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)

Page Range		15061-15062
FR Document		2017-05896

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 Issue 56 (Friday, March 24, 2017)

[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

Federal Register / Vol. 82, No. 56 / Friday, March 24, 2017 / Notices 15061

Using average wage rates for relevant that stockpile N95 respirators and high- by respirators and surgical gowns.
job categories from 2016 BLS data, the level protective surgical gowns. NIOSH seeks to sample N95 respirators
total annual costs associated with these DATES: Electronic or written and high-protection level surgical
data collections per year are submissions must be received by [30 gowns from a variety of stockpiles
$116,746.13 as shown in Table 2 above, days from FRN posting]. representing contemporary storage
for a total cost for all three years of ADDRESSES: You may submit responses, conditions from across the nation. To
$350,238.39. identified by CDC–2017–0024 and that end, the information sought in this
docket number NIOSH–297, by any of Notice is aimed at ensuring that study
Request for Comments
the following methods: findings are broadly applicable to U.S.
In accordance with the Paperwork • Federal eRulemaking Portal: stockpiles.
Reduction Act, comments on AHRQ’s www.regulations.gov. Follow the Background: Various entities
information collection are requested instructions for submitting comments. stockpile personal protective equipment
with regard to any of the following: (a) • Mail: National Institute for (PPE) in preparation for public health
Whether the proposed collection of Occupational Safety and Health, NIOSH responses to outbreaks of high
information is necessary for the proper Docket Office, 1090 Tusculum Avenue, consequence infectious diseases such as
performance of AHRQ health care MS C–34, Cincinnati, Ohio 45226–1998. SARS, influenza, and Ebola, where PPE
research and health care information Instructions: All information received demand may outpace supply.
dissemination functions, including in response to this notice must include Stockpiling PPE is a costly endeavor
whether the information will have the agency name and docket number that includes PPE purchase, storage
practical utility; (b) the accuracy of [CDC–2017–0024; NIOSH–297]. All space, product rotation over time, and
AHRQ’s estimate of burden (including relevant responses received will be environmental controls for heat,
hours and costs) of the proposed posted without change to humidity, dust, and sunlight. Resource
collection(s) of information; (c) ways to www.regulations.gov, including any limitations may lead facilities to
enhance the quality, utility and clarity personal information provided. For stockpile PPE in environments that do
of the information to be collected; and access to the docket to read background not meet manufacturer storage
(d) ways to minimize the burden of the documents or information received, go recommendations or exceed shelf life,
collection of information upon the to www.regulations.gov. All information increasing the potential for PPE
respondents, including the use of received in response to this notice will degradation. Even when resources exist
automated collection techniques or also be available for public examination to store PPE per manufacturer’s
other forms of information technology. and copying at the NIOSH Docket environmental recommendations, the
Comments submitted in response to influence of long-term storage time
Office, 1150 Tusculum Avenue, Room
this notice will be summarized and alone on PPE performance has been
155, Cincinnati, OH 45226–1998.
included in the Agency’s subsequent questioned. Additionally, large
FOR FURTHER INFORMATION CONTACT:
request for OMB approval of the quantities of stockpiled PPE obtained
proposed information collection. All Kerri Wizner, NIOSH, National Personal
during previous nationwide responses
comments will become a matter of Protective Technology Laboratory,
may now be exceeding its shelf life and
public record. Research Branch, 626 Cochrans Mill
expected replacement costs will likely
Road, Building 19A, Pittsburgh, PA
Sharon B. Arnold,
far exceed available budgets. Data is
15236, (412) 386–5225, (not a toll free
needed to better understand the
Acting Director. number).
potential impact upon worker health
[FR Doc. 2017–05839 Filed 3–23–17; 8:45 am] SUPPLEMENTARY INFORMATION: NIOSH and safety.
BILLING CODE 4160–90–P seeks information about personal Information Needs: Information is
protective equipment (PPE) needed to assist NIOSH in identifying
environmental storage conditions and important factors to focus the research
DEPARTMENT OF HEALTH AND inventory for federal, state, municipal, study design. Information is needed
HUMAN SERVICES county, and hospital system stockpiles. from facilities that stockpile N95
Maintaining PPE stockpiles for public respirators and high-level protective
Centers for Disease Control and health emergencies is a significant cost
Prevention surgical gowns for use during public
and time investment for these various health emergencies. Please ensure the
[Docket Number CDC–2017–0024, NIOSH– entities, which may include purchasing type of stockpile you are affiliated with
297] new products, maintaining inventory is included in the responses to any of
records, and lease or purchase of the below questions.
Effect of Stockpiling Conditions on the environmentally controlled storage 1. Please describe the type of
Performance of Medical N95 space away from contaminated areas, stockpile with which you are affiliated
Respirators and High-Level Protective dust, sun light, extreme temperatures, (e.g., federal, state, county). Please
Surgical Gowns excessive moisture, and damaging describe the end users of the stockpiled
AGENCY: National Institute for chemicals. The information provided by products (e.g., healthcare workers,
Occupational Safety and Health respondents to this Notice will be used public).
(NIOSH) of the Centers for Disease to inform a research study design where 2. Please describe the extent to which
Control and Prevention (CDC), N95 respirators and high-protection environmental controls are
Department of Health and Human level surgical gowns are sampled from implemented and maintained. For
stockpiles and tested against established example, does the stockpile employ
jstallworth on DSK7TPTVN1PROD with NOTICES

