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)
Centers for Disease Control and Prevention
Federal Register Volume 80, Issue 92 (May 13, 2015)
| Page Range | 27314-27315 | |
| FR Document | 2015-11513 |
[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
![27314 Federal Register / Vol. 80, No. 92 / Wednesday, May 13, 2015 / Notices
Leroy A. Richardson, FOR FURTHER INFORMATION CONTACT: To Proposed Project
Chief, Information Collection Review Office, request more information on the Retrospective evaluation of the
Office of Scientific Integrity, Office of the proposed project or to obtain a copy of
Associate Director for Science, Office of the
prevalence of acute flaccid myelitis with
the information collection plan and MRI grey matter findings among
Director, Centers for Disease Control and instruments, contact the Information
Prevention. children aged ≤18 years—NEW—
Collection Review Office, Centers for National Center for Immunization and
[FR Doc. 2015–11510 Filed 5–12–15; 8:45 am] Disease Control and Prevention, 1600 Respiratory Diseases, Centers for
BILLING CODE 4163–18–P Clifton Road, NE., MS–D74, Atlanta, Disease Control and Prevention (CDC).
Georgia 30329; phone: 404–639–7570;
Email: omb@cdc.gov. Background and Brief Description
DEPARTMENT OF HEALTH AND
SUPPLEMENTARY INFORMATION: Acute onset limb weakness,
HUMAN SERVICES
Under the Paperwork Reduction Act commonly referred to as acute flaccid
Centers for Disease Control and of 1995 (PRA) (44 U.S.C. 3501–3520), paralysis (AFP), is a relatively
Prevention Federal agencies must obtain approval uncommon syndrome among children.
from the Office of Management and From August–October 2014, several
[60Day–15–15AHO; Docket No. CDC–2015– Budget (OMB) for each collection of clusters of AFP among children were
0031]
information they conduct or sponsor. In reported from several states within the
Proposed Data Collection Submitted addition, the PRA also requires Federal United States (U.S.) and an
for Public Comment and agencies to provide a 60-day notice in epidemiologic investigation was
Recommendations the Federal Register concerning each initiated to elucidate the possible causes
proposed collection of information, of these cases.
AGENCY: Centers for Disease Control and including each new proposed CDC originally collected data under
Prevention (CDC), Department of Health collection, each proposed extension of OMB Control Numbers 0920–1011 and
and Human Services (HHS). existing collection of information, and 0920–0009. Cases were characterized by
ACTION: Notice with comment period. each reinstatement of previously distinctive abnormalities on spinal
approved information collection before magnetic resonance imaging (MRI), in
SUMMARY: The Centers for Disease submitting the collection to OMB for which pathologic changes were largely
Control and Prevention (CDC), as part of approval. To comply with this restricted to the central grey matter of
its continuing efforts to reduce public requirement, we are publishing this the spinal cord. Due to these findings
burden and maximize the utility of notice of a proposed data collection as and to differentiate this illness from
government information, invites the described below. other forms of AFP, CDC used the term
general public and other Federal Comments are invited on: (a) Whether ‘acute flaccid myelitis’ (AFM).
agencies to take this opportunity to the proposed collection of information The main goal of this study is to
comment on proposed and/or is necessary for the proper performance obtain data in order to estimate the
continuing information collections, as of the functions of the agency, including baseline rate of AFM that is
required by the Paperwork Reduction whether the information shall have accompanied by MRI changes confined
Act of 1995. This notice invites practical utility; (b) the accuracy of the to spinal grey matter among children
comment on a proposed information agency’s estimate of the burden of the ≤18 years of age that were seen at six
collection for a retrospective evaluation proposed collection of information; (c) pediatric medical centers in the United
of the prevalence of acute flaccid ways to enhance the quality, utility, and States. Data on spinal MRIs from years
myelitis with MRI grey matter findings clarity of the information to be 2005–2014 will be collected from six
among children aged ≤18 years. collected; (d) ways to minimize the sentinel medical centers. Physicians at
DATES: Written comments must be burden of the collection of information these medical centers will examine the
received on or before July 13, 2015. on respondents, including through the MRI reports and extract data on specific
ADDRESSES: You may submit comments, use of automated collection techniques variables using a database developed by
identified by Docket No. CDC–2015– or other forms of information CDC.
