54560 Federal Register / Vol. 70, No. 178 / Thursday, September 15, 2005 / Notices 

Administration, 9200 Corporate Blvd., 

Rockville, MD 20850, 301–827–5283, 

ext. 123, e-mail: mea@cdrh.fda.gov, or 

FDA Advisory Committee Information 

Line, 1–800–741–8138 (301–443–0572 

in the Washington, DC area), code 

3014512518. Please call the Information 

Line for up-to-date information on this 

meeting. 

Agenda: On October 11, 2005, the 

committee will hear a presentation on 

the FDA Critical Path Initiative and a 

presentation by the Office of 

Surveillance and Biometrics in the 

Center for Devices and Radiological 

Health outlining their responsibility for 

the review of postmarket study design. 

Subsequently, on October 11 and 12, 

2005, the committee will discuss and 

make recommendations on the 

classification of the following 

unclassified dental devices: 

• Root canal cleanser, product code 

KJJ, intended to cleanse a root canal 

after endodontic instrumentation; 

• Retraction cord, product code 

MVL, intended for temporary retraction 

and hemostasis of the gingival margin; 

• Root apex locator, product code 

LQY, intended to measure the length of 

the root canal; 

• Dental mouthguards, product code 

MQC, intended to provide protection 

against bruxism, teeth clenching, and 

grinding; 

• Artificial saliva, product code LFD, 

intended for the relief of chronic and 

temporary xerostomia; 

• Oral wound dressing, product code 

MGQ, intended to provide pain relief 

from aphthous ulcers, canker sores, and 

minor oral lesions; and 

• Electrical anesthesia, product code 

LWM, intended, through the application 

of electrical current, to provide 

analgesia or anesthesia during dental 

procedures. 

Also, on October 12, 2005, the 

committee will discuss and make 

recommendations regarding the overthe-counter (OTC) use of dental 

mouthguards.Background information 

for the topics, including the agenda and 

questions for the committee, will be 

available to the public 1 business day 

before the meeting on the Internet at 

http://www.fda.gov/cdrh/ 

panelmtg.html. More information 

regarding product code classification 

can be accessed by visiting http:// 

www.accessdata.fda.gov/scripts/cdrh/ 

cfdocs/cfPCD/classification.cfm or by 

contact person. Material for the October 

11 and 12 sessions will be posted on 

October 7, 2005. 

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 by October 3, 2005. On October 

11, 2005 and October 12, 2005, oral 

presentations from the public will be 

scheduled for approximately 30 minutes 

at the beginning of committee 

deliberations and for approximately 30 

minutes near the end of the 

deliberations. Time allotted for each 

presentation may be limited. Those 

desiring to make formal oral 

presentations should notify the contact 

person before October 3, 2005, 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. 

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 AnnMarie 

Williams, Conference Management 

Staff, 301–594–1283, ext. 113, at least 7 

days in advance of the meeting. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: September 6, 2005. 

Scott Gottlieb, 

Deputy Commissioner for Policy. 

[FR Doc. 05–18363 Filed 9–14–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Nonprescription 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). At least one portion of the 

meeting will be closed to the public. 

Name of Committee: Nonprescription 

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 20, 2005, from 8 a.m. 

to 5:30 p.m., and on October 21, 2005, 

from 8 a.m. to 12 noon. 

Location: Holiday Inn Washington 

Silver Spring, The Ballrooms, 8777 

Georgia Ave., Silver Spring, MD. The 

hotel telephone number is 301–589–

0800. 

Contact Person: Darrell Lyons, Center 

for Drug Evaluation and Research (HFD–

021), Food and Drug Administration, 

5600 Fishers Lane (for express delivery, 

5630 Fishers Lane, rm. 1093), Rockville, 

MD 20857, 301–827–6760, FAX: 301–

827–6778, e-mail: lyonsd@cder.fda.gov, 

or FDA Advisory Committee 

Information Line, 1–800–741–8138 

(301–443–0572 in the Washington, DC 

area), code 3014512541. Please call the 

Information Line for up-to-date 

information on this meeting. 

Agenda: The committee will discuss 

the benefits and risks of antiseptic 

products marketed for consumer use 

(e.g., antibacterial hand-washes and 

body-washes). The discussion will 

include topics such as the efficacy of 

antiseptics intended for use by 

consumers and potential risks to the 

individual and the general population 

from using these products. The 

background material will become 

available no later than the day before 

the meeting and will be posted under 

the Nonprescription Drugs Advisory 

Committee (NDAC) on FDA’s Web site 

at http://www.fda.gov/ohrms/dockets/ 

ac/acmenu.htm. (Click on the year 2005 

and scroll down to NDAC). 

