[Federal Register Volume 83, Number 31 (Wednesday, February 14, 2018)]
[Notices]
[Pages 6563-6573]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02957]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[CDC-2018-0004; NIOSH-233-B]


NIOSH List of Antineoplastic and Other Hazardous Drugs in 
Healthcare Settings: Proposed Additions to the NIOSH Hazardous Drug 
List 2018

AGENCY: Centers for Disease Control and Prevention, HHS.

ACTION: Notice of draft document available for public comment.

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SUMMARY: The National Institute for Occupational Safety and Health 
(NIOSH) of the Centers for Disease Control and Prevention (CDC) 
announces the availability for public comment on the drugs proposed for 
placement on the NIOSH List of Antineoplastic and Other Hazardous Drugs 
in Healthcare Settings, 2018 (List), as well as the NIOSH Policy and 
Procedures for Developing the NIOSH List of Antineoplastic and Other 
Hazardous Drugs in Healthcare Settings.

DATES: Comments must be received by April 16, 2018.

ADDRESSES: Comments may be submitted, identified by docket numbers CDC-
2018-0004 and NIOSH-233-B, by either of the following two methods:
     Federal eRulemaking Portal: www.regulations.gov. Follow 
the instructions for submitting comments.
     Mail: NIOSH Docket Office, Robert A. Taft Laboratories, 
MS-C34, 1090 Tusculum Avenue, Cincinnati, OH 45226-1998.
    Instructions: All information received in response to this notice 
must include the agency name and the docket numbers (CDC-2018-0004; 
NIOSH-233-B). All relevant comments received will be posted without 
change to www.regulations.gov, including any personal information 
provided.

FOR FURTHER INFORMATION CONTACT: Barbara MacKenzie, NIOSH, Robert A. 
Taft Laboratories, 1090 Tusculum Avenue, MS-C26, Cincinnati, OH 45226, 
telephone (513) 533-8132 (not a toll free number), Email: 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Public Participation

    Interested parties are invited to participate in this action by 
submitting written views, opinions, recommendation, and/or data. 
Comments are invited on any topic related to the drugs identified in 
this notice, including those evaluated for

[[Page 6564]]

placement on the NIOSH List of Antineoplastic and Other Hazardous Drugs 
in Healthcare Settings, 2018. NIOSH also seeks comment on the draft 
Policy and Procedures for Developing the NIOSH List of Antineoplastic 
and Other Hazardous Drugs in Healthcare Settings, available in the 
docket for this action. NIOSH invites comments specifically on the 
following questions related to this action:
    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?

II. Background

    In September 2004, NIOSH published NIOSH Alert: Preventing 
Occupational Exposures to Antineoplastic and Other Hazardous Drugs in 
Health Care Settings (Alert).\1\ The 2004 Alert set out a general NIOSH 
policy for the identification of hazardous drugs and contained examples 
of U.S. Food and Drug Administration (FDA)-approved drugs that were 
deemed to be hazardous to workers in health care and other settings and 
may require special handling. This initial list of hazardous drugs was 
updated in 2010,\2\ 2012,\3\ 2014,\4\ and 2016.\5\ The latest 
publication, entitled NIOSH List of Antineoplastic and Other Hazardous 
Drugs in Healthcare Settings, 2016 (2016 Update), covered all new 
approved drugs and drugs with new warnings through December 2013.
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    \1\ See https://www.cdc.gov/niosh/docs/2004-165/.
    \2\ See https://www.cdc.gov/niosh/docs/2010-167/.
    \3\ See https://www.cdc.gov/niosh/docs/2012-150/.
    \4\ See https://www.cdc.gov/niosh/docs/2014-138/default.html.
    \5\ See https://www.cdc.gov/niosh/docs/2016-161/default.html.
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III. Policy and Procedures for Developing the NIOSH List of 
Antineoplastic and Other Hazardous Drugs in Healthcare Settings

