Federal Register / Vol. 75, No. 220 / Tuesday, November 16, 2010 / Notices 70015 

Dated: November 9, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–28849 Filed 11–15–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

External Defibrillators; Public 

Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

The Food and Drug Administration 

(FDA) is announcing the following 

public workshop: FDA Public Workshop 

on External Defibrillators. The purpose 

of the public workshop is to share 

FDA’s understanding of the risks and 

benefits of external defibrillators, to 

clarify FDA’s current expectations for 

how industry should identify, report, 

and take action on problems observed 

with these devices, and to promote 

innovation for next-generation devices 

that will bring safer, more effective 

external defibrillators to market. 

Dates and Time: The public workshop 

will be held on December 15, 2010, from 

8 a.m. to 5:30 p.m., and on December 

16, 2010, from 8 a.m. to 2 p.m. Persons 

interested in attending this public 

workshop must register by 5 p.m. on 

December 8, 2010. 

Location: The public workshop will 

be held in the Great Room at the Food 

and Drug Administration, White Oak 

Campus, Bldg. 31, 10903 New 

Hampshire Ave., Silver Spring, MD 

20903. 

Contact: Megan Moynahan, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, rm. 5404, 

Silver Spring, MD 20903, 301–796– 

5435, FAX: 301–847–8510, or e-mail: 

Megan.Moynahan@fda.hhs.gov. 

Registration and Requests for Oral 

Presentations: Registration is free and 

will be on a first-come, first-served 

basis. To register for the public 

workshop, please visit the following 

Web site: http://www.fda.gov/ 

MedicalDevices/NewsEvents/ 

WorkshopsConferences/ucm232062.htm 

(or go the FDA Medical Devices New & 

Events—Workshops & Conferences 

calendar and select this public 

workshop from the posted events list). 

Please provide complete contact 

information for each attendee, including 

name, title, affiliation, address, e-mail, 

and telephone number. For those 

without Internet access, please call the 

contact person to register. Registration 

requests should be received by 5 p.m. 

on December 8, 2010. Early registration 

is recommended because seating is 

limited and, therefore, FDA may limit 

the number of participants from each 

organization. If time and space permit, 

onsite registration on the day of the 

public workshop will be provided 

beginning at 7:30 a.m. 

Registrants requesting to present 

written material or to make oral 

presentations at the public workshop, 

please call the contact person by 

November 29, 2010. 

If you need special accommodations 

due to a disability, please contact Susan 

Monahan (e-mail: 

Susan.Monahan@fda.hhs.gov) at least 7 

days in advance. 

SUPPLEMENTARY INFORMATION: 

I. Background 

External defibrillators (including 

automated external defibrillators 

(AEDs)) are life-saving devices designed 

to restore normal heart rhythms 

following sudden cardiac arrest. Each 

year, nearly 300,000 Americans collapse 

from sudden cardiac arrest. In sudden 

cardiac arrest, the heart unexpectedly 

stops pumping blood to the body. When 

normal heart rhythms are not restored 

quickly, sudden cardiac arrest can cause 

death. 

External defibrillators are important, 

life-saving devices. However, over the 

past 5 years we have seen persistent 

safety problems with all types of 

external defibrillators, across all 

manufacturers of these devices. From 

January 1, 2005, to July 10, 2010, there 

were a total of 68 recalls, of which 9 

occurred in 2005 increasing to 17 in 

2009 (the last complete year for which 

data are available). During this period, 

FDA received over 28,000 medical 

device reports (MDRs), of which 4,210 

occurred in 2005 increasing to 7,807 in 

2009 (the last complete year for which 

data are available). FDA conducted 

multiple inspections of all external 

defibrillator manufacturers throughout 

this time period. 

Many of the types of problems we 

have identified are preventable, 

correctable, and impact patient safety. 

As part of a comprehensive review, FDA 

identified several industry practices that 

have contributed to these persistent 

safety risks including industry practices 

for designing and manufacturing 

defibrillators, handling user complaints, 

conducting recalls, and communicating 

with users. In some cases, these 

practices can contribute to device 

performance problems, place undue 

burden on users, and put patients at 

risk. 

