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.
table that charts list comparision
Inventory as of this Action
Requested
Previously Approved
12/31/2025
36 Months From Approved
01/31/2023
12,000
0
805,759
6,000
0
402,874
0
0
0
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).
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.
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:
(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;
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.
Form 0920-1011 CDC Case Report Form: Serious Adverse Events Following Ceftriaxone Injection in Healthcare Settings
Published 30dy221011.pdf
EEI GenICR_Sup St A_10.03.22.docx
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