69318 Federal Register / Vol. 65, No. 222 / Thursday, November 16, 2000 / Notices

Substantial Evidence of Effectiveness of

New Animal Drugs—21 CFR Part 514—

(OMB Control No. 0910–0356)—

Extension

Description: Congress enacted the

Animal Drug Availability Act of 1996

(ADAA) (Public Law 104–250) on

October 9, 1996. As directed by the

ADAA, FDA published a final rule July

28, 1999 (64 FR 40746), amending part

514 (21 CFR part 514) to further define

substantial evidence in a manner that

encourages the submission of new

animal drug applications (NADA’s),

supplemental NADA’s and encourages

dose range labeling. Substantial

evidence is the standard that a sponsor

must meet to demonstrate the

effectiveness of a new animal drug for

its intended uses under the conditions

of use suggested in its proposed

labeling. It is defined as evidence

consisting of one or more adequate and

well-controlled studies, such as a study

in a target species, study in laboratory

animals, field study, bioequivalence

study, or an in vitro study, on the basis

of which it could fairly and reasonably

be concluded by qualified experts that

the new animal drug will have the effect

it purports or is represented to have

under the conditions of use prescribed,

recommended, or suggested in the

labeling or proposed labeling thereof.

The provisions of § 514.4(a) provide the

agency with greater flexibility to make

case-specific scientific determinations

regarding the number and types of

adequate and well-controlled studies

that will provide, in an efficient

manner, substantial evidence that a new

animal drug is effective. The agency

believes this regulation over time, will

reduce the number of adequate and

well-controlled studies necessary to

demonstrate the effectiveness of certain

combination new animal drugs, will

eliminate the need for an adequate and

well-controlled dose titration study, and

may, in limited instances, reduce or

eliminate the number of adequate and

well-controlled field investigations

necessary to demonstrate by substantial

evidence the effectiveness of a new

animal drug.

Description of Respondents:

Respondents to this collection of

information are persons and businesses,

including small businesses. In the

Federal Register of August 16, 2000 (65

FR 49989), the FDA published a 60-day

notice concerning the proposed

extension of this collection of

information and requested comments.

No comments were received on the

estimated annual reporting burden. We

therefore believe the total burden

estimate of 544,036 hours for the annual

reporting and recordkeeping burden

should remain unchanged.

FDA estimates the burden of the

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section No. of respondents Annual frequency per

response

Total annual

responses Hours per response Total hours

514.4(a) 190 4.5 860 632.6 544,036

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

The estimated annual reporting

burden is based on consultation by the

Center for Veterinary Medicine with

several of the major research and

development firms that conduct the

majority of studies submitted to

establish substantial evidence of

effectiveness of new animal drugs and

agency records.

Dated: November 9, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–29325 Filed 11–15–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Consumer Roundtable; Notice of

Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

The Food and Drug Administration

(FDA) is announcing the following

meeting: Consumer roundtable to

discuss consumer protection priorities

for the agency. The roundtable will

provide an opportunity for FDA to

engage in an open dialogue with

individual consumer stakeholders on a

variety of regulatory and consumer

oriented issues. The roundtable is part

of the agency’s ongoing consultation

with stakeholders.

Date and Time: The meeting will be

held on December 13, 2000, 9 a.m. to 4

p.m.

Location: The meeting will be held at

the Penthouse Conference Room, Hubert

H. Humphrey Bldg., 200 Independence

Ave. SW., Washington, DC.

Contact: Karen R. Mahoney, Office of

Consumer Affairs (HFE–88), Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–827–

4393, FAX 301–827–2866, e-mail:

kmahoney@oc.fda.gov.

Registration: Preregistration is

required as space is limited. Send

registration information (including

name, title, organization name, address,

telephone, fax number, and e-mail) to

the contact person by December 6, 2000.

If you need special accommodations

due to a disability, please contact Karen

R. Mahoney (address above) at least 7

days in advance.

Background information on this

meeting will be available on the FDA

Internet site at http://www.fda.gov/

opacom/hpmeetings.html.

Transcripts: Transcripts of the

meeting may be requested in writing

from the Freedom of Information Office

(HFI–35), Food and Drug

Administration, 5600 Fishers Lane, rm.

12A–16, Rockville, MD 20857,

approximately 15 working days after the

meeting at a cost of 10 cents per page.

Dated: November 9, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–29424 Filed 10–15–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Oncologic Drugs 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: Oncologic Drugs

Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on

FDA’s regulatory issues.

Federal Register / Vol. 65, No. 222 / Thursday, November 16, 2000 / Notices 69319

Date and Time: The meeting will be

held on December 13, 2000, 8:30 a.m. to

5:30 p.m. and December 14, 2000, 8 a.m.

to 5:30 p.m.

Location: Holiday Inn, Versailles

Ballroom, 8120 Wisconsin Ave.,

Bethesda, MD.

Contact Person: Karen M. TempletonSomers, Center for Drug Evaluation and

Research (HFD–21), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–7001, email: SomersK@cder.fda.gov, or FDA

Advisory Committee Information Line,

1–800–741–8138 (301–443–0572 in the

Washington, DC area), code 12542.

