11174 Federal Register / Vol. 66, No. 36 / Thursday, February 22, 2001 / Notices

www.fda.gov/ohrms/dockets/dockets/

92s0251/92s0251.htm.

The electronic submission of

slaughter notices is part of CVM’s

ongoing initiative to provide a method

for paperless submissions. The final

guidance implements provisions of the

GPEA. The GPEA of 1998 (Public Law

105–277) requires Federal agencies, by

October 21, 2003, to provide: (1) For the

option of the electronic maintenance,

submission, or disclosure of

information, if practicable, as a

substitute for paper; and (2) for the use

and acceptance of electronic signatures,

when practicable.

Section 512(j) of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C.

360(b)(j)) gives FDA the authority to

issue regulations setting out conditions

for marketing animals treated with

investigational new animal drugs for

food use. Under this authority, FDA

issued § 511.1(b)(4) (21 CFR

511.1(b)(4)), which requires that

sponsors obtain authorization to

slaughter these animals for use as

human food. Under § 511.1(b)(5), CVM

issues to sponsors a slaughter

authorization letter that sets the terms

under which the animals treated with

investigational new animal drugs may

be slaughtered. USDA also monitors the

slaughter of animals treated with

investigational new animal drugs under

the authority of the Meat Inspection Act

(21 U.S.C. 601–95). To assist CVM and

USDA with this monitoring, the

slaughter authorization states that

sponsors must submit slaughter notices

each time such animals are to be

slaughtered unless CVM waives the

notice in the authorization letter.

Currently, slaughter notices are

submitted to CVM on paper. This

guidance will give sponsors the option

to submit a slaughter notice as an e-mail

attachment to CVM and USDA by the

Internet.

Before submitting slaughter notices by

e-mail, sponsors should first register

and follow the instructions in the

guidance for industry (#108) entitled

‘‘How to Use E–mail to Submit

Information to the Center for Veterinary

Medicine.’’

II. Significance of Guidance

This Level 1 guidance is being issued

consistent with FDA’s good guidance

practices regulation (21 CFR 10.115; 65

FR 56468, September 19, 2000). The

guidance represents the agency’s current

thinking about using e-mail to submit a

slaughter notice. This guidance 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 statutes and regulations.

III. Paperwork Reduction Act of 1995

In the notice announcing the

availability of the draft version of this

guidance, FDA published a notice of the

proposed collection of information

related to the guidance. The Federal

Register notice also requested

comments on the burden estimates for

the guidance documents. No comments

were received on the estimated annual

reporting burden. The annual reporting

burden estimate of 27 hours therefore

remains unchanged. In the Federal

Register of September 21, 2000 (65 FR

57192), the agency announced that it

was submitting the collection of

information to the Office of

Management and Budget (OMB) for

review and clearance under the

Paperwork Reduction Act of 1995. The

information collection provisions

related to this guidance document have

been approved under OMB control

number 0910–0450. This approval

expires November 30, 2003. An agency

may not conduct or sponsor, and a

person is not required to respond to, a

collection of information unless it

displays a currently valid OMB control

number.

IV. Electronic Access

Persons with access to the Internet

may obtain the document at http://

www.fda.gov/cvm.

V. Comments

As with all of FDA’s guidances, the

public is encouraged to submit written

comments with new data or other new

information pertinent to this guidance.

FDA will periodically review the

comments in the docket and, where

appropriate, will amend the guidance.

The agency will notify the public of any

such amendments through a notice in

the Federal Register.

Interested persons may, at any time,

submit written comments on the

guidance to the Dockets Management

Branch (address above). 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. 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.

Dated: February 14, 2001.

Ann M. Witt,

Acting Associate Commissioner for Policy.

[FR Doc. 01–4419 Filed 2–21–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D–0005]

Draft Guidance for Industry on

Labeling Over-the-Counter Human

Drug Products; Updating Labeling in

ANDA’s; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance for

industry entitled ‘‘Labeling Over-theCounter Human Drug Products;

Updating Labeling in ANDA’s.’’ This

draft guidance is intended to assist

manufacturers, packers, and distributors

of over-the-counter (OTC) drug products

marketed under abbreviated new drug

applications (ANDA’s) and

manufacturers of reference listed drugs

(RLD’s) to implement the agency’s

regulation on standardized content and

format requirements for the labeling of

OTC drug products.

DATES: Submit written comments on the

draft guidance for industry by April 23,

2001.

ADDRESSES: Copies of the draft guidance

for industry are available on the Internet

at http://www.fda.gov/cder/guidance/

index.htm. Submit written requests for

single copies of the draft guidance to the

Drug Information Branch (HFD–210),

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 request.

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.

FOR FURTHER INFORMATION CONTACT:

Gerald M. Rachanow, Center for Drug

Evaluation and Research (HFD–560),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–2222.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a draft

guidance for industry entitled ‘‘Labeling

OTC Human Drug Products; Updating

Federal Register / Vol. 66, No. 36 / Thursday, February 22, 2001 / Notices 11175

Labeling in ANDA’s.’’ This is one of

several guidances the agency is

developing to help manufacturers,

packers, and distributors implement the

recently issued final rule establishing

standardized content and format

requirements for the labeling of all OTC

drug products. Once finalized, these

guidances will supersede all other

statements, feedback, and

correspondence provided by the agency

on these matters since the issuance of

the final rule.

