60 day FRN

SSA Attachment 2 Published 60-Day FRN.pdf

Validated Interview and Survey of Outpatient Providers on Antibiotic Stewardship Interventions

60 day FRN

OMB: 0920-1308

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Federal Register / Vol. 85, No. 27 / Monday, February 10, 2020 / Notices

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–20–20GX; Docket No. CDC–2020–
0009]

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

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 proposed and/or continuing
information collection, as required by
the Paperwork Reduction Act of 1995.
This notice invites comment on a
proposed information collection project
titled Validated Follow-up Interview of
Clinicians on Outpatient Antibiotic
Stewardship Interventions. This
collection aims to perform an interview
of outpatient clinicians regarding the
acceptability and perceived clinicianlevel barriers associated with our yearlong implementation of interventions
designed around the Core Elements of
Outpatient Antibiotic Stewardship.
DATES: CDC must receive written
comments on or before April 10, 2020.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2020–
0009 by any of the following methods:
• 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–D74, Atlanta,
Georgia 30329.
Instructions: All submissions received
must include the agency name and
SUMMARY:

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.
5. Assess information collection costs.

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.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact Jeffrey M. Zirger, of
the Information Collection Review
Office, Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS–
D74, Atlanta, Georgia 30329; phone:
404–639–7570; Email: [email protected].
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; and

Proposed Project
Validated Follow-up Interview of
Clinicians on Outpatient Antibiotic
Stewardship Interventions—New—
Division of Healthcare Quality
Promotion (DHQP), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
The Code of Federal Regulations
under subsections C and D of § 247d–5
authorizes education of medical and
health services personnel in
antimicrobial resistance and appropriate
use of antibiotics and the funding of
eligible entities to increase capacity to
detect, monitor, and combat
antimicrobial resistance. Through the
Centers for Disease Control and
Prevention’s SHEPheRD funding
mechanism, the University of Utah has
been awarded a contract to perform
such work as stated above within a
research framework in the urgent care
setting, with interventions based on the
Core Elements of Outpatient Antibiotic
Stewardship. Intermountain Healthcare
is the subcontractor for this work, and
operates the clinics participating in the
intervention arm of this research study.
The proposed request for data collection
will allow Intermountain Healthcare to
explore knowledge, attitudes, and
practices among clinicians to identify
barriers and facilitators after the
implementation of the antibiotic
stewardship program in the urgent care
setting of participating clinics. CDC
requests approval for 207 estimated
annualized burden hours. There is no
cost to respondents other than their
time.

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ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Number
responses per
respondent

Average
burden per
response
(in hrs.)

Total burden
(in hrs.)

Type of respondent

Form name

Urgent Care Clinician ........................
Urgent Care Clinician ........................

Interview Guide ................................
Survey ..............................................

40
250

15
8

4
5

40
167

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

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

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

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

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

207

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Federal Register / Vol. 85, No. 27 / Monday, February 10, 2020 / Notices
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2020–02540 Filed 2–7–20; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–20–0728]

jbell on DSKJLSW7X2PROD with NOTICES

Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled the National
Notifiable Diseases Surveillance System
(NNDSS) to the Office of Management
and Budget (OMB) for review and
approval. CDC previously published a
‘‘Proposed Data Collection Submitted
for Public Comment and
Recommendations’’ notice on November
4, 2019 to obtain comments from the
public and affected agencies. CDC did
not receive comments related to the
previous notice. This notice serves to
allow an additional 30 days for public
and affected agency comments.
CDC will accept all comments for this
proposed information collection project.
The Office of Management and Budget
is particularly interested in comments
that:
(a) 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;
(b) Evaluate the accuracy of the
agencies estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected;
(d) 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 submission of
responses; and
(e) Assess information collection
costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and

