7456 Federal Register / Vol. 79, No. 26 / Friday, February 7, 2014 / Notices 

OS specifically requests comments on 

(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. 

Darius Taylor, 

Deputy, Information Collection Clearance 

Officer. 

[FR Doc. 2014–02641 Filed 2–6–14; 8:45 am] 

BILLING CODE 4168–11–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Scientific Information Request on 

Public Reporting of Cost Measures in 

Health 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), HHS. 

ACTION: Request for scientific 

information submissions. 

SUMMARY: The Agency for Healthcare 

Research and Quality (AHRQ) is seeking 

scientific information submissions from 

the public on public reporting of cost 

measures in health. Scientific 

information is being solicited to inform 

our technical brief on Public Reporting 

of Cost Measures in Health, which is 

currently being conducted by the 

Evidence-based Practice Centers for the 

AHRQ Effective Health Care Program. 

Access to published and unpublished 

pertinent scientific information on 

public reporting of cost measures in 

health will improve the quality of this 

technical brief. AHRQ is conducting this 

technical brief pursuant to Section 1013 

of the Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003, Public Law 108–173, and Section 

902(a) of the Public Health Service Act, 

42 U.S.C. 299a(a). 

DATES: Submission Deadline on or 

before March 10, 2014. 

ADDRESSES: 

Online submissions: http://

effectivehealthcare.AHRQ.gov/

index.cfm/submit-scientificinformation-packets/. Please select the 

study for which you are submitting 

information from the list to upload your 

documents. 

Email submissions: SIPS@epc-src.org. 

Print submissions: 

Mailing Address: Portland VA 

Research Foundation, Scientific 

Resource Center, ATTN: Scientific 

Information Packet Coordinator, PO Box 

69539, Portland, OR 97239. 

Shipping Address (FedEx, UPS, etc.): 

Portland VA Research Foundation, 

Scientific Resource Center, ATTN: 

Scientific Information Packet 

Coordinator, 3710 SW U.S. Veterans 

Hospital Road, Mail Code: R&D 71, 

Portland, OR 97239. 

FOR FURTHER INFORMATION CONTACT: 

Robin Paynter, Research Librarian, 

Telephone: 503–220–8262 ext. 58652 or 

Email: SIPS@epc-src.org. 

SUPPLEMENTARY INFORMATION: The 

Agency for Healthcare Research and 

Quality has commissioned the Effective 

Health Care (EHC) Program Evidencebased Practice Centers to complete a 

technical brief of the evidence for Public 

Reporting of Cost Measures in Health. 

The EHC Program is dedicated to 

identifying as many studies as possible 

that are relevant to the questions for 

each of its technical briefs. In order to 

do so, we are supplementing the usual 

manual and electronic database searches 

of the literature by requesting 

information from the public (e.g., details 

of studies conducted). We are looking 

for studies that report on public 

reporting of cost measures in health, 

including those that describe adverse 

events. The entire research protocol, 

including the key questions, is also 

available online at: http://

effectivehealthcare.AHRQ.gov/ehc/

products/562/1838/public-reportingcost-measures-protocol-140113.pdf 

This notice is to notify the public that 

the EHC program would find the 

following information on public 

reporting of cost measures in health 

helpful: 

D A list of completed studies your 

organization has sponsored for this 

indication. In the list, indicate whether 

results are available on 

ClinicalTrials.gov along with the 

ClinicalTrials.gov trial number. 

D For completed studies that do not 

have results on ClinicalTrials.gov, a 

summary, including the following 

elements: Study number, study period, 

design, methodology, indication and 

diagnosis, proper use instructions, 

inclusion and exclusion criteria, 

primary and secondary outcomes, 

baseline characteristics, number of 

patients screened/eligible/enrolled/lost 

to follow-up/withdrawn/analyzed, 

effectiveness/efficacy, and safety results. 

• A list of ongoing studies your 

organization has sponsored for this 

indication. In the list, please provide the 

ClinicalTrials.gov trial number or, if the 

trial is not registered, the protocol for 

the study including a study number, the 

study period, design, methodology, 

indication and diagnosis, proper use 

instructions, inclusion and exclusion 

criteria, and primary and secondary 

outcomes. 

D Description of whether the above 

studies constitute ALL Phase II and 

above clinical trials sponsored by your 

organization for this indication and an 

index outlining the relevant information 

in each submitted file. 

