80 FR 30463 - NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings: Proposed Additions to the NIOSH Hazardous Drug List 2016; Request for Comment

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 80, Issue 102 (May 28, 2015)

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability of the following draft document for public comment entitled ``NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings: Proposed Additions to the NIOSH Hazardous Drug List 2016.'' The document and instructions for submitting comments can be found at www.regulations.gov. This guidance document does not have the force and effect of law.

[Federal Register Volume 80, Number 102 (Thursday, May 28, 2015)]
[Notices]
[Pages 30463-30464]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-12857]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[CDC-2015-0034; NIOSH 233-A]


NIOSH List of Antineoplastic and Other Hazardous Drugs in 
Healthcare Settings: Proposed Additions to the NIOSH Hazardous Drug 
List 2016; Request for Comment

AGENCY: National Institute for Occupational Safety and Health (NIOSH) 
of the Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (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 of the following draft document for public 
comment entitled ``NIOSH List of Antineoplastic and Other Hazardous 
Drugs in Healthcare Settings: Proposed Additions to the NIOSH Hazardous 
Drug List 2016.'' The document and instructions for submitting comments 
can be found at www.regulations.gov.
    This guidance document does not have the force and effect of law.

Table of Contents

     DATES:
     ADDRESSES:
     FOR FURTHER INFORMATION CONTACT:
     SUPPLEMENTARY INFORMATION:

DATES: Electronic or written comments must be received by July 27, 
2015.

ADDRESSES: You may submit comments, identified by CDC-2015-0034 and 
Docket Number NIOSH 233-A, by either of the two following methods:
     Federal eRulemaking Portal: 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.
    Instructions: All information received in response to this notice 
must include the agency name and the docket number (CDC-2015-0034; 
NIOSH 233-A). All relevant comments received will be posted without 
change to www.regulations.gov, including any personal information 
provided. All electronic comments should be formatted as Microsoft 
Word. Please make reference to CDC-2015-0034 and Docket Number NIOSH 
233-A. All information received in response to this notice will also be 
available for public examination and copying at the NIOSH Docket 
Office, 1150 Tusculum Avenue, Room 155, Cincinnati, OH 45226.

FOR FURTHER INFORMATION CONTACT: Barbara MacKenzie, NIOSH, Division of 
Applied Research and Technology, Robert A. Taft Laboratories, 1090 
Tusculum Avenue, MS C-26, Cincinnati, Ohio 45226. (513) 533-8132 (not a 
toll free number). Email: [email protected].

SUPPLEMENTARY INFORMATION: The NIOSH Alert: ``Preventing Occupational 
Exposures to Antineoplastic and Other Hazardous Drugs in Health Care 
Settings'' was published in September 2004 (http://www.cdc.gov/niosh/docs/2004-165/). This Alert contained Appendix A which was a list of 
drugs that were deemed to be hazardous and may require special 
handling. This list of hazardous drugs was updated in 2010, 2012 and 
2014 and covered all new approved drugs and drugs with new warnings up 
to December 2011 (http://www.cdc.gov/niosh/docs/2014-138). Between 
January 2012 and December 2013, 60 new drugs received FDA approval and 
270 drugs received new warnings based on reported adverse effects in 
patients. From this list of 330 drugs, 44 drugs were identified by 
NIOSH as potential hazardous drugs. In addition to these 44 drugs, the 
panel members were asked to comment on the addition of one drug 
requested by several stakeholders. Three additional drugs had safe 
handling recommendations from the manufacturer and NIOSH is following 
these recommendations. Therefore, these 3 drugs will be listed as 
hazardous without requiring further review. A panel consisting of peer 
reviewers and stakeholders was asked to review and comment on the 45 
potentially hazardous drugs. Reviewers were not asked to provide a 
consensus opinion

[[Page 30464]]

and NIOSH made the final determination regarding proposed additions to 
the 2016 hazardous drug list.
    NIOSH reviewed the recommendations of the peer reviewers and 
stakeholders and determined that 33 drugs in addition to the 3 drugs 
with manufacturer's warnings, were determined to have one or more 
characteristics of a hazardous drug and this list of 36 drugs is being 
published for comment in CDC-2015-0034 and NIOSH Docket Number 233-A. 
The list of proposed additions can be found at www.regulations.gov.

    Dated: May 20, 2015.
John Howard,
Director, National Institute for Occupational Safety and Health, 
Centers for Disease Control and Prevention.
[FR Doc. 2015-12857 Filed 5-27-15; 8:45 am]
 BILLING CODE 4163-19-P