    The NIOSH Director has developed draft policy and procedures, 
entitled Policy and Procedures for Developing the NIOSH List of 
Antineoplastic and Other Hazardous Drugs in Healthcare Settings, to 
formalize the methodology NIOSH uses to guide the addition of hazardous 
drugs to the List (see https://www.cdc.gov/niosh/topics/hazdrug/default.html). The draft document clarifies and details the purpose of 
the List, which is to assist employers in providing safe and healthful 
workplaces by offering a list of drugs that meet the NIOSH definition 
of a hazardous drug, and sets out the procedures used by NIOSH to 
identify such drugs. The draft policy and procedures will be finalized 
after consideration of comments to this docket and from peer 
reviewers.\6\
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    \6\ See https://www.cdc.gov/niosh/topics/hazdrug/peer-review-plan.html for the charge to peer reviewers.
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    According to the draft hazardous drugs policy and procedures, NIOSH 
defines a hazardous drug as a drug that is:
    1. Approved for use in humans \7\ by the FDA; \8\ and
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    \7\ Although only drugs approved by the FDA for use in humans 
are included in the definition of a hazardous drug, some of those 
drugs may be used in veterinary settings for treatment of animals 
and may be a hazard for veterinary care workers.
    \8\ 21 U.S.C. 301 et seq.
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    2. Not otherwise regulated by the U.S. Nuclear Regulatory 
Commission; \9\ and
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    \9\ 10 CFR parts 19, 20, and 35. See https://www.nrc.gov/materials/miau/med-use.html.
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    3. Either:
    a. Accompanied by prescribing information in the ``package insert'' 
\10\ that includes special handling information to protect workers 
handling the drug; or
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    \10\ See Drug Advertising: A Glossary of Terms at https://www.fda.gov/drugs/resourcesforyou/consumers/prescriptiondrugadvertising/ucm072025.htm. ``Prescribing information 
is also called product information, product labeling, or the package 
insert (``the PI''). It is generally drafted by the drug company and 
approved by the FDA. This information travels with a drug as it 
moves from the company to the pharmacist. It includes the details 
and directions healthcare providers need to prescribe the drug 
properly. It is also the basis for how the drug company can 
advertise its drug. The prescribing information includes such 
details about the drug as: Its chemical description; how it works; 
how it interacts with other drugs, supplements, foods, and 
beverages; what condition(s) or disease(s) it treats; who should not 
use the drug; serious side effects, even if they occur rarely; 
commonly occurring side effects, even if they are not serious; 
effects on specific groups of patients, such as children, pregnant 
women, or older adults and how to use it in these populations.''
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    b. Exhibits one or more of the following types of toxicity in 
humans, animal models, or in vitro systems: Carcinogenicity; 
teratogenicity or other developmental toxicity; reproductive toxicity; 
organ toxicity at low doses; genotoxicity; or structure and toxicity 
profile that mimics existing drugs determined hazardous by exhibiting 
any one of the previous five toxicity types.
    In accordance with the draft hazardous drugs policy and procedures, 
NIOSH uses FDA databases to identify new drug approvals and drugs with 
new safety warnings.
    Information pertaining to each new drug and drugs with new safety 
warnings is screened to determine whether a specific drug is 
potentially hazardous. Potentially hazardous drugs are those for which 
the manufacturer has provided special handling information intended to 
protect workers, or for which available toxicity information suggests 
that a drug may exhibit one of the types of toxicity in the NIOSH 
definition of a hazardous drug. Drugs for which insufficient toxicity 
information is available and drugs for which the available information 
suggests no toxic effect or a toxic effect that does not meet the NIOSH 
definition of a hazardous drug are not proposed for placement on the 
List and are not further considered. Drugs for which special handling 
information is available are published on the NIOSH website and 
proposed for placement on the List; these drugs are not further 
evaluated.
    Drugs for which the available information suggests that the drug 
exhibits one or more toxic effects that meet the NIOSH definition of a 
hazardous drug are further evaluated to determine whether the drug 
should be proposed for placement on the List. To conduct the evaluation 
of drugs for which information suggests a toxic effect, NIOSH may 
consult the following sources of information to determine whether each 
screened drug might exhibit at least one type of toxicity in the NIOSH 
definition of a hazardous drug:
    a. Information in the drug package insert;
    b. FDA information pertaining to new drug safety labeling changes; 
\11\
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    \11\ See https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/.
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    c. When available, relevant information about carcinogenicity from:
    (1) The National Toxicology Program (NTP) within the U.S. 
Department of Health and Human Services; \12\
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    \12\ NTP (National Toxicology Program, DHHS) [2016]. 14th report 
on carcinogens. Research Triangle Park, NC: U.S. Department of 
Health and Human Services, Public Health Service. See https://ntp.niehs.nih.gov/pubhealth/roc/index-1.html.
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    (2) U.S. Environmental Protection Agency (EPA); \13\
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    \13\ EPA (Environmental Protection Agency). Integrated Risk 
Information System (IRIS) Assessments. See https://cfpub.epa.gov/ncea/iris2/atoz.cfm.

