35944 Federal Register / Vol. 65, No. 109 / Tuesday, June 6, 2000 / Notices

a.m. and 12 noon. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before July 6, 2000, 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.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: May 31, 2000.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 00–14213 Filed 6–5–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0965]

‘‘Guidance for Industry: Recognition

and Use of a Standard for the Uniform

Labeling of Blood and Blood

Components;’’ Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a guidance document

entitled ‘‘Guidance for Industry:

Recognition and Use of a Standard for

the Uniform Labeling of Blood and

Blood Components.’’ The guidance

document describes a system for the

uniform labeling of blood and blood

components for transfusion, Source

Plasma, and other components for use

in further manufacturing. The guidance

will assist manufacturers in complying

with the labeling requirements under

FDA’s regulations.

DATES: Submit written comments at any

time.

ADDRESSES: Submit written requests for

single copies of the guidance entitled

‘‘Guidance for Industry: Recognition

and Use of a Standard for the Uniform

Labeling of Blood and Blood

Components’’ to the Office of

Communication, Training, and

Manufacturers Assistance (HFM–40),

Center for Biologics Evaluation and

Research, Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448. Send one

self-addressed adhesive label to assist

the office in processing your requests.

The document may also be obtained by

mail by calling the CBER Voice

Information System at 1–800–835–4709

or 301–827–1800, or by fax by calling

the FAX Information System at 1–888–

CBER–FAX or 301–827–3844. See the

SUPPLEMENTARY INFORMATION section for

electronic access to the guidance

document.

Submit written comments on the

guidance document to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: For

information about this notice: Sharon A.

Carayiannis, Center for Biologics

Evaluation and Research (HFM–17),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–827–6210.

For technical information: Kenneth A.

Zemann, Center for Biologics Evaluation

and Research (HFM–375), Food and

Drug Administration, 1401 Rockville

Pike, Rockville, MD 20852–1448, 301–

827–3543, or FAX 301–827–3534.

SUPPLEMENTARY INFORMATION:

I. Background

The International Council for

Commonality in Blood Banking

Automation (ICCBBA) prepared and

submitted to FDA a draft document

entitled ‘‘United States Industry

Consensus Standard for the Uniform

Labeling of Blood and Blood

Components Using ISBT 128,’’ Version

1.2.0 (draft Standard). The ICCBBA

requested that ISBT 128 replace the

current ‘‘ABC Codabar’’ system as an

approved machine readable barcode for

labeling blood and blood components.

On November 21, 1998, FDA made the

draft Standard available on its website

for public comment. In the Federal

Register of November 27, 1998 (63 FR

65600), FDA announced the availability

of the draft Standard and requested

public comment on both the use of ISBT

128 and timeframes for implementation.

The ICCBBA revised the draft Standard

in response to public comment and

submitted to FDA the revised document

entitled ‘‘United States Industry

Consensus Standard for the Uniform

Labeling of Blood and Blood

Components Using ISBT 128,’’ Version

1.2.0, dated November 1999 (the

Version 1.2.0 Standard).

FDA has reviewed the draft Standard,

the comments received, and the Version

1.2.0 Standard. FDA believes that

conformance to the Version 1.2.0

Standard, prepared and revised by

ICCBBA, will help facilitate the use of

a uniform container label for blood and

blood components. FDA is announcing

the availability of a guidance entitled

‘‘Guidance for Industry: Recognition

and Use of a Standard for the Uniform

Labeling of Blood and Blood

Components’’ that recognizes as

acceptable the Version 1.2.0 Standard

prepared by ICCBBA, and the

implementation of the ISBT 128

uniform labeling system, except where

inconsistent with FDA’s regulations

under 21 CFR 606.121. Although FDA

finds use of the Version 1.2.0 Standard

acceptable, FDA has identified

inconsistencies between the Version

1.2.0 Standard and Federal regulations.

FDA intends to revise the regulations to

remove these inconsistencies. The

guidance provides recommendations to

follow where discrepancies exist

between the Version 1.2.0 Standard and

the current regulations, pending

completion of rulemaking to remove

these discrepancies.

This guidance document represents

the agency’s current thinking with

regard to use of the Version 1.2.0

Standard for use in labeling blood,

blood components for transfusion,

Source Plasma, and other components

for further manufacturing use. 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 requirement of the

applicable statute, regulations, or both.

As with other guidance documents,

FDA does not intend this document to

be all-inclusive and cautions that not all

information may be applicable to all

situations. The document is intended to

provide information and does not set

forth requirements.

II. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments regarding this

guidance document at any time. Two

copies of any comments are to be

submitted, except individuals may

submit one copy. Comments should be

identified with the docket number

found in the brackets in the heading of

this document. A copy of the document

and received comments are available for

public examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

III. Paperwork Reduction Act of 1995

The labeling regulations on which the

guidance is based are reported under the

Office of Management and Budget

(OMB) control number 0910–0116. FDA

tentatively concludes that this guidance

contains no new collections of

information. Therefore, clearance by

OMB under the Paperwork Reduction

Act of 1995 is not required.

