50230 Federal Register / Vol. 76, No. 156 / Friday, August 12, 2011 / Notices 

TABLE 1—LIST OF THE CHEMICALS AND CHEMICAL COMPOUNDS IDENTIFIED BY FDA AS HARMFUL AND POTENTIALLY

HARMFUL CONSTITUENTS IN TOBACCO PRODUCTS AND TOBACCO SMOKE—Continued 

Constituent 

Carcinogen (CA), respiratory toxicant (RT), cardiovascular toxicant (CT), 

reproductive or developmental toxicant (RDT), addictive (AD) 

Uranium-235 ................................................................................................................................................................... CA, RT 

Uranium-238 ................................................................................................................................................................... CA, RT 

Vinyl acetate ................................................................................................................................................................... CA, RT 

Vinyl chloride .................................................................................................................................................................. CA 

Dated: August 9, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–20502 Filed 8–11–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0556] 

Center for Devices and Radiological 

Health 510(k) Clearance Process; 

Recommendations Proposed in 

Institute of Medicine Report: ‘‘Medical 

Devices and the Public’s Health, The 

FDA 510(k) Clearance Process at 35 

Years;’’ Public Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public meeting entitled: 

‘‘Recommendations Proposed in 

Institute of Medicine Report: ‘Medical 

Devices and the Public’s Health, The 

FDA 510(k) Clearance Process at 35 

Years.’ ’’ The purpose of the public 

meeting is to encourage public comment 

on the recommendations proposed in 

the Institute of Medicine (IOM) report. 

Date and Time: The public meeting 

will be held on September 16, 2011, 

from 8:30 a.m. to 5 p.m. Submit 

electronic and written comments by 

September 30, 2011. 

Location: The public meeting will be 

held at the Silver Spring Hilton Hotel, 

8727 Colesville Rd., Silver Spring, MD 

20910. 

Contact Person: Philip Desjardins, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

rm. 5452, Silver Spring, MD 20993, 

301–796–5678, 

philip.desjardins@fda.hhs.gov. 

Registration and Requests for Oral 

Presentations: Registration is free and 

will be on a first-come, first-served 

basis. Persons interested in attending 

this meeting must register online by 5 

p.m. on September 15, 2011. For those 

without Internet access, please call the 

contact person to register. 

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 

meeting will be provided beginning at 

7:30 a.m. 

If you need special accommodations 

due to a disability, please contact Susan 

Monahan (email: 

Susan.Monahan@fda.hhs.gov or phone: 

301–796–5661) no later than September 

15, 2011. 

To register for the public meeting, 

please visit http://www.fda.gov/ 

MedicalDevices/NewsEvents/ 

WorkshopsConferences/default.htm (or 

go to the FDA Medical Devices News & 

Events—Workshops & Conferences 

calendar and select this public meeting 

from the posted events list). Please 

provide complete contact information 

for each attendee, including name, title, 

affiliation, address, email, telephone, 

and FAX number. Registrants will 

receive confirmation once they have 

been accepted. You will be notified if 

you are on a waitlist. 

This meeting includes a public 

comment session. During online 

registration you may indicate if you 

wish to make an oral presentation 

during a public comment session at the 

public meeting, and which topic you 

wish to address in your presentation. 

FDA has included topics for comment 

in this document. FDA will do its best 

to accommodate requests to speak. 

Individuals and organizations with 

common interests are urged to 

consolidate or coordinate their 

presentations, and request time for a 

joint presentation. FDA will determine 

the amount of time allotted to each 

presenter and the approximate time 

each oral presentation is to begin. All 

requests to make oral presentations, as 

well as presentation materials, must be 

sent to the contact person by September 

15, 2011. 

Comments: Regardless of attendance 

at the public meeting, interested persons 

may submit either electronic or written 

comments until September 30, 2011. 

Submit electronic comments to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. It is only 

necessary to send one set of comments. 

It is no longer necessary to send two 

copies of mailed comments. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. Received comments may be 

seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

SUPPLEMENTARY INFORMATION: 

I. What is the background and purpose 

for holding this public meeting? 

In September 2009, FDA’s Center for 

Devices and Radiological Health (CDRH) 

convened an internal 510(k) Working 

Group as part of a two-pronged, 

comprehensive assessment of the 

premarket notification (510(k)) process. 

The first prong of this evaluation 

consisted of an internal evaluation of 

the 510(k) process, resulting in the 

publication of the CDRH preliminary 

internal evaluation entitled ‘‘510(k) 

Working Group Preliminary Report and 

Recommendations’’ (http:// 

www.fda.gov/downloads/AboutFDA/ 

CentersOffices/CDRH/CDRHReports/ 

UCM220784.pdf). This preliminary 

report was intended to communicate 

preliminary findings and 

recommendations regarding the 510(k) 

program and actions CDRH might take 

to address identified areas of concern. 

The report was issued on August 5, 

2010 (75 FR 47307). After reviewing 

public comment, CDRH issued a plan of 

action for implementation of the 

previously announced 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 76, No. 156 / Friday, August 12, 2011 / Notices 50231 

recommendations on January 19, 2011 

(http://www.fda.gov/downloads/ 

AboutFDA/CentersOffices/CDRH/ 

CDRHReports/UCM239450.pdf). 

