13396 Federal Register / Vol. 80, No. 49 / Friday, March 13, 2015 / Notices 

Further information regarding the 

Webcast, including the Web address for 

the Webcast, will be made available at 

least 2 days in advance of the meeting 

at the following Web site: http://www.

fda.gov/AdvisoryCommittees/

CommitteesMeetingMaterials/Medical

Devices/MedicalDevicesAdvisory

Committee/Gastroenterology-Urology

DevicesPanel/default.htm. Select the 

link for 2015 Meeting Materials. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before April 30, 2015. Oral 

presentations from the public will be 

scheduled between approximately 1 

p.m. and 2 p.m. on May 14 and between 

approximately 9 a.m. and 10 a.m. on 

May 15. Those individuals interested in 

making formal oral presentations should 

notify the contact person and submit a 

brief statement of the general nature of 

the evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before April 15, 2015. Time allotted 

for each presentation may be limited. If 

the number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by April 20, 2015. 

FDA is opening a docket for public 

comment on this document. The Docket 

No. is FDA–2015–N–0722. The docket 

will close on May 28, 2015. Interested 

persons are encouraged to use the 

docket to submit electronic or written 

comments regarding this meeting. 

Comments received on or before April 

30, 2015, will be provided to the 

committee. Comments received after 

that date will be taken into 

consideration by the Agency. Submit 

electronic comments to http://

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management, Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. Submit a 

single copy of electronic comments or 

two paper copies of any mailed 

comments. Comments are to be 

identified with the docket number 

found in brackets in the heading of this 

document. Received comments may be 

seen in the Divisions 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. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact AnnMarie 

Williams, at AnnMarie.Williams@

fda.hhs.gov or 301–796–5966 at least 7 

days in advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: March 9, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–05710 Filed 3–12–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; 60 Day Comment 

Request; Assessment of NHLBI’s 

Global Health Initiative Collaborating 

Centers of Excellence (NHLBI) 

SUMMARY: In compliance with the 

requirement of Section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

National Heart, Lung, and Blood 

Institute (NHLBI), the National 

Institutes of Health (NIH), will publish 

periodic summaries of proposed 

projects to the Office of Management 

and Budget (OMB) for review and 

approval. 

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 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. 

To Submit Comments and For Further 

Information: To obtain a copy of the 

data collection plans and instruments, 

submit comments in writing, or request 

more information on the proposed 

project, contact: Deshiree Belis, 6705 

Rockledge Drive, Suite 6070, Bethesda, 

MD 20892, or call non-toll-free number 

(301)-435–1032, or Email your request 

to: deshiree.belis@nih.gov. Formal 

requests for additional plans and 

instruments must be requested in 

writing. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60 days of the date of 

this publication. 

Proposed Collection: Assessment of 

NHLBI’s Global Health Initiative 

Collaborating Centers of Excellence, 

0925-New, National Heart, Lung, and 

Blood Institute (NHLBI), the National 

Institutes of Health (NIH). 

Need and Use of Information 

Collection: This collection proposes to 

conduct a one-time outcome evaluation 

of the NHLBI Global Health Initiative 

Centers of Excellence (GHI COE) 

Program to examine the extent to which 

the program achieved its intended 

objectives in developing sustainable 

research and research training capacity, 

and advancing information about the 

prevention and treatment of chronic 

non-communicable chronic 

cardiovascular and pulmonary diseases 

(CVPD) in low- and middle-income 

country (LMIC) populations. The 

outcome evaluation will utilize a mixedmethods approach to comprehend each 

COE’s processes, short term outcomes, 

and sustainability outcomes/efforts. 

Specifically, the evaluation will involve 

triangulating quantitative data sources 

(e.g., archived systematic reporting 

data), and qualitative data sources (e.g., 

archival data and key informant 

interview data). Data collected will be 

used to develop a Case Study report for 

each COE outlining their experience 

with implementing their program as 

well as a comprehensive cross-site 

Lessons Learned Report describing 

knowledge and experiences from the 

overall program, including similarities 

and differences across a variety of 

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Federal Register / Vol. 80, No. 49 / Friday, March 13, 2015 / Notices 13397 

project settings and conditions. 

Findings from interviews will be 

incorporated into the Case Studies 

report and Lessons Learned report, 

which will be used by CTRIS to inform 

NHLBI and NIH stakeholders about 

structural issues relevant to planning 

both global and domestic biomedical 

research and training programs with 

diverse operational conditions and 

challenges. Additionally, COEs may 

utilize the Case Studies report as a 

marketing tool to attract additional 

funding and media coverage. 

