69772 Federal Register / Vol. 70, No. 221 / Thursday, November 17, 2005 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Drug and Biological Product 

Consolidation; Investigational New 

Drug Application Number Conversion 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that the Center for Drug Evaluation and 

Research (CDER) will assign new 

numbers to a group of investigational 

new drug applications (INDs). In 2003, 

FDA transferred certain product 

oversight responsibilities from the 

Center for Biologics Evaluation and 

Research (CBER) to CDER. The 

consolidation of INDs transferred from 

CBER with CDER INDs resulted in INDs 

with duplicate numbers. To resolve this 

issue, CDER is renumbering some INDs 

that were submitted to CDER before the 

consolidation. This Federal Register 

notice serves to notify sponsors in lieu 

of sending letters to them. 

ADDRESSES: Information on CDER IND 

renumbering is available on the Internet 

at http://www.fda.gov/cder/regulatory/ 

applications/INDrenumbering.htm. 

FOR FURTHER INFORMATION CONTACT: 

Samuel Y. Wu, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., bldg. WO22, rm. 1121, 

Silver Spring, MD 20993, 301–796–

0637. 

SUPPLEMENTARY INFORMATION: 

I. Therapeutic Biological Products 

Transferred to CDER 

On October 1, 2003, FDA transferred 

responsibility for regulating most 

therapeutic biologics, with certain 

exceptions (e.g., cell and gene therapy 

products and therapeutic vaccines), 

from the Office of Therapeutics 

Research and Review, CBER, to the 

Office of New Drugs, CDER, and the 

Office of Pharmaceutical Science, CDER 

(68 FR 38067, June 26, 2003). 

Applications for the therapeutic 

biological products now under CDER’s 

review—including INDs, biologics 

license applications, investigational 

device exemptions, and new drug 

applications—were transferred to CDER. 

For more information on the transfer of 

therapeutic biological products from 

CBER to CDER, see FDA’s Web site 

http://www.fda.gov/cber/transfer/ 

transfer.htm. 

II. Duplicate IND Numbers 

The consolidation of INDs transferred 

from CBER to CDER has resulted in 

duplicate IND numbers. To resolve this 

issue, INDs numbered below 14,000 that 

were submitted to CDER before the 

consolidation will be assigned new 

numbers. To determine the new 

number, CDER has added 80,000 to the 

original IND number. For example, IND 

8,999 will become IND 88,999 and IND 

11,192 will become 91,192. INDs that 

were originally submitted to CBER and 

transferred to CDER will retain their 

numbers. 

III. Web Site for Information on 

Renumbered INDs 

FDA has created a Web site with more 

detailed information about the IND 

number conversion scheme. The Web 

site address is http://www.fda.gov/cder/ 

regulatory/applications/ 

INDrenumbering.htm. 

Dated: November 8, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–22802 Filed 11–16–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Notice of a Meeting 

Pursuant to Public Law 92–463, 

notice is hereby given of a meeting of 

the Substance Abuse and Mental Health 

Services Administration (SAMHSA) 

National Advisory Council in December 

2005. 

The SAMHSA National Advisory 

Council will meet in an open session 

December 6 from 9 a.m. to 5:30 p.m. and 

on December 7 from 9 a.m. to 12:30 p.m. 

The meeting will include a SAMHSA 

Administrator’s Report, presentations 

on SAMHSA’s response to Hurricanes 

Katrina and Rita, discussions 

concerning issues on SAMHSA’s 

appropriation and budget, and 

discussions on current administrative, 

legislative and program developments. 

In addition, the recipients of two 

SAMHSA-funded model programs will 

describe their approaches to prevent 

and treat substance abuse and mental 

health disorders. On December 7, the 

Race Against Drugs Motorcar will be on 

display in the SAMHSA parking lot. 

Attendance by the public at the 

meeting will be limited to space 

available. Public comments are 

welcome. Please communicate with the 

individual listed as contact below to 

make arrangements to comment or to 

request special accommodations for 

persons with disabilities. 

Substantive program information, a 

summary of the meeting, and a roster of 

Council members will be available, as 

soon as possible after the meeting, either 

by accessing the SAMHSA Council Web 

site, www.samhsa.gov/council/council, 

or may be obtained by communicating 

with the contact whose name and 

telephone number is listed below. The 

transcript for the meeting will also be 

available on the SAMHSA Council Web 

site within three weeks after the 

meeting. 

Committee Name: SAMHSA National 

Advisory Council. 

Date/Time: Tuesday, December 6, 

2005, 9 a.m. to 5:30 p.m. (Open). 

Wednesday, December 7, 2005, 9 a.m. to 

12:30 p.m. (Open). 

Place: 1 Choke Cherry Road, Sugarloaf 

and Seneca Conference Rooms, 

Rockville, Maryland 20857. 

Contact: Toian Vaughn, Executive 

Secretary, SAMHSA National Advisory 

Council and SAMHSA Committee 

Management Officer, 1 Choke Cherry 

Road, Room 8–1089, Rockville, 

Maryland 20857. Telephone: (240) 276–

2307; FAX: (240) 276–2220 and E-mail: 

toian.vaughn@samhsa.hhs.gov. 

Dated: November 10, 2005. 

Toian Vaughn, 

Executive Secretary, SAMHSA National, 

Advisory Council and SAMHSA Committee, 

Management Officer. 

[FR Doc. 05–22788 Filed 11–16–05; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[COTP Mobile–05–051] 

Notice, Request for Comments; Letter 

of Recommendation, Gulf LNG Clean 

Energy Marine Terminal Project, 

Jackson County, MS 

AGENCY: Coast Guard, DHS. 

ACTION: Request for comments; notice of 

public meeting. 

SUMMARY: In accordance with the 

requirements in 33 CFR 127.009, the 

U.S. Coast Guard Captain of the Port 

(COTP) Mobile, AL is preparing a letter 

of recommendation as to the suitability 

of the Pascagoula Bar, Horn Island Pass, 

Lower Pascagoula, and Bayou Casotte 

Channels for liquefied natural gas (LNG) 

marine traffic. The letter of 

recommendation is in response to a 

letter of intent submitted by Gulf LNG