65978 Federal Register / Vol. 66, No. 246 / Friday, December 21, 2001 / Notices

implementation, the agency is soliciting

comments from the public. This

guidance represents the agency’s current

thinking on major, minor, and telephone

amendments to ANDAs. 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.

II. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments on the

guidance. 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 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.

III. Electronic Access

Persons with access to the Internet

may obtain the document at either http:/

/www.fda.gov/cder/guidance/index.htm

or http://www.fda.gov/ohrms/dockets/

default.htm.

Dated: December 3, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–31454 Filed 12–20–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D–0493]

Draft Guidance for Industry:

Exemptions from the Warning Label

Requirement for Juice—

Recommendations for Effectively

Achieving a 5-Log Reduction;

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availability of a draft guidance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 ‘‘Exemptions from

the Warning Label Requirement for

Juice—Recommendations for Effectively

Achieving a 5-Log Reduction.’’ This

draft document is intended to provide

guidance to fruit and vegetable juice

producers about FDA’s revised

recommendations for effectively

achieving a 5-log pathogen reduction

that is the basis for exempting juice

products from the warning label

requirement established by a July 8,

1998, final rule entitled ‘‘Food Labeling:

Warning and Notice Statement; Labeling

of Juice Products’’ (the juice labeling

rule). A 5-log reduction is also a

requirement of the January 19, 2001,

final rule entitled ‘‘Hazard Analysis and

Critical Control Point (HACCP);

Procedures for the Safe and Sanitary

Processing and Importing of Juice’’ (the

juice HACCP rule). This draft guidance

describes FDA’s current

recommendations for effectively

achieving a 5-log pathogen reduction in

juice.

DATES: Submit written or electronic

comments to ensure adequate

consideration in preparation of the final

guidance document by February 19,

2002. Comments on this guidance may

be submitted at any time.

ADDRESSES: Submit written requests for

single copies of the draft guidance to

Jennifer A. Burnham, Center for Food

Safety and Applied Nutrition (CFSAN)

(address below).

Submit written comments on the

document to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. Submit

electronic comments to http://

www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT:

Jennifer A. Burnham, Center for Food

Safety and Applied Nutrition (HFS–

306), Food and Drug Administration,

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

202–260–0773, FAX: 202–205–4422.

SUPPLEMENTARY INFORMATION:

I. Background

FDA has revised its guidance for

effectively achieving a 5-log pathogen

reduction in juice. The purpose of this

guidance is to encourage those juice

processors not yet subject to the juice

HACCP rule (e.g., small and very small

processors who are not subject to the

juice HACCP rule until January 21, 2003

and January 20, 2004, respectively) who

are performing a 5-log reduction to

attain exemption from the warning label

requirement to apply effective 5-log

reduction treatments based upon

current science. This draft guidance also

provides guidance to processors at retail

who are not subject to the juice HACCP

rule and who are performing a 5-log

reduction to attain exemption from the

warning label requirements.

In the Federal Register of July 8,

1998, FDA issued the juice labeling rule

(63 FR 37030). That final rule requires

a warning statement on fruit and

vegetable juices and juice ingredients

that have not been processed to prevent,

reduce, or eliminate pathogenic

microorganisms that may be present.

Specifically, under 21 CFR 101.17(g),

juice and juice ingredients must bear a

warning label if they have not been

processed to achieve a 5-log pathogen

reduction, or a reduction that is equal

to, or greater than, the criterion

established for process controls by any

final regulation requiring the

application of HACCP principles to the

processing of juice and juice

ingredients. The warning label was

intended to provide a measure of public

safety until final HACCP regulations

could be established and implemented.

In the Federal Register of January 19,

2001 (66 FR 6138), FDA issued the juice

HACCP rule; this rule mandates the

implementation of HACCP principles

and an effective 5-log pathogen

reduction treatment to ensure the safe

and sanitary processing of fruit and

vegetable juices and ingredients. In the

juice HACCP rule, FDA set forth certain

criteria for achieving the 5-log pathogen

reduction, which are consistent with

current scientific knowledge as

described in the juice HACCP rule. This

draft guidance will assist juice

processors in effectively achieving a 5-

log pathogen reduction in a manner

consistent with that knowledge.

This document is being issued

consistent with FDA’s good guidance

practices regulation (21 CFR 10.115).

The draft guidance entitled ‘‘Guidance

for Industry: Exemptions from the

Warning Label Requirement for Juice—

Recommendations for Effectively

Achieving a 5-Log Reduction’’ is being

issued as a level 1 draft guidance

consistent with GGPs. This draft

guidance represents the agency’s current

recommendations for effectively

achieving a 5-log pathogen reduction in

juice. 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.

II. Comments

Interested persons may submit written

or electronic comments to the Dockets

Management Branch (address above) on

the draft guidance by February 19, 2002.

However, interested persons may

submit written or electronic comments

at any time. 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 the brackets in

the heading of this document. The draft

guidance and received comments may

Federal Register / Vol. 66, No. 246 / Friday, December 21, 2001 / Notices 65979

be seen in the Dockets Management

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

Monday through Friday.

III. Electronic Access

Persons with access to the Internet

may obtain the document at the CFSAN

home page at http://www.cfsan.fda.gov.

Dated: December 14, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–31453 Filed 12–20–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4644–N–51]

Federal Property Suitable as Facilities

To Assist the Homeless

AGENCY: Office of the Assistant

Secretary for Community Planning and

Development, HUD.

ACTION: Notice.

SUMMARY: This Notice identifies

unutilized, underutilized, excess, and

surplus Federal property reviewed by

HUD for suitability for possible use to

assist the homeless.

