Federal Register / Vol. 66, No. 36 / Thursday, February 22, 2001 / Notices 11173

addition, CVM will identify those

documents in guidances or regulations.

This docket is accessible on the Internet

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

dockets/92s0251/92s0251.htm. 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.

CVM accepts certain types of

submissions by e-mail with no

requirement for a paper copy. These

types of documents are listed in public

docket 97S–0251 as required by § 11.2.

CVM’s ability to receive and process

information submitted electronically is

limited by its current information

technology capabilities and the

requirements of the electronic records;

electronic signatures regulation. This

guidance outlines general standards that

should be used for the successful

electronic submission of any

information by e-mail.

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

information electronically. The

document does not create or confer any

rights for or on any person and will not

operate to bind FDA or the public.

Alternative methods may be used as

long as they satisfy the requirements 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 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 140 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 0910–0453. 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. 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.

Dated: February 14, 2001.

Ann M. Witt,

Acting Associate Commissioner for Policy.

[FR Doc. 01–4313 Filed 2–21–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D–1314]

Guidance for Industry on How to Use

E–Mail to Submit a Notice of Intent to

Slaughter for Human Food Purposes;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of the guidance for industry

(#87) entitled ‘‘How to Use E–Mail to

Submit a Notice of Intent to Slaughter

for Human Food Purposes.’’ The

purpose of this document is to provide

guidance to new animal drug sponsors

(sponsors) on how to submit an

electronic notice of intent to slaughter

for human food purposes (slaughter

notices) to the Center for Veterinary

Medicine (CVM) and the U.S.

Department of Agriculture (USDA). This

electronic submission is part of CVM’s

ongoing initiative to provide a method

for paperless submissions. This

guidance implements provisions of the

Government Paperwork Elimination Act

(GPEA).

DATES: Submit written comments at any

time.

ADDRESSES: Submit written requests for

single copies of this 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 the

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. See the

SUPPLEMENTARY INFORMATION section for

electronic access to the guidance

document.

FOR FURTHER INFORMATION CONTACT:

Janis R. Messenheimer, Center for

Veterinary Medicine (HFV–135), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–827–

7578, e-mail: jmessenh@cvm.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of June 29,

2000 (65 FR 40106), FDA published the

notice of availability of the draft

guidance entitled ‘‘How to Use E–Mail

to Submit a Notice of Intent to Slaughter

for Human Food Purposes.’’ Interested

persons were given until August 28,

2000, to submit comments. FDA

received no comments.

In the Federal Register of March 20,

1997 (62 FR 13430), FDA published the

electronic records; electronic signatures

regulation. This regulation (21 CFR part

11) provides for the voluntary

submission of parts or all of regulatory

records in electronic format without an

accompanying paper copy. This rule

also established public docket number

92N–0251 to provide a permanent

location for a list of the documents or

parts of documents that are acceptable

for submission in electronic form

without paper records and the agency

units to which such submissions may be

made. CVM will identify in this public

docket the types of documents which

may be submitted in electronic form, as

an e-mail attachment by Internet, as

those documents are identified in final

guidance or regulations. This docket is

accessible on the Internet at http://

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