36246 Federal Register / Vol. 63, No. 127 /Thursday, July 2, 1998 / Notices

Selection of members representing

consumer interests is conducted

through procedures which include use

of a consortium of consumer

organizations which has the

responsibility for recommending

candidates for the agency’s selection.

Candidates should possess appropriate

qualifications to understand and

contribute to the committee’s work.

Nominations shall include a complete

curriculum vitae of each nominee and

shall state the the nominee is aware of

the nomination, is willing to serve as a

member, and appears to have no conflict

of interest that would preclude

membership. FDA will ask the potential

candidates to provide detailed

information concerning such matters as

financial holdings, employment, and

research grants and/or contracts to

permit evaluation of possible sources of

conflict of interest. The nomination

should state whether the nominee is

interested only in a particular advisory

committee or in any advisory

committee. The term of office is up to

4 years, depending on the appointment

date.

This notice is issued under the

Federal Advisory Committee Act (5

U.S.C. app. 2) and 21 CFR part 14

relating to advisory committees.

Dated: June 26, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98–17603 Filed 7–1–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 92F–0443]

Dow Corning Corp.; Filing of Food

Additive Petition; Amendment

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

filing notice for a food additive petition

filed by Dow Corning Corp. to indicate

that the petitioner has also proposed

that the food additive regulations be

amended to provide for the safe use of

tetramethyltetravinylcyclotetrasiloxane

as an optional polymerization inhibitor

in the manufacture of

dimethylpolysiloxane coatings

produced by cross-linking a vinylcontaining dimethylpolysiloxane with

methylhydrogen-containing

polysiloxane and

dimethylmethylhydrogen polysiloxane

polymers using a platinum catalyst.

FOR FURTHER INFORMATION CONTACT:

Julius Smith, Center for Food Safety and

Applied Nutrition (HFS–215), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3091.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

February 12, 1993 (58 FR 8290), FDA

announced that a petition (FAP 3B4346)

had been filed by Dow Corning Corp.,

P.O. Box 994, Midland, MI 48686–0994,

proposing to amend § 175.300 Resinous

and polymeric coatings (21 CFR

175.300), § 175.320 Resinous and

polymeric coatings for polyolefin films

(21 CFR 175.320), and § 176.170

Components of paper and paperboard

in contact with aqueous and fatty foods

(21 CFR 176.170) to provide for the safe

use of dimethylpolysiloxane coatings

produced by cross-linking a vinylcontaining dimethylpolysiloxane with

methylhydrogen-containing

polysiloxane and

dimethylmethylhydrogen polysiloxane

polymers using a platinum catalyst. The

petition also proposed that the food

additive regulations be amended to

provide for the safe use of 3,5-dimethyl1-hexyne-3-ol, 1-ethynylcyclohexene,

bis(methoxymethyl)ethyl maleate and

methylvinyl cyclosiloxane as optional

polymerization inhibitors. Additionally,

the petition proposed that the

regulations be amended to provide for

the safe use of 5-chloro-2-methyl-4-

isothiazolin-3-one and 2-methyl-4-

isothiazolin-3-one mixture, optionally

containing magnesium nitrate, as an

antimicrobial agent for emulsion-based

silicone coating formulations.

Subsequent to publication of the filing

notice, the petitioner amended the

petition to request the use of

tetramethyltetravinylcyclotetrasiloxane

as an optional polymerization inhibitor

in the manufacture of

dimethylpolysiloxane coatings

produced by cross-linking a vinylcontaining dimethylpolysiloxane with

methylhydrogen-containing

polysiloxane and

dimethylmethylhydrogen polysiloxane

polymers using a platinum catalyst.

Therefore, FDA is amending the filing

notice of February 12, 1993, to indicate

that the petitioner requests that the food

additive regulations be amended to

provide for the safe use of

tetramethyltetravinylcyclotetrasiloxane

as an optional polymerization inhibitor

in the manufacture of

dimethylpolysiloxane coatings

produced by cross-linking a vinylcontaining dimethylpolysiloxane with

methylhydrogen-containing

polysiloxane and

dimethylmethylhydrogen polysiloxane

polymers using a platinum catalyst.

The agency has determined under 21

CFR 25.32(i) that this action is of a type

that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

Dated: June 11, 1998.

Laura M. Tarantino,

Acting Director, Office of Premarket

Approval, Center for Food Safety and Applied

Nutrition.

[FR Doc. 98–17548 Filed 7–1–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98F–0484]

Eastman Chemical Co.; Filing of Food

Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Eastman Chemical Co. has filed a

petition proposing that the food additive

regulations be amended to provide for

the safe use of di-2-

ethylhexylterephthalate as a component

of closure- sealing gaskets for food

containers.

FOR FURTHER INFORMATION CONTACT:

Hortense S. Macon, Center for Food

Safety and Applied Nutrition (HFS–

205), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–418–3086.

SUPPLEMENTARY INFORMATION: Under the

Federal Food, Drug, and Cosmetic Act

(sec. 409(b)(5) (21 U.S.C. 348(b)(5))),

notice is given that a food additive

petition (FAP 8B4593) has been filed by

Eastman Chemical Co., P.O. Box 431,

Kingsport, TN 37662. The petition

proposes to amend the food additive

regulations in § 177.1210 Closures with

sealing gaskets for food containers (21

CFR 177.1210) to provide for the safe

use of di-2-ethylhexyl terephthalate as a

component of closure-sealing gaskets for

food containers.

The agency has determined under 21

CFR 25.32(i) that this action is of the

type that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment
Federal Register / Vol. 63, No. 127 /Thursday, July 2, 1998 / Notices 36247

nor an environmental impact statement

is required.

Dated: June 17, 1998.

