[Federal Register Volume 74, Number 81 (Wednesday, April 29, 2009)]
[Notices]
[Pages 19570-19571]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-9779]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket Number 105-A]


Updating the List of Hazardous Drugs for the NIOSH Alert: 
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 available 
for public comment entitled ``Updating the List of Hazardous Drugs for 
the NIOSH Alert: 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/review/public/105a/.

DATES: Comments must be postmarked by June 30, 2009.

ADDRESSES: You may submit comments to [email protected] or to the 
NIOSH Docket Office, Robert A. Taft Laboratories, MS-C34, 4676 Columbia 
Parkway, Cincinnati, OH 45226 or by facsimile (513) 533-8285. Comments 
should be in Microsoft Word format and should reference NIOSH docket 
number 105-A. NIOSH includes all comments received without change in 
the docket, including any personal information provided. After the 
comment period has closed, comments will be able to be accessed 
electronically at http://www.cdc.gov/NIOSH under the link to the NIOSH 
docket. As appropriate, NIOSH will post comments with the commenters' 
names, affiliations and other information, on the Internet.
    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/). 
Since that time, approximately 60 new drugs have received FDA approval 
and approximately 60 drugs have received special warnings (usually 
black box warnings) based on reported adverse effects in patients. An 
additional 18 drugs were included from the updated National Institutes 
of Health (NIH) Hazardous Drug List. From this list of approximately 
150 drugs, 62 drugs were determined to have one or more characteristic 
of a hazardous drug and published for comment in NIOSH docket number 
105.
    After review by experts, public review and comment, input from 
stakeholders and review of the scientific literature, NIOSH has 
proposed a second draft list of hazardous drugs. A number of drugs were 
removed from the initial proposed list based on comments from the 
various groups and organizations. The second draft list identifies 24 
drugs that fit the NIOSH definition of hazardous drugs. Based on 
comments received by NIOSH, Bacillus Calmette-Guerin (BCG) will be 
removed from Appendix A in the 2004

[[Page 19571]]

NIOSH Alert on Hazardous Drugs (http://www.cdc.gov/niosh/docs/2004-165/) due to potential adverse effects in some patients from cross-
contamination.
    This guidance document does not have the force and effect of law.

FOR FURTHER INFORMATION CONTACT: Barbara MacKenzie, NIOSH, Robert A. 
Taft Laboratories, MS-C26, 4676 Columbia Parkway, Cincinnati, OH 45226, 
telephone (513) 533-8132, E-mail: [email protected].
    Reference: http://www.cdc.gov/niosh/docs/2004-102/. Web address for 
this document: http://www.cdc.gov/niosh/review/public/105a/. All 
information received in response to this notice will be available for 
public examination and copying at the NIOSH Docket Office, 4676 
Columbia Parkway, Room 111, Cincinnati, Ohio, 45226, telephone (513) 
533-8303.

    Dated: April 22, 2009.
Christine M. Branche,
Acting Director, National Institute for Occupational Safety and Health, 
Centers for Disease Control and Prevention.
[FR Doc. E9-9779 Filed 4-28-09; 8:45 am]
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