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Wireless Telecommunications Bureau Signed: DEPARTMENT OF HEALTH AND and Wireline Competition Bureau (the Dayna C. Brown, HUMAN SERVICES Bureaus) may implement, and (3) certify Secretary and Clerk of the Commission. Centers for Disease Control and its challenge. The USAC system will [FR Doc. 2018–03166 Filed 2–12–18; 4:15 pm] validate a challenger’s evidence using Prevention BILLING CODE 6715–01–P an automated challenge validation [CDC–2018–0004; NIOSH–233–B] process. Once all valid challenges have been identified, a challenged party that NIOSH List of Antineoplastic and Other chooses to respond to any valid FEDERAL RESERVE SYSTEM Hazardous Drugs in Healthcare challenge(s) may submit additional data Settings: Proposed Additions to the via the online USAC portal during the Change in Bank Control Notices; NIOSH Hazardous Drug List 2018 established response window. A Acquisitions of Shares of a Bank or AGENCY: Centers for Disease Control and challenged party may submit technical Bank Holding Company information that is probative regarding Prevention, HHS. ACTION: Notice of draft document the validity of a challenger’s speed tests, The notificants listed below have available for public comment. including speed test data and other applied under the Change in Bank device-specific data collected from Control Act (12 U.S.C. 1817(j)) and transmitter monitoring software or, SUMMARY: The National Institute for § 225.41 of the Board’s Regulation Y (12 alternatively, may submit its own speed Occupational Safety and Health test data that conforms to the same CFR 225.41) to acquire shares of a bank (NIOSH) of the Centers for Disease standards and requirements specified by or bank holding company. The factors Control and Prevention (CDC) the Commission and the Bureaus for that are considered in acting on the announces the availability for public challengers. notices are set forth in paragraph 7 of comment on the drugs proposed for the Act (12 U.S.C. 1817(j)(7)). placement on the NIOSH List of In conjunction with the qualified 4G The notices are available for Antineoplastic and Other Hazardous LTE data separately collected pursuant Drugs in Healthcare Settings, 2018 immediate inspection at the Federal to OMB 3060–1242 that will be used to (List), as well as the NIOSH Policy and Reserve Bank indicated. The notices create the map of areas presumptively Procedures for Developing the NIOSH also will be available for inspection at eligible for MF–II support, the List of Antineoplastic and Other information collected under this MF–II the offices of the Board of Governors. Hazardous Drugs in Healthcare Settings. challenge process collection will enable Interested persons may express their DATES: Comments must be received by the Commission to efficiently resolve views in writing to the Reserve Bank April 16, 2018. disputes concerning the eligibility or indicated for that notice or to the offices ineligibility of an area initially deemed of the Board of Governors. Comments ADDRESSES: Comments may be ineligible for MF–II support and must be received not later than March submitted, identified by docket numbers CDC–2018–0004 and NIOSH–233–B, by establish the final map of areas eligible 7, 2018. for such support, thereby furthering the either of the following two methods: A. Federal Reserve Bank of Atlanta • Commission’s goal of targeting MF–II Federal eRulemaking Portal: support to areas that lack adequate (Kathryn Haney, Director of www.regulations.gov. Follow the mobile voice and broadband coverage Applications) 1000 Peachtree Street NE, instructions for submitting comments. • absent subsidies through a transparent Atlanta, Georgia 30309. Comments can Mail: NIOSH Docket Office, Robert process. also be sent electronically to A. Taft Laboratories, MS–C34, 1090 [email protected]: Tusculum Avenue, Cincinnati, OH The Commission received approval 45226–1998. from OMB for the information collection 1. Brandt J. Dufrene, Sr., individually Instructions: All information received requirements contained in OMB 3060– and as trustee for The FSC Trust No. 1, in response to this notice must include 1251 on February 7, 2018. and Brandt J. Dufrene, Jr., individually the agency name and the docket and as the trustee for The FSC Trust No. Federal Communications Commission. numbers (CDC–2018–0004; NIOSH– 2 and the Brandt J. Dufrene, Jr. Trust Marlene H. Dortch, 233–B). All relevant comments received No. 1, all of Metairie, Louisiana; to Secretary, Office of the Secretary. will be posted without change to retain voting shares of First St. Charles [FR Doc. 2018–03000 Filed 2–13–18; 8:45 am] www.regulations.gov, including any Bancshares, Inc., and thereby indirectly personal information provided. BILLING CODE 6712–01–P retain First National Bank USA, both FOR FURTHER INFORMATION CONTACT: Boutte, Louisiana. Barbara MacKenzie, NIOSH, Robert A. Board of Governors of the Federal Reserve Taft Laboratories, 1090 Tusculum FEDERAL ELECTION COMMISSION System, February 9, 2018. Avenue, MS–C26, Cincinnati, OH Ann E. Misback, 45226, telephone (513) 533–8132 (not a Sunshine Act Meeting Secretary of the Board. toll free number), Email: [FR Doc. 2018–03082 Filed 2–13–18; 8:45 am] [email protected]. TIME AND DATE: Thursday, February 15, SUPPLEMENTARY INFORMATION: 2018 at 10:00 a.m. BILLING CODE P I. Public Participation PLACE: 999 E Street NW, Washington, DC (Ninth Floor). Interested parties are invited to participate in this action by submitting STATUS: This Meeting, open to the written views, opinions, public, has been cancelled. recommendation, and/or data. CONTACT PERSON FOR MORE INFORMATION: Comments are invited on any topic Judith Ingram, Press Officer, Telephone: related to the drugs identified in this (202) 694–1220. notice, including those evaluated for

