[Federal Register Volume 88, Number 164 (Friday, August 25, 2023)]
[Notices]
[Pages 58280-58281]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-18362]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-23-1309]


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'' 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 
June 09, 2023, to obtain comments from the public and affected 
agencies. CDC did not receive comments 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 (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 50.34 Form 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 OMB approval for an estimated 2,153 annualized burden 
hours. There is no cost to respondents other than their time to 
participate.

[[Page 58281]]



                                        Estimated Annualized Burden Hours
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                                                                                     Number of    Average burden
          Type of respondents                   Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
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Medical Scientists, Except              CDC Specimen Submission            2,098              12            5/60
 Epidemiologists, State Public Health    50.34 Form.
 Lab, Medical Assistant, Doctor's
 Office/Hospital.
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 Public Health 
Ethics and Regulations, Office of Science, Centers for Disease Control 
and Prevention.
[FR Doc. 2023-18362 Filed 8-24-23; 8:45 am]
BILLING CODE 4163-18-P