Att B - 60 day FRN

22892

Federal Register / Vol. 87, No. 74 / Monday, April 18, 2022 / Notices

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;
3. Enhance the quality, utility, and
clarity of the information to be
collected;
4. Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submissions
of responses; and
5. Assess information collection costs.
Proposed Project
Data Calls for the Laboratory
Response Network (LRN) (OMB Control
No. 0920–0881, Exp. 06/30/2022)—
Extension—National Center for
Emerging Zoonotic and Infectious
Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
The Laboratory Response Network
(LRN) was established by the

collection is covered by OMB Control
No. 0920–0850. Periodically, CDC may
conduct a Special Data Call to obtain
additional information from LRN
laboratories regarding biological or
chemical terrorism, or emerging
infectious disease preparedness.
Although the LRN Program Office at
CDC has an extensive database of
information regarding all network
members, LRN Special Data Calls are
sometimes needed to address issues
concerning the response capabilities of
member facilities for priority threat
agents or to assess the network’s ability
to respond to new emerging threats.
Special Data Calls may be conducted via
broadcast email that asks respondents to
send information via email to the LRN
Help Desk or through online survey
tools (i.e., Survey Monkey) which
require respondents to go to a web link
and answer a series of questions.

Department of Health and Human
Services (HHS), Centers for Disease
Control and Prevention (CDC) in
accordance with Presidential Decision
Directive 39 which outlined national
anti-terrorism policies and assigned
specific missions to Federal
Departments and Agencies. The
Administration has stated that it is the
policy of the United States to use all
appropriate means, to deter, defeat, and
respond to all terrorist attacks on our
territory and resources, both with
people and facilities. The LRN’s mission
is to maintain an integrated national and
international network of laboratories
that can respond quickly to suspected
acts of biological, chemical, or
radiological terrorism, emerging
infectious diseases, and other public
health threats and emergencies. Federal,
state and local public health laboratories
join the LRN voluntarily.
When laboratories join, they assume
specific responsibilities and are
required to provide facility information
to the LRN Program Office at CDC, as
well as test results for real samples or
proficiency tests. LRN laboratories
participate in Proficiency Testing
Challenges, Exercises and Validation
Studies each year. LRN information

This request for Extension is for a
Generic Clearance that is necessary for
any impromptu data calls that are
needed. CDC requests OMB approval for
an estimated 94 annual burden hours.
There are no costs to respondents other
than their time to participate.

ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)

Total burden
hours

Form name

Public Health Laboratories ................

Special Data Call .............................

187

1

30/60

94

Total ...........................................

...........................................................

........................

........................

........................

94

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2022–08215 Filed 4–15–22; 8:45 am]
BILLING CODE 4163–18–P

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

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Number
responses per
respondent

Number of
respondents

Type of respondent

[60-Day–22–1011; Docket No. CDC–2022–
0047]

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).

AGENCY:

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ACTION:

Notice with comment period.

The Centers for Disease
Control and Prevention (CDC), as part of
its continuing effort to reduce public
burden and maximize the utility of
government information, invites the
general public and other federal
agencies the opportunity to comment on
a continuing information collection, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on a request for extension of
an approved information collection
titled Emergency Epidemic Investigation
Data Collections. CDC uses the
information collected to identify
prevention and control measures in
response to outbreaks and other public
health events.

SUMMARY:

CDC must receive written
comments on or before June 17, 2022.

DATES:

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You may submit comments,
identified by Docket No. CDC–2022–
0047 by either of the following methods:

ADDRESSES:

• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
• Mail: Jeffrey M. Zirger, Information
Collection Review Office, Centers for
Disease Control and Prevention, 1600
Clifton Road NE, MS H21–8, Atlanta,
Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. CDC will post, without
change, all relevant comments to
regulations.gov.
Please note: Submit all comments
through the Federal eRulemaking portal
(regulations.gov) or by U.S. mail to the
address listed above.

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22893

Federal Register / Vol. 87, No. 74 / Monday, April 18, 2022 / Notices
To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact Jeffrey M. Zirger,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS
H21–8, Atlanta, Georgia 30329; phone:
404–639–7570; email: omb@cdc.gov.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. In addition, the PRA also
requires federal agencies to provide a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each new
proposed collection, each proposed
extension of existing collection of
information, and each reinstatement of
previously approved information
collection before submitting the
collection to the OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
The OMB is particularly interested in
comments that will help:
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;
3. Enhance the quality, utility, and
clarity of the information to be
collected;
4. Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
FOR FURTHER INFORMATION CONTACT:

