2019-14297. Agency Forms Undergoing Paperwork Reduction Act Review

In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled “The Drug Overdose Surveillance and Epidemiology (DOSE)” to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on April 2, 2019 to obtain comments from the public and affected agencies. CDC received one comment related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.

CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:

(a) 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;

(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(c) Enhance the quality, utility, and clarity of the information to be collected;

(d) 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 submission of responses; and

(e) Assess information collection costs.

To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call [phone] or send an email to [e-mail]. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to [phone]. Provide written comments within 30 days of notice publication.

Proposed Project

Drug Overdose Surveillance and Epidemiology (DOSE)—New—National Center for Injury Prevention and Control (NCIPC), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The rapid increase in opioid overdose deaths since 2013, numerous severe fentanyl and fentanyl analog outbreaks occurring since 2015 across the United States, and the declaration of the opioid overdose epidemic as a national public health emergency on October 26, 2017 have highlighted the urgent need to rapidly establish and enhance timely surveillance of suspected drug, opioid, heroin, and stimulant overdoses. These data are critical to inform timely local, state, and regional response, especially to acute and/or widespread multi-state outbreaks.

This new data collection effort is an essential component toward reducing the opioid crisis, one of HHS Department's top priorities. DOSE data is critical to our ability to rapidly identify outbreaks and provide situational awareness of changes in emergency department (ED) visits involving suspected drug, opioid, heroin and stimulant overdoses at the local, state, and regional level. This will be accomplished by standardizing and enhancing sharing of existing ED data locally collected by 52 health departments (all 50 state health departments, the health department of Puerto Rico, and the health department of the District of Columbia) with CDC. In addition, CDC leadership communicates with HHS on an ongoing basis and this data is part of its request to better monitor, plan and implement programs to prevent overdose and reduce subsequent harms.

DOSE proposes to fund 52 health departments (50 state health departments, the health department of Puerto Rico and the health department of the District of Columbia) to rapidly share existing ED data on counts of ED visits involving suspected drug, opioid, heroin, and stimulant overdoses using two standard data forms (i.e., the Rapid ED overdose data form and the ED discharge overdose data form) and standard CDC case definitions.

The system will leverage ED syndromic data and hospital discharge data on ED visits already routinely collected by state and territorial health departments. No new data will be systematically collected from EDs, and health departments will be reimbursed by CDC for the burden related to sharing ED data with CDC. Fifty-two funded health departments (50 state health departments, Puerto Rico, and the District of Columbia) will rapidly share existing ED data with CDC on a monthly basis using the Rapid ED overdose data form and standard CDC case definitions. Data may come from different local ED data systems, but is expected to cover at least 75% of ED visits in the jurisdiction (e.g., state).

CDC will require all participating health departments to provide counts of ED visits involving suspected drug, opioid, heroin, and stimulant overdoses by county, age group, sex, and time (i.e., month and year) in a standardized manner using the Rapid ED overdose data form, which is an Excel data template. This form also collects data quality indicators such as percent of ED visits missing data on key variables (i.e., metadata). In order to assess and improve rapid ED data sharing, all 52 participating health departments will also be asked to share counts of ED visits involving suspected drug, opioid, heroin and stimulant overdoses by county, age group, sex, and time (i.e., month and year) from more finalized hospital discharge files, the current surveillance standard. The data will be shared with CDC on a quarterly or yearly basis using a standardized Excel data form, the ED discharge overdose data form, and standard CDC case definitions. The total estimated annual burden hours are 1,542. There are no costs to the respondents other than their time.

Estimated Annualized Burden Hours

Type of respondent	Form name	Number of respondents	Number of responses per respondent	Average burden per response (hours)
State health departments, the DC health department and PR health department	Rapid ED overdose data form	28	12	3
Jurisdictions sharing case-level ED data with CDC through the NSSP BioSense (OMB #0920-0824)	Rapid ED overdose data form	24	12	30/60
State health departments, the DC health department and PR health department	ED discharge overdose data form	26	4	3
State health departments, the DC health department and PR health department	ED discharge overdose data form—Year	26	1	3

Jeffrey M. Zirger,

Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention.