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
Federal Register / Vol. 74, No. 162 / Monday, August 24, 2009 / Notices 42675 

U.S.C. 375(b)) authorizes FDA to 

disseminate information concerning 

imminent danger to public health by 

any regulated product. The Center for 

Devices and Radiological Health 

(CDRH), communicates these risks to 

user communities through two 

publications: (1) The Public Health 

Notification (PHN) and (2) the 

Preliminary Public Health Notification 

(PPHN). The PHN is published when 

CDRH has information or a message to 

convey to health care practitioners that 

they would want to know in order to 

make informed clinical decisions about 

the use of a device or device type, and 

that information may not be readily 

available to the affected target audience 

in the health care community. CDRH 

can make recommendations that will 

help the health care practitioner 

mitigate or avoid the risk. 

The PPHN is also published when 

CDRH has information to convey to 

health care practitioners that they 

would want to know in order to make 

informed clinical decisions about the 

use of a device or device type. However, 

two additional conditions exist that 

make the use of this type of notification 

preferable: (1) CDRH’s understanding of 

the problem, its cause(s), and the scope 

of the risk that is still evolving, so that 

in order to minimize the risk, the center 

believes that health care practitioners 

needs the information they can provide, 

however incomplete, as soon as possible 

and (2) the problem is actively being 

investigated by the center, private 

industry, another agency or some other 

reliable entity, so that the center expects 

to be able to update the PPHN when 

definitive new information becomes 

available. Notifications are sent to 

organizations affected by risks discussed 

in the notification, such as hospitals, 

nursing homes, hospices, home health 

care agencies, retail pharmacies, and 

other health care providers. Through a 

process for identifying and addressing 

postmarket safety issues related to 

regulated products, CDRH determines 

when to publish notifications. 

Section 1701(a)(4) of the Public 

Health Service Act (42 U.S.C. 

300u(a)(4)), authorizes FDA to conduct 

research relating to health information. 

FDA seeks to evaluate the clarity, 

timeliness and impact of safety alerts 

and public health advisories by 

surveying a sample of recipients. 

Subjects will receive a questionnaire to 

be completed and returned to FDA. The 

information to be collected will address 

how clearly notifications for reducing 

risks are explained, the timeliness of the 

information and whether the reader has 

taken any action to eliminate or reduce 

risk as a result of the information in the 

alert. Subjects will also be asked 

whether they wish to receive future 

notifications electronically, as well as 

how the PHN program might be 

improved. 

The information collected will be 

used to shape FDA’s editorial policy for 

the PHN and PPHN. Understanding how 

target audiences view these publications 

will aid in deciding what changes 

should be considered in their content 

and format, and method of 

dissemination. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

PHS Act No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Section 1701(a)(4) 308 3 924 .17 157 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Based on the history of the PHN 

program, it is estimated that an average 

of three collections will be conducted a 

year. The total burden of response time 

is estimated at 10 minutes per survey. 

This was derived by CDRH staff 

completing the survey and through 

discussions with the contacts in trade 

organizations. 

Dated: August 17, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–20247 Filed 8–21–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Proposed Projects 

Title: Refugee Unaccompanied Minor 

Placement Report & Minor Progress 

Reports; ORR–3 and ORR–4. 

OMB No.: 0970–0034. 

Description: The two reports collect 

information necessary to administer the 

Unaccompanied Refugee Minor (URM) 

program. The ORR–3 (Placement 

Report) is submitted to the Office of 

Refugee Resettlement (ORR) by the State 

agency at initial placement and 

whenever there is a change in the 

child’s status, including termination 

from the program. The ORR–4 (Progress 

Report) is submitted annually and 

records the child’s progress toward the 

goals listed in the child’s case plan. 

Respondents: State governments. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses 

per respondent 

Average 

burden 

hours per 

response 

Total 

burden 

hours 

ORR–3 ............................................................................................................................. 15 63 0.25 236.25 

ORR–4 ............................................................................................................................. 15 63 0.30 283.50 

Estimated Total Annual Burden 

Hours: 519.75 

In compliance with the requirements 

of Section 506(c)(2)(A) of the Paperwork 

Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Administration, 

Office of Information Services, 370 


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