[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Type of respondents Form name respondents responses per response (in (in hours)
respondent hours)
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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