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[[Page 6565]]

    (3) World Health Organization's International Agency for Research 
on Cancer (IARC); \14\ and
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    \14\ IARC Monographs on the Evaluation of Carcinogenic Risks to 
Humans, Lyon, France. See http://monographs.iarc.fr/ENG/Classification/index.php.
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    (4) NIOSH.\15\
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    \15\ NIOSH Carcinogen List. See https://www.cdc.gov/niosh/topics/cancer/npotocca.html.
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    d. When available, relevant information about reproductive 
toxicity, teratogenicity, or developmental toxicity from the NTP Center 
for the Evaluation of Risks to Human Reproduction (CERHR), and from its 
successor, the Office of Health Assessment and Translation (OHAT);
    e. When available, published, peer-reviewed scientific literature 
about the hazard potential of a particular drug for workers in a 
healthcare setting, including any relevant studies cited in the drug 
package insert; and
    f. When available, toxicity information from Safety Data Sheets 
(SDSs) provided by the manufacturer.
    Reviewing the available human, animal, and in vitro data from those 
sources, NIOSH uses criteria included in the hazardous drugs policy and 
procedures to determine whether the available evidence demonstrates or 
supports any of the types of toxicity in the NIOSH definition of a 
hazardous drug. NIOSH makes an initial determination about each drug 
and then requests review and comment from independent peer reviewers.
    After consideration of the peer reviews, NIOSH sorts all screened 
and evaluated drugs into one of five categories:

 Category 1--Special handling information
 Category 2--Insufficient toxicity information available to 
meet the NIOSH definition of a hazardous drug
 Category 3--Available information shows no toxic effect or 
shows a toxic effect that does not meet the NIOSH definition of a 
hazardous drug
 Category 4--Available toxicity information demonstrates or 
supports a determination that the drug does not meet the NIOSH 
definition of a hazardous drug
 Category 5--Available toxicity information demonstrates or 
supports a determination that the drug meets the NIOSH definition of a 
hazardous drug

    The categorized drugs are identified in a Federal Register notice 
available for public and stakeholder comment for 60 days.
    After consideration of all public and stakeholder comments 
received, NIOSH makes a final determination about the disposition of 
all identified drugs and publishes a notice in the Federal Register 
announcing publication of the NIOSH List of Antineoplastic and Other 
Hazardous Drugs in Healthcare Settings, 2018 on the NIOSH website.

IV. Identifying Potentially Hazardous Drugs

    Consistent with the hazardous drugs policy and procedures described 
above, NIOSH consulted two FDA databases on a monthly basis since the 
2016 Update to identify newly-approved drugs and biologics \16\ and 
already-approved drugs for which the manufacturer has issued a new 
safety warning.\17\ Through the monthly FDA database search, conducted 
from January 2014 through December 2015, NIOSH identified 74 new drugs 
that had received FDA approval and 199 drugs with new safety warnings. 
In addition to the drugs identified by the FDA database searches, the 
NIOSH Director received a request to evaluate two drugs, 
dihydroergotamine and isotretinoin, for placement on the List by an 
interested party. In sum, 275 drugs were identified between January 
2014 and December 2015 and screened.
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    \16\ [email protected]: FDA Approved Drug Products. https://www.accessdata.fda.gov/scripts/cder/daf/.
    \17\ Drug Safety Labeling Changes. https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/.
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V. Screening of Potentially Hazardous Drugs

