[Federal Register Volume 78, Number 70 (Thursday, April 11, 2013)]
[Notices]
[Pages 21607-21608]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-08461]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


National Institute for Occupational Safety and Health Partnership 
Opportunity on a Research Project To Evaluate the Performance of 
Isolation Gowns

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 opportunity to support research.

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SUMMARY: The NIOSH National Personal Protective Technology Laboratory 
is initiating a research study in support of American Society for 
Testing and Materials (ASTM) International standards development to 
establish minimum performance requirements for isolation gowns for 
health care workers. NIOSH is seeking to identify currently marketed 
isolation gown products. All manufacturers are requested to submit 
samples to NIOSH free of charge for testing. There will be no cost to 
the manufacturers for testing. Not all submitted products may be 
tested, depending on the response to this announcement and the results 
of screening tests. Each manufacturer that submits gowns that are 
tested will receive the test results from their gowns. Through 
submission of the gown samples, manufacturers will be making an 
important contribution to ASTM, International's process to establish an 
important standard for evaluating the protection provided for health 
care workers by isolation gowns. Participating manufacturers will be 
recognized as contributing to the establishment of the performance 
standard. Manufacturers whose products are tested will also receive the 
results of all gowns tested in a blinded format.
    Gown Criteria: Candidate gowns for inclusion in the research 
program must meet the following criteria: (1) The gowns must be 
identified (labeled) as ``isolation gowns'' and have full coverage in 
the back to provide protection for the health care worker and the 
patient; (2) A minimum of 100 units for each code (model) of disposable 
(single use) gown submitted; (3) A minimum of 200 ``new'' (unprocessed, 
unused, unwashed) reusable gowns for each model submitted. Reusable 
gown submissions must include a labeling recommendation for the maximum 
number of laundering cycles to be included in this study. Half of the 
gown samples will be tested after one laundering and drying cycle and 
half of the gown samples will be tested as laundered for the maximum 
number of cycles claimed by the manufacturer; and, (4) Samples should 
be provided in finished package format, with any claims that may not be 
noted on the packaging or labels provided by the manufacturer. NIOSH 
will not return any gowns submitted for this testing.

DATES: Submit letters of interest to provide gowns and participate in 
this research program prior to May 13, 2013.

ADDRESSES: Interested manufacturers should submit a letter of interest 
with information about their isolation gowns' capabilities to: NIOSH, 
National Personal Protective Technology Laboratory, Attn: Selcen 
Kilinc, PO Box 18070, Pittsburgh, PA 15236, Email address: [email protected]
    Background: It has been reported by user groups (e.g. Association 
of Perioperative Registered Nurses and Association for Professionals in 
Infection Control and Epidemiology) as well as U.S. Food and Drug 
Administration (FDA), that performance properties and levels of 
protection for isolation gowns are poorly understood and defined. NIOSH 
and FDA are currently working with the ASTM International Committee on 
Personal Protective Clothing and Equipment--Biological Subcommittee, to 
establish a standard that defines criteria for measurement and minimum 
levels of performance for isolation gowns. Development of a standard is 
expected

[[Page 21608]]

to improve users' understanding of levels of protection to be provided.
    Product testing results will be provided to the ASTM Committee on 
Personal Protective Clothing and Equipment--Biological Subcommittee 
(a.k.a. ASTM Task Force), which will utilize the data as the scientific 
basis to develop a standard establishing minimum performance criteria 
for single-use and reusable isolation gowns. The research objective is 
to evaluate performance properties, such as strength and barrier 
properties, of isolation gowns to be provided to the ASTM Task Force as 
scientific input for establishing minimum performances for conformance 
to this standard.
    In this study, all testing will be conducted blind. Results will be 
shared with the ASTM Task Force only in a blinded format. Results will 
be shared with the individual manufacturers for their gowns only. The 
final summary of the testing will be shared in a blinded format only 
with all manufacturers that participated.
    Randomized samples will be tested by both NIOSH and Nelson Labs. 
The ASTM Task Force will review and analyze all test results. 
Establishment of the minimum requirement for each property will be the 
responsibility of the ASTM Task Force. NIOSH plans to conduct testing 
to measure the following properties: Fabric weight, breaking strength, 
tear strength, seam strength, water resistance (impact penetration and 
hydrostatic pressure), microbial/viral penetration resistance, air 
permeability, evaporative resistance, and thermal insulation.
    Neither this announcement, nor product submittals in response to 
this announcement, obligates NIOSH to enter into a contractual 
agreement with any respondent. Inquiries should be sent to Selcen 
Kilinc at [email protected]. NIOSH reserves the right to establish a 
partnership based on scientific analysis and capabilities found by way 
of this announcement or other searches, if determined to be in the best 
interest of the government.

    Dated: April 5, 2013.
John Howard,
Director, National Institute for Occupational Safety and Health, 
Centers for Disease Control and Prevention.
[FR Doc. 2013-08461 Filed 4-10-13; 8:45 am]
BILLING CODE 4163-19-P