Federal Register / Vol. 70, No. 201 / Wednesday, October 19, 2005 / Notices 60841 

8. Other Business 

Federal Communications Commission. 

Roderick Porter, 

Acting Chief, International Bureau. 

[FR Doc. 05–20614 Filed 10–18–05; 8:45 am] 

BILLING CODE 6712–01–P 

FEDERAL MARITITME COMMISSION 

Notice of Agreement Filed 

The Commission hereby gives notice 

of the filing of the following agreement 

under the Shipping Act of 1984. 

Interested parties may submit comments 

on an agreement to the Secretary, 

Federal Maritime Commission, 

Washington, DC 20573, within ten days 

of the date this notice appears in the 

Federal Register. Copies of agreements 

are available through the Commission’s 

Office of Agreements (202–523–5793 or 

tradeanalysis@fmc.gov). 

Agreement No.: 011488–002. 

Title: CSAV/Lauritzen Reefers Space 

Charter Agreement. 

Parties: CSAV Sud Americana de 

Vapores S.A. and LauritzenCool AB. 

Filing Party: Wayne R. Rohde, Esq., 

Sher & Blackwell LLP, 1850 M Street, 

NW., Suite 900, Washington, DC 20036. 

Synopsis: The amendment changes 

LauritzenCool AB to NYKLauritzenCool 

AB in the agreement, changes the 

agreement name, and republishes the 

agreement. 

Dated: October 14, 2005. 

By Order of the Federal Maritime 

Commission. 

Karen V. Gregory, 

Assistant Secretary. 

[FR Doc. 05–20914 Filed 10–18–05; 8:45 am] 

BILLING CODE 6730–01–P 

FEDERAL MARITIME COMMISSION 

Ocean Transportation Intermediary 

License Applicants 

Notice is hereby given that the 

following applicants have filed with the 

Federal Maritime Commission an 

application for license as a Non-VesselOperating Common Carrier and Ocean 

Freight Forwarder—Ocean 

Transportation Intermediary pursuant to 

section 19 of the Shipping Act of 1984 

as amended (46 U.S.C. app. 1718 and 46 

CFR 515). 

Persons knowing of any reason why 

the following applicants should not 

receive a license are requested to 

contact the Office of Transportation 

Intermediaries, Federal Maritime 

Commission, Washington, DC 20573. 

Non-Vessel-Operating Common Carrier 

Ocean Transportation Intermediary 

Applicants 

Ameroasia Int’l, 1315 Magnolia Avenue, 

#3, Gardena, CA 90247. Officer: Jun 

Yin, President (Qualifying 

Individual). 

West Point Relocation, 10505 Glenoaks 

Blvd., Pacoima, CA 91331. Officer: 

Elo Chhen, President (Qualifying 

Individual). 

Hoyer Global (USA), Inc., 16055 Space 

Center Blvd., Suite 500, Houston, TX 

77062. Officers: Ylna Flores, Secretary 

(Qualifying Individual), Cor Mol, 

CEO. 

Embarque Puerto Plata, Inc., 1426 

Cromwell Avenue, Bronx, NY 10452. 

Officers: Estebaldo Garcia, President 

(Qualifying Individual), Hyde Garcia, 

Vice President. 

S.F. Systems Ltd., 167–10 South 

Condult Avenue, Suite 205, Jamaica, 

NY 11434. Officer: Richard Shifu Lin, 

President, (Qualifying Individual). 

NEX Worldwide Express Inc., 267 Fifth 

Avenue, Suite B–1, New York, NY 

10016, Officers: Hasan Akipek, 

Secretary (Qualifying Individual), 

Kayhan Ozcilingir, President. 

Zenith Logistic (USA) Inc., 67–39 165 

Street, Fresh Meadows, NY 11356. 

Officers: Xiao Jun He, Vice President 

(Qualifying Individual). 

Advanced Courier Express (ACE), Ltd., 

dba Hanjin Express NY, JFK 

International Airport Bldg. #9, Suite 

#14, Jamaica, NY 11430. Officer: 

Byung Min Kim, President 

(Qualifying Individual). 

Colorado International Transportation 

Company, 541 East Cimarron Street, 

Colorado Springs, CO 80903. Officers: 

Anthony T. Marulli, Treasurer 

(Qualifying Individual), Edward 

Sobczewski, President. 