0031 by any of the following methods: technology; and (e) estimates of capital Data will then be sent to CDC, where
• Federal eRulemaking Portal: or start-up costs and costs of operation, 2005–2013 data will be compared with
Regulation.gov. Follow the instructions maintenance, and purchase of services 2014 data in order to assess if 2014 rates
for submitting comments. to provide information. Burden means of AFM were higher than in previous
• Mail: Leroy A. Richardson, the total time, effort, or financial years. Furthermore, this evaluation will
Information Collection Review Office, resources expended by persons to provide important information
Centers for Disease Control and generate, maintain, retain, disclose or regarding characteristics of patients
Prevention, 1600 Clifton Road NE., MS– provide information to or for a Federal presenting with AFM and grey matter
D74, Atlanta, Georgia 30329. agency. This includes the time needed changes, assist in determining the
Instructions: All submissions received to review instructions; to develop, potential for surveillance focusing on
must include the agency name and acquire, install and utilize technology MRI findings because AFM is not
Docket Number. All relevant comments and systems for the purpose of routinely conducted in the United
received will be posted without change collecting, validating and verifying States and identify possible risk factors.
to Regulations.gov, including any information, processing and The data will be used to estimate a
asabaliauskas on DSK5VPTVN1PROD with NOTICES
personal information provided. For maintaining information, and disclosing baseline for the rate of AFM that occurs
access to the docket to read background and providing information; to train in the United States each year. This
documents or comments received, go to personnel and to be able to respond to information has not been previously
Regulations.gov. a collection of information, to search collected, since the U.S. does not collect
Please note: All public comment should be data sources, to complete and review routine surveillance for AFM/AFP.
submitted through the Federal eRulemaking the collection of information; and to The participation of respondents is
portal (Regulations.gov) or by U.S. mail to the transmit or otherwise disclose the voluntary. There is no cost to the
address listed above. information. respondents other than their time. The
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![Federal Register / Vol. 80, No. 92 / Wednesday, May 13, 2015 / Notices 27315
total estimated annual burden hours for
the proposed project are 4,250 hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of Avg. burden
Number of Total burden
Type of respondents Form name responses per per response
respondents (in hrs.)
respondent (in hrs.)
Physicians ...................... Retrospective MRI Assessment for Acute Flac- 6 8,500 5/60 4,250
cid Myelitis: Patient Summary Form.
Total ........................ .............................................................................. ........................ ........................ ........................ 4,250
Leroy A. Richardson, • Mail: Leroy A. Richardson, agency’s estimate of the burden of the
Chief, Information Collection Review Office, Information Collection Review Office, proposed collection of information; (c)
Office of Scientific Integrity, Office of the Centers for Disease Control and ways to enhance the quality, utility, and
Associate Director for Science, Office of the Prevention, 1600 Clifton Road NE., MS– clarity of the information to be
Director, Centers for Disease Control and D74, Atlanta, Georgia 30329. collected; (d) ways to minimize the
Prevention. Instructions: All submissions received burden of the collection of information
[FR Doc. 2015–11513 Filed 5–12–15; 8:45 am] must include the agency name and on respondents, including through the
BILLING CODE 4163–18–P Docket Number. All relevant comments use of automated collection techniques
received will be posted without change or other forms of information
to Regulations.gov, including any technology; and (e) estimates of capital
DEPARTMENT OF HEALTH AND personal information provided. For or start-up costs and costs of operation,
HUMAN SERVICES access to the docket to read background maintenance, and purchase of services
documents or comments received, go to to provide information. Burden means
Centers for Disease Control and Regulations.gov. the total time, effort, or financial
Prevention resources expended by persons to
Please note: All public comment should be
[60Day–15–0728; Docket No. CDC–2015– submitted through the Federal eRulemaking generate, maintain, retain, disclose or
0033] portal (Regulations.gov) or by U.S. mail to the provide information to or for a Federal
address listed above. agency. This includes the time needed
Proposed Data Collection Submitted to review instructions; to develop,
for Public Comment and FOR FURTHER INFORMATION CONTACT: To
request more information on the acquire, install and utilize technology
Recommendations and systems for the purpose of
proposed project or to obtain a copy of
AGENCY: Centers for Disease Control and the information collection plan and collecting, validating and verifying
Prevention (CDC), Department of Health instruments, contact the Information information, processing and
and Human Services (HHS). Collection Review Office, Centers for maintaining information, and disclosing
Disease Control and Prevention, 1600 and providing information; to train
ACTION: Notice with comment period.
