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View ICR - Agency Submission
OMB Control No:
0920-1310
ICR Reference No:
202512-0920-010
Status:
Received in OIRA
Previous ICR Reference No:
202409-0920-016
Agency/Subagency:
HHS/CDC
Agency Tracking No:
0920-1310
Title:
[NCEZID] Public Health Laboratory Testing for Emerging Antibiotic Resistance and Fungal Threats
Type of Information Collection:
No material or nonsubstantive change to a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
Date Submitted to OIRA:
01/06/2026
Requested
Previously Approved
Expiration Date
12/31/2027
12/31/2027
Responses
185,836
185,930
Time Burden (Hours)
57,846
57,872
Cost Burden (Dollars)
0
0
Abstract:
Antibiotic resistance has the potential to impact all Americans at every stage of life and CDC is working to drive aggressive action and empower the nation to comprehensively respond to these threats. The goal of this study is to establish a network of public health laboratories to improve detection and characterization of urgent antibiotic resistant threats in healthcare-associated infections, carbapenem-resistant Enterobacteriaceae (CRE), carbapenem-resistant Pseudomonas aeruginosa (CRPA), carbapenem-resistant Acinetobacter baumannii (CRAB), and Candida species, including C. auris. This Change Request includes addition and removal of instruments along with other changes. These changes decrease the overall burden.
Authorizing Statute(s):
US Code:
42 USC 241
Name of Law: PHSA
EO: EO 13676 Name/Subject of EO: Combating Antibiotic-Resistant Bacteria
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
89 FR 51345
06/17/2024
30-day Notice:
Federal Register Citation:
Citation Date:
89 FR 80900
10/04/2024
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
30
IC Title
Form No.
Form Name
AR Lab Network Alert Report Form for Carbapenemase-producing Organisms
n/a
AR Lab Network Alert Report Form for Carbapenemase-producing Organisms
AR Lab Network Alert and Monthly Data Report Form for Candida
n/a
AR Lab Network Alert and Monthly Data Report Form for Candida
AR Lab Network Alert and Monthly Data Report Form for Neisseria gonorrhoeae
n/a
AR Lab Network Alert and Monthly Data Report Form for Neisseria gonorrhoeae (SHARP)
AR Lab Network Annual Report of Testing Methods for Carbapenemase-producing Organisms
n/a
Annual Report of Method Tracking
AR Lab Network DAART data elements for Neisseria gonorrhoeae
n/a
AR Lab Network DAART data elements for Neisseria gonorrhoeae
AR Lab Network Form for Phylogenetic Tree-level Mycotics Reporting
n/a
AR Lab Network Form for Phylogenetic Tree-level Mycotics Reporting (C. auris Whole Genome Sequencing)
AR Lab Network Monthly Data Report Form for Carbapenemase-producing Organisms
n/a
Monthly Data Report Form for Carbapenemase-producing Organisms
Antifungal Resistant Tinea Dermatophytes - Annual Evaluation and Performance Measurement Report
I12
Antifungal Resistant Tinea/Dermatophytes
Antimicrobial Susceptibility Testing (AST) of Invasive Haemophilus Influenzae (H. Influenzae) in Jurisdiction - Annual Evaluation and Performance Measurement Report
I13
Antimicrobial Susceptibility Testing (AST) of Invasive Haemophilus Influenzae (H. Influenzae) in Jurisdiction
Azole Resistance in Clinical Aspergillus Fumigatus Isolates - Annual Evaluation and Performance Measurement Report
I7
Azole Resistance in Clinical Aspergillus Fumigatus Isolates
C. Auris Colonization Screening in Jurisdiction-Annual Evaluation and Performance Measurement Report
I5
C. Auris Colonization Screening in Jurisdiction
C. Auris Whole Genome Sequencing (WGS) in Jurisdiction- Annual Evaluation and Performance Measurement Report
I16
C. Auris Whole Genome Sequencing (WGS) in Jurisdiction
CSV files updates for Carbapenemase-producing organisms-IT Maintenance
Candida Species Identification in Jurisdiction- Annual Evaluation and Performance Measurement Report
I3
Candida Enhanced Yeast Surveillance for Species Identification
Carbapenemase-Producing Orgranism (CPO) Screening in Jurisdiction - Annual Evaluation and Performance Measurement Report
I6
Carbapenemase-Producing Organism (CPO) Screening in Jurisdiction
Characterization of the Clinical Laboratory Network in Jurisdiction - Annual Evaluation and Performance Measurement Report
I20
Characterization of the Clinical Laboratory Network in Jurisdiction
Clostridioides Difficile (C. Difficile) Testing in Jurisdiction - Annual Evaluation and Performance Measurement Report
I11
Clostridioides Difficile (C. Difficile) Testing in Jurisdiction
Communication and Coordination of Actionable Epi Lab Data in Jurisdiction - Annual Evaluation and Performance Measurement Report
I19
Communication and Coordination of Actionable Lab Data in Jurisdiction
Expanded Drug Susceptibility Testing (ExAST) in Jurisdiction- Annual Evaluation and Performance Measurement Report
I2
Expanded Drug Susceptibility Testing (ExAST) in Jurisdiction
Gonococcal (GC) Antimicrobial Susceptibility Testing (AST) in Jurisdiction - Annual Evaluation and Performance Measurement Report
I9
Gonococcal (GC) Antimicrobial Susceptibility Testing (AST) in Jurisdiction
HAIAR Whole Genome Sequencing (WGS) of Gram-negative AR Threats in Jurisdiction- Annual Evaluation and Performance Measurement Report
I4
Whole Genome Sequencing (WGS) of Carbapenemase-Producing AR Threats in Jurisdiction
HL7 Messages updates-IT Maintenance
Healthcare Wastewater-based Surveillance - Annual Evaluation and Performance Measurement Report
I18
Healthcare Wasterwater-based Surveillance
Implementation of new HL7 messages-IT Initial Set up
Molecular Mtb Testing- Annual Evaluation and Performance Measurement Report
I15
Molecular Mtb Testing
Monitoring CRE CRPA in Companion Animals to from Humans - Annual Evaluation and Performance Measurement Report
I17
Monitoring CRE/CRPA in Companion Animals to/from Humans
Mycoplasm Gentalium (MG)- Annual Evaluation and Performance Measurement Report
I14
Mycoplasma Gentalium (MG)
N. Gonorrhoeae Whole Genome Sequencing (WGS)- Annual Evaluation and Performance Measurement Report
I8
N. Gonorrhoeae Whole Genome Sequencing (WGS)
Neisseria Ghonorrhoeae Etest for SHARP
I21
Neisseria Ghonorrhoeae
Routine Testing by Genera in Jurisdiction- Annual Evaluation and Performance Measurement Report
I1
Routine Testing by Genus in Jurisdiction
Updates to HL7 reporting including additional testing , or LIMS re-validation
Whole Genome Sequencing (WGS) of S. Pneumonaie - Annual Evaluation and Performance Measurement Report
I10
Whole Genome Sequencing (WGS) of S. Pneumonaie
ICR Summary of Burden
Total Request
Previously Approved
Change Due to New Statute
Change Due to Agency Discretion
Change Due to Adjustment in Estimate
Change Due to Potential Violation of the PRA
Annual Number of Responses
185,836
185,930
0
-94
0
0
Annual Time Burden (Hours)
57,846
57,872
0
-26
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Miscellaneous Actions
Burden decreases because of Program Change due to Agency Discretion:
Yes
Burden Reduction Due to:
Miscellaneous Actions
Short Statement:
Burden adjustments are primarily due to reducing the frequency of reporting.
Annual Cost to Federal Government:
$12,583,265
Does this IC contain surveys, censuses, or employ statistical methods?
Yes
Part B of Supporting Statement
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
No
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
No
Agency Contact:
Kevin Joyce 404 639-1944 kdj7@cdc.gov
Common Form ICR:
No
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Certification Date:
01/06/2026
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