20996 Federal Register / Vol. 65, No. 76 / Wednesday, April 19, 2000 / Notices

II. Electronic Access

In order to receive these guidance

documents via your fax machine, call

the CDRH FOD system at 800–899–0381

or 301–827–0111 from a touch-tone

telephone. Press 1 to enter the system

and enter the document number listed

above followed by the pound sign (#).

Follow the remaining voice prompts to

complete your request.

Persons interested in obtaining a copy

of these guidance documents may do so

by using the Internet. CDRH maintains

an entry on the Internet for easy access

to information including text, graphics,

and files that may be downloaded to a

personal computer with access to the

Internet. Updated on a regular basis, the

CDRH home page includes these

guidance documents, device safety

alerts, Federal Register reprints,

information on premarket submissions

(including lists of approved applications

and manufacturers’ addresses), small

manufacturers’ assistance, information

on video conferencing and electronic

submissions, mammography matters,

and other device-oriented information.

The CDRH home page may be accessed

at http://www.fda.gov/cdrh. These

guidance documents are also available

at http://www.fda.gov/cdrh/ODE.

III. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments regarding

these guidance documents by July 18,

2000. Two copies of any comments are

to be submitted, except that individuals

may submit one copy. Comments are to

be identified with the docket number for

each guidance document as listed in the

table in the SUPPLEMENTARY INFORMATION

section of this document. If you wish to

comment on more than one guidance

document, please submit your

comments separately for each guidance

document. The guidance documents

and received comments may be seen in

the Dockets Management Branch

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

through Friday.

Dated: April 3, 2000.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 00–9710 Filed 4–18–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Industry Grassroots Meeting: Report

on Partnership Activities

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of meeting.

The Food and Drug Administration

(FDA), Office of Regulatory Affairs, San

Francisco District Office is announcing

the following meeting entitled ‘‘Industry

Grassroots Meeting: Report on

Partnership Activities.’’ The purpose of

the meeting is to report the Partnership

Among Industry and Regulators (PAIR)

Committee activities and to solicit input

from participants for future activities

and projects for the PAIR Committee.

The PAIR Committee was formed as a

result of an action item coming out of

a similar grassroots meeting held at the

Oakland Federal Bldg. in January of

1997.

Date and Time: The meeting will be

held on May 10, 2000, from 8 a.m. to 5

p.m.

Location: The meeting will be held at

the Oakland Federal Bldg., North

Tower, 3d Floor Auditorium, 1301 Clay

St., Oakland, CA 94612.

Contact: Jake Pearson, San Francisco

District Office (HFR–PA 160), 510–337–

6877, FAX 510–337–6701, e-mail

jpearson@ora.fda.gov, or Kathryn D.

Macropol (HFR–PA 140), 510–337–

6867, e-mail kmacropo@ora.fda.gov,

Food and Drug Administration, 1431

Harbor Bay Pkwy., Alameda, CA 94502.

Information is also available at the PAIR

website at http://www.pair-ca.org.

Registration: There is no charge to

attend the meeting; however,

registration is required. The meeting is

open to all interested in management

and regulatory affairs activities of

industries regulated by FDA. While

attendance would most benefit those

industries located in Northern

California, all interested groups are

encouraged to attend. You may register

via the Internet at http://www.pairca.org and by completing the online

registration form. Alternatively, you can

register by sending your name, title,

firm name, address, telephone, fax

number, and e-mail address (if

available) to the contacts listed above.

Please include any topics of interest you

would like to have included in the

program.

If you need special accommodations

due to a disability, please notify Jake

Pearson at least 7 days in advance.

Dated: April 12, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–9712 Filed 4–18–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D–4201]

Guidance for Industry: Dioxin in Anticaking Agents Used in Animal Feed

and Feed Ingredients; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a revised guidance for

industry (#98) entitled ‘‘Dioxin in Anticaking Agents Used in Animal Feed and

Feed Ingredients.’’ The guidance is

intended to notify members of the feed

industry of recent findings regarding the

presence of dioxins congeners that may

be present in anti-caking agents in

animal feeds and to offer general advice

regarding monitoring of these products.

This guidance has been revised in

response to comments.

DATES: Submit written comments at any

time.

ADDRESSES: Submit written comments

on this guidance document to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852. Copies of the guidance

document entitled ‘‘Dioxin in Anticaking Agents Used in Animal Feed and

Feed Ingredients’’ may be obtained on

the Internet from the CVM home page at

http://www.fda.gov/cvm/fda/TOCs/

guideline.html. Persons without Internet

access may submit written requests for

single copies of the guidance to the

Communications Staff (HFV–12), Center

for Veterinary Medicine, Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that

office in processing your requests.

FOR FURTHER INFORMATION CONTACT:

For general questions regarding the

guidance document: Judy A.

Gushee, Center for Veterinary

Medicine (HFV–230), Food and

Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–827–

0150, e-mail: jgushee@cvm.fda.gov.

For scientific questions regarding the

guidance document: Randall A.

