[Federal Register Volume 84, Number 26 (Thursday, February 7, 2019)]
[Notices]
[Pages 2517-2518]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01333]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60-Day-19-19LI; Docket No. CDC-2018-0120]


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 Long-term sequela of Rocky 
Mountain spotted fever (RMSF). This project will look back at 
hospitalized cases of RMSF to see if they fully recovered from their 
illness, or if they still experience long-term neurological effects 
potentially tied to their RMSF episode.

DATES: CDC must receive written comments on or before April 8, 2019.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0120 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

    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

[[Page 2518]]

(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.
    Rocky Mountain spotted fever (RMSF), a life-threatening and rapidly 
progressive tickborne disease, is caused by infection with the 
bacterium Rickettsia rickettsii. Infection begins 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 126 hours. Authorizing Legislation comes from 
Section 301 of the Public Health Service Act (42 U.S.C. 241).

                                                            Estimated Annualized Burden Hours
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                                                                                                             Number of    Average burden
              Type of respondents                               Form name                    Number of     responses per   per response    Total burden
                                                                                            respondents     respondent      (in hours)      (in hours)
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General Public.................................  Patient screening questionnaire........             250               1           10/60              42
                                                 Neurological exam form.................             125               1           40/60              84
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    Total......................................  .......................................  ..............  ..............  ..............             126
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Jeffrey M. Zirger,
Acting Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2019-01333 Filed 2-6-19; 8:45 am]
BILLING CODE 4163-18-P