31936 Federal Register / Vol. 66, No. 114 / Wednesday, June 13, 2001 / Notices

reclassification of these devices into one

of three regulatory categories; (3) advise

on any possible risks to health

associated with the use of devices; (4)

advise on formulation of product

development protocols; (5) review

premarket approval applications for

medical devices; (6) review guidelines

and guidance documents; (7)

recommend exemption to certain

devices from the application of portions

of the Federal Food, Drug, and Cosmetic

Act (the act); (8) advise on the necessity

to ban a device; (9) respond to requests

from the agency to review and make

recommendations on specific issues or

problems concerning the safety and

effectiveness of devices; and (10) make

recommendations on the quality in the

design of clinical studies regarding the

safety and effectiveness of marketed and

investigational devices.

II. Consumer and Industry

Representation

Section 520(f)(3) of the act (21 U.S.C.

360j(f)(3)), as amended by the Medical

Device Amendments of 1976, provides

that each medical device panel include

as members one nonvoting

representative of consumer interests and

one nonvoting representative of

interests of the medical device

manufacturing industry.

III. Nomination Procedures

A. Consumer Representatives

Any interested person may nominate

one or more qualified persons as a

member of a particular advisory

committee or panel to represent

consumer interests as identified in this

notice. Self-nominations are also

accepted. To be eligible for selection,

the applicant’s experience and/or

education will be evaluated against

Federal civil service criteria for the

position to which the person will be

appointed.

Nominations shall include a complete

curriculum vitae of each nominee and

shall state that the nominee is aware of

the nomination, is willing to serve as a

member, and appears to haveno 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 panel or in any advisory

committee or panel. The term of office

is up to 4 years, depending on the

appointment date.

B. Industry Representatives

Any organization in the medical

device manufacturing industry (industry

interests) wishing to participate in the

selection of an appropriate member of a

particular panel may nominate one or

more qualified persons to represent

industry interests. Persons who

nominate themselves as industry

representatives for the panels will not

participate in the selection process. It is,

therefore, recommended that all

nominations be made by someone with

an organization, trade association, or

firm who is willing to participate in the

selection process.

Nominees shall be full-time

employees of firms that manufacture

products that would come before the

panel, or consulting firms that represent

manufacturers. Nominations shall

include a complete curriculum vita of

each nominee. The term of office is up

to 4 years, depending on the

appointment date.

IV. Selection Procedures

A. Consumer Representatives

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.

B. Industry Representatives

Regarding nominations for members

representing the interests of industry, a

letter will be sent to each person that

has made a nomination, and to those

organizations indicating an interest in

participating in the selection process,

together with a complete list of all such

organizations and the nominees. This

letter will state that it is the

responsibility of each nominator or

organization indicating an interest in

participating in the selection process to

consult with the others in selecting a

single member representing industry

interests for the panel within 60 days

after receipt of the letter. If no

individual is selected within 60 days,

the agency will select the nonvoting

member representing industry interests.

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 7, 2001.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 01–14814 Filed 6–13–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0236]

New Food Chemicals Codex

Monographs, Revisions of Certain

Food Chemicals Codex Monographs,

Revision of a General Test Procedure,

and New Test Solutions; Opportunity

for Public Comment

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

opportunity for public comment on

proposed new Food Chemicals Codex

specification monographs, proposed

changes to certain Food Chemicals

Codex specification monographs, a

proposed revision of a general test

procedure, and proposed new test

solutions. Additions, revisions, and

corrections to current specification

monographs for certain substances used

as food ingredients, as well as new

monographs and test solutions, and a

revised test procedure, are being

prepared by the National Academies,

Institute of Medicine (IOM), Committee

on Food Chemicals Codex (the

committee). This material is expected to

be included in the next publication of

the Food Chemicals Codex (the third

supplement to the fourth edition),

scheduled for public release in the

summer of 2001.

DATES: Submit written comments by

July 30, 2001. (The committee advises

that comments received after this date

may not be considered for the third

supplement to the fourth edition.

Comments received too late for

consideration for the third supplement

will be considered for the fifth edition

of the Food Chemicals Codex.)

ADDRESSES: Submit written comments

and supporting data and documentation

to the Committee on Food Chemicals

Codex/FO–3038, Food and Nutrition

Board, Institute of Medicine, 2101

Constitution Ave. NW., Washington, DC

20418. Copies of the proposed new

Food Chemicals Codex specification

monographs, proposed new test

solutions, proposed changes to certain

monographs, and proposed revision to a

Federal Register / Vol. 66, No. 114 / Wednesday, June 13, 2001 / Notices 31937

general test procedure may be obtained

upon written request from the IOM

(address above) or may be examined at

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852. Requests for copies should

specify by name the monographs, test

procedure, or test solutions desired. For

electronic access see the SUPPLEMENTARY

INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT:

Ricardo A. Molins, Project Director/FO–

3038, Committee on Food Chemicals

Codex, Food and Nutrition Board,

Institute of Medicine, 2101 Constitution

Ave. NW., Washington, DC 20418, 202–

334–2580; or Paul M. Kuznesof,

Division of Product Manufacture and

Use (HFS–246), Office of Premarket

Approval, Center for Food Safety and

Applied Nutrition, Food and Drug

Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3009.

