71600 Federal Register / Vol. 77, No. 232 / Monday, December 3, 2012 / Notices 

1Please see U.S. Department of Health and 

Human Services, Report to Congress, National 

Strategy for Quality Improvement in Health Care, 

(March 2011), available at http:// 

www.healthcare.gov/law/resources/reports/ 

nationalqualitystrategy032011.pdf. 

similar information or report available. 

T–MSIS will remove current multiple 

reporting for similar data by the state to 

CMS. 

Although T–MSIS will report more 

frequently, (monthly vs. quarterly) the 

amount of data collected through the 

expanded dataset will enable efficient 

processing to more efficiently satisfy 

data collection needs, thus eliminating 

additional similar duplicate current 

reporting processes. 

Form Number: CMS–R–284 (OCN 

0938–0345). Frequency: Quarterly 

(MSIS) and Monthly (T–MSIS). Affected 

Public: State, Local, or Tribal 

Governments. Number of Respondents: 

51. Total Annual Responses: 816. Total 

Annual Hours: 8,160. (For policy 

questions regarding this collection 

contact Kay Spence. at 410–786–1617. 

For all other issues call 410–786–1326.) 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS Web Site 

address at http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or 

Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786– 

1326. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received by the OMB desk officer at 

the address below, no later than 5 p.m. 

on January 2, 2013: OMB, Office of 

Information and Regulatory Affairs, 

Attention: CMS Desk Officer, Fax 

Number: (202) 395–6974, Email: 

OIRA_submission@omb.eop.gov. 

Dated: November 27, 2012. 

Martique Jones, 

Director, Regulations Development Group, 

Division-B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2012–29052 Filed 11–30–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–4169–NC] 

Medicare Program; Request for 

Information To Aid in the Design and 

Development of a Survey Regarding 

Patient Experiences With Emergency 

Department Care 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Request for information. 

SUMMARY: This document is a request for 

information regarding consumer and 

patient experiences with emergency 

department care. 

DATES: The information solicited in this 

notice must be received at the address 

provided below by February 1, 2013. 

ADDRESSES: In responding to this 

solicitation, please reply via email to 

CMS ED_Survey@cms.hhs.gov or by 

postal mail at Centers for Medicare and 

Medicaid Services, Attention: Sai Ma, 

Mailstop C1–14–18, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

FOR FURTHER INFORMATION CONTACT: Sai 

Ma (410) 786–1479. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In accordance with section 3011 of 

the Affordable Care Act, the Department 

of Health and Human Services (HHS) 

developed the National Quality Strategy 

to create national aims and priorities to 

guide local, state, and national efforts to 

improve the quality of health care. This 

strategy established three aims 

supported by six priorities that focus on 

better care, healthy people/healthy 

communities, and affordable care.1 The 

six priorities include: (1) Making care 

safer by reducing harm caused by the 

delivery of care; (2) ensuring that each 

person and family are engaged as 

partners in their care; (3) promoting 

effective communication and 

coordination of care; (4) promoting the 

most effective prevention and treatment 

practices for the leading causes of 

mortality, starting with cardiovascular 

disease; (5) working with communities 

to promote wide use of best practices to 

enable healthy living; and (6) making 

quality care more affordable for 

individuals, families, employers, and 

governments by developing and 

spreading new health care delivery 

models Surveys focusing on the patient 

and caregiver experience, including 

those discussed later and the Emergency 

Department care survey under 

development, support the goals of the 

National Quality Strategy for providing 

better care. 

The Centers for Medicare & Medicaid 

Services (CMS) has already 

implemented patient experience surveys 

for health and drug plans, inpatient 

hospitals, and home health agencies. 

While CMS and the Agency for 

Healthcare Research and Quality 

(AHRQ) have developed additional 

Consumer Assessment of Healthcare 

Providers and Systems (CAHPS®) 

surveys for in-center hemodialysis 

facilities, nursing homes, and clinician 

and group practices, none of these 

surveys address consumers’ and 

patients’ experiences with emergency 

department services. A patient’s 

experience in an emergency department 

is an essential component of their 

overall healthcare experience in a 

hospital, and we believe that a patient 

survey evaluating such care will further 

support the HHS’s goals and priorities. 

The target population for the 

emergency department patient 

experience of care survey is consumers/ 

patients and caregivers of patients who 

received emergency department care. 

The emergency department is a unique 

environment within the health care 

system, bridging the world of outpatient 

and inpatient care. This makes existing 

patient experience instruments designed 

for either outpatient care or inpatient 

care only partially relevant for capturing 

patient experiences (for example, none 

of the existing surveys addresses 

patients’ experience regarding 

transitions from emergency room to 

inpatient care). Having a rigorous, welldesigned emergency department survey 

will allow us to understand patients’ 

perspectives on their experiences in 

emergency departments and how such 

experiences change over time. This 

information will ultimately be used to 

help improve the quality of care patients 

receive in emergency departments. 

We are in the process of reviewing 

potential topic areas, as well as publicly 

available instruments and measures, for 

the purpose of developing a consumer 

and patient experience survey that will 

enable objective comparisons of 

emergency department experiences 

across the country. The principal focus 

is to develop a survey for consumers 

and patients 18 years of age and older. 

