[Federal Register Volume 84, Number 246 (Monday, December 23, 2019)]
[Notices]
[Pages 70553-70554]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27553]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-20-20DC; Docket No. CDC-2019-0113]
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 ``2019 Lung Injury Response
Understanding Vaping Practices In the United States.'' This is a
formative study to identify why people are getting sick after vaping/
dabbing, in order to narrow the list of products, substances, and risk
factors requiring further public health action.
DATES: CDC must receive written comments on or before February 21,
2020.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2019-
0113 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: 404-639-7570; 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
2019 Lung Injury Response Understanding Vaping Practices In the
United States--New--National Center for Injury Prevention and Control
(NCIPC), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and Prevention (CDC), National
Center for Injury Prevention and Control (NCIPC) requests approval for
a New Information Collection, ``2019 Lung Injury Response Understanding
Vaping Practices In the United States.''
In early August 2019, initial cases of e-cigarette, or vaping,
product use associated lung injury (EVALI) were reported to CDC. As of
November 13, 2019, 2,172 EVALI cases have been reported to CDC from 49
states, the District of Columbia, the US Virgin Islands, and Puerto
Rico; 42 deaths have been reported among these cases. A multi-state
centrally coordinated response for this severe pulmonary injury was
established at CDC to assist each state/local/territory jurisdiction in
making rapid, practical decisions for actions to prevent and control
this public health problem.
To date, all EVALI patients have reported a history of using e-
cigarette, or vaping, products. The latest national and state findings
suggest products containing THC, particularly from informal sources
like friends, or family, or in-person or online dealers, are linked to
most of the cases and play a major role in the outbreak. In addition,
vitamin E has been identified as a chemical of concern among people
with e-cigarette, or vaping, product use associated lung injury
(EVALI). However, while it appears that vitamin E acetate is associated
with EVALI, evidence is not yet sufficient to rule out contribution of
other chemicals of concern to EVALI. Many different substances and
product sources are still under investigation, and it may be that there
is more than one cause of this outbreak. At present, there is very
little data on which to compare EVALI cases to individuals who are
vaping the same products at the same frequency but have not developed
EVALI. Comparing EVALI cases to people who vape but have not developed
EVALI in a timely way is very important for narrowing the list of
products, substances, and risk factors requiring further public health
action (e.g., continuing to refine communication messages) and
additional studies (e.g., prioritizing samples for laboratory testing).
Further, there is insufficient data for guiding the selection of
controls for a rigorous case control study (lack of uniformity in
demographic characteristics and product brands and types).
The data collected will be used to identify product types,
``brands'', devices, and frequency of use (collectively referred to as
use characteristics) from a geographically diverse convenience sample
of individuals who report vaping THC but have not developed EVALI.
These data will enable CDC to compare the
[[Page 70554]]
frequency of use characteristics between the convenience sample and
EVALI cases to prioritize follow up on hypotheses about potential risk
factors and causes of the outbreak as well as to refine, target, and
prioritize additional information gathering, e.g., epidemiological
analyses, laboratory testing, and analysis of pathological specimen.
The proposed approach leverages on an opt-in internet panel survey
to rapidly collect specific information on a demographically and
geographically diverse convenience sample of individuals who report
vaping THC but have not developed EVALI. Because such sampling frame is
not population representative and not suitable for generalizing about
populations, only un-weighted data will be obtained from the opt-in
internet panel survey and only unweighted, aggregate results will be
shared with partners or publicly. The data collected will not be used
to produce national, regional, or state-representative estimates;
rather, the data will be used to help prioritize hypotheses for future
epidemiological, laboratory, and clinical analyses as part of CDC's
ongoing lung injury response.
There is no cost to respondents other than the time to participate.
The annualized burden is estimated at 5,000 hours. Authorizing
legislation comes from Section 301 of the Public Health Service Act (42
U.S.C. 241).
Estimated Total Burden Hours
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Number Average burden
Type of respondent Form name Number of responses per per response Total burden
respondents respondent (in hrs.) (in hrs.)
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Individuals................... Understanding 120,000 1 2/60 4,000
Vaping
Practices in
the United
States Survey--
screening
questions.
Individuals................... Understanding 6,000 1 10/60 1,000
Vaping
Practices in
the United
States Survey--
full survey.
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Total..................... ................ .............. .............. .............. 5,000
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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. 2019-27553 Filed 12-20-19; 8:45 am]
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