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placement on the NIOSH List of Other Hazardous Drugs in Healthcare In accordance with the draft Antineoplastic and Other Hazardous Settings, to formalize the methodology hazardous drugs policy and procedures, Drugs in Healthcare Settings, 2018. NIOSH uses to guide the addition of NIOSH uses FDA databases to identify NIOSH also seeks comment on the draft hazardous drugs to the List (see https:// new drug approvals and drugs with new Policy and Procedures for Developing www.cdc.gov/niosh/topics/hazdrug/ safety warnings. the NIOSH List of Antineoplastic and default.html). The draft document Information pertaining to each new Other Hazardous Drugs in Healthcare clarifies and details the purpose of the drug and drugs with new safety Settings, available in the docket for this List, which is to assist employers in warnings is screened to determine action. NIOSH invites comments providing safe and healthful workplaces whether a specific drug is potentially specifically on the following questions by offering a list of drugs that meet the hazardous. Potentially hazardous drugs related to this action: NIOSH definition of a hazardous drug, are those for which the manufacturer 1. Has NIOSH appropriately identified and sets out the procedures used by has provided special handling and categorized the drugs considered for NIOSH to identify such drugs. The draft information intended to protect placement on the NIOSH List of policy and procedures will be finalized workers, or for which available toxicity Antineoplastic and Other Hazardous after consideration of comments to this information suggests that a drug may Drugs in Healthcare Settings, 2018? 6 docket and from peer reviewers. exhibit one of the types of toxicity in the 2. Is information available from FDA According to the draft hazardous or other Federal agencies or in the NIOSH definition of a hazardous drug. drugs policy and procedures, NIOSH Drugs for which insufficient toxicity published, peer-reviewed scientific defines a hazardous drug as a drug that literature about a specific drug or drugs information is available and drugs for is: which the available information identified in this notice that would 1. Approved for use in humans 7 by justify the reconsideration of NIOSH’s suggests no toxic effect or a toxic effect the FDA; 8 and that does not meet the NIOSH definition categorization decision? 2. Not otherwise regulated by the U.S. 3. Does the draft Policy and of a hazardous drug are not proposed for Nuclear Regulatory Commission; 9 and Procedures for Developing the NIOSH placement on the List and are not 3. Either: List of Antineoplastic and Other further considered. Drugs for which a. Accompanied by prescribing special handling information is Hazardous Drugs in Healthcare Settings 10 include a methodology for reviewing information in the ‘‘package insert’’ available are published on the NIOSH toxicity information that is appropriate that includes special handling website and proposed for placement on for this activity? information to protect workers handling the List; these drugs are not further the drug; or evaluated. II. Background b. Exhibits one or more of the Drugs for which the available In September 2004, NIOSH published following types of toxicity in humans, information suggests that the drug NIOSH Alert: Preventing Occupational animal models, or in vitro systems: exhibits one or more toxic effects that Exposures to Antineoplastic and Other Carcinogenicity; teratogenicity or other meet the NIOSH definition of a Hazardous Drugs in Health Care developmental toxicity; reproductive hazardous drug are further evaluated to Settings (Alert).1 The 2004 Alert set out toxicity; organ toxicity at low doses; determine whether the drug should be a general NIOSH policy for the genotoxicity; or structure and toxicity proposed for placement on the List. To identification of hazardous drugs and profile that mimics existing drugs conduct the evaluation of drugs for contained examples of U.S. Food and determined hazardous by exhibiting any which information suggests a toxic Drug Administration (FDA)-approved one of the previous five toxicity types. effect, NIOSH may consult the following drugs that were deemed to be hazardous sources of information to determine to workers in health care and other 6 See https://www.cdc.gov/niosh/topics/hazdrug/ whether each screened drug might peer-review-plan.html for the charge to peer settings and may require special exhibit at least one type of toxicity in handling. This initial list of hazardous reviewers. 7 Although only drugs approved by the FDA for the NIOSH definition of a hazardous 2 3 drugs was updated in 2010, 2012, use in humans are included in the definition of a drug: 2014,4 and 2016.5 The latest hazardous drug, some of those drugs may be used publication, entitled NIOSH List of in veterinary settings for treatment of animals and a. Information in the drug package Antineoplastic and Other Hazardous may be a hazard for veterinary care workers. insert; 8 21 U.S.C. 301 et seq. b. FDA information pertaining to new Drugs in Healthcare Settings, 2016 9 10 CFR parts 19, 20, and 35. See https:// drug safety labeling changes; 11 (2016 Update), covered all new www.nrc.gov/materials/miau/med-use.html. approved drugs and drugs with new 10 See Drug Advertising: A Glossary of Terms at c. When available, relevant warnings through December 2013. https://www.fda.gov/drugs/resourcesforyou/ information about carcinogenicity from: consumers/prescriptiondrugadvertising/ III. Policy and Procedures for ucm072025.htm. ‘‘Prescribing information is also (1) The National Toxicology Program Developing the NIOSH List of called product information, product labeling, or the (NTP) within the U.S. Department of Antineoplastic and Other Hazardous package insert (‘‘the PI’’). It is generally drafted by Health and Human Services; 12 the drug company and approved by the FDA. This Drugs in Healthcare Settings information travels with a drug as it moves from the (2) U.S. Environmental Protection The NIOSH Director has developed company to the pharmacist. It includes the details Agency (EPA); 13 and directions healthcare providers need to draft policy and procedures, entitled prescribe the drug properly. It is also the basis for Policy and Procedures for Developing how the drug company can advertise its drug. The 11 See https://www.accessdata.fda.gov/scripts/ the NIOSH List of Antineoplastic and prescribing information includes such details about cder/safetylabelingchanges/. the drug as: Its chemical description; how it works; 12 NTP (National Toxicology Program, DHHS) how it interacts with other drugs, supplements, [2016]. 14th report on carcinogens. Research 1 See https://www.cdc.gov/niosh/docs/2004-165/. foods, and beverages; what condition(s) or Triangle Park, NC: U.S. Department of Health and 2 See https://www.cdc.gov/niosh/docs/2010-167/. disease(s) it treats; who should not use the drug; Human Services, Public Health Service. See https:// 3 See https://www.cdc.gov/niosh/docs/2012-150/. serious side effects, even if they occur rarely; ntp.niehs.nih.gov/pubhealth/roc/index-1.html. 4 See https://www.cdc.gov/niosh/docs/2014-138/ commonly occurring side effects, even if they are 13 EPA (Environmental Protection Agency). default.html. not serious; effects on specific groups of patients, Integrated Risk Information System (IRIS) 5 See https://www.cdc.gov/niosh/docs/2016-161/ such as children, pregnant women, or older adults Assessments. See https://cfpub.epa.gov/ncea/iris2/ default.html. and how to use it in these populations.’’ atoz.cfm.

