Federal Register / Vol. 78, No. 4 / Monday, January 7, 2013 / Notices 951 

TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JULY 1, 

2012, THROUGH SEPTEMBER 30, 2012—Continued 

PMA No., Docket No. Applicant Trade name Approval date 

P080030, FDA–2012–M– 

0712.

Glaukos Corp .................... Glaukos iStent® Trabecular Micro-Bypass Stent and 

Inserter.

June 25, 2012. 

P110007, FDA–2012–M– 

0734.

Abbott Medical Optics, Inc Healon® EndoCoat OpViscosurgical Ophthalmic Device (OVD) (3% Sodium Hyaluronate).July 2, 2012. 

P110037, FDA–2012–M– 

0713.

Roche Molecular Systems, 

Inc.

COBAS® AmpliPrep/COBAS® TaqMan® CMV Test .... July 5, 2012. 

P110030, FDA–2012–M– 

0735.

QIAGEN Manchester, Ltd therascreen® KRAS RGQ PCR Kit ............................... July 6, 2012. 

P110043, FDA–2012–M– 

0833.

Abbott Vascular ................. Omnilink Elite Vascular Balloon-Expandable Stent 

System.

July 31, 2012. 

P040024/S056, FDA–2012– 

M–0968.

Medicis Aesthetics Holdings, Inc.Restylane L Injectable Gel ............................................ August 30, 2012. 

P110006, FDA–2012–M– 

1011.

U-Systems, Inc .................. somo-v® Automated Breast Ultrasound System 

(ABUS).

September 18, 2012 

II. Electronic Access 

Persons with access to the Internet 

may obtain the documents at http:// 

www.fda.gov/MedicalDevices/ 

ProductsandMedicalProcedures/ 

DeviceApprovalsandClearances/ 

PMAApprovals/default.htm. 

Dated: December 31, 2012. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2013–00004 Filed 1–4–13; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–1205] 

Accessible Medical Device Labeling in 

a Standard Content and Format Public 

Workshop; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

following public workshop entitled 

‘‘Accessible Standardized Medical 

Device Labeling.’’ The purpose of this 

public workshop is to discuss the 

growing need for medical device 

labeling to be delivered in a clear, 

concise, and readily accessible format so 

that patients, caregivers, and healthcare 

providers may access and utilize device 

labeling as efficiently and effectively as 

possible. This public workshop aims to 

engage stakeholders in active discussion 

with FDA and to encourage public 

comments regarding standard content 

and format for medical device labeling 

and the use of a repository containing 

medical device labeling. 

DATES: The public workshop will be 

held on April 29, 2013, from 8 a.m. to 

5 p.m. and April 30, 2013, from 8 a.m. 

to 4 p.m. 

ADDRESSES: The public workshop will 

be held at the FDA White Oak Campus, 

10903 New Hampshire Ave., Building 

31 Conference Center, the Great Room 

(rm. 1503A), Silver Spring, MD 20993. 

Entrance for the public meeting 

participants (non-FDA employees) is 

through Building 1 where routine 

security check procedures will be 

performed. For parking and security 

information, please refer to http:// 

www.fda.gov/AboutFDA/ 

WorkingatFDA/BuildingsandFacilities/ 

WhiteOakCampusInformation/ 

ucm241740.htm. 

FOR FURTHER INFORMATION CONTACT: 

Mary Weick-Brady, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 5426, 301–796–6089, 

FAX: 301–847–8510, email: 

Mary.Brady@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Registration: Registration is free and 

available on a first-come, first-served 

basis. Persons interested in attending 

this public workshop must register 

online by April 5, 2013. Early 

registration is recommended because 

facilities are 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 a.m. 

If you need special accommodations 

due to a disability, please contact Joyce 

Raines by email: 

Joyce.Raines@fda.hhs.gov or phone: 

301–796–5709 at least 7 days prior to 

the public workshop. 

