A Vapor Containment Performance Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs; Extension of Comment Period, 69226-69227 [2015-28456]

Download as PDF 69226 Federal Register / Vol. 80, No. 216 / Monday, November 9, 2015 / Notices provided through cooperative agreement funding and technical assistance administered by CDC’s National Center for Injury Prevention and Control (NCIPC). The goal of this ICR is to collect information needed to monitor cooperative agreement programs funded under the Core State Violence and Injury Prevention Program (Core SVIPP) (CDC–RFA–CE16–1602). Information to be collected will provide crucial data for program performance monitoring and provide CDC with the capacity to respond in a timely manner to requests for information about the program from the Department of Health and Human Services (HHS), the White House, Congress, and other sources. Awardees will report progress and activity information to CDC on an annual schedule using an Excel-based fillable technical assistance provided to them, as needed, to support attainment of their performance measures. With the tools, the use of a standard set of data elements, definitions and specifications at all levels will help to improve the quality and comparability of performance information that is received by CDC for multiple awardees and multiple award types by ensuring that the same information is collected on all strategies and performance measures with slightly different areas of emphasis, depending on the awardee type (BASE, Enhanced with 1 Component, or Enhanced 2 Components). OMB approval is requested for three years. Participation in the information collection is required as a condition of funding. There are no costs to respondents other than their time. electronic templates. Each awardee will submit three information collection tools: Annual Progress Report, Evaluation and Performance Management Plan, and Injury Indicator Spreadsheets. In Year 1, each awardee will have additional burden related to initial collection of the reporting tools. Initial population of the tools is a onetime activity, after completing the initial population of the tools, pertinent information only needs to be updated annually for each report. CDC will use the information collected to monitor each awardee’s progress and to identify facilitators and challenges to program implementation and achievement of outcomes. Monitoring allows CDC to determine whether an awardee is meeting performance and goals and to make adjustments in the type and level of ESTIMATED ANNUALIZED BURDEN HOURS Number of responses per respondent Average burden per response (in hours) 20 1 22 440 20 20 1 1 11 2 220 40 20 5 1 1 14 73 280 365 5 5 1 1 58 3 290 15 5 5 1 1 14 146 70 730 5 5 1 1 116 4 580 20 5 1 14 70 ........................ ........................ ........................ 3,120 Number of respondents Type of respondents Form name Core SVIPP BASE Awardees ........... Initial Population-Annual Progress Report. Annual Progress Report ................... Evaluation and Performance Management Plan. Injury Indicator Spreadsheet ............ Initial Population-Annual Progress Report. Annual Progress Report ................... Evaluation and Performance Management Plan. Injury Indicator Spreadsheet ............ Initial Population-Annual Progress Report. Annual Progress Report ................... Evaluation and Performance Management Plan. Injury Indicator Spreadsheet ............ ........................................................... Core SVIPP 1—Enhanced Component Awardees. Core SVIPP 2—Enhanced Component Awardees. Total ........................................... 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. DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2015–28408 Filed 11–6–15; 8:45 am] [Docket Number CDC–2015–0075; NIOSH– 288] srobinson on DSK5SPTVN1PROD with NOTICES BILLING CODE 4163–18–P Centers for Disease Control and Prevention A Vapor Containment Performance Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs; Extension of Comment Period National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), AGENCY: VerDate Sep<11>2014 19:52 Nov 06, 2015 Jkt 238001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 Total burden (in hours) Department of Health and Human Services (HHS). ACTION: Notice and extension of comment period. On September 8, 2015, the Director of the National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), published a notice in the Federal Register [80 FR 53802] announcing the availability of the following draft document for public comment entitled A Vapor Containment Performance Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs. Written comments SUMMARY: E:\FR\FM\09NON1.SGM 09NON1 Federal Register / Vol. 80, No. 216 / Monday, November 9, 2015 / Notices were to be received by November 9, 2015. NIOSH is extending the public comment period for an additional 120 days. NIOSH is extending the comment period on the document published September 8, 2015 (80 FR 53802). Electronic or written comments must be received by March 8, 2016. ADDRESSES: You may submit comments, identified by CDC–2015–0075 and docket number NIOSH–288, by any of the 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 45226–1998. FOR FURTHER INFORMATION CONTACT: Deborah V. Hirst, NIOSH, Division of Applied Research and Technology, Alice Hamilton Laboratories, 1090 Tusculum Avenue, MS R–5, Cincinnati, Ohio 45226, telephone (513) 841–4141 (not a toll free number), Email: hazardousdrugs@cdc.gov. DATES: Dated: November 2, 2015. John Howard, Director, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. [FR Doc. 2015–28456 Filed 11–6–15; 8:45 am] BILLING CODE 4163–19–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifiers: CMS–10434 and CMS–R–131] Agency Information Collection Activities: Proposed Collection; Comment Request Centers for Medicare & Medicaid Services. ACTION: Notice. AGENCY: The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS’ intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our srobinson on DSK5SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 19:52 Nov 06, 2015 Jkt 238001 burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency’s functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. DATES: Comments must be received by January 8, 2016. ADDRESSES: When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways: 1. Electronically. You may send your comments electronically to https:// www.regulations.gov. Follow the instructions for ‘‘Comment or Submission’’ or ‘‘More Search Options’’ to find the information collection document(s) that are accepting comments. 2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number, Room C4–26–05, 7500 Security Boulevard, Baltimore, Maryland 21244–1850. To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following: 1. Access CMS’ Web site address at https://www.cms.hhs.gov/ PaperworkReductionActof1995. 2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov. 3. Call the Reports Clearance Office at (410) 786–1326. FOR FURTHER INFORMATION CONTACT: Reports Clearance Office at (410) 786– 1326. SUPPLEMENTARY INFORMATION: Contents This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection’s supporting statement and associated materials (see ADDRESSES). CMS–10434 Medicaid and CHIP Program (MACPro) PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 69227 CMS–R–131 Advance Beneficiary Notice of Noncoverage (ABN) Under the PRA (44 U.S.C. 3501– 3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term ‘‘collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice. Information Collection 1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Medicaid and CHIP Program (MACPro); Use: While currently approved by OMB under the regular PRA process, CMS is proposing to have all current and upcoming MACPro collections approved under OMB’s generic process. We are also transitioning MACPro to a fully functioning electronic system such that MACPro becomes the sole system of record. MACPro will be the required means for states to amend Medicaid and CHIP state plans, waivers, and demonstrations. Templates that will be submitted for approval under MACPro include certain collections approved under our generic umbrella (CMS– 10398, OMB 0938–1148), relevant collections approved as a regular standalone information collection requests, and upcoming collections. Form Number: CMS–10434 (OMB Control Number: 0938–1188); Frequency: Monthly, yearly, quarterly, semiannually, once, or occasionally; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 56; Total Annual Responses: 3,360; Total Annual Hours: 89,012. (For policy questions regarding this collection contact Annette Pearson at 410–786– 6858). 2. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Advance Beneficiary Notice of Noncoverage (ABN); Use: The Advance Beneficiary Notice (ABN) is delivered by Part B paid E:\FR\FM\09NON1.SGM 09NON1

