[Federal Register Volume 84, Number 63 (Tuesday, April 2, 2019)]
[Notices]
[Pages 12610-12612]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06305]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60 Day-19-19ACB; Docket No. CDC-2019-0021]


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 (DOSE).'' 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

[[Page 12611]]

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.

DATES: CDC must receive written comments on or before June 3, 2019.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2019-
0021 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Jeffery 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: 404-639-7570; 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; and
    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.
    5. Assess information collection costs.

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 responses, 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 DHHS'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. The 52 funded health departments 
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. 
There are no costs to the respondents other than their time.

[[Page 12612]]



                                        Estimated Annualized Burden Hours
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                                                                   Total no. of   Average burden   Total annual
      Type of respondent            Form name         No. of       responses per   per response       burden
                                                    respondents     respondent        (hours)         (hours)
----------------------------------------------------------------------------------------------------------------
State health departments, the   Rapid ED                      28              12               3           1,088
 DC health department and PR     overdose data
 health department.              form.
Jurisdictions sharing case-     Rapid ED                      24              12             0.5             144
 level ED data with CDC          overdose data
 through the NSSP BioSense       form.
 (OMB #0920-0824).
State health departments, the   ED discharge                  26               4               3             312
 DC health department and PR     overdose data
 health department.              form.
State health departments, the   ED discharge                  26               1               3              78
 DC health department and PR     overdose data
 health department.              form.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           1,542
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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. 2019-06305 Filed 4-1-19; 8:45 am]
 BILLING CODE 4163-19-P