Request for Information on Development of a Performance Test Protocol for Closed System Transfer Devices That Incorporate Air-Cleaning Technology To Provide Worker Protection During Pharmacy Compounding and Administration of Hazardous Drugs, 2863-2864 [2016-00827]
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Federal Register / Vol. 81, No. 11 / Tuesday, January 19, 2016 / Notices
ACTION:
Meeting notice.
Notice of this meeting is being
provided according to the requirements
of the Federal Advisory Committee Act,
5 U.S.C. App. 10(a)(2). This notice
provides the schedule and agenda for
the January 25, 2016 meeting of the
World War One Centennial Commission
(the Commission). The meeting is open
to the public.
DATES: The meeting will be held on
Monday, January 25, 2016 starting at 10
a.m. Eastern Standard Time (EST), and
ending no later than 12:30 p.m., (EST).
ADDRESSES: The meeting will be held at
the office of the Jones Day Law firm at
51 Louisiana Ave. NW., Washington, DC
20001–2105. This location is
handicapped accessible. The meeting
will be open to the public and will also
be available telephonically. Persons
attending in person are requested to
refrain from using perfume, cologne,
and other fragrances (see https://
www.accessboard.gov/about/policies/
fragrance.htm for more information).
Persons wishing to listen to the
proceedings may dial 712–432–1001
and enter access code 474845614. Note
this is not a toll-free number. Written
Comments may be submitted to the
Commission and will be made part of
the permanent record of the
Commission. Comments must be
received by 5:00 p.m., (EST), January 21,
2016, and may be provided by email to:
daniel.dayton@
worldwar1centennial.org. Contact
Daniel S. Dayton at daniel.dayton@
worldwar1centennial.org to register to
comment in person during the meeting’s
30 minute public comment period.
Registered speakers/organizations will
be allowed 5 minutes and will need to
provide written copies of their
presentations. Requests to comment at
the meeting must be received by 5 p.m.
Eastern time, January 21, 2016. Written
presentations may be provided to Mr.
Dayton at daniel.dayton@
worldwar1centennial.org until
Thursday, January 21, 2016. Please
contact Mr. Dayton at the email address
above to obtain meeting materials.
FOR FURTHER INFORMATION CONTACT:
Daniel S. Dayton, Designated Federal
Officer, World War 1 Centennial
Commission, 701 Pennsylvania Avenue
NW., 123, Washington, DC 20004–2608,
at 202–380–0725 (note: this is not a tollfree number).
SUPPLEMENTARY INFORMATION:
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUMMARY:
291, div. B, S3091, Dec. 19, 2014)), as
a commission to ensure a suitable
observance of the centennial of World
War I, to provide for the designation of
memorials to the service of members of
the United States Armed Forces in
World War I, and for other purposes.
Under this authority, the Committee
will plan, develop, and execute
programs, projects, and activities to
commemorate the centennial of World
War I, encourage private organizations
and State and local governments to
organize and participate in activities
commemorating the centennial of World
War I, facilitate and coordinate activities
throughout the United States relating to
the centennial of World War I, serve as
a clearinghouse for the collection and
dissemination of information about
events and plans for the centennial of
World War I, and develop
recommendations for Congress and the
President for commemorating the
centennial of World War I. The
Commission does not have an
appropriation and operated solely on
donated funds.
Agenda: Monday, January 25, 2016
Old Business
• Approval of minutes of previous
meetings
• Public Comment Period
New Business
• Commission Operating Status
• Requests for Support
• WWI Memorial at Pershing Park—
Discussion and Vote
• International Report
• Chairman’s Report
• Next Meeting
Other business as may properly come
before the Commission Adjourns.
Dated: January 13, 2016.
Daniel S. Dayton,
Designated Federal Official, World War I
Centennial Commission.
[FR Doc. 2016–00911 Filed 1–15–16; 8:45 am]
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Centers for Disease Control and
Prevention
[Docket Number CDC–2015–0075; NIOSH–
288]
Request for Information on
Development of a Performance Test
Protocol for Closed System Transfer
Devices That Incorporate Air-Cleaning
Technology To Provide Worker
Protection During Pharmacy
Compounding and Administration of
Hazardous Drugs
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: Request for information and
comment.
