9824 Federal Register / Vol. 74, No. 43 / Friday, March 6, 2009 / Notices 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under 

section 505(i) of the Federal Food, Drug, 

and Cosmetic Act (the act) (21 U.S.C. 

355(i)) became effective: June 7, 1994. 

FDA has verified the applicant’s claim 

that the date the investigational new 

drug application became effective was 

on June 7, 1994. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the act: April 29, 2005. FDA 

has verified the applicant’s claim that 

the new drug application (NDA) for 

Arranon (NDA 21–877) was initially 

submitted on April 29, 2005. 

3. The date the application was 

approved: October 28, 2005. FDA has 

verified the applicant’s claim that NDA 

21–877 was approved on October 28, 

2005. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the U.S. Patent and 

Trademark Office applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its application for patent extension, 

this applicant seeks 5 years of patent 

term extension. 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments and ask for a 

redetermination by May 5, 2009. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

September 2, 2009. To meet its burden, 

the petition must contain sufficient facts 

to merit an FDA investigation. (See H. 

Rept. 857, part 1, 98th Cong., 2d sess., 

pp. 41–42, 1984.) Petitions should be in 

the format specified in 21 CFR 10.30. 

Comments and petitions should be 

submitted to the Division of Dockets 

Management. Three copies of any 

mailed information are to be submitted, 

except that individuals may submit one 

copy. Comments are to be identified 

with the docket number found in 

brackets in the heading of this 

document. Comments and petitions may 

be seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

Dated: February 17, 2009. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. E9–4770 Filed 3–5–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meetings. 

The meetings 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 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, FIRCA and 

GRIP in Behavioral and Social Sciences. 

Date: March 24, 2009. 

Time: 8 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: One Washington Circle Hotel, One 

Washington Circle Conference Room, 

Washington, DC 20037. 

Contact Person: Manana Sukhareva, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3214, 

MSC 7808, Bethesda, MD 20892. 301–435– 

1116, sukharem@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, PAR–08–1 

60: Metabolic Effects Psychotropic 

Medications. 

Date: March 25–26, 2009. 

Time: 8 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Reed A. Graves, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6166, 

MSC 7892, Bethesda, MD 20892. (301) 402– 

6297, gravesr@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Millennium 

Promise Awards: Non-communicable 

Disease. 

Date: March 25, 2009. 

Time: 8 a.m. to 5:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Admiral Fell Inn, 888 South 

Broadway, Baltimore, MD 21231. 

Contact Person: Cathy Wedeen, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3213, 

MSC 7808, Bethesda, MD 20892. 301–435– 

1191, wedeenc@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, ICBG 

Review. 

Date: March 25–26, 2009. 

Time: 8:30 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Doubletree Hotel Bethesda, 8120 

Wisconsin Avenue, Bethesda, MD 20814. 

Contact Person: Dan D. Gerendasy, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5132, 

MSC 7843, Bethesda, MD 20892. 301–594– 

6830, gerendad@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Tools for 

Zebrafish Research. 

Date: March 27, 2009. 

Time: 8 a.m. to 2 p.m. 

Agenda: To review and evaluate grant 

applications, Place: The River Inn, 924 

Twenty-Fifth Street, NW. Conference, 

Washington, DC 20037. 

Contact Person: Neelakanta Ravindranath, 

PhD, Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5140, 

MSC 7843, Bethesda, MD 20892. 301–435– 

1034, ravindrn@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review, Special Emphasis Panel, Zebrafish 

Genetic Screens. 

Date: March 27, 2009. 

Time: 2 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: The River Inn, 924 Twenty-Fifth 

Street, NW. Conference, Washington, DC 

20037. 

Contact Person: Neelakanta Ravindranath, 

PhD, Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5140, 

MSC 7843, Bethesda, MD 20892. 301–435– 

1034, ravindrn@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Enzyme 

Specificity Program Project. 

Date: April 1–2, 2009. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: David R. Jollie, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4150, 

MSC 7806, Bethesda, MD 20892. (301) 435– 

1722, jollieda@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, 

Epigenomics of Human Health and Disease. 

Date: April 2–3, 2009. 

Time: 8 a.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, 7400 Wisconsin 

Avenue, Bethesda, MD 20814. 

Contact Person: Michael K. Schmidt, PhD, 

Scientific Review Officer, Center for 

mstockstill on PROD1PC66 with NOTICES

Federal Register / Vol. 74, No. 43 / Friday, March 6, 2009 / Notices 9825 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 2214, 

MSC 7890, Bethesda, MD 20892. (301) 435– 

1147, mschmidt@mail.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Assays, 

Detectors, and Devices. 

Date: April 2–3, 2009. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Doubletree Hotel Bethesda, 8120 

Wisconsin Avenue, Bethesda, MD 20814. 

Contact Person: Alexander Gubin, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Rm 5144, MSC 

7812, Bethesda, MD 20892. 301–435–2902, 

gubina@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Member 

Conflicts in Biological Chemistry and 

Macromolecular Biophysics. 

Date: April 2–3, 2009. 

Time: 11 a.m. to 10 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Donald L. Schneider, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5160, 

MSC 7842, Bethesda, MD 20892. (301) 435– 

1727, schneidd@csr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research; 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: February 26, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–4622 Filed 3–5–09; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[Docket No. USCG–2009–0114] 

National Boating Safety Advisory 

Council 

AGENCY: Coast Guard, DHS. 

