Proposed Data Collection Submitted for Public Comment and Recommendations, 70550-70551 [2019-27555]
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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: omb@cdc.gov.
E:\FR\FM\23DEN1.SGM
23DEN1
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
Fmt 4703
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.
VerDate Sep<11>2014
Average
burden per
response
(in hours)
Sfmt 4703
E:\FR\FM\23DEN1.SGM
23DEN1
]]>Agencies
[Federal Register Volume 84, Number 246 (Monday, December 23, 2019)]
[Notices]
[Pages 70550-70551]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27555]
-----------------------------------------------------------------------
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
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
-----------------------------------------------------------------------
SUMMARY: 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 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.
DATES: CDC must receive written comments on or before February 21,
2020.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2019-
0115 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 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].
[[Page 70551]]
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
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.
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 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.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Type of respondents Form name respondents responses per response (in (in hours)
respondent hours)
----------------------------------------------------------------------------------------------------------------
Medical Assistant, Doctor's CDC Specimen 2,000 3 5/60 480
Office/Hospital. Submission
50.34 Form.
19-1042 Medical Scientists, CDC Specimen 98 193 5/60 1,513
Except Epidemiologists, State Submission
Public Health Lab. 50.34 Form.
Medical Assistant, Doctor's Global File 15 11 20/60 54
Office/Hospital. Accessioning
Template.
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 2,047
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2019-27555 Filed 12-20-19; 8:45 am]
BILLING CODE 4163-18-P
