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This draft guidance describes the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This draft guidance document is being

distributed for comment purposes only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:

40110 Federal Register / Vol. 65, No. 126 / Thursday, June 29, 2000 / Notices

I. Background

In the Federal Register of March 20,

1997 (62 FR 13430), FDA published the

electronic records and 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 which

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 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 number 92S–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 and electronic signatures

regulation. This guidance outlines

general standards which should be used

for the submission of any information

by e-mail.

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

represent’s the agency’s current thinking

about using e-mail to submit

information electronically. 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, regulation, 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 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

Information to the Center for Veterinary

Medicine.

Description: CVM is responsible for

developing and administering guidances

that explain how to adhere to the

electronic records and electronic

signatures regulations (part 11). The

electronic records and electronic

signatures regulations provide for the

voluntary submission of parts or all of

regulatory records in electronic format

without an accompanying paper copy.

These regulations comply 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.

The draft guidance document

describes the procedures for persons

who are sponsors of new animal drugs

who wish to file submissions by e-mail.

The draft guidance instructs those who

wish to submit information to CVM by

e-mail to first register with them.

Registration entails sending a letter to

CVM with a sponsor password and the

names, phone numbers, and mail and email addresses of a sponsor coordinator

and any person who will submit

information electronically to CVM. This

letter is sent on paper and

electronically. Other information

collection provisions described in the

guidance are the submission of e-mails

with the individual passwords of those

who submit information electronically

and e-mails with any changes to the

sponsor’s registration. CVM will use all

the information submitted to process

electronic submissions.

Description of Respondents: The

likely respondents to this collection of

information are new animal drug

sponsors.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1

No. of Respondents Annual

Frequency per Response Total Annual Responses Hours per Response Total Hours

190 0.74 140 1 140

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.

IV. Comments

The 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.

Federal Register / Vol. 65, No. 126 / Thursday, June 29, 2000 / Notices 40111

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 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. 00–16395 Filed 6–26–00; 10:07 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration,

HHS.

[Document Identifier: HCFA–10012]

Emergency Clearance: Public

Information Collection Requirements

Submitted to the Office of Management

and Budget (OMB)

AGENCY: Health Care Financing

Administration, HHS.

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding this burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) The

necessity and utility of the proposed

information collection for the proper

performance of the agency’s functions;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

We are, however, requesting an

emergency review of the Information

collections referenced below. In

compliance with the requirement of

section 3506(c)(2)(A) of the Paperwork

Reduction Act of 1995, we have

submitted to the Office of Management

and Budget (OMB) the following

requirements for emergency review. We

are requesting an emergency review

because the collection of this

information is needed prior to the

expiration of the normal time limits

under OMB’s regulations at 5 CFR part

1320. This collection of information will

be used to test the effectiveness of three

possible Medicare smoking cessation

benefits and to make inferences that are

generalizable to the Medicare program.

Using a comparison trial with restricted

randomization of study locales, this

study will compare three variations in a

potential Medicare smoking cessation

benefit on smoking cessation and

abstinence rates. Smoking cessation for

seniors is currently receiving attention

from Congress and the White House.

Senator Graham (D–FL) has proposed a

smoking cessation Medicare benefit,

while the White House provides for a

smoking cessation demonstration in the

President’s Plan to Modernize and

Strengthen Medicare for the 21st

Century. In response to this White

House initiative, HCFA is launching this

demonstration to test smoking cessation

as a possible covered benefit under the

Medicare program. If this information is

not collected, public harm is likely to

occur. Considerable evidence indicates

that much greater improvement in

health status could be accomplished if

currently existing, effective and

commonly available preventative

practices and services were

implemented more widely; therefore,

this demonstration could help improve

the health of the Medicare population.

HCFA is requesting OMB review and

approval of this collection by July 5,

2000, with a 180-day approval period.

Written comments and

recommendations will be accepted from

the public if received by the individuals

designated below by July 3, 2000.

During this 180-day period, we will

publish a separate Federal Register

notice announcing the initiation of an

extensive 60-day agency review and

public comment period on these

requirements. We will submit the

requirements for OMB review and an

extension of this emergency approval.

Type of Information Collection

Request: New Collection;

Title of Information Collection:

Healthy Aging Smoking Cessation

Demonstration;

Form No.: HCFA–10012 (OMB no.

0938–NEW);

Use: The goals of the Healthy Aging

Project are to test the effectiveness of

three possible Medicare smoking

cessation benefits and to make

inferences that are generalizable to the

Medicare program. Using a comparison

trial with restricted randomization of

study locales, this study will compare

three variations in a potential Medicare

smoking cessation benefit on smoking

cessation and abstinence rates.;

Frequency: Semi-annually;

Affected Public: Individuals or

Households;

Number of Respondents: 43,500;

Total Annual Responses: 130,500;

Total Annual Hours: 58,000.

To obtain copies of the supporting

statement and any related forms for the

proposed paperwork collections

referenced above, access HCFA’s Web

Site address at http://www.hcfa.gov/

regs/prdact95.htm, or E-mail your

request, including your address, phone

number, to Paperwork@hcfa.gov, or call

the Reports Clearance Office on (410)

786–1326.

Interested persons are invited to send

comments regarding the burden or any

other aspect of these collections of

Information requirements. However, as

noted above, comments on these

Information collection and

recordkeeping requirements must be

mailed and/or faxed to the designees

referenced below, by July 3, 2000:

Health Care Financing Administration,

Office of Information Services, Security

and Standards Group, Division of HCFA

Enterprise Standards Attention: Dawn

Willinghan, Room N2–14–26, 7500

Security Boulevard, Baltimore,

Maryland 21244–1850; and

Office of Information and Regulatory

Affairs, Office of Management and

Budget, Room 10235, New Executive

Office Building, Washington, DC 20503,

Fax Number: (202) 395–6974 or (202)

395–5167, Attn: Allison Herron Eydt,

HCFA Desk Officer.

Dated: June 1, 2000.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA Office

of Information Services, Security and

Standards Group, Division of HCFA

Enterprise Standards.

[FR Doc. 00–16455 Filed 6–28–00; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–901–1]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Health Care Financing

Administration, HHS.

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send