[Federal Register Volume 87, Number 59 (Monday, March 28, 2022)]
[Notices]
[Pages 17294-17295]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: Regulations.gov. 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
----------------------------------------------------------------------------------------------------------------
                                                                  Average number  Average burden
          Respondents                 Forms          Number of     of responses    per response    Total burden
                                                    respondents   per respondent      (hours)          hours
----------------------------------------------------------------------------------------------------------------
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).
                                                 ---------------------------------------------------------------
    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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