Federal Register / Vol. 65, No. 76 / Wednesday, April 19, 2000 / Notices 20997

Lovell, Center for Veterinary

Medicine (HFV–222), Food and

Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–827–

0176, e-mail: rlovell@cvm.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

In theFederal Register of October 15,

1999 (64 FR 55948), FDA published a

notice of availability of a guidance

entitled ‘‘Dioxin in Anti-caking Agents

Used in Animal Feed and Feed

Ingredients.’’ This guidance was issued

as a Level 1 guidance consistent with

FDA’s good guidance practices (62 FR

8961, February 27, 1997). It was

implemented without prior public

comment because of concern for the

public health. The guidance was

intended to notify the feed industry of

recent findings regarding the presence

of dioxins in mined clays that may be

used as anti-caking agents in animal

feeds and to offer general advice

regarding monitoring of these clays. The

agency received comments regarding

this guidance and has revised the

guidance in response to the comments.

The following is a discussion of the

issues raised by the comments.

II. Discussion of Comments

The agency received two comments

on the guidance. One comment was

from the feed industry objecting to the

term ‘‘mined clay products’’ and one

was from a company that produces

limestone objecting to the term ‘‘lime.’’

(Comment 1) One comment noted that

the term ‘‘mined clay products’’ was not

appropriate because materials labeled as

silicate and lime also tested positive to

one or more of the dioxin congeners. We

agree with the comment that the term

was inappropriate for the scope of the

affected product. FDA was attempting to

use a generic term to describe the source

of products of concern. FDA has revised

the guidance document by replacing the

term ‘‘mined clay products’’ with ‘‘clay

and non-clay anti-caking products.’’ We

have added the term ‘‘anti-caking’’ to

emphasize that our primary concern is

for the use of these products in feed and

feed ingredients and not when used as

litter or absorbents.

This comment also noted that of the

terms montmorillonite, bentonite, and

ground clay, only montmorillonite has a

mineral definition. It was also noted

that the animal feed industry and its

suppliers do not follow scientific

terminology for classification and

description of these anti-caking animal

feed ingredients. The comment

recommended that FDA contact the U.S.

Geological Survey (USGS) and the Clay

Minerals Society (CMS) for assistance in

mineral terminology. It was also

suggested that the samples, which were

analyzed for dioxin, be evaluated for

their mineralogy and then properly

classified based on the mineralogical

components according to accepted

scientific guidelines.

FDA was aware that many of the

terms used by suppliers and the feed

industry were only loosely based on

mineralogy and were often more closely

associated with some property (e.g., ball

clay) of the product than mineralogical

components. However, FDA did not

fully understand the scope of the

interchanging of the terms used by

suppliers of these products. FDA agrees

that classifying these products based

upon the mineralogical components

according to accepted scientific

guidelines is preferred. FDA has

contacted the USGS regarding analyzing

the samples for their mineralogy. We

have also contacted the USGS and the

CMS for information on developing a

scientifically accurate naming scheme

based on mineralogy. We plan to seek

the assistance of the feed industry and

the Association of American Feed

Control Officials (AAFCO) to implement

a scientifically accurate naming scheme

based on mineralogy.

(Comment 2) Another comment

objected to the use of the term ‘‘lime.’’

The National Lime Association (NLA)

noted that limestone is a naturally

occurring mineral, while lime is not.

Lime, according to the NLA, consists of

either calcium oxide or calcium

hydroxide and results from reacting

‘‘limestone’’ (calcium carbonate) and

heat.

FDA does not dispute the NLA’s

definition of lime and, as mentioned

above, has revised the terminology for

the products of concern from ‘‘mined

clay products’’ to ‘‘clay and non-clay

anti-caking products.’’ FDA realizes that

this does not directly address the NLA’s

concern that a product might have been

incorrectly identified in the survey.

FDA reported the findings based on

what was on the label of the product

sampled or by what the product was

called by the company when the FDA

investigator collected it.

In essence, the concern expressed by

the NLA for the correct identification of

the product is the same as that

expressed by the other comment and is

a concern shared by FDA. We encourage

the NLA to work with its members,

companies producing limestone, the

feed industry, and AAFCO to ensure a

scientifically accurate naming scheme is

applied to the products supplied to the

feed industry.

III. Status of this Guidance

This guidance represents the agency’s

current thinking on the presence of

dioxin congeners in anti-caking agents.

It does not create or confer any rights for

or on any person and does not operate

to bind FDA or the public. An

alternative approach may be used if

such approach satisfies the

requirements of the applicable statute,

regulations, or both.

FDA plans to continue to sample

regulated clay and non-clay anti-caking

products for dioxin in conjunction with

the Environmental Protection Agency

and other Government agencies. Plans

are also underway to sample other feed

components for dioxin.

IV. Comments

As with all of FDA’s guidances, the

public is encouraged to submit to the

Dockets Management Branch (address

above) written comments with new data

or other new information regarding this

guidance. The comments will be

periodically reviewed, and, where

appropriate, the guidance will be

amended. The public will be notified of

any such amendments through a notice

in the Federal Register.

Dated: April 11, 2000.

Margaret M. Dotzel,

Acting Associate Commissioner for Policy.

[FR Doc. 00–9711 Filed 4–18–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D–0790]

Draft Guidance for Industry: The Use

of Published Literature in Support of

New Animal Drug Approval;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability for comment of a draft

guidance for industry entitled ‘‘The Use

of Published Literature in Support of

New Animal Drug Approval.’’ The draft

guidance is intended to fulfill the

section of the FDA Modernization Act of

1997 (FDAMA) that requires the agency

to issue guidance to clarify the

circumstances in which published

matter may be the basis for approval of

a supplemental application. The draft

guidance also clarifies the

circumstances in which published