[Federal Register Volume 84, Number 246 (Monday, December 23, 2019)]
[Notices]
[Pages 70550-70551]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27555]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-20-20EC; Docket No. CDC-2019-0115]


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 proposed and/or 
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 which is a system used to record specimen metadata 
and patient data related to test order requests submitted by external 
partners (state public health laboratories, 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 February 21, 
2020.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2019-
0115 by any of the following methods:
     Federal eRulemaking Portal: 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-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to Regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (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 Jeffery M. Zirger, of the Information 
Collection Review Office, Centers for Disease Control and Prevention, 
1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-
7570; Email: [email protected].

[[Page 70551]]


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; and
    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.
    5. Assess information collection costs.

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. 
CDC requests approval for 2,047 annual burden hours. There is no cost 
to respondents other than their time.

                                        Estimated Annualized Burden Hours
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                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondents           Form name       respondents    responses per   response  (in    (in hours)
                                                                    respondent        hours)
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Medical Assistant, Doctor's     CDC Specimen               2,000               3            5/60             480
 Office/Hospital.                Submission
                                 50.34 Form.
19-1042 Medical Scientists,     CDC Specimen                  98             193            5/60           1,513
 Except Epidemiologists, State   Submission
 Public Health Lab.              50.34 Form.
Medical Assistant, Doctor's     Global File                   15              11           20/60              54
 Office/Hospital.                Accessioning
                                 Template.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           2,047
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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. 2019-27555 Filed 12-20-19; 8:45 am]
 BILLING CODE 4163-18-P