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(3) World Health Organization’s • Category 1—Special handling to identify newly-approved drugs and International Agency for Research on information biologics 16 and already-approved drugs Cancer (IARC); 14 and • Category 2—Insufficient toxicity for which the manufacturer has issued (4) NIOSH.15 information available to meet the a new safety warning.17 Through the NIOSH definition of a hazardous drug monthly FDA database search, d. When available, relevant • Category 3—Available information information about reproductive toxicity, conducted from January 2014 through shows no toxic effect or shows a toxic December 2015, NIOSH identified 74 teratogenicity, or developmental toxicity effect that does not meet the NIOSH from the NTP Center for the Evaluation new drugs that had received FDA definition of a hazardous drug approval and 199 drugs with new safety of Risks to Human Reproduction • Category 4—Available toxicity (CERHR), and from its successor, the warnings. In addition to the drugs information demonstrates or supports identified by the FDA database searches, Office of Health Assessment and a determination that the drug does not Translation (OHAT); the NIOSH Director received a request meet the NIOSH definition of a to evaluate two drugs, e. When available, published, peer- hazardous drug • dihydroergotamine and isotretinoin, for reviewed scientific literature about the Category 5—Available toxicity placement on the List by an interested hazard potential of a particular drug for information demonstrates or supports party. In sum, 275 drugs were identified workers in a healthcare setting, a determination that the drug meets between January 2014 and December the NIOSH definition of a hazardous including any relevant studies cited in 2015 and screened. the drug package insert; and drug f. When available, toxicity The categorized drugs are identified V. Screening of Potentially Hazardous information from Safety Data Sheets in a Federal Register notice available for Drugs (SDSs) provided by the manufacturer. public and stakeholder comment for 60 days. Upon identification by NIOSH, each Reviewing the available human, After consideration of all public and drug was screened to determine whether animal, and in vitro data from those stakeholder comments received, NIOSH the manufacturer specified special sources, NIOSH uses criteria included makes a final determination about the handling information in the package in the hazardous drugs policy and disposition of all identified drugs and insert or if information in the package procedures to determine whether the publishes a notice in the Federal insert suggests that a drug may exhibit available evidence demonstrates or Register announcing publication of the at least one of the types of toxicity in the supports any of the types of toxicity in NIOSH List of Antineoplastic and Other NIOSH definition of a hazardous drug. the NIOSH definition of a hazardous Hazardous Drugs in Healthcare Settings, For 18 drugs, existing toxicity drug. NIOSH makes an initial 2018 on the NIOSH website. information did not support placement determination about each drug and then on the List (see Table 1) and for 211 requests review and comment from IV. Identifying Potentially Hazardous drugs and combination drugs, the independent peer reviewers. Drugs available information suggests no toxic After consideration of the peer Consistent with the hazardous drugs effect or a toxic effect that does not meet reviews, NIOSH sorts all screened and policy and procedures described above, the NIOSH definition of a hazardous evaluated drugs into one of five NIOSH consulted two FDA databases on drug (see Table 2); those drugs are not categories: a monthly basis since the 2016 Update proposed for placement on the List.

