[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.
                                                 ---------------------------------------------------------------
    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]
 BILLING CODE 4163-18-P