MTM International Logistics LLC, 9725 

NW 52nd Street, Suite #118, Miami, 

FL 33178. Officers: Guillermo Sigfrio 

Carbi Haubold, Manager (Qualifying 

Individual), Mariano Banez Perez, 

Manager. 

Prodemeca Corp., 4744 NW 114th 

Avenue, Suite #202, Doral, FL 33178. 

Officers: Michael Tomasiccmio, 

President (Qualifying Individual), 

Michele Tomasicchio, President. 

Amilcar Rene Estrada dba Transportes 

Estrada, 7400 #B Harry Hines Blvd., 

Dallas, TX 75235, Officer: Amilcar 

Bene Estrada, Owner (Qualifying 

Individual). 

Non-Vessel-Operating Common Carrier 

and Ocean Freight Forwarder 

Transportation Intermediary 

Applicants 

J.M.S. Logistics Corp., 6611 NW 84 

Avenue, Miami, FL 33166. Officer: 

Soraima I. Martinez, President 

(Qualifying Individual). 

Intercargo Express, 10911 Dennis Road, 

#405, Dallas, TX 75229. Reyna Isabel 

Bleeker, Sole Proprietor. 

Allen Lund Company, Inc., 4529 

Angeles Crest Highway, #300, La 

Canada, CA 91011. Officer: Robert R. 

Bush, Manager (Qualifying 

Individual). 

Ocean Freight Forwarder—Ocean 

Transportation Intermediary 

Applicants 

AM Worldwide, Inc., 2928–B Greens 

Road, Suite 450, Houston, TX 77032. 

Officers: Anthony Mello, President 

(Qualifying Individual) Kimberly 

Mello, Vice President. 

Guempel Lynnwood Corporation dba 

Galaxsea, Freight Forwarding, 13024 

Beverly Park Road, Suite 101, 

Mukilteo, WA 98275. Officers: Terrina 

R. Guempel, President (Qualifying 

Individual), John Guempel, Vice 

President. 

All-in-One Shipping, Inc., 8358 West 

Oakland Park Blvd. Suite 203g, 

Sunrise, FL 33351. Officer: Joshua 

Sean Morales, President (Qualifying 

Individual). 

FM Shipping, 26542 Soteio Street, 

Mission Viejo, CA 92692. Officers: 

Imad Farah, President (Qualifying 

Individual), Raed Mashaqi, Vice 

President. 

BF International Inc., 3080 North Rield 

Place, Suite 109, Roswell, GA 30076. 

Officers: Markos Baghoasarian, 

President (Qualifying Individual), 

Edgar Bagdosaryan, Vice President. 

Kimmel Worldwide Logistics, L.L.C., 46 

Haywood Street, Suite #215, 

Asheville, NC 28801. Officers: Tylene 

Kay Ashcroft, Vice President 

(Qualifying Individual), Paul J. 

Samuels, President. 

Gunhill Shipping, 1444 E. Gunhill 

Road, Bronx, NY 10469. Officer: Dave 

Stewart, President (Qualifying 

Individual). 

Active Shipping of New York, Inc., 178–

28 Jamaica Avenue, Jamaica, NY 

11432. Officers: Rohan Moonisar, Vice 

President (Qualifying Individual), 

Tara B. Ramnath, President. 

Omega Forwarding Group LLC, 18860 

Woodfield Road, Unit C, 

Gaithersburg, MD 20879. Officers: 

Raguel Fazio, Export Manager 

(Qualifying Individual), Pablo Yanez, 

President. 

Transcarveca USA Corp., 8375 N.W. 

68th Street, Miami, FL 33166. Officer: 

Luis Alberto Fuenmayor, President 

(Qualifying Individual). 

60842 Federal Register / Vol. 70, No. 201 / Wednesday, October 19, 2005 / Notices 

Dated: October 14, 2005. 

Karen V. Gregory, 

Assistant Secretary. 

[FR Doc. 05–20913 Filed 10–18–05; 8:45 am] 

BILLING CODE 6730–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Notice of Meeting 

In accordance with section 10(d) of 

the Federal Advisory Committee Act (5 

U.S.C., Appendix 2), announcement is 

made of a Health Care Policy and 

Research Special Emphasis Panel (SEP) 

meeting. 

A Special Emphasis Panel is a group 

of experts in fields related to health care 

research who are invited by the Agency 

for Healthcare Research and quality 

(AHRQ), and agree to be available, to 

conduct on an as needed basis, 

scientific reviews of applications for 

AHRQ support. Individual members of 

the Panel do not attend regularly 

scheduled meetings and do not serve for 

fixed terms or a long period of time. 