TABLE 1—INSUFFICIENT TOXICITY INFORMATION AVAILABLE TO MEET NIOSH DEFINITION OF HAZARDOUS DRUG [Category 2]

Belimumab Protriptyline Betamethasone Elosulfase Sebelipase alfa Cholic acid Desipramine Dexamethasone Pegaspargase Velaglucerase

TABLE 2—AVAILABLE INFORMATION SHOWS A TOXIC EFFECT THAT DOES NOT MEET THE NIOSH DEFINITION OF HAZARDOUS DRUG [Category 3]

Abatacept Desvenlafaxine Rasagiline Aclidinium Dexlansoprazole Lamivudine Regadenosone Diclofenac Lansoprazole Rifaximin Adenosine Diltiazem Ledipasvir/Sofosbuvir Rilpivirine 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

14 IARC Monographs on the Evaluation of 15 NIOSH Carcinogen List. See https:// 17 Drug Safety Labeling Changes. https:// Carcinogenic Risks to Humans, Lyon, France. See www.cdc.gov/niosh/topics/cancer/npotocca.html. www.accessdata.fda.gov/scripts/cder/safety http://monographs.iarc.fr/ENG/Classification/ 16 Drugs@FDA: FDA Approved Drug Products. labelingchanges/. index.php. https://www.accessdata.fda.gov/scripts/cder/daf/.

