Federal Register / Vol. 73, No. 200 / Wednesday, October 15, 2008 / Notices 61135 

reports from the Ethics Subcommittee and 

National Biosurveillance Advisory 

Subcommittee; progress report on Healthiest 

Nation; and discussions on globalization. 

Agenda items are subject to change as 

priorities dictate. 

Contact Person for More Information: Brad 

Perkins, M.D., M.B.A., Executive Officer, 

Advisory Committee to the Director, CDC, 

1600 Clifton Road, NE., M/S D–14, Atlanta, 

Georgia 30333. Telephone 404/639–7000. 

The Director, Management Analysis and 

Services Office, has been delegated the 

authority to sign Federal Register notices 

pertaining to announcements of meetings and 

other committee management activities, for 

both the CDC and the Agency for Toxic 

Substances and Disease Registry. 

Dated: October 8, 2008. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. E8–24499 Filed 10–14–08; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0523] 

FDA–Regulated Products that Contain 

Bisphenol-A; Request for Information 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for information. 

SUMMARY: The Food and Drug 

Administration (FDA) is requesting 

assistance in the identification of types 

of FDA-regulated products that contain 

Bisphenol A (BPA), whether as a 

component of the product or its 

packaging, and any information relating 

to the leaching of BPA from the 

packaging to the product and/or from 

the product from the product following 

human administration. 

DATES: Submit written or electronic 

comments and information by December 

29, 2008. 

ADDRESSES: Submit written comments 

and information to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Submit electronic comments and 

information to http:// 

www.regulations.gov. Information 

submitted will be reviewed by the FDA 

BPA Task Force. 

FOR FURTHER INFORMATION CONTACT: 

Norris Alderson, Office of Science and 

Health Coordination (HF–32), Food and 

Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827– 

3340, FAX 301–827–3042, e-mail: 

norris.alderson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

BPA is a chemical commodity used 

primarily in the production of 

polycarbonate plastics and epoxy resins. 

Such plastics and resins have many 

applications including as components of 

packaging for food and drink, and as 

components of certain medical products 

and their packaging. Consequently, low 

levels of residual BPA may be present 

in such products. On April 14, 2008, the 

National Toxicology Program (NTP) 

released a draft brief on BPA for public 

comment and peer review. The NTP 

draft brief raises concerns that exposure 

to BPA could be linked to 

developmental problems of the 

endocrine system in infants and young 

children. The NTP draft brief also 

contains an exposure estimate to BPA 

for infants and young children due to 

leaching of BPA to food from plastic 

baby bottles and the linings of certain 

baby food containers. NTP has 

subsequently released a final report on 

BPA on September 3, 2008. 

In response to the NTP draft brief, 

Commissioner von Eschenbach has 

convened an agency-wide task force to 

facilitate cross-agency review of current 

research and new information on BPA 

for all FDA-regulated products. The 

review will include the NTP brief and 

all other available information on the 

exposure of US consumers to BPA from 

FDA-regulated products. 

During the course of this process the 

task force has been making an inventory 

of all FDA-regulated products that are 

known to contain BPA. The task force 

has already completed a thorough 

assessment of the potential exposure to 

BPA due to leaching from food-contact 

materials and is now interested in 

additional information on other types of 

products, specifically medical devices, 

biological products (including blood, 

blood products, vaccines, and cell and 

gene therapies, and drugs. 

To ensure that we have current 

information to support our review of 

issues related to BPA risks, we are 

requesting information on the presence 

and levels of BPA for products with 

either direct or indirect patient contact. 

This would include situations where the 

BPA is a component of the product or 

its packaging. Information relating to the 

leaching of BPA from the packaging to 

the product and/or from the product to 

patients is also of interest. 

At this time, exposure to BPA from 

the use of the following BPA-related 

materials provides an initial basis for 

the agency’s query: 

∑ Polycarbonate. 

∑ Polyether sulfone. 

∑ Polycarbonate/siloxane co-polymer. 

∑Biostable polyurethanes. 

∑ Epoxy resin. 

The agency’s query also extends to 

products that contain certain bisphenol 

acrylic oligomers, such as the following: 

∑Bisphenol A diglycidylether 

methacrylate (BIS-GMA). 

∑Bisphenol A diglycidylether 

(BADGE). 

∑Bisphenol A dimethacrylate (BISDMA). 

∑ Ethoxylated bisphenol A diacrylates. 

II. Information Requested for FDARegulated Products 

A. Medical Devices and Articles Used in 

Product Manufacturing 

Direct contact devices would include, 

but not be limited to, those with direct 

contact with tissue, blood, other fluids, 

such as cerebrospinal fluid, and skin. 

Implants, catheters, and most dental 

devices are additional examples of 

devices with direct patient contact. 

Indirect patient contact or external 

communicating devices would include, 

but are not limited to the following: 

∑Components of blood pathway 

circuits, (e.g., hemodialysis, 

apheresis, and cardiopulmonary 

bypass). 

∑Respiratory tubing circuits. 

∑Blood and parenteral solution 

administration sets. 

∑ Apheresis instrument harnesses 

including separation bowls and 

break away closures. 

∑ Hard casing for leukocyte reduction 

filters. 

∑ Platelet rich plasma preparation 

devices including tubes for 

centrifugation of blood. 

∑Tops for vials or other container 

closures. 

∑ Large volume containers used in 

preparation of raw materials for 

biological products production 

when lined with epoxy material 

that contains BPA. 

∑ Materials used for preparation of 

cell/tissue/gene therapies, 

including: T-flasks, roller bottles, 

cell factories, cell culture beads, 

hard conical tubes, and disposable 

plastic pipettes. 

In submitting your comments, we ask 

you to provide information with respect 

to any Class I, Class II, and Class III 

medical device that has direct or 

indirect patient contact. Whenever 

possible, include a description of the 

analytical method used to develop the 

submitted data and information. 

If the device contains polycarbonate 

or BPA, we request the submission of 

data concerning the following: 


jlentini on PROD1PC65 with NOTICES
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