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instruments, call (404) 639–7570 or
send an email to [email protected]. Direct
written comments and/or suggestions
regarding the items contained in this
notice to the Attention: CDC Desk
Officer, Office of Management and
Budget, 725 17th Street NW,
Washington, DC 20503 or by fax to (202)
395–5806. Provide written comments
within 30 days of notice publication.
Proposed Project
National Notifiable Diseases
Surveillance System (OMB Control No.
0920–0728, Exp. 4/30/2022)—
Revision—Center for Surveillance,
Epidemiology and Laboratory Services
(CSELS), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The Public Health Services Act (42
U.S.C. 241) authorizes CDC to
disseminate nationally notifiable
condition information. The National
Notifiable Diseases Surveillance System
(NNDSS) is based on data collected at
the state, territorial and local levels as
a result of legislation and regulations in
those jurisdictions that require health
care providers, medical laboratories,
and other entities to submit healthrelated data on reportable conditions to
public health departments. These
reportable conditions, which include
infectious and non-infectious diseases,
vary by jurisdiction depending upon
each jurisdiction’s health priorities and
needs. Each year, the Council of State
and Territorial Disease Epidemiologists
(CSTE), supported by CDC, determines
which reportable conditions should be
designated nationally notifiable or
under standardized surveillance.
CDC requests a three-year approval for
a Revision for the NNDSS (OMB Control
No. 0920–0728, Expiration Date 04/30/
2022). This Revision includes requests
for approval to: (1) Receive case
notification data for Blastomycosis
which is now under standardized
surveillance; (2) receive case
notification data for 2019-Novel
Coronavirus (2019-nCoV) which was
declared a public health emergency of
international concern by the World
Health Organization (WHO) on 01/30/
2020 and declared a public health
emergency by the U.S. Department of
Health and Human Services (HHS) on
01/31/2020; and (3) receive diseasespecific data elements for Carbon
Monoxide (CO) Poisoning, Congenital
Syphilis, and Sexually Transmitted
Disease (not congenital).
The NNDSS currently facilitates the
submission and aggregation of case
notification data voluntarily submitted
to CDC from 60 jurisdictions: Public

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health departments in every U.S. state,
New York City, Washington DC, five
U.S. territories (American Samoa, the
Commonwealth of Northern Mariana
Islands, Guam, Puerto Rico, and the U.S.
Virgin Islands), and three freely
associated states (Federated States of
Micronesia, the Republic of the
Marshall Islands, and the Republic of
Palau). This information is shared
across jurisdictional boundaries and
both surveillance and prevention and
control activities are coordinated at
regional and national levels.
Approximately 90% of case
notifications are encrypted and
submitted to NNDSS electronically from
already existing databases by automated
electronic messages. When automated
transmission is not possible, case
notifications are faxed, emailed,
uploaded to a secure network, or
entered into a secure website. All case
notifications that are faxed, emailed,
and uploaded are done so in the form
of an aggregate weekly or annual report,
not individual cases. These different
mechanisms used to send case
notifications to CDC vary by the
jurisdiction and the disease or
condition. Private personally
identifiable information (PII) is
collected from automated electronic
messages and information can be
retrieved by PII. In addition, some
combinations of submitted data
elements could potentially be used to
identify individuals. Private information
is not to be disclosed unless otherwise
compelled by law. All data are treated
in a secure manner consistent with the
technical, administrative, and
operational controls required by the
Federal Information Security
Management Act of 2002 (FISMA) and
the 2010 National Institute of Standards
and Technology (NIST) Recommended
Security Controls for Federal
Information Systems and Organizations.
Weekly tables of nationally notifiable
diseases are available through CDC
WONDER and data.cdc.gov. Annual
summaries of finalized nationally
notifiable disease data are published on
CDC WONDER and data.cdc.gov, and
disease-specific data are published by
individual CDC programs.
The burden estimates include the
number of hours that the public health
department uses to process and send
case notification data from their
jurisdiction to CDC. Specifically, the
burden estimates include separate
burden hours incurred for automated
and non-automated transmissions,
separate weekly burden hours incurred
for modernizing surveillance systems as
part of NNDSS Modernization Initiative
(NMI) implementation, separate burden

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