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TABLE 2—AVAILABLE INFORMATION SHOWS A TOXIC EFFECT THAT DOES NOT MEET THE NIOSH DEFINITION OF HAZARDOUS DRUG—Continued [Category 3] Aripiprazole Dulaglutide Losartan Asenapine Duloxetine Lovastatin Sacubitril/Valsartan Asparaginase erwinia Edoxaban Lumacaftor/Ivacaftor Sapropterin Avanafil Efavirenz Maraviroc Saquinavir Baclofen Efinaconazole Methadone Saxagliptin Beclomethasone Eliglustat Methoxy polyethylene glycol- Selegiline epoetin beta Bedaquiline Eltrombopag Methylphenidate Selexipag Benazepril Eluxadoline Methylprednisolone Sertraline 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 Sugammadex Canagliflozin Ferumoxytol Sulfasalazine Filgrastim Netupitant/Palonosetron Sulfur hexafluoride lipid type-A Cangrelor Flibanserin Suvorexant Captopril Fluoxetine Nortriptyline Tadalafil Carbidopa Fluvoxamine Olanzapine Taligucerase Cariprazine Fondaparinux Olodaterol Tamsulosin Cefepime Gabapentin Omeprazole Tapentadol Cefoperazone Galantamine Ondasetron Ceftazidime/Avibactam Gemfibrozil Oritavancin Tedizolide Ceftriaxone Granisetron Oxybutynin Telithromycin Cinacalcet Hydrocodone Oxycodone Telmisartan Citalopram Hydrocortisone Oxymorphone Ticagrelor Clindamycin Hydromorphone Tolvaptan Clomipramine Ibandronate Palonosetron Trazodone Clozapine Triamcinolone Collagenase clostridium histolytica Imipramine Pantoprazole Trimipramine Dabigatran Paricalcitol Trypan blue Daclatasvir Ingenol Pegfilgrastim Uridine Dalbavancin Insulin degludec Peginterferon alpha-2A Vardenafil Dalteparin Insulin glargine Peginterferon alpha-2B Varenicline Dapagliflozin Insulin glulisine Venlafaxine alfa-2b Peramivir Vigabatrin Daptomycin Interferon beta-1a Pramlintide Vilazodone Darunavir Interferon gamma-1b Prazosin Vorapaxar Deferasirox Rabeprazole Vortioxetine Denosumab Ivacaftor Ramipril Zolpidem Deoxycholic acid Ivermectin

Finally, the information available for types of toxicity in humans, animal VII. Peer and Stakeholder Review of 44 drugs suggests one or more toxic models, or in vitro systems: Potentially Hazardous Drugs effects; those drugs were evaluated by Carcinogenicity; teratogenicity or other NIOSH conducted peer and NIOSH, as discussed below, and were developmental toxicity; reproductive stakeholder review of all evaluated shared with peer reviewers and toxicity; organ toxicity at low doses; drugs.20 Four independent peer stakeholders.18 genotoxicity; and/or a structure and reviewers and eight stakeholders VI. Evaluation of Potentially Hazardous toxicity profile of an isomer or close reviewed and commented on the 44 Drugs chemical analog of a drug on the List. drugs. De-identified peer and Consistent with the draft hazardous Using criteria articulated in the draft stakeholder reviews will be placed in drugs policy and procedures, NIOSH hazardous drugs policy and the docket for this action. procedures,19 NIOSH reviewed the evaluated the 44 drugs identified as VIII. Evaluated Drugs That Do Not Meet available information and sought to potentially hazardous to determine the NIOSH Definition of a Hazardous determine whether the evidence for whether each meets the NIOSH Drug definition of a hazardous drug by each drug either demonstrates or exhibiting one or more of the following supports a determination of toxicity. After consideration of the peer and Initial determinations were made about stakeholder reviews, NIOSH determined 18 Historically, NIOSH has conducted peer review each evaluated drug and then the list of that the available toxicity information and stakeholder review concurrently, prior to evaluated drugs was given to peer for 23 drugs does not meet the NIOSH publication of the list of drugs proposed for definition of a hazardous drug (Category addition to the List. Beginning with the 2020 reviewers and stakeholders for Update, NIOSH will conduct peer review prior to additional evaluation. publication of the list of drugs proposed for 20 See https://www.cdc.gov/niosh/review/peer/isi/ addition, and will conduct public comment and hazdrug2018-pr.html for the charge to peer stakeholder review concurrently. 19 See section VII.C. reviewers.

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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]

Aglucosidase Diazoxide Lanreotide Metreleptin Alendronate Finafloxacin Milnacipran Alogliptin Idelalisib Peginterferon beta-1A Calcipotriene Tasimelteon Clarithromycin Lamotrigine

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

BILLING CODE 4163–19–P

21 The manufacturers of trabectedin and categorized by NIOSH as ‘‘hazardous’’ since April commenters. See https://www.cdc.gov/niosh/docs/ added special handling 10, 2017, they will be formally added to the 2018 2016-161/default.html. information to the package inserts after publication Update unless compelling evidence in support of of the 2016 Update. Although these drugs have been not placing them on the List is offered by public

