72844 Federal Register / Vol. 70, No. 234 / Wednesday, December 7, 2005 / Notices 

Dated: November 30, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–23676 Filed 12–6–05; 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; 

Amendment of Notice 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

amendment to the notice of public 

workshop on FDA clinical trial statutory 

and regulatory requirements. This 

workshop was announced in the 

Federal Register of September 21, 2005 

(70 FR 55405). The amendment is made 

to reflect a change in the Location 

portion of the document. There are no 

other changes. 

FOR FURTHER INFORMATION CONTACT: 

David Arvelo, Food and Drug 

Administration, 4040 North Central 

Expressway, suite 900, Dallas TX 75204, 

214–253–4952, FAX: 214–253–4970, email: oraswrsbr@ora.fda.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of September 21, 2005 

(70 FR 55405), FDA announced that a 

public workshop entitled ‘‘Industry 

Exchange Workshop on Food and Drug 

Administration Clinical Trial 

Requirements’’ would be held on 

Wednesday, February 8, 2006. On page 

55405, in the first column, the Location 

portion of the document is amended to 

read as follows: 

Location: The public workshop will 

be held at the Renaissance Houston 

Hotel Greenway Plaza, 6 Greenway 

Plaza East, Houston, TX 77046, 713–

629–1200, FAX: 713–629–4702. 

Dated: November 30, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–23675 Filed 12–6–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Risk Management, Corrective and 

Preventive Actions, and Training: An 

Educational Forum; Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

SUMMARY: The Food and Drug 

Administration (FDA), Office of 

Regulatory Affairs, Southwest Region, 

Dallas District Office, in collaboration 

with the FDA Medical Device Industry 

Coalition (FMDIC) is announcing a 

public workshop entitled ‘‘Risk 

Management, Corrective and Preventive 

Actions, and Training: An Educational 

Forum.’’ This public workshop is 

intended to provide information about 

FDA’s medical device quality systems 

regulation (QSR) to regulated industry, 

particularly small businesses. 

Date and Time: The public workshop 

will be held on April 28, 2006, from 8 

a.m. to 5 p.m. 

Location: The public workshop will 

be held at The Westin City Center, 650 

North Pearl St., Dallas, TX 75201. 

Directions to the facility are available at 

the FMDIC Web site at http:// 

www.fmdic.org/. 

Contact Person: David Arvelo or 

Cassandra Davis, Food and Drug 

Administration, 4040 North Central 

Expressway, suite 900, Dallas, TX 

75204, 214–253–4952 or 214–253–4951, 

FAX: 214–253–4970, e-mail 

oraswrsbr@ora.fda.gov. 

Registration: FMDIC has a $150 early 

registration fee. Early registration begins 

on February 1, 2006, and ends April 14, 

2006. Registration is $175 from April 15, 

2006, to April 28, 2006. To register 

online, please visit http:// 

www.fmdic.org/. As an alternative, you 

may send registration information 

including name, title, firm name, 

address, telephone and fax numbers, 

and e-mail, along with a check or money 

order for the appropriate amount 

payable to the FMDIC, to Dr. William 

Hyman, Texas A&M University, 

Department of Biomedical Engineering, 

3120 TAMU, College Station, TX 

75843–3120. Course space will be filled 

in order of receipt of registration with 

appropriate fees. Seats are limited; 

please submit registration form as soon 

as possible. Those accepted into the 

course will receive confirmation. 

Registration will close after the course is 

filled. Registration at the site will be 

done on a space-available basis on the 

day of the public workshop beginning at 

8 a.m. The cost of registration at the site 

is $175 payable to the FMDIC. The 

registration fee will be used to offset 

expenses of hosting the conference, 

including meals, refreshments, meeting 

rooms, and materials. 

If you need special accommodations 

due to a disability, please contact David 

Arvelo or Cassandra Davis at least 7 

days in advance. 

SUPPLEMENTARY INFORMATION: The 

workshop is being held in response to 

the interest in the topics discussed from 

small medical device manufacturers in 

the Dallas District area. FMDIC and FDA 

present this workshop to help achieve 

objectives set forth in section 406 of the 

Food and Drug Administration 

Modernization Act of 1997 (21 U.S.C. 

393), which include working closely 

with stakeholders and maximizing the 

availability and clarity of information to 

stakeholders and the public. This is also 

consistent with the purposes of FDA’s 

Regional Small Business Program, 

which are, in part, to respond to 

industry inquiries, develop educational 

materials, and sponsor workshops and 

conferences to provide firms, 

particularly small businesses, with 

firsthand working knowledge of FDA’s 

requirements and compliance policies. 

This workshop is also consistent with 

the Small Business Regulatory 

Enforcement Fairness Act of 1996 

(Public Law 104–121), as an outreach 

activity by Government agencies to 

small businesses. 

The goal of the workshop is to present 

information that will enable 

manufacturers and regulated industry to 

better comply with the medical device 

QSR. The following topics will be 

discussed at the workshop: (1) Overview 

of the International Organization for 

Standardization (ISO) standard EN 

14971, and residual risk, (2) 

incorporating risk management 

throughout the product lifecycle, (3) 

overview of a closed-loop corrective and 

preventive action (CAPA) system, (4) 

CAPA effectiveness, (5) overview of a 

training program, and (6) training 

program effectiveness. 

Transcripts: Transcripts of the public 

workshop will not be available due to 

the format of this workshop. Course 

handouts may be requested in writing 

from the Freedom of Information Office 

(HFI–35), Food and Drug 

Administration, 5600 Fishers Lane, rm. 

12A–16, Rockville, MD 20857, 

approximately 15 working days after the 

public workshop at a cost of 10 cents 

per page.