A Vapor Containment Performance Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs; Request for Comment, 53802-53803 [2015-22525]
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53802
Federal Register / Vol. 80, No. 173 / Tuesday, September 8, 2015 / Notices
information is aircraft traveling within
the United States.
This revision makes several
modification to this information
collection. They are as follows:
• In current practice, CDC does not
process applications for travel permits.
The issuance of travel restrictions is a
collaborative process between public
health partners, e.g., state health
departments, the Department of
Homeland Security, and CDC. There is
no standardized collection of
information involved. This change
results in the removal of the Ill Person
Travel Permit from the list of
information collections as well as the
removal of the associated burden.
• Reports of communicable disease or
death from domestic conveyances are
the facilitation of reporting using
electronic means, i.e., Air Traffic
Control and the Domestic Events
Network for domestic flights.
The resulting change in burden is a
reduction of 3,678 hours.
For reports of death or communicable
disease made by master of a vessel or
person in charge of a conveyance
engaged in interstate traffic, the
requested burden is approximately 23
hours. This total is estimated from 200
respondents submitting domestic
reports of death or communicable
disease a year, with an average burden
of 7 minutes per report. This totals 23
hours. There is no burden to
respondents other than the time
required to make the report of illness or
death.
almost always submitted electronically
via radio, so the current Master of
Vessel or Conveyance Illness Report has
been rendered obsolete. In addition,
CDC has issued guidance stating that
reports to CDC, instead of local health
authorities, regarding domestic reports
of communicable disease or death on
board conveyances meet the
requirements of the regulation;
therefore, information collections
related to copies sent to state health
departments are no longer necessary.
This primary concerns interstate flights.
• CDC is also requesting an
adjustment to the burden associated
with reports of communicable disease or
death from domestic conveyances. CDC
is reducing the burden from 15 minutes
per report to 7 minutes. This is due to
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Number of
respondents
Average
burden per
response
(in hours)
Total burden
(in hours)
Type of respondent
Form name
Master of a vessel or person in
charge of a conveyance.
42 CFR 70.4 Report by the master
of a vessel or person in charge of
conveyance of the incidence of a
communicable disease occurring
while in interstate travel.
200
1
7/60
23
Total ...........................................
...........................................................
........................
........................
........................
23
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.
[FR Doc. 2015–22549 Filed 9–4–15; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[CDC–2015–0075, Docket Number NIOSH–
288]
asabaliauskas on DSK5VPTVN1PROD with NOTICES
A Vapor Containment Performance
Protocol for Closed System Transfer
Devices Used During Pharmacy
Compounding and Administration of
Hazardous Drugs; 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:
VerDate Sep<11>2014
17:18 Sep 04, 2015
Jkt 235001
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 A Vapor Containment
Performance Protocol for Closed System
Transfer Devices Used During Pharmacy
Compounding and Administration of
Hazardous Drugs. 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.
SUMMARY:
Table of Contents
• DATES:
• ADDRESSES:
• FOR FURTHER INFORMATION
CONTACT:
• SUPPLEMENTARY INFORMATION:
Electronic or written comments
must be received by November 9, 2015.
ADDRESSES: You may submit comments,
identified by CDC–2015–0075 and
Docket Number NIOSH–288, by either
of the two following methods:
• Federal eRulemaking Portal:
www.regulations.gov Follow the
instructions for submitting comments.
• Mail: NIOSH Docket Office, Robert
A. Taft Laboratories, 1090 Tusculum
DATES:
PO 00000
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Avenue, MS–C34, Cincinnati, Ohio
45226.
Instructions: All information received
in response to this notice must include
the agency name and the docket number
(CDC–2015–0075; NIOSH–288). 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–2015–0075 and
Docket Number NIOSH–288. 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 45226–1998.
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, (513) 841–4141 (not a toll
free number), Email: hazardousdrugs@
cdc.gov.
The
purpose of the protocol is to test a
closed system transfer device’s (CSTD)
capability to perform as a closed system.
During an evaluation of the protocol,
SUPPLEMENTARY INFORMATION:
E:\FR\FM\08SEN1.SGM
08SEN1
Federal Register / Vol. 80, No. 173 / Tuesday, September 8, 2015 / Notices
registered pharmacists, familiar with the
use of CSTDs, tested the protocol’s
prescribed compounding and
administration tasks using five
commercially available CSTDs. They
also performed the assigned tasks using
a negative control condition without a
CSTD. Prescribed tasks were performed
in a NIOSH-developed environmental
test chamber with 70% isopropyl
alcohol (IPA) as the challenge agent. A
highly specific gas analyzer, with
measurement capabilities specific to
IPA and with a low limit of detection
(LOD), was used to detect vapor
concentrations of escaped IPA during
the tasks. The protocol is not intended
for CSTDs designed to operate using aircleaning technologies. This protocol has
multiple applications and can be used
by manufacturers to evaluate prototype
CSTDs, by consumers to compare CSTD
products, or by jurisdictions wishing to
adopt the protocol for a CSTD
performance certification procedure.
A panel consisting of peer reviewers
and stakeholders was asked to review
and comment on the draft guidance
document and protocol. NIOSH
reviewed the recommendations of the
peer reviewers and stakeholders then
made the final determination regarding
document content as well as the
decision not to propose a specific pass/
fail performance threshold. The protocol
is being published for comment in CDC–
2015–0075 and Docket Number NIOSH–
288 and can be found at
www.regulations.gov.
Dated: September 1, 2015.
John Howard,
Director, National Institute for Occupational
Safety and Health, Centers for Disease Control
and Prevention.
[FR Doc. 2015–22525 Filed 9–4–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10221]
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
ACTION:
Notice.
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
(PRA), federal agencies are required to
publish notice in the Federal Register
SUMMARY:
VerDate Sep<11>2014
17:18 Sep 04, 2015
Jkt 235001
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, and to allow
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate 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 on the collection(s) of
information must be received by the
OMB desk officer by October 8, 2015.
ADDRESSES: When commenting on the
proposed information collections,
please reference the document identifier
or OMB control number. To be assured
consideration, comments and
recommendations must be received by
the OMB desk officer via one of the
following transmissions: OMB, Office of
Information and Regulatory Affairs,
Attention: CMS Desk Officer, Fax
Number: (202) 395–5806 OR Email:
OIRA_ submission@omb.eop.gov.
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: Under the
Paperwork Reduction Act of 1995 (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 (44 U.S.C.
3506(c)(2)(A)) requires federal agencies
PO 00000
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53803
to publish a 30-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 that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Reinstatement without change
of a previously approved collection;
Title of Information Collection: Site
Investigation for Independent
Diagnostic Testing Facilities (IDTFs);
Use: We enroll Independent Diagnostic
Testing Facilities (IDTFs) into the
Medicare program via a uniform
application, the CMS 855B.
Implementation of enhanced procedures
for verifying the enrollment information
has improved the enrollment process as
well as identified and prevented
fraudulent IDTFs from entering the
Medicare program. As part of this
process, verification of compliance with
IDTF performance standards is
necessary. The primary function of the
site investigation form for IDTFs is to
provide a standardized, uniform tool to
gather information from an IDTF that
tells us whether it meets certain
standards to be a IDTF (as found in 42
CFR 410.33(g)) and where it practices or
renders its services. The site
investigation form has been used in the
past to aid in verifying compliance with
the required performance standards
found in 42 CFR 410.33(g). No revisions
have been made to this form since the
last submission for OMB approval. Form
Number: CMS–10221 (OMB Control
Number: 0938–1029); Frequency:
Occasionally; Affected Public: Private
Sector (Business or other for-profits and
Not-for-profit institutions); Number of
Respondents: 900; Total Annual
Responses: 900; Total Annual Hours:
1,800. (For policy questions regarding
this collection contact Kim McPhillips
at 410–786–5374).
Dated: September 2, 2015.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2015–22530 Filed 9–4–15; 8:45 am]
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]]>Agencies
[Federal Register Volume 80, Number 173 (Tuesday, September 8, 2015)]
[Notices]
[Pages 53802-53803]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-22525]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[CDC-2015-0075, Docket Number NIOSH-288]
A Vapor Containment Performance Protocol for Closed System
Transfer Devices Used During Pharmacy Compounding and Administration of
Hazardous Drugs; 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 A Vapor Containment Performance Protocol for Closed
System Transfer Devices Used During Pharmacy Compounding and
Administration of Hazardous Drugs. 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 November 9,
2015.
ADDRESSES: You may submit comments, identified by CDC-2015-0075 and
Docket Number NIOSH-288, by either of the two following methods:
Federal eRulemaking Portal: www.regulations.gov Follow the
instructions for submitting comments.
Mail: NIOSH Docket Office, Robert A. Taft Laboratories,
1090 Tusculum Avenue, MS-C34, Cincinnati, Ohio 45226.
Instructions: All information received in response to this notice
must include the agency name and the docket number (CDC-2015-0075;
NIOSH-288). 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-2015-0075 and Docket Number NIOSH-
288. 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 45226-1998.
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, (513) 841-4141 (not a
toll free number), Email: hazardousdrugs@cdc.gov.
SUPPLEMENTARY INFORMATION: The purpose of the protocol is to test a
closed system transfer device's (CSTD) capability to perform as a
closed system. During an evaluation of the protocol,
[[Page 53803]]
registered pharmacists, familiar with the use of CSTDs, tested the
protocol's prescribed compounding and administration tasks using five
commercially available CSTDs. They also performed the assigned tasks
using a negative control condition without a CSTD. Prescribed tasks
were performed in a NIOSH-developed environmental test chamber with 70%
isopropyl alcohol (IPA) as the challenge agent. A highly specific gas
analyzer, with measurement capabilities specific to IPA and with a low
limit of detection (LOD), was used to detect vapor concentrations of
escaped IPA during the tasks. The protocol is not intended for CSTDs
designed to operate using air-cleaning technologies. This protocol has
multiple applications and can be used by manufacturers to evaluate
prototype CSTDs, by consumers to compare CSTD products, or by
jurisdictions wishing to adopt the protocol for a CSTD performance
certification procedure.
A panel consisting of peer reviewers and stakeholders was asked to
review and comment on the draft guidance document and protocol. NIOSH
reviewed the recommendations of the peer reviewers and stakeholders
then made the final determination regarding document content as well as
the decision not to propose a specific pass/fail performance threshold.
The protocol is being published for comment in CDC-2015-0075 and Docket
Number NIOSH-288 and can be found at www.regulations.gov.
Dated: September 1, 2015.
John Howard,
Director, National Institute for Occupational Safety and Health,
Centers for Disease Control and Prevention.
[FR Doc. 2015-22525 Filed 9-4-15; 8:45 am]
BILLING CODE 4163-19-P
