Att 2_60dFY2020DV

70552

Federal Register / Vol. 84, No. 246 / Monday, December 23, 2019 / Notices

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–20–20DV; Docket No. CDC–2019–
0114]

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 ‘‘Chronic Q Fever in the United
States: Enhanced Clinical Surveillance.’’
This enhanced medical surveillance for
chronic Q fever will collect specific
clinical data not otherwise collected
during routine public health
surveillance to allow for better
characterization of the clinical
presentation and risk factors of chronic
Q fever in the United States.
DATES: CDC must receive written
comments on or before February 21,
2020.
SUMMARY:

You may submit comments,
identified by Docket No. CDC–2019–
0114 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

ADDRESSES:

technological collection techniques or
other forms of information technology,
e.g., permitting electronic submissions
of responses.
5. Assess information collection costs.

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, of
the 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

Proposed Project
Chronic Q Fever in the United States:
Enhanced Clinical Surveillance—New—
National Center for Emerging Zoonotic
and Infectious Diseases (NCEZID),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
Q fever is a worldwide zoonosis
caused by Coxiella burnetii with acute
and chronic disease presentations.
Chronic Q fever can manifest months to
years after the primary infection and is
rare, occurring in <5% of persons with
an acute infection. Chronic Q fever can
take on several clinical forms, including
endocarditis, chronic hepatitis, chronic
vascular infections, osteomyelitis, and
osteoarthritis. In the United States, Q
fever cases are reported via the National
Notifiable Disease Surveillance System;
however, limited information is
collected on the various clinical
manifestation of chronic Q fever or
patients pre-existing risk factors. Data
on outcomes other than death or
hospitalizations are not collected by the
current surveillance.
Because of this lack of data, the true
burden and proportion of cases
exhibiting endocarditis and other forms
of chronic Q fever in the United States
is unknown. We plan to establish an
enhanced medical surveillance for
chronic Q fever by working with
consulting clinicians to gather
additional and more specific clinical
data not otherwise collected during
routine public health surveillance for
chronic Q fever. This information will
allow for better characterization of the
clinical presentation and risk factors of
chronic Q fever in the United States.
The results will help characterize an
under-recognized disease and provide
valuable data to educate physicians on
identifying and diagnosing these cases.
CDC is requesting approval for five
burden hours annually. There is no cost
to respondents other than their time.

lotter on DSKBCFDHB2PROD with NOTICES

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Number of
responses per
respondent

Average
burden per
response
(in hours)

Total burden
(in hours)

Type of respondents

Form name

Physician ...........................................

Chronic Q fever enhanced surveillance report form.

15

1

20/60

5

Total ...........................................

...........................................................

........................

........................

........................

5

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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: [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.
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)

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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

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