To register for the public workshop, 

please visit FDA’s Medical Devices 

News & Events—Workshops & 

Conferences calendar at http:// 

www.fda.gov/MedicalDevices/ 

NewsEvents/WorkshopsConferences/ 

default.htm. Select this public 

workshop from the posted events list. 

Please provide complete contact 

information for each attendee, including 

name, title, affiliation, address, email, 

and telephone number. Those without 

Internet access should contact Mary 

Weick-Brady to register (see FOR

FURTHER INFORMATION CONTACT). 

Registrants will receive confirmation 

after they have been accepted. You will 

be notified if you are on a waiting list. 

Streaming Webcast of the Public 

Workshop: This public workshop will 

also be Webcast. Persons interested in 

viewing the Webcast must register 

online by April 5, 2013, 5 p.m. EST. 

Early registration is recommended 

because Webcast connections are 

limited. Organizations are requested to 

register all participants, but to view 

using one connection per location. 

Webcast participants will be sent 

technical system requirements after 

registration and will be sent connection 

access information after April 5, 2013. If 

you have never attended a Connect Pro 

event before, test your connection at 

https://collaboration.fda.gov/common/ 

help/en/support/meeting_test.htm. To 

get a quick overview of the Connect Pro 

program, visit http://www.adobe.com/ 

go/connectpro_overview. FDA has 

verified the Web site addresses in this 

document, but FDA is not responsible 

for any subsequent changes to the Web 

sites after this document publishes in 

the Federal Register. 

Requests for Oral Presentations: This 

public workshop includes a public 

comment session and topic-focused 

sessions. During online registration, you 

may indicate if you wish to present 

during a public comment session and 

which topics you want to address. All 

topic-focused sessions will be held 


wreier-aviles on DSK7SPTVN1PROD with 
952 Federal Register / Vol. 78, No. 4 / Monday, January 7, 2013 / Notices 

during the general session. Standard 

content and format of full labeling and 

a shortened version of labeling will be 

addressed on the first day. The labeling 

repository will be discussed in a 

focused session on the second day. FDA 

has included general topics in this 

document. FDA will do its best to 

accommodate requests to make public 

comments. Individuals and 

organizations with common interests are 

urged to consolidate or coordinate their 

presentations, and request time for a 

joint presentation, or submit requests for 

designated representatives to participate 

in the focused sessions. Following the 

close of registration, FDA will 

determine the amount of time allotted to 

each presenter and the approximate 

time each oral presentation is to begin, 

and will select and notify participants 

by April 12, 2013. All requests to make 

oral presentations must be received by 

the close of registration on April 5, 

2013, at 5 p.m. If selected for 

presentation, any presentation materials 

must be emailed to Mary Weick-Brady 

(see FOR FURTHER INFORMATION CONTACT) 

no later than March 29, 2013. No 

commercial or promotional material 

will be permitted to be presented or 

distributed at the public workshop. 

Comments: FDA is holding this public 

workshop to obtain information on 

medical device labeling. In order to 

permit the widest possible opportunity 

to obtain public comment, FDA is 

soliciting either electronic or written 

comments on all aspects of the public 

workshop topics. The deadline for 

submitting comments related to this 

public workshop is April 12, 2013. 

Regardless of attendance at the public 

workshop, interested persons may 

submit either electronic comments to 

http://www.regulations.gov or written 

comments regarding this document 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. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. In addition, 

when responding to specific questions 

as outlined in section II of this 

document, please identify the question 

you are addressing. Received comments 

may be seen in the Division of Dockets 

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

Monday through Friday, and will be 

posted to the docket at http:// 

www.regulations.gov. 

Transcripts: 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 

(see Comments). 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 the Division 

of Freedom of Information (ELEM– 

1029), Food and Drug Administration, 

12420 Parklawn Dr., Element Bldg., 

Rockville, MD 20857. A link to the 

transcripts will also be available 

approximately 45 days after the public 

workshop on the Internet at http:// 

www.fda.gov/MedicalDevices/ 

NewsEvents/WorkshopsConferences/ 

default.htm. (Select this public 

workshop from the posted events list). 

