Federal Register / Vol. 74, No. 162 / Monday, August 24, 2009 / Notices 42673 

3104. Comments regarding this 

proposed action will be accepted until 

September 23, 2009. 

A. Stanley Meiburg, 

Acting Regional Administrator, Region 4. 

[FR Doc. E9–20288 Filed 8–21–09; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Request for Information Relevant to 

the Regionalization of Emergency 

Medical Care Delivery Systems and 

Demonstration Model Development 

AGENCY: Department of Health and 

Human Services, Office of the Secretary. 

ACTION: Notice. 

SUMMARY: This is a time-sensitive 

Request for Information (RFI) issued by 

the Emergency Care Coordination 

Center in the Office of the Assistant 

Secretary for Preparedness and 

Response on behalf of the Council on 

Emergency Medical Care (CEMC) and 

the Federal Interagency Committee on 

Emergency Medical Services 

(FICEMS)—collectively known as the 

Emergency Care Enterprise (ECE). The 

information requested is meant to 

ascertain key concepts, best practices, 

and operational approaches to support 

regionalized, comprehensive and 

accountable emergency care and trauma 

systems. The information will be 

analyzed by the ECCC to help guide the 

development of demonstration programs 

that design and evaluate innovative 

models of regionalized, coordinated and 

accountable emergency care and trauma 

systems. 

ADDRESSES: Responses to this RFI may 

be submitted electronically to 

eccc@hhs.gov by COB September 30th 

2009. 

FOR FURTHER INFORMATION CONTACT: For 

further information on this RFI or the 

Emergency Care Coordination Center 

(ECCC), please contact Melicia Seay, 

Program Analyst, by e-mail at 

melicia.seay@hhs.gov or by phone at 

202–260–1383. 

SUPPLEMENTARY INFORMATION: The 

Emergency Care Coordination Center 

(ECCC) was created in order to: (1) Lead 

an enterprise to promote and fund 

research in emergency medicine and 

trauma health care, (2) promote regional 

partnerships and more effective 

emergency medical systems in order to 

enhance appropriate triage, distribution, 

and care of routine community patients, 

and (3) promote local, regional, and 

State emergency medical systems’ 

preparedness for and response to public 

health events. The office addresses the 

full spectrum of issues that have impact 

on care in hospital emergency 

departments, encompassing the 

complete continuum of patient care 

from the pre-hospital environment to 

disposition from emergency or trauma 

care. The Office coordinates with 

existing executive departments and 

agencies that perform functions relating 

to emergency medical systems in order 

to ensure unified strategy, policy, and 

implementation. 

The issue of regionalization is one of 

great interest across academic and 

clinical communities and is frequently 

touted as a potential solution to 

healthcare reform. The Future of 

Emergency Care reports published by 

the Institute of Medicine in 2006 

recommended the establishment of a 

demonstration program to promote 

coordinated, regionalized, and 

accountable emergency care delivery 

systems. As demonstrated by existing 

systems for trauma, cardiac arrest, and 

stroke patients, regionalized emergency 

care systems help get the right patients 

to the right hospitals in the right amount 

of time, improve patient outcomes, and 

reduce costs. These systems typically 

require careful coordination amongst 9– 

1–1 dispatch, pre-hospital emergency 

medical services, EMS system medical 

direction, categorization/designation of 

medical facilities, interfacility transfer 

protocols, data collection/analysis, and 

ongoing system-wide quality 

improvement. 

Yet regionalization of emergency care 

remains poorly defined and often 

misunderstood, with competing 

definitions, a variety of organizational 

and financial structures, and a lack of 

understanding regarding the 

implementation, evaluation, feasibility, 

and long term consequences of regional 

emergency care. Even amongst the State 

Trauma Systems, for instance, there is 

wide-scale variability in terms of 

resourcing mechanisms, support levels, 

functionality, and systems-wide 

interoperability. While some states have 

data mechanisms in place to monitor 

emergency care system status including 

medical facility bed availability and 

patient tracking, these systems vary in 

terms of management, sophistication 

and purpose, often collecting and 

reporting different data without uniform 

data definitions or agreement on which 

data should be collected. 

The ECCC, in coordination with the 

CEMC and FICEMS, aims to 

demonstrate model systems for 

Emergency Care through the 

development of regionalization 

demonstration projects that will provide 

information and lessons learned while 

generating guidance for the nationwide 

deployment of regionalized and 

accountable emergency care delivery 

systems. 

Issues on Which Information Is 

Requested 

The ECCC seeks input regarding 

regionalization of emergency care, with 

a focus on identification of the 

challenges and opportunities that could 

be addressed through federally funded 

national demonstration projects. The 

scope of emergency care being 

considered is defined as beginning with 

an event, disease, or condition that 

causes an individual to seek care 

through EMS or in an ED setting and 

ending with departure from the ED 

(either by admission to another hospital 

department, through discharge from the 

ED, or via transfer to another hospital). 

We welcome your comments, research 

findings, and/or practical experience on 

the following topics that can be used 

both to enhance our knowledge of 

regional emergency care networks and 

to help formulate guidance and 

strategies for potential Federal programs 

to develop regional emergency care 

systems. Please provide concise 

responses in the context of 

regionalization to any or all of the 

following topics. 

