Supporting Statement A
Emergency Epidemic Investigations
OMB No. 0920-0008
Project Officer: Ron Edwards Sr.
Program Analyst, EIS Program
Career Development Division
Office of Workforce and Career Development
Centers for
Disease Control and Prevention
1600 Clifton Road, NE, MS E-92
Atlanta, GA 30333
Voice: (404) 498-6316
Fax:
(404) 498-6535
December 2, 2009
Emergency Epidemic Investigations
OMB No. 0920-0008
Justification
Circumstances Making the Collection of Information Necessary
The investigation of emergency problems is an integral part of the mission of the Centers for Disease Control and Prevention (CDC) and is authorized by the Public Health Service Act (42 USC Sec. 301 [241] (a) (Attachment A). Early recognition of adverse health conditions and rapid application of prevention and control measures are fundamental to CDC’s contribution to healthy people in a healthy world. Epidemics and natural and human-made disasters create extraordinary demands for health services. Because of the immediacy, complexity, and volume of these demands, frequently states and foreign countries look to CDC for short-term epidemiologic and laboratory expertise in a broad variety of diseases and conditions, as well as expertise in dealing with rare infections and unknown agents. During epidemic investigations, emphasis is placed on the etiology and transmission of diseases so that prevention and control measures can be rapidly instituted.
During most emergency situations, CDC specialists (epidemiologists, biostatisticians, laboratory specialists, etc.) work under the aegis of a state or local health department. Often, such investigations are completed by the state or local government, with technical assistance from CDC. Occasionally, an investigation must be continued or is multi-state or global in nature. (In these cases, CDC collects or sponsors the collection of information from the public.) CDC is requesting a three-year extension of the current OMB approval that allows us to collect data during emergency situations.
The circumstances in which emergency data collection authority is used include those in which:
The agent is unknown, and CDC must provide assistance in collecting and analyzing data on the conditions surrounding and preceding the onset of the problem
The outbreak involves more than one state and uniform data is needed
A delay in data collection would result in the loss of epidemiologic information essential to assist laboratory investigations
A delay in investigation would hamper the ability of public health officials to provide information to the public and implement control measures
A delay in data collection would result in disassembly of the respondent population
Since OMB last approved this data collection in March 2007, CDC’s Epidemic Intelligence Service has conducted hundreds of epidemic investigations to protect the public’s health worldwide. Investigations have identified the causes of outbreaks of E. coli, tuberculosis, salmonella, H1N1, and more, and findings have slowed or stopped the spread of disease, and resulted in reduced morbidity and mortality among people in affected areas.
CDC is requesting that this clearance maintain the 90-day outbreak investigation period. If more than 90 days are needed to complete an outbreak investigation, CDC will begin procedures to conduct a full clearance request (regular or emergency).
Purpose and Use of the Information
One of the objectives of CDC’s epidemic services is to provide for the prevention and control of epidemics and protect the civilian population from public health crises such as human-made or natural biological disasters and chemical emergencies. CDC meets this objective, in part, by training investigators, maintaining laboratory capabilities for identifying potential problems, collecting and analyzing data, and recommending appropriate actions to protect health and save lives. Data on the conditions surrounding and preceding the onset of a problem must be collected in a timely fashion so that information can be used to develop prevention and control techniques, to interrupt disease transmission, to help identify the cause of the outbreak, etc.
In general, CDC is the federal agency most likely to receive the request to assist in investigating unusual clusters of morbidity or mortality, large outbreaks, and incidents affecting more than one state. The following are examples of categories and circumstances of emergency investigations carried out during recent years:
Outbreaks of diseases with unknown etiology and transmission, which are highly contagious, and which have high case fatality
Known diseases which are highly contagious, virulent, and have unknown source of infection or mode of transmission
Questionable increase in number of cases of known diseases
Incidences of infectious outbreaks among children
Health effects associated with forest fires
Outbreaks of sudden illness in employment surroundings
Outbreaks of illness in hospital neonatal nurseries
Outbreaks of illness on cruise ships
Use of Information Technology and Burden Reduction
Because the events necessitating the collection of information are of an emergency nature, most data collection is done by direct interview or written questionnaire. Interviews are conducted to be as unobtrusive as possible, and only the minimal information necessary is collected.
Efforts to Identify Duplication and Use of Similar Information
Literature searches and discussions with state and local public health officials are initially conducted to determine the extent of existing information. If found, previous information is used whenever appropriate to contribute to an investigation. However, an emergency situation generally requires the collection of data specific to the particular epidemic or emergency, because each event is unique in many aspects.
Each investigation does contribute to the general knowledge about a particular type of problem or emergency, and data collections are designed to incorporate knowledge gained from similar situations in the past. Some questionnaires have been standardized, such as investigations of outbreaks aboard aircraft or cruise vessels.
Impact on Small Businesses or Other Small Entities
Every effort is made to minimize the burden on all respondents to questionnaires and interviews administered during the collection of information in emergency or epidemic situations. If during an emergency investigation the need for further study is recognized, CDC will design a formal project and submit a separate clearance request to OMB (regular or emergency).
Consequences of Collecting the Information Less Frequently
Emergency investigations are one-time efforts related to a specific outbreak or circumstance. If during the emergency investigation, the need for further study is recognized, CDC will design a project and request separate OMB clearance.
Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
The data collections covered by this OMB clearance are consistent with the guidelines.
