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 

mstockstill on DSK4VPTVN1PROD with NOTICES

50234 Federal Register / Vol. 76, No. 156 / Friday, August 12, 2011 / Notices 

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 those who 

are to respond, including the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

Direct Comments to OMB: 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: Office 

of Management and Budget, Office of 

Regulatory Affairs, 

OIRA_submission@omb.eop.gov or by 

fax to 202–395–6974, Attention: Desk 

Officer for NIH. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans, contact: Quandra Scudder, 

Project Officer, National Institute on 

Drug Abuse NIDA, NIH, 6001 Executive 

Boulevard, Bethesda, MD 20892–9557, 

or call non-toll-free number (301) 594– 

0394 or E-mail your request, including 

your address to scudderq@nida.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30 days of the date of 

this publication. 

Dated: August 4, 2011. 

Mary Affeldt, 

Executive Officer, (OM Director) NIDA. 

[FR Doc. 2011–20542 Filed 8–11–11; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Cancer 

Institute Initial Review Group; Subcommittee 

G—Education. 

Date: September 20–21, 2011. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hilton Washington/Rockville, 1750 

Rockville Pike, Rockville, MD 20852. 

Contact Person: Jeannette F. Korczak, PhD, 

Scientific Review Administrator, Resources 

and Training Review Branch, Division of 

Extramural Activities, National Cancer 

Institute, NIH, 6116 Executive Blvd., Room 

8115, Bethesda, MD 20892, 301–496–9767, 

korczakj@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS) 

Dated: August 8, 2011. 

Anna P. Snouffer, 

Deputy Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2011–20536 Filed 8–11–11; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Environmental 

Health Sciences Notice of Meetings 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of meetings of the 

Interagency Breast Cancer and 

Environmental Research Coordinating 

Committee. 

The meetings will be open to the 

public, with attendance limited to space 

available. Individuals who plan to 

attend and need special assistance, such 

as sign language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

Name of Committee: Interagency Breast 

Cancer and Environmental Research 

Coordinating Committee. 

Date: October 12, 2011. 

Time: 1 p.m. to 3 p.m. 

Agenda: The purpose of the meeting is to 

continue the work of the Research Process 

Subcommittee as it addresses a broad set of 

objectives related to the overall mandate of 

the IBCERC. The meeting agenda will be 

available on the Web at http:// 

www.niehs.nih.gov/about/orgstructure/ 

boards/ibcercc/. 

Place: NIEHS/National Institutes of Health, 

Building 4401, East Campus, 79 T.W. 

Alexander Drive, Research Triangle Park, NC 

27709 (Telephone Conference Call). 

To attend the meeting, please RSVP via email to ibcercc@niehs.nih.gov at least 10 days 

in advance and instructions for joining the 

meeting will be provided. 

Contact Person: Gwen W. Collman, PhD, 

Director, Division of Extramural Research 

and Training (DERT), Nat. Inst. of 

Environmental Health Sciences, National 

Institutes of Health, 615 Davis Dr., KEY615/ 

3112, Research Triangle Park, NC 27709, 

(919) 541–4980, collman@niehs.nih.gov. 

Name of Committee: Interagency Breast 

Cancer and Environmental Research 

Coordinating Committee. 

Date: October 26, 2011. 

Time: 1 p.m. to 3 p.m. 

Agenda: The purpose of the meeting is to 

continue the work of the Research Process 

Subcommittee as it addresses a broad set of 

objectives related to the overall mandate of 

the IBCERC. The meeting agenda will be 

available on the Web at http:// 

www.niehs.nih.gov/about/orgstructure/ 

boards/ibcercc/. 

To attend the meeting, please RSVP via email to ibcercc@niehs.nih.gov at least 10 days 

in advance and instructions for joining the 

meeting will be provided. 

Place: NIEHS/National Institutes of Health, 

Building 4401, East Campus, 79 T.W. 

Alexander Drive, Research Triangle Park, NC 

27709 (Telephone Conference Call). 

Contact Person: Gwen W. Collman, PhD, 

Director, Division of Extramural Research 

and Training (DERT), Nat. Inst. of 

Environmental Health Sciences, National 

Institutes of Health, 615 Davis Dr., KEY615/ 

3112, Research Triangle Park, NC 27709, 

(919) 541–4980, collman@niehs.nih.gov. 

Name of Committee: Interagency Breast 

Cancer and Environmental Research 

Coordinating Committee. 

Date: November 10, 2011. 

Time: 1 p.m. to 3 p.m. 

Agenda: The purpose of the meeting is to 

continue the work of the Research Process 

Subcommittee as it addresses a broad set of 

objectives related to the overall mandate of 

the IBCERC. The meeting agenda will be 

available on the Web at http:// 

www.niehs.nih.gov/about/orgstructure/ 

boards/ibcercc/. 

Place: NIEHS/National Institutes of Health, 

Building 4401, East Campus, 79 T.W. 

Alexander Drive, Research Triangle Park, NC 

27709 (Telephone Conference Call). 

To attend the meeting, please RSVP via email to ibcercc@niehs.nih.gov at least 10 days 

in advance and instructions for joining the 

meeting will be provided. 

Contact Person: Gwen W. Collman, PhD, 

Director, Division of Extramural Research 

and Training (DERT), Nat. Inst. of 

Environmental Health Sciences, National 

Institutes of Health, 615 Davis Dr., KEY615/ 

3112, Research Triangle Park, NC 27709, 

(919) 541–4980, collman@niehs.nih.gov. 

Any member of the public interested in 

presenting oral comments to the committee 

should submit their remarks in writing at 

least 10 days in advance of the meeting. 

Comments in document format (i.e. WORD, 

Rich Text, PDF) may be submitted via e-mail 

to ibcercc@niehs.nih.gov or mailed to the 

mstockstill on DSK4VPTVN1PROD with NOTICES