Agencies

[Federal Register Volume 80, Number 216 (Monday, November 9, 2015)]
[Notices]
[Pages 69226-69227]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-28456]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket Number CDC-2015-0075; NIOSH-288]


A Vapor Containment Performance Protocol for Closed System 
Transfer Devices Used During Pharmacy Compounding and Administration of 
Hazardous Drugs; Extension of Comment Period

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 and extension of comment period.

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SUMMARY: On September 8, 2015, the Director of the National Institute 
for Occupational Safety and Health (NIOSH) of the Centers for Disease 
Control and Prevention (CDC), published a notice in the Federal 
Register [80 FR 53802] announcing the availability of the following 
draft document for public comment entitled A Vapor Containment 
Performance Protocol for Closed System Transfer Devices Used During 
Pharmacy Compounding and Administration of Hazardous Drugs. Written 
comments

[[Page 69227]]

were to be received by November 9, 2015. NIOSH is extending the public 
comment period for an additional 120 days.

DATES: NIOSH is extending the comment period on the document published 
September 8, 2015 (80 FR 53802). Electronic or written comments must be 
received by March 8, 2016.

ADDRESSES: You may submit comments, identified by CDC-2015-0075 and 
docket number NIOSH-288, by any of the 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 45226-1998.

FOR FURTHER INFORMATION CONTACT: Deborah V. Hirst, NIOSH, Division of 
Applied Research and Technology, Alice Hamilton Laboratories, 1090 
Tusculum Avenue, MS R-5, Cincinnati, Ohio 45226, telephone (513) 841-
4141 (not a toll free number), Email: hazardousdrugs@cdc.gov.

    Dated: November 2, 2015.
John Howard,
Director, National Institute for Occupational Safety and Health, 
Centers for Disease Control and Prevention.
[FR Doc. 2015-28456 Filed 11-6-15; 8:45 am]
BILLING CODE 4163-19-P
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