Comments in Response to the Federal Register Notice and Efforts to Consult Outside Agency
The 60-day Federal Register Notice was published in the Federal Register August 19, 2009 (Attachment B). CDC received one public comment and has sent a response (Attachment G).
As previously stated, CDC participates in the investigation at the request of the state or local health department or country, and the data collection plan is developed in collaboration with the health department(s) or country. Other federal agencies, such as the Food and Drug Administration, the Department of Agriculture, the Environmental Protection Agency, Department of Homeland Security, or the Department of State are involved in some investigations. These collaborating agencies are concerned with the overall conduct of epidemic investigations and aspects of the investigation related to their authorities. They generally have little input into development of questionnaires and interviews for the epidemiologic investigations conducted by CDC.
Explanation of Any Payment or Gift to Respondents
Respondents are not remunerated.
Assurance of Confidentiality
The CDC Confidentiality and Privacy Officer has reviewed this application and has determined that the Privacy Act is applicable. Full names are not always collected; but at times collection of names is necessary, particularly for correlation with laboratory reports. It should be noted that when CDC staff participate in epidemic investigations at the request of the state or local health departments and collect individually identified data, those records are being added to the already established record system of the health department, and the Privacy Act is not applicable. Names are generally retained by the collaborating state or local health department.
However, individually identified data are often brought to CDC for analysis, and under those circumstances, the Privacy Act does apply. Records are covered under CDC Privacy Act system notice 09-20-0113, “Epidemic Investigation Case Records.” (Attachment C) In limited circumstances, confidentiality may be pledged for some epidemiologic surveys. The authority of such data collection is Sections 304 and 306, with confidentiality assured under Section 308(d) of the Public Health Service Act. The use of this authority must be approved by the CDC Director. No cases requiring such as assurance of confidentiality have occurred since the previous OMB submission.
IRB approval is not required for the Emergency Epidemic Investigations (Attachment F). These investigations are not considered research, based on the description and justification, and also on the definition of research defined by the Federal Policy for the Protection of Human Subjects (45 CFR 46).
Justification for Sensitive Questions
Questions that might be considered sensitive (e.g., regarding sexual behavior or attitudes) are included only when considered necessary for the particular epidemic or emergency situation being investigated. Before administering questionnaires or interviews, investigators inform respondents (either verbally or in writing) that participation is voluntary, and that respondents are not personally identified in any published reports of the study.
Estimates of Annualized Burden Hours and Costs
Attachments D and E list a brief description, number of respondents, and burden information for each use of the emergency epidemic investigation requiring clearance since the previous submission. Copies of the forms developed for this data collection project are attached as appendices to this information collection request. The following table presents a summary of the total burden CDC is requesting for this clearance:
Respondents |
Form Name |
# of Respondents |
# of Responses per Respondent |
Average Burden per Response (in hours) |
Total Burden (in hours) |
General Public |
Emergency Epidemic Investigations |
15,000 |
1 |
15/60 |
3,750 |
State of local officials |
Emergency Epidemic Investigations |
100 |
1 |
15/60 |
25 |
Predicting the number of epidemic investigations that might occur in any given year is difficult. During the past year, the Epidemic Intelligence Service (EIS) Program coordinated 400 Epidemic Assistance Investigations (Epi-Aids) and state-based field investigations, with approximately 15,000 respondents. Epidemics are prevented and controlled by mobilizing and deploying CDC staff, primarily EIS officers, to respond rapidly to disease outbreaks and disaster situations.
The hourly wage was based on the U.S. national average for 2008 taken form the Bureau of Labor Statistics website.
Total Burden Hours |
Responses per Respondent |
Hourly Wage |
Total Burden |
3,750 |
1 |
$25.08 |
$94,050 |
25 |
1 |
$25.08 |
$627.00 |
Estimate of Other Total Annual Cost Burden to Respondents or Record keepers
There are no capital or maintenance costs.
Annualized Cost to the Federal Government
The annual cost to the Government is estimated to be $350,000. The cost factors considered are related to routine procedures of the medical epidemiologists and statistical personnel in planning investigations; design, preparation, printing, and distribution of questionnaires; and editing, coding, tabulation, analysis, and presentation of the information.
Explanation for Program Changes or Adjustments
CDC is not requesting any changes to the program.
Plans for Tabulation and Publication and Project Time Schedule
The epidemiologic data provide information that is necessary for controlling an epidemic or emergency and preventing further unnecessary morbidity and premature mortality. Therefore, collecting data as soon as possible after the onset of the epidemic or emergency is critical to the epidemiologic analysis. Data analysis is the responsibility of the principal epidemiologist. Any publication of data derived from epidemic studies is subject to review by state health departments, CDC, or foreign countries.
Reason(s) Display of OMB Expiration Date is Inappropriate
CDC is not requesting an exemption to the display of the expiration date.
Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exemptions to the certifications statement.
ATTACHMENTS
ATTACHMENT A Authorizing Legislation
ATTACHMENT B Federal Register Notice
ATTACHMENT C Epidemic Investigation Case Records System Notice
ATTACHMENT D OMB Forms for Epidemic Investigations 2006 – 2008
ATTACHMENT E State/Local Officials Questionnaire
ATTACHMENT F IRB Determination
ATTACHMENT G Comment and Response to 60-day FRN
| File Type | application/msword |
| File Title | Emergency Epidemic Investigations |
| Author | mll1 |
| Last Modified By | bqs1 |
| File Modified | 2009-12-02 |
| File Created | 2009-12-02 |