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54560 Federal Register / Vol. 70, No.

178 / Thursday, September 15, 2005 / Notices

Administration, 9200 Corporate Blvd., submissions may be made to the contact to 5:30 p.m., and on October 21, 2005,
Rockville, MD 20850, 301–827–5283, person by October 3, 2005. On October from 8 a.m. to 12 noon.
ext. 123, e-mail: mea@cdrh.fda.gov, or 11, 2005 and October 12, 2005, oral Location: Holiday Inn Washington
FDA Advisory Committee Information presentations from the public will be Silver Spring, The Ballrooms, 8777
Line, 1–800–741–8138 (301–443–0572 scheduled for approximately 30 minutes Georgia Ave., Silver Spring, MD. The
in the Washington, DC area), code at the beginning of committee hotel telephone number is 301–589–
3014512518. Please call the Information deliberations and for approximately 30 0800.
Line for up-to-date information on this minutes near the end of the Contact Person: Darrell Lyons, Center
meeting. deliberations. Time allotted for each for Drug Evaluation and Research (HFD–
Agenda: On October 11, 2005, the presentation may be limited. Those 021), Food and Drug Administration,
committee will hear a presentation on desiring to make formal oral 5600 Fishers Lane (for express delivery,
the FDA Critical Path Initiative and a presentations should notify the contact 5630 Fishers Lane, rm. 1093), Rockville,
presentation by the Office of person before October 3, 2005, and MD 20857, 301–827–6760, FAX: 301–
Surveillance and Biometrics in the submit a brief statement of the general 827–6778, e-mail: lyonsd@cder.fda.gov,
Center for Devices and Radiological nature of the evidence or arguments or FDA Advisory Committee
Health outlining their responsibility for they wish to present, the names and Information Line, 1–800–741–8138
the review of postmarket study design. addresses of proposed participants, and (301–443–0572 in the Washington, DC
Subsequently, on October 11 and 12, an indication of the approximate time area), code 3014512541. Please call the
2005, the committee will discuss and requested to make their presentation. Information Line for up-to-date
make recommendations on the Persons attending FDA’s advisory information on this meeting.
classification of the following committee meetings are advised that the Agenda: The committee will discuss
unclassified dental devices: agency is not responsible for providing the benefits and risks of antiseptic
• Root canal cleanser, product code access to electrical outlets. products marketed for consumer use
KJJ, intended to cleanse a root canal FDA welcomes the attendance of the (e.g., antibacterial hand-washes and
after endodontic instrumentation; public at its advisory committee body-washes). The discussion will
• Retraction cord, product code meetings and will make every effort to include topics such as the efficacy of
MVL, intended for temporary retraction accommodate persons with physical antiseptics intended for use by
and hemostasis of the gingival margin; disabilities or special needs. If you consumers and potential risks to the
• Root apex locator, product code require special accommodations due to individual and the general population
LQY, intended to measure the length of a disability, please contact AnnMarie from using these products. The
the root canal; Williams, Conference Management background material will become
• Dental mouthguards, product code
