40108 Federal Register / Vol. 65, No. 126 / Thursday, June 29, 2000 / Notices

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D–1316]

Draft Guidance for Industry on How to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availability of the draft guidance for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

draft guidance is neither final nor is it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draft guidance document is to provide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 request

for a meeting or teleconference about a

new animal drug submission as an email attachment by Internet. These

electronic submissions are 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draft guidance implements provisions of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draft guidance at any time, however,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on the draft guidance to the Dockets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full title of the draft guidance and the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Copies of the draft guidance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 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of the draft guidance to the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 (part 11 (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 requests

for meetings and teleconferences 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 requests for

meetings or teleconferences 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 CVM’’ when it

becomes final.

On request, CVM will hold meetings

and/or teleconferences to assist

sponsors with new animal drug

submissions and general questions.

Currently, meeting and teleconference

requests are submitted to CVM on

paper. CVM would like to allow

sponsors to request meetings and

teleconferences in a manner more

efficient and time saving to them. This

draft guidance will give sponsors the

option to submit a request for a meeting

or teleconference as an e-mail

attachment 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

on submitting a request for a meeting or

teleconference about new animal drug

submissions by e-mail. 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,

Federal Register / Vol. 65, No. 126 / Thursday, June 29, 2000 / Notices 40109

when appropriate, and other forms of

information technology.

Title: How to Use E–Mail to Submit a

Request for a Meeting or Teleconference

to the Office of New Animal Drug

Evaluation.

Description: As part of new animal

drug development, sponsors often meet

with CVM scientists to formulate a

rational approach to studies to be

conducted and to discuss how to meet

the statutory requirements for new

animal drug approval under section 512

of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 360b). Requests for

meetings and teleconferences about

NAD submissions are currently

submitted on paper to CVM. CVM is

responsible for developing and

administering a guidance that explains

how to adhere to the Electronic Records;

Electronic Signatures regulations (part

11). These regulations provide for the

voluntary submission of parts or all of

regulatory records in electronic format

without an accompanying paper copy

and complies with the GPEA. The GPEA

requires Federal agencies, by October

21, 2003, to give persons who are

required to maintain, submit, or disclose

information the option of doing so

electronically when practicable as a

substitute for paper.

This draft guidance describes the

procedure for persons who are new

animal drug sponsors to submit a

request for a meeting or teleconference

to the Office of New Animal Drug

Evaluation by e-mail on FDA Form No.

3489. The information of the sponsors

should include on the form: The

sponsor’s name and address, a list of

requested participants, an indication of

audio-visual needs, and an agenda. The

likely respondents to this collection of

information are sponsors who will be

conducting clinical investigations under

21 CFR 511.1(b).

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

FDA Form No. No. of

Respondents

Annual

Frequency per

Respondent

Total Annual

Responses

Hours per

Response Total Hours

3489 190 .88 168 0.69 116

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 requests for

meetings or teleconferences submitted

by e-mail and on paper.

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

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. 00–16394 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–1315]

Draft Guidance for Industry on How to

Use E-Mail to Submit Information to

the Center for Veterinary Medicine;

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 (#108) entitled ‘‘How to Use EMail to Submit Information to the

Center for Veterinary Medicine.’’ This

draft guidance is neither final nor is it

in effect at this time. The draft guidance

document is intended to provide

guidance on how to submit information

to the Center for Veterinary Medicine

(CVM) 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 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 information collection

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 document

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 Information to the Center for

Veterinary Medicine’’ 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: