Proposed Data Collection Submitted for Public Comment and Recommendations, 70553-70554 [2019-27553]
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Federal Register / Vol. 84, No. 246 / Monday, December 23, 2019 / Notices
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–27554 Filed 12–20–19; 8:45 am]
BILLING CODE 4163–18–P
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
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
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.
SUMMARY:
CDC must receive written
comments on or before February 21,
2020.
DATES:
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.
lotter on DSKBCFDHB2PROD with NOTICES
ADDRESSES:
VerDate Sep<11>2014
19:32 Dec 20, 2019
Jkt 250001
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: omb@cdc.gov.
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.
FOR FURTHER INFORMATION CONTACT:
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)
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
70553
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
E:\FR\FM\23DEN1.SGM
23DEN1
70554
Federal Register / Vol. 84, No. 246 / Monday, December 23, 2019 / Notices
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 unweighted 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
Type of respondent
Individuals .........................................
Individuals .........................................
Total ...........................................
Understanding Vaping Practices in
the United States Survey—
screening questions.
Understanding Vaping Practices in
the United States Survey—full
survey.
...........................................................
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–20–19BDE]
lotter on DSKBCFDHB2PROD with NOTICES
Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled ‘‘The Maternal
Mortality Review Information
Application (MMRIA)’’ to the Office of
Management and Budget (OMB) for
review and approval. CDC previously
published a ‘‘Proposed Data Collection
Submitted for Public Comment and
Recommendations’’ notice on June 20,
2019 to obtain comments from the
public and affected agencies. CDC
received four comments related to the
previous notice. This notice serves to
allow an additional 30 days for public
and affected agency comments.
CDC will accept all comments for this
proposed information collection project.
The Office of Management and Budget
VerDate Sep<11>2014
19:32 Dec 20, 2019
Number of
respondents
Form name
Jkt 250001
Frm 00062
Fmt 4703
Average
burden per
response
(in hrs.)
Total burden
(in hrs.)
120,000
1
2/60
4,000
6,000
1
10/60
1,000
........................
........................
........................
5,000
is particularly interested in comments
that:
(a) 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;
(b) Evaluate the accuracy of the
agencies estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected;
(d) 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 submission of
responses; and
(e) Assess information collection
costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570 or
send an email to omb@cdc.gov. Direct
written comments and/or suggestions
regarding the items contained in this
notice to the Attention: CDC Desk
Officer, Office of Management and
Budget, 725 17th Street NW,
Washington, DC 20503 or by fax to (202)
PO 00000
Number
responses per
respondent
Sfmt 4703
395–5806. Provide written comments
within 30 days of notice publication.
Proposed Project
The Maternal Mortality Review
Information Application (MMRIA)—
New—National Center for Chronic
Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and
Prevention (CDC) seeks OMB approval
to collect information through the
Maternal Mortality Review Information
Application (MMRIA) for three years.
MMRIA is a standardized data
collection system that allows Maternal
Mortality Review Committees (MMRCs)
across the country to abstract relevant
data (clinical and non-clinical) from a
variety of sources, document committee
decisions, and analyze data in order to
better understand the contributing
factors and preventability of maternal
deaths and thus to develop
recommendations for prevention.
About 700 women die each year in
the United States as a result of
pregnancy or delivery complications, a
chain of events initiated by pregnancy,
or the aggravation of an unrelated
condition by the physiologic effects of
pregnancy. Furthermore, considerable
racial disparities exist, with black
women almost four times more likely to
die from pregnancy-related
complications than white women.
E:\FR\FM\23DEN1.SGM
23DEN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Number Average burden
Type of respondent Form name Number of responses per per response Total burden
respondents respondent (in hrs.) (in hrs.)
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