Rather, they are asked to participate in 

particular review meetings which 

require their type of expertise. 

Substantial segments of the upcoming 

SEP meeting listed below will be closed 

to the public in accordance with the 

Federal Advisory Committee Act, 

section 10(d) of 5 U.S.C., Appendix 2 

and 5 U.S.C. 552b(c)(6). Grant 

applications for ‘‘The Centers for 

Education and Research on 

Therapeutics (CERTs),’’ are to be 

reviewed and discussed at this meeting. 

These discussions are likely to reveal 

personal information concerning 

individuals associated with the 

applications. This information is 

exempt from mandatory disclosure 

under the above-cited statutes. 

SEP Meeting on: The Centers for 

Education and Research on 

Therapeutics (CERTs). 

Date: November 2–3, 2005 (Open on 

November 2 from 8 a.m. to 8:15 a.m. and 

closed for the remainder of the meeting). 

Place: John M. Eisenberg Building, 

AHRQ Conference Center, 540 Gaither 

Road, Rockville, Maryland 20850. 

Contact Person: Anyone wishing to 

obtain a roster of members, agenda or 

minutes of the non-confidential portions 

of this meeting should contact Mrs. 

Bonnie Campbell, Committee 

Management Officer, Office of 

Extramural Research, Education and 

Priority Populations, AHRQ, 540 

Gaither Road, Room 2038, Rockville, 

Maryland 20850, Telephone (301) 427- 

1554. 

Agenda items for this meeting are 

subject to change as priorities dictate. 

Dated: October 07, 2005. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 05–20937 Filed 10–18–05; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2003D–0367] 

Guidance for Industry on Providing 

Regulatory Submissions in Electronic 

Format—Human Pharmaceutical 

Product Applications and Related 

Submissions Using the Electronic 

Common Technical Document 

Specifications; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘Providing Regulatory 

Submissions in Electronic Format—

Human Pharmaceutical Product 

Applications and Related Submissions 

Using the eCTD Specifications.’’ This is 

one in a series of guidance documents 

on providing regulatory submissions to 

FDA in electronic format. This guidance 

discusses issues related to the electronic 

submission of new drug applications 

(NDAs), abbreviated new drug 

applications (ANDAs), biologics license 

applications (BLAs), investigational new 

drug applications (INDs), master files, 

advertising material, and promotional 

labeling using the electronic common 

technical document (eCTD) 

specifications. The submission of these 

documents in electronic format should 

improve the agency’s efficiency in 

processing, archiving, and reviewing 

them. 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Division of Drug Information (HFD–

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, or to the Office of 

Communication, Training, and 

Manufacturers Assistance (HFM–40), 

Center for Biologics Evaluation and 

Research, Food and Drug 

Administration, 1401 Rockville Pike, 

Rockville, MD 20852–1448. Send one 

self-addressed adhesive label to assist 

that office in processing your requests. 

Submit telephone requests to 800–835–

4709 or 301–827–1800. Submit written 

comments on the 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.fda.gov/dockets/ 

ecomments. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Randy Levin, Center for Drug Evaluation 

and Research (HFD–001), Food and 

Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–594–

5411, e-mail: levinr@cder.fda.gov, or 

Robert Yetter, Center for Biologics 

Evaluation and Research (HFM–25), 

Food and Drug Administration, 1401 

Rockville Pike, Rockville, MD 20852, 

301–827–0373. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Providing Regulatory Submissions in 

Electronic Format—Human 

Pharmaceutical Product Applications 

and Related Submissions Using the 

eCTD Specifications.’’ This document 

provides guidance to industry regarding 

submission of marketing applications 

(NDAs, ANDAs, BLAs), INDs, and 

related submissions (master files, 

advertising, and promotional labeling) 

in electronic format based on the 

International Conference on 

Harmonisation eCTD specifications. 

In the Federal Register of August 29, 

2003 (68 FR 52044), FDA made 

available a draft guidance for industry 

entitled ‘‘Providing Regulatory 

Submissions in Electronic Format—

Human Pharmaceutical Product 

Applications and Related Submissions’’

and gave interested persons an 

opportunity to submit comments by 

October 28, 2003. The agency 

considered received comments as it 

finalized this guidance. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking on providing 

applications and related submissions in 

electronic format. 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