Proposed Data Collections Submitted for Public Comment and Recommendations, 53764-53765 [2013-21190]

Download as PDF 53764 Federal Register / Vol. 78, No. 169 / Friday, August 30, 2013 / Notices ESTIMATED ANNUALIZED BURDEN HOURS—Continued Form name CTSU Supply Request Form ................................ CTSU Web Site Customer Satisfaction Survey ... CTSU Helpdesk Customer Satisfaction Survey ... CTSU OPEN Survey ............................................ PIO Customer Satisfaction Survey ....................... Dated: August 26, 2013. Vivian Horovitch-Kelley, NCI Project Clearance Liaison, National Institutes of Health. DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day–13–13AGH] tkelley on DSK3SPTVN1PROD with NOTICES Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404–639–7570 or send comments to Kimberly S. Lane, 1600 Clifton Road, MS–D74, Atlanta, GA 30333 or send an email to omb@cdc.gov. 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; and (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. Written comments should be received within 60 days of this notice. Proposed Project Examining Traumatic Brain Injury in Youth—NEW—National Center for Jkt 229001 Care Care Care Care Care Practitioner Practitioner Practitioner Practitioner Practitioner Traumatic brain injury (TBI) is one of the highest priorities in public health because of its magnitude, economic and human impact, and preventability. The Centers for Disease Control and Prevention (CDC) estimates that approximately 1.7 million TBIs are sustained in the United States annually, either alone or in conjunction with another injury or condition. These figures may be an underestimation as they do not include people who are treated in physicians’ offices or outpatient facilities, those who did not seek medical care, military personnel, or Americans living abroad. Moreover, the number of sports and recreation-related TBIs treated in U.S. emergency departments is increasing and has increased steadily since the early 2000s. Children, ages 0 to 4 years and adolescents, ages 15–19, are at the greatest risk of sustaining a TBI. A TBI is caused by a bump, blow or jolt to the head or a penetrating head injury that disrupts the normal function of the brain. The severity of a TBI may range from ‘‘mild’’ (a brief change in mental status or consciousness) to ‘‘severe’’ (an extended period of unconsciousness or amnesia after the injury). In 1996, Congress passed Public Law 104–166, the Traumatic Brain Injury Act, which charged CDC with implementing projects to reduce the incidence of traumatic brain injury. The CDC definition of TBI uses selected codes of the International Classification of Diseases, 9th Clinical Modification (ICD–9 CM) to identify cases of TBI from hospital and non-hospital databases containing billing records for services rendered to patients. It is thought, however, that the ICD–9 CM codes currently used in CDC’s surveillance system to capture cases of TBI are not sufficiently sensitive to capture diagnosed TBI. CDC, therefore, would like to collect de-identified medical information of a representative sample PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 Number of responses per respondent 75 275 325 60 100 Background and Brief Description BILLING CODE 4140–01–P 18:00 Aug 29, 2013 Health Health Health Health Health Injury Prevention and Control (NCIPC), Centers for Disease Control and Prevention (CDC). [FR Doc. 2013–21225 Filed 8–29–13; 8:45 am] VerDate Mar<15>2010 Number of respondents Type of respondent 12 1 1 1 1 Average burden per response (in hours) 10/60 15/60 15/60 15/60 5/60 Total annual burden hour 150 69 81 15 8 of pediatric patients, from two clinical settings, who received a confirmed diagnosis of mild to severe TBI and link these patients to their administrative medical claims forms. Collectively, the data will allow CDC to estimate the sensitivity of currently utilized ICD–9 CM codes to capture cases of diagnosed TBI, as well as ICD–9 CM codes not currently being utilized that may improve the sensitivity to capture cases of TBI. We propose to conduct a retrospective cross-sectional study of a random sample of patients with a suspected TBI within two clinical settings (Emergency Departments and Concussion Clinics). Information for this study is being collected to better understand the coding practices related to TBI among children within multiple clinical settings. The data will benefit public health by providing a more accurate case definition of TBI for the Central Nervous System (CNS) Injury Surveillance. Results from this study will be shared with CDC stakeholders, such as state and local health departments, clinicians and TBI-related medical researchers through CDC reports and peer-reviewed publications. CDC requests OMB approval for three years to abstract data from medical and billing records dated April 1st to September 30, 2013. Data will be collected electronically, analyzed with findings compiled in a final report. The following information is needed from the medical record: Age at injury, encrypted or randomly generated identification number (that can be linked to billing system), head injury assessment