daltland on DSKBBV9HB2PROD with NOTICES VerDate Sep<11>2014 23:19 Feb 13, 2018 Jkt 244001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 E:\FR\FM\14FEN1.SGM 14FEN1 6568 Federal Register / Vol. 83, No. 31 / Wednesday, February 14, 2018 / Notices fetal in in Drug) human in at doses embryo-fetal developmental other developmental low doses Healthcare or reductions embryo-fetal at low in trials, List List List List List other other Hazardous milk at ossification or harm .or of the the the the the effects, toxicity: on on on on on .clinical Drugs other breast in toxin skeletal Teratogenicity rabbits of and neurotoxicity fetal Definition and and human ecb830aa Teratogenicity Teratogenicity patients in Placement Placement Placement Placement Placement spread developmental in rats Hazardous and and mortality doses: doses in 7-5031 NIOSH studies other decreased low low present failure Other toxicity: or the at at toxicity doses toxicity and Proposing Proposing Proposing Proposing Proposing clinical and rabbits low for for for rabbits, for for in ovarian embryo-fetal Insert Insert Insert Insert in at Meets toxicity toxicity weight and Drug Reproductive https://dailymed.nlm.nih.gov/dailymed/druglnfo.cfm?setid=939b5 d1f-9fb2-4499-80ef-0607aa6b114e toxicity: toxicity Teratogenicity Organ https://dailymed.nlm.nih.gov/dailymed/druglnfo.cfm?setid=38b48 https://dailymed.nlm.nih.gov/dailymed/druglnfo.cfm?setid=fff5d8 patients Organ 05-4ffd-4e8e-8e63-6f129697563e Reproductive body https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all& rats 2a8-960b-4591-985 dose developmental toxicity: toxicity query=botufinum+toxin+type+A&pagesize=200&page=1* Rationale Package Rationale Package -- Package Package Rationale Rationale Rationale 5 1 1 1 2 IV 1V IM No Antineoplastic No mg No No No Yes Yes Yes units of mg/kg mg/kg 750 ...... Capsule meg/day 20 ,, ...... 9 : Category Neurotoxin List S-15 suspension Antiepileptic 1-1000 & Antineoplastic Antineoplastic Antineoplastic oral ...... NIOSH ...... Tablet, c the ...... Information on :·········································No No No No.e No lnformationd lnformation lnformation Information ...... Table Table Table Table ...... 3 ...... Handling ...... Placement ...... Handling Handling Handling Handling ...... Class~> Class Class Class Ctass Update Update Update Update Drug Drug Drug Drugc Drug for Special New Dosage Dosage New Formulation Formulation 2018 2018 2018 New Dosage: New Formulation Formulation Formulation Special Special Special New Dosage Dosage AHFS AHFS AHFS AHFS Special AHFS .2018 -- 1 Proposed Name toxins, including Drugs (Category Drug 4. forms OnabotulinumtoxinA Generic Clobazam Botulinum all and AbobotulinimtoxinA Settings Table

daltland on DSKBBV9HB2PROD with NOTICES VerDate Sep<11>2014 22:07 Feb 13, 2018 Jkt 244001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4725 E:\FR\FM\14FEN1.SGM 14FEN1 EN14FE18.000 Federal Register / Vol. 83, No. 31 / Wednesday, February 14, 2018 / Notices 6569 in effects litter offspring in cancers in fetal fetal disposal total cytotoxic, developmental is doses and cfm?setid=Ofd36 cfm?setid=de03b and weight several low List List List List list developmental adverse other of drug loss Info. Info. including at or body the the the the the other handling loss, on on on on on or studies; c rat recurrence reduced bde6 properties information: OSHA in or * Teratogenicity fd3e9571 post-implantation Placement Placement Placement rabbits Placement Placement .gov/dailymed/drug cancer; oxytocic tumors handling and nih.govldailymed/drug nih Teratogenicity and applicable e-73f93ac1 with post-implantation doses; * humans progression nlm. and .nlm. rats C-cell in -93c9-8530865db3f9 special low toxicity toxicity: follow in Proposing Proposing Proposing Proposing Proposing at mice patients for for for for for increased thyroid Insert Insert Insert Insert Insert Insert of rats and doses should in low rats users loss https://dailymed.nlm.nih.gov/dailymed/druglnfo.cfm?setid=c3875 https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all& humans malformations procedures Carcinogenicity: Carcinogenicity at Manufacturer 79e-cee0-4334-bd1 Reproductive Reproductive https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all& in https://dailymed cb9~c4f6:-4167 query=Dihydroergotamine toxicity: toxicity: https:/ldailymed. studies query=Exenatide d69-2dca-459c-93b4-541 Package Package Rationale Rationale Package Rationale Package Package Rationale Rationale Package 2 1 3 2 3 2 IV mg mg No No No No No No No No SQ SQ Yes .... .Yes .Yes : 1 spray 60 Tablet binder mg/m ...... IV, meg/kg , mg/week stimulator 2 ...... nasal Antidiabetic , Antineoplastic Antineoplastic O.S-0.8 receptor SQ, ...... , OAS-2,25 ...... IM, SHT ...... IV, , Erythropoiesis ...... : ...... : No No No No No lnformation lnformation lnformation lnformation lnformation Information Table Table Table Table Table ...... Handling Handling Handling Handling Handling Handling ...... Class Class Class Class Class Update Update Update Update Update Drug Drug Drug Orug .Drug New New Dosage Dosage Dosage Dosage New Formulation Formulation Formulation 2018 2018 2018 Oosage New New Formulation Formulation 2018 2018 Special Special Special Special AHFS AHFS AHFS AHFS Special Special AHFS alfa lnotuzumab Dihydroergotamine ozogamicin Darbepoetin Exenatide

