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 

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50232 Federal Register / Vol. 76, No. 156 / Friday, August 12, 2011 / Notices 

1Products that are built with or consist of 

computer and/or software components or 

applications are subject to regulation as devices 

when they meet the definition of a device in section 

201(h) of the FD&C Act. That provision defines a 

device as ‘‘* * * an instrument, apparatus, 

implement, machine, contrivance, implant, in vitro 

reagent * * *’’, that is ‘‘* * * intended for use in 

the diagnosis of disease or other conditions, or in 

the cure, mitigation, treatment, or prevention of 

disease, in man * * * ’’ or ‘‘* * * intended to 

affect the structure or any function of the body of 

man or other animals * * *’’. 

2This means that FDA intends to exercise its 

discretion to decline to pursue enforcement actions 

for violations of the FD&C Act and applicable 

regulations by a manufacturer of a mobile medical 

app, as specified in the draft guidance, ‘‘Mobile 

Medical Applications.’’ This does not constitute a 

change in the requirements of the FD&C Act or any 

applicable regulations. 

requirements. To register for the public 

workshop—whether attending in person 

or for the webcast—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 workshop from the posted events 

list). Please provide complete contact 

information for each attendee, including 

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

telephone, and FAX number. Registrants 

will receive confirmation once they 

have been accepted. You will be 

notified if you are on a waitlist. 

This workshop 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 workshop, 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 

9, 2011. 

Comments: Regardless of attendance 

at the public workshop, interested 

persons may submit either electronic or 

written comments until October 19, 

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 workshop? 

The purpose of the workshop is to 

provide a forum for discussion with 

FDA and to encourage public comment 

from interested stakeholders on the 

following issues previously raised in the 

notice of availability for the draft 

guidance (76 FR 43689, July 21, 2011): 

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 stand-alone software that provides 

clinical decision support. 

Given the rapid expansion and broad 

applicability of mobile applications 

(mobile apps), FDA issued the draft 

guidance, ‘‘Mobile Medical 

Applications’’ on July 21, 2011, to 

clarify the types of mobile apps to 

which the FDA intends to apply its 

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

MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/ucm263280.htm). 

At this time, FDA intends to apply its 

regulatory requirements to a subset of 

mobile apps that the Agency is calling 

mobile medical applications (mobile 

medical apps). For purposes of the draft 

guidance and the public workshop 

discussion, a ‘‘mobile medical app’’ is a 

mobile application that meets the 

definition of ‘‘device’’ in section 201(h) 

of the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) (21 U.S.C. 321(h)) 1; and 

either: 

• Is used as an accessory to a 

regulated medical device; or 

• Transforms a mobile platform into a 

regulated medical device. 

This narrowly-tailored approach 

focuses on a subset of mobile apps that 

either have traditionally been 

considered medical devices or affect the 

performance or functionality of a 

currently regulated medical device. 

Although some mobile apps that do 

not meet the definition of a mobile 

medical app may meet the FD&C Act’s 

definition of a device, FDA intends to 

exercise enforcement discretion 2

towards those mobile apps. 

II. What are the specific issues for 

discussion and public comment at the 

public workshop? 

We welcome comments on all aspects 

of the draft guidance as well as the 

following specific issues: 

1. FDA generally considers extensions 

of medical devices as accessories to 

those medical devices. Accessories have 

been typically regulated under the same 

classification as the connected medical 

device. However, we recognize potential 

limitations to this policy for mobile 

medical apps. FDA seeks comment on 

how the Agency should approach 

accessories and particularly mobile 

medical apps that are accessories to 

other medical devices so safety and 

effectiveness can be reasonably assured. 

For example, one possible approach 

could be the following: 

• An accessory that does not change 

the intended use of the connected 

device, but aids in the use of the 

connected medical device could be 

regulated as class I. For example, such 

an accessory would be similar to an 

infusion pump stand, which is currently 

classified as a class I device because it 

supports the intended use of an infusion 

pump (class II medical device). A 

mobile medical app that simply 

supports the intended use of a regulated 

medical device could be classified as 

class I with design controls as part of 

the quality systems requirements; 

• An accessory that extends the 

intended use of the connected medical 

device could be classified with the 

connected device. For example, if a 

mobile medical app that performs more 

detailed analysis than the connected 

medical device while maintaining the 

original intended use, which is data 

analysis, could be classified in the same 

classification as the connected medical 

device; and 

• An accessory that creates a new 

intended use from that of the connected 

device(s) could be classified according 

to the risk posed to patient safety by the 

new intended use, for example, if the 

intended use of a mobile medical app is 

to provide prognosis relating to a certain 

disease or condition and the mobile 

medical app is connected to a device 

that does not have that intended use, the 

mobile medical app may have a 

different level of risk than the connected 

device, resulting in a different 

classification to assure safety and 

effectiveness of the mobile medical app. 