OMB approval is requested for 3 

years. There are no costs to respondents 

other than their time. The total 

estimated annualized burden hours are 

36. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total annual 

burden hour 

Principal Investigators ...................................................................................... 9 1 1 9 

Training Directors ............................................................................................ 9 1 1 9 

Developed Country Partners ........................................................................... 9 1 1 9 

Trainees ........................................................................................................... 9 1 1 9 

Dated: February 23, 2015. 

Lynn Susulske, 

NHLBI Project Clearance Liaison, National 

Institutes of Health. 

[FR Doc. 2015–05722 Filed 3–12–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

[1651–0100] 

Agency Information Collection 

Activities: Petition for Remission or 

Mitigation of Forfeitures and Penalties 

Incurred 

AGENCY: U.S. Customs and Border 

Protection, Department of Homeland 

Security. 

ACTION: 30-Day notice and request for 

comments; extension of an existing 

collection of information. 

SUMMARY: U.S. Customs and Border 

Protection (CBP) of the Department of 

Homeland Security will be submitting 

the following information collection 

request to the Office of Management and 

Budget (OMB) for review and approval 

in accordance with the Paperwork 

Reduction Act: Petition for Remission or 

Mitigation of Forfeitures and Penalties 

Incurred (CBP Form 4609). This is a 

proposed extension of an information 

collection that was previously 

approved. CBP is proposing that this 

information collection be extended with 

a change to the burden hours, but no 

changes to the information collected. 

This document is published to obtain 

comments from the public and affected 

agencies. 

DATES: Written comments should be 

received on or before April 13, 2015 to 

be assured of consideration. 

ADDRESSES: Interested persons are 

invited to submit written comments on 

this proposed information collection to 

the Office of Information and Regulatory 

Affairs, Office of Management and 

Budget. Comments should be addressed 

to the OMB Desk Officer for Customs 

and Border Protection, Department of 

Homeland Security, and sent via 

electronic mail to oira_submission@

omb.eop.gov or faxed to (202) 395–5806. 

FOR FURTHER INFORMATION CONTACT: 

Requests for additional information 

should be directed to Tracey Denning, 

U.S. Customs and Border Protection, 

Regulations and Rulings, Office of 

International Trade, 90 K Street NE., 

10th Floor, Washington, DC 20229– 

1177, at 202–325–0265. 

SUPPLEMENTARY INFORMATION: This 

proposed information collection was 

previously published in the Federal 

Register (79 FR 77019) on December 23, 

2014, allowing for a 60-day comment 

period. This notice allows for an 

additional 30 days for public comments. 

This process is conducted in accordance 

with 5 CFR 1320.10. CBP invites the 

general public and other Federal 

agencies to comment on proposed and/ 

or continuing information collections 

pursuant to the Paperwork Reduction 

Act of 1995 (Pub. L. 104–13; 44 U.S.C. 

3507). The comments should address: 

(a) Whether the collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s 

estimates of the burden of the collection 

of information; (c) ways to enhance the 

quality, utility, and clarity of the 

information to be collected; (d) ways to 

minimize the burden, including the use 

of automated collection techniques or 

the use of other forms of information 

technology; and (e) the annual costs to 

respondents or record keepers from the 

collection of information (total capital/ 

startup costs and operations and 

maintenance costs). The comments that 

are submitted will be summarized and 

included in the CBP request for OMB 

approval. All comments will become a 

matter of public record. In this 

document, CBP is soliciting comments 

concerning the following information 

collection: 

Title: Petition for Remission or 

Mitigation of Forfeitures and Penalties 

Incurred. 

OMB Number: 1651–0100. 

Form Number: Form 4609. 

Abstract: CBP Form 4609, Petition for 

Remission or Mitigation of Forfeitures 

and Penalties Incurred, is completed 

and filed with the CBP Port Director by 

individuals who have been found to be 

in violation of one or more provisions 

of the Tariff Act of 1930, or other laws 

administered by CBP. Persons who 

violate the Tariff Act are entitled to file 

a petition seeking mitigation of any 

statutory penalty imposed or remission 

of a statutory forfeiture incurred. This 

petition is submitted on CBP Form 

4609. The information provided on this 

form is used by CBP personnel as a basis 

for granting relief from forfeiture or 

penalty. CBP Form 4609 is authorized 

by 19 U.S.C. 1618 and provided for by 

19 CFR 171.1. It is accessible at: http://

www.cbp.gov/sites/default/files/

documents/CBP%20Form%204609.pdf 

Action: CBP proposes to extend the 

expiration date of this information 

collection with a change to the burden 

hours resulting from updated estimates 

of the number of responses. There are 

no changes to the information collected. 

Type of Review: Extension (with 

change). 

Affected Public: Businesses. 

Estimated Number of Respondents: 

1,610. 

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