Services (HHS).
ACTION: Request for information. performance standards. The research controls against humidity, temperature,
study will be designed to obtain sunlight, dust, or chemical exposure?
SUMMARY: The National Institute for scientific data to assess (1) the potential Please describe how these controls are
Occupational Safety and Health to extend manufacturer-recommended implemented, monitored, regularity of
(NIOSH) of the Centers for Disease shelf life and (2) the effect of common, monitoring, and what optimal
Control and Prevention announces the albeit sometimes non-ideal, stockpile conditions are. Available guidance
request for information about facilities conditions on the protections provided documents used for the stockpile would

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15062 Federal Register / Vol. 82, No. 56 / Friday, March 24, 2017 / Notices

be welcome. What are the barriers to SUMMARY: The Administration for Wisconsin Avenue, Bethesda, MD 20892
maintaining these controls? What Community Living published a (Telephone Conference Call).
factors are currently not being proposed collection of information Contact Person: Greg Bissonette, Ph.D.,
controlled that you feel are relevant to document in the Federal Register on Scientific Review Officer, National Institute
this effort? March 13, 2017. (82 FR 13457 and on Aging, National Institutes of Health,
3. How do you monitor for N95 13458) The document title and Gateway Building, Suite 2W200, 7201
summary incorrectly stated that no Wisconsin Avenue, Bethesda, Md 20892,
respirator and high-level protective
changes were proposed to the currently 301–402–1622, bissonettegb@mail.nih.gov.
surgical gown deterioration? What are
signs of deterioration you consider (e.g., approved collection. (Catalogue of Federal Domestic Assistance
cosmetic, box damage, expiration FOR FURTHER INFORMATION CONTACT: Program Nos. 93.866, Aging Research,
dates)? What are barriers in determining Heather Menne at 202–795–7733 or National Institutes of Health, HHS)
deterioration? Heather.Menne@acl.hhs.gov. Dated: March 20, 2017.
4. If applicable, please describe your Melanie J. Pantoja,
Corrections
process for PPE rotation. For example, Program Analyst, Office of Federal Advisory
please describe your process for The Title of the Notice should read: Committee Policy.
ensuring new products are purchased Agency Information Collection [FR Doc. 2017–05837 Filed 3–23–17; 8:45 am]
upon expiration of shelf-life for Activities; Proposed Collection; Public
BILLING CODE 4140–01–P
currently stockpiled N95 respirators/ Comment Request; Proposed Extension
high-level surgical gowns. Quantity with Modifications of a Currently
estimates of the stockpiled N95 Approved Collection; National Survey
DEPARTMENT OF HEALTH AND
respirator/surgical gown inventory of Older Americans Act Participants.
HUMAN SERVICES
exceeding the recommended shelf life Under the SUMMARY section, page 13457,
would be valuable to the design of this column two, correct the last sentence in National Institutes of Health
study. the section to read: ‘‘This notice solicits
5. If stockpiled N95 respirators/ comments on a proposed extension with National Institute of Allergy and
surgical gowns are purchased from a modifications to a currently approved Infectious Diseases; Notice of Closed
distributor (i.e. not directly from the collection.’’ Meeting
manufacturer), please describe your Dated: March 20, 2017.
process for obtaining information on Daniel P. Berger, Pursuant to section 10(d) of the
storage practices from these distributors. Acting Administrator and Assistant Secretary Federal Advisory Committee Act, as
6. What types of controls are available for Aging. amended (5 U.S.C. App.), notice is
in the shipping environment? Do they [FR Doc. 2017–05827 Filed 3–23–17; 8:45 am]
hereby given of the following meeting.
