Att 2_60d FRN

Att 2 Published 60dy2020EC (1).pdf

Enterprise Laboratory Information Management System

Att 2_60d FRN

OMB: 0920-1309

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70550

Federal Register / Vol. 84, No. 246 / Monday, December 23, 2019 / Notices

for Disease Control and Prevention
(CDC).
Background and Brief Description
Under the Public Health Service Act
(42 United States Code 264), and under
42 Code of Federal Regulations (CFR)
71.4 and 71.5, CDC can order air carriers
and maritime vessels arriving from
another country to submit a certain
information related to passengers and
crew that CDC believes were exposed to
co-traveler infected with a
communicable disease of public health
concern.
Stopping a communicable disease
outbreak—whether it is naturally
occurring or intentionally caused—
requires the use of the most rapid and
effective public health tools available.
Basic public health practices, such as
collaborating with airlines in the
identification and notification of
potentially exposed contacts, are critical
tools in the fight against the
introduction, transmission, and spread

currently located in their jurisdiction. In
general, state and local health
departments are responsible for the
contact investigations. In rare cases,
CDC may use the manifest data to
perform the contact investigation
directly. In either case, CDC works with
state and local health departments to
ensure individuals are contacted and
provided appropriate public health
follow-up.
CDC estimates that for each traveler
manifest ordered, airlines require
approximately six hours to review the
order, search their records, and send
those records to CDC. There is no cost
to respondents other than their time
perform these actions. The total
estimated hourly burden to respondents
as a result of this information collection
is 600 hours per year. While CDC has
included maritime conveyance manifest
orders in the public health rationale for
this information collection, these orders
are rare and are not included in the
burden table.

of communicable diseases in the United
States.
The collection of pertinent contact
information enables Quarantine Public
Health Officers in CDC’s Division of
Global Migration and Quarantine
(DGMQ) to notify state and local health
departments in order for them to make
contact with individuals who may have
been exposed to a contagious person
during travel and identify appropriate
next steps.
In the event that there is a confirmed
case of communicable disease of public
health concern aboard an aircraft or
maritime vessel, CDC collects manifest
information for those passengers and
crew at risk for exposure. This specific
manifest information collection differs
depending on the communicable
disease that is confirmed during air or
maritime travel. CDC then uses this
passenger and crew manifest
information to coordinate with state and
local health departments so they can
follow-up with residents who live or are

ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondent

Airline Medical Officer or
and Information Systems
Airline Medical Officer or
and Information Systems

Equivalent/Computer
Manager.
Equivalent/Computer
Manager.

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

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–27557 Filed 12–20–19; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–20–20EC; Docket No. CDC–2019–
0115]

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.

lotter on DSKBCFDHB2PROD with NOTICES

AGENCY:

The Centers for Disease
Control and Prevention (CDC), as part of
its continuing effort to reduce public

SUMMARY:

VerDate Sep<11>2014

19:32 Dec 20, 2019

Jkt 250001

Number of
respondents

Form name

International TB Manifest Template.
International Non-TB
Manifest Template.
.......................................

360/60

306

49

1

360/60

294

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

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

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

600

CDC must receive written
comments on or before February 21,
2020.
You may submit comments,
identified by Docket No. CDC–2019–
0115 by any of the following methods:

ADDRESSES:

Fmt 4703

Total burden
(in hours)

1

DATES:

Frm 00058

Average
burden per
response
(in hours)

51

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 Enterprise Laboratory Information
Management System which is a system
used to record specimen metadata and
patient data related to test order
requests submitted by external partners
(state public health laboratories,
International organizations, federal
institutions, hospitals, doctor’s offices,
etc.) to the CDC Infectious Diseases
testing laboratories.

PO 00000

Number of
responses per
respondent

Sfmt 4703

• 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
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 Jeffery 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].

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70551

Federal Register / Vol. 84, No. 246 / Monday, December 23, 2019 / Notices
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
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,

SUPPLEMENTARY INFORMATION:

information (as applicable) information
about the submitting organization
requesting the testing, patient history (as
applicable), owner information and
animal history (as applicable) and
epidemiological information. The
collection of this type of data is
pertinent in ensuring a specimen’s
testing results are linked to the correct
patient and the final test reports are
delivered to the appropriate submitting
organization to aid in making proper
health-related decisions related to the
patient. Furthermore, the data provided
on this form may be used by the CDC
to identify sources of potential
outbreaks and other public-health
related events. When the form is filled
out, a user in the submitting
organization prints a hard copy of it that
will be included in the specimen’s
shipping package sent to the CDC. The
printed form has barcodes on it that
allow the CDC testing laboratory to scan
its data directly into ELIMS where the
specimen’s testing lifecycle is tracked
and managed.
Likewise, the Global File
Accessioning Template records the
same data as the 50.34 Form but
provides the capability to submit
information for a batch of specimens
(typically 50–1,000 specimens per
batch) to a specific CDC laboratory for
testing. The CDC testing laboratory
electronically uploads the Global File
Accessioning Template into ELIMS
where the batch of specimens are then
logged and are ready to be tracked
through their respective testing and
reporting workflow. CDC requests
approval for 2,047 annual burden hours.
There is no cost to respondents other
than their time.

e.g., permitting electronic submissions
of responses.
5. Assess information collection costs.
Proposed Project
Enterprise Laboratory Information
Management System (ELIMS)—Existing
Collection in Use without an OMB
Control Number—National Center for
Emerging and Zoonotic Infectious
Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
The collection of specimen
information designated for testing by the
CDC occurs on a regular and recurring
basis (multiple times per day) using an
electronic PDF file called the CDC
Specimen Submission 50.34 Form or an
electronic XSLX file called the Global
File Accessioning Template.
Hospitals, doctor’s offices, medical
clinics, commercial testing labs,
universities, state public health
laboratories, U.S. federal institutions
and foreign institutions use the CDC
Specimen Submission Form 50.34 when
submitting a single specimen to CDC
Infectious Diseases laboratories for
testing. The CDC Specimen Submission
50.34 Form consists of over 200 data
entry fields (of which five are
mandatory fields that must be
completed by the submitter) that
captures information about the
specimen being sent to the CDC for
testing. The type of data captured on the
50.34 Form identifies the origin of the
specimen (human, animal, food,
environmental, medical device or
biologic), CDC test order name/code,
specimen information, patient
information (as applicable), animal

ESTIMATED ANNUALIZED BURDEN HOURS
Form name

Medical Assistant, Doctor’s Office/Hospital

CDC Specimen Submission
50.34 Form.
CDC Specimen Submission
50.34 Form.
Global File Accessioning Template.

19–1042 Medical Scientists, Except Epidemiologists, State Public Health Lab.
Medical Assistant, Doctor’s Office/Hospital
Total ...................................................

lotter on DSKBCFDHB2PROD with NOTICES

Number of
respondents

Type of respondents

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

Number of
responses per
respondent
3

5/60

480

98

193

5/60

1,513

15

11

20/60

54

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

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

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

2,047

[FR Doc. 2019–27555 Filed 12–20–19; 8:45 am]
BILLING CODE 4163–18–P

19:32 Dec 20, 2019

Jkt 250001

PO 00000

Frm 00059

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Total burden
(in hours)

2,000

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.

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Average
burden per
response
(in hours)

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File Modified2019-12-21
File Created2019-12-21

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