Notice2022-06432
Proposed Data Collection Submitted for Public Comment and Recommendations
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 28, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
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, Laboratory Response Network (LRN). The LRN is created to maintain an integrated national and international network of laboratories that can respond to suspected acts of biological, chemical, or radiological terrorism and other public health emergencies.
Full Text
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<title>Federal Register, Volume 87 Issue 59 (Monday, March 28, 2022)</title>
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[Federal Register Volume 87, Number 59 (Monday, March 28, 2022)]
[Notices]
[Pages 17294-17295]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-06432]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-22-0850; Docket No. CDC-2022-0039]
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, Laboratory Response Network
(LRN). The LRN is created to maintain an integrated national and
international network of laboratories that can respond to suspected
acts of biological, chemical, or radiological terrorism and other
public health emergencies.
DATES: CDC must receive written comments on or before May 27, 2022.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2022-
0039 by either of the following methods:
<bullet> Federal eRulemaking Portal: <a href="http://Regulations.gov">Regulations.gov</a>. Follow the
instructions for submitting comments.
<bullet> 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 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 Jeffrey M. Zirger, Information Collection
Review Office, Centers for Disease Control and Prevention, 1600 Clifton
Road NE, MS H21-8, Atlanta, Georgia 30329; phone: 404-639-7570; Email:
<a href="/cdn-cgi/l/email-protection#d7b8bab597b4b3b4f9b0b8a1"><span class="__cf_email__" data-cfemail="355a5857755651561b525a43">[email protected]</span></a>.
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.
Proposed Project
Laboratory Response Network (LRN) (OMB Control No. 0920-0850, Exp.
4/30/2022)--Revision--National Center for Emerging and Zoonotic
Infectious Diseases (NCEZID), Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
The Laboratory Response Network (LRN) was established by the
Department of Health and Human Services (HHS), Centers for Disease
Control and Prevention (CDC) in accordance with Presidential Decision
Directive 39, which outlined national anti-terrorism policies and
assigned specific missions to federal departments and agencies. The
LRN's mission is to maintain an integrated national and international
network of laboratories that can respond to suspected acts of
biological, chemical, or radiological terrorism and other public health
emergencies.
Federal, state and local public health laboratories join the LRN
voluntarily. When laboratories join, they assume specific
responsibilities and are required to provide information to the LRN
Program Office at CDC. Each laboratory must submit and maintain
complete information regarding the testing capabilities of the
laboratory. Biennially, laboratories are required to review, verify and
update their testing capability information. This information is needed
so that the LRN Program Office can determine the ability of the Network
to respond to a biological or chemical terrorism event. The sensitivity
of all information associated with the LRN requires that CDC obtain
personal information about all individuals accessing the LRN website.
Since CDC must be able to contact all laboratory personnel during an
event, each laboratory staff member who obtains access to the
restricted LRN website must provide his or her contact information to
the LRN Program Office.
As a requirement of membership, LRN laboratories must report all
biological and chemical testing results to the LRN Program using a CDC
developed software tool called the LRN Results Messenger, or through
their laboratory information management system (LIMS) which CDC refers
to as Data Integration. CDC migrated laboratories to a centralized
cloud-based LRN Results Messenger that is accessed through CDC Secure
Access Management Services (SAMS). This new LRN Data Portal Results
Messenger (LDPRM) can be rapidly modified for a new or emerging threat,
and the burden of maintenance is removed from the member laboratory.
This information obtained from LRN laboratories is essential for
surveillance of anomalies, to support response to an event that may
involve multiple agencies, and to manage limited resources.
LRN laboratories are also required to participate in Challenge
Panels or
[[Page 17295]]
Validation Studies and report their results to CDC. LRN laboratories
participate in multiple Challenge Panels, Exercises and/or Validation
Studies every year. These activities consist of 5-21,000 simulated
samples provided by CDC. These challenges are necessary to verify the
testing capability of the LRN laboratories. Because biological or
chemical agents perceived to be of bioterrorism concern can occur
rarely, some LRN laboratories have difficulty maintaining proficiency
in certain testing methods as a result of day-to-day testing. Thus,
simulated samples are distributed to ensure proficiency across LRN
member laboratories. LRN laboratories also enter the results of these
simulated samples into the LRN Results Messenger or through Data
Integration for evaluation by CDC.
During a surge event resulting from a bioterrorism or chemical
terrorism attack, or during an emerging infectious disease outbreak,
LRN Laboratories must submit all testing results using LRN Results
Messenger or through Data Integration. CDC uses these results to track
the progression of a bioterrorism event, respond in the most efficient
and effective way possible, and share this data with other federal
partners involved in the response. Data is collected via two primary
avenues, the program LRN Results Messenger or through Electronic
Laboratory Reporting (ELR), and results include details about the type
and source of samples as well as the tests performed and the numerical
and empirical results of those tests.
An LRN laboratory must provide its testing capabilities, physical
and shipping addresses, United States Department of Agriculture (USDA)
and Select Agent Permits, and specified responsible individuals' names,
phone numbers and email addresses. After registering with the LRN
website, a user must provide his/her first and last name, work phone
number, alternate phone number, email address, and month and day of
birth. During reporting of results, sample details, tests performed,
results obtained, and conclusions of tests are required.
The LRN website has remained virtually the same and has only
undergone routine maintenance since 2015 to keep it in working order.
There have been many improvements to the LRN website over the course of
the past three years: (1) The LRN website migrated to CDC Secure Access
Management Services (SAMS) servers to provide a more secured login and
user authentication, (2) A new CDC template was implemented to support
508 compliance and responsive designs, (3) LRN user role structures
were upgraded to provide more efficient administrative and user
maintenance workflow, and (4) The website database and code was
restructured to prepare the system for future modernization efforts.
CDC also conducted LRN-B Challenge Panels (CP) and LRN-C
Proficiency Testing (PT). The purpose of CP and PT is to simulate real
samples for labs that would not have regularly performed some of the
LRN procedures. Having the ability to conduct LRN CPs and PTs has led
to improved laboratory performance and better preparedness. In FY18 the
LRN-B CP passing rate was 97%. In FY19 and FY20, the passing rate was
88% and 90%. In FY18 the LRN-C PT passing was 96%. In FY19 and FY20,
the passing rate was 95% and 96%, respectively.
This data collection is authorized under the Public Health Service
Act, (42 U.S.C. 241) Section 301.
CDC requests OMB approval for an estimated 422,716 annual burden
hours. There is no cost to respondents other than their time to
participate.
Estimated Annualized Burden Hours
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Average number Average burden
Respondents Forms Number of of responses per response Total burden
respondents per respondent (hours) hours
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Public Health Laboratories.... Biennial 130 1 2 260
Requalification.
Routine Testing 130 25 4 13,000
Results (LRN-B).
Challenge Panel/ 130 2 12 3,120
Validation
Testing Results
(LRN-B).
Surge Event 130 625 4 325,000
Testing Results
(LRN-B).
BioFire 16 1 2 32
Inventory
Records (LRN-B).
Proficiency 44 4 392 68,992
Testing/
Characterizatio
n Results (LRN-
C).
Surge Event 57 3 72 12,312
Testing Results/
Exercises (LRN-
C: SPaSE,
Surge, ERE).
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Total..................... ................ .............. .............. .............. 422,716
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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. 2022-06432 Filed 3-25-22; 8:45 am]
BILLING CODE 4163-18-P
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