I. Background 

Currently, there are no regulations 

that explicitly define and describe a 

standard content and format for medical 

device labeling. FDA is concerned that 

the lack of standard content and format 

may translate into an increased risk of 

medical device error. Also, there is no 

single available source of medical 

device labeling for people to view, 

search, and download for devices that 

are used in clinical and non-clinical 

environments. FDA is aware of and 

concerned with the risk of medical 

errors that result from lost or 

inaccessible labeling. 

FDA conducted a two-phase research 

study with Research Triangle Institute 

(RTI) focusing on healthcare 

professionals and their experiences with 

medical device labeling, and what they 

would want in a standard version of 

device labeling. Key findings from the 

survey helped create an outline for 

standard content and format for medical 

device labeling identifying the most 

relevant sections. Participants also 

expressed the need for a condensed 

version of labeling to act as a quick 

reference for safe and effective use of 

devices. Participants indicated that 

having a ‘‘quick guide’’ describing 

proper device operation and use would 

be more convenient and effective with 

the option of referring to a more 

comprehensive form of labeling should 

it be required. 

FDA also conducted a survey with the 

National Family Caregivers Association 

(NFCA) on medical device labeling to 

elicit home caregivers’ experiences with 

medical device labeling for devices that 

are used in the home. Respondents 

indicated what sections of medical 

device labeling they believed would be 

most important when operating or 

troubleshooting a device in the home 

care environment. Respondents also 

stated they would like a standard 

content and format of labeling with 

access to a ‘‘quick guide’’ for proper 

instructions for use. The majority of 

respondents stated they would make use 

of a searchable Web site that contained 

labeling for medical devices. 

Accessible labeling has been a 

growing problem for healthcare 

professionals who operate medical 

devices, lay caregivers, and patients 

themselves. As more medical devices 

migrate out of clinical care 

environments and into patients’ homes, 

the assurance that devices are being 

used properly and safely no longer 

resides with a healthcare professional; 

rather, the responsibility is with the 

patient, spouse, sibling, or even 

children. When medical devices are sent 

home with patients or are moved from 

one location to another, the labeling 

often becomes misplaced, lost, 

damaged, or discarded, which may 

result in adverse events or other 

complications due to misinterpretations 

and absence of proper labeling. 

FDA is holding this public workshop 

to address these growing concerns and 

to solicit responses from the medical 

devices industry, healthcare 

practitioners, caregivers, and patients 

regarding a standard content and format 

of medical device labeling and methods 

to make medical device labeling 

accessible and searchable while keeping 

patient safety a priority. 

II. Topics for Discussion at the Public 

Workshop 

The workshop sessions will focus on 

the following general topics: 

A. Summary of FDA Work on Labeling 

1. RTI two-phase research study of 

healthcare professionals regarding 

device labeling. 

2. NFCA survey of consumers on 

medical device labeling. 

3. Cooperative Research and 

Development Agreement with 

Kwikpoint for the development of visual 

language for device labeling. 

4. The Center for Drug Evaluation and 

Research measures of success with 

standard labeling and the use of a drug 

repository. 

B. Standard Content and Format of 

Device Labeling 

1. Review the outline for a draft 

standard content and format of medical 

device labeling. 

2. Current thinking on a standard 

content and format of medical device 

labeling. 

3. Use of symbols in medical device 

labeling. 

4. Discuss a shortened version of 

standard medical device labeling. 

C. Repository of Medical Device 

Labeling for Home Use Devices 

1. Online access to device labeling. 


wreier-aviles on DSK7SPTVN1PROD with 
Federal Register / Vol. 78, No. 4 / Monday, January 7, 2013 / Notices 953 

2. Panel discussions on using an 

online device labeling site. 

3. Discuss the types of devices whose 

labeling should be on the site. 

