33452 Federal Register / Vol. 74, No. 132 / Monday, July 13, 2009 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Orthopaedic and Rehabilitation 

Devices Panel of the Medical Devices 

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: Orthopaedic and 

Rehabilitation Devices Panel of the 

Medical Devices 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 August 18 and 19, 2009, from 

8 a.m. to 5 p.m. 

Location: Hilton Washington DC 

North/Gaithersburg, Salons A, B and C, 

620 Perry Pkwy., Gaithersburg, MD. 

Contact Person: Ronald P. Jean, 

Center for Devices and Radiological 

Health (HFZ–410), Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD, 20850, 240–276–3676, or 

FDA Advisory Committee Information 

Line, 1–800–741–8138 (301–443–0572 

in the Washington, DC area), code 

3014512521. Please call the Information 

Line for up-to-date information on this 

meeting. A notice in the Federal 

Register about last minute modifications 

that impact a previously announced 

advisory committee meeting cannot 

always be published quickly enough to 

provide timely notice. Therefore, you 

should always check the agency’s Web 

site and call the appropriate advisory 

committee hot line/phone line to learn 

about possible modifications before 

coming to the meeting. 

Agenda: On August 18, 2009, the 

committee will discuss, make 

recommendations and vote on a 

premarket approval application (PMA) 

for the CoMplete Acetabular Hip 

System, sponsored by DePuy 

Orthopaedics. This device system is 

intended for use as a primary joint 

replacement prosthesis in total hip 

arthroplasty, and is indicated for 

skeletally mature patients suffering 

severe pain and disability due to 

structural damage in the hip joint from 

non-inflammatory degenerative joint 

disease and its composite diagnoses of 

osteoarthritis or post-traumatic arthritis. 

On August 19, 2009, the committee will 

discuss, make recommendations and 

vote on a PMA for Durolane, sponsored 

by Q–Med AB. This device is indicated 

for the treatment of pain caused by 

osteoarthritis of the knee in patients 

who have failed to respond adequately 

to conservative non-pharmacological 

therapy and simple analgesics, e.g., 

acetaminophen. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm, click on the year 2009 and 

scroll down to the appropriate advisory 

committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before August 4, 2009. Oral 

presentations from the public will be 

scheduled at approximately 1 p.m., 

immediately following lunch on both 

days. Those desiring to make formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before July 27, 

2009. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by July 28, 2009. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Ann Marie 

Williams, Conference Management 

Staff, 301–796–5966, at least 7 days in 

advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/ 

AdvisoryCommittee/ 

AboutAdvisoryCommittee/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: July 1, 2009. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E9–16409 Filed 7–10–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Environmental 

Health Sciences; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting 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: National Institute of 

Environmental Health Sciences Special 

Emphasis Panel; ARRA Stem Cell 

Competitive Supplement Review. 

Date: July 27, 2009. 

Time: 2 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Nat. Inst. of Environmental Health 

Sciences, Building 101, Rodbell Auditorium, 

111 T. W. Alexander Drive, Research 

Triangle Park, NC 27709 (Telephone 

Conference Call). 

Contact Person: Sally Eckert-Tilotta, PhD, 

Scientific Review Administrator, Nat. 

Institute of Environmental Health Sciences, 

Office of Program Operations, Scientific 

Review Branch, P.O. Box 12233, Research 

Triangle Park, NC 27709. (919) 541–1446. 

Eckertt1@niehs.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.115, Biometry and Risk 

Estimation—Health Risks from 

Environmental Exposures; 93.142, NIEHS 

Hazardous Waste Worker Health and Safety 

Training; 93.143, NIEHS Superfund 

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