In the Federal Register of March 17,

1999 (64 FR 13254), FDA published a

final rule establishing standardized

content and format requirements for the

labeling of OTC drug products. This rule

is intended to standardize labeling for

all OTC drug products so consumers can

easily read and understand OTC drug

product labeling and use these products

safely and effectively.

The regulation for this new

standardized labeling requires

manufacturers to present OTC drug

labeling information in a prescribed

order and format. This new format will

require revision of all existing labeling.

Following issuance of the final rule,

the agency received several inquiries

from manufacturers of generic OTC drug

products seeking guidance on whether

they may convert products to the new

labeling format before the applicable

innovator (or RLD) product revises its

labeling. This guidance addresses those

inquiries.

Generally, the agency believes

manufacturers of generic OTC drug

products (i.e., products marketed under

ANDA’s) need not wait to implement

the new labeling format until after the

RLD holder has submitted its labeling.

This guidance is intended to facilitate

the updating of labeling in ANDA’s to

meet the new OTC drug products format

requirement. Accordingly, the agency

has developed labeling examples as

guidance for manufacturers to follow.

Two such labeling examples are

attached to the draft guidance. The

additional labeling examples that the

agency proposes to develop will be

made available for review in this docket

and at the Internet site referenced in this

draft guidance before the close of the

comment period.

This draft guidance is being issued

consistent with FDA’s good guidance

practices regulation (21 CFR 10.115; 65

FR 56468, September 19, 2000). The

draft guidance represents the agency’s

current thinking on updating labeling in

ANDA’s consistent with the new OTC

drug products standardized labeling

content and format. 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 an approach satisfies the

requirements of the applicable statutes

and regulations.

Interested persons may, on or before

April 23, 2001, submit written

comments on the draft guidance to the

Dockets Management Branch (address

above). 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 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: February 8, 2001.

Ann M. Witt,

Acting Associate Commissioner for Policy.

[FR Doc. 01–4312 Filed 2–21–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D–0059]

Draft Guidance for Industry on

Separate Marketing Applications and

Definition of Clinical Data for Purposes

of Assessing User Fees; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance for

industry entitled ‘‘Separate Marketing

Applications and Clinical Data for

Purposes of Assessing User Fees.’’ This

draft guidance revises a procedural

guidance entitled ‘‘Attachment E—

Interim Guidance: Separate Marketing

Applications and Clinical Data for

Purposes of Assessing User Fees Under

the User Fee Act of 1992’’ issued in July

1993 (the July 1993 interim guidance),

which provided guidance on the

agency’s policy on ‘‘bundling’’

applications and a definition of

‘‘clinical data’’ for user fee purposes.

This draft guidance deletes two

appendices in the July 1993 interim

guidance and directs readers to the

agency publication entitled ‘‘Approved

Drug Products with Therapeutic

Equivalence Evaluations’’ (the Orange

Book) for a listing of routes of

administration and dosage forms.

DATES: Submit written comments on

this draft guidance by March 26, 2001.

General comments are welcome at any

time.

ADDRESSES: Copies of this draft

guidance for industry are available on

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

guidance and http:/www.fda.gov/cder/

pdufa/default.htm. Submit written

requests for single copies of the draft

guidance entitled ‘‘Separate Marketing

Applications and Clinical Data for

Purposes of Assessing User Fees’’ to the

Drug Information Branch (HFD–210),

Center for Drug Evaluation and

Research, Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, or 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. The

document may also be obtained by fax

by calling the FAX Information System

at 1–888–CBER–FAX or 301–827–3844.

Send one self-addressed adhesive label

to assist the office in processing your

request. 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.

FOR FURTHER INFORMATION CONTACT:

Michael D. Jones, Center for Drug

Evaluation and Research (HFD–5),

Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857, 301–594–2041, FAX 301–

827–5562, or

Carla A. Vincent, Center for Biologics

Evaluation and Research (HFM–

110), 1401 Rockville Pike,

Rockville, MD 20852, 301–827–

3503, FAX 301–827–2875.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a draft

guidance for industry entitled ‘‘Separate

Marketing Applications and Clinical

Data for Purposes of Assessing User

Fees.’’ This draft guidance revises the

July 1993 interim guidance.

The agency is deleting from the 1993

interim guidance the list of routes of

administration in appendix A and

dosage forms in appendix B.

FDA is deleting appendices A and B

so that the guidance reflects current

agency policy, as developed over the

past few years (see Docket Nos. 93P–

0421, 95P–0262, 96P–0317, and 96P–

0459). Among other things, in the

review of abbreviated new drug

applications, the Center for Drug

Evaluation and Research generally has

not considered different mechanisms of

release, particularly for suppository,

delayed, and controlled release

products, as different dosage forms.