[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]


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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