10700 Federal Register / Vol. 66, No. 33 / Friday, February 16, 2001 / Notices

practices regulation (21 CFR 10.115; 65

FR 56468, September 19, 2000). The

guidance represents the agency’s current

thinking on intermediates in drug

substance synthesis, bulk actives

postapproval changes, chemistry,

manufacturing, and controls

documentation. 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 statutes

and regulations.

II. Comments

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 guidance.

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 http://

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

or http://www.fda.gov/cvm.

Dated: February 8, 2001.

Ann M. Witt,

Acting Associate Commissioner for Policy.

[FR Doc. 01–3956 Filed 2–15–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D–1313]

Guidance for Industry on How to Use

E–Mail to Submit a Notice of Final

Disposition of Animals Not Intended

for Immediate Slaughter; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of the final guidance for

industry (#86) entitled ‘‘How to Use E–

Mail to Submit a Notice of Final

Disposition of Animals Not Intended for

Immediate Slaughter’’ to the Center for

Veterinary Medicine (CVM). This final

guidance provides guidelines to new

animal drug sponsors (sponsors) on how

to submit a notice of final disposition of

animals not intended for immediate

slaughter (NFDA) as an e-mail

attachment by Internet. This electronic

submission is part of CVM’s ongoing

initiative to provide a method for

paperless submissions. This final

guidance implements provisions of the

Government Paperwork Elimination Act

(GPEA).

DATES: Submit written comments on the

final guidance at any time.

ADDRESSES: Submit written comments

on the final guidance to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

Comments should be identified with the

full title of the final guidance and the

docket number found in brackets in the

heading of this document.

Copies of the final guidance

document entitled ‘‘How to Use E–Mail

to Submit a Notice of Final Disposition

of Animals Not Intended for Immediate

Slaughter’’ may be obtained on the

Internet from the CVM home page at

http://www.fda.gov/cvm/. Persons

without Internet access may submit

written requests for single copies of the

final 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.

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 40104), FDA published the

notice of availability of the draft

guidance entitled ‘‘How to Use E–Mail

to Submit a Notice of Final Disposition

of Animals Not Intended for Immediate

Slaughter’’ (hereinafter referred to as the

June 2000 notice). 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 final 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 docket

number 92S–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. The docket

is accessible on the Internet at http://

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

92s0251.htm. CVM will identify in this

public docket the types of documents

that may be submitted in electronic

form as those documents are identified

in final guidance or regulations.

The electronic submission of NFDA’s

is part of CVM’s ongoing initiative to

provide a method for paperless

submissions. This initiative reflects the

principles behind 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.

Before submitting NFDA’s by e-mail,

sponsors should first register and follow

the instructions in final guidance for

industry (#108) entitled ‘‘How to Use E–

Mail to Submit Information to the

Center for Veterinary Medicine.’’ This

final guidance is also available at http:/

/www.fda.gov/cvm.

CVM monitors the final disposition of

food animals treated with

investigational new animal drugs in

situations where the treated animals do

not enter the human food chain

immediately at the completion of the

investigational study. Monitoring of the

final disposition of such food animals is

consistent with CVM’s responsibility to

protect the public health under the

Federal Food, Drug, and Cosmetic Act.

In addition, acceptable standards of

study conduct such as those set out in

21 CFR 514.117 include sponsors

accounting for the disposition of all

animals treated with investigational

new animal drugs. Furthermore, CVM

requests this information because some

animals are held for 30 days after the

investigational drug withdrawal period

ends, and CVM does not request a

notice of intent to slaughter for human

food purposes for these animals.

Animals held for this period may still be

sent for slaughter, however. CVM issues

a slaughter authorization letter to

sponsors that sets the terms under

which animals treated with

investigational new animal drugs may

be slaughtered (21 CFR 511.1(b)(5)).

Also in this letter, CVM requests that

sponsors submit NFDA’s for animals

that are treated with investigational new

animal drugs and are not intended for

immediate slaughter. NFDA’s have

historically been submitted to CVM on

Federal Register / Vol. 66, No. 33 / Friday, February 16, 2001 / Notices 10701

paper. This final guidance will give

sponsors the option to submit an NFDA

as an e-mail attachment to CVM via the

Internet.

II. Significance of Guidance

This Level 1 final guidance is being

issued consistent with FDA’s good

guidance practices regulation (21 CFR

10.115; 65 FR 56468, September 19,

2000). The final guidance represents the

agency’s current thinking about using email to submit an NFDA. It does not

create or confer any rights for or on any

person and will not operate to bind FDA

or the public. An alternative approach

may be used if such approach satisfies

the requirements of the applicable

statutes and regulations.

III. Paperwork Reduction Act of 1995

In the June 2000 notice, 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 document.

No comments were received on the

estimated annual reporting burden. The

annual reporting burden estimate of 262

hours therefore remains unchanged. In

the Federal Register of September 21,

2000 (65 FR 57193), 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. 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. The information collection

provisions related to this final guidance

have been approved under OMB control

number 0910–0453. This approval

expires November 30, 2003.

IV. 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 final

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 submit to the

Dockets Management Branch (address

above) written comments on this final

guidance at any time. Two copies of any

comments are to be submitted, except

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

final 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 9, 2001.

Ann M. Witt,

Acting Associate Commissioner for Policy.

[FR Doc. 01–3886 Filed 2–15–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D–1316]

Guidance for Industry on How to Use

E–Mail to Submit a Request for a

Meeting or Teleconference to the

Office of New Animal Drug Evaluation;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of the final guidance for

industry (#88) entitled. ‘‘How to Use E–

Mail to Submit a Request for a Meeting

or Teleconference to the Office of New

Animal Drug Evaluation’’ in the Center

for Veterinary Medicine (CVM). This

final guidance provides guidelines to

new animal drug sponsors (sponsors) on

how to submit a request for a meeting

or teleconference about a new animal

drug submission as an e-mail

attachment by Internet. These electronic

submissions are part of CVM’s ongoing

initiative to provide a method for

paperless submissions. This final

guidance implements provisions of the

Government Paperwork Elimination Act

(GPEA).

DATES: Submit written comments at any

time.

ADDRESSES: Copies of the final guidance

document entitled ‘‘How to Use E–Mail

to Submit a Request for a Meeting or

Teleconference to the Office of New

Animal Drug Evaluation’’ may be

obtained on the Internet from the CVM

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

. Persons without Internet access may

submit written requests for single copies

of the final 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 final

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. Comments

should be identified with the full title

of the final guidance document and the

docket number found in brackets in the

heading of this 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 40108), FDA published the

notice of availability of the draft

guidance entitled ‘‘How to Use E–Mail

to Submit a Request for a Meeting or

Teleconference to the Office of New

Animal Drug Evaluation’’ giving

interested persons 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, final 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 final rule also established

public docket number 97S–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 that may be submitted in

electronic form as those documents are

identified in final guidance or

regulations. This docket is accessible on

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

ohrms/dockets/dockets/92s0251/

92s0251.htm.

The electronic submission of requests

for meetings and teleconferences 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.

On request, CVM will hold meetings

and/or teleconferences to assist

sponsors with new animal drug

submissions and general questions.

Currently, sponsors submit meeting and