80_FR_69442 80 FR 69226 - A Vapor Containment Performance Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs; Extension of Comment Period

80 FR 69226 - A Vapor Containment Performance Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs; Extension of Comment Period

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

Federal Register Volume 80, Issue 216 (November 9, 2015)

Page Range69226-69227
FR Document2015-28456

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

Federal Register, Volume 80 Issue 216 (Monday, November 9, 2015)
[Federal Register Volume 80, Number 216 (Monday, November 9, 2015)]
[Notices]
[Pages 69226-69227]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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

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: [email protected].

    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



                                                69226                              Federal Register / Vol. 80, No. 216 / Monday, November 9, 2015 / Notices

                                                provided through cooperative agreement                                  electronic templates. Each awardee will                                       technical assistance provided to them,
                                                funding and technical assistance                                        submit three information collection                                           as needed, to support attainment of their
                                                administered by CDC’s National Center                                   tools: Annual Progress Report,                                                performance measures. With the tools,
                                                for Injury Prevention and Control                                       Evaluation and Performance                                                    the use of a standard set of data
                                                (NCIPC). The goal of this ICR is to                                     Management Plan, and Injury Indicator                                         elements, definitions and specifications
                                                collect information needed to monitor                                   Spreadsheets. In Year 1, each awardee                                         at all levels will help to improve the
                                                cooperative agreement programs funded                                   will have additional burden related to                                        quality and comparability of
                                                under the Core State Violence and                                       initial collection of the reporting tools.                                    performance information that is
                                                Injury Prevention Program (Core SVIPP)                                  Initial population of the tools is a one-                                     received by CDC for multiple awardees
                                                (CDC–RFA–CE16–1602).                                                    time activity, after completing the initial                                   and multiple award types by ensuring
                                                  Information to be collected will                                      population of the tools, pertinent                                            that the same information is collected
                                                provide crucial data for program                                        information only needs to be updated                                          on all strategies and performance
                                                performance monitoring and provide                                      annually for each report.                                                     measures with slightly different areas of
                                                CDC with the capacity to respond in a                                     CDC will use the information                                                emphasis, depending on the awardee
                                                timely manner to requests for                                           collected to monitor each awardee’s                                           type (BASE, Enhanced with 1
                                                information about the program from the                                  progress and to identify facilitators and                                     Component, or Enhanced 2
                                                Department of Health and Human                                          challenges to program implementation                                          Components).
                                                Services (HHS), the White House,                                        and achievement of outcomes.                                                     OMB approval is requested for three
                                                Congress, and other sources. Awardees                                   Monitoring allows CDC to determine                                            years. Participation in the information
                                                will report progress and activity                                       whether an awardee is meeting                                                 collection is required as a condition of
                                                information to CDC on an annual                                         performance and goals and to make                                             funding. There are no costs to
                                                schedule using an Excel-based fillable                                  adjustments in the type and level of                                          respondents other than their time.

                                                                                                                       ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                                                                Average
                                                                                                                                                                                                    Number of
                                                                                                                                                                         Number of                                           burden per re-             Total burden
                                                          Type of respondents                                                Form name                                                            responses per
                                                                                                                                                                        respondents                                              sponse                  (in hours)
                                                                                                                                                                                                    respondent                 (in hours)

                                                Core SVIPP BASE Awardees ...........                     Initial Population-Annual Progress                                               20                           1                         22              440
                                                                                                            Report.
                                                                                                         Annual Progress Report ...................                                       20                           1                         11              220
                                                                                                         Evaluation and Performance Man-                                                  20                           1                          2               40
                                                                                                            agement Plan.
                                                                                                         Injury Indicator Spreadsheet ............                                        20                           1                        14               280
                                                Core SVIPP 1—Enhanced Compo-                             Initial Population-Annual Progress                                                5                           1                        73               365
                                                  nent Awardees.                                            Report.
                                                                                                         Annual Progress Report ...................                                          5                         1                         58              290
                                                                                                         Evaluation and Performance Man-                                                     5                         1                          3               15
                                                                                                            agement Plan.
                                                                                                         Injury Indicator Spreadsheet ............                                           5                         1                        14                70
                                                Core SVIPP 2—Enhanced Compo-                             Initial Population-Annual Progress                                                  5                         1                       146               730
                                                  nent Awardees.                                            Report.
                                                                                                         Annual Progress Report ...................                                          5                         1                       116               580
                                                                                                         Evaluation and Performance Man-                                                     5                         1                         4                20
                                                                                                            agement Plan.
                                                                                                         Injury Indicator Spreadsheet ............                                           5                         1                         14               70

                                                     Total ...........................................   ...........................................................   ........................   ........................   ........................          3,120