AGENCY:
The National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC) requests
information for the development of a
test protocol to evaluate the
performance of closed system drugtransfer devices (CSTDs) that adopt aircleaning technologies. CSTDs are
generally available in two design types:
(1) One that uses a physical barrier to
block the unintended release of drug
into the surrounding environment or the
intake of environmental contaminants
into the sterile drug pathway and (2)
one that uses air cleaning or filtration
technologies to prevent the unintended
release of drug into the surrounding
environment or the intake of
environmental contaminants into the
sterile drug pathway. A draft protocol
titled, ‘‘A Vapor Containment
Performance Protocol for Closed System
Transfer Devices Used During Pharmacy
Compounding and Administration of
Hazardous Drugs,’’ was developed by
NIOSH to evaluate how protective the
physical barrier-type CSTD devices
were as an indicator of how effective
they would be at preventing hazardous
drug escape from the closed system.
This RFI seeks information from the
public regarding the feasibility of
developing a protocol applicable to
CSTDs using air cleaning or filtration
technologies and to request information
from stakeholders on this topic.
SUMMARY:
•
•
•
•
The World War One Centennial
Commission was established by Public
Law 112–272 (as amended (Pub. L. 113–
17:50 Jan 15, 2016
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Table of Contents
Background
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DATES:
ADDRESSES:
INSTRUCTIONS:
FOR FURTHER INFORMATION:
19JAN1
asabaliauskas on DSK5VPTVN1PROD with NOTICES
2864
Federal Register / Vol. 81, No. 11 / Tuesday, January 19, 2016 / Notices
• BACKGROUND:
• INFORMATION NEEDS:
DATES: Electronic or written comments
should be received on or before 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: https://
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, OH 45226–1998.
Instructions: All information received
in response to this notice must include
the agency name and 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. For
access to the docket to read background
documents or comments received, go to
www.regulations.gov. 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:
Gayle DeBord, NIOSH, Division of
Applied Research and Technologies,
Robert A. Taft Laboratories, 1090
Tusculum Avenue, MS–R2, Cincinnati,
Ohio 45226, Phone: (513) 841–4256 [not
a toll-free number], Email:
hazardousdrugs@cdc.gov.
Background: The purpose of the RFI
is to seek information relative to the
development of a performance
evaluation protocol for CSTDs using air
cleaning or filtration technologies. The
draft protocol released for public
comment on September 8, 2015 [80 FR
53802] is applicable to barrier-type
CSTDs only. This RFI expands the scope
of the previous RFI to seek information
to support development of a companion
protocol that would apply to CSTDs
using air cleaning or filtration
technologies, thus covering the
remainder of the currently known CSTD
marketplace.
Information Needs: Additional data
and information are needed to assist
NIOSH to develop or adapt a test
protocol for evaluating the efficiency of
air cleaning or filtration technologies
CSTDs. In particular, NIOSH requests
submission of existing test protocols
developed for efficacy testing of air
cleaning or filtration technologies
CSTDs.
The National Institute for
Occupational Safety and Health seeks
VerDate Sep<11>2014
17:50 Jan 15, 2016
Jkt 238001
public comments in response to the
following questions. Please feel free to
comment on any or all of the questions
below:
1. Are there any other types of CSTDs
available that would not fit into the two
categories described, i.e., (1) barrier
systems, and (2) air-cleaning or filtration
technologies?
2. Is there an existing test protocol for
evaluation of the protective efficacy of
air-cleaning or filtration technologies
CSTDs? Can this test protocol, and/or
the details of the underlying procedures
and test data be shared with NIOSH?
Please apply the following questions
to a protocol you have developed, one
you are aware of, or one you believe to
be feasible to develop:
3. Are there any special restrictions,
limiting assumptions or requirements
for expertise required to conduct the
protocol?
4. What are the performance criteria
used with the protocol tests to
determine acceptability and judge
conformity?
