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

20998 Federal Register / Vol. 65, No. 76 / Wednesday, April 19, 2000 / Notices

literature may be the basis for approval

of an original application. The draft

guidance is intended to provide specific

advice on when FDA may be able to rely

on published literature, with or without

the submission of underlying data, to

support new animal drug approval.

DATES: Submit written comments on the

draft guidance for industry by July 18,

2000.

ADDRESSES: Submit written requests for

single copies of the draft 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.

Submit written comments on this draft

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. Copies of

the draft guidance may be obtained on

the Internet at http://www.fda.gov/cvm/

fda/TOCs/guideline.html.

FOR FURTHER INFORMATION CONTACT: Gail

L. Schmerfeld, Center for Veterinary

Medicine (HFV–100), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20850, 301–594–1620, email: gschmer1@cvm.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

Section 403(b) of FDAMA (Public Law

105–115) requires FDA to issue

guidances to clarify the requirements

for, and facilitate the submission of data

to support, the approval of

supplemental applications for articles

approved under the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 301 et seq.)

or section 351 of the Public Health

Service Act (42 U.S.C. 262). This

provision includes a requirement that

FDA publish guidance to clarify

circumstances in which published

matter may be the basis for approval of

a supplemental application.

This draft guidance for industry

clarifies the circumstances in which

published literature may be the basis for

approval of both original and

supplemental new animal drug

applications. Specifically, the draft

guidance describes the circumstances

under which FDA could rely on

published literature without access to

the underlying data and the

circumstances under which the

applicant should provide additional

information about a published study.

II. Significance of Guidance

This draft guidance represents the

agency’s current thinking with regard to

the use of published literature in

support of new animal drug approval. 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. The agency has

developed this draft guidance in

accordance with the agency’s good

guidance practices (62 FR 8961,

February 27, 1997), which set forth the

policies and procedures for the

development, issuance, and use of

guidance documents.

III. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments on the draft

guidance by July 18, 2000. Two copies

of any comments are to be submitted,

except individuals may submit one

copy. Comments are to be identified

with the docket number found in

brackets in the heading of this

document. A copy of the draft guidance

and received comments are available for

public examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

Dated: April 10, 2000.

Margaret M. Dotzel,

Acting Associate Commissioner for Policy.

[FR Doc. 00–9713 Filed 4–18–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources And Services

Administration

Agency Information Collection

Activities: Proposed Collection:

Comment Request

In compliance with the requirement

for opportunity for public comment on

proposed data collection projects

(section 3506(c)(2)(A) of Title 44, United

States Code, as amended by the

Paperwork Reduction Act of 1995,

Public Law 104–13), the Health

Resources and Services Administration

(HRSA) publishes periodic summaries

of proposed projects being developed

for submission to OMB under the

Paperwork Reduction Act of 1995. To

request more information on the

proposed project or to obtain a copy of

the data collection plans and draft

instruments, call the HRSA Reports

Clearance Officer on (301) 443–1129.

Comments are invited on: (a) Whether

the proposed collection of information

is necessary for the proper performance

of the functions of the agency, including

whether the information shall have

practical utility; (b) the accuracy of the

agency’s estimate of the burden of the

proposed collection of information; (c)

ways to enhance the quality, utility, and

clarity of the information to be

collected; and (d) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques

or other forms of information

technology.

Proposed Project: National Donor

Sabbath Organ Procurement

Organization Survey—New

November 10–12, 2000, will mark the

fifth annual National Donor Sabbath

(NDS), a time for clergy throughout the

Nation to help increase awareness about

the critical need for organs and tissues.

In support of the 1999 NDS, the Health

Resources and Services Administration,

Office of Special Programs, Division of

Transplantation (DoT) distributed to 61

Organ Procurement Organizations

(OPO) in the U.S. more than 300,000

organ donor awareness lapel pins

attached to paper backings containing

NDS information. The OPOs were asked

to distribute the pins to their local

clergy to be used for further distribution

and education of their congregation.

DoT plans to replicate this activity for

2000 NDS.

While DoT believed the 1999 pin

distribution to be a positive educational

tool there exists a need to properly

investigate the efficacy of the pins as an

aid in promoting NDS. The Division

wishes to examine the pin distribution

in 2000 NDS in order to plan the most

effective, efficient, and cost effective

role for DoT in subsequent observances

of NDS. Investigation will consist of

requesting each OPO to complete a short

survey concerning usage, distribution,

and impact of the pins. This is a onetime survey.