[Federal Register Volume 76, Number 148 (Tuesday, August 2, 2011)]
[Notices]
[Page 46299]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-19460]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket Number NIOSH-190]


NIOSH List of Antineoplastic and Other Hazardous Drugs in 
Healthcare Settings 2012: Proposed Additions and Deletions to the NIOSH 
Hazardous Drug List

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 2012: Proposed Additions and Deletions to 
the NIOSH Hazardous Drug List.'' The document and instructions for 
submitting comments can be found at http://www.cdc.gov/niosh/docket/review/docket190/default.html.
    This guidance document does not have the force and effect of law.
    Public Comment Period: Comments must be received by October 3, 
2011.

ADDRESSES: Written comments may be submitted to the NIOSH Docket 
Office, identified by Docket Number NIOSH-190, by any of the following 
methods:
     Mail: NIOSH Docket Office, Robert A. Taft Laboratories, 
MS-C34, 4676 Columbia Parkway, Cincinnati, Ohio 45226.
     Facsimile: (513) 533-8285.
     E-mail: [email protected].
    All information received in response to this notice will be 
available for public examination and copying at the NIOSH Docket 
Office, 4676 Columbia Parkway, Cincinnati, Ohio 45226.
    A complete electronic docket containing all comments submitted will 
be available on the NIOSH web page at http://www.cdc.gov/niosh/docket, 
and comments will be available in writing by request. NIOSH includes 
all comments received without change in the docket, including any 
personal information provided. All electronic comments should be 
formatted as Microsoft Word. Please make reference to Docket Number 
NIOSH-190.

SUPPLEMENTARY INFORMATION:
    Background: 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 and covered all new approved drugs 
and drugs with new warning since 2007 (http://www.cdc.gov/niosh/docs/2010-167/). Between June 2007 and December 2009, 48 new drugs received 
FDA approval and 115 drugs received special warnings (usually black box 
warnings) based on reported adverse effects in patients. The complete 
list of these drugs can be found at: http://www.cdc.gov/niosh/docket/review/docket190/pdfs/Proposedchanges07112011.pdf. From this list of 
169 drugs, 45 drugs were identified by NIOSH as candidate hazardous 
drugs. Seven of these drugs had safe handling recommendations from the 
manufacturer and NIOSH is accepting these recommendations as 
appropriate. Therefore, these seven 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 remaining 38 
potentially hazardous drugs. In addition, the panel members were asked 
to comment on the removal of 15 drugs from the 2010 Hazardous Drug 
List. Reviewers were not asked to provide a consensus opinion and NIOSH 
made the final determination regarding additions and deletions to the 
2010 hazardous drug List.
    NIOSH reviewed the recommendations of the peer reviewers and 
stakeholders and determined that 24 drugs in addition to the 7 drugs 
with manufacturer's warnings, were determined to have one or more 
characteristics of a hazardous drug and this list of 31 drugs is being 
published for comment in NIOSH Docket Number 190. In addition, 15 drugs 
from the 2010 Hazardous Drug List are being considered for removal. 
Four drugs were evaluated for reclassification, two drugs are radio-
pharmaceuticals which are covered by specific handling regulations set 
by the Nuclear Regulatory Commission and nine others are not available 
in the United States at this time. In order to keep the list as current 
as possible, NIOSH will remove any drugs that are no longer available 
in the United States. If any of these drugs were to become available at 
a later date, NIOSH would reconsider them for review.

FOR FURTHER INFORMATION CONTACT: Barbara MacKenzie, NIOSH, Robert A. 
Taft Laboratories, 4676 Columbia Parkway, MS-C26, Cincinnati, Ohio 
45226, telephone (513) 533-8132, E-mail [email protected].
    Reference: http://www.cdc.gov/niosh/docket/review/docket190/pdfs/PanelSummary05092011.pdf.

     Dated: July 22, 2011.
John Howard,
Director, National Institute for Occupational Safety and Health, 
Centers for Disease Control and Prevention.
[FR Doc. 2011-19460 Filed 8-1-11; 8:45 am]
BILLING CODE 4163-19-P