Staff, 301–594–1283, ext. 113, at least 7 available no later than the day before
MQC, intended to provide protection
days in advance of the meeting. the meeting and will be posted under
against bruxism, teeth clenching, and
Notice of this meeting is given under the Nonprescription Drugs Advisory
grinding;
• Artificial saliva, product code LFD, the Federal Advisory Committee Act (5 Committee (NDAC) on FDA’s Web site
intended for the relief of chronic and U.S.C. app. 2). at http://www.fda.gov/ohrms/dockets/
temporary xerostomia; Dated: September 6, 2005. ac/acmenu.htm. (Click on the year 2005
• Oral wound dressing, product code and scroll down to NDAC).
Scott Gottlieb,
MGQ, intended to provide pain relief Procedure: On October 20, 2005, from
Deputy Commissioner for Policy.
from aphthous ulcers, canker sores, and 8 a.m. to 5:30 p.m., the meeting is open
[FR Doc. 05–18363 Filed 9–14–05; 8:45 am] to the public. Interested persons may
minor oral lesions; and BILLING CODE 4160–01–S
• Electrical anesthesia, product code present data, information, or views,
LWM, intended, through the application orally or in writing, on issues pending
of electrical current, to provide before the committee. Written
DEPARTMENT OF HEALTH AND submissions may be made to the contact
analgesia or anesthesia during dental HUMAN SERVICES
procedures. person by October 13, 2005. Oral
Also, on October 12, 2005, the Food and Drug Administration presentations from the public will be
committee will discuss and make scheduled between approximately 1
recommendations regarding the over- Nonprescription Drugs Advisory p.m. and 2 p.m. on October 20, 2005.
the-counter (OTC) use of dental Committee; Notice of Meeting Time allotted for each presentation may
mouthguards.Background information be limited. Those desiring to make
for the topics, including the agenda and AGENCY: Food and Drug Administration, formal oral presentations should notify
questions for the committee, will be HHS. the contact person before October 13,
available to the public 1 business day ACTION: Notice. 2005, and submit a brief statement of
before the meeting on the Internet at the general nature of the evidence or
http://www.fda.gov/cdrh/ This notice announces a forthcoming arguments they wish to present, the
panelmtg.html. More information meeting of a public advisory committee names and addresses of proposed
regarding product code classification of the Food and Drug Administration participants, and an indication of the
can be accessed by visiting http:// (FDA). At least one portion of the approximate time requested to make
www.accessdata.fda.gov/scripts/cdrh/ meeting will be closed to the public. their presentation.
cfdocs/cfPCD/classification.cfm or by Name of Committee: Nonprescription Closed Committee Deliberations: On
contact person. Material for the October Drugs Advisory Committee. October 21, 2005, from 8 a.m. to 12
11 and 12 sessions will be posted on General Function of the Committee: noon, the meeting will be closed to
October 7, 2005. To provide advice and permit discussion and review of trade
Procedure: Interested persons may recommendations to the agency on secret and/or confidential information
present data, information, or views, FDA’s regulatory issues. (5 U.S.C. 552b(c)(4)).
orally or in writing, on issues pending Date and Time: The meeting will be Persons attending FDA’s advisory
before the committee. Written held on October 20, 2005, from 8 a.m. committee meetings are advised that the