4. Does the protocol apply to
compounding operations,
administration activities or both?
5. Does this protocol use a surrogate
or does it require testing against the
actual hazardous drugs?
6. If a surrogate is used,
a. Does the surrogate represent all
hazardous drugs or a subset?
b. Which criteria are used in selection
of the surrogate?
c. Describe how the selection criteria
address the degree to which the
surrogate or surrogates are
representative of the class of hazardous
drugs to which they apply.
d. Does the surrogate introduce any
potential worker exposure hazards?
7. List the hazardous drugs for which
this protocol has been used.
a. How were these hazardous drugs
selected?
b. Were there any hazardous drugs for
which the test protocol was not or
would not be successful or compatible?
c. During protocol application, in
what state were the hazardous drugs,
e.g., full strength as delivered, full
strength reconstituted, patient dose with
diluent, or drug cocktail?
8. What procedure(s) can be used to
verify that the protocol is applicable for
new hazardous drugs as they are
identified and brought to market?
9. Can the test protocol be used
effectively for different formulations of
the same active pharmaceutical
ingredient?
10. If applicable, are you willing to
share details of your test protocol with
NIOSH? Would you be willing for the
protocol details to be shared publicly or
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
would you require the test protocol
details to be protected as proprietary
information?
11. If applicable, are you willing to
share test results from the application of
your air cleaning or filtration
technologies CSTD test protocol with
NIOSH?
12. Are you interested in being a
collaborative partner with NIOSH on the
development of an air cleaning or
filtration technologies CSTD test
protocol?
Responses to this notice are not offers
and cannot be accepted by the
Government to form a binding contract
or to issue a grant. Information obtained
as a result of this RFI may be used by
the government for program planning on
a non-attribution basis. Please do not
include any information that might be
considered proprietary, confidential, or
personally identifying (such as home
address or social security number).
Dated: January 12, 2016.
John Howard,
Director, National Institute for Occupational
Safety and Health, Centers for Disease Control
and Prevention.
[FR Doc. 2016–00827 Filed 1–15–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–16–15BBU]
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
E:\FR\FM\19JAN1.SGM
19JAN1
]]>Agencies
[Federal Register Volume 81, Number 11 (Tuesday, January 19, 2016)]
[Notices]
[Pages 2863-2864]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-00827]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket Number CDC-2015-0075; NIOSH-288]
Request for Information on Development of a Performance Test
Protocol for Closed System Transfer Devices That Incorporate Air-
Cleaning Technology To Provide Worker Protection During Pharmacy
Compounding and Administration of Hazardous Drugs
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: Request for information and comment.
-----------------------------------------------------------------------
SUMMARY: The National Institute for Occupational Safety and Health
(NIOSH) of the Centers for Disease Control and Prevention (CDC)
requests information for the development of a test protocol to evaluate
the performance of closed system drug-transfer devices (CSTDs) that
adopt air-cleaning technologies. CSTDs are generally available in two
design types: (1) One that uses a physical barrier to block the
unintended release of drug into the surrounding environment or the
intake of environmental contaminants into the sterile drug pathway and
(2) one that uses air cleaning or filtration technologies to prevent
the unintended release of drug into the surrounding environment or the
intake of environmental contaminants into the sterile drug pathway. A
draft protocol titled, ``A Vapor Containment Performance Protocol for
Closed System Transfer Devices Used During Pharmacy Compounding and
Administration of Hazardous Drugs,'' was developed by NIOSH to evaluate
how protective the physical barrier-type CSTD devices were as an
indicator of how effective they would be at preventing hazardous drug
escape from the closed system.
This RFI seeks information from the public regarding the
feasibility of developing a protocol applicable to CSTDs using air
cleaning or filtration technologies and to request information from
stakeholders on this topic.
Table of Contents
DATES:
ADDRESSES:
INSTRUCTIONS:
FOR FURTHER INFORMATION:
[[Page 2864]]
BACKGROUND:
INFORMATION NEEDS:
DATES: Electronic or written comments should be received on or before
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: https://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,
OH 45226-1998.