personnel and to be able to respond to
Clifton Road NE., MS–D74, Atlanta,
SUMMARY: The Centers for Disease a collection of information, to search
Georgia 30329; phone: 404–639–7570;
Control and Prevention (CDC), as part of data sources, to complete and review
Email: omb@cdc.gov.
its continuing efforts to reduce public the collection of information; and to
SUPPLEMENTARY INFORMATION: Under the
burden and maximize the utility of transmit or otherwise disclose the
Paperwork Reduction Act of 1995 (PRA) information.
government information, invites the (44 U.S.C. 3501–3520), Federal agencies
general public and other Federal must obtain approval from the Office of Proposed Project
agencies to take this opportunity to Management and Budget (OMB) for each National Notifiable Diseases
comment on proposed and/or collection of information they conduct Surveillance System (OMB Control No.
continuing information collections, as or sponsor. In addition, the PRA also 0920–0728, Expires 01/31/2017)—
required by the Paperwork Reduction requires Federal agencies to provide a Revision—Center for Surveillance,
Act of 1995. This notice invites 60-day notice in the Federal Register Epidemiology and Laboratory Services
comment on a proposed revision of the concerning each proposed collection of (CSELS), Centers for Disease Control
National Notifiable Diseases information, including each new and Prevention (CDC).
Surveillance System (NNDSS) proposed collection, each proposed
information collection. The NNDSS is extension of existing collection of Background and Brief Description
the nation’s public health surveillance information, and each reinstatement of The Public Health Services Act (42
system that monitors the occurrence and previously approved information U.S.C. 241) authorizes CDC to
spread of diseases and conditions that collection before submitting the disseminate nationally notifiable
are nationally notifiable or under collection to OMB for approval. To condition information. The Nationally
national surveillance. comply with this requirement, we are Notifiable Diseases Surveillance System
asabaliauskas on DSK5VPTVN1PROD with NOTICES
DATES: Written comments must be publishing this notice of a proposed (NNDSS) is based on data collected at
received on or before July 13, 2015. data collection as described below. the state, territorial and local levels as
ADDRESSES: You may submit comments, Comments are invited on: (a) Whether a result of legislation and regulations in
identified by Docket No. CDC–2015– the proposed collection of information those jurisdictions that require health
0033 by any of the following methods: is necessary for the proper performance care providers, medical laboratories,
• Federal eRulemaking Portal: of the functions of the agency, including and other entities to submit health-
Regulation.gov. Follow the instructions whether the information shall have related data on reportable conditions to
for submitting comments. practical utility; (b) the accuracy of the public health departments. These
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Document Created: 2015-12-16 07:46:45
Document Modified: 2015-12-16 07:46:45
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice with comment period. | |
| Dates | Written comments must be received on or before July 13, 2015. | |
| 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] | |
| FR Citation | 80 FR 27314 |
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