sources, modes of transmission, or risk
factors so that effective prevention and
control measures can be implemented.
During an unanticipated outbreak or
urgent public health event, immediate
action by CDC is necessary to minimize
or prevent public harm. The legal
justification for EEIs are found in the
Public Health Service Act (42 U.S.C.
Sec. 301 [241] (a)).
Successful investigations are
dependent on rapid and flexible data
collection that evolves during the
investigation and is customized to the
unique circumstances of each outbreak
or urgent public health event. Data
collection elements will be those
necessary to identify the agents, sources,
mode of transmission, or risk factors.
Examples of potential data collection
methods include telephone or face-toface interview; email, web, or other type
of electronic questionnaire; paper-andpencil questionnaire; focus groups;
medical record review and abstraction;
laboratory record review and
abstraction; collection of clinical
samples; and environmental assessment.
Respondents will vary depending on the
nature of the outbreak or urgent public
health event. Examples of potential
respondents include health care
professionals, patients, laboratorians,
and the general public.
CDC projects 60 EEIs in response to
outbreaks or urgent public health events
characterized by undetermined agents,
undetermined sources, undetermined
transmission, or undetermined risk
factors annually. The projected average
number of respondents is 200 per EEI,
for a total of 12,000 respondents. CDC
estimates the average burden per
response is 30 minutes and each
respondent will be asked to respond
once. Based on the reported burden for
EEIs that have been performed during
previous years, the total estimated
annual burden hours are 6,000.
Participation in EEIs is voluntary and
there are no anticipated costs to
respondents other than their time.

e.g., permitting electronic submissions
of responses; and
5. Assess information collection costs.
Proposed Project
Emergency Epidemic Investigation
Data Collections (OMB Control No.
0920–1011, Exp. 1/31/2023)—Extension
—Division of Scientific Education and
Professional Development (DSEPD),
Center for Surveillance, Education, and
Laboratory Services (CSELS), Centers for
Disease Control and Prevention(CDC).
Background and Brief Description
CDC previously conducted Emergency
Epidemic Investigations (EEIs) under
Office of Management and Budget
(OMB) Control No. 0920–0008. In 2013,
CDC received OMB approval (OMB
Control No. 0920–1011) for a new OMB
generic clearance for a three-year period
to collect vital information during EEIs
in response to outbreaks or other urgent
public health events (i.e., natural,
biological, chemical, nuclear,
radiological), characterized by
undetermined agents, undetermined
sources, undetermined transmission, or
undetermined risk factors. This generic
clearance was approved in 2020 for a
three-year extension, which expires on
1/31/2023. CDC seeks OMB approval for
an extension of this Generic clearance
for an additional three-year period.
Supporting effective emergency
epidemic investigations is one of the
most important ways that CDC protects
the health of the public. CDC is
frequently called upon to conduct EEIs
at the request of local, state, or
international health authorities seeking
support to respond to outbreaks or
urgent public health events. In response
to external partner requests, CDC
provides necessary epidemiologic
support to identify the agents, sources,
modes of transmission, or risk factors to
effectively implement rapid prevention
and control measures to protect the
public’s health. Data collection is a
critical component of the epidemiologic
support provided by CDC; data are
analyzed to determine the agents,

ESTIMATED ANNUALIZED BURDEN HOURS

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Type of respondent

Emergency Epidemic Investigation
Participants.
Total ...........................................

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Number of
respondents

Form name

Emergency Epidemic Investigation
Data Collection Instruments.
...........................................................

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Number of
responses per
respondent

Average
burden per
response
(in hours)

Total burden
hours
(in hours)

12,000

1

30/60

6,000

........................

........................

........................

6,000

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22894

Federal Register / Vol. 87, No. 74 / Monday, April 18, 2022 / Notices

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2022–08216 Filed 4–15–22; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3424–PN]

Medicare and Medicaid Programs:
Application From Det Norske Veritas
for Continued Approval of Its Hospital
Accreditation Program
Centers for Medicare and
Medicaid Services, HHS.
ACTION: Notice.
AGENCY:

This notice acknowledges the
receipt of an application from Det
Norske Veritas for continued
recognition as a national accrediting
organization for hospitals that wish to
participate in the Medicare or Medicaid
programs.
DATES: To be assured consideration,
comments must be received at one of
the addresses provided below, no later
than 5 p.m. on May 18, 2022.
ADDRESSES: In commenting, please refer
to file code CMS–3424–PN. Because of
staff and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
Comments, including mass comment
submissions, must be submitted in one
of the following three ways (please
choose only one of the ways listed):
1. Electronically. You may submit
electronic comments on this regulation
to http://www.regulations.gov. Follow
the ‘‘submit a comment’’ instructions.
2. By regular mail. You may mail
written comments to the following
address ONLY: Centers for Medicare &
Medicaid Services, Department of
Health and Human Services, Attention:
CMS–3424–PN, P.O. Box 8016,
Baltimore, MD 21244–8010.
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.
3. By express or overnight mail. You
may send written comments to the
following address ONLY: Centers for
Medicare & Medicaid Services,
Department of Health and Human
Services, Attention: CMS–3424–PN,
Mail Stop C4–26–05, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
For information on viewing public
comments, see the beginning of the
SUPPLEMENTARY INFORMATION section.