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

Agenda: On December 13, 2000, the

committee will discuss: (1) New drug

application (NDA)20–726/S–006,

Femara (letrozole) Tablets, 2.5 mg,

Novartis Pharmaceuticals Corp.,

indicated as first-line therapy in

postmenopausal women with advanced

breast cancer; and (2) NDA 21–240,

histamine hydrochloride injection (1

mg/ml), Maxim Pharmaceuticals, Inc.,

indicated for adjunctive use with

interleukin-2 (aldesleukin) in the

treatment of adult patients with

advanced metastatic melanoma that has

metastasized to the liver. On December

14, 2000, the committee will discuss: (1)

Biologics license application (BLA) 99–

0786, Campath, (alemtuzumab),

Millenium and Ilex Partners, LP., and

Millenium Pharmaceuticals, indicated

for the treatment of patients with

chronic lymphocytic leukemia who

have been treated with alkylating agents

and who have failed fludarabine

therapy; and (2) single patient

exemptions to the use of nonapproved

oncology drugs and biologics.

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 December 6, 2000. Oral

presentations from the public will be

scheduled between approximately 8:45

a.m. and 9:15 a.m., and 1:30 p.m. and

1:45 p.m. on December 13, 2000, and

between approximately 8:15 a.m. and

8:45 a.m., and 1 p.m. and 1:15 p.m. on

December 14, 2000. Time allotted for

each presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before December 6, 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.

After the scientific presentations, a 30-

minute open public session may be

conducted for interested persons who

have submitted their request to speak by

December 6, 2000, to address issues

specific to the submission or topic

before the committee.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: November 8, 2000.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 00–29285 Filed 11–15–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Advisory Council; Notice of Meeting

In accordance with section 10(a)(2) of

the Federal Advisory Committee Act

(Pub. L. 92–463), announcement is

made of the following National

Advisory body scheduled to meet

during the month of December 2000.

Name: Advisory Commission on

Childhood Vaccines (ACCV).

Date and Time: December 6, 2000;

9:00 a.m.—5:00 p.m.

Place: DoubleTree Hotel, 1750

Rockville Pike, Rockville, Maryland

20852.

The meeting is open to the public.

The full Commission will meet on

Wednesday, December 6, from 9:00 a.m.

to 5:00 p.m. Agenda items will include,

but not be limited to: a presentation of

the Petitioners Attorney Perspective, a

summary of the National Vaccine

Program Office (NVPO) Vaccine Risk

Communication Workshop, a

presentation on the Parent

Understanding of Immunication Survey

Results, and a FDA Workshop summary

on Evaluation of New Vaccines. Updates

from the Department of Justice and the

National Vaccine Program Office, and

routine program reports.

Public comment will be permitted

before lunch and at the end of the

Commission meeting on December 6,

2000. Oral presentations will be limited

to 5 minutes per public speaker. Persons

interested in providing an oral

presentation should submit a written

request, along with a copy of their

presentation to: Ms. Cheryl Lee,

Principal Staff Liaison, Division of

Vaccine Injury Compensation, Bureau of

Health Professions, Health Resources

and Services Administration, Room 8A–

46, 5600 Fishers Lane, Rockville, MD

20857, Telephone (301) 443–6593.

Requests should contain the name,

address, telephone number, and any

business or professional affiliation of

the person desiring to make an oral

presentation. Groups having similar

interests are requested to combine their

comments and present them through a

single representative. The allocation of

time may be adjusted to accommodate

the level of expressed interest. The

Division of Vaccine Injury

Compensation will notify each presenter

by mail or telephone of their assigned

presentation time.

Persons who do not file an advance

request for a presentation, but desire to

make an oral statement, may sign-up in

the Conference Room at the DoubleTree

Hotel on December 6, 2000. These

persons will be allocated time as time

permits.

Anyone requiring information

regarding the Commission should

contact Ms. Lee, Division of Vaccine

Injury Compensation, Bureau of Health

Professions, Health Resources and

Services Administration, Room 8A–46,

5600 Fishers Lane, Rockville, Maryland

20857, Telephone (301) 443–6593.

Agenda items are subject to change as

priorities dictate.

Dated: November 13, 2000.

Jane M. Harrison,

Director, Division of Policy Review and

Coordination.

[FR Doc. 00–29327 Filed 11–15–00; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Advisory Council; Notice of Meeting

In accordance with section 10(a)(2) of

the Federal Advisory Committee Act

(Public Law 92–463), announcement is

made of the following National

Advisory body scheduled to meet

during the month of December 2000.

Name: Council on Graduate Medical

Education (COGME).

Date and Time: December 13, 2000; 8:30

a.m.–4:30 p.m.; December 14, 2000; 8:30

a.m.–10:30 p.m.

Place: Holiday Inn Capitol, 550 C Street,

SW., Washington, DC 20024.

The meeting is open to the public.

Agenda

The agenda will include: Welcome and

opening comments from the Administrator,

Health Resources and Services

Administration; the Associate Administrator

for Health Professions; and the Acting

Executive Secretary of COGME. New COGME

members will be introduced. The Council

will be given an update on the COGME and

the National Advisory Council on Nurse