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)

Page Range		30463-30464
FR Document		2015-12857

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 Issue 102 (Thursday, May 28, 2015)

[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

30464 Federal Register / Vol. 80, No. 102 / Thursday, May 28, 2015 / Notices

and NIOSH made the final proposed collection of information is Child maltreatment is both
determination regarding proposed necessary for the proper performance of widespread and impactful. It is
additions to the 2016 hazardous drug the functions of the agency, including estimated that 1 in 58 U.S. children had
list. whether the information will have been maltreated in a 1-year period (i.e.,
NIOSH reviewed the practical utility; (b) Evaluate the victims of physical, sexual, and
recommendations of the peer reviewers accuracy of the agencies estimate of the emotional abuse or neglect). Millions of
and stakeholders and determined that burden of the proposed collection of other American children are exposed to
33 drugs in addition to the 3 drugs with information, including the validity of maltreatment that does not meet
manufacturer’s warnings, were the methodology and assumptions used; thresholds for clinical significance, but
determined to have one or more (c) Enhance the quality, utility, and is nonetheless detrimental to child
characteristics of a hazardous drug and clarity of the information to be health.
this list of 36 drugs is being published collected; (d) Minimize the burden of
Parent training is arguably the single
for comment in CDC–2015–0034 and the collection of information on those
most effective prevention initiative
NIOSH Docket Number 233–A. The list who are to respond, including through
of proposed additions can be found at developed to date. Although there are
the use of appropriate automated,
www.regulations.gov. potentially far-reaching impacts of
electronic, mechanical, or other
parent training to improve public
Dated: May 20, 2015. technological collection techniques or
health, empirically-supported parent
John Howard, other forms of information technology,
training is not widely available. The
Director, National Institute for Occupational
e.g., permitting electronic submission of
public health challenge is how to make
Safety and Health, Centers for Disease Control responses; and (e) Assess information
the content of these empirically-
and Prevention. collection costs.
To request additional information on supported parent training programs—
[FR Doc. 2015–12857 Filed 5–27–15; 8:45 am] which largely focus on the same
the proposed project or to obtain a copy
BILLING CODE 4163–19–P
of the information collection plan and parenting skills and approaches—
instruments, call (404) 639–7570 or accessible to the majority of American
send an email to omb@cdc.gov. Written parents.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES comments and/or suggestions regarding To leverage the strength of
the items contained in this notice empirically supported parent training as
Centers for Disease Control and should be directed to the Attention: a broadly disseminated prevention tool,
Prevention CDC Desk Officer, Office of Management the CDC has developed a resource tool
and Budget, Washington, DC 20503 or called ‘‘Essentials for Parenting
[30Day–15–15KZ]
by fax to (202) 395–5806. Written Toddlers and Preschoolers (EFP)’’. This
Agency Forms Undergoing Paperwork comments should be received within 30 web-based resource includes the typical
Reduction Act Review days of this notice. content of empirically supported parent
training programs and uses a
The Centers for Disease Control and Proposed Project
psychoeducational approach including
Prevention (CDC) has submitted the Research on the Efficacy and modeling (through its videos) and
following information collection request Feasibility of Essentials for Parenting practice (through its activities).
to the Office of Management and Budget Toddlers and Preschoolers—New—
This study is an empirical evaluation
(OMB) for review and approval in National Center for Injury Prevention
accordance with the Paperwork using an intensive repeated measures
and Control (NCIPC), Centers for
Reduction Act of 1995. The notice for design to test the efficacy, feasibility,
Disease Control and Prevention (CDC).
the proposed information collection is and use of EFP as administered in
published to obtain comments from the Background and Brief Description guided and unguided formats. The
public and affected agencies. The Centers for Disease Control and proposed data collection fits into
Written comments and suggestions Prevention (CDC) seeks a two-year OMB NCIPC’s research agenda’s priorities in
from the public and affected agencies approval to conduct a new information preventing child maltreatment.
concerning the proposed collection of collection for a study entitled, There are no costs to respondents
information are encouraged. Your ‘‘Research on the Efficacy and other than their time. The total
comments should address any of the Feasibility of Essentials for Parenting estimated annual burden hours are
following: (a) Evaluate whether the Toddlers and Preschoolers’’. 2,050.

ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Type of respondents Form name responses per
respondents response
respondent (in hours)

Parents (both Natural Navigation [NN] and Form 1—Screening and Demographics 400 1 15/60
Guided Navigation [GN] groups). Questionnaires—Attachment I1.
Form 2—Detailed Assessment Measures— 200 2 45/60
asabaliauskas on DSK5VPTVN1PROD with NOTICES

Attachment I2.
Form 3—Core Assessment Measures (Rotat- 200 18 15/60
ing)—Attachment I3.
Form 4—Parental EFP Skills Knowledge 200 8 15/60
Scale—Attachment I4.
Form 5—Parental EFP Skills Usefulness 200 6 15/60
Scale—Attachment I5.

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Document Created: 2018-02-21 10:33:40
Document Modified: 2018-02-21 10:33:40

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of draft document available for public comment.
Dates		Electronic or written comments must be received by July 27, 2015.
Contact		<bullet> SUPPLEMENTARY INFORMATION:
FR Citation		80 FR 30463

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 SERVICESCenters for Disease Control and Prevention

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

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