    Upon identification by NIOSH, each drug was screened to determine 
whether the manufacturer specified special handling information in the 
package insert or if information in the package insert suggests that a 
drug may exhibit at least one of the types of toxicity in the NIOSH 
definition of a hazardous drug. For 18 drugs, existing toxicity 
information did not support placement on the List (see Table 1) and for 
211 drugs and combination drugs, the available information suggests no 
toxic effect or a toxic effect that does not meet the NIOSH definition 
of a hazardous drug (see Table 2); those drugs are not proposed for 
placement on the List.

         Table 1--Insufficient Toxicity Information Available To Meet NIOSH Definition of Hazardous Drug
                                                  [Category 2]
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Belimumab                             Dinutuximab                           Protriptyline
Betamethasone                         Elosulfase                            Sebelipase alfa
Cholic acid                           Mepolizumab                           Secukinumab
Daratumumab                           Obinutuzumab                          Siltuximab
Desipramine                           Omalizumab                            Vedolizumab
Dexamethasone                         Pegaspargase                          Velaglucerase
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 Table 2--Available Information Shows a Toxic Effect That Does Not Meet
                 the NIOSH Definition of Hazardous Drug
                              [Category 3]
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Abatacept          Desvenlafaxine     Ketoconazole      Rasagiline
Aclidinium         Dexlansoprazole    Lamivudine        Regadenosone
Adalimumab         Diclofenac         Lansoprazole      Rifaximin
Adenosine          Diltiazem          Ledipasvir/       Rilpivirine
                                       Sofosbuvir
Aflibercept        Dimethyl fumarate  Lesinurad         Risedronate
Albiglutide        Dolasetron         Levetiracetam     Rivaroxaban
Alcaftadine        Doripenem          Levomilnacipran   Rivastigmine
Alirocumab         Doxazosin          Linaclotide       Rocuronium
Almotriptan        Doxepin            Linagliptin       Rolapitant
Anagrelide         Doxycycline        Lincomycin        Ropinirole
Apixaban           Droxidopa          Lisinopril        Rufinamide

[[Page 6566]]