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

agency is not responsible for providing Agenda: The subcommittee will do DEPARTMENT OF HEALTH AND
access to electrical outlets. the following: (1) Present the structure HUMAN SERVICES
FDA welcomes the attendance of the and function of the Office of Oncology
public at its advisory committee Drug Products in CDER, (2) discuss Food and Drug Administration
meetings and will make every effort to issues involved with the conduct of [Docket No. 2005D–0348]
accommodate persons with physical certain pediatric postmarketing studies
disabilities or special needs. If you for products approved for oncologic Draft Guidance for Industry and Food
require special accommodations due to indications, (3) review status of studies and Drug Administration Staff;
a disability, please contact LaNise Giles for specific off-patent drugs for pediatric Procedures for Handling Post-
at 301–827–7001, at least 7 days in oncology, and (4) consider other off- Approval Studies Imposed by
advance of the meeting. Premarket Approval Application Order;
patent oncology drugs for which
Notice of this meeting is given under Availability
pediatric studies are needed, as
the Federal Advisory Committee Act (5
U.S.C. app. 2). mandated by the Best Pharmaceuticals AGENCY: Food and Drug Administration,
for Children Act. When available, HHS.
Dated: September 8, 2005. background materials for this meeting
Scott Gottlieb, ACTION: Notice.
will be posted 1 business day before the
Deputy Commissioner for Policy. meeting on FDA’s Web site at http:// SUMMARY: The Food and Drug
[FR Doc. 05–18366 Filed 9–14–05; 8:45 am] www.fda.gov/ohrms/dockets/ac/ Administration (FDA) is announcing the
BILLING CODE 4160–01–S acmenu.htm. (Click on the year 2005 availability of the draft guidance
and scroll down to Oncologic Drugs entitled ‘‘Procedures for Handling Post-
Advisory Committee; Pediatric Approval Studies Imposed by PMA
DEPARTMENT OF HEALTH AND Subcommittee.) Order.’’ The draft guidance is designed
HUMAN SERVICES to assist the Center for Devices and
Procedure: Interested persons may
Radiological Health (CDRH) and
Food and Drug Administration present data, information, or views, sponsors to meet their responsibilities to
orally or in writing, on issues pending track post-approval studies (sometimes
Pediatric Oncology Subcommittee of before the subcommittee. Written
the Oncologic Drugs Advisory called Condition of Approval Studies)
submissions may be made to the contact that are mandated for market approval
Committee; Notice of Meeting person by October 13, 2005. Oral of medical devices.
AGENCY: Food and Drug Administration, presentations from the public will be DATES: Submit written or electronic
HHS. scheduled between approximately 11:45 comments on this draft guidance by
ACTION: Notice. a.m. and 12:15 p.m., and between November 14, 2005.
approximately 3 p.m. and 3:30 p.m.
ADDRESSES: Submit written requests for
This notice announces a forthcoming Time allotted for each presentation may
meeting of a public advisory committee single copies on a 3.5′′ diskette of the
be limited. Those desiring to make
of the Food and Drug Administration draft guidance document entitled
formal oral presentations should notify ‘‘Procedures for Handling Post-Approval
(FDA). The meeting will be open to the the contact person before October 13,
public. Studies Imposed by PMA Order’’ to the
2005, and submit a brief statement of Division of Small Manufacturers,
Name of Committee: Pediatric the general nature of the evidence or
Oncology Subcommittee of the International, and Consumer Assistance
arguments they wish to present, the (HFZ–220), Center for Devices and
Oncologic Drugs Advisory Committee. names and addresses of proposed
General Function of the Committee: Radiological Health, Food and Drug
participants, and an indication of the Administration, 1350 Piccard Dr.,
To provide advice and
approximate time requested to make Rockville, MD 20850. Send one self-
recommendations to the agency on
their presentation. addressed adhesive label to assist that
FDA’s regulatory issues.
Date and Time: The meeting will be Persons attending FDA’s advisory office in processing your request, or fax
held on October 20, 2005, from 8 a.m. committee meetings are advised that the your request to 301–443–8818. See the
to 5 p.m. agency is not responsible for providing SUPPLEMENTARY INFORMATION section for
Location: Food and Drug access to electrical outlets. information on electronic access to the
Administration, Center for Drug draft guidance.
FDA welcomes the attendance of the Submit written comments concerning
Evaluation and Research (CDER), public at its advisory committee
Advisory Committee Conference Room, this draft guidance to the Division of
meetings and will make every effort to Dockets Management (HFA–305), Food
rm. 1066, 5630 Fishers Lane, Rockville, accommodate persons with physical
MD. and Drug Administration, 5630 Fishers
disabilities or special needs. If you Lane, rm. 1061, Rockville, MD 20852.
Contact Person: Victoria Ferretti-
require special accommodations due to Submit electronic comments to http://
Aceto, Center for Drug Evaluation and
a disability, please contact Victoria www.fda.gov/dockets/ecomments.
Research (HFD–21), Food and Drug
Administration, 5600 Fishers Lane, (for Ferretti-Aceto at least 7 days in advance Identify comments with the docket
express delivery, 5630 Fishers Lane, rm. of the meeting. number found in brackets in the
1093), Rockville, MD 20857, 301–827– Notice of this meeting is given under heading of this document.
7001, FAX: 301–827–6776, e-mail: the Federal Advisory Committee Act (5 FOR FURTHER INFORMATION CONTACT:
ferrettiv@cder.fda.gov, or FDA Advisory U.S.C. app. 2). Steven H. Chasin, Office of Surveillance
Committee Information Line, 1–800– Dated: September 6, 2005. and Biometrics, Division of Postmarket
741–8138 (301–443–0572 in the Surveillance, Center for Devices and
Scott Gottlieb,
Washington, DC area), code Radiological Health (HFZ–500), Food
3014512542. Please call the Information Deputy Commissioner for Policy. and Drug Administration, 9200
Line for up-to-date information on this [FR Doc. 05–18330 Filed 9–14–05; 8:45 am] Corporate Blvd., Rockville, MD 20850,
meeting. BILLING CODE 4160–01–S 301–594–3674

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