[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.
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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)
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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.
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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