[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]
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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
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Average
Number of Number of burden per
Type of respondents Form name respondents responses per response (in
respondent hours)
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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.
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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