Federal Register / Vol. 65, No. 109 / Tuesday, June 6, 2000 / Notices 35945

IV. Electronic Access

Persons with access to the Internet

may obtain the guidance document and

the Version 1.2.0 Standard at http://

www.fda.gov/cber/guidelines.htm.

Dated: May 25, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–14211 Filed 6–2–00; 11:16 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D–1277]

Draft Guidance for Industry: Fumonisin

Levels in Human Foods and Animal

Feeds; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance

document entitled ‘‘Guidance for

Industry: Fumonisin Levels in Human

Foods and Animal Feeds.’’ The purpose

of this draft guidance is to identify for

the industry recommended maximum

fumonisin levels that FDA considers

adequate to protect human and animal

health and that are achievable in human

foods and animal feeds with the use of

good agricultural and good

manufacturing practices. FDA considers

this guidance to be a prudent public

health measure during the development

of a better understanding of the human

health risk associated with fumonisins

and the development of a long-term risk

management policy and program by the

agency for the control of fumonisins in

human foods and animal feeds.

DATES: Submit written comments by

August 7, 2000.

ADDRESSES: Submit written requests for

single copies of the draft guidance

entitled ‘‘Draft Guidance for Industry:

Fumonisin Levels in Human Foods and

Animal Feeds’’ to Henry Kim, Center for

Food Safety and Applied Nutrition

(CFSAN) (address below), or Randall A.

Lovell, Center for Veterinary Medicine

(CVM) (address below). Send one selfaddressed adhesive label to assist that

office in processing your request. The

draft guidance, CFSAN’s ‘‘Background

Paper in Support of Fumonisin Levels

in Corn and Corn Products Intended for

Human Consumption,’’ and CVM’s

‘‘Background Paper in Support of

Fumonisin Levels in Animal Feed,’’

may also be accessed at the CFSAN or

CVM home page on the Internet at http:/

/www.cfsan.fda.gov and http://

www.fda.gov/cvm, respectively.

Submit written comments on the draft

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. Comments

and requests for copies should be

identified with the docket number

found in brackets in the heading of this

document.

FOR FURTHER INFORMATION CONTACT:

Henry Kim, Center for Food Safety

and Applied Nutrition (HFS–306),

Food and Drug Administration, 200

C St. SW., Washington, DC 20204,

202–260–0631, FAX 202–205–4422,

or

Randall A. Lovell, Center for

Veterinary Medicine (HFV–222),

Food and Drug Administration,

7500 Standish Pl., Rockville, MD

20855, 301–827–0176, FAX 301–

827–1484.

SUPPLEMENTARY INFORMATION: FDA has

developed a draft guidance document

regarding the maximum recommended

levels of fumonisins in corn used for

production of human foods and animal

feeds. Fumonisins are naturally

occurring toxins produced by the molds

Fusarium moniliforme (F.

verticillioides), F. proliferatum, and

other Fusarium species that are common

contaminants of corn. Fumonisins have

been linked to a variety of significant

adverse health effects in livestock and

experimental animals. Although human

epidemiological studies are

inconclusive at this time, based on a

wide variety of significant adverse

animal health effects, FDA believes that

an association between fumonisins and

human disease is possible.

The purpose of the draft guidance is

to identify for the industry

recommended maximum fumonisin

levels that FDA considers adequate to

protect human and animal health and

that are achievable in human foods and

animal feeds with the use of good

agricultural and good manufacturing

practices. FDA considers this guidance

to be a prudent public health measure

during the development of a better

understanding of the human health risk

associated with fumonisins and the

development of a long-term risk

management policy and program by the

agency for the control of fumonisins in

human foods and animal feeds. Based

on information obtained from future

national and international workshops

on the risk from exposure to fumonisins,

FDA will consider whether to establish

tolerances, regulatory limits, or action

levels, as appropriate, for fumonisins in

human foods and animal feeds,

respectively, under 21 CFR Part 109—

Unavoidable Contaminants in Food for

Human Consumption and FoodPackaging Material and under 21 CFR

Part 509—Unavoidable Contaminants in

Animal Food and Food-Packaging

Material.

The agency has adopted good

guidance practices (GGP’s) that set forth

the agency’s policies and procedures for

the development, issuance, and use of

guidance documents (62 FR 8961,

February 27, 1997). The draft guidance

document entitled ‘‘Guidance for

Industry: Fumonisin Levels in Human

Foods and Animal Feeds’’ is being

issued as a level 1 draft guidance

consistent with GGP’s. This draft

guidance represents the agency’s current

thinking on the control of fumonisins in

human foods and animal feeds as a

prudent public health measure. 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 and regulations.

Interested persons may submit written

comments to the Dockets Management

Branch (address above) on the draft

guidance by August 7, 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 found in

brackets in the heading of this

document. The draft guidance, CFSAN’s

‘‘Background Paper in Support of

Fumonisin Levels in Corn and Corn

Products Intended for Human

Consumption,’’ CVM’s ‘‘Background

Paper in Support of Fumonisin Levels

in Animal Feed,’’ and received

comments may be seen in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

Dated: May 26, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–14106 Filed 6–5–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–2540–96]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Health Care Financing

Administration.