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