 
Aripiprazole       Dulaglutide        Losartan          Ruxolitinib
Asenapine          Duloxetine         Lovastatin        Sacubitril/
                                                         Valsartan
Asparaginase       Edoxaban           Lumacaftor/       Sapropterin
 erwinia                               Ivacaftor
Avanafil           Efavirenz          Maraviroc         Saquinavir
Baclofen           Efinaconazole      Methadone         Saxagliptin
Beclomethasone     Eliglustat         Methoxy           Selegiline
                                       polyethylene
                                       glycol-epoetin
                                       beta
Bedaquiline        Eltrombopag        Methylphenidate   Selexipag
Benazepril         Eluxadoline        Methylprednisolo  Sertraline
                                       ne
Bimatoprost        Empagliflozin      Minocycline       Sildenafil
Boceprevir         Escitalopram       Mirabegron        Simeprevir
Brexpiprazole      Esomeprazole       Mirtazapine       Simvastatin
Bupivacaine        Etidronate         Morphine          Sitagliptin
Buprenorphine      Evolocumab         Moxifloxacin      Sofosbuvir
Bupropion          Ezopiclone         Naloxegol         Somatropin
Calcitonin         Fentanyl           Natalizumab       Sugammadex
Canagliflozin      Ferumoxytol        Necitumumab       Sulfasalazine
Canakinumab        Filgrastim         Netupitant/       Sulfur
                                       Palonosetron      hexafluoride
                                                         lipid type-A
Cangrelor          Flibanserin        Nivolumab         Suvorexant
Captopril          Fluoxetine         Nortriptyline     Tadalafil
Carbidopa          Fluvoxamine        Olanzapine        Taligucerase
Cariprazine        Fondaparinux       Olodaterol        Tamsulosin
Cefepime           Gabapentin         Omeprazole        Tapentadol
Cefoperazone       Galantamine        Ondasetron        Tavaborole
Ceftazidime/       Gemfibrozil        Oritavancin       Tedizolide
 Avibactam
Ceftriaxone        Granisetron        Oxybutynin        Telithromycin
Cinacalcet         Hydrocodone        Oxycodone         Telmisartan
Citalopram         Hydrocortisone     Oxymorphone       Ticagrelor
Clindamycin        Hydromorphone      Palbociclib       Tolvaptan
Clomipramine       Ibandronate        Palonosetron      Trazodone
Clozapine          Ibrutinib          Panitumumab       Triamcinolone
Collagenase        Imipramine         Pantoprazole      Trimipramine
 clostridium
 histolytica
Dabigatran         Infliximab         Paricalcitol      Trypan blue
Daclatasvir        Ingenol            Pegfilgrastim     Uridine
Dalbavancin        Insulin degludec   Peginterferon     Vardenafil
                                       alpha-2A
Dalteparin         Insulin glargine   Peginterferon     Varenicline
                                       alpha-2B
Dapagliflozin      Insulin glulisine  Pembrolizumab     Venlafaxine
Dapsone            Interferon alfa-   Peramivir         Vigabatrin
                    2b
Daptomycin         Interferon beta-   Pramlintide       Vilazodone
                    1a
Darunavir          Interferon gamma-  Prazosin          Vorapaxar
                    1b
Deferasirox        Ipilimumab         Rabeprazole       Vortioxetine
Denosumab          Ivacaftor          Ramipril          Zolpidem
Deoxycholic acid   Ivermectin         Ramucirumab
------------------------------------------------------------------------

    Finally, the information available for 44 drugs suggests one or 
more toxic effects; those drugs were evaluated by NIOSH, as discussed 
below, and were shared with peer reviewers and stakeholders.\18\
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    \18\ Historically, NIOSH has conducted peer review and 
stakeholder review concurrently, prior to publication of the list of 
drugs proposed for addition to the List. Beginning with the 2020 
Update, NIOSH will conduct peer review prior to publication of the 
list of drugs proposed for addition, and will conduct public comment 
and stakeholder review concurrently.
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VI. Evaluation of Potentially Hazardous Drugs

    Consistent with the draft hazardous drugs policy and procedures, 
NIOSH evaluated the 44 drugs identified as potentially hazardous to 
determine whether each meets the NIOSH definition of a hazardous drug 
by exhibiting one or more of the following types of toxicity in humans, 
animal models, or in vitro systems: Carcinogenicity; teratogenicity or 
other developmental toxicity; reproductive toxicity; organ toxicity at 
low doses; genotoxicity; and/or a structure and toxicity profile of an 
isomer or close chemical analog of a drug on the List. Using criteria 
articulated in the draft hazardous drugs policy and procedures,\19\ 
NIOSH reviewed the available information and sought to determine 
whether the evidence for each drug either demonstrates or supports a 
determination of toxicity. Initial determinations were made about each 
evaluated drug and then the list of evaluated drugs was given to peer 
reviewers and stakeholders for additional evaluation.
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    \19\ See section VII.C.
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VII. Peer and Stakeholder Review of Potentially Hazardous Drugs

    NIOSH conducted peer and stakeholder review of all evaluated 
drugs.\20\ Four independent peer reviewers and eight stakeholders 
reviewed and commented on the 44 drugs. De-identified peer and 
stakeholder reviews will be placed in the docket for this action.
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    \20\ See https://www.cdc.gov/niosh/review/peer/isi/hazdrug2018-pr.html for the charge to peer reviewers.
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VIII. Evaluated Drugs That Do Not Meet the NIOSH Definition of a 
Hazardous Drug

    After consideration of the peer and stakeholder reviews, NIOSH 
determined that the available toxicity information for 23 drugs does 
not meet the NIOSH definition of a hazardous drug (Category

[[Page 6567]]

4). These drugs are not proposed for placement on the List and are 
identified in Table 3.

