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

10702 Federal Register / Vol. 66, No. 33 / Friday, February 16, 2001 / Notices

teleconference requests 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

final guidance will give sponsors the

option to submit a request for a meeting

or teleconference as an e-mail

attachment by the Internet.

Before submitting requests for

meetings or teleconferences by e-mail,

sponsors should first register and follow

the instructions in the final guidance for

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

Mail to Submit Information to CVM.’’

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 on submitting

a request for a meeting or teleconference

about new animal drug submissions by

e-mail. The final guidance does not

create or confer any rights for or on any

person and will not operate to bind FDA

or the public. An alternative method

may be used if such approach satisfies

the requirements of the applicable

statutes and regulations.

III. Paperwork Reduction Act of 1995

In the document announcing the

availability of the draft version of this

guidance (65 FR 40108), FDA published

notice of the proposed collection of

information related to the guidance. The

Federal Register document 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 116

hours, therefore remains unchanged. In

the Federal Register of September 21,

2000 (65 FR 57194), 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 final guidance document

have been approved under OMB control

number 0910–0452. 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.

This approval expires November 30,

2003.

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 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, 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 individuals may submit one

copy. Comments should 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 9, 2001.

Ann M. Witt,

Acting Associate Commissioner for Policy.

[FR Doc. 01–3887 Filed 2–15–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–565]

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

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, has submitted to the

Office of Management and Budget

(OMB) the following proposal for the

collection of information. Interested

persons are invited to send comments

regarding the 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.

Type of Information Collection

Request: Extension of a currently

approved collection; Title of

Information Collection: Medicare

Qualification Statement for Federal

Employees and Supporting Regulations

in 42 CFR 406.15; Form No.: HCFA–565

(OMB# 0938–0501); Use: The HCFA–

565 is completed by an individual filing

for hospital insurance (HI) benefits (Part

A) based upon their federal

employment. This information is

necessary to determine if HCFA/SSA

can use federal employment prior to

1983 to qualify for free Part A. The data

is passed to the HI master record, the

Enrollment Data Base (EDB). An HI

record showing appropriate entitlement

is established and if applicable, a

Medicare card is issued. Frequency:

Other (one time only); Affected Public:

Individuals or Households, Federal

Government, and State, Local, or Tribal

Government; Number of Respondents:

4,300; Total Annual Responses: 4,300;

Total Annual Hours: 731.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, access

HCFA’s WEB SITE ADDRESS at http://

www.hcfa.gov/regs/prdact95.htm, or Email your request, including your

address and phone number, to

Paperwork@hcfa.gov, or call the Reports

Clearance Office on (410) 786–1326.

Written comments and

recommendations for the proposed

information collections must be mailed

within 30 days of this notice directly to

the OMB Desk Officer designated at the

following address: OMB Human

Resources and Housing Branch,

Attention: Allison Eydt, New Executive

Office Building, Room 10235,

Washington, DC 20503.

Dated: January 30, 2001.

John P. Burke, III,

HCFA Reports Clearance Officer, HCFA,

Office of Information Services, Security and

Standards Group, Division of HCFA

Enterprise Standards.

[FR Doc. 01–3972 Filed 2–15–01; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–10011]

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

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, has submitted to the

Office of Management and Budget

(OMB) the following proposal for the

collection of information. Interested

persons are invited to send comments

regarding the burden estimate or any