FOR FURTHER INFORMATION CONTACT:

Mark Johnston, room 7262, Department

of Housing and Urban Development,

451 Seventh Street SW., Washington,

DC 20410; telephone (202) 708–4300;

TTY number for the hearing- and

speech-impaired (202) 708–2565 (these

telephone numbers are not toll-free), or

call the toll-free Title V information line

at 1–800–927–7588.

SUPPLEMENTARY INFORMATION: In

accordance with 24 CFR part 581 and

section 501 of the Stewart B. McKinney

Homeless Assistance Act (42 U.S.C.

11411), as amended, HUD is publishing

this Notice to identify Federal buildings

and other real property that HUD has

reviewed for suitability for use to assist

the homeless. The properties were

reviewed using information provided to

HUD by Federal landholding agencies

regarding unutilized and underutilized

buildings and real property controlled

by such agencies or by GSA regarding

its inventory of excess or surplus

Federal property. This Notice is also

published in order to comply with the

December 12, 1988 Court Order in

National Coalition for the Homeless v.

Veterans Administration, No. 88–2503–

OG (D.D.C.).

Properties reviewed are listed in this

Notice according to the following

categories: Suitable/available, suitable/

unavailable, suitable/to be excess, and

unsuitable. The properties listed in the

three suitable categories have been

reviewed by the landholding agencies,

and each agency has transmitted to

HUD: (1) Its intention to make the

property available for use to assist the

homeless, (2) its intention to declare the

property excess to the agency’s needs, or

(3) a statement of the reasons that the

property cannot be declared excess or

made available for use as facilities to

assist the homeless.

Properties listed as suitable/available

will be available exclusively for

homeless use for a period of 60 days

from the date of this Notice. Where

property is described as for ‘‘off-site use

only’’ recipients of the property will be

required to relocate the building to their

own site at their own expense.

Homeless assistance providers

interested in any such property should

send a written expression of interest to

HHS, addressed to Brian Rooney,

Division of Property Management,

Program Support Center, HHS, room

5B–41, 5600 Fishers Lane, Rockville,

MD 20857; (301) 443–2265. (This is not

a toll-free number.) HHS will mail to the

interested provider an application

packet, which will include instructions

for completing the application. In order

to maximize the opportunity to utilize a

suitable property, providers should

submit their written expressions of

interest as soon as possible. For

complete details concerning the

processing of applications, the reader is

encouraged to refer to the interim rule

governing this program, 24 CFR part

581.

For properties listed as suitable/to be

excess, that property may, if

subsequently accepted as excess by

GSA, be made available for use by the

homeless in accordance with applicable

law, subject to screening for other

Federal use. At the appropriate time,

HUD will publish the property in a

Notice showing it as either suitable/

available or suitable/unavailable.

For properties listed as suitable/

unavailable, the landholding agency has

decided that the property cannot be

declared excess or made available for

use to assist the homeless, and the

property will not be available.

Properties listed as unsuitable will

not be made available for any other

purpose for 20 days from the date of this

Notice. Homeless assistance providers

interested in a review by HUD of the

determination of unsuitability should

call the toll free information line at 1–

800–927–7588 for detailed instructions

or write a letter to Clifford Taffet at the

address listed at the beginning of this

Notice. Included in the request for

review should be the property address

(including zip code), the date of

publication in the Federal Register, the

landholding agency, and the property

number.

For more information regarding

particular properties identified in this

Notice (i.e., acreage, floor plan, existing

sanitary facilities, exact street address),

providers should contact the

appropriate landholding agencies at the

following addresses: GSA: Mr. Brian K.

Polly, Assistant Commissioner, General

Services Administrati9on, Office of

Property Disposal, 18th and F Streets,

NW., Washington, DC 20405; (202) 501–

0052; NAVY: Mr. Charles C. Cocks,

Director, Department of the Navy, Real

Estate Policy Division, Naval Facilities

Engineering Command, Washington

Navy Yard, 1322 Patterson Ave., SE.,

Suite 1000, Washington, DC 20374–

5065; (202) 685–9200; (These are not

toll-free numbers).

Dated: December 13, 2001.

John D. Garrity,

Director, Office of Special Needs Assistance

Programs.

TITLE V, FEDERAL SURPLUS PROPERTY

PROGRAM FEDERAL REGISTER REPORT

FOR 12/21/01

Suitable/Available Properties

Building (by State)

Maryland

Stillpond Housing

521 Round Top Road

Chestertown Co: Queen Anne’s MD 21620–

Landholding Agency: GSA

Property Number: 54200140013

Status: Excess

Comment: 1000 sq. ft., most recent use—

residential

GSA Number: 4–U–MD–603

Stillpond Housing

131 Fairview Drive

Chesterview Co: Queen Anne’s MD 21620–

Landholding Agency: GSA

Property Number: 54200140014

Status: Excess

Comment: 1000 sq. ft., most recent use—

residential

GSA Number: 4–U–MD–603

Stillpond Housing

100 Farwell Road

Chesterview Co: Queen Anne’s MD 21620–

Landholding Agency: GSA

Property Number: 54200140015

Status: Excess

Comment: 1000 sq. ft., most recent use—

residential presence of lead paint

GSA Number: 4–U–MD–603

Stillpond Housing

115 Rolling Road

Chesterview Co: Kent MD 21620–

Landholding Agency: GSA

Property Number: 54200140016

Status: Excess

Comment: 750 sq. ft., most recent use—

residential

GSA Number: 4–U–MD–603

Stillpond Housing

303 Oriole Road