instruct points-of-use on storage BILLING CODE 4154–01–P The meeting will be closed to the
requirements? Other use limitations/ public in accordance with the
instructions? provisions set forth in sections
7. Please provide information about DEPARTMENT OF HEALTH AND 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
the N95 respirator and high-level HUMAN SERVICES as amended. The grant applications and
surgical gown inventory available in the the discussions could disclose
stockpile, including brands, models, National Institutes of Health confidential trade secrets or commercial
and related estimated numbers to help property such as patentable material,
National Institute on Aging; Notice of and personal information concerning
us better understand the type and
Closed Meeting individuals associated with the grant
quantities of PPE that may be affected
by this research. Pursuant to section 10(d) of the applications, the disclosure of which
Federal Advisory Committee Act, as would constitute a clearly unwarranted
Frank Hearl,
amended (5 U.S.C. App.), notice is invasion of personal privacy.
Chief of Staff, National Institute for
Occupational Safety and Health, Centers for
hereby given of the following meeting. Name of Committee: National Institute of
Disease Control and Prevention. The meeting will be closed to the Allergy and Infectious Diseases; Special
[FR Doc. 2017–05896 Filed 3–23–17; 8:45 am]
public in accordance with the Emphasis Panel NIAID Investigator Initiated
provisions set forth in sections Program Project Applications (P01)
BILLING CODE 4163–19–P
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Date: April 18–19, 2017.
as amended. The grant applications and Time: 9:00 a.m. to 5:00 p.m.
DEPARTMENT OF HEALTH AND the discussions could disclose Agenda: To review and evaluate grant
confidential trade secrets or commercial applications.
HUMAN SERVICES
property such as patentable material, Place: National Institutes of Health, 5601
Administration for Community Living and personal information concerning Fishers Lane, Rockville, MD 20892
individuals associated with the grant (Telephone Conference Call)
Agency Information Collection applications, the disclosure of which Contact Person: Geetanjali Bansal, Ph.D.,
Activities; Proposed Collection; Public would constitute a clearly unwarranted Scientific Reviewer Officer, Scientific Review
Comment Request; Proposed invasion of personal privacy. Program, Division of Extramural Activities,
Extension With Modifications of a Room 3G49, National Institutes of Health/
Name of Committee: National Institute on
jstallworth on DSK7TPTVN1PROD with NOTICES

Currently Approved Collection; NIAID, 5601 Fishers Lane, MSC 9834,
Aging Special Emphasis Panel; Brain Bethesda, MD 20892–9834, (240) 669–5073,
National Survey of Older Americans Lymphatics and Alzheimer’s Disease. geetanjali.bansal@nih.gov.
Act Participants; Correction Date: April 18, 2017.
Time: 12:00 p.m. to 5:00 p.m. (Catalogue of Federal Domestic Assistance
AGENCY: Administration for Community Agenda: To review and evaluate grant Program Nos. 93.855, Allergy, Immunology,
Living, HHS. applications. and Transplantation Research; 93.856,
Place: National Institute on Aging, Microbiology and Infectious Diseases
ACTION: Notice of correction.
Gateway Building, Suite 2W200, 7201 Research, National Institutes of Health, HHS)

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Document Created: 2018-02-01 15:10:37
Document Modified: 2018-02-01 15:10:37

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.
Dates		Electronic or written submissions must be received by [30 days from FRN posting].
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).
FR Citation		82 FR 15061

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 SERVICESCenters for Disease Control and Prevention

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

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