[Federal Register Volume 86, Number 78 (Monday, April 26, 2021)]
[Notices]
[Pages 22052-22053]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08576]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-21-1268; Docket No. CDC-2021-0043]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing effort to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies the opportunity to comment on a proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project titled ``Drug Overdose Surveillance and 
Epidemiology''. This information collection is designed to improve 
local, state, and regional situational awareness of drug, opioid, 
heroin, and stimulant overdose trends and respond to acute local and 
multi-state drug outbreaks.

DATES: CDC must receive written comments on or before June 25, 2021.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2021-
0043 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Jeffrey M. Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to Regulations.gov.

    Please note:  Submit all comments through the Federal 
eRulemaking portal (regulations.gov) or by U.S. mail to the address 
listed above.


FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact Jeffrey M. Zirger, Information Collection 
Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7118; Email: 
[email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to the OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    The OMB is particularly interested in comments that will help:
    1. 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;
    2. Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to 
be collected;
    4. 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 
submissions of responses; and
    5. Assess information collection costs.

Proposed Project

    Drug Overdose Surveillance and Epidemiology (DOSE) (OMB Control No. 
0920-1268, Exp. 8/31/2022)--Extension--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 data collection effort, an essential component toward reducing 
the opioid crisis, is one of the top priorities for HHS. Drug Overdose 
Surveillance and Epidemiology (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 the sharing of 
existing ED data 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 harm.
    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. Although data may come from different local ED data 
systems, it 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 percentage of ED visits missing data on key 
variables

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(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 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 1,272. 
There are no costs to the respondents other than their time.

                                        Estimated Annualized Burden Hours
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                                                                   Total number   Average burden
      Type of respondent            Form name        Number of     of responses    per response    Total annual
                                                    respondents   per respondent      (hours)     burden (hours)
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Participating health            Rapid ED                      19              12               3             684
 departments sharing aggregate   overdose data
 data from local syndromic or    form.
 hospital discharge file.
Participating health            Rapid ED                      33              12           30/60             198
 departments sharing case-       overdose data
 level ED data with CDC          form.
 through the NSSP BioSense
 (OMB #0920-0824) *.
Participating health            ED discharge                  26               4               3             312
 department sharing finalized    overdose data
 hospital discharge data on a    form.
 quarterly basis.
Participating health            ED discharge                  26               1               3              78
 department sharing finalized    overdose data
 hospital discharge data on a    form.
 yearly basis.
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2021-08576 Filed 4-23-21; 8:45 am]
BILLING CODE 4163-18-P