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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View Generic ICR - OIRA Conclusion
OMB Control No:
0920-1011
ICR Reference No:
202209-0920-030
Status:
Active
Previous ICR Reference No:
202201-0920-010
Agency/Subagency:
HHS/CDC
Agency Tracking No:
0920-1011
Title:
Emergency Epidemic Investigation Data Collections
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
12/22/2022
Retrieve Notice of Action (NOA)
Date Received in OIRA:
10/07/2022
Terms of Clearance:
revious terms continue: Approved consistent with the understanding that GenICs under this generic will be limited to acute public health emergencies resulting from outbreaks or events with undetermined agent, source, mode of transmission, or risk factors. Data collection for investigations conducted under this generic will not exceed 90 days. Investigations conducted for the primary purpose of program evaluation, surveillance, needs assessment, or research (e.g., to contribute to generalizable knowledge) are excluded from this generic pathway.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
12/31/2025
36 Months From Approved
01/31/2023
Responses
12,000
0
805,759
Time Burden (Hours)
6,000
0
402,874
Cost Burden (Dollars)
0
0
0
Abstract:
The EEI Generic ICR is specifically designed to support CDC mission-critical functions by allowing CDC to deploy to the field to conduct Emergency Epidemic Investigations (EEIs) at the request of, and under the public health authority of, external partners seeking support for a rapid response to urgent public health problems. Recent investigation that have benefited from this EEI Generic ICR included the early response to the COVID 19 Pandemic, Monkeypox outbreak, and E-cigarette or Vaping Use-Associated Lung Injury (EVALI), among other high profile acute public health events. In these situations, insufficient information is available to allow for development of data collection instruments before the response team travels to the field. Data collection instruments and methods must be rapidly created and implemented, usually while investigators are in the field, to direct appropriate public health action. Often specific questions will change or new questions will evolve during the course of the investigation as new information is revealed. While most EEIs involve 2 to 3 weeks of data collection, data collections might take longer. Data collection for investigations conducted under this generic will not exceed 90 days. If data collection is required for a longer period of time, a new request will be submitted to OMB explaining the circumstances for the extended data collection and providing the forms that will be used for that collection (by this point, the content and scope of the inquiry should be clearer).
Authorizing Statute(s):
US Code:
42 USC 301
Name of Law: PHSA
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:
87 FR 22892
04/18/2022
30-day Notice:
Federal Register Citation:
Citation Date:
87 FR 55811
09/12/2022
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
7
IC Title
Form No.
Form Name
Investigation of Multistate Outbreak of Severe Illness related to consumption of Diamond ShruumzTM Brand products-United States_2024
0920-1011
Diamond Shruumz Outbreak Investigation Case Report Form
Post-product recall investigation of a multistate cluster of VIM-producing carbapenem resistant Pseudomonas aeruginosa associated with artificial tear use
0920-1011
VIM-CRPA Outbreak Chart Abstraction Form]
Serious adverse events, including deaths, of unknown etiology following ceftriaxone administration among patients in multiple healthcare facility types, AL and multiple states, September 2024-Present
0920-1011
CDC Case Report Form: Serious Adverse Events Following Ceftriaxone Injection in Healthcare Settings
VIM-Carbapenem Resistant Pseudomonas aeruginosa (VIM-CRPA) Outbreak Investigation Abstraction Form
0920-1011, 0920-1011
Chart Abstraction Form
,
Facility Product List
[NCEZID] Multistate investigation of serious adverse events, including deaths, of unknown etiology following ceftriaxone administration_Sep 2024-Present
0920-1011, 0920-1011
Case Report Form - Ceftriaxone Injection in Healthcare Settings - Public Health Departments
,
Case Report Form - Ceftriaxone Injection in Healthcare Settings - Healthcare Providers
[NCEZID] Undetermined Risk Factors for carbapenemase-producing carbapenem-resistant Enterobacterales (CP-CRE) among Children in Healthcare Settings
0920-1011
Case Report Form - (CP-CRE) among Children in U.S. Healthcare Settings
[NCEZID] Undetermined Risk Ractors for Carbapenemase-producing Carbapenem-resistant Enterobacterales (CP-CRE) Among Children in Healthcare Settings - United States
n/a
Case Report Form
ICR Summary of Burden
Total Approved
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
12,000
805,759
0
-793,759
0
0
Annual Time Burden (Hours)
6,000
402,874
0
-396,874
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
Yes
Burden Reduction Due to:
Miscellaneous Actions
Short Statement:
Even though the Federal Register Notice published as an extension, this is a revision request for a currently approved submission for a burden change. Projecting annualized burden is difficult because the occurrence of Emergency Epidemic Investigations is unpredictable. The annualized burden for the EEI Generic ICR since it was first approved in March 2014 ranged from 19,326 respondents during Year 1 (April 2014 to March 2015) to 0 respondents during Year 4 (April 2017 to March 2018); 6,274 burden hours during Year 1 to 0 burden hours during Year 4; and an average burden per respondent of 20/60 minutes during Year 1 to about 30/60 minutes during Year 2 (April 2015 to March 2016). While the actual burden for EEIs approved under the EEI Generic ICR was slightly higher than was originally projected for Year 1, it was much lower than projected for subsequent years. The higher burden in Year 1 is due in large part to Ebola response data collections, which were unprecedented in CDC history. During 2020 the initial COVID-19 investigations required a burden of 3,200 respondents and 1,600 hours. Events of this scale could occur again, though this cannot be predicted in advance. Adjustments to cost burdens are based on Bureau of Labor Statistics (Year 2021) and OMB (2021) wage and salary adjustments.
Annual Cost to Federal Government:
$2,130,576
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.
Yes
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.
Yes
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?
Yes
Agency Contact:
Thelma Sims 4046394771
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:
10/07/2022
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