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daltland on DSKBBV9HB2PROD with NOTICES VerDate Sep<11>2014 22:07 Feb 13, 2018 Jkt 244001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4725 E:\FR\FM\14FEN1.SGM 14FEN1 EN14FE18.002 Federal Register / Vol. 83, No. 31 / Wednesday, February 14, 2018 / Notices 6571 b a in rats in in disposal cytotoxic, leukemia other developmental spontaneous rats is post and or embryo-fetal patients in and in List List developmental List List List other offspring drug lnfo.cfm?setid=Se31 myeloid in or toxicity, the the the the the doses other handling death on on on on on pulmonary toxicity low or 7 growth at a2 Teratogenicity and 7 information: OSHA teratogenesis, neonatal and ddcd499 embryo-fetal Teratogenicity rabbits syndrome/acute reduced Placement Placement Placement Placement Placement and .gov/dailymed/drug cardiac developmentaltoxicity: in 72d6af0a handling and toxicity, doses nih Teratogenicity and applicable studies; malformations * other low nlm. doses and toxicity: or at special toxicity fol.low loss, Proposing Proposing Proposing Proposing low Proposing lethality clinical at -4b9d-90f4-9482c3aec9ff malformations for for for for for in e-4064-bff3-3 myelodysplastic embryo-fetal Insert Insert Insert Insert Insert and toxicity /dailymed. should -b971-45e1-9c31-29cea8c87ce b2-077 Teratogenicity Carcinogenicity Organ patients; implantation https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all& https://dailymed.nlm.nih.gov/dailymed/druglnfo.cfm?setid=492db https:/ patients abortions Reproductive 78e-be17 developmental procedures https://dailymed.nlm.nih.gov/dailymed/druglnfo.cfm?setid=Se81 users https://dailymed.nlm.nih.gov/dailymed/druglnfo.cfm?setid=472bd 4a7 query= d 6a9-864f-4aba-8085-37ee1 Manufacturer toxicity: toxicity: toxicity Package Rationale Package Package Rationale Package Package Rationale Rationale Rationale 2 1 1 1 1 1 IV IV mg mg mg No No No No No Yes Yes Yes .Yes .Yes mg/kg mg/m 80 Tablet Tablet ...... , 200 .400 ...... Capsule , 1.5 2-6 Antineoplastic Antineoplastic Antineoplastic Antineoplastic Antineoplastic ...... : ...... ·' No No No No No ...... : lnformation lnformation lnformation lnformation Information Table Table Table Table Table ...... Handling Handling Handling Handling Handling ...... Class Class Class Class Class Update Update Update Update Update Drug Drug Drug Drug Drug Dosage New Dosage Dosage Dosage New New Formulation Formulation 2018 2018 2018 2018 Dosage New New Formulation Formulation Formulation 2018 Special Special Special Special Special AHFS AHFS AHFS AHFS AHFS Trabectedin Triazolam Sonidegib

