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

The Director, Management Analysis 

and Services Office has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both the 

Centers for Disease Control and 

Prevention, and the Agency for Toxic 

Substances and Disease Registry. 

Dana Redford, 

Acting Director, Management Analysis and 

Services Office, Centers for Disease Control 

and Prevention. 

[FR Doc. 2013–00007 Filed 1–4–13; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–D–0530] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Guidance on 

Medical Devices: The Pre-Submission 

Program and Meetings With FDA Staff; 

Withdrawal 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Withdrawal of notice. 

SUMMARY: This document withdraws a 

Food and Drug Administration (FDA) 

notice that published in the Federal 

Register of December 11, 2012 (77 FR 

73662). 

DATES: This notice is withdrawn on 

January 7, 2013. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

5156, Daniel.Gittleson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA 

published a notice in the Federal 

Register of December 11, 2012 (77 FR 

73662), informing interested parties that 

the proposed collection of information 

entitled ‘‘Guidance on Medical Devices: 

The Pre-Submission Program and 

Meetings with FDA Staff’’ had been 

submitted to the Office of Management 

and Budget (OMB) for review and 

clearance under the Paperwork 

Reduction Act of 1995 and inviting the 

public to submit comments on the 

proposed study to OMB. As of the date 

of this notice, FDA has not finalized the 

policy document underlying this 

information collection request. Thus, 

FDA is withdrawing the proposed 

collection of information published on 

December 11, 2012, at this time. 

Dated: December 31, 2012. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2013–00009 Filed 1–4–13; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2012–M–0712, FDA– 

2012–M–0713, FDA–2012–M–0734, FDA– 

2012–M–0735, FDA–2012–M–0814, FDA– 

2012–M–0833, FDA–2012–M–0893, FDA– 

2012–M–0965, FDA–2012–M–0968, FDA– 

2012–M–1011, and FDA–2012–M–1013] 

Medical Devices; Availability of Safety 

and Effectiveness Summaries for 

Premarket Approval Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing a 

list of premarket approval applications 

(PMAs) that have been approved. This 

list is intended to inform the public of 

the availability of safety and 

effectiveness summaries of approved 

PMAs through the Internet and the 

Agency’s Division of Dockets 

Management. 

ADDRESSES: Submit written requests for 

copies of summaries of safety and 

effectiveness data to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Please cite the appropriate docket 

number as listed in table 1 of this 

document when submitting a written 

request. See the SUPPLEMENTARY 

INFORMATION section for electronic 

access to the summaries of safety and 

effectiveness. 

FOR FURTHER INFORMATION CONTACT: 

Nicole Wolanski, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 1650, Silver Spring, 

MD 20993–0002, 301–796–6570. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In accordance with sections 515(d)(4) 

and (e)(2) of the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) (21 U.S.C. 

360e(d)(4) and (e)(2)), notification of an 

order approving, denying, or 

withdrawing approval of a PMA will 

continue to include a notice of 

opportunity to request review of the 

order under section 515(g) of the FD&C 

Act. The 30-day period for requesting 

reconsideration of an FDA action under 

§ 10.33(b) (21 CFR 10.33(b)) for notices 

announcing approval of a PMA begins 

on the day the notice is placed on the 

Internet. Section 10.33(b) provides that 

FDA may, for good cause, extend this 

30-day period. Reconsideration of a 

denial or withdrawal of approval of a 

PMA may be sought only by the 

applicant; in these cases, the 30-day 

period will begin when the applicant is 

notified by FDA in writing of its 

decision. 

The regulations provide that FDA 

publish a quarterly list of available 

safety and effectiveness summaries of 

PMA approvals and denials that were 

announced during that quarter. The 

following is a list of approved PMAs for 

which summaries of safety and 

effectiveness were placed on the 

Internet from July 1, 2012, through 

September 30, 2012. There were no 

denial actions during this period. The 

list provides the manufacturer’s name, 

the product’s generic name or the trade 

name, and the approval date. 

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

2012, THROUGH SEPTEMBER 30, 2012 

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

P980022/S010, FDA–2012– 

M–0965.

Medtronic MiniMed, Inc ..... Guardian Telemetered Glucose Monitoring System 

(TGMS).

January 7, 2004. 

P000008/S017, FDA–2012– 

M–1013.

Allergan, Inc ...................... LAP–BAND TM Adjustable Gastric Banding System ..... February 16, 2011. 

P100049, FDA–2012–M– 

0893.

Torax Medical, Inc ............. LINXTM Reflux Management System ........................... March 22, 2012. 

P010031/S232, FDA–2012– 

M–0814.

Medtronic, Inc .................... Concerto/Concerto II; Consulta; Maximo II; and 

Protecta/Protecta XT Families of CRT–Ds.

April 4, 2012. 


wreier-aviles on DSK7SPTVN1PROD with 
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 


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