value (indicator variable, Yes/No), Traumatic injury mechanism, Glasgow Coma Scale (GCS) score, ICD– 9 CM codes and External cause of injury (E) codes if available, Head injury assessment value (indicator), Confirmed Diagnosis of TBI (Yes/No), based on the TBI case definition and if yes, Injury Type. The necessary data fields from the hospital billing system are: Encrypted or randomly generated identification number (that can be linked to medical chart), diagnosis codes (all available E:\FR\FM\30AUN1.SGM 30AUN1 53765 Federal Register / Vol. 78, No. 169 / Friday, August 30, 2013 / Notices fields for ICD–9–CM, E and V-codes), procedural codes (all available fields for ICD–9 CM, CPT–4) From the abstracted medical chart data contained in the TBI Data Abstraction Tool, a frequency of all observed ICD–9 CM codes will be created. Calculations of frequencies and code sensitivity of the ICD–9 CM codes will be calculated to develop recommendations for specific ICD–9 CM in the CDC IDC–9 Code definition. The TBI Data Abstraction tool will be used to create the final analytic dataset for the ‘Examining Traumatic Brain Injury in Youth’ project. Data will be abstracted into the dataset in two separate phases during the study. During the first phase, a trained Research Assistant (RA) will review each sampled medical chart to determine whether the patient experienced a TBI during the specified visit according to the CDC TBI definition. The RA will first review the selection criteria to confirm eligibility into the study. Approximately, 150 medical records from Emergency Department Patients, obtained from emergency medical records (EMR) will be abstracted to determine if they fit the TBI case definition: (1) Any period of observed or self-reported confusion, memory dysfunction, or loss of consciousness, (2) observed signs of neurological/neuropsychological dysfunction or (3) an injury to the head that resulted in amnesia, skull fracture, or intracranial lesion. It is estimated that this data abstraction will take 105 minutes per record, totaling 263 annual burden hours. Also, 50 Concussion Service Patient records will be obtained from a hospital concussion clinic. These records will be abstracted to determine if they fit the TBI case definition as well. It is estimated that this abstraction will take 105 minutes per record, totaling 88 annual burden hours. The total annualized burden hours per year are 351. The RA will be blinded to all ICD–9 CM codes while reviewing medical charts and entering data into the TBI Data extraction tool. There are no costs to respondents other than their time. ESTIMATED ANNUALIZED BURDEN HOURS Type of respondents Form name Number of respondents Number of responses per respondent Avg. burden per response (in hrs.) Emergency Department Patient .. 150 ................... 1 105/60 .............. 263 Concussion Services Patient ....... Allscripts ED electronic medical record (EMR) system. Microsoft Access Patient List ..... 50 ..................... 1 105/60 .............. 88 Total ...................................... .................................................... .......................... ............................ .......................... 351 Kimberly S. Lane, Deputy Director, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. [FR Doc. 2013–21190 Filed 8–29–13; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier CMS–10497] Agency Information Collection Activities: Proposed Collection; Comment Request Centers for Medicare & Medicaid Services. ACTION: Notice. The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS’ intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the tkelley on DSK3SPTVN1PROD with NOTICES VerDate Mar<15>2010 18:00 Aug 29, 2013 Jkt 229001 Comments must be received by October 29, 2013. ADDRESSES: When commenting, please reference the document identifier or OMB control number (OCN). To be assured consideration, comments and recommendations must be submitted in any one of the following ways: 1. Electronically. You may send your comments electronically to https:// www.regulations.gov. Follow the instructions for ‘‘Comment or Submission’’ or ‘‘More Search Options’’ to find the information collection document(s) that are accepting comments. 2. By Regular Mail. You may mail written comments to the following address: CMS, Office of Strategic DATES: AGENCY: SUMMARY: proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency’s functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 Total burden (in hrs.) Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number llllll, Room C4–26–05, 7500 Security Boulevard, Baltimore, Maryland 21244–1850. To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following: 1. Access CMS’ Web site address at https://www.cms.hhs.gov/ PaperworkReductionActof1995. 2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov. 3. Call the Reports Clearance Office at (410) 786–1326. FOR FURTHER INFORMATION CONTACT: Reports Clearance Office at (410) 786– 1326. SUPPLEMENTARY INFORMATION: Contents This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection’s supporting statement and associated materials (see ADDRESSES). E:\FR\FM\30AUN1.SGM 30AUN1

