[Federal Register Volume 80, Number 92 (Wednesday, May 13, 2015)]
[Notices]
[Pages 27314-27315]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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