82 FR 15061 - Effect of Stockpiling Conditions on the Performance of Medical N95 Respirators and High-Level Protective Surgical Gowns

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

Federal Register Volume 82, Issue 56 (March 24, 2017)

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention announces the request for information about facilities that stockpile N95 respirators and high-level protective surgical gowns.

[Federal Register Volume 82, Number 56 (Friday, March 24, 2017)]
[Notices]
[Pages 15061-15062]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-05896]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket Number CDC-2017-0024, NIOSH-297]


Effect of Stockpiling Conditions on the Performance of Medical 
N95 Respirators and High-Level Protective Surgical 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: Request for information.

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SUMMARY: The National Institute for Occupational Safety and Health 
(NIOSH) of the Centers for Disease Control and Prevention announces the 
request for information about facilities that stockpile N95 respirators 
and high-level protective surgical gowns.

DATES: Electronic or written submissions must be received by [30 days 
from FRN posting].

ADDRESSES: You may submit responses, identified by CDC-2017-0024 and 
docket number NIOSH-297, by any of the following 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-2017-0024; NIOSH-
297]. All relevant responses 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 information 
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 45226-1998.

FOR FURTHER INFORMATION CONTACT: Kerri Wizner, NIOSH, National Personal 
Protective Technology Laboratory, Research Branch, 626 Cochrans Mill 
Road, Building 19A, Pittsburgh, PA 15236, (412) 386-5225, (not a toll 
free number).

SUPPLEMENTARY INFORMATION: NIOSH seeks information about personal 
protective equipment (PPE) environmental storage conditions and 
inventory for federal, state, municipal, county, and hospital system 
stockpiles. Maintaining PPE stockpiles for public health emergencies is 
a significant cost and time investment for these various entities, 
which may include purchasing new products, maintaining inventory 
records, and lease or purchase of environmentally controlled storage 
space away from contaminated areas, dust, sun light, extreme 
temperatures, excessive moisture, and damaging chemicals. The 
information provided by respondents to this Notice will be used to 
inform a research study design where N95 respirators and high-
protection level surgical gowns are sampled from stockpiles and tested 
against established performance standards. The research study will be 
designed to obtain scientific data to assess (1) the potential to 
extend manufacturer-recommended shelf life and (2) the effect of 
common, albeit sometimes non-ideal, stockpile conditions on the 
protections provided by respirators and surgical gowns. NIOSH seeks to 
sample N95 respirators and high-protection level surgical gowns from a 
variety of stockpiles representing contemporary storage conditions from 
across the nation. To that end, the information sought in this Notice 
is aimed at ensuring that study findings are broadly applicable to U.S. 
stockpiles.
    Background: Various entities stockpile personal protective 
equipment (PPE) in preparation for public health responses to outbreaks 
of high consequence infectious diseases such as SARS, influenza, and 
Ebola, where PPE demand may outpace supply. Stockpiling PPE is a costly 
endeavor that includes PPE purchase, storage space, product rotation 
over time, and environmental controls for heat, humidity, dust, and 
sunlight. Resource limitations may lead facilities to stockpile PPE in 
environments that do not meet manufacturer storage recommendations or 
exceed shelf life, increasing the potential for PPE degradation. Even 
when resources exist to store PPE per manufacturer's environmental 
recommendations, the influence of long-term storage time alone on PPE 
performance has been questioned. Additionally, large quantities of 
stockpiled PPE obtained during previous nationwide responses may now be 
exceeding its shelf life and expected replacement costs will likely far 
exceed available budgets. Data is needed to better understand the 
potential impact upon worker health and safety.
    Information Needs: Information is needed to assist NIOSH in 
identifying important factors to focus the research study design. 
Information is needed from facilities that stockpile N95 respirators 
and high-level protective surgical gowns for use during public health 
emergencies. Please ensure the type of stockpile you are affiliated 
with is included in the responses to any of the below questions.
    1. Please describe the type of stockpile with which you are 
affiliated (e.g., federal, state, county). Please describe the end 
users of the stockpiled products (e.g., healthcare workers, public).
    2. Please describe the extent to which environmental controls are 
implemented and maintained. For example, does the stockpile employ 
controls against humidity, temperature, sunlight, dust, or chemical 
exposure? Please describe how these controls are implemented, 
monitored, regularity of monitoring, and what optimal conditions are. 
Available guidance documents used for the stockpile would

[[Page 15062]]

be welcome. What are the barriers to maintaining these controls? What 
factors are currently not being controlled that you feel are relevant 
to this effort?
    3. How do you monitor for N95 respirator and high-level protective 
surgical gown deterioration? What are signs of deterioration you 
consider (e.g., cosmetic, box damage, expiration dates)? What are 
barriers in determining deterioration?
    4. If applicable, please describe your process for PPE rotation. 
For example, please describe your process for ensuring new products are 
purchased upon expiration of shelf-life for currently stockpiled N95 
respirators/high-level surgical gowns. Quantity estimates of the 
stockpiled N95 respirator/surgical gown inventory exceeding the 
recommended shelf life would be valuable to the design of this study.
    5. If stockpiled N95 respirators/surgical gowns are purchased from 
a distributor (i.e. not directly from the manufacturer), please 
describe your process for obtaining information on storage practices 
from these distributors.
    6. What types of controls are available in the shipping 
environment? Do they instruct points-of-use on storage requirements? 
Other use limitations/instructions?
    7. Please provide information about the N95 respirator and high-
level surgical gown inventory available in the stockpile, including 
brands, models, and related estimated numbers to help us better 
understand the type and quantities of PPE that may be affected by this 
research.

Frank Hearl,
Chief of Staff, National Institute for Occupational Safety and Health, 
Centers for Disease Control and Prevention.
[FR Doc. 2017-05896 Filed 3-23-17; 8:45 am]
 BILLING CODE 4163-19-P