Laura M. Tarantino,

Acting Director, Office of Premarket

Approval, Center for Food Safety and Applied

Nutrition.

[FR Doc. 98–17547 Filed 7–1–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 95N–0195]

Agreement on Mutual Recognition

Between the United States of America

and the European Community; Third

Party Review Program Under the

Sectoral Annex on Medical Devices;

Conformity Assessment Bodies

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is identifying the

process for designating Conformity

Assessment Bodies (CAB’s) under the

Sectoral Annex on Medical Devices to

the Agreement on Mutual Recognition

Between the United States of America

and the European Community (MRA).

The MRA was signed in London on May

18, 1998, but it has not entered into

force. FDA has published a proposed

rule on the parts of the MRA affecting

FDA-regulated products. This notice

announces the process for CAB’s to

become eligible for designation under

the Sectoral Annex on Medical Devices

(Medical Devices Annex). The

availability of the draft guidance

detailing the requirements for

performing evaluations, training for

CAB’s, and content of evaluation reports

by FDA is announced elsewhere in this

issue of the Federal Register. Also

announced elsewhere in this issue of

the Federal Register is an emergency

processing request for Office of

Management and Budget review of the

information collection provisions of this

notice.

FOR FURTHER INFORMATION CONTACT:

Regarding the U.S./European

Community MRA: John F. Stigi,

Director, Division of Small

Manufacturers Assistance (HFZ–

220), Center for Devices and

Radiological Health, Food and Drug

Administration, 1350 Piccard Dr.,

Rockville, MD 20850, 301–443–

6597, or FAX: 301–443–8818.

Regarding the process for being

recognized to assess U.S. CAB’s or

for naming a recognized accreditor:

Robert L. Gladhill, Conformity

Assessment Systems Evaluation,

National Institute of Standards and

Technology, NN, 282 Gaithersburg,

MD 20899, 301–975–4273, or FAX:

301–963–2871.

SUPPLEMENTARY INFORMATION:

I. Background

On June 20, 1997, the United States

and the European Community (EC)

completed negotiation of the MRA that

covered a variety of product sectors,

including telecommunication

equipment, recreational craft,

pharmaceuticals, and medical devices.

The Medical Devices Annex applies

only to medical devices manufactured

for export to the United States or EC.

The EC consists of the following

member States: Austria, Belgium,

Denmark, Finland, France, Germany,

Greece, Ireland, Italy, Luxembourg, The

Netherlands, Portugal, Spain, Sweden,

and the United Kingdom. FDA issued a

proposed rule on April 10, 1998 (63 FR

17744), to add a new section to its

regulations setting out requirements

through which FDA may normally

endorse certain reports of conformity

assessments. The Medical Device Annex

applies to reports of quality system

evaluations of all medical devices and

premarket evaluations of selected

medical devices provided by designated

conformity assessment bodies.

Assuming the MRA enters into force

and a final rule becomes effective, a 3-

year transition period will start during

which time both sides will engage in

confidence building activities. After the

3-year transition period and the

confidence building activities are

successfully completed, the operational

period will begin.

The MRA consists of a framework

agreement and individual sectoral

annexes (i.e., those product sectors

covered by the MRA). The framework

agreement covers the general aspects of

the implementation of the agreement as

well as the requirements governing the

CAB’s, such as designation, listing,

suspension, and withdrawal.

Within the framework agreement

there is a provision that FDA and EC

Designating Authorities review the

Medical Devices Annex. It is anticipated

that aspects of the Medical Devices

Annex will be modified by agreement of

FDA and EC Designating Authority as

laws and policies change. This

provision was included because of

FDA’s concern during the negotiations

that there could be a change in the

status of the FDA Third Party Review

Pilot Program for medical devices that

would change the nature of the

agreement.

Under the MRA, an EC CAB could

conduct quality system evaluations for

all classes of devices and premarket

510(k) evaluations for selected devices

based on FDA requirements. Similarly,

a U.S. CAB could conduct quality

system evaluations for all classes of

devices and product type examinations

and verifications for selected devices

based on EC requirements. In addition,

an alert system would be set up during

the transition period and maintained

thereafter by which FDA and regulatory

authorities will notify each other when

there is an immediate danger to public

health. As part of that system, FDA and

EC will notify each other of any

confirmed problem reports, corrective

actions, or recalls.

The MRA may: (1) Be an important

means of facilitating movement of

medical devices important to human

health between the United States and

EC, (2) enhance public health by

allowing better use of scarce FDA

resources, (3) enhance harmonization of

U.S. and EC regulatory systems, and (4)

permit FDA to better utilize its

regulatory resources to focus on

manufacturers located in other

countries.

Under the MRA, both the United

States and the EC may eventually be

able to save resources by utilizing

evaluations of manufacturers conducted

by the other party, thereby saving

overseas travel time and expense.

However, CAB’s will be required to

participate in rigorous joint activities in

order to demonstrate proficiency in

conducting FDA and EC evaluations.

Based on demonstrated proficiency

during a 3-year transition period, both

FDA and EC are expected to ‘‘normally

endorse’’ evaluations conducted by the

other party’s CAB’s, while reserving the

final decision making to themselves and

reserving the right to conduct their own

evaluations should significant

deficiencies be found in any reports.

II. Third Party Review Program

The Medical Devices Annex identifies

legislation, regulations, and related

procedures under which: (1) Products

are regulated as medical devices by each

party (i.e., FDA and the EC); (2) CAB’s

are designated and confirmed; and (3)

evaluation reports are prepared.

Assuming the MRA enters into force

and a final rule becomes effective, FDA

will be the Designating Authority for

U.S. CAB’s and the EC Regulatory

Authorities will be the Designating

Authority for EC CAB’s. FDA intends to

use the National Voluntary Conformity

Assessment System Evaluation