Federal Register / Vol. 78, No. 4 / Monday, January 7, 2013 / Notices 949 

EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST

Cost component Total 

cost 

Annualized 

cost 

Project Development ............................................................................................................................................... $273,838 $136,919 

Data Collection Activities ......................................................................................................................................... 153,119 76,560 

Data Processing and Analysis ................................................................................................................................. 171,764 85,882 

Publication of Results .............................................................................................................................................. 14,753 7,377 

Project Management ................................................................................................................................................ 10,032 5,016 

Overhead ................................................................................................................................................................. 377,696 188,848 

Total .................................................................................................................................................................. 1,001,202 500,601 

Request for Comments 

In accordance with the Paperwork 

Reduction Act, comments on AHRQ’s 

information collection are requested 

with regard to any of the following: (a) 

Whether the proposed collection of 

information is necessary for the proper 

performance of AHRQ health care 

research and health care information 

dissemination functions, including 

whether the information will have 

practical utility; (b) the accuracy of 

AHRQ’s estimate of burden (including 

hours and costs) of the proposed 

collection(s) of information; (c) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(d) ways to minimize the burden of the 

collection of information upon the 

respondents, including the use of 

automated collection techniques, or 

other forms of information technology. 

Comments submitted in response to 

this notice will be summarized and 

included in the Agency’s subsequent 

request for OMB approval of the 

proposed information collection. All 

comments will become a matter of 

public record. 

Dated: December 20, 2012. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2012–31592 Filed 1–4–13; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention (CDC) 

Office for State, Tribal, Local and 

Territorial Support (OSTLTS) 

In accordance with Presidential 

Executive Order No. 13175, November 

6, 2000, and the Presidential 

Memorandum of November 5, 2009 and 

September 23, 2004, Consultation and 

Coordination with Indian Tribal 

Governments, CDC/Agency for Toxic 

Substances and Disease Registry 

(ATSDR), announces the following 

meeting and Tribal Consultation 

Session: 

Name: Tribal Advisory Committee 

(TAC) Meeting and 10th Biannual Tribal 

Consultation Session. 

Times and Dates: 

8:00 a.m.–9:30 a.m., February 5, 2013 

(TAC Meeting). 

8:00 a.m.–5:00 p.m., February 6, 2013 

(10th Biannual Tribal Consultation 

Session). 

8:00 a.m.–4:00 p.m., February 7, 2013 

(TAC Meeting). 

Place: The TAC Meeting and Tribal 

Consultation Session will be held at 

CDC Headquarters, 1600 Clifton Road, 

NE., Global Communications Center, 

Auditorium B3, Atlanta, Georgia. 

Status: All meetings are being hosted 

by CDC/ATSDR. Meetings on February 

5, 6, and 7, 2013, are open to the public. 

Purpose: In 2011–2012, CDC began 

revising its existing Tribal Consultation 

Policy (issued in 2005) with the primary 

purpose of providing guidance across 

the agency to work effectively with 

American Indian/Alaska Native (AI/AN) 

tribes, communities, and organizations 

to enhance AI/AN access to CDC 

resources and programs. Within the 

CDC Consultation Policy, it is stated 

that CDC will conduct government-togovernment consultation with elected 

tribal officials or their authorized 

representatives before taking actions 

and/or making decisions that affect 

them. Consultation is an enhanced form 

of communication that emphasizes 

trust, respect, and shared responsibility. 

It is an open and free exchange of 

information and opinion among parties 

that leads to mutual understanding and 

comprehension. CDC believes that 

consultation is integral to a deliberative 

process that results in effective 

collaboration and informed decision 

making with the ultimate goal of 

reaching consensus on issues. Although 

formal responsibility for the agency’s 

overall government-to-government 

consultation activities rests within the 

CDC Office of the Director (OD), other 

CDC Center, Institute, and Office (CIO) 

leadership shall actively participate in 

TAC meetings and HHS-sponsored 

regional and national tribal consultation 

sessions as frequently as possible. 

Matters To Be Discussed: The TAC 

will convene their advisory committee 

meeting with discussions and 

presentations from various CDC senior 

leaders on activities and areas identified 

by TAC members and other tribal 

leaders as priority public health issues. 

The following topics are scheduled for 

presentation and discussion during the 

TAC Meeting; however, discussion is 

not limited to these topics: substance 

abuse/mental health, community based 

participatory public health, success 

stories, and grant information and 

opportunities at CDC for Native 

participation. 

The 10th Biannual Tribal 

Consultation Session will engage CDC 

senior leadership from the CDC OD and 

various CDC CIOs. Sessions that will be 

held during the Tribal Consultation 

include the following: a listening 

session with the director of CDC, 

roundtable discussions with CDC senior 

leadership and an opportunity for tribal 

testimony. 

Additional opportunities will be 

provided during the Consultation 

Session for tribal testimony. Tribal 

Leaders are encouraged to submit 

written testimony by 12:00 a.m., EST on 

January 25, 2013, to Kimberly Cantrell, 

Deputy Associate Director for Tribal 

Support, OSTLTS, via mail to 4770 

Buford Highway NE., MS E–70, Atlanta, 

Georgia 30341 or email to 

klw6@cdc.gov. Depending on the time 

available, it may be necessary to limit 

the time of each presenter. 

The agenda is subject to change as 

priorities dictate. 

Information about the TAC, CDC’s 

Tribal Consultation Policy, and previous 

meetings may be referenced on the 

following web link: http://www.cdc.gov/ 

tribal. 

Contact Person For More Information: 

Kimberly Cantrell, Deputy Associate 

Director for Tribal Support, OSTLTS, 

via mail to 4770 Buford Highway NE., 

MS E–70, Atlanta, Georgia 30341 or 

email to klw6@cdc.gov. 


wreier-aviles on DSK7SPTVN1PROD with 
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