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BILLING CODE 4163–19–C published on the NIOSH website and Refugee cash assistance, refugee medical X. Drugs Removed From the NIOSH announced in a Federal Register notice. assistance, health screening, and List of Hazardous Drugs Dated: February 8, 2018. services for unaccompanied refugee John Howard, minors as well as by program In a petition to NIOSH in February administration. This breakdown of 2017, the pharmaceutical company Director, National Institute for Occupational Safety and Health, Centers for Disease Control financial status data on expenditures Theravance Biopharma requested the and Prevention. and obligations allows ORR to track removal of the drug telavancin from the [FR Doc. 2018–02957 Filed 2–13–18; 8:45 am] program expenditures in greater detail NIOSH List of Antineoplastic and Other BILLING CODE 4163–19–P to anticipate any funding issues and to Hazardous Drugs in Healthcare meet the requirements of ORR 22 Settings. The petition included an regulations at 45 CFR 400.211 to collect analysis of animal developmental DEPARTMENT OF HEALTH AND these data for use in estimating annual toxicity studies and argued that HUMAN SERVICES costs of the refugee resettlement ‘‘[p]lacing telavancin in the NIOSH program. ORR must implement the category of a hazardous drug greatly Administration for Children and methodology at 45 CFR 400.211 each overstates the occupational risk to Families year after receipt of its annual healthcare workers handling appropriation to ensure that the telavancin.’’ In response, NIOSH Submission for OMB Review; appropriated funds will be adequate for evaluated the information provided in Comment Request assistance to entering refugees. The the petition as well as other sources Title: Office of Refugee Resettlement provided to NIOSH by the manufacturer estimating methodology prescribed in Cash and Medical Assistance Program the ORR regulations requires the use of and determined that telavancin does not Quarterly Report on Expenditures and meet the NIOSH definition of a actual past costs by program Obligations. component. In the event that the hazardous drug. NIOSH informed users OMB No.: 0970–0407. of the 2016 List of this determination methodology indicates that Description: The Office of Refugee appropriated funds are inadequate, ORR via a web posting and responded to Resettlement (ORR) reimburses, to the Theravance Biopharma with a letter must take steps to reduce federal extent of available appropriations, expenses, such as by limiting the dated April 12, 2017.23 Accordingly, certain non-federal costs for the telavancin does not appear in the 2018 number of months of eligibility for provision of cash and medical Refugee Cash Assistance and Refugee update to the NIOSH List of assistance to refugees and other eligible Medical Assistance. This proposed Antineoplastic and Other Hazardous persons, along with allowable expenses single-page report on expenditures and Drugs in Healthcare Settings. This for the administration of the refugee obligations will allow ORR to collect the decision is considered final. resettlement program at the State level. necessary data to ensure that funds are States, Wilson/Fish projects (alternative XI. Final List of Drugs Proposed for adequate for the projected need and projects for the administration of the Placement on the NIOSH List of thereby meet the requirements of both Hazardous Drugs refugee resettlement program), and State Replacement Designees currently the Refugee Act and ORR regulations. After consideration of all public submit the ORR–2 Financial Status Respondents: State Agencies, the comments received in the docket for Report in accordance with 45 CFR part District of Columbia, Replacement this action, NIOSH will develop a final 92 and 45 CFR part 74. This proposed Designees under 45 CFR 400.301(c), and list of drugs to be placed on the NIOSH data collection would collect financial Wilson-Fish Grantees (State 2 Agencies) List of Antineoplastic and Other status data (i.e., amounts of administering or supervising the Hazardous Drugs in Healthcare Settings, expenditures and obligations) broken administration of programs under Title 2018. The 2018 Update will be down by the four program components: IV of the Act.

ANNUAL BURDEN ESTIMATES

Number of Number of responses Average Total burden Instrument respondents per burden hours hours respondent per response

ORR Financial Status Report Cash and Medical Assistance Program, Quar- terly Report on Expenditures and Obligations ...... 57 4 1.50 342

Estimated Total Annual Burden should be identified by the title of the having its full effect if OMB receives it Hours: 342. information collection. Email address: within 30 days of publication. Written Copies of the proposed collection may [email protected]. comments and recommendations for the be obtained by writing to the OMB Comment: OMB is required to proposed information collection should Administration for Children and make a decision concerning the be sent directly to the following: Office Families, Office of Planning, Research collection of information between 30 of Management and Budget, Paperwork _ and Evaluation, 330 C Street SW, and 60 days after publication of this Reduction Project, Email: OIRA Washington, DC 20201. Attention document in the Federal Register. [email protected], Attn: Reports Clearance Officer. All requests Therefore, a comment is best assured of

22 Harstad EB and Coleman R. Petition of and Other Hazardous Drugs in Healthcare Settings. 23 NIOSH letter to Eric Harstad and Rebecca Theravance Biopharma US, Inc. to Remove February 28, 2017. Coleman. April 12, 2017. Telavancin from the NIOSH List of Antineoplastic

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