SUPPLEMENTARY INFORMATION: By

contract with IOM, FDA supports the

preparation of the Food Chemicals

Codex, a compendium of specification

monographs for substances used as food

ingredients. Before any specifications

are included in a Food Chemicals Codex

publication, public announcement is

made in the Federal Register. All

interested parties are invited to

comment and to make suggestions for

consideration. Suggestions should be

accompanied by supporting data or

other documentation to facilitate and

expedite review by the committee.

In the Federal Register of August 8,

2000 (65 FR 48521), and of January 22,

2001 (66 FR 6624), as corrected on

February 9, 2001 (66 FR 9710), FDA

announced that the committee was

considering new and revised

monographs, new and revised general

test procedures, revised test solutions,

and revisions to a policy for inclusion

in the third supplement to the fourth

edition of the Food Chemicals Codex.

FDA is now announcing that the

committee is soliciting comments and

information on additional proposed new

Food Chemicals Codex specification

monographs, on additional proposed

changes to certain monographs, on an

additional proposed revised general test

procedure, and on proposed new test

solutions. These new and revised

monographs, revised test procedure, and

new test solutions are also expected to

be published in the third supplement to

the fourth edition of the Food Chemicals

Codex. If comments are received that

cannot be addressed by the committee

before publication of the third

supplement, the new monographs or

test solutions, revised monographs, or

revised test procedure affected will be

considered for the fifth edition of the

Food Chemicals Codex. Copies of the

proposed items may be obtained upon

written request from IOM at the address

listed above or through the Internet at

http://www.iom.edu/fcc.

FDA emphasizes, however, that it will

not consider adopting and incorporating

any of the committee’s new or revised

monographs, revised test procedure, or

new test solutions into FDA regulations

without ample opportunity for public

comment. If FDA decides to propose the

adoption of new monographs and test

solutions and changes that have

received final approval of the

committee, it will announce its

intention and provide an opportunity

for public comment in the Federal

Register.

The committee invites comments and

suggestions by all interested parties on

specifications to be included in the 33

proposed new monographs, 22 proposed

revisions of current monographs,

proposed revised general test procedure,

and 2 proposed new test solutions listed

below:

I. Proposed New Monographs

Acidified sodium chlorite solutions

Aspartame-acesulfame salt

Curdlan

Flavor Chemicals

2,6-Dimethoxyphenol

3,4-Dimethyl-1,2-cyclopentandione

5-Ethyl-3-hydroxy-4-methyl-2(5H)-

furanone

3-Ethyl pyridine

Furfuryl mercaptan

Geranyl isovalerate

2,3-Heptandione

Hexyl butyrate

Hexyl hexanoate

Isoamyl isobutyrate

Isobutyl formate

Isobutyl hexanoate

Linalool oxide

Methyl hexanoate

Methyl isovalerate

Methyl thiobutyrate

Methyl valerate

5-Methyl furfural

beta-Naphthylethyl ether

Phenylethyl cinnamate

Phenylethyl propionate

Propyl mercaptan

Propyl formate

delta-Tetradecalactone

2-Tridecanone

gamma-Cyclodextrin

Polyglycerol polyricinoleic acid

Pork collagen

Solin oil

Sucrose acetate isobutyrate

II. Current Monographs to which the

Committee Proposes to Make Revisions

Calcium sulfate (Formula weight and

CAS number revised to show the

dihydrate; Heavy Metals

determination deleted)

Canola oil (Description and Functional

Use in Foods modified; Heavy

Metals determination deleted)

Cellulose gum (Specifications for Degree

of Substitution and Sodium

modified; Heavy Metals

determination deleted)

Citric acid (Description revised; Heavy

Metals and Ultraviolet Absorbance

specifications deleted;

Tridodecylamine specification

revised; Readily Carbonizable

Substances test replaced; Residue

on Ignition test reworded)

Cocoa butter substitute (Description

corrected; Heavy Metals

determination deleted)

Ethoxyquin (Description, Assay Limit,

and Assay Test modified; Heavy

Metals specification deleted; Lead,

p-Phenetidine, and p-PhenetidineRelated Impurities specifications

added)

Flavor Chemicals

Acetoin (structures revised)

2-Acetylpyrrole (physical form and melting

range revised; water deleted)

Anisole (assay revised)

Ethylene brassylate (assay revised)

Ethyl phenylglycidate (assay revised)

Geranyl benzoate (assay revised)

alpha-Ionone (assay revised)

dl-Menthyl acetate (solubility in alcohol

added)

4-Methyl-2-pentanone (refractive index

revised)

delta-Nonalactone (refractive index and

specific gravity revised)

(E)-2-Nonen-1-ol (refractive index revised)

delta-Octalactone (specific gravity revised)

(E)-2-Undecenol (solubility in alcohol

added)

Maltitol (Description corrected; Assay

limit of D-Maltitol revised; entire

Identification, Assay, and Reducing

Sugars tests provided; Other

Hydrogenated Saccharides

specifications added)

