Federal Register / Vol. 70, No. 234 / Wednesday, December 7, 2005 / Notices 72843 

new facilities; (2) develops project 

management requirements (including 

determination of methods, means of 

project completion, and selection of 

resources); (3) provides critical path 

method scheduling support for all large 

capital construction projects and all 

repair and improvements (R&I) projects; 

and (4) provides central cost estimating 

support for all large capital construction 

projects, all R&I projects, special 

projects, feasibility studies, as 

requested, and certain work orders, as 

requested. 

Design Engineering Management 

Office (CAJCC). (1) Prepares 

architectural and engineering designs, 

and specifications for construction of 

modifications and renovations to CDCowned facilities; (2) provides 

architectural and engineering technical 

expertise and is the technical authority 

on new facilities, and modifications and 

renovations on facility project designs; 

(3) provides furniture, fixture, and 

equipment designs, and project 

management services for all CDC 

facilities; (4) provides record and 

guideline document support services to 

all BFO offices; and (5) maintains CDC 

Design Standards and Guidelines for use 

as basis of design for construction of 

new facilities, and modifications and 

renovations in CDC-owned facilities. 

Facilities Maintenance & Engineering 

Office (CAJCD). (1) Operates, maintains, 

repairs, and modifies CDC’s Atlanta area 

plant facilities and other designated 

CDC facilities throughout the United 

States (US) and Puerto Rico (PR), and 

conducts a maintenance and repair 

program for CDC’s program support 

equipment; (2) develops services for 

new, improved, and modified 

equipment to meet program needs; (3) 

provides technical assistance, reviews 

maintenance and operation programs, 

and recommends appropriate action for 

all Atlanta area facilities and other 

designated CDC facilities throughout the 

US and PR; (4) provides 

recommendations, priorities, and 

services for new, improved, or modified 

equipment to meet program needs; (5) 

provides maintenance and operation of 

the central energy plant including 

structures, utilities production and 

distribution systems, and equipment; (6) 

conducts a program of custodial 

services, waste disposal, incinerations, 

disposal of biological waste, and other 

building services at all CDC Atlanta area 

facilities and other designated CDC 

facilities throughout the US and PR; (7) 

provides landscape development, 

repair, and maintenance at all CDC 

Atlanta area facilities and other 

designated CDC facilities throughout the 

US and PR; (8) provides hauling and 

moving services for CDC in the Atlanta 

area; (9) provides an Integrated Pest 

Management Program to control insect 

and rodents for CDC in Atlanta area 

facilities; (10) develops required 

contractual services and provides 

supervision for work performed in these 

areas; (11) establishes and maintains a 

computerized system for maintenance 

services, for stocking and ordering 

supplies, and replacement parts; (12) 

provides for pick-up and delivery of 

supplies and replacement parts; to work 

sites; (13) maintains adequate stock 

levels of supplies and replacement 

parts; (14) as needed, prepares designs 

and contract specifications, and 

coordinates completion of contract 

maintenance projects; (15) manages 

CDC’s Energy Conservation Program for 

all CDC facilities; (16) reviews all 

construction documents for energy 

conservation goals and compliance with 

applicable CDC construction standards; 

(17) participates on all core teams and 

VE teams; (18) provides maintenance 

and inspection for fire extinguishers and 

fire sprinkler systems; (19) provides 

services for the procurement of natural 

gas; (20) develops and maintains a 

standard equipment list for all CDC 

facilities; (21) assists the Design 

Engineering Management Office and the 

Capital Improvements Management 

Office with facility-related issues; (22) 

provides building coordinators to 

interface with program personnel and 

all work to keep the building and 

equipment functioning; and (23) 

responsible for new building 

commissioning. 

Real Property Management Office 

(CAJCE). (1) Conducts the real estate 

activities throughout CDC, including the 

acquisition of leased space, the 

purchase and disposal of real property 

for CDC nationwide (with emphasis on 

current and long-range planning for 

utilization of existing and future real 

property resources); (2) responsible for 

space assignment and utilization of all 

CDC space, both owned and leased, 

nationwide; (3) provides technical 

assistance in space planning to meet 

programmatic needs; (4) responsible for 

executing all easements for owned 

property; (5) administers day-to-day 

management of leased facilities and 

ensures contract compliance by lessors; 

(6) provides technical assistance and 

prepares contract specifications for all 

repair and improvement projects in 

leased space; (7) maintains liaison with 

the General Services Administration 

Regional Offices; (8) performs all 

functions relating to leasing and/or 

acquisition of real property under CDC 

delegation of authority for leasing, 

including direct lease actions; and (9) 

coordinates the relocation of CDC 

personnel within owned and leased 

space. 

Dated: November 28, 2005. 

William H. Gimson, 

Chief Operating Officer, Centers for Disease 

Control and Prevention (CDC). 

[FR Doc. 05–23689 Filed 12–6–05; 8:45 am] 

BILLING CODE 4160–18–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2004N–0535] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

MedWatch: Food and Drug 

Administration Medical Products 

Reporting Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘MedWatch: Food and Drug 

Administration Medical Products 

Reporting Program’’ has been approved 

by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Karen Nelson, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1482. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of December 27, 2004 

(69 FR 77256), the agency announced 

that the proposed information collection 

had been submitted to OMB for review 

and clearance under 44 U.S.C. 3507. An 

agency may not conduct or sponsor, and 

a person is not required to respond to, 

a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0291. 

As requested by the agency, in 

addition to the approval of the revised 

forms, the existing forms are approved 

for continued use for the next 12 

months to allow for the industry to 

make necessary changes to their 

computerized systems. 

The approval expires on October 31, 

2008. A copy of the supporting 

statement for this information collection 

is available on the Internet at http:// 

www.fda.gov/ohrms/dockets. 

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.