ACTION: Committee Management; notice 

of meeting. 

SUMMARY: The National Boating Safety 

Advisory Council (NBSAC) and its 

subcommittees will meet on April 4, 5, 

and 6, 2009, in Orlando, FL. The 

meetings will be open to the public. 

DATES: NBSAC will meet April 4, 2009, 

from 8:30 a.m. to 12 noon, and on April 

6, 2009, from 8:30 a.m. to 5 p.m. The 

Boats and Associated Equipment 

Subcommittee will meet on April 4, and 

the Prevention through People 

Subcommittee and the Recreational 

Boating Safety Strategic Planning 

Subcommittee will meet on April 5, 

2009. Please note that the meetings may 

conclude early if the council has 

completed it business. 

All written materials, comments, and 

requests to make oral presentations at 

the meetings should reach Mr. Jeff 

Ludwig by March 13, 2009, via one of 

the methods described in ADDRESSES. 

Requests to have a copy of your material 

distributed to each member of the 

committee prior to the meeting should 

reach Mr. Ludwig by March 13, 2009. 

ADDRESSES: The meeting will be held at 

the Grand Bohemian Hotel,325 S. 

Orange Ave, Orlando, FL 32801. 

Please send written material, 

comments, and requests to make oral 

presentations to Mr. Jeff Ludwig by one 

of the submission methods described 

below. All materials, comments, and 

requests must be identified by docket 

number USCG–2009–0114. 

Submission Methods: Please use only 

one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• E-mail: jeffrey.a.ludwig@uscg.mil. 

Include the docket number in the 

subject line of the message. 

• Fax: (202) 372–1932. 

• Mail: Mr. Jeff Ludwig, COMDT 

(CG–54221), 2100 2nd Street, SW., 

Washington, DC 20593. 

Instructions: All submissions received 

must include the words ‘‘U.S. Coast 

Guard’’ and docket number USCG– 

2009–0114. All submissions received 

will be posted without alteration at 

http://www.regulations.gov, including 

any personal information provided. 

Anyone can search the electronic form 

of comments received into any of our 

dockets by the name of the individual 

submitting the comment (or signing the 

comment, if submitted on behalf of an 

association, business, labor union, etc.). 

You may review a Privacy Act notice 

regarding our public dockets in the 

January 17, 2008 issue of the Federal 

Register (73 FR 3316). 

Docket: For access to the docket to 

read background documents or 

submissions received by the NBSAC, go 

to http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Jeff Ludwig, COMDT (CG–54221), 2100 

2nd Street, SW., Washington, DC 20593; 

(202) 372–1061; 

Jeffrey.a.ludwig@uscg.mil. 

SUPPLEMENTARY INFORMATION: Notice of 

this meeting is given under the Federal 

Advisory Committee Act, 5 U.S.C. App. 

(Pub. L. 92–463). NBSAC was 

established by the Federal Boat Safety 

Act of 1971. That law requires the 

Secretary of Homeland Security, and the 

Commandant of the Coast Guard by 

delegation, to consult with NBSAC in 

prescribing Federal regulations, and on 

other major matters regarding boating 

safety. See 46 U.S.C. 4302(c) and 

13110(c). 

NBSAC will meet for the purpose of 

discussing issues related to recreational 

boating safety. 

A. Tentative Agendas of Meetings 

National Boating Safety Advisory 

Council (NBSAC): 

Saturday, April 4, 2009: 

(1) Remarks—Mr. James P. Muldoon, 

NBSAC Chairman; 

(2) Chief, Office of Auxiliary and 

Boating Safety Update on NBSAC 

Resolutions and Recreational Boating 

Safety Program report. 

(3) Executive Secretary’s report. 

(4) Chairman’s session. 

(5) TSAC Liaison’s report. 

(6) NAVSAC Liaison’s report. 

(7) National Association of State 

Boating Law Administrators report. 

(8) Boats and Associated Equipment 

Subcommittee meeting. 

Sunday, April 5, 2009: 

(9) Prevention through People 

Subcommittee meeting. 

(10) Recreational Boating Safety 

Strategic Planning Subcommittee 

meeting. 

Monday, April 6, 2009: 

(11) Prevention through People 

Subcommittee report. 

(12) Boats and Associated Equipment 

Subcommittee report. 

(13) Recreational Boating Safety 

Strategic Planning Subcommittee report. 

A more detailed agenda can be found 

at: http://www.uscgboating.org/nbsac/ 

nbsac.htm, after March 27, 2009. 

B. NBSAC Subcommittees 

Prevention Through People 

Subcommittee: Discuss current 

regulatory projects, grants, contracts, 

and new issues affecting the prevention 

of boating accidents through outreach 

and education of boaters. 

Boats and Associated Equipment 

Subcommittee: Discuss current 

regulatory projects, grants, contracts, 

and new issues affecting boats and 

associated equipment. 

Recreational Boating Safety Strategic 

Planning Subcommittee: Discuss current 

status of the strategic planning process 

and any new issues or factors that could 

impact, or contribute to, the 

development of the strategic plan for the 

recreational boating safety program. 

mstockstill on PROD1PC66 with NOTICES