1670-0015 Published 60 day FRN 2020

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Federal Register / Vol. 85, No. 61 / Monday, March 30, 2020 / Notices
offer protection from particulate
materials at an N95 filtration
efficiency level per 42 CFR 84.181
3. Elastomeric, air-purifying respirators
and appropriate particulate filters/
cartridges
4. Powered Air Purifying Respirator
(PAPR)
5. Portable Ventilators, including
portable devices intended to
mechanically control or assist
patient breathing by delivering a
predetermined percentage of
oxygen in the breathing gas
6. Drug product with active ingredient
chloroquine phosphate or
hydroxychloroquine HCl
7. Sterilization services for any device
as defined in section 201(h) of the
Federal Food, Drug, and Cosmetic
Act and sterilizers as defined in 21
CFR 880.6860, 880.6870, and
880.6880, including devices that
already have FDA marketing
authorization and those that do not
have FDA marketing authorization
but are intended for the same uses
8. Disinfecting devices intended to kill
pathogens and other kinds of
microorganisms by chemical means
or physical means, including those
defined in 21 CFR 876.1500,
880.6992, and 892.1570 and other
sanitizing and disinfecting products
suitable for use in a clinical setting
9. Medical gowns or apparel, e.g.,
surgical gowns or isolation gowns
10. Personal protective equipment (PPE)
coveralls, e.g., Tyvek Suits
11. PPE face masks, including any
masks that cover the user’s nose
and mouth and may or may not
meet fluid barrier or filtration
efficiency levels
12. PPE surgical masks, including masks
that covers the user’s nose and
mouth and provides a physical
barrier to fluids and particulate
materials
13. PPE face shields, including those
defined at 21 CFR 878.4040 and
those intended for the same
purpose
14. PPE gloves or surgical gloves,
including those defined at 21 CFR
880.6250 (exam gloves) and
878.4460 (surgical gloves) and such
gloves intended for the same
purposes
15. Ventilators, anesthesia gas machines
modified for use as ventilators, and
positive pressure breathing devices
modified for use as ventilators
(collectively referred to as
‘‘ventilators’’), ventilator tubing
connectors, and ventilator
accessories as those terms are
described in FDA’s March 2020
Enforcement Policy for Ventilators

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and Accessories and Other
Respiratory Devices During the
Coronavirus Disease 2019 (COVID–
19) Public Health Emergency
located at https://www.fda.gov/
media/136318/download
Authority
The authority for this Notice is
Executive Order 13910 and section 102
of the Defense Production Act of 1950,
50 U.S.C. 4512, as amended.
Wilma M. Robinson,
Deputy Executive Secretary, Department of
Health and Human Services.
[FR Doc. 2020–06641 Filed 3–26–20; 11:15 am]
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DEPARTMENT OF HOMELAND
SECURITY
[Docket No. CISA–2020–0002]

Notice of Request for Extension of a
Currently Approved Information
Collection for Chemical-Terrorism
Vulnerability Information (CVI)
Cybersecurity and
Infrastructure Security Agency, DHS.
ACTION: 60-Day notice and request for
comments; extension of Information
Collection Request: 1670–0015.
AGENCY:

The Infrastructure Security
Division (ISD) within the Cybersecurity
and Infrastructure Security Agency
(CISA) will submit the following
Information Collection Request (ICR) to
the Office of Management and Budget
(OMB) for review and clearance in
accordance with the Paperwork
Reduction Act of 1995. The submission
proposes to renew the information
collection for an additional three years
and update the burden estimates.
DATES: Comments are encouraged and
will be accepted until May 29, 2020.
ADDRESSES: You may send comments,
identified by docket number through the
Federal eRulemaking Portal: http://
www.regulations.gov. Follow the
instructions for sending comments.
Instructions: All submissions received
must include the agency name ‘‘CISA’’
and docket number CISA–2020–0002.
All comments received will be posted
without change to http://
www.regulations.gov, including any
personal information provided.
Comments that include trade secrets,
confidential commercial or financial
information, Chemical-terrorism
Vulnerability Information (CVI),1
SUMMARY:

1 For more information about CVI see 6 CFR
27.400 and the CVI Procedural Manual at
www.dhs.gov/publication/safeguarding-cvi-manual.

