46996 Federal Register / Vol. 74, No. 176 / Monday, September 14, 2009 / Notices 

Title: HMM/Hanjin Reciprocal Space 

Charter Agreement. 

Parties: Hyundai Merchant Marine 

Co., Ltd. and Hanjin Shipping Co., Ltd. 

Filing Parties: Robert B. Yoshitomi, 

Esq., Nixon Peabody LLP, 555 West 5th 

Street, 46th Floor, Los Angeles, CA 

90013–1025 and David F. Smith, Esq., 

Sher & Blackwell LLP, 1850 M Street, 

NW., Suite 900, Washington, DC 20036. 

Synopsis: The agreement authorizes 

the parties to share vessel space in the 

trade between U.S. East Coast ports, on 

the one hand, and ports in the Indian 

Subcontinent, Middle East, and Asia, on 

the other. The parties requested 

expedited review. 

By Order of the Federal Maritime 

Commission. 

Dated: September 3, 2009. 

Karen V. Gregory, 

Secretary. 

[FR Doc. E9–22055 Filed 9–11–09; 8:45 am] 

BILLING CODE 6730–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0395] 

Draft Guidance for Industry and Food 

and Drug Administration Staff; Clinical 

Study Designs for Surgical Ablation 

Devices for Treatment of Atrial 

Fibrillation; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance 

entitled ‘‘Clinical Study Designs for 

Surgical Ablation Devices for Treatment 

of Atrial Fibrillation.’’ This draft 

guidance provides FDA’s proposed 

recommendations on clinical trial 

designs for surgical ablation devices 

intended for the treatment of atrial 

fibrillation. This draft guidance is not 

final nor is it in effect at this time. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

written or electronic comments on the 

draft guidance by December 14, 2009. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance 

document entitled ‘‘Clinical Study 

Designs for Surgical Ablation Devices 

for Treatment of Atrial Fibrillation’’ to 

the Division of Small Manufacturers, 

International, and Consumer Assistance, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

rm. 4613, Silver Spring, MD 20993. 

Send one self-addressed adhesive label 

to assist that office in processing your 

request, or fax your request to 301–847– 

8149. See the SUPPLEMENTARY

INFORMATION section for information on 

electronic access to the guidance. 

Submit written comments concerning 

this draft guidance to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Submit electronic comments to http:// 

www.regulations.gov. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Elias Mallis, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 1312, Silver Spring, 

MD 20993, 301–796–6216. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Atrial fibrillation (AF) is a complex 

arrhythmia of the heart. Its precise 

mechanisms remain unclear. This draft 

guidance describes elements of 

suggested clinical study design for 

surgical ablation devices used to treat 

patients with longstanding persistent 

AF and patients with symptomatic 

paroxysmal AF, such as inclusion and 

exclusion criteria and assessment of 

effectiveness, which may differ for these 

patient populations. 

II. Significance of Guidance 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on clinical study designs for surgical 

ablation devices for treatment of atrial 

fibrillation. It does not create or confer 

any rights for or on any person and does 

not operate to bind FDA or the public. 

An alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statute 

and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by using 

the Internet. To receive ‘‘Clinical Study 

Designs for Surgical Ablation Devices 

for Treatment of Atrial Fibrillation,’’ 

you may either send an e-mail request 

to dsmica@fda.hhs.gov to receive an 

electronic copy of the document or send 

a fax request to 301–847–8149 to receive 

a hard copy. Please use the document 

number 1676 to identify the guidance 

you are requesting. 

CDRH maintains an entry on the 

Internet for easy access to information 

including text, graphics, and files that 

may be downloaded to a personal 

computer with Internet access. Updated 

on a regular basis, the CDRH home page 

includes device safety alerts, Federal 

Register reprints, information on 

premarket submissions (including lists 

of approved applications and 

manufacturers’ addresses), small 

manufacturer’s assistance, information 

on video conferencing and electronic 

submissions, Mammography Matters, 

and other device-oriented information. 

The CDRH Web site may be accessed at 

http://www.fda.gov/cdrh. A search 

capability for all CDRH guidance 

documents is available at http:// 

www.fda.gov/cdrh/guidance.html. 

Guidance documents are also available 

at http://www.regulations.gov. 

IV. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in 21 CFR part 812 have 

been approved under OMB control 

number 0910–0078; the collections of 

information in 21 CFR 50 and 21 CFR 

56 have been approved under OMB 

control number 0910–0130; and the 

collections of information under 21 CFR 

part 814 have been approved under 

OMB control number 0910–0231. 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES), written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

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 Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: August 28, 2009. 

Catherine M. Cook, 

Associate Director for Regulations and Policy, 

Center for Devices and Radiological Health. 

[FR Doc. E9–22019 Filed 9–11–09; 8:45 am] 

BILLING CODE 4160–01–S 


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