Procedure: On October 20, 2005, from 

8 a.m. to 5:30 p.m., the meeting is open 

to the public. 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 by October 13, 2005. Oral 

presentations from the public will be 

scheduled between approximately 1 

p.m. and 2 p.m. on October 20, 2005. 

Time allotted for each presentation may 

be limited. Those desiring to make 

formal oral presentations should notify 

the contact person before October 13, 

2005, 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. 

Closed Committee Deliberations: On 

October 21, 2005, from 8 a.m. to 12 

noon, the meeting will be closed to 

permit discussion and review of trade 

secret and/or confidential information 

(5 U.S.C. 552b(c)(4)). 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Federal Register / Vol. 70, No. 178 / Thursday, September 15, 2005 / Notices 54561 

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 LaNise Giles 

at 301–827–7001, at least 7 days in 

advance of the meeting. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: September 8, 2005. 

Scott Gottlieb, 

Deputy Commissioner for Policy. 

[FR Doc. 05–18366 Filed 9–14–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Pediatric Oncology Subcommittee of 

the Oncologic 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: Pediatric 

Oncology Subcommittee of the 

Oncologic 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 20, 2005, from 8 a.m. 

to 5 p.m. 

Location: Food and Drug 

Administration, Center for Drug 

Evaluation and Research (CDER), 

Advisory Committee Conference Room, 

rm. 1066, 5630 Fishers Lane, Rockville, 

MD. 

Contact Person: Victoria FerrettiAceto, 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: 

ferrettiv@cder.fda.gov, or FDA Advisory 

Committee Information Line, 1–800–

741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512542. Please call the Information 

Line for up-to-date information on this 

meeting. 

Agenda: The subcommittee will do 

the following: (1) Present the structure 

and function of the Office of Oncology 

Drug Products in CDER, (2) discuss 

issues involved with the conduct of 

certain pediatric postmarketing studies 

for products approved for oncologic 

indications, (3) review status of studies 

for specific off-patent drugs for pediatric 

oncology, and (4) consider other offpatent oncology drugs for which 

pediatric studies are needed, as 

mandated by the Best Pharmaceuticals 

for Children Act. When available, 

background materials for this meeting 

will be posted 1 business day before the 

meeting on FDA’s Web site at http:// 

www.fda.gov/ohrms/dockets/ac/ 

acmenu.htm. (Click on the year 2005 

and scroll down to Oncologic Drugs 

Advisory Committee; Pediatric 

Subcommittee.) 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the subcommittee. Written 

submissions may be made to the contact 

person by October 13, 2005. Oral 

presentations from the public will be 

scheduled between approximately 11:45 

a.m. and 12:15 p.m., and between 

approximately 3 p.m. and 3:30 p.m. 

Time allotted for each presentation may 

be limited. Those desiring to make 

formal oral presentations should notify 

the contact person before October 13, 

2005, 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. 

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 Victoria 

Ferretti-Aceto at least 7 days in advance 

of the meeting. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: September 6, 2005. 

Scott Gottlieb, 

Deputy Commissioner for Policy. 

[FR Doc. 05–18330 Filed 9–14–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005D–0348] 

Draft Guidance for Industry and Food 

and Drug Administration Staff; 

Procedures for Handling PostApproval Studies Imposed by 

Premarket Approval Application Order; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance 

entitled ‘‘Procedures for Handling PostApproval Studies Imposed by PMA 

Order.’’ The draft guidance is designed 

to assist the Center for Devices and 

Radiological Health (CDRH) and 

sponsors to meet their responsibilities to 

track post-approval studies (sometimes 

called Condition of Approval Studies) 

that are mandated for market approval 

of medical devices. 

DATES: Submit written or electronic 

comments on this draft guidance by 

November 14, 2005. 

ADDRESSES: Submit written requests for 

single copies on a 3.5′′ diskette of the 

draft guidance document entitled 

‘‘Procedures for Handling Post-Approval 

Studies Imposed by PMA Order’’ to the 

Division of Small Manufacturers, 

International, and Consumer Assistance 

(HFZ–220), Center for Devices and 

Radiological Health, Food and Drug 

Administration, 1350 Piccard Dr., 

Rockville, MD 20850. Send one selfaddressed adhesive label to assist that 

office in processing your request, or fax 

your request to 301–443–8818. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

draft guidance. 

Submit written comments concerning 

this draft guidance to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Submit electronic comments to http:// 

www.fda.gov/dockets/ecomments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Steven H. Chasin, Office of Surveillance 

and Biometrics, Division of Postmarket 

Surveillance, Center for Devices and 

Radiological Health (HFZ–500), Food 

and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

301–594–3674