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]
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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]
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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:
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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:
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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:
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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
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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
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]]>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]
-----------------------------------------------------------------------
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: 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
