Agency Forms Undergoing Paperwork Reduction Act Review, 39909-39910 [2020-14329]
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Federal Register / Vol. 85, No. 128 / Thursday, July 2, 2020 / Notices
Setting
• Any, including single- and
multicenter
Design
•
•
•
•
•
RCTs, N≥10 per group
NRCSs, N≥30 per group
Case-control studies, N≥100 per group
Single group studies, N≥500
Studies may be prospective or
retrospective
• Exclude: case reports and series of
individually-reported case reports
Dated: June 26, 2020.
Virginia Mackay-Smith,
Associate Director.
[FR Doc. 2020–14237 Filed 7–1–20; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–20–20EC]
khammond on DSKJM1Z7X2PROD 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 Enterprise
Laboratory Information Management
System (ELIMS) 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 December
23, 2019 to obtain comments from the
public and affected agencies. CDC
received one comment 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
VerDate Sep<11>2014
21:18 Jul 01, 2020
Jkt 250001
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
instruments, call (404) 639–7570.
Comments and recommendations for the
proposed information collection 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. 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
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
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39909
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. There is no cost to
respondents other than their time. The
total burden hours are 2,131 hours.
E:\FR\FM\02JYN1.SGM
02JYN1
39910
Federal Register / Vol. 85, No. 128 / Thursday, July 2, 2020 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Average
burden per
response
(in hours)
Form name
Medical Assistant, Doctor’s Office/Hospital ....
19–1042 Medical Scientists, Except Epidemiologists, State Public Health Lab.
Medical Assistant, Doctor’s Office/Hospital ....
CDC Specimen Submission 50.34 Form .......
CDC Specimen Submission 50.34 Form .......
2,000
98
3
193
5/60
5/60
Global File Accessioning Template ...............
15
11
20/60
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2020–14329 Filed 7–1–20; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–20–20PJ; Docket No. CDC–2020–
0073]
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 ‘‘Formative Research on
Community-Level Factors that Promote
the Primary Prevention of Adverse
Childhood Experiences (ACEs) and
Opioid Misuse Among Children, Youth,
and Families in Tribal American Indian
and Alaska Native (AI/AN)
Communities.’’ The proposed collection
is designed to conduct formative
qualitative studies to identify
community-level protective factors and
primary prevention strategies across a
range of Tribal communities to prevent
adverse childhood experiences (ACEs)
and opioid misuse.
DATES: CDC must receive written
comments on or before August 31, 2020.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2020–
0073 by any of the following methods:
SUMMARY:
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Number of
respondents
Type of respondents
VerDate Sep<11>2014
21:18 Jul 01, 2020
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• Federal eRulemaking Portal: https://
www.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 https://
www.regulations.gov.
Please note: Submit all comments through
the Federal eRulemaking portal (https://
www.regulations.gov) or by U.S. mail to the
address listed above.
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–
D74, 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;
FOR FURTHER INFORMATION CONTACT:
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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
Formative Research on CommunityLevel Factors That Promote the Primary
Prevention of Adverse Childhood
Experiences (ACEs) and Opioid Misuse
Among Children, Youth, and Families
in Tribal American Indian and Alaska
Native (AI/AN) Communities—New—
National Center for Injury Prevention
and Control (NCIPC), Centers for
Disease Control and Prevention (CDC)
Background and Brief Description
Adverse childhood experiences
(ACEs) are preventable, potentially
traumatic events that occur in
childhood (0–17 years) such as
experiencing violence, abuse, or neglect;
witnessing violence in the home; and
having a family member attempt or die
by suicide. There is a robust evidence
base linking ACEs to a variety of poor
health outcomes across the life span,
including depression, alcohol and
substance use disorder, and violence
perpetration and victimization. The
ongoing opioid epidemic is a complex
and significant public health crisis that
exposes children to opioid misuse,
violence, and other ACEs, and
challenges the ability of Health and
Human Service (HHS) systems to
mitigate the effects of opioid misuse and
ACEs on children and families across
the U.S. American Indian/Alaska Native
(AI/AN) populations experience a
disproportionate burden of opioid
misuse and ACEs, and ACE-related
E:\FR\FM\02JYN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 128 (Thursday, July 2, 2020)]
[Notices]
[Pages 39909-39910]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14329]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-20-20EC]
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 Enterprise Laboratory Information Management
System (ELIMS) 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 December
23, 2019 to obtain comments from the public and affected agencies. CDC
received one comment 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 instruments, call
(404) 639-7570. Comments and recommendations for the proposed
information collection 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. 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
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.
There is no cost to respondents other than their time. The total burden
hours are 2,131 hours.
[[Page 39910]]
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per
Type of respondents Form name respondents responses per response (in
respondent hours)
----------------------------------------------------------------------------------------------------------------
Medical Assistant, Doctor's Office/ CDC Specimen Submission 2,000 3 5/60
Hospital. 50.34 Form.
19-1042 Medical Scientists, Except CDC Specimen Submission 98 193 5/60
Epidemiologists, State Public Health 50.34 Form.
Lab.
Medical Assistant, Doctor's Office/ Global File Accessioning 15 11 20/60
Hospital. Template.
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2020-14329 Filed 7-1-20; 8:45 am]
BILLING CODE 4163-18-P