Dated: December 31, 2012. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2013–00003 Filed 1–4–13; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: 

Comment Request 

ACTION: Notice. 

Summary: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects (section 3506(c)(2)(A) of Title 

44, United States Code, as amended by 

the Paperwork Reduction Act of 1995, 

Pub. L. 104–13), the Health Resources 

and Services Administration (HRSA) 

publishes periodic summaries of 

proposed projects being developed for 

submission to the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and draft instruments, email 

paperwork@hrsa.gov or call the HRSA 

Reports Clearance Officer at (301) 443– 

1984. 

HRSA especially requests comments 

on: (1) The necessity and utility of the 

proposed information collection for the 

proper performance of the agency’s 

functions, (2) the accuracy of the 

estimated burden, (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected, and (4) the 

use of automated collection techniques 

or other forms of information 

technology to minimize the information 

collection burden. 

Information Collection Request Title: 

Bureau of Health Professions (BHPr) 

Performance Data Collection (OMB No. 

0915–0061)—Revision 

Abstract: Over 40 BHPr programs 

award grants to health professions 

schools and training programs across 

the United States to develop, expand, 

and enhance training, and to strengthen 

the distribution of the health workforce. 

Many of these programs are governed by 

the Public Health Service Act (42 U.S.C. 

201 et seq.), specifically Titles III, VII, 

and VIII. Performance information is 

collected in the HRSA Performance 

Report for Grants and Cooperative 

Agreements (PRGCA). Data collection 

activities at application, progress, and 

annual performance satisfy statutory 

and programmatic requirements for 

performance measurement and 

evaluation (including specific Title III, 

VII, and VIII requirements), as well as 

Government Performance and Results 

Act (GPRA) requirements. The 

Affordable Care Act impacted a broad 

range of health workforce programs 

administered by BHPr. It reauthorized 

many of these programs and, in some 

cases, expanded eligibility, modified 

program activities, and/or established 

new requirements. The Affordable Care 

Act also created new health professions 

programs. Therefore, it was necessary to 

reexamine BHPr’s existing performance 

measures to ensure that they address 

these changes, meet evolving program 

management needs, and respond to 

emerging workforce concerns. 

The purpose of the proposed revised 

data collection is to enhance analysis 

and reporting of grantee training 

activities and education, identify 

intended practice locations, and report 

outcomes of funded initiatives. Data 

collected from these grant programs will 

also provide a description of the 

program activities of more than 1,600 

reporting grantees to better inform 

policymakers on the barriers, 

opportunities, and outcomes involved 

in health care workforce development. 

The proposed measures focus on five 

key outcomes: (1) Increasing the 

workforce supply of diverse welleducated practitioners, (2) influencing 

the distribution of practitioners to 

practice in underserved and rural areas, 

(3) enhancing the quality of education, 

(4) diversifying the pipeline for new 

health professionals, and (5) supporting 

educational infrastructure to increase 

the capacity to train more health 

professionals. 

Revisions to the current reporting will 

require the collection of baseline data at 

the grant application and award stages 

and will include improved performance 

reporting at three levels of 

measurement: individual-level, 

program-specific, and program clusterlevel. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose, or provide the information 

requested. This includes the time 

needed to review instructions, to 

develop, acquire, install and utilize 

technology and systems for the purpose 

of collecting, validating and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information, to train 

personnel and to be able to respond to 

a collection of information, to search 

data sources, to complete and review 

the collection of information, and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this Information 

Collection Request are summarized in 

the table below. 

The annual estimate of burden is as 

follows: 

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Application ............................................................................ 2,500 1 2,500 8 20,000 

Program Aggregate Data Collection * ................................. 500 1 500 10 5,000 

Individual-level Data Collection ............................................ 800 1 800 5 4,000 

Total .............................................................................. ........................ ........................ ........................ ........................ 29,000 

* Program aggregate data collection will only be required for programs that do not provide direct financial support to students.


wreier-aviles on DSK7SPTVN1PROD with