Notice2024-00693
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
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Published
January 16, 2024
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 10 (Tuesday, January 16, 2024)</title>
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[Federal Register Volume 89, Number 10 (Tuesday, January 16, 2024)]
[Notices]
[Pages 2614-2615]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-00693]
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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.
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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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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 <a href="https://www.cdc.gov/niosh/docs/2016-161/">https://www.cdc.gov/niosh/docs/2016-161/</a>.
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 C-cell 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?
[[Page 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 <a href="https://www.accessdata.fda.gov/scripts/cder/daf/">https://www.accessdata.fda.gov/scripts/cder/daf/</a>.
FDA [2012]. US Food and Drug Administration Pharmacology Review of
Perjeta. Retrieved from <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125409Orig1s000PharmR.pdf">https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125409Orig1s000PharmR.pdf</a> 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. <a href="https://www.cdc.gov/niosh/docs/2016-161/">https://www.cdc.gov/niosh/docs/2016-161/</a> 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. <a href="https://www.cdc.gov/niosh/docs/2023-129/">https://www.cdc.gov/niosh/docs/2023-129/</a>.
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
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