[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]
 BILLING CODE 4163-18-P