Federal Register / Vol. 79, No. 230 / Monday, December 1, 2014 / Notices 71111 

into account the probable risks and 

benefits of currently available devices or 

alternative forms of treatment. 

The information collected will assist 

FDA in making determinations on the 

following: (1) Whether to grant HUD 

designation of a medical device; (2) 

exempt an HUD from the effectiveness 

requirements under sections 514 and 

515 of the FD&C Act, provided that the 

device meets requirements set forth 

under section 520(m) of the FD&C Act; 

and (3) whether to grant marketing 

approval(s) for the HUD. Failure to 

collect this information would prevent 

FDA from making a determination on 

the factors listed previously in this 

document. Further, the collected 

information would also enable FDA to 

determine whether the holder of an 

HUD is in compliance with the HUD 

provisions under section 520(m) of the 

FD&C Act. 

The number of respondents in tables 

1, 2, and 3 of this document are an 

average based on data for the previous 

3 years, i.e., fiscal years 2011 through 

2013. The number of annual reports 

submitted under § 814.126(b)(1) in table 

1 reflects 32 respondents with approved 

HUD applications. Likewise, under 

§ 814.126(b)(2) in table 2, the number of 

recordkeepers is 247. 

In the Federal Register of June 10, 

2014 (79 FR 33197), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity/21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Request for HUD designation—814.102 ............................. 16 1 16 40 640 

Humanitarian device exemption (HDE) application— 

814.104 ............................................................................. 7 1 7 320 2,240 

HDE amendments and resubmitted HDEs—814.106 ......... 14 5 70 50 3,500 

HDE supplements—814.108 ............................................... 112 1 112 80 8,960 

Notification of withdrawal of an HDE—814.116(e)(3) ......... 8 1 8 1 8 

Notification of withdrawal of institutional review board approval—814.124(b) ........................................................... 3 1 3 2 6 

Periodic reports—814.126(b)(1) .......................................... 32 1 32 120 3,840 

Total .............................................................................. ........................ ........................ ........................ ........................ 19,194 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity/21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeping 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

HDE Records—814.126(b)(2) .............................................. 247 1 247 2 494 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Dated: November 24, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–28183 Filed 11–28–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1952] 

Seventh Annual Sentinel Initiative; 

Public Workshop; Amendment of 

Notice 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

amendment of notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

amendment to the notice of a public 

workshop entitled ‘‘Seventh Annual 

Sentinel Initiative’’ to be held on 

February 5, 2015. The workshop was 

announced in the Federal Register of 

October 22, 2014. This amendment 

reflects the addition of a Comments 

section and updates an incorrect Web 

site in the Meeting Materials section. 

FOR FURTHER INFORMATION CONTACT: 

Carlos Bell, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 6358, Silver Spring, 

MD 20993, 301–796–3714, FAX: 301– 

847–3529, email: SentinelInitiative@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

In the Federal Register of October 22, 

2014 (79 FR 63130), FDA announced 

that a public workshop entitled 

‘‘Seventh Annual Sentinel Initiative’’ 

will be held on February 5, 2015. 

1. On page 63131, in the second 

column, in the sixth line of the Meeting 

Materials section, the Web site ‘‘http:// 

www.brookings.edu//health/events’’ is 

changed to read ‘‘http://

www.brookings.edu/events’’. 

2. On page 63131, in the second 

column, a Comments section is added 

between the Meeting Materials section 

and the Transcripts section to read: 

‘‘Comments: FDA is holding this 

public workshop to obtain information 

about a variety of topics on active 

medical product surveillance. The 

deadline for submitting comments 

regarding this public workshop is March 

10, 2015. 

Regardless of attendance in person or 

through the Web cast, interested persons 

may submit either electronic comments 

to http://www.regulations.gov or 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. 

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, and 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
71112 Federal Register / Vol. 79, No. 230 / Monday, December 1, 2014 / Notices 

will be posted to the docket at http://

www.regulations.gov.’’ 

Dated: November 20, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–28196 Filed 11–28–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Eye Institute; Notice of 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

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

hereby given of a meeting of the 

National Advisory Eye Council. 

The meeting will be open to the 

public as indicated below, 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. 

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/or contract proposals 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 and/or contract proposals, 

the disclosure of which would 

constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Advisory 

Eye Council 

Date: January 22, 2015. 

Open: 8:30 a.m. to 2:00 p.m. 

Agenda: Following opening remarks by the 

Director, NEI, there will be presentations by 

the staff of the Institute and discussions 

concerning Institute programs. 