The second prong of the 

comprehensive assessment of the 510(k) 

process was an independent study by 

the IOM. At the request of FDA, IOM 

evaluated the 510(k) clearance process 

and made recommendations aimed at 

protecting the health of the public and 

making available a mechanism to 

achieve timely access of medical 

devices to the market. On July 29, 2011, 

IOM released the report ‘‘Medical 

Devices and the Public’s Health, The 

FDA 510(k) Clearance Process at 35 

Years’’ (report) (http://www.iom.edu/ 

Reports/2011/Medical-Devices-and-thePublics-Health-The-FDA–510kClearance-Process-at-35–Years.aspx). 

The report contains eight 

recommendations aimed at improving 

regulation of medical devices. The 

recommendations are the subject of this 

public meeting. 

II. What are the specific issues for 

discussion and public comment at the 

public meeting? 

FDA welcomes comments on the 

following recommendations provided in 

the IOM report: 

1. The Food and Drug Administration 

should obtain adequate information to 

inform the design of a new medical 

device regulatory framework for class II 

devices so that the current 510(k) 

process, in which the standard for 

clearance is substantial equivalence to 

previously cleared devices, can be 

replaced with an integrated premarket 

and postmarket regulatory framework 

that effectively provides a reasonable 

assurance of safety and effectiveness 

throughout the device life cycle. Once 

adequate information is available to 

design an appropriate medical device 

regulatory framework, Congress should 

enact legislation to do so. 

2. FDA should develop and 

implement a comprehensive strategy to 

collect, analyze, and act on medical 

device postmarket performance 

information. 

3. FDA should review its postmarket 

regulatory authorities for medical 

devices to identify existing limitations 

on their use and to determine how the 

limitations can be addressed. 

4. FDA should investigate the 

viability of a modified de novo process 

as a mechanism for evaluating the safety 

and effectiveness of class II devices. 

5. FDA should develop and 

implement a program of continuous 

quality improvement to track regulatory 

decisions on medical devices, identify 

potential process improvements in the 

medical device regulatory framework, 

and address emerging issues that affect 

decisionmaking. 

6. FDA should commission an 

assessment to determine the effect of its 

regulatory process for class II devices on 

facilitating or inhibiting innovation in 

the medical device industry. 

7. FDA should develop procedures 

that ensure the safety and effectiveness 

of software used in devices, software 

used as devices, and software used as a 

tool in producing devices. 

8. FDA should promptly call for PMA 

applications for or reclassify class III 

devices that remain eligible for 510(k) 

clearance. 

III. Where can I find out more about 

this public meeting? 

Background information on the public 

meeting, registration information, the 

agenda, information about lodging, 

transcripts, and other relevant 

information will be posted, as it 

becomes available, on the Internet at 

http://www.fda.gov/MedicalDevices/ 

NewsEvents/WorkshopsConferences/ 

default.htm. 

IV. Will there be transcripts of the 

meeting? 

Please be advised that as soon as a 

transcript is available, it will be 

accessible at http:// 

www.regulations.gov. It may be viewed 

at the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. A transcript 

will also be available 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. 

Dated: August 9, 2011. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2011–20575 Filed 8–11–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0530] 

Mobile Medical Applications Draft 

Guidance; Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public workshop entitled: ‘‘Mobile 

Medical Applications Draft Guidance.’’ 

The purpose of the workshop is to 

provide a forum for discussion with 

FDA and to encourage public comment 

on the following topics: FDA’s recently 

issued draft guidance document entitled 

‘‘Mobile Medical Applications,’’ how 

FDA should approach accessories and 

particularly mobile medical 

applications that are accessories to other 

medical devices, and standalone 

software that provides clinical decision 

support. 

Date and Time: The public workshop 

will be held on September 12 and 13, 

2011. Submit electronic and written 

comments by October 19, 2011. 

Location: The public workshop will 

be held at the FDA White Oak Campus, 

10903 New Hampshire Ave., Building 

31 Conference Center, the Great Room 

(rm. 1503), Silver Spring, MD 20993– 

0002. 

Contact Person: Bakul Patel, Center 

for Devices and Radiological Health, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 66, rm. 

5456, Silver Spring, MD 20993, 301– 

796–5528, Bakul.Patel@fda.hhs.gov. 

Registration and Requests for Oral 

Presentations: Registration is free and 

will be on a first-come, first-served 

basis. Persons interested in attending 

this workshop must register online by 5 

p.m. on September 9, 2011. For those 

without Internet access, please call the 

contact person to register. 

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. Non-U.S. citizens are subject 

to additional security screening, and 

they should register as soon as possible. 

If you need special accommodations 

due to a disability, please contact Susan 

Monahan (e-mail: 

Susan.Monahan@fda.hhs.gov or phone: 

301–796–5661) no later than September 

9, 2011. 

This workshop will also be provided 

via webcast. Persons interested in 

participating by webcast must register 

online by 5 p.m. on September 9, 2011. 

Early registration is recommended 

because webcast connections are 

limited. Organizations are requested to 

register all participants, but view using 

one connection per location. Webcast 

participants will be sent connection 

mstockstill on DSK4VPTVN1PROD with NOTICES