[Federal Register Volume 84, Number 85 (Thursday, May 2, 2019)]
[Notices]
[Pages 18846-18847]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08930]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-19-19LI]
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 Long-term sequela of Rocky Mountain spotted
fever (RMSF) 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 February
7, 2019 to obtain comments from the public and affected agencies. CDC
did not receive 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 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 [email protected]. 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) 395-5806. Provide
written comments within 30 days of notice publication.
Proposed Project
Long-term sequela of Rocky Mountain spotted fever (RMSF)--New ICR--
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID),
Centers for Disease Control and Prevention (CDC).
Background and Brief Description
Data collection for this investigation was initiated in July 2018
following OMB approval on 7/22/2018, with a second approval on 11/15/
2018 under the Emergency Epidemic Investigations (EEI) Generic ICR (OMB
Control Number 0920-1011, exp 1/31/2020). A full OMB package is being
submitted to allow for continuation of the project. CDC is seeking
three years of OMB approval.
Rocky Mountain spotted fever (RMSF), a life-threatening and rapidly
progressive tickborne disease, is caused by infection with the
bacterium Rickettsia rickettsii. Infection begins
[[Page 18847]]
with non-specific symptoms like fever, headache, and muscle pain, but
when left untreated the bacteria can cause damage to blood vessels
throughout the body leading to organ and tissue damage. Delay in
recognition and treatment of RMSF can result in irreparable damage
leading to amputation of extremities, neurological deficits (such as
hearing loss, paralysis, and encephalopathy), and death.
Case series in the peer-reviewed literature document long term
sequelae (LTS) from RMSF in anywhere from 3-55% of cases, yet
characterization of the long-term impacts is still not well understood,
and only a handful of studies have examined them in detail. Results of
neurologic damage caused during acute RMSF illness may include symptoms
ranging from paresthesia, insomnia and behavioral concerns to loss of
hearing, motor or language dysfunction, and chronic pain.
This study will gather information related to neurologic sequela
following RMSF illness. Information for this study will come from three
sources: Medical charts, patient interviews, and neurological exams
with a cognitive/developmental assessment for children. Resulting data
will provide information to healthcare providers, patients, and policy
makers about the long term consequences of severe RMSF, including time
to recovery, self-reported impact to daily function, and will look to
identify risk factors during acute illness which may be associated with
long term impairment.
There is no cost to respondents other than the time to participate.
Total estimated burden is 42 hours.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
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General Public........................ Patient screening 84 1 10/60
questionnaire.
Neurological exam form.. 42 1 40/60
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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. 2019-08930 Filed 5-1-19; 8:45 am]
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