                                                Leroy A. Richardson,                                                    DEPARTMENT OF HEALTH AND                                                      Department of Health and Human
                                                Chief, Information Collection Review Office,                            HUMAN SERVICES                                                                Services (HHS).
                                                Office of Scientific Integrity, Office of the                                                                                                         ACTION: Notice and extension of
                                                Associate Director for Science, Office of the                           Centers for Disease Control and                                               comment period.
                                                Director, Centers for Disease Control and                               Prevention
                                                Prevention.                                                                                                                                           SUMMARY:   On September 8, 2015, the
                                                [FR Doc. 2015–28408 Filed 11–6–15; 8:45 am]                             [Docket Number CDC–2015–0075; NIOSH–                                          Director of the National Institute for
                                                                                                                        288]                                                                          Occupational Safety and Health
                                                BILLING CODE 4163–18–P

                                                                                                                        A Vapor Containment Performance                                               (NIOSH) of the Centers for Disease
                                                                                                                        Protocol for Closed System Transfer                                           Control and Prevention (CDC),
                                                                                                                        Devices Used During Pharmacy                                                  published a notice in the Federal
                                                                                                                                                                                                      Register [80 FR 53802] announcing the
srobinson on DSK5SPTVN1PROD with NOTICES




                                                                                                                        Compounding and Administration of
                                                                                                                        Hazardous Drugs; Extension of                                                 availability of the following draft
                                                                                                                        Comment Period                                                                document for public comment entitled
                                                                                                                                                                                                      A Vapor Containment Performance
                                                                                                                        AGENCY:  National Institute for                                               Protocol for Closed System Transfer
                                                                                                                        Occupational Safety and Health                                                Devices Used During Pharmacy
                                                                                                                        (NIOSH) of the Centers for Disease                                            Compounding and Administration of
                                                                                                                        Control and Prevention (CDC),                                                 Hazardous Drugs. Written comments


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                                                                            Federal Register / Vol. 80, No. 216 / Monday, November 9, 2015 / Notices                                           69227