Your contribution is very beneficial to 

the Program. The contents of all 

submissions will be made available to 

the public upon request. Materials 

submitted must be publicly available or 

can be made public. Materials that are 

considered confidential; marketing 

materials; study types not included in 

the review; or information on 

indications not included in the review 

cannot be used by the Effective Health 

Care Program. This is a voluntary 

request for information and all costs for 

complying with this request must be 

borne by the submitter. 

The draft of this review will be posted 

on AHRQ’s EHC program Web site and 

available for public comment for a 

period of 4 weeks. If you would like to 

be notified when the draft is posted, 

please sign up for the email list at: 

http://effectivehealthcare.AHRQ.gov/

index.cfm/join-the-email-list1/. 

The technical brief will answer the 

following questions. This information is 

provided as background. AHRQ is not 

requesting that the public provide 

answers to these questions. The entire 

research protocol, is also available 

online at: http://

effectivehealthcare.AHRQ.gov/ehc/

products/562/1838/public-reportingcost-measures-protocol-140113.pdf 

1. What measures of costs about 

healthcare providers and facilities have 

been publicly reported? 

a. Who produces these reports and 

where are they available? 

b. For what facilities are costs 

reported? 

c. At what level are these data 

aggregated (e.g. provider, facility, etc.)? 

d. How are the cost data reported (e.g., 

dollar amounts, symbols, graphs etc.)? 

e. How are the costs of providers/

facilities compared (e.g., how many 

facilities, regional verses national 

comparisons etc.)? 

2. Are the measures of costs that are 

being reported consumer centered? 

a. How are consumers instructed to 

use the data? 

b. What techniques are used to guide 

consumers to interpret the data 

appropriately? 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 79, No. 26 / Friday, February 7, 2014 / Notices 7457 

c. Is there evidence that the data is 

used by consumers? 

d. Is the data relevant to consumers 

making healthcare decisions? 

e. Is the data easily accessible and 

presented in a consumer friendly way? 

3. What are the intended and 

unintended consequences of consumers’ 

use of public-reported cost data? 

a. Do consumers find the public 

reporting of cost measures relevant and 

are consumers satisfied with the 

experience? 

b. Does the public reporting of cost 

measures impact (or have the potential 

to impact) consumers’ decisions or 

behaviors? 

c. What are the potential unintended 

consequences of public reporting of cost 

measures? 

d. Are there key research gaps and 

needs for future research? 

Dated: January 24, 2014. 

Richard Kronick, 

AHRQ Director. 

[FR Doc. 2014–02170 Filed 2–6–14; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–14–13AGH] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

The Centers for Disease Control and 

Prevention (CDC) publishes a list of 

information collection requests under 

review by the Office of Management and 

Budget (OMB) in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

requests, call (404) 639–7570 or send an 

email to omb@cdc.gov. Send written 

comments to CDC Desk Officer, Office of 

Management and Budget, Washington, 

DC 20503 or by fax to (202) 395–5806. 

Written comments should be received 

within 30 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 requests OMB approval for one 

year 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). 

A review of the medical coding data 

for additional ICD–9 CM codes that are 

not part of the CDC TBI definition will 

also take place to determine whether the 

addition of any of these codes improves 

the sensitivity of the CDC TBI definition 

to detect TBI. 

The Emergency Department medical 

records of 150 patients will be 

abstracted in order to review ICD–9 

codes and TBI diagnoses. Each record 

will take 60 minutes to abstract. Also, 

50 patient medical records from the 

Concussion Clinic, located within the 

hospital, will be abstracted in order to 

review the selection criteria to confirm 

eligibility, which includes age of the 

patient, and the valid encounter with 

physician or nurse related to an injury 

consistent with a TBI. Each record will 

take 60 minutes to abstract. The same 

Research Assistant will be abstracting 

the data within the Emergency 

Department and the Concussion Clinic. 

There are no costs to respondents 

other than their time. The total 

estimated annual burden hours are 200. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of 

respondent Form name Number of respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hrs.) 

Emergency Department Research Assistant .. TBI Records Data Tool .................................. 1 150 1 

Concussion Clinic Research Assistant ........... TBI Records Data Tool .................................. 1 50 1 

mstockstill on DSK4VPTVN1PROD with NOTICES