To date, FDA has addressed 

individual device problems on a caseby-case basis. However, our analysis of 

MDRs, recalls, and inspections confirms 

that common problems persist across all 

types of external defibrillators and all 

manufacturers. One purpose of the 

public workshop is to share FDA’s 

understanding of the risks and benefits 

of external defibrillators and to clarify 

FDA’s current expectations for how 

industry should identify, report, and 

take action on problems observed with 

these devices. 

In addition, to promote innovation 

and to better understand patient 

outcomes, FDA is collaborating with the 

University of Colorado’s Department of 

Emergency Medicine and the Centers for 

Disease Control and Prevention (CDC) to 

develop a multi-city AED registry that 

will link with the CDC-funded Cardiac 

Arrest Registry to Enhance Survival 

(CARES). The registry will provide the 

infrastructure to foster the development 

of innovative AED features such as 

automated integration into local 9–1–1 

systems. FDA will work with multiple 

stakeholders to facilitate the 

development of next-generation 

defibrillators, enhance surveillance of 

defibrillators in community settings, 

and improve the rapid delivery of 

treatment for sudden cardiac arrest 

patients. One purpose of the public 

workshop on December 15 and 16, 2010, 

is to advance these efforts by bringing 

together government, industry, 

academia, and users, including 

clinicians and consumers, to share 

perspectives. 

II. Topics for Discussion at the Public 

Workshop 

The public workshop will be 

organized to allow facilitated discussion 

by industry, academia, clinicians, users, 

and regulators on the following broad 

topic areas: 

1. What are the nature, scope, and 

impact of external defibrillator problems 

that have been observed? What are the 

root causes of these problems? 

2. How should problems with external 

defibrillators be identified, reported, 

and acted upon by industry and users? 

3. What factors or criteria should be 

considered when designing external 

defibrillators for use in different 

environments (hospital, community, 

home)? 

4. What features of next generation 

devices can be defined that will increase 

the diffusion of new technologies, 

enhance device interoperability, and 

improve ease of use? 

mstockstill on DSKH9S0YB1PROD with NOTICES

70016 Federal Register / Vol. 75, No. 220 / Tuesday, November 16, 2010 / Notices 

5. How might device registries 

improve our ability to identify early 

device performance signals, or enhance 

the use of external defibrillators? 

III. Transcripts 

Please be advised that as soon as a 

transcript is available, it can be obtained 

in either hardcopy or on CD–ROM, after 

submission of a Freedom of Information 

request. Written requests are to be sent 

to Division of Freedom of Information 

(HFI–35), Office of Management 

Programs, Food and Drug 

Administration, 5600 Fishers Lane, rm. 

6–30, Rockville, MD 20857. A link to 

the transcripts will also be available on 

the Internet at http://www.fda.gov/ 

MedicalDevices/NewsEvents/ 

WorkshopsConferences/default.htm 

(select this public workshop from the 

posted events list), approximately 45 

days after the public workshop. 

Dated: November 9, 2010. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2010–28763 Filed 11–15–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Citizenship and Immigration 

Services 

Agency Information Collection 

Activities: Form I–566, Extension of a 

Currently Approved Information 

Collection; Comment Request 

ACTION: 30-Day Notice of Information 

Collection Under Review: Form I–566, 

Interagency Record of Individual 

Requesting Change/Adjustment To or 

From A or G Status or Requesting A, G, 

or NATO Dependent Employment 

Authorization; OMB Control No. 1615– 

0027. 

The Department of Homeland 

Security, U.S. Citizenship and 

Immigration Services (USCIS) will be 

submitting the following information 

collection request to the Office of 

Management and Budget (OMB) for 

review and clearance in accordance 

with the Paperwork Reduction Act of 

1995. The information collection was 

previously published in the Federal 

Register on August 26, 2010, at 75 FR 

52538, allowing for a 60-day public 

comment period. USCIS did not receive 

any comments for this information 

collection. 

