84 FR 85 pgs. 18846-18847 - Agency Forms Undergoing Paperwork Reduction Act Review
Type: NOTICEVolume: 84Number: 85Pages: 18846 - 18847
Pages: 18846, 18847Docket number: [30Day-19-19LI]
FR document: [FR Doc. 2019-08930 Filed 5-1-19; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Centers for Disease Control and Prevention
Official PDF Version: PDF Version
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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 omb@cdc.gov. 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.
[top] Rocky Mountain spotted fever (RMSF), a life-threatening and rapidly progressive tickborne disease, is caused by infection with the bacterium Rickettsia rickettsii. Infection begins
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.
| Type of respondents | Form name | Number of respondents | Number of responses per respondent | Average burden per response (in hours) |
|---|---|---|---|---|
| General Public | Patient screening questionnaire | 84 | 1 | 10/60 |
| Neurological exam form | 42 | 1 | 40/60 |
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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