Agencies

[Federal Register Volume 78, Number 169 (Friday, August 30, 2013)]
[Notices]
[Pages 53764-53765]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-21190]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-13-13AGH]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    In compliance with the requirement of Section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995 for opportunity for public comment on 
proposed data collection projects, the Centers for Disease Control and 
Prevention (CDC) will publish periodic summaries of proposed projects. 
To request more information on the proposed projects or to obtain a 
copy of the data collection plans and instruments, call 404-639-7570 or 
send comments to Kimberly S. Lane, 1600 Clifton Road, MS-D74, Atlanta, 
GA 30333 or send an email to omb@cdc.gov.
    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; and (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. Written comments should be received 
within 60 days of this notice.

Proposed Project

    Examining Traumatic Brain Injury in Youth--NEW--National Center for 
Injury Prevention and Control (NCIPC), Centers for Disease Control and 
Prevention (CDC).

Background and Brief Description

    Traumatic brain injury (TBI) is one of the highest priorities in 
public health because of its magnitude, economic and human impact, and 
preventability. The Centers for Disease Control and Prevention (CDC) 
estimates that approximately 1.7 million TBIs are sustained in the 
United States annually, either alone or in conjunction with another 
injury or condition. These figures may be an underestimation as they do 
not include people who are treated in physicians' offices or outpatient 
facilities, those who did not seek medical care, military personnel, or 
Americans living abroad. Moreover, the number of sports and recreation-
related TBIs treated in U.S. emergency departments is increasing and 
has increased steadily since the early 2000s. Children, ages 0 to 4 
years and adolescents, ages 15-19, are at the greatest risk of 
sustaining a TBI. A TBI is caused by a bump, blow or jolt to the head 
or a penetrating head injury that disrupts the normal function of the 
brain. The severity of a TBI may range from ``mild'' (a brief change in 
mental status or consciousness) to ``severe'' (an extended period of 
unconsciousness or amnesia after the injury).
    In 1996, Congress passed Public Law 104-166, the Traumatic Brain 
Injury Act, which charged CDC with implementing projects to reduce the 
incidence of traumatic brain injury. The CDC definition of TBI uses 
selected codes of the International Classification of Diseases, 9th 
Clinical Modification (ICD-9 CM) to identify cases of TBI from hospital 
and non-hospital databases containing billing records for services 
rendered to patients. It is thought, however, that the ICD-9 CM codes 
currently used in CDC's surveillance system to capture cases of TBI are 
not sufficiently sensitive to capture diagnosed TBI. CDC, therefore, 
would like to collect de-identified medical information of a 
representative sample of pediatric patients, from two clinical 
settings, who received a confirmed diagnosis of mild to severe TBI and 
link these patients to their administrative medical claims forms. 
Collectively, the data will allow CDC to estimate the sensitivity of 
currently utilized ICD-9 CM codes to capture cases of diagnosed TBI, as 
well as ICD-9 CM codes not currently being utilized that may improve 
the sensitivity to capture cases of TBI. We propose to conduct a 
retrospective cross-sectional study of a random sample of patients with 
a suspected TBI within two clinical settings (Emergency Departments and 
Concussion Clinics).
    Information for this study is being collected to better understand 
the coding practices related to TBI among children within multiple 
clinical settings. The data will benefit public health by providing a 
more accurate case definition of TBI for the Central Nervous System 
(CNS) Injury Surveillance. Results from this study will be shared with 
CDC stakeholders, such as state and local health departments, 
clinicians and TBI-related medical researchers through CDC reports and 
peer-reviewed publications.
    CDC requests OMB approval for three years to abstract data from 
medical and billing records dated April 1st to September 30, 2013. Data 
will be collected electronically, analyzed with findings compiled in a 
final report. The following information is needed from the medical 
record: Age at injury, encrypted or randomly generated identification 
number (that can be linked to billing system), head injury assessment 
value (indicator variable, Yes/No), Traumatic injury mechanism, Glasgow 
Coma Scale (GCS) score, ICD-9 CM codes and External cause of injury (E) 
codes if available, Head injury assessment value (indicator), Confirmed 
Diagnosis of TBI (Yes/No), based on the TBI case definition and if yes, 
Injury Type. The necessary data fields from the hospital billing system 
are: Encrypted or randomly generated identification number (that can be 
linked to medical chart), diagnosis codes (all available