 Table 3--Available Toxicity Information Does Not Demonstrate or Support
 a Determination That the Drug Meets the NIOSH Definition of a Hazardous
                                  Drug
                              [Category 4]
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------------------------------------------------------------------------
Aglucosidase                  Diazoxide             Lanreotide
Alectinib                     Elotuzumab            Metreleptin
Alendronate                   Finafloxacin          Milnacipran
Alogliptin                    Golimumab             Nintedanib
Apremilast                    Idelalisib            Peginterferon beta-
                                                     1A
Calcipotriene                 Isavuconazonium       Pirfenidone
Cetuximab                     Itraconazole          Tasimelteon
Clarithromycin                Lamotrigine
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IX. Drugs Proposed for Placement on the NIOSH List of Hazardous Drugs

    NIOSH determined that the available toxicity information for 20 
drugs and one class of drug demonstrates or supports a NIOSH 
determination that they meet the NIOSH definition of a hazardous drug 
are proposed for placement on the List (Category 5). These drugs are 
proposed for placement on the list and are identified in Table 4.
    Two additional drugs have special handling information specified by 
the manufacturer and are proposed for placement on the List (see Table 
4).\21\
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    \21\ The manufacturers of trabectedin and inotuzumab ozogamicin 
added special handling information to the package inserts after 
publication of the 2016 Update. Although these drugs have been 
categorized by NIOSH as ``hazardous'' since April 10, 2017, they 
will be formally added to the 2018 Update unless compelling evidence 
in support of not placing them on the List is offered by public 
commenters. See https://www.cdc.gov/niosh/docs/2016-161/default.html.

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X. Drugs Removed From the NIOSH List of Hazardous Drugs

    In a petition to NIOSH in February 2017, the pharmaceutical company 
Theravance Biopharma requested the removal of the drug telavancin from 
the NIOSH List of Antineoplastic and Other Hazardous Drugs in 
Healthcare Settings.\22\ The petition included an analysis of animal 
developmental toxicity studies and argued that ``[p]lacing telavancin 
in the NIOSH category of a hazardous drug greatly overstates the 
occupational risk to healthcare workers handling telavancin.'' In 
response, NIOSH evaluated the information provided in the petition as 
well as other sources provided to NIOSH by the manufacturer and 
determined that telavancin does not meet the NIOSH definition of a 
hazardous drug. NIOSH informed users of the 2016 List of this 
determination via a web posting and responded to Theravance Biopharma 
with a letter dated April 12, 2017.\23\ Accordingly, telavancin does 
not appear in the 2018 update to the NIOSH List of Antineoplastic and 
Other Hazardous Drugs in Healthcare Settings. This decision is 
considered final.
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    \22\ Harstad EB and Coleman R. Petition of Theravance Biopharma 
US, Inc. to Remove Telavancin from the NIOSH List of Antineoplastic 
and Other Hazardous Drugs in Healthcare Settings. February 28, 2017.
    \23\ NIOSH letter to Eric Harstad and Rebecca Coleman. April 12, 
2017.
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XI. Final List of Drugs Proposed for Placement on the NIOSH List of 
Hazardous Drugs

    After consideration of all public comments received in the docket 
for this action, NIOSH will develop a final list of drugs to be placed 
on the NIOSH List of Antineoplastic and Other Hazardous Drugs in 
Healthcare Settings, 2018. The 2018 Update will be published on the 
NIOSH website and announced in a Federal Register notice.

    Dated: February 8, 2018.
John Howard,
Director, National Institute for Occupational Safety and Health, 
Centers for Disease Control and Prevention.
[FR Doc. 2018-02957 Filed 2-13-18; 8:45 am]
 BILLING CODE 4163-19-P