61136 Federal Register / Vol. 73, No. 200 / Wednesday, October 15, 2008 / Notices 

∑The rate and extent of BPA release 

from devices under clinically 

relevant extraction conditions. 

∑ What conditions affect the release 

and leaching of BPA? 

∑ Estimates of patient exposure to 

BPA from use of the device. 

FDA is interested in possible 

alternatives to BPA. 

∑ Are you aware of available 

alternatives to the use of BPA in 

certain medical devices? Provide 

information concerning the 

alternative material and any 

associated risks. 

FDA is interested in receiving 

information concerning devices that 

have been shown to release BPA, 

including cardiopulmonary bypass 

circuits, hemodialysis circuits and 

certain dental devices. For these devices 

provide the following information: 

∑ Describe the device type and 

intended use. 

∑ Describe how the device directly or 

indirectly contacts a patient. 

∑ Describe whether, and how, the 

device is used in pediatric patients, 

and describe the pediatric 

population by age and gender. 

∑ Identify and attach any study reports 

related to BPA release from this 

device type. 

B. Human-Use Biological Products and 

Drugs (Including Protein Drugs) 

For products that are: (1) Formulated 

with BPA-containing components or (2) 

liquid-based dosage forms [including 

solutions, suspensions, semisolids 

(cream, lotion, ointment, foam, gel etc.)] 

and packaged in plastic containers or in 

metal canisters with plastic lining or 

coating (e.g., epoxy) if either the 

container or the coating have been made 

by using BPA, please provide the 

following information: 

∑ NDA/ANDA/BLA number. 

∑ Drug product name, dosage form 

and route of administration. 

∑Components and composition of the 

formulation. 

∑Container closure system (CCS) and 

components in direct contact with 

the formulation. 

∑ Drug Master File number(s) for the 

CCS, if applicable. 

∑ Levels of BPA found either as an 

extractable (in model solvents from 

the CCS) or a leachable (in the 

formulation) through expiry, if 

known. 

∑ Identify the analytical method(s) for 

quantitation of BPA. 

∑ Acceptance criteria either as an 

extractable or leachable, if 

established. 

Please also provide summary reports 

from any studies that you may have 

performed to evaluate the toxicity and 

to justify the safety of BPA in these 

products. 

C. Other FDA-Regulated Products 

We are also soliciting any relevant 

information on the use of, and potential 

exposure to, BPA from any other FDAregulated products, including cosmetics, 

that have not been discussed in the 

above paragraphs. 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments and information. Submit a 

single copy of electronic comments and 

information or two paper copies of any 

mailed comments and information, 

except that individuals may submit one 

paper copy. Comments and information 

are to be identified with the name of the 

technology and the docket number 

found in brackets in the heading of this 

document. A copy of this notice and 

received comments may be seen in the 

Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

Dated: October 3, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–24506 Filed 10–14–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0038] 

Anti-Infective 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: Anti-Infective 

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 November 18, 2008, from 8 a.m. 

to 5 p.m., November 19, 2008, from 8 

a.m. to 5:30 p.m. and on November 20, 

2008, from 8 a.m. to 12 noon. 

Location: Holiday Inn/College Park, 

The Ballroom, 10000 Baltimore Ave., 

College Park, MD. The hotel telephone 

number is 301–345–6700. 

Contact Person: Janie Kim, 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: 

janie.kim@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138(301–443–0572 in the 

Washington, DC area), code 

3014512530. 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 November 18, 2008, the 

committee will discuss the justification 

of the non-inferiority margin for 

complicated skin and skin structure 

infections. On November 19, 2008, the 

committee will discuss: (1) New drug 

application (NDA) 022–110, telavancin 

powder for reconstitution and 

intravenous administration, Theravance, 

Inc., proposed for the treatment of 

complicated skin and skin structure 

infection, and (2) NDA 022–153, 

oritavancin, Targanta Therapeutics 

Corp., proposed for the treatment of 

complicated skin and skin structure 

infection. On November 20, 2008, the 

committee will discuss NDA 022–269, 

iclaprim, Arpida AG, proposed for the 

treatment of complicated skin and skin 

structure infection. 

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/ohrms/ 

dockets/ac/acmenu.htm, click on the 

year 2008 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 November 4, 2008. 

Oral presentations from the public will 

be scheduled between approximately 1 

p.m. to 1:15 p.m. on November 18, 2008, 

between approximately 11:30 a.m. to 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 200 / Wednesday, October 15, 2008 / Notices 61137 

11:45 a.m. and 4:15 p.m. to 4:30 p.m. on 

November 19, 2008, and between 

approximately 10:15 a.m. to 10:30 a.m. 

on November 20, 2008. 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 October 24, 2008. 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 

October 28, 2008. 

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 Janie Kim 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/oc/advisory/ 

default.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: October 6, 2008. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E8–24354 Filed 10–14–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0038] 

Arthritis 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: Arthritis 

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 November 24, 2008, from 8:30 

a.m. to 4:30 p.m. 

Location: Hilton Washington DC/ 

Silver Spring, The Ballrooms, 8727 

Colesville Rd., Silver Spring, MD. The 

hotel phone number is 301–589–5200. 

Contact Person: Nicole Vesely, 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, 301–827–6793, FAX: 301– 

827–6776, e-mail: 

nicole.vesely@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512532. 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: The committee will discuss 

new drug application (NDA) 21–856, 

ULORIC (febuxostat), Takeda 

Pharmaceuticals North America, Inc., 

for the proposed treatment of 

hyperuricemia in patients with gout. 

FDA intends to make background 

material available to the public no later 

than 2 business day 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/ohrms/ 

dockets/ac/acmenu.htm, click on the 

year 2008 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 November 7, 2008. 

Oral presentations from the public will 

be scheduled between approximately 2 

p.m. and 3 p.m. 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 October 30, 2008. 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 

October 31, 2008. 

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 Nicole 

Vesely 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/oc/advisory/ 

default.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: October 3, 2008. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E8–24355 Filed 10–14–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0038] 

Circulatory System 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 


jlentini on PROD1PC65 with NOTICES