Place: National Institutes of Health, 

Terrace Level Conference Rooms, 5635 

Fishers Lane, Bethesda, MD 20892. 

Closed: 2:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications and/or proposals. 

Place: National Institutes of Health, 

Terrace Level Conference Rooms, 5635 

Fishers Lane, Bethesda, MD 20892. 

Contact Person: Anne E Schaffner, Ph.D., 

Chief, Scientific Review Branch, Division of 

Extramural Research National Eye Institute, 

National Institutes of Health, 5635 Fishers 

Lane, Suite 1300, MSC 9300, Bethesda, MD 

20892–9300, (301) 451–2020. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

Information is also available on the 

Institute’s/Center’s home page: 

www.nei.nih.gov, where an agenda and any 

additional information for the meeting will 

be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.867, Vision Research, 

National Institutes of Health, HHS) 

Dated: November 24, 2014. 

Melanie J. Gray, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2014–28165 Filed 11–28–14; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Office of the Secretary 

[Docket No. DHS–2014–0074] 

Privacy Act of 1974; Department of 

Homeland Security U.S. Immigration 

and Customs Enforcement–005 Trade 

Transparency Analysis and Research 

(TTAR) System of Records 

AGENCY: Privacy Office, Department of 

Homeland Security. 

ACTION: Notice of Privacy Act system of 

records. 

SUMMARY: In accordance with the 

Privacy Act of 1974, the Department of 

Homeland Security proposes to update 

and reissue a current Department of 

Homeland Security system of records 

titled, ‘‘Department of Homeland 

Security/Immigration and Customs 

Enforcement–005 Trade Transparency 

Analysis and Research (TTAR) System 

of Records.’’ This system of records is 

being modified to (1) update existing 

and include new categories of 

individuals, (2) clarify existing and 

include new categories of records, (3) 

reflect a proposed change to the 

retention period of the system’s data, 

and (4) update the description of the 

record sources. In addition, the 

Department is notifying the public of 

changes triggered by the replacement of 

the TTAR SORN’s associated IT system, 

the Data Analysis and Research for 

Trade Transparency System (DARTTS), 

with FALCON–DARTTS, which 

replicates the functionality of and serves 

the same user groups as legacy 

DARTTS. The TTAR SORN is also being 

updated to expand coverage to a new IT 

system called FALCON-Roadrunner. 

The FALCON–DARTTS and FALCONRoadrunner Privacy Impact 

Assessments are posted on the 

Department privacy Web site (see 

www.dhs.gov/privacy). The exemptions 

for the existing system of records notice 

will continue to be applicable for this 

system of records notice. This updated 

system will be included in the 

Department of Homeland Security’s 

inventory of record systems. 

DATES: Submit comments on or before 

December 31, 2014. This updated 

system will be effective December 31, 

2014. 

ADDRESSES: You may submit comments, 

identified by docket number DHS– 

2014–0074 by one of the following 

methods: 

• Federal e-Rulemaking Portal: 

http://www.regulations.gov. Follow the 

instructions for submitting comments. 

• Fax: 202–343–4010. 

• Mail: Karen L. Neuman, Chief 

Privacy Officer, Privacy Office, 

Department of Homeland Security, 

Washington, DC 20528. 

Instructions: All submissions received 

must include the agency name and 

docket number for this rulemaking. All 

comments received will be posted 

without change to http://

www.regulations.gov, including any 

personal information provided. 

Docket: For access to the docket to 

read background documents or 

comments received go to http://

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: For 

general questions, please contact: Lyn 

Rahilly, Privacy Officer, U.S. 

Immigration and Customs Enforcement, 

500 12th Street SW., Mail Stop 5004, 

Washington, DC 20536, phone: 202– 

732–3300, email: ICEPrivacy@dhs.gov. 

For privacy questions, please contact: 

Karen Neuman, Chief Privacy Officer, 

Privacy Office, Department of Homeland 

Security, Washington, DC 20528, phone: 

202–343–1717. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In accordance with the Privacy Act of 

1974, 5 U.S.C. 552a, the Department of 

Homeland Security (DHS) U.S. 

Immigration and Customs Enforcement 

(ICE) proposes to update and reissue a 

current DHS system of records titled 

‘‘DHS/ICE–005 Trade Transparency 

Analysis and Research (TTAR) System 

of Records.’’ This system allows ICE 

Homeland Security Investigations (HSI) 

to collect and maintain records for the 

purpose of enforcing criminal and civil 

laws pertaining to customs violations, 

including trade-based money 

laundering. With this update, ICE is 

notifying the public of changes triggered 

by the replacement of the TTAR SORN’s 


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