40106 Federal Register / Vol. 65, No. 126 / Thursday, June 29, 2000 / Notices

address, and information about the

treated animals. The likely respondents

to this collection of information are new

animal drug sponsors who have

conducted clinical investigations under

§ 511.1(b).

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1

FDA Form No. No. of Respondents Annual Frequency

per Response

Total Annual

Responses Hours per Response Total Hours

3487 190 1.7 324 0.81 262

1There are no capital costs or operating and maintenance costs associated with this collection of information.

The estimates in Table 1 of this

document resulted from discussions

with new animal drug sponsors. The

estimated burden includes NFDA’s

submitted on paper and by e-mail.

IV. Comments

This draft guidance document is being

distributed for comment purposes only

and is not intended for implementation

at this time. Interested persons may

submit to the Dockets Management

Branch (address above) written

comments regarding this draft guidance

document. Submit written comments by

August 28, 2000, to ensure adequate

consideration in preparation of the final

document. 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.

Submit written comments concerning

the information collection requirements

to the Dockets Management Branch by

August 28, 2000. A copy of the

document and received comments may

be seen in the Dockets Management

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

Monday through Friday.

Dated: June 16, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–16392 Filed 6–26–00; 10:07 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D–1314]

Draft Guidance for Industry on How to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availability of the draft guidance for

industry (#87) entitled ‘‘How to Use E–

Mail to Submit a Notice of Intent to

Slaughter for Human Food Purposes’’ in

the Center for Veterinary Medicine

(CVM) and U.S. Department of

Agriculture (USDA). This draft guidance

is neither final nor is it in effect at this

time. The purpose of this draft guidance

document is to provide guidance to new

animal drug sponsors (sponsors) on how

to submit a notice of intent to slaughter

for human food purposes (slaughter

notices) 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 draft guidance

implements provisions of the

Government Paperwork Elimination Act

(GPEA).

DATES: Submit written comments on the

draft guidance at any time, however,

comments should be submitted by

August 28, 2000 to ensure their

adequate consideration in preparation of

the final document. Submit written

comments on the collection of

information requirements by August 28,

2000.

ADDRESSES: 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.

Comments should be identified with the

full title of the draft guidance and the

docket number found in brackets in the

heading of this document.

Copies of the draft guidance

document entitled ‘‘How to Use E–Mail

to Submit a Notice of Intent to Slaughter

for Human Food Purposes’’ 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 draft 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

collection of information requirements

to the Dockets Management Branch

(address above). Comments should be

identified with 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 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 public

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. CVM will

identify in this public docket the types

of documents that may be submitted in

electronic form as those documents that

are identified in final guidances or

regulations. This docket is accessible on

the Internet at http://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 draft

guidance implements provisions of the

GPEA. The GPEA of 1998 (Public Law

105–277) requires Federal agencies, by

October 21, 2003, to provide for: (1) The

option of the electronic maintenance,

submission, or disclosure of

information, if practicable, as a

substitute for paper; and (2) the use and

acceptance of electronic signatures,

when practicable. In order to submit

slaughter notices by e-mail, sponsors

should first register and follow the

instructions in draft guidance for

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

Submit Information to the Center for

Federal Register / Vol. 65, No. 126 / Thursday, June 29, 2000 / Notices 40107

Veterinary Medicine’’ when it becomes

final.

Section 512(j) of the Federal Food,

Drug, and Cosmetic Act (the act) (21

U.S.C. 360b(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))

that requires that sponsor obtain

authorization to slaughter these animals

for food. Under § 511.1(b)(5), CVM

issues a slaughter authorization letter to

sponsors 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.

II. Significance of Guidance

This Level 1 draft guidance is being

issued consistent with FDA’s good

guidance practices (62 FR 8961,

February 27, 1997). The draft guidance

represents the agency’s current thinking

about using e-mail to submit a slaughter

notice. 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 statute,

regulations, or both.

III. Paperwork Reduction Act of 1995

Under the Paperwork Reduction Act

of 1995 (the PRA) (44 U.S.C. 3501–

3520), Federal agencies must obtain

approval from the Office of Management

and Budget (OMB) for each collection of

information they conduct or sponsor.

‘‘Collection of information’’ is defined

in 44 U.S.C. 3502(3) and 5 CFR

1320.3(c) and includes agency requests

or requirements that members of the

public submit reports, keep records, or

provide information to a third party.

Section 3506(c)(2)(A) of the PRA (44

U.S.C. 3506(c)(2)(A)) requires Federal

agencies to provide a 60-day notice in

the Federal Register concerning each

proposed collection of information

before submitting the collection to OMB

for approval. To comply with this

requirement, FDA is publishing a notice

of the proposed collection of

information set forth in this document.

With respect to the following

collection of information, FDA invites

comments on: (1) Whether the proposed

collection of information is necessary

for the proper performance of FDA’s

functions, including whether the

information will have practical utility;

(2) the accuracy of FDA’s estimate of the

burden of the proposed collection of

information, including the validity of

the methodology and assumptions used;

(3) ways to enhance the quality, utility,

and clarity of the information to be

collected; and (4) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques,

when appropriate, and other forms of

information technology.

Title: How to Use E–Mail to Submit a

Notice of Intent to Slaughter for Human

Food Purposes.

Description: Under § 511.1(b)(5), CVM

issues slaughter authorizations for food

animals treated with investigational

new animal drugs. To assist CVM with

the monitoring of the slaughter of food

animals treated with investigational

new animal drugs, the slaughter

authorization letter CVM sends to

sponsors states that they must submit

slaughter notices each time such

animals are to be slaughtered unless the

authorization letter waives that notice.

Currently, slaughter notices are

submitted to CVM on paper (OMB

Control No. 0910–0117). This draft

guidance will give sponsors the option

to submit a slaughter notice as an e-mail

attachment to CVM by the Internet.

The draft guidance describes the

procedures for persons who are

sponsors of new animal drugs and who

wish to file a slaughter notice on FDA

Form No. 3488 by e-mail. The

information that should be filed on the

form includes: Identify the sponsor, the

animals to be slaughtered, and the

compound used to treat the animals.

The likely respondents to this collection

of information are sponsors who have

conducted clinical investigations under

§ 511.1(b).

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1

FDA Form No. No. of Respondents Annual Frequency

per Response

Total Annual

Responses Hours per Response Total Hours

3488 190 0.35 66 0.41 27

1There are no capital costs or operating and maintenance costs associated with this collection of information.

Submitting a slaughter notice

electronically represents a new medium

for submission of information currently

submitted on paper. The reporting

burden for compilation and submission

of this information on paper is included

in OMB clearance of the information

collection provisions of § 511.1 (OMB

Control No. 0910–0117). The estimates

in table 1 of this document reflect the

burden associated with putting the same

information on FDA Form No. 3488 and

resulted from discussions with sponsors

about the time necessary to complete

this form.

IV. Comments

This draft guidance document is being

distributed for comment purposes only

and is not intended for implementation

at this time. Interested persons may

submit to the Dockets Management

Branch (address above) written

comments regarding this draft guidance.

Submit written comments by August 28,

2000, to ensure adequate consideration

in preparation of the final 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. Written comments

concerning the information collection

requirements must be received by

August 28, 2000. A copy of 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: June 16, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–16393 Filed 6–26–00; 10:07 am]

BILLING CODE 4160–01–F