[Federal Register Volume 85, Number 174 (Tuesday, September 8, 2020)]
[Notices]
[Pages 55456-55457]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19743]


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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

[[Page 55457]]

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.

                                        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.
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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. 2020-19743 Filed 9-4-20; 8:45 am]
BILLING CODE 4163-18-P