[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