The purpose of this notice is to allow 

an additional 30 days for public 

comments. Comments are encouraged 

and will be accepted until December 16, 

2010. This process is conducted in 

accordance with 5 CFR 1320.10. 

Written comments and/or suggestions 

regarding the item(s) contained in this 

notice, especially regarding the 

estimated public burden and associated 

response time, should be directed to the 

Department of Homeland Security 

(DHS), and to the Office of Management 

and Budget (OMB) USCIS Desk Officer. 

Comments may be submitted to: USCIS, 

Chief, Regulatory Products Division, 20 

Massachusetts Avenue, Washington, DC 

20529–2020. Comments may also be 

submitted to DHS via facsimile to 202– 

272–8352 or via e-mail at 

rfs.regs@dhs.gov, and to the OMB USCIS 

Desk Officer via facsimile at 202–395– 

5806 or via email at 

oira_submission@omb.eop.gov. When 

submitting comments by e-mail please 

make sure to add OMB Control Number 

1615–0027 in the subject box. Written 

comments and suggestions from the 

public and affected agencies should 

address one or more of the following 

four points: 

(1) Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; 

(2) Evaluate the accuracy of the 

agencies estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

(4) Minimize the burden of the 

collection of information on those who 

are to respond, including through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses. 

Overview of This Information 

Collection 

(1) Type of Information Collection: 

Extension of a currently approved 

information collection. 

(2) Title of the Form/Collection: 

Interagency Record of Individual 

Requesting Change/Adjustment To or 

From A or G Status or Requesting A, G, 

or NATO Dependent Employment 

Authorization. 

(3) Agency form number, if any, and 

the applicable component of the 

Department of Homeland Security 

sponsoring the collection: Form I–566; 

U.S. Citizenship and Immigration 

Services (USCIS). 

(4) Affected public who will be asked 

or required to respond, as well as a brief 

abstract: Primary: Individuals or 

Households. This information collection 

facilitates processing of applications for 

benefits filed by dependents of 

diplomats, international organizations, 

and NATO personnel by U.S. 

Citizenship and Immigration Services, 

and the Department of State. 

(5) An estimate of the total number of 

respondents and the amount of time 

estimated for an average respondent to 

respond: 5,800 responses at 15 minutes 

(.25) per response. 

(6) An estimate of the total public 

burden (in hours) associated with the 

collection: 1,450 annual burden hours. 

If you need a copy of the information 

collection instrument, please visit the 

Web site at: http://www.regulations.gov. 

We may also be contacted at: USCIS, 

Regulatory Products Division, 20 

Massachusetts Avenue, NW., 

Washington, DC 20529–2020; 

Telephone 202–272–8377. 

Dated: November 9, 2010. 

Stephen Tarragon, 

Deputy Chief, Regulatory Products Division, 

U.S. Citizenship and Immigration Services, 

Department of Homeland Security. 

[FR Doc. 2010–28860 Filed 11–15–10; 8:45 am] 

BILLING CODE 9111–97–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Citizenship and Immigration 

Services 

Agency Information Collection 

Activities: Form I–290B, Extension of 

an Existing Information Collection; 

Comment Request 

ACTION: 60-Day Notice of Information 

Collection under Review: Form I–290B, 

Notice of Appeal to the Office of 

Administrative Appeals; OMB Control 

No.1615–0095. 

The Department of Homeland 

Security, U.S. Citizenship and 

Immigration Services will be submitting 

the following information collection 

request for review and clearance in 

accordance with the Paperwork 

Reduction Act of 1995. The information 

collection is published to obtain 

comments from the public and affected 

agencies. Comments are encouraged and 

will be accepted for sixty days until 

January 18, 2011. 

During this 60-day period, USCIS will 

be evaluating whether to revise the 

Form I–290B. Should USCIS decide to 

revise the Form I–290B it will advise the 

public when we publish the 30-day 

mstockstill on DSKH9S0YB1PROD with NOTICES