80 FR 27314 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 80, Issue 92 (May 13, 2015)

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.

[Federal Register Volume 80, Number 92 (Wednesday, May 13, 2015)]
[Notices]
[Pages 27314-27315]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-11513]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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., 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 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 start-
up 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 
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

[[Page 27315]]

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

                                                            Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                             Number of      Avg. burden
              Type of respondents                               Form name                    Number of     responses per   per response    Total burden
                                                                                            respondents     respondent       (in hrs.)       (in hrs.)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Physicians.....................................  Retrospective MRI Assessment for Acute                6           8,500            5/60           4,250
                                                  Flaccid Myelitis: Patient Summary Form.
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................  ..............  ..............  ..............           4,250
--------------------------------------------------------------------------------------------------------------------------------------------------------


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