Rapeseed oil, fully hydrogenated

(Description and Functional Use in

Foods modified; Heavy Metals

determination deleted)

Rapeseed oil, superglycerinated

(Description and Functional Use in

Foods modified; Heavy Metals

determination deleted)

III. Proposed Revised General Test

Procedure

Peroxide Value (A second Peroxide

Value test has been added to

Appendix VII: Fats and Related

Substances)

IV. Proposed New Test Solutions

Nickel Standard Solution TS (10

milligrams per kilogram)

Acetic Acid TS, Strong (5 Normal)

31938 Federal Register / Vol. 66, No. 114 / Wednesday, June 13, 2001 / Notices

V. Comments and Electronic Access

Interested persons may submit to the

Committee on Food Chemicals Codex

written comments regarding the

monographs, general test procedure, and

test solutions identified in this notice by

July 30, 2001. Timely submission will

allow comments to be considered for the

third supplement to the fourth edition

of the Food Chemicals Codex.

Comments received after this date may

not be considered for the third

supplement, but will be considered for

the fifth edition of the Food Chemicals

Codex. Those wishing to make

comments are encouraged to submit

supporting data and documentation

with their comments. Two copies of any

comments regarding the monographs,

the general test procedure, or the test

solutions listed in this notice are to be

submitted to the Committee on Food

Chemicals Codex (address above).

Comments and supporting data or

documentation are to be identified with

the docket number found in brackets in

the heading of this document and each

submission should include the

statement that it is in response to this

Federal Register notice. The committee

staff will forward a copy of each

comment to the Dockets Management

Branch (address above). Received

comments may be seen in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday. Copies

of the proposed changes may also be

obtained through the Internet at http://

www.iom.edu/fcc.

Dated: June 4, 2001.

L. Robert Lake,

Director of Regulations and Policy, Center

for Food Safety and Applied Nutrition.

[FR Doc. 01–14864 Filed 6–12–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Transmissible Spongiform

Encephalopathies 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). At least one portion of the

meeting will be closed to the public.

Name of Committee: Transmissible

Spongiform Encephalopathies (TSE)

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 June 28, 2001, 8 a.m. to 5 p.m.

and on June 29, 2001, 8 a.m. to 11:30

a.m.

Location: Holiday Inn, Versailles

Ballroom I and II, 8120 Wisconsin Ave.,

Bethesda, MD.

Contact: William Freas, or Sheila D.

Langford, Center for Biologics

Evaluation and Research (HFM–71),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–827–0314, or FDA Advisory

Committee Information Line, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area), code 12392.

Please call the Information Line for upto-date information on this meeting.

Agenda: On June 28, 2001, the

committee will review and discuss the

suitability of blood donors who have

lived or traveled in various countries

based on recent information concerning

new-variant Creutzfeldt-Jakob disease

and bovine spongiform encephalopathy

in those countries. In the afternoon, the

committee will discuss the safety of

FDA-regulated plasma derivatives

prepared in establishments proposing to

use on the same manufacturing line,

plasma which does and plasma which

does not comply with current U.S.

standards, with regard to donor deferral

for vCJB risk factors. On June 29, 2001,

the committee will discuss the interim

results of a new study on the

inactivation of TSE agent by the

manufacturing process for gelatin.

Procedure: On June 28, 2001, from 8

a.m. to 4:30 p.m. and June 29, 2001,

from 8 a.m. to 11:30 a.m., the meeting

is open to the public. 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 by June 15, 2001. Oral

presentations from the public will be

scheduled between approximately 10:50

a.m. and 11:30 a.m., and between

approximately 2:30 p.m. and 3:10 p.m.

on June 28, 2001, and between

approximately 10 a.m. and 10:30 a.m.

on June 29, 2001. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before June 15, 2001, 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.

Closed Committee Deliberations: On

June 28, 2001, from 4:30 p.m. to 5 p.m.,

the meeting will be closed to permit

discussion and review of trade secret

and/or confidential information (5

U.S.C. 552b(c)(4)). This portion of the

meeting will be closed to permit

discussion of this material.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: June 5, 2001.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 01–14812 Filed 6–12–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D–0224]

Draft Guidance for Industry: Mass

Spectrometry for Confirmation of the

Identity of Animal Drug Residues;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance entitled

‘‘Guidance for Industry: Mass

Spectrometry for Confirmation of the

Identity of Animal Drug Residues.’’ This

draft guidance describes the basic

principles the agency recommends for

development, evaluation, or application

of qualitative mass spectrometric

methods for confirming the identity of

new animal drug residues. This draft

document is intended for technical

professionals familiar with mass

spectrometry. A glossary at the end of

the draft guidance defines key terms

used throughout the document.

DATES: Submit written comments by

September 11, 2001.

ADDRESSES: Submit written requests for

single copies of this draft guidance to

the Communications Staff (HFV–12),

Center for Veterinary Medicine (CVM),

Food and Drug Administration, 7500

Standish Pl., Rockville, MD 20855. Send

one self-addressed adhesive label to

assist the office in processing your

requests. See the SUPPLEMENTARY

INFORMATION section for electronic

access to the draft guidance document.

Submit written comments to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852, e-mail: