[Federal Register Volume 88, Number 111 (Friday, June 9, 2023)]
[Notices]
[Pages 37880-37881]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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:
     Federal eRulemaking Portal: 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 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 www.regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (www.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 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: [email protected].

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.
                                                 ---------------------------------------------------------------
    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]
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