Notice2023-12360
Proposed Data Collection Submitted for Public Comment and Recommendations
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 9, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
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 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 (ELIMS). This data collection is used by CDC to record specimen metadata and patient data related to test order requests submitted by external partners (SPHLs, International organizations, Federal institutions, hospitals, doctor's offices, etc.) to the CDC Infectious Diseases testing laboratories.
Full Text
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<title>Federal Register, Volume 88 Issue 111 (Friday, June 9, 2023)</title>
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[Federal Register Volume 88, Number 111 (Friday, June 9, 2023)]
[Notices]
[Pages 37880-37881]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-12360]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-23-1309; Docket No. CDC-2023-0047]
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.
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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 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 (ELIMS).
This data collection is used by CDC to record specimen metadata and
patient data related to test order requests submitted by external
partners (SPHLs, 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 August 8, 2023.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2023-
0047 by either of the following methods:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">www.regulations.gov</a>. Follow
the instructions for submitting comments.
<bullet> Mail: Jeffrey M. Zirger, Information Collection Review
Office, Centers for Disease Control and Prevention, 1600 Clifton Road
NE, MS H21-8, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. CDC will post, without change, all relevant comments
to <a href="http://www.regulations.gov">www.regulations.gov</a>.
Please note: Submit all comments through the Federal eRulemaking
portal (<a href="http://www.regulations.gov">www.regulations.gov</a>) 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, Information Collection
Review Office, Centers for Disease Control and Prevention, 1600 Clifton
Road NE, MS H21-8, Atlanta, Georgia 30329; Telephone: 404-639-7570;
Email: <a href="/cdn-cgi/l/email-protection#553a3837153631367b323a23"><span class="__cf_email__" data-cfemail="d5bab8b795b6b1b6fbb2baa3">[email protected]</span></a>.
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;
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; and
5. Assess information collection costs.
[[Page 37881]]
Proposed Project
Enterprise Laboratory Information Management System (ELIMS) (OMB
Control No. 0920-1309, Exp. 11/30/2023)--Revision--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 to 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 OMB approval for an estimated 2,153 annual burden
hours. There is no cost to respondents other than their time for
participation.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondents Form name Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
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Medical Scientists, Except CDC Specimen 2,098 12 5/60 2,098
Epidemiologists, State Public Submission
Health Lab, Medical 50.34 Form.
Assistant, Doctor's Office/
Hospital.
Medical Assistant, Doctor's Global File 15 11 20/60 55
Office/Hospital. Accessioning
Template.
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Total..................... ................ .............. .............. .............. 2,153
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health
Ethics and Regulations, Office of Science, Centers for Disease Control
and Prevention.
[FR Doc. 2023-12360 Filed 6-8-23; 8:45 am]
BILLING CODE 4163-18-P
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