81 FR 2863 - 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

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

Federal Register Volume 81, Issue 11 (January 19, 2016)

Page Range		2863-2864
FR Document		2016-00827

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.

Federal Register, Volume 81 Issue 11 (Tuesday, January 19, 2016)

[Federal Register Volume 81, Number 11 (Tuesday, January 19, 2016)]
[Notices]
[Pages 2863-2864]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-00827]


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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.

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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: http://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: [email protected].
    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]
 BILLING CODE 4163-19-P

Federal Register / Vol. 81, No. 11 / Tuesday, January 19, 2016 / Notices 2863

ACTION: Meeting notice. 291, div. B, S3091, Dec. 19, 2014)), as DEPARTMENT OF HEALTH AND
a commission to ensure a suitable HUMAN SERVICES
SUMMARY: Notice of this meeting is being observance of the centennial of World
provided according to the requirements War I, to provide for the designation of Centers for Disease Control and
of the Federal Advisory Committee Act, Prevention
memorials to the service of members of
5 U.S.C. App. 10(a)(2). This notice
the United States Armed Forces in [Docket Number CDC–2015–0075; NIOSH–
provides the schedule and agenda for
World War I, and for other purposes. 288]
the January 25, 2016 meeting of the
World War One Centennial Commission Under this authority, the Committee
Request for Information on
(the Commission). The meeting is open will plan, develop, and execute Development of a Performance Test
to the public. programs, projects, and activities to Protocol for Closed System Transfer
DATES: The meeting will be held on commemorate the centennial of World Devices That Incorporate Air-Cleaning
Monday, January 25, 2016 starting at 10 War I, encourage private organizations Technology To Provide Worker
a.m. Eastern Standard Time (EST), and and State and local governments to Protection During Pharmacy
ending no later than 12:30 p.m., (EST). organize and participate in activities Compounding and Administration of
ADDRESSES: The meeting will be held at commemorating the centennial of World Hazardous Drugs
the office of the Jones Day Law firm at War I, facilitate and coordinate activities
51 Louisiana Ave. NW., Washington, DC throughout the United States relating to AGENCY: National Institute for
20001–2105. This location is the centennial of World War I, serve as Occupational Safety and Health
handicapped accessible. The meeting a clearinghouse for the collection and (NIOSH) of the Centers for Disease
will be open to the public and will also dissemination of information about Control and Prevention (CDC),
be available telephonically. Persons Department of Health and Human
events and plans for the centennial of
attending in person are requested to Services (HHS).
World War I, and develop
refrain from using perfume, cologne, ACTION: Request for information and
recommendations for Congress and the
and other fragrances (see http:// President for commemorating the comment.
www.accessboard.gov/about/policies/ centennial of World War I. The SUMMARY: The National Institute for
fragrance.htm for more information). Commission does not have an Occupational Safety and Health
Persons wishing to listen to the appropriation and operated solely on (NIOSH) of the Centers for Disease
proceedings may dial 712–432–1001 donated funds. Control and Prevention (CDC) requests
and enter access code 474845614. Note information for the development of a
this is not a toll-free number. Written Agenda: Monday, January 25, 2016
test protocol to evaluate the
Comments may be submitted to the performance of closed system drug-
Old Business
Commission and will be made part of transfer devices (CSTDs) that adopt air-
the permanent record of the • Approval of minutes of previous cleaning technologies. CSTDs are
Commission. Comments must be meetings generally available in two design types:
received by 5:00 p.m., (EST), January 21,
2016, and may be provided by email to: • Public Comment Period (1) One that uses a physical barrier to
block the unintended release of drug
daniel.dayton@ New Business into the surrounding environment or the
worldwar1centennial.org. Contact intake of environmental contaminants
Daniel S. Dayton at daniel.dayton@ • Commission Operating Status
into the sterile drug pathway and (2)
worldwar1centennial.org to register to • Requests for Support one that uses air cleaning or filtration
comment in person during the meeting’s
• WWI Memorial at Pershing Park— technologies to prevent the unintended
30 minute public comment period. release of drug into the surrounding
Registered speakers/organizations will Discussion and Vote
environment or the intake of
be allowed 5 minutes and will need to • International Report
environmental contaminants into the
provide written copies of their • Chairman’s Report sterile drug pathway. A draft protocol
presentations. Requests to comment at
the meeting must be received by 5 p.m. • Next Meeting titled, ‘‘A Vapor Containment
Other business as may properly come Performance Protocol for Closed System
Eastern time, January 21, 2016. Written
Transfer Devices Used During Pharmacy
presentations may be provided to Mr. before the Commission Adjourns.
Compounding and Administration of
Dayton at daniel.dayton@ Dated: January 13, 2016. Hazardous Drugs,’’ was developed by
worldwar1centennial.org until
Daniel S. Dayton, NIOSH to evaluate how protective the
Thursday, January 21, 2016. Please
Designated Federal Official, World War I physical barrier-type CSTD devices
contact Mr. Dayton at the email address
Centennial Commission. were as an indicator of how effective
above to obtain meeting materials.
[FR Doc. 2016–00911 Filed 1–15–16; 8:45 am] they would be at preventing hazardous
FOR FURTHER INFORMATION CONTACT: drug escape from the closed system.
Daniel S. Dayton, Designated Federal BILLING CODE 6820–95–P
This RFI seeks information from the
Officer, World War 1 Centennial public regarding the feasibility of
Commission, 701 Pennsylvania Avenue developing a protocol applicable to
NW., 123, Washington, DC 20004–2608,
asabaliauskas on DSK5VPTVN1PROD with NOTICES

CSTDs using air cleaning or filtration
at 202–380–0725 (note: this is not a toll- technologies and to request information
free number). from stakeholders on this topic.
SUPPLEMENTARY INFORMATION:
Table of Contents
Background
• DATES:
The World War One Centennial • ADDRESSES:
Commission was established by Public • INSTRUCTIONS:
Law 112–272 (as amended (Pub. L. 113– • FOR FURTHER INFORMATION:

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Document Created: 2016-01-16 01:10:39
Document Modified: 2016-01-16 01:10:39

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Request for information and comment.
Dates		Electronic or written comments should be received on or before March 8, 2016.
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: [email protected]
FR Citation		81 FR 2863

81 FR 2863 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention

Federal Register Volume 81, Issue 11 (January 19, 2016)

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