NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings: Proposed Additions to the NIOSH Hazardous Drug List 2016; Request for Comment, 30463-30464 [2015-12857]

Download as PDF 30463 Federal Register / Vol. 80, No. 102 / Thursday, May 28, 2015 / Notices Sampling recruitment methods may include, but not be limited to: Use of social networking sites, the Internet, print marketing materials, and other methods to find and enroll respondents into the research study. All data collection tools will be pretested and interviews conducted by trained personnel. The data collection will take place at a time and place that is convenient to the respondent. Locations will be private. Data collection may be audio-recorded and transcribed with the consent of the respondent. The data collections supported under this generic information collection will be used to provide insight regarding barriers and facilitators to HIV prevention, care, and treatment in the United States and territories, and thus suggest ways CDC might improve programmatic activities along the continuum of HIV prevention, treatment and care. The total estimated annualized burden hours are 918. There are no costs to respondents other than their time. ESTIMATED ANNUALIZED BURDEN HOURS Type of respondent General General General General General General General Public—Adults Public—Adults Public—Adults Public—Adults Public—Adults Public—Adults Public—Adults Number of respondents Form name ................................... ................................... ................................... ................................... ................................... ................................... ................................... Study Screener .............................................. Contact Information Form .............................. Consent Form ................................................ Demographic Survey ...................................... Interview Guide .............................................. Provider Demographic Survey ....................... Provider Interview Guide ................................ Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. instructions for submitting comments can be found at www.regulations.gov. This guidance document does not have the force and effect of law. [FR Doc. 2015–12808 Filed 5–27–15; 8:45 am] • DATES: • ADDRESSES: • FOR FURTHER INFORMATION CONTACT: • SUPPLEMENTARY INFORMATION: BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [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 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. AGENCY: 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 asabaliauskas on DSK5VPTVN1PROD with NOTICES VerDate Sep<11>2014 18:18 May 27, 2015 Jkt 235001 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 DATES: Centers for Disease Control and Prevention SUMMARY: Table of Contents PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 Number of responses per respondent 1,600 600 600 500 500 100 100 1 1 1 1 1 1 1 Average burden per response (in hours) 5/60 1/60 5/60 15/60 1 15/60 45/60 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: hazardousdrugs@cdc.gov. SUPPLEMENTARY INFORMATION: The NIOSH Alert: ‘‘Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings’’ was published in September 2004 (https://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 (https://www.cdc.gov/niosh/docs/2014138). 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 E:\FR\FM\28MYN1.SGM 28MYN1 30464 Federal Register / Vol. 80, No. 102 / Thursday, May 28, 2015 / Notices 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day–15–15KZ] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies. Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and (e) Assess information collection costs. To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639–7570 or send an email to omb@cdc.gov. Written comments and/or suggestions regarding the items contained in this notice should be directed to the Attention: CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395–5806. Written comments should be received within 30 days of this notice. Proposed Project Research on the Efficacy and Feasibility of Essentials for Parenting Toddlers and Preschoolers—New— National Center for Injury Prevention and Control (NCIPC), Centers for Disease Control and Prevention (CDC). Background and Brief Description The Centers for Disease Control and Prevention (CDC) seeks a two-year OMB approval to conduct a new information collection for a study entitled, ‘‘Research on the Efficacy and Feasibility of Essentials for Parenting Toddlers and Preschoolers’’. Child maltreatment is both widespread and impactful. It is estimated that 1 in 58 U.S. children had been maltreated in a 1-year period (i.e., victims of physical, sexual, and emotional abuse or neglect). Millions of other American children are exposed to maltreatment that does not meet thresholds for clinical significance, but is nonetheless detrimental to child health. Parent training is arguably the single most effective prevention initiative developed to date. Although there are potentially far-reaching impacts of parent training to improve public health, empirically-supported parent training is not widely available. The public health challenge is how to make the content of these empiricallysupported parent training programs— which largely focus on the same parenting skills and approaches— accessible to the majority of American parents. To leverage the strength of empirically supported parent training as a broadly disseminated prevention tool, the CDC has developed a resource tool called ‘‘Essentials for Parenting Toddlers and Preschoolers (EFP)’’. This web-based resource includes the typical content of empirically supported parent training programs and uses a psychoeducational approach including modeling (through its videos) and practice (through its activities). This study is an empirical evaluation using an intensive repeated measures design to test the efficacy, feasibility, and use of EFP as administered in guided and unguided formats. The proposed data collection fits into NCIPC’s research agenda’s priorities in preventing child maltreatment. There are no costs to respondents other than their time. The total estimated annual burden hours are 2,050. ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Form name Parents (both Natural Navigation [NN] and Guided Navigation [GN] groups). asabaliauskas on DSK5VPTVN1PROD with NOTICES Type of respondents Form 1—Screening and Demographics Questionnaires—Attachment I1. Form 2—Detailed Assessment Measures— Attachment I2. Form 3—Core Assessment Measures (Rotating)—Attachment I3. Form 4—Parental EFP Skills Knowledge Scale—Attachment I4. Form 5—Parental EFP Skills Usefulness Scale—Attachment I5. VerDate Sep<11>2014 20:06 May 27, 2015 Jkt 235001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\28MYN1.SGM Number of responses per respondent Average burden per response (in hours) 400 1 15/60 200 2 45/60 200 18 15/60 200 8 15/60 200 6 15/60 28MYN1

Agencies

[Federal Register Volume 80, Number 102 (Thursday, May 28, 2015)]
[Notices]
[Pages 30463-30464]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

-----------------------------------------------------------------------

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: hazardousdrugs@cdc.gov.

SUPPLEMENTARY INFORMATION: The NIOSH Alert: ``Preventing Occupational 
Exposures to Antineoplastic and Other Hazardous Drugs in Health Care 
Settings'' was published in September 2004 (https://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 (https://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
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