However, we are also interested in how 

a survey could also be developed for 

pediatric patients. 

II. Solicitation of Information 

We are soliciting the submission of 

suggested topic areas (such as 

‘‘communication with providers,’’ ‘‘pain 

control’’ or ‘‘waiting time’’) as well as 

publicly available instruments for 

capturing patient experiences with 

emergency department care. We are 

interested in instruments and items that 

can measure quality of care from the 

patient’s and caregiver’s perspective, 

including pediatric patients, and track 

changes over time. 


emcdonald on DSK67QTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 232 / Monday, December 3, 2012 / Notices 71601 

We are looking for suggested topic 

areas and publicly available instruments 

in which—(1) The source of information 

is from consumers and patients who 

directly received care at an emergency 

department or caregivers who were 

directly involved in the care (for 

example, parents of young children); 

and (2) patients or caregivers identified 

the information as important to them in 

evaluating emergency department care 

(for example, wait time, medical staff 

and physician communication). Existing 

instruments that have been tested, have 

a high degree of reliability and validity, 

and evidence of wide use is preferred. 

The following information would be 

especially helpful in any comments 

responding to this request for 

information: 

• A brief cover letter summarizing the 

information requested above for 

submitted instruments and topic areas, 

respectively, and how the submission 

will help fulfill the intent of the patient 

experiences survey; 

• (Optional) Information about the 

person submitting the material for the 

purposes of follow up questions about 

the submission which includes the 

following: 

++ Name. 

++ Title. 

++ Organization. 

++ Mailing address. 

++ Telephone number. 

++ Email address. 

++ Indication that the topic area or 

instrument is publicly available. 

• When submitting topic areas, we 

encourage including to the extent 

available the following information: 

++ Detailed descriptions of the 

suggested topic area(s) and specific 

purpose(s). 

++ Relevant peer-reviewed journal 

articles or full citations. 

• When submitting publicly available 

instruments or survey questions, we 

encourage including to the extent 

available the following information: 

++ Name of the instrument. 

++ Copies of the full instrument in all 

available languages. 

++ Topic areas included in the 

instrument. 

++ Measures derived from the 

instrument. Instrument reliability 

(internal consistency, test-retest, etc) 

and validity (content, construct, 

criterion-related). 

++ Results of cognitive testing. 

++ Results of field testing. 

++ Current use of the instrument 

(who is using it, what it is being used 

for, what population it is being used 

with, how instrument findings are 

reported, and by whom the findings are 

used). 

++ Relevant peer-reviewed journal 

articles or full citations. 

++ CAHPS® trademark status. 

++ Survey administration 

instructions. 

++ Data analysis instructions. 

++ Guidelines for reporting survey 

data. 

We are developing this survey and 

plan to submit it to AHRQ for 

recognition as a Consumer Assessment 

of Healthcare Providers and Systems 

(CAHPS®) survey. The survey will be 

developed in accordance with CAHPS®

Survey Design Principles and 

implementation instructions will be 

based on those for CAHPS® instruments 

(https://www.cahps.AHRQ.gov/AboutCAHPS/Principles.aspx). 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: October 2, 2012. 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2012–29104 Filed 11–30–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0477] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Investigational 

Device Exemptions Reports and 

Records 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by January 2, 

2013. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, Fax: 202– 

395–7285, or emailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0078. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

5156, Daniel.Gittleson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Investigational Device Exemptions 

Reports and Records—(OMB Control 

Number 0910–0078)—Extension 

Section 520(g) of the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act) 

(21 U.S.C. 360j(g)) establishes the 

statutory authority to collect 

information regarding investigational 

devices, and establishes rules under 

which new medical devices may be 

tested using human subjects in a clinical 

setting. The Food and Drug 

Administration Modernization Act of 

1997 (Pub. L. 105–115) added section 

520(g)(6) to the FD&C Act and permitted 

changes to be made to either the 

investigational device or to the clinical 

protocol without FDA approval of an 

investigational device exemption (IDE) 

supplement. An IDE allows a device, 

which would otherwise be subject to 

provisions of the FD&C Act, such as 

premarket notification or premarket 

approval, to be used in investigations 

involving human subjects in which the 

safety and effectiveness of the device is 

being studied. The purpose of part 812 

(21 CFR part 812) is to encourage, to the 

extent consistent with the protection of 

public health and safety and with 

ethical standards, the discovery and 

development of useful devices intended 

for human use. The IDE regulation is 

designed to encourage the development 

of useful medical devices and allow 

investigators the maximum freedom 

possible, without jeopardizing the 

health and safety of the public or 

violating ethical standards. To do this, 

the regulation provides for different 

levels of regulatory control, depending 

on the level of potential risk the 

investigational device presents to 

human subjects. Investigations of 

significant risk devices, ones that 

present a potential for serious harm to 

the rights, safety, or welfare of human 

subjects, are subject to the full 

requirements of the IDE regulation. 

Nonsignificant risk device 

investigations, i.e., devices that do not 

present a potential for serious harm, are 


emcdonald on DSK67QTVN1PROD with NOTICES