2. FDA has not addressed in its draft 

guidance, ‘‘Mobile Medical 

Applications,’’ stand-alone software 

(mobile or traditional workstation) that 

analyzes, processes, or interprets 

medical device data (collected 

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Federal Register / Vol. 76, No. 156 / Friday, August 12, 2011 / Notices 50233 

electronically or through manual entry 

of the device data) for purposes of 

automatically assessing patient specific 

data or for providing support in making 

clinical decisions. FDA plans to address 

such stand-alone software in a separate 

guidance. In order to provide a 

reasonable assurance of the safety and 

effectiveness of such software, and to 

ensure consistency between the draft 

guidance, ‘‘Mobile Medical 

Applications,’’ and the planned 

guidance on stand-alone software that 

provides clinical decision support 

(CDS), FDA is seeking comment on the 

following issues: 

• What factors should FDA consider 

in determining the risk classification of 

different types of software that provide 

CDS functionality? Please provide 

examples of how those factors would be 

applied for such software that you 

believe should be in class I, class II, and 

class III; 

• How should the FDA assess standalone software that provides CDS 

functionality, to assure reasonable safety 

and effectiveness? For example, to what 

extent can FDA rely on a manufacturer’s 

demonstration that it has a robust 

quality system with appropriate quality 

assurance and design controls? Under 

what circumstances should the 

submission of clinical data be required?; 

and 

• Are there specific controls that 

manufacturers should implement that 

could change the risk classification or 

reduce the premarket data requirements 

for particular types of stand-alone 

software that provide CDS 

functionality? 

III. Where can I find out more about 

this public workshop? 

Background information on the public 

workshop, 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 hard 

copy 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. 2011–20574 Filed 8–11–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 

Comment Request; Web-Based Skills 

Training for SBIRT (Screening Brief 

Intervention and Referral to Treatment) 

SUMMARY: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Institute on Drug Abuse (NIDA), the 

National Institutes of Health (NIH) has 

submitted to the Office of Management 

and Budget (OMB) a request for review 

and approval of the information 

collection listed below. This proposed 

information collection was previously 

published in the Federal Register on 

May 24, 2011, Vol 76, #100, page 

30177–30178, and allowed 60 days for 

public comment. One request for the 

draft instruments was received from the 

public. These were provided to the 

requestor. The purpose of this notice is 

to allow an additional 30 days for public 

comment. The National Institutes of 

Health may not conduct or sponsor, and 

the respondent is not required to 

respond to, an information collection 

that has been extended, revised, or 

implemented on or after October 1, 

1995, unless it displays a currently valid 

OMB control number. 

Proposed Collection 

Title: Web-based Skills Training for 

SBIRT (Screening Brief Intervention and 

Referral to Treatment). 

Type of Information Collection 

Request: NEW. 

Need and Use of Information 

Collection: The project aims to increase 

the provision of screening, brief 

intervention, and referral to treatment 

(SBIRT) for substance use in primary 

care by developing an engaging, 

interactive case-based training program 

that will be delivered over the Internet, 

providing convenient access to 

screening and brief intervention skills 

training and resources for busy PCPs. 

The goal of this study is to evaluate the 

effectiveness of this training on provider 

behavior and/or patient outcome and 

the program’s utility as a training tool in 

a real-world medical setting. The 

training is named SBIRT–PC. Study 

participants will be randomly assigned 

to complete SBIRT–PC or a control 

training, consisting of online reading 

materials. Effectiveness will be 

evaluated in terms of differential SBIRTrelated knowledge, attitudes, selfefficacy, self-reported clinical practices, 

skills as measured by virtual 

standardized patient evaluations (VSPE) 

and a telephone-based standardized 

patient (SP) interaction. Participants in 

each condition will also complete a 

training satisfaction questionnaire. 

Frequency of Response: On occasion. 

Affected Public: Private sector; 

businesses or other for-profit. 

Type of Respondents: Primary Care 

Providers. 

The annual reporting burden is as 

follows: 

Type of respondents 

Estimated 

number of 

respondents 

Estimated 

number of 

responses per 

respondent 

Average 

burden 

hours per 

set of 

responses 

Estimated 

total annual 

burden hours 

requested 

Primary Care Providers ................................................................................... 94 1 2.0 188 

There are no Capital Costs to report. 

There are no Operating or Maintenance 

Costs to report. 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of the following points: 

(1) Whether the proposed collection of 

information is necessary for the proper 

performance of the function of the 

agency, including whether the 

information will have practical utility; 

(2) The accuracy of the agency’s 

estimate of the burden of the proposed 

collection of information, including the 

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