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SUMMARY:

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Joy
Webb, (410) 786–1667. Lillian William,
(410) 786–8636.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All
comments received before the close of
the comment period are available for
viewing by the public, including any
personally identifiable or confidential
business information that is included in
a comment. We post all comments
received before the close of the
comment period on the following
website as soon as possible after they
have been received: http://
www.regulations.gov. Follow the search
instructions on that website to view
public comments. CMS will not post on
Regulations.gov public comments that
make threats to individuals or
institutions or suggest that the
individual will take actions to harm the
individual. CMS continues to encourage
individuals not to submit duplicative
comments. We will post acceptable
comments from multiple unique
commenters even if the content is
identical or nearly identical to other
comments.
FOR FURTHER INFORMATION CONTACT:

I. Background
Under the Medicare program, eligible
beneficiaries may receive covered
services from a hospital provided
certain requirements are met. Section
1861(e) of the Social Security Act (the
Act), establishes distinct criteria for
facilities seeking designation as a
hospital. Regulations concerning
provider agreements are at 42 CFR part
489 and those pertaining to activities
relating to the survey and certification
of facilities are at 42 CFR part 488. The
regulations at 42 CFR part 482 specify
the minimum conditions that a hospital
must meet to participate in the Medicare
program.
Generally, to enter into an agreement,
a hospital must first be certified by a
state survey agency (SA) as complying
with the conditions or requirements set
forth in part 482 of our regulations.
Thereafter, the hospital is subject to
regular surveys by a SA to determine
whether it continues to meet these
requirements.
Section 1865(a)(1) of the Act provides
that, if a provider entity demonstrates
through accreditation by a Centers for
Medicare & Medicaid Services (CMS)
approved national accrediting
organization (AO) that all applicable
Medicare conditions are met or
exceeded, we will deem those provider
entities as having met the requirements.
Accreditation by an AO is voluntary and
is not required for Medicare
participation.

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If an AO is recognized by the
Secretary of the Department of Health
and Human Services (the Secretary) as
having standards for accreditation that
meet or exceed Medicare requirements,
any provider entity accredited by the
national accrediting body’s approved
program would be deemed to meet the
Medicare conditions. A national AO
applying for approval of its
accreditation program under part 488,
subpart A, must provide CMS with
reasonable assurance that the AO
requires the accredited provider entities
to meet requirements that are at least as
stringent as the Medicare conditions.
Our regulations concerning the approval
of AOs are set forth at §§ 488.4 and
488.5. The regulations at § 488.5(e)(2)(i)
require AOs to reapply for continued
approval of its accreditation program
every 6 years or sooner as determined
by CMS.
Det Norske Veritas’ current term of
approval for their hospital accreditation
program expires September 26, 2022.
II. Approval of Deeming Organization
Section 1865(a)(2) of the Act and our
regulations at § 488.5 require that our
findings concerning review and
approval of a national AO’s
requirements consider, among other
factors, the applying AO’s requirements
for accreditation; survey procedures;
resources for conducting required
surveys; capacity to furnish information
for use in enforcement activities;
monitoring procedures for provider
entities found not in compliance with
the conditions or requirements; and
ability to provide CMS with the
necessary data for validation.
Section 1865(a)(3)(A) of the Act
further requires that we publish, within
60 days of receipt of an organization’s
complete application, a notice
identifying the national accrediting
body making the request, describing the
nature of the request, and providing at
least a 30-day public comment period.
We have 210 days from the receipt of a
complete application to publish notice
of approval or denial of the application.
The purpose of this proposed notice
is to inform the public of Det Norske
Veritas’ request for continued approval
of its hospital accreditation program.
This notice also solicits public comment
on whether Det Norske Veritas’
requirements meet or exceed the
Medicare conditions of participation
(CoPs) for hospitals.
III. Evaluation of Deeming Authority
Request
Det Norske Veritas submitted all the
necessary materials to enable us to make
a determination concerning its request

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