A Performance Test Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs, 63482-63484 [2016-22132]

Agencies

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

[Federal Register Volume 81, Number 179 (Thursday, September 15, 2016)]
[Notices]
[Pages 63482-63484]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22132]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[CDC-2016-0090, Docket Number NIOSH 288-A]


A Performance Test Protocol for Closed System Transfer Devices 
Used 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: Notice of public meeting and request for public comment on a 
draft testing protocol.

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SUMMARY: The National Institute for Occupational Safety and Health 
(NIOSH) of the Centers for Disease Control and Prevention (CDC) 
announces a public meeting concerning a universal closed system drug-
transfer device (CSTD) testing protocol entitled, A Performance Test 
Protocol for Closed System Transfer Devices Used During Pharmacy 
Compounding and Administration of Hazardous Drugs, https://www.cdc.gov/niosh/topics/hazdrug/default.html/.
    This is an opportunity for public comment on the protocol, the 
proposed list of surrogates, and to respond to NIOSH questions 
regarding the protocol.
    To view the protocol and related materials, visit 
www.regulations.gov and enter CDC-2016-0090 in the search field and 
click ``Search.''

[[Page 63483]]

Table of Contents

I. Background
II. Protocol
III. Public Meeting

DATES: The public meeting will be held on November 7, 2016, 9:00 a.m.-
3:00 p.m. Eastern Time, or until after the last public commenter has 
spoken, whichever occurs first. Electronic or written comments must be 
received by December 7, 2016.

ADDRESSES: The public meeting will be held at the Alice Hamilton 
Laboratories, Conference Room C, 5555 Ridge Avenue, Cincinnati, OH 
45213. Virtual attendance using LiveMeeting and audio conference will 
be available.
    You may submit written comments, identified by CDC-2016-0090 and 
Docket Number NIOSH 288-A, by either of the following two 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.
    Instructions: All information received in response to this notice 
must include the agency name and docket number [CDC-2016-0090; NIOSH 
288-A]. All relevant comments received will be posted without change to 
https://www.regulations.gov, including any personal information 
provided. 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 Ave., MS R-5, Cincinnati, OH 45226. (513) 841-4141 (not a toll 
free number) or email DHirst@cdc.gov.

SUPPLEMENTARY INFORMATION:
    I. Background: Closed system drug-transfer devices (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. On September 8, 2015, NIOSH released the 
draft test protocol, A Vapor Containment Performance Protocol for 
Closed System Transfer Devices Used During Pharmacy Compounding and 
Administration of Hazardous Drugs, for public review. The draft 
protocol was developed by NIOSH to evaluate how containment effective 
the physical barrier-type CSTDs were as an indicator of how protective 
they would be at preventing hazardous drug escape from the closed 
system. After significant public comment and several inquiries, on 
January 19, 2016, NIOSH published a Request for Information for the 
development of a test protocol to evaluate the performance of CSTDs 
that adopt air-cleaning or filtration technologies. Since the Federal 
Register docket for both the draft protocol and the request for 
information closed on March 8, 2016, NIOSH has done the following:
    a. Generated a list of surrogates to test both types of CSTDs.
    b. Met individually with CSTD manufacturers who requested informal 
meetings to discuss the current draft protocol and/or items NIOSH 
should consider in developing a new performance test protocol for air-
cleaning CSTDs. This was in answer to NIOSH's Request for Information 
question #12, Are you interested in being a collaborative partner with 
NIOSH on the development of an air cleaning or filtration technologies 
CSTD test protocol?
    c. Drafted a new universal performance test protocol applicable to 
both barrier and air-cleaning types of CSTDs.
    II. Protocol: The proposed protocol will apply to both barrier and 
air-cleaning types of CSTDs, NIOSH will host a public meeting to give 
an update of new protocol developments. The update will include 
discussions covering proposed drug surrogates, benefits, and challenges 
with developing a new universal test protocol, and to allow the public 
to comment. Special emphasis will be placed upon the following:
     Proposed surrogates: Surrogates were identified based on 
vapor pressure and water solubility. Drug surrogates were chosen with 
vapor pressures up to 100 times that of the most volatile drug vapor 
pressure known to exist on the NIOSH hazardous drug list. The increased 
surrogate vapor pressure should offer a safety factor to the test 
protocol.
    [cir] Is the 100 times the vapor pressure safety factor adequate?
    [cir] Should other chemical properties besides vapor pressure and 
water solubility be considered?
    [cir] Are there other surrogates NIOSH should consider for testing 
the performance of CSTDs?
    [cir] Will any of the NIOSH's list of proposed surrogates cause 
damage to the CSTD plastic and/or parts (i.e., needles, septum, etc.)?
    [cir] Are there other aspects specific to air cleaning technologies 
that are not being challenged with the proposed surrogate testing 
protocol?
    [cir] Are there other aspects specific to the barrier CSTD 
technologies that are not being adequately challenged with the proposed 
surrogate testing protocol?
     Sampling Strategy: The new draft protocol relies upon 
analytical chemistry analysis of at least two simultaneously-collected 
sorbent tube air samples to detect drug surrogate escape from the CSTD.
    [cir] Should less or more sampling tubes be used inside the 
environmental test chamber?
    [cir] How should the sampling tubes be positioned inside the 
environmental test chamber?
    [cir] Since contaminant levels will no longer be immediately known, 
background concentrations will not be realized until after test 
completion and sample analysis. What metrics should be applied to the 
background concentrations and how should they impact the reported 
concentrations observed during conduct of the protocol tasks?
     Design of environmental test chamber: NIOSH proposes to 
keep the same environmental test chamber as that proposed for the 
original vapor containment test protocol, however airflow through the 
chamber will cease during the actual test procedures and air sampling.
    [cir] Should NIOSH keep the current design of the environmental 
test chamber?
     If not, what other designs should be considered and what 
validation requirements should be placed upon them?
    [cir] Sampling for escaped surrogate will be performed by a 
sampling pump and air sampling tubes.
     Are there concerns that the sample pump discharge air plus 
task-associated hand movements will be insufficient to provide adequate 
air mixing?
     Compounding and Administration tasks:
    [cir] NIOSH has updated Task 1 and Task 2 in Appendix A of the 
performance test protocol to incorporate the adoption of CSTD 
manufacturers' Instructions for Use (IFU).
     Should other manipulations be added or deleted from the 
current tasks listed in order to comply with a manufacturer's IFU?
    [cir] For purposes of challenging a CSTD's containment performance,