                                                were to be received by November 9,                      burden estimates or any other aspect of               CMS–R–131 Advance Beneficiary
                                                2015. NIOSH is extending the public                     this collection of information, including               Notice of Noncoverage (ABN)
                                                comment period for an additional 120                    any of the following subjects: (1) The                  Under the PRA (44 U.S.C. 3501–
                                                days.                                                   necessity and utility of the proposed                 3520), federal agencies must obtain
                                                DATES:  NIOSH is extending the                          information collection for the proper                 approval from the Office of Management
                                                comment period on the document                          performance of the agency’s functions;                and Budget (OMB) for each collection of
                                                published September 8, 2015 (80 FR                      (2) the accuracy of the estimated                     information they conduct or sponsor.
                                                53802). Electronic or written comments                  burden; (3) ways to enhance the quality,              The term ‘‘collection of information’’ is
                                                must be received by March 8, 2016.                      utility, and clarity of the information to            defined in 44 U.S.C. 3502(3) and 5 CFR
                                                                                                        be collected; and (4) the use of                      1320.3(c) and includes agency requests
                                                ADDRESSES: You may submit comments,
                                                                                                        automated collection techniques or                    or requirements that members of the
                                                identified by CDC–2015–0075 and                         other forms of information technology to
                                                docket number NIOSH–288, by any of                                                                            public submit reports, keep records, or
                                                                                                        minimize the information collection                   provide information to a third party.
                                                the following methods:                                  burden.
                                                  • Federal eRulemaking Portal:                                                                               Section 3506(c)(2)(A) of the PRA
                                                www.regulations.gov—Follow the                          DATES: Comments must be received by                   requires federal agencies to publish a
                                                instructions for submitting comments.                   January 8, 2016.                                      60-day notice in the Federal Register
                                                  • Mail: National Institute for                        ADDRESSES: When commenting, please                    concerning each proposed collection of
                                                Occupational Safety and Health, NIOSH                   reference the document identifier or                  information, including each proposed
                                                Docket Office, 1090 Tusculum Avenue,                    OMB control number. To be assured                     extension or reinstatement of an existing
                                                MS C–34, Cincinnati, Ohio 45226–1998.                   consideration, comments and                           collection of information, before
                                                FOR FURTHER INFORMATION CONTACT:                        recommendations must be submitted in                  submitting the collection to OMB for
                                                Deborah V. Hirst, NIOSH, Division of                    any one of the following ways:                        approval. To comply with this
                                                Applied Research and Technology,                          1. Electronically. You may send your                requirement, CMS is publishing this
                                                Alice Hamilton Laboratories, 1090                       comments electronically to http://                    notice.
                                                Tusculum Avenue, MS R–5, Cincinnati,                    www.regulations.gov. Follow the
                                                                                                        instructions for ‘‘Comment or                         Information Collection
                                                Ohio 45226, telephone (513) 841–4141
                                                (not a toll free number), Email:                        Submission’’ or ‘‘More Search Options’’                  1. Type of Information Collection
                                                hazardousdrugs@cdc.gov.                                 to find the information collection                    Request: Revision of a currently
                                                                                                        document(s) that are accepting                        approved collection; Title of
                                                  Dated: November 2, 2015.                              comments.                                             Information Collection: Medicaid and
                                                John Howard,                                              2. By regular mail. You may mail                    CHIP Program (MACPro); Use: While
                                                Director, National Institute for Occupational           written comments to the following                     currently approved by OMB under the
                                                Safety and Health, Centers for Disease Control          address: CMS, Office of Strategic                     regular PRA process, CMS is proposing
                                                and Prevention.                                         Operations and Regulatory Affairs,                    to have all current and upcoming
                                                [FR Doc. 2015–28456 Filed 11–6–15; 8:45 am]             Division of Regulations Development,                  MACPro collections approved under
                                                BILLING CODE 4163–19–P                                  Attention: Document Identifier/OMB                    OMB’s generic process. We are also
                                                                                                        Control Number, Room C4–26–05, 7500                   transitioning MACPro to a fully
                                                                                                        Security Boulevard, Baltimore,                        functioning electronic system such that
                                                DEPARTMENT OF HEALTH AND                                Maryland 21244–1850.                                  MACPro becomes the sole system of
                                                HUMAN SERVICES                                            To obtain copies of a supporting                    record. MACPro will be the required
                                                                                                        statement and any related forms for the               means for states to amend Medicaid and
                                                Centers for Medicare & Medicaid                         proposed collection(s) summarized in                  CHIP state plans, waivers, and
                                                Services                                                this notice, you may make your request                demonstrations. Templates that will be
                                                [Document Identifiers: CMS–10434 and                    using one of following:                               submitted for approval under MACPro
                                                CMS–R–131]                                                1. Access CMS’ Web site address at                  include certain collections approved
                                                                                                        http://www.cms.hhs.gov/                               under our generic umbrella (CMS–
                                                Agency Information Collection                           PaperworkReductionActof1995.                          10398, OMB 0938–1148), relevant
                                                Activities: Proposed Collection;                          2. Email your request, including your               collections approved as a regular stand-
                                                Comment Request                                         address, phone number, OMB number,                    alone information collection requests,
                                                                                                        and CMS document identifier, to                       and upcoming collections. Form
                                                AGENCY: Centers for Medicare &
                                                                                                        Paperwork@cms.hhs.gov.                                Number: CMS–10434 (OMB Control
                                                Medicaid Services.
                                                                                                          3. Call the Reports Clearance Office at             Number: 0938–1188); Frequency:
                                                ACTION: Notice.                                         (410) 786–1326.                                       Monthly, yearly, quarterly, semi-
                                                SUMMARY:   The Centers for Medicare &                   FOR FURTHER INFORMATION CONTACT:                      annually, once, or occasionally;
                                                Medicaid Services (CMS) is announcing                   Reports Clearance Office at (410) 786–                Affected Public: State, Local, or Tribal
                                                an opportunity for the public to                        1326.                                                 Governments; Number of Respondents:
                                                comment on CMS’ intention to collect                    SUPPLEMENTARY INFORMATION:                            56; Total Annual Responses: 3,360;
                                                information from the public. Under the                                                                        Total Annual Hours: 89,012. (For policy
                                                Paperwork Reduction Act of 1995 (the                    Contents                                              questions regarding this collection
                                                PRA), federal agencies are required to                    This notice sets out a summary of the               contact Annette Pearson at 410–786–
                                                publish notice in the Federal Register                  use and burden associated with the                    6858).
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                                                concerning each proposed collection of                  following information collections. More                  2. Type of Information Collection
                                                information (including each proposed                    detailed information can be found in                  Request: Extension of a currently
                                                extension or reinstatement of an existing               each collection’s supporting statement                approved collection; Title of
                                                collection of information) and to allow                 and associated materials (see                         Information Collection: Advance
                                                60 days for public comment on the                       ADDRESSES).                                           Beneficiary Notice of Noncoverage
                                                proposed action. Interested persons are                 CMS–10434 Medicaid and CHIP                           (ABN); Use: The Advance Beneficiary
                                                invited to send comments regarding our                    Program (MACPro)                                    Notice (ABN) is delivered by Part B paid


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Document Created: 2015-12-14 15:05:17
Document Modified: 2015-12-14 15:05:17
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice and extension of comment period.
DatesNIOSH 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.
ContactDeborah 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: [email protected]
FR Citation80 FR 69226 

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