Instructions: All information received in response to this notice
must include the agency name and 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. For
access to the docket to read background documents or comments received,
go to www.regulations.gov. 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: Gayle DeBord, NIOSH, Division of
Applied Research and Technologies, Robert A. Taft Laboratories, 1090
Tusculum Avenue, MS-R2, Cincinnati, Ohio 45226, Phone: (513) 841-4256
[not a toll-free number], Email: hazardousdrugs@cdc.gov.
Background: The purpose of the RFI is to seek information relative
to the development of a performance evaluation protocol for CSTDs using
air cleaning or filtration technologies. The draft protocol released
for public comment on September 8, 2015 [80 FR 53802] is applicable to
barrier-type CSTDs only. This RFI expands the scope of the previous RFI
to seek information to support development of a companion protocol that
would apply to CSTDs using air cleaning or filtration technologies,
thus covering the remainder of the currently known CSTD marketplace.
Information Needs: Additional data and information are needed to
assist NIOSH to develop or adapt a test protocol for evaluating the
efficiency of air cleaning or filtration technologies CSTDs. In
particular, NIOSH requests submission of existing test protocols
developed for efficacy testing of air cleaning or filtration
technologies CSTDs.
The National Institute for Occupational Safety and Health seeks
public comments in response to the following questions. Please feel
free to comment on any or all of the questions below:
1. Are there any other types of CSTDs available that would not fit
into the two categories described, i.e., (1) barrier systems, and (2)
air-cleaning or filtration technologies?
2. Is there an existing test protocol for evaluation of the
protective efficacy of air-cleaning or filtration technologies CSTDs?
Can this test protocol, and/or the details of the underlying procedures
and test data be shared with NIOSH?
Please apply the following questions to a protocol you have
developed, one you are aware of, or one you believe to be feasible to
develop:
3. Are there any special restrictions, limiting assumptions or
requirements for expertise required to conduct the protocol?
4. What are the performance criteria used with the protocol tests
to determine acceptability and judge conformity?
4. Does the protocol apply to compounding operations,
administration activities or both?
5. Does this protocol use a surrogate or does it require testing
against the actual hazardous drugs?
6. If a surrogate is used,
a. Does the surrogate represent all hazardous drugs or a subset?
b. Which criteria are used in selection of the surrogate?
c. Describe how the selection criteria address the degree to which
the surrogate or surrogates are representative of the class of
hazardous drugs to which they apply.
d. Does the surrogate introduce any potential worker exposure
hazards?
7. List the hazardous drugs for which this protocol has been used.
a. How were these hazardous drugs selected?
b. Were there any hazardous drugs for which the test protocol was
not or would not be successful or compatible?
c. During protocol application, in what state were the hazardous
drugs, e.g., full strength as delivered, full strength reconstituted,
patient dose with diluent, or drug cocktail?
8. What procedure(s) can be used to verify that the protocol is
applicable for new hazardous drugs as they are identified and brought
to market?
9. Can the test protocol be used effectively for different
formulations of the same active pharmaceutical ingredient?
10. If applicable, are you willing to share details of your test
protocol with NIOSH? Would you be willing for the protocol details to
be shared publicly or would you require the test protocol details to be
protected as proprietary information?
11. If applicable, are you willing to share test results from the
application of your air cleaning or filtration technologies CSTD test
protocol with NIOSH?
12. Are you interested in being a collaborative partner with NIOSH
on the development of an air cleaning or filtration technologies CSTD
test protocol?
Responses to this notice are not offers and cannot be accepted by
the Government to form a binding contract or to issue a grant.
Information obtained as a result of this RFI may be used by the
government for program planning on a non-attribution basis. Please do
not include any information that might be considered proprietary,
confidential, or personally identifying (such as home address or social
security number).
Dated: January 12, 2016.
John Howard,
Director, National Institute for Occupational Safety and Health,
Centers for Disease Control and Prevention.
[FR Doc. 2016-00827 Filed 1-15-16; 8:45 am]
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