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17593

Sensitive Security Information (SSI),2 or
Protected Critical Infrastructure
Information (PCII) 3 should not be
submitted to the public docket.
Comments containing trade secrets,
confidential commercial or financial
information, CVI, SSI, or PCII should be
appropriately marked and packaged in
accordance with applicable
requirements and submitted by mail to
the DHS/CISA/Infrastructure Security
Division, CFATS Program Manager at
CISA, 245 Murray Lane SW, Mail Stop
0610, Arlington, VA 20528–0610.
Comments must be identified by docket
number CISA–2020–0002.
FOR FURTHER INFORMATION CONTACT:
Lona Saccomando, 703–235–5263,
[email protected].
SUPPLEMENTARY INFORMATION: The
CFATS Program identifies and regulates
the security of high-risk chemical
facilities using a risk-based approach.
Congress initially authorized the CFATS
Program under Section 550 of the
Department of Homeland Security
Appropriations Act of 2007, Public Law
109–295 (2006) and reauthorized it
under the Protecting and Securing
Chemical Facilities from Terrorist
Attacks Act of 2014 4 or ‘‘CFATS Act of
2014’’ (Pub. L. 113–254, 6 U.S.C. 621 et
seq.). The Department implemented the
CFATS Program through rulemaking
and issued an Interim Final Rule (IFR)
on April 9, 2007 and a final rule on
November 20, 2007. See 72 FR 17688
and 72 FR 65396.
Pursuant to 6 U.S.C. 623, the CFATS
regulations establish the requirements
under 6 CFR 27.400 that covered
persons must follow to safeguard certain
documents and other information
developed under the regulations from
unauthorized disclosure. This
information is identified as CVI and, by
law, receives protection from public
disclosure and misuse. This collection
will be used to manage the CVI program
in support of CFATS. The current
information collection for the CVI
program (IC 1670–0015) will expire on
January 31, 2021.5
CISA proposes one revision from the
previously approved collection.
Specifically, to increase the loaded
2 For more information about SSI see 49 CFR part
1520 and the SSI Program web page at www.tsa.gov/
for-industry/sensitive-security-information.
3 For more information about PCII see 6 CFR part
29 and the PCII Program web page at www.dhs.gov/
pcii-program.
4 The CFATS Act of 2014 codified the CFATS
program into the Homeland Security Act of 2002.
See 6 U.S.C. 621 et seq., as amended by Public Law
116–2.
5 The current information collection for CVI (i.e.,
IC 1670–0015) may be viewed at https://
www.reginfo.gov/public/do/PRAViewICR?ref_
nbr=201704-1670-002.

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average hourly wage rate of respondents
from $78.93 to $79.75 based on updated
BLS wage and compensation data.
This process is conducted in
accordance with 5 CFR 1320.8.
CISA’s Methodology in Estimating the
Burden for the Chemical-Terrorism
Vulnerability Information
Authorization
Number of Respondents
The current information collection
estimated that 20,000 respondents
submit a request to become a CVI
Authorized User Number annually. The
table below provides the number of
respondents over the past three years
(i.e., Fiscal Year (FY) 2017 through FY
2019).
FY
2017
Number of Respondents ..........................

FY
2018

FY
2019

I 19,392 I 16,504 I 13,667

Due to past fluctuations and
uncertainty regarding the number of
future respondents, CISA believes that
20,000 continues to be a reasonable
estimate. Therefore, CISA proposes to
retain the estimated the annual number
of respondents.
Estimated Time per Respondent
In the current information collection,
the estimated time per respondent to
prepare and submit a CVI Authorization
is 0.50 hours (30 minutes). CISA
proposes to retain the estimated time
per respondent.
Annual Burden Hours
The annual burden hours for the CVI
Authorization is [0.50 hours × 20,000
respondents × 1 response per
respondent], which equals 10,000 hours.
Total Capital/Startup Burden Cost
CISA provides access to CSAT free of
charge and assumes that each
respondent already has computer
hardware and access to the internet for
basic business needs. Therefore, there
are no annualized capital or start-up
costs incurred by chemical facilities of
interest or high-risk chemical facilities
for this information collection.