[[Page 53765]]

fields for ICD-9-CM, E and V-codes), procedural codes (all available 
fields for ICD-9 CM, CPT-4) From the abstracted medical chart data 
contained in the TBI Data Abstraction Tool, a frequency of all observed 
ICD-9 CM codes will be created. Calculations of frequencies and code 
sensitivity of the ICD-9 CM codes will be calculated to develop 
recommendations for specific ICD-9 CM in the CDC IDC-9 Code definition.
    The TBI Data Abstraction tool will be used to create the final 
analytic dataset for the `Examining Traumatic Brain Injury in Youth' 
project. Data will be abstracted into the dataset in two separate 
phases during the study. During the first phase, a trained Research 
Assistant (RA) will review each sampled medical chart to determine 
whether the patient experienced a TBI during the specified visit 
according to the CDC TBI definition. The RA will first review the 
selection criteria to confirm eligibility into the study. 
Approximately, 150 medical records from Emergency Department Patients, 
obtained from emergency medical records (EMR) will be abstracted to 
determine if they fit the TBI case definition: (1) Any period of 
observed or self-reported confusion, memory dysfunction, or loss of 
consciousness, (2) observed signs of neurological/neuropsychological 
dysfunction or (3) an injury to the head that resulted in amnesia, 
skull fracture, or intracranial lesion. It is estimated that this data 
abstraction will take 105 minutes per record, totaling 263 annual 
burden hours. Also, 50 Concussion Service Patient records will be 
obtained from a hospital concussion clinic. These records will be 
abstracted to determine if they fit the TBI case definition as well. It 
is estimated that this abstraction will take 105 minutes per record, 
totaling 88 annual burden hours. The total annualized burden hours per 
year are 351. The RA will be blinded to all ICD-9 CM codes while 
reviewing medical charts and entering data into the TBI Data extraction 
tool.
    There are no costs to respondents other than their time.

                                                            Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                      Number of responses      Avg. burden per        Total burden (in
        Type of respondents                 Form name         Number of respondents      per respondent       response (in hrs.)           hrs.)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Emergency Department Patient.......  Allscripts ED           150...................  1....................  105/60...............  263
                                      electronic medical
                                      record (EMR) system.
Concussion Services Patient........  Microsoft Access        50....................  1....................  105/60...............  88
                                      Patient List.
                                                            --------------------------------------------------------------------------------------------
    Total..........................  ......................  ......................  .....................  .....................  351
--------------------------------------------------------------------------------------------------------------------------------------------------------


Kimberly S. Lane,
Deputy Director, Office of Scientific Integrity, Office of the 
Associate Director for Science, Office of the Director, Centers for 
Disease Control and Prevention.
[FR Doc. 2013-21190 Filed 8-29-13; 8:45 am]
BILLING CODE 4163-18-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.