Federal Register / Vol. 66, No. 246 / Friday, December 21, 2001 / Notices 65977

City: llllll

State: llllll

Zip Code: llllll

Phone: ( ) llllll

FAX: ( ) llllll

E-mail: llllll

Transcripts: Transcripts of the public

workshop may be requested in writing

from the Freedom of Information Office

(HFI–35), Food and Drug

Administration, 5600 Fishers Lane, rm.

12A–16, Rockville, MD 20857,

approximately 15 working days after the

public workshop at a cost of 10 cents

per page.

SUPPLEMENTARY INFORMATION: The

workshop is being held in response to

a request by the State of Missouri to

present information that would be

helpful to regulated industry. The Small

Business Program presents this

workshop to help achieve objectives set

forth in section 406 of the Food and

Drug Administration Modernization Act

of 1997 (21 U.S.C. 393), which include

working closely with stakeholders and

maximizing the availability and clarity

of information to stakeholders and the

public. This is consistent with the

purposes of the Small Business

Program, which are in part to respond

to industry inquiries, develop

educational materials, sponsor

workshops and conferences to provide

firms, particularly small businesses,

with firsthand working knowledge of

FDA’s requirements and compliance

policies. This workshop is also

consistent with the Small Business

Regulatory Enforcement Fairness Act of

1996 (Public Law 104–121), as outreach

activities by Government agencies to

small businesses.

The goal of the workshop is to present

information that will enable

manufacturers and regulated industry to

better comply with labeling

requirements, especially in light of

growing concerns about food allergens.

Information presented will be based on

agency position as articulated through

regulation, compliance policy guides,

and information previously made

available to the public. Topics to be

discussed at the workshop include: (1)

FDA food regulations, (2) food labeling,

(3) allergen declaration, (4) good

manufacturing practices, and (5) the

Nutrition Labeling Education Act. FDA

expects that participation in this

workshop will provide regulated

industry with greater understanding of

the regulatory and policy perspectives

on food labeling and allergen

declaration.

Dated: December 18, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–31572 Filed 12–19–01; 12:37

pm]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D–0465]

Guidance for Industry on Major, Minor,

and Telephone Amendments to

Abbreviated New Drug Applications;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a guidance for industry

entitled ‘‘Major, Minor, and Telephone

Amendments to Abbreviated New Drug

Applications.’’ This guidance is a

second revision of the guidance entitled

‘‘Major, Minor, FAX, and Telephone

Amendments to Original Abbreviated

New Drug Applications.’’ FDA’s Office

of Generic Drugs (OGD) determined that

further revision of the policy regarding

determination of major, minor, and

telephone amendments was necessary to

help streamline the review of

abbreviated new drug applications

(ANDAs).

DATES: Submit written or electronic

comments on the guidance by March 21,

2002. General comments on agency

guidance documents are welcome at any

time.

ADDRESSES: Submit written requests for

single copies of this guidance to the

Division of Drug Information (HFD–

240), Center for Drug Evaluation and

Research, Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857. Send one selfaddressed adhesive label to assist that

office in processing your requests.

Submit written comments on the

guidance 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. See

the SUPPLEMENTARY INFORMATION section

for electronic access to the guidance

document.

FOR FURTHER INFORMATION CONTACT: Rita

R. Hassall, Center for Drug Evaluation

and Research (HFD–600), Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–827–

5845.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of

a guidance for industry entitled ‘‘Major,

Minor, and Telephone Amendments to

Abbreviated New Drug Applications.’’

The guidance is intended to document

OGDs policy regarding the

determination of major, minor, and

telephone amendments to original and

supplemental ANDAs. This guidance

first published in August 1999 and was

originally entitled ‘‘Major, Minor, FAX,

and Telephone Amendments to Original

Abbreviated New Drug Applications.’’ It

was revised in May 2000 to explain that

the issuance of a major, minor, or FAX

amendment would stop the review

clock.

The second revision of this guidance

(1) deletes the FAX amendment

designation, which was found to be

unnecessary, (2) now applies to

supplemental applications as well, and

(3) changes the criteria for determining

the type of amendment. The changes in

criteria should result in more

amendments being categorized as

‘‘minor’’ and fewer as ‘‘major.’’ A minor

amendment request (generally reviewed

within 30 to 60 days) has a higher

priority than a major amendment. Since

the review of a minor amendment takes

place sooner than a major amendment

after the original review, there is not a

long break in the review process for a

minor amendment. The response to a

major amendment request, however,

goes into the 180-day queue. This

process causes a greater time lapse from

when the original review was done and

results in reviewers having to

refamiliarize themselves with the

application. It is expected that the new

policy will help in moving applications

through the approval process more

quickly than under the previous policy.

Thus the total time for approval of

ANDAs will be reduced.

Because it lessens the burden on

industry, this guidance is being issued

as a Level 1 guidance for immediate

implementation, consistent with FDA’s

good guidance practices regulation (21

CFR 10.115). As with other Level 1

guidances for immediate

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