[Federal Register Volume 80, Number 92 (Wednesday, May 13, 2015)]

[Notices]

[Pages 27314-27315]

From the Federal Register Online via the Government Publishing Office [http://www.gpo.gov/]

[FR Doc No: 2015-11513]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-15-15AHO; Docket No. CDC-2015-0031]

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 efforts to reduce public burden and maximize the 

utility of government information, invites the general public and other 

Federal agencies to take this opportunity to comment on proposed and/or 

continuing information collections, as required by the Paperwork 

Reduction Act of 1995. This notice invites comment on a proposed 

information collection for a retrospective evaluation of the prevalence 

of acute flaccid myelitis with MRI grey matter findings among children 

aged <=18 years.

DATES: Written comments must be received on or before July 13, 2015.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-

0031 by any of the following methods:

 Federal eRulemaking Portal: Regulation.gov. Follow the 

instructions for submitting comments.

 Mail: Leroy A. Richardson, 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. All relevant comments received will be posted 

without change to Regulations.gov, including any personal information 

provided. For access to the docket to read background documents or 

comments received, go to Regulations.gov.

 Please note: All public comment should be submitted 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 the Information Collection Review Office, 

Centers for Disease Control and Prevention, 1600 Clifton Road, NE., MSD74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: omb@cdc.gov.

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 OMB for approval. To 

comply with this requirement, we are publishing this notice of a 

proposed data collection as described below.

 Comments are invited on: (a) Whether the proposed collection of 

information is necessary for the proper performance of the functions of 

the agency, including whether the information shall have practical 

utility; (b) the accuracy of the agency's estimate of the burden of the 

proposed collection of information; (c) ways to enhance the quality, 

utility, and clarity of the information to be collected; (d) ways to 

minimize the burden of the collection of information on respondents, 

including through the use of automated collection techniques or other 

forms of information technology; and (e) estimates of capital or startup costs and costs of operation, maintenance, and purchase of services 

to provide information. Burden means the total time, effort, or 

financial resources expended by persons to generate, maintain, retain, 

disclose or provide information to or for a Federal agency. This 

includes the time needed to review instructions; to develop, acquire, 

install and utilize technology and systems for the purpose of 

collecting, validating and verifying information, processing and 

maintaining information, and disclosing and providing information; to 

train personnel and to be able to respond to a collection of 

information, to search data sources, to complete and review the 

collection of information; and to transmit or otherwise disclose the 

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information.

Proposed Project

 Retrospective evaluation of the prevalence of acute flaccid 

myelitis with MRI grey matter findings among children aged <=18 years--

NEW--National Center for Immunization and Respiratory Diseases, Centers 

for Disease Control and Prevention (CDC).

Background and Brief Description

 Acute onset limb weakness, commonly referred to as acute flaccid 

paralysis (AFP), is a relatively uncommon syndrome among children. From 

August-October 2014, several clusters of AFP among children were 

reported from several states within the United States (U.S.) and an 

epidemiologic investigation was initiated to elucidate the possible 

causes of these cases.

 CDC originally collected data under OMB Control Numbers 0920-1011 

and 0920-0009. Cases were characterized by distinctive abnormalities on 

spinal magnetic resonance imaging (MRI), in which pathologic changes 

were largely restricted to the central grey matter of the spinal cord. 

Due to these findings and to differentiate this illness from other 

forms of AFP, CDC used the term `acute flaccid myelitis' (AFM).

 The main goal of this study is to obtain data in order to estimate 

the baseline rate of AFM that is accompanied by MRI changes confined to 

spinal grey matter among children <=18 years of age that were seen at 

six pediatric medical centers in the United States. Data on spinal MRIs 

from years 2005-2014 will be collected from six sentinel medical 

centers. Physicians at these medical centers will examine the MRI 

reports and extract data on specific variables using a database 

developed by CDC.

 Data will then be sent to CDC, where 2005-2013 data will be 

compared with 2014 data in order to assess if 2014 rates of AFM were 

higher than in previous years. Furthermore, this evaluation will 

provide important information regarding characteristics of patients 

presenting with AFM and grey matter changes, assist in determining the 

potential for surveillance focusing on MRI findings because AFM is not 

routinely conducted in the United States and identify possible risk 

factors.

 The data will be used to estimate a baseline for the rate of AFM 

that occurs in the United States each year. This information has not 

been previously collected, since the U.S. does not collect routine 

surveillance for AFM/AFP.

 The participation of respondents is voluntary. There is no cost to 

the respondents other than their time. The

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total estimated annual burden hours for the proposed project are 4,250 

hours.

 Estimated Annualized Burden Hours

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 Number of Avg. burden

 Type of respondents Form name Number of responses per per response Total burden

 respondents respondent (in hrs.) (in hrs.)

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Physicians..................................... Retrospective MRI Assessment for Acute 6 8,500 5/60 4,250

 Flaccid Myelitis: Patient Summary Form.

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 Total...................................... ....................................... .............. .............. .............. 4,250

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Leroy A. Richardson,

Chief, Information Collection Review Office, Office of Scientific 

Integrity, Office of the Associate Director for Science, Office of the 

Director, Centers for Disease Control and Prevention.

[FR Doc. 2015-11513 Filed 5-12-15; 8:45 am]

 BILLING CODE 4163-18-P

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