Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Notices 55405 

listed in this document have repeatedly 

failed to submit reports required by 

§ 314.81. In addition, under § 314.200, 

we find that the holders of the 

applications have waived any 

contentions concerning the legal status 

of the drug products. Therefore, under 

these findings, approval of the 

applications listed in this document, 

and all amendments and supplements 

thereto, is hereby withdrawn, effective 

September 21, 2005. 

Dated: August 29, 2005. 

Steven Galson, 

Director, Center for Drug Evaluation and 

Research. 

[FR Doc. 05–18873 Filed 9–20–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Industry Exchange Workshop on Food 

and Drug Administration Clinical Trial 

Requirements; Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

SUMMARY: The Food and Drug 

Administration (FDA) Dallas District, in 

cooperation with the Society of Clinical 

Research Associates (SoCRA), is 

announcing a workshop on FDA clinical 

trial statutory and regulatory 

requirements. This 2-day workshop for 

the clinical research community targets 

sponsors, monitors, clinical 

investigators, institutional review 

boards, and those who interact with 

them for the purpose of conducting 

FDA-regulated clinical research. The 

workshop will include both industry 

and FDA perspectives on proper 

conduct of clinical trials regulated by 

FDA. 

Date and Time: The public workshop 

is scheduled for Wednesday, February 

8, 2006, from 8:15 a.m. to 5 p.m. and 

Thursday, February 9, 2006, from 8:15 

a.m. to 4 p.m. 

Location: The public workshop will 

be held at the Crowne Plaza Hotel 

Houston Medical Center, 6701 South 

Main, Houston, TX 77030, 713–797–

1110, FAX: 713–796–8291. 

Contact: David Arvelo, Food and Drug 

Administration, 4040 North Central 

Expressway, suite 900, Dallas, TX 

75204, 214–253–4952, FAX: 214–253–

4970, e-mail: oraswrsbr@ora.fda.gov. 

Registration: Send registration 

information (including name, title, firm 

name, address, telephone, and fax 

number) and the registration fee of $485 

(member), $560 (nonmember), or $460 

(government employee nonmember). 

(Registration fee for nonmembers 

includes a 1-year membership.) The 

registration fee for FDA employees is 

waived. Make the registration fee 

payable to SoCRA, P.O. Box 101, 

Furlong, PA 18925. To register via the 

Internet go to http://www.socra.org/ 

html/FDA_Conference.htm (FDA has 

verified the Web site address, but is not 

responsible for subsequent changes to 

the Web site after this document 

publishes in the Federal Register). The 

registrar will also accept payment by 

major credit cards. For more 

information on the meeting, or for 

questions on registration, contact 800–

SoCRA92 (800–762–7292), or 215–345–

7369, or via e-mail: socramail@aol.com. 

Attendees are responsible for their own 

accommodations. To make reservations 

at the Crowne Plaza Hotel Houston 

Medical Center at the reduced 

conference rate, contact the Crowne 

Plaza Hotel Houston Medical Center 

(see Location) before January 17, 2005. 

The registration fee will be used to 

offset the expenses of hosting the 

conference, including meals, 

refreshments, meeting rooms, and 

materials. 

Space is limited, therefore interested 

parties are encouraged to register early. 

Limited onsite registration may be 

available. Please arrive early to ensure 

prompt registration. If you need special 

accommodations due to a disability, 

please contact David Arvelo (see 

Contact) at least 7 days in advance of 

the workshop. 

SUPPLEMENTARY INFORMATION: The 

workshop on FDA clinical trials 

statutory and regulatory requirements, 

helps fulfill the Department of Health 

and Human Services and FDA’s 

important mission to protect the public 

health by educating researchers on 

proper conduct of clinical trials. Topics 

for discussion include the following: (1) 

FDA regulation of the conduct of 

clinical research; (2) medical device, 

drug, and biological product aspects of 

clinical research; (3) investigator 

initiated research; (4) pre-investigational 

new drug application meetings and FDA 

meeting process; (5) informed consent 

requirements; (6) ethics in subject 

enrollment; (7) FDA regulation of 

institutional review boards; (8) 

electronic records requirements; (9) 

adverse event reporting; (10) how FDA 

conducts bioresearch inspections; and 

(11) what happens after the FDA 

inspection. FDA has made education of 

the research community a high priority 

to ensure the quality of clinical data and 

protect research subjects. The workshop 

helps to implement the objectives of 

section 406 of the FDA Modernization 

Act (21 U.S.C. 393) and the FDA Plan 

for Statutory Compliance, which 

includes working more closely with 

stakeholders and ensuring access to 

needed scientific and technical 

expertise. The workshop also furthers 

the goals of the Small Business 

Regulatory Enforcement Fairness Act 

(Public Law 104–121) by providing 

outreach activities by Government 

agencies directed to small businesses. 

Dated: September 15, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–18871 Filed 9–20–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Psychopharmacologic Drugs Advisory 

Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: 

Psychopharmacologic Drugs Advisory 

Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on October 25, 2005, from 8 a.m. 

to 5 p.m. and on October 26, 2005, from 

8 a.m. to 3 p.m. 

Location: Hilton, The Ballrooms, 620 

Perry Pkwy., Gaithersburg, MD. The 

hotel phone number is 301–977–8900. 

Contact Person: Karen TempletonSomers, Center for Drug Evaluation and 

Research (HFD–21), Food and Drug 

Administration, 5600 Fishers Lane (for 

express delivery, 5630 Fishers Lane, rm. 

1093), Rockville, MD 20857, 301–827–

7001, FAX: 301–827–6776, e-mail: 

somersk@cder.fda.gov, or FDA Advisory 

Committee Information Line, 1–800–

741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512544. Please call the Information 

Line for up-to-date information on this 

meeting. The background material will 

become available no later than the day 

before the meeting and will be posted 

on FDA’s Web site at http://