[[Page 63484]]

should the number of repetitions for each CSTD:Task pairing be less 
than or greater than 4?
     What special considerations has NIOSH not considered in 
developing the new draft performance test protocol?
    III. Public Meeting: NIOSH will hold a public meeting to discuss a 
universal closed system drug-transfer device (CSTD) testing (draft) 
protocol entitled, A Performance Test Protocol for Closed System 
Transfer Devices Used During Pharmacy Compounding and Administration of 
Hazardous Drugs. The meeting will allow commenters the opportunity to 
address the new draft protocol, the proposed list of hazardous drug 
test surrogates, and to discuss NIOSH questions regarding the new 
protocol.
    The meeting is open to the public, limited only by the capacity (80 
attendees) of the conference room. Confirm your attendance to this 
meeting by sending an email to DHirst@cdc.gov by October 21, 2016. An 
email confirming registration will be sent from NIOSH and will include 
details needed to participate.
    Registration is required for both in-person and LiveMeeting 
participation. An email confirming registration will be sent from NIOSH 
for both in-person participation and audio conferencing participation.
    Details required to participate via the audio conferencing will be 
provided by NIOSH in a separate email. This option will be available to 
participants on a first come, first served basis and is limited to the 
first 100 participants.
    Non-U.S. Citizens: Because of CDC Security Regulations, any non-
U.S. citizen wishing to attend this meeting in-person must provide the 
following information to Deborah V. Hirst. Requests may be submitted by 
facsimile (513) 841-4506, or emailed to DHirst@cdc.gov, no later than 
September 28, 2016. The information required includes:

Name:
Gender:
Date of Birth:
Place of Birth (city, province, state, country):
Citizenship:
Passport Number:
Date of Passport Issue:
Date of Passport Expiration:
Type of Visa:
U.S. Naturalization Number (if a naturalized citizen):
U.S. Naturalization Date (if a naturalized citizen):
Visitor's Organization:
Organization Address:
Organization Telephone Number:
Visitor's Position/Title within the Organization:

    This information will be transmitted to the CDC Security Office for 
approval. Visitors will be notified as soon as approval has been 
obtained. If access approval is not granted to a non-U.S. Citizen, the 
individual may participate by LiveMeeting and audio conference.
    Requests to provide oral comments at the public meeting should be 
submitted by telephone (513) 841-4141, facsimile (513) 841-4506, or 
emailed to DHirst@cdc.gov with ``Request to Speak'' in the subject 
line. Requests can also be mailed to Deborah V. Hirst, 1090 Tusculum 
Ave., MS R-5, Cincinnati, OH 45226. All requests to speak should 
contain the name, address, telephone number, and relevant business 
affiliations of the speaker, and the approximate time requested for 
oral comments. Requests must be received by October 21, 2016.
    Oral comments from each speaker will be limited to 10 minutes. 
After reviewing the requests to make oral comments, NIOSH will notify 
the speaker when his/her oral comments are scheduled. If a participant 
is not in attendance when he/she is scheduled to speak, the remaining 
participants will be heard in order. After the last scheduled speaker 
is heard, participants who missed their assigned times may be allowed 
to speak, limited by time available.
    Attendees who wish to speak but did not submit a request for the 
opportunity to make oral comments may be given this opportunity after 
the scheduled speakers are heard, at the discretion of the presiding 
officer and limited by time available.
    Oral comments will be transcribed and included in the docket.

John Howard,
Director, National Institute for Occupational Safety and Health, 
Centers for Disease Control and Prevention.
[FR Doc. 2016-22132 Filed 9-14-16; 8:45 am]
 BILLING CODE 4163-19-P