other individuals may also complete
this instrument (e.g., Federal, State, and
local government employees and
contractors). For the purpose of this
notice, CISA maintains this assumption.
Therefore, to estimate the total annual
burden, CISA multiplied the annual
burden of 10,000 hours by the loaded
average hourly wage rate of SSOs of
$79.75 per hour.6 Therefore, the total
annual burden cost for the CVI
Authorization instrument is $797,474
[10,000 total annual burden hours ×
$79.75 per hour].
Analysis
Agency: Department of Homeland
Security, Cybersecurity and
Infrastructure Agency, Infrastructure
Security Division, Infrastructure
Security Compliance Division.
Title: CFATS Chemical-terrorism
Vulnerability Information.
OMB Number: 1670–0015.
Instrument: Chemical-terrorism
Vulnerability Information
Authorization.
Frequency: ‘‘On occasion’’ and
‘‘Other’’.
Affected Public: Business or other forprofit.
Number of Respondents: 20,000
respondents (rounded estimate).
Estimated Time per Respondent: 0.50
hours.
Total Burden Hours: 10,000 annual
burden hours.
Total Burden Cost (capital/startup):
$0.
Total Recordkeeping Burden: $0.
Total Burden Cost: $797,474.
Richard S. Libby,
Deputy Chief Information Officer, Department
of Homeland Security, Cybersecurity and
Infrastructure Security Agency.
[FR Doc. 2020–06499 Filed 3–27–20; 8:45 am]
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Total Recordkeeping Burden
There are no recordkeeping burden
costs incurred by chemical facilities of
interest or high-risk chemical facilities
for this information collection.
Total Annual Burden Cost
CISA assumes that the majority of
individuals who will complete this
instrument are Site Security Officers
(SSOs), although a smaller number of

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6 The wage used for an SSO equals that of
Managers, All (11–9199), with a load factor of
1.43508 to account for benefits in addition to wages
https://www.bls.gov/oes/2018/may/oes119199.htm.
The load factor is estimated by dividing total
compensation by total wages and salaries for the
Management, Professional and Related series
($60.79/$42.36), which can be found at https://
www.bls.gov/news.release/ecec.t04.htm.

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DEPARTMENT OF HOMELAND
SECURITY
U.S. Immigration and Customs
Enforcement
[OMB Control Number 1653–0048]

Agency Information Collection
Activities: Extension, Without Change,
of a Currently Approved Collection:
ICE Mutual Agreement Between
Government and Employers (IMAGE)
U.S. Immigration and Customs
Enforcement, Department of Homeland
Security.
ACTION: 30-Day notice.
AGENCY:

In accordance with the
Paperwork Reduction Act (PRA) of 1995
the Department of Homeland Security
(DHS), U.S. Immigration and Customs
Enforcement (ICE) will submit the
following Information Collection
Request (ICR) to the Office of
Management and Budget (OMB) for
review and clearance. This information
collection was previously published in
the Federal Register on January 27,
2020, allowing for a 60-day comment
period. ICE received no comments. The
purpose of this notice is to allow an
additional 30 days for public comments.
DATES: Comments are encouraged and
will be accepted until April 29, 2020.
ADDRESSES: Written comments and
recommendations should be sent within
30 days of publication of this notice to
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
30-day Review—Open for Public
Comments’’ or by using the search
function.
FOR FURTHER INFORMATION CONTACT: For
specific question related to collection
activities, please contact: John Morris
(202–732–5409), john.j.morris@
ice.dhs.gov, U.S. Immigration and
Customs Enforcement.
SUPPLEMENTARY INFORMATION:
SUMMARY:

Comments
Written comments and suggestions
from the public and affected agencies
concerning the proposed collection of
information should address one or more
of the following four points:
(1) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
(2) Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;

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