSH 

is conducting external peer review of its 

reevaluations. NIOSH has completed the 

peer review of pertuzumab and will 

conduct the peer review of liraglutide 

concurrently with the public review. 

The charges to the public and peer 

reviewers are provided below. 

Public and Peer Review Charge for the 

Reevaluation of Pertuzumab on the 

NIOSH List of Hazardous Drugs 

The manufacturer’s request to 

reevaluate the inclusion of pertuzumab 

on the NIOSH List proposed that 

pertuzumab does not present a potential 

hazard to healthcare worker exposures 

because the properties of the drug limit 

the potential for exposure and therefore 

adverse health effects from that 

exposure. NIOSH developed a scenario 

for worker exposure to pertuzumab to 

evaluate this proposal. Based on this 

scenario NIOSH determined that 

pertuzumab does not meet the NIOSH 

definition of a hazardous drug and 

recommends that it be removed from the 

List. Please review the NIOSH 

reevaluation of pertuzumab and 

consider the following questions. 

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? 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 10 / Tuesday, January 16, 2024 / Notices 2615 

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? 

Public and Peer Review Charge for the 

Reevaluation of Liraglutide on the 

NIOSH List of Hazardous Drugs 

The manufacturer’s request to 

reevaluate the inclusion of liraglutide 

on the NIOSH List proposed that it does 

not present a potential hazard to 

healthcare worker exposures because 

the properties of the drug limit the 

potential for exposure and therefore 

adverse health effects from that 

exposure. To reevaluate this drug, 

NIOSH reviewed data regarding the 

hazards and potential for systemic 

exposure to liraglutide. Based on this 

reevaluation NIOSH determined that 

liraglutide does not meet the NIOSH 

definition of a hazardous drug and 

recommends that it be removed from the 

List. Please review the NIOSH 

reevaluation of liraglutide and consider 

the following questions. 

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? 

References 

FDA [2009]. Liraglutide Pharmacology 

Review. Retrieved from https://www.

accessdata.fda.gov/scripts/cder/daf/. 

FDA [2012]. US Food and Drug 

Administration Pharmacology Review of 

Perjeta. Retrieved from https://www.

accessdata.fda.gov/drugsatfda_docs/ 

nda/2012/125409Orig1s000PharmR.pdf 

NIOSH [2016]. NIOSH list of 

antineoplastic and other hazardous drugs 

in healthcare settings, 2016. By Connor 

TH, MacKenzie BA, DeBord DG, Trout 

DB, O’Callaghan JP. 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 2016–161. 

https://www.cdc.gov/niosh/docs/2016- 

161/ NIOSH [2023]. Procedures for 

developing the NIOSH list of hazardous 

drugs in healthcare settings. By 

Whittaker C, Ovesen JL, MacKenzie BA, 

Hartley T, Berry KA, Piacentino J. 

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 No. 

2023–129. https://www.cdc.gov/niosh/ 

docs/2023-129/. 

John J. Howard, 

Director, National Institute for Occupational 

Safety and Health, Centers for Disease Control 

and Prevention. 

[FR Doc. 2024–00693 Filed 1–12–24; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–24–0576] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

In accordance with the Paperwork 

Reduction Act of 1995, the Centers for 

Disease Control and Prevention (CDC) 

has submitted the information 

collection request titled ‘‘Possession, 

Use, and Transfer of Select Agents and 

Toxins (42 CFR part 73)’’ to the Office 

of Management and Budget (OMB) for 

review and approval. CDC previously 

published a ‘‘Proposed Data Collection 

Submitted for Public Comment and 

Recommendations’’ notice on August 

15, 2023, to obtain comments from the 

public and affected agencies. CDC did 

not receive any comments related to the 

previous notice. This notice serves to 

allow an additional 30 days for public 

and affected agency comments. 

The CDC will accept all comments for 

this proposed information collection 

project. The OMB is particularly 

interested in comments that: 

(a) Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; 

(b) Evaluate the accuracy of the 

agencies estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

(c) Enhance the quality, utility, and 

clarity of the information to be 

collected; 

(d) Minimize the burden of the 

collection of information on those who 

are to respond, including, through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses; and 

(e) Assess information collection 

costs. 

To request additional information on 

the proposed project or to obtain a copy 

of the information collection plan and 

instruments, call (404) 639–7570. 

Comments and recommendations for the 

proposed information collection should 

be sent within 30 days of publication of 

this notice to www.reginfo.gov/public/ 

do/PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. Direct written 

comments and/or suggestions regarding 

the items contained in this notice to the 

Attention: CDC Desk Officer, Office of 

Management and Budget, 725 17th 

Street NW, Washington, DC 20503 or by 

fax to (202) 395–5806. Provide written 

comments within 30 days of notice 

publication. 

Proposed Project 

Possession, Use, and Transfer of Select 

Agents and Toxins (OMB Control No. 

0920–0576, Exp. 1/31/2024)— 

Revision—Office of Readiness and 

Response (ORR), Centers for Disease 

Control and Prevention (CDC) 

Background and Brief Description 

Subtitle A of the Public Health 

Security and Bioterrorism Preparedness 

and Response Act of 2002, (42 U.S.C. 

262a), requires the United States 

Department of Health and Human 

Services (HHS) to regulate the 

possession, use, and transfer of 

biological agents or toxins that have the 

potential to pose a severe threat to 

public health and safety (select agents 

and toxins). Subtitle B of the Public 

Health Security and Bioterrorism 

Preparedness and Response Act of 2002 

(which may be cited as the Agricultural 

Bioterrorism Protection Act of 2002), (7 

U.S.C. 8401), requires the United States 

Department of Agriculture (USDA) to 

regulate the possession, use, and 

transfer of biological agents or toxins 


ddrumheller on DSK120RN23PROD with NOTICES1