40104 Federal Register / Vol. 65, No. 126 / Thursday, June 29, 2000 / Notices

In the Federal Register of March 13,

2000 (65 FR 13405), the agency

requested comments on the proposed

collections of information. No

comments were received.

Dated: June 22, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–16398 Filed 6–28–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Pharmacy Compounding Advisory

Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). The meeting will be open to the

public.

Name of Committee: Pharmacy

Compounding Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on

FDA’s regulatory issues.

Date and Time: The meeting will be

held on July 13 and 14, 2000, 8:30 a.m.

to 5 p.m.

Location: CDER Advisory Committee

conference room 1066, 5630 Fishers

Lane, Rockville, MD.

Contact Person: Jayne E. Peterson or

Tony A. Slater, Jr., Center for Drug

Evaluation and Research (CDER) (HFD–

21), Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857, 301–827–7001, e-mail:

PETERSONJ@CDER.FDA.GOV, or FDA

Advisory Committee Information Line,

1–800–741–8138 (301–443–0572 in the

Washington, DC area), code 12440.

Please call the Information Line for upto-date information on this meeting.

Agenda: On July 13, 2000, the

committee will review five drug

products for inclusion on a list of drug

products that cannot be compounded

because they have been withdrawn or

removed from the market because such

drug products or components of such

drug products have been found to be

unsafe or not effective (see 21 CFR

216.24 (64 FR 10944, March 8, 1999))

whereby FDA amended its regulations

to include such a list of drug products).

In the Federal Register of January 4,

2000 (65 FR 256), FDA published a

proposed rule amending these

regulations to add two drug products to

the list: (1) Aminopyrine (all drug

products containing aminopyrine) and

(2) astemizole (all drug products

containing astemizole). In addition to

these two drug products, the committee

will review the following three drug

products: (1) Grepafloxacin (all drug

products containing grepafloxacin), (2)

troglitazone (all drug products

containing troglitazone), and (3)

cisapride (all drug products containing

cisapride). Beginning at approximately

10 a.m., and continuing on July 14,

2000, at approximately 8:30 a.m., the

committee will discuss and provide

FDA with advice about drug products

that present demonstrable difficulties

for compounding that reasonably

demonstrate an adverse effect on the

safety or effectiveness of those drug

products.

Procedure: Interested persons may

present data, information, or views,

orally or in writing on issues pending

before the committee. Written

submissions may be made to the contact

person by July 3, 2000. On July 13,

2000, oral presentations from the public

will be scheduled between

approximately 1 p.m. and 2 p.m. On

July 14, 2000, oral presentations from

the public will be scheduled between

approximately 8:30 a.m. and 9:30 a.m.

Time allotted for each presentation may

be limited. Those desiring to make

formal oral presentations should notify

the contact person before July 3, 2000,

and submit a brief statement of the

general nature of the evidence or

arguments they wish to present, the

names and addresses of proposed

participants, and an indication of the

approximate time requested to make

their presentation.

FDA regrets that it was unable to

publish this notice 15 days prior to the

July 13 and 14, 2000, Pharmacy

Compounding Advisory Committee

meeting. Because the agency believes

there is some urgency to bring these

issues to public discussion and

qualified members of the Pharmacy

Compounding Advisory Compounding

Advisory Committee meeting were

available at this time, the Commissioner

of Food and Drugs concluded that it was

in the public interest to hold this

meeting even if there was not sufficient

time for the customary 15-day public

notice.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: June 20, 2000.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 00–16397 Filed 6–28–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D–1313]

Draft 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 draft guidance for

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

Mail to Submit a Notice of Final

Disposition of Animals Not Intended for

Immediate Slaughter’’ in the Center for

Veterinary Medicine (CVM). This draft

guidance is neither final nor is it in

effect at this time. The draft guidance

document is intended to provide

guidance 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. 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 a Notice of Final Disposition

of Animals Not Intended for Immediate

Slaughter’’ may be obtained on the

Federal Register / Vol. 65, No. 126 / Thursday, June 29, 2000 / Notices 40105

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 and 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 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 NFDA’s

is part of CVM’s ongoing initiative to

provide a method for paperless

submissions. It 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.

In order to submit NFDA’s by e-mail,

sponsors should first register and follow

the instructions in draft guidance for

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

Mail to Submit Information to the

Center for Veterinary Medicine’’ when it

becomes final.

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 its responsibility to

protect the public health under the

Federal Food, Drug, and Cosmetic Act

(the act). In addition, acceptable

standards of study conduct such as

those set out in § 514.117 (21 CFR

514.117) would 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

investigational new animal drug

sponsors that sets the terms under

which animals treated with

investigational new animal drugs may

be slaughtered (§ 511.1(b)(5) (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 paper. This

draft 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 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 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,

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 Final Disposition of Animals

Not Intended for Immediate Slaughter.

Description: 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. CVM believes that

monitoring of the final disposition of

such food animals is consistent with its

responsibility to protect the public

health under the act. In addition, CVM

believes that acceptable standards of

study conduct such as those set out in

§ 514.117 would 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.

The draft guidance document

describes the procedures for persons

who are sponsors of new animal drugs

who wish to file an NFDA electronically

on FDA Form #3487. The information

sponsors should include on the form

includes the sponsor’s name and

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