A. Existing Models. Please describe 

existing trauma or EMS regions in terms 

of characteristics such as: overall 

structure and organization, boundaries 

and geography, governance or oversight 

mechanisms and authorities, triagetransfer protocols, sustained financial 

support and provider reimbursement, 

data collection procedures, resource 

tracking, and communication/ 

coordination of relationships amongst 

State leadership, 9–1–1 services and/or 

EMS system medical direction, 

individual regions, etc. If desired, 

include opinions regarding the overall 

functioning and effectiveness of existing 

systems. 

B. Analysis of Current Practices in 

Regionalized Clinical Care. Whether at 

the local, State, or inter-State level, 

please provide suggestions and 

justifications as to which existing 

systems or specific elements of 

regionalized care models specifically 

merit further investigation, 

development, or targeted alteration and 

which clinical conditions are most 

suitable to regionalized care delivery. 

Please provide specific evidence where 

available and applicable. 

C. Communications Infrastructure. 

Please provide information on 

appropriate data elements that should 

be incorporated within regionalization 

systems to provide for situational 


erowe on DSK5CLS3C1PROD with NOTICES
42674 Federal Register / Vol. 74, No. 162 / Monday, August 24, 2009 / Notices 

awareness on resource availability. List 

the measurable variables and data 

elements that you believe need to be 

defined and captured in order to 

effectively support regional delivery of 

care. Also include any suggestions as to 

which common data elements, at a 

minimum, should be included within a 

standardized data language to facilitate, 

encourage, and improve the support and 

integration of the various state resource 

tracking mechanisms. 

D. Opportunities and challenges in 

regionalized care delivery. Please share 

your opinions on the potential benefits, 

obstacles, drawbacks, and consequences 

(both intended and unintended) of 

regionalized healthcare models, 

providing specific evidence where 

feasible. If possible, elaborate on the 

effects regionalization may produce on 

providers’ financial viability, patient 

access to care, healthcare service 

utilization rates, disaster preparedness 

efforts, and response capabilities. 

E. Evaluation of regionalized care 

delivery systems. Please provide 

comments on how regionalized care 

systems can be objectively assessed and 

evaluated, including suggestions on 

appropriate measures of programmatic 

success or failure and opinions on 

which data sources could be used to 

establish compliance with regional 

performance benchmarks. Where 

possible, also list measurable ways to 

assess regionalization’s impact with 

regard to health outcomes, including 

factors such as morbidity and mortality, 

time-to-care, condition-specific 

treatment, quality of care, patient safety, 

etc. 

F. Adaptation of regionalization to 

emergency medical care. Given the legal 

requirement to screen and stabilize ED 

patients, the need for time-sensitive, 

high-quality care in emergency settings, 

and the diversity of patient populations 

and geographic locations, please 

provide insights or commentary on how 

the concept of regionalization could be 

adapted and/or customized to fit the 

unique aspects of emergency medical 

care. 

G. Additional information. Please 

provide any additional opinions, 

suggestions, or comments as to how the 

ECCC and the Emergency Care 

Enterprise can shape demonstration 

projects of regionalized, coordinated, 

and accountable systems of emergency 

care to effectively utilize limited 

resources, facilitate information 

management and flow, increase the 

efficiency and effectiveness of the 

emergency healthcare delivery system, 

and enhance the overall quality of care 

provided. 

Please indicate which type of 

institution or organization you are 

primarily affiliated with (using the 

following categories): 

• Academia; 

• Small Business; 

• Healthcare Facility; 

• Trauma or EMSS region; 

• Federal Government; 

• State Government; 

• Healthcare Professional; 

• Patient Advocacy Group; 

• Other (briefly define). 

This request for information is for 

planning purposes only and shall not be 

interpreted as a solicitation for 

applications or as an obligation on the 

part of the government. The government 

will not pay for the preparation of any 

information submitted or for the 

government’s use of that information. 

Dated: August 14, 2009. 

Nicole Lurie, 

Assistant Secretary for Preparedness and 

Response, Rear Admiral, U.S. Public Health 

Service. 

[FR Doc. E9–20162 Filed 8–21–09; 8:45 am] 

BILLING CODE 4150–37–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0360] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; FDA Public Health 

Notification Readership Survey 

(formerly known as ‘‘Safety Alert/ 

Public Health Advisory Readership 

Survey’’) 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. 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 of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

FDA Public Health Notification 

Readership Survey. 

DATES: Submit written or electronic 

comments on the collection of 

information by October 23, 2009. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3793. 

SUPPLEMENTARY INFORMATION: Under the 

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. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

FDA Public Health Notification 

Readership Survey (formerly known as 

Safety Alert/Public Health Advisory 

Readership Survey) (PHS Act, Section 

1701 (a)(4)); OMB Control Number 

0910–0341–Extension 

Section 705(b) of the Federal Food, 

Drug, and Cosmetic Act (the act) (21 


erowe on DSK5CLS3C1PROD with NOTICES