6214 Federal Register / Vol. 65, No. 26 / Tuesday, February 8, 2000 / Notices

and each was returned to the agency as

undeliverable.

In a certified, return-receipt letter sent

to Bestblood, Ltd., dated March 4, 1998,

at both addresses mentioned previously

and returned as undeliverable, FDA

indicated that an attempt to conduct an

inspection at the facility was

unsuccessful. The letter advised the

firm that, under 21 CFR 601.5(b)(1) and

(b)(2), when FDA finds that authorized

employees have been unable to gain

access to an establishment for the

purpose of carrying out an inspection

required under § 600.21, or the

manufacturing of products or of a

product has been discontinued to an

extent that a meaningful inspection

cannot be made, proceedings for license

revocation may be instituted. FDA also

indicated that a meaningful inspection

could not be made at the establishment

and issued to the firm a notice of FDA’s

intent to revoke U.S. License No. 1116

and announced its intent to offer an

opportunity for a hearing.

Under 21 CFR 12.21(b), FDA

published in the Federal Register of

April 15, 1999 (64 FR 18623), a notice

of opportunity for a hearing on a

proposal to revoke the licenses of

Bestblood, Ltd. In the notice, FDA

explained that the proposed license

revocation was based on the inability of

authorized FDA employees to conduct a

meaningful inspection of the facility

because it was no longer in operation,

and noted that documentation in

support of license revocation had been

placed on file with the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5600 Fishers

Lane, rm. 1061 Rockville, MD 20852.

The notice provided the firm 30 days to

submit a written request for a hearing

and 60 days to submit any data and

information justifying a hearing. The

notice provided other interested persons

with 60 days to submit written

comments on the proposed revocation.

The firm did not respond within the 30-

day time period with a written request

for a hearing. The 30-day time period

prescribed in the notice of opportunity

for a hearing and in the regulations, may

not be extended. No other comments

were received.

Accordingly, under 21 CFR 12.38,

section 351 of the Public Health Service

Act (42 U.S.C. 262), and under the

authority delegated to the Commissioner

of Food and Drugs (21 CFR 5.10) and

redelegated to the Director, Center for

Biologics Evaluation and Research (21

CFR 5.68) the establishment license

(U.S. License No. 1116) and the product

licenses issued to Bestblood, Ltd., are

revoked, effective February 8, 2000.

Dated: January 13, 2000.

Mark Elengold,

Deputy Director for Operations, Center for

Biologics Evaluation and Research.

[FR Doc. 00–2768 Filed 2–7–00; 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.

Date and Time: The meeting will be

held on March 16, 2000, from 8:30 a.m.

to 5:30 p.m., and March 17, 2000, from

8 a.m. to 1 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, 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 up-to-date information on this

meeting.

Agenda: On March 16, 2000, the

committee will discuss: (1) New drug

application (NDA) 21–063, Eloxatin

(oxaliplatin), Sanofi Pharmaceuticals,

Inc., indicated for the first-line

treatment of patients with advanced

colorectal cancer in combination with

5–U based chemotherapy; and (2) NDA

20–571/SE1–009, Camptosar Injection

(irinotecan hydrochloride injection),

Pharmacia and Upjohn Co., indicated as

a component of first-line therapy for

patients with metastatic carcinoma of

the colon or rectum. On March 17, 2000,

the committee will discuss NDA 21–

174, gemtuzumab zogamicin, WyethAyerst Laboratories, indicated for the

treatment of patients with CD33 positive

acute myeloid leukemia in relapse.

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 March 8, 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 March 16, 2000, and

between approximately 8:15 a.m. and

8:45 a.m. on March 17, 2000. Time

allotted for each presentation may be

limited. Those desiring to make formal

oral presentations should notify the

contact person before March 8, 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 March 8, 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: January 28, 2000.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 00–2770 Filed 2–7–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 99N–2912]

Review of Supplemental Applications

for Approved New Animal Drugs;

Center Responsibility and Standards

for Prompt Review; Availability of Draft

Guidance

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: As required by the Food and

Drug Administration Modernization Act

of 1997 (FDAMA), the Food and Drug

Administration’s (FDA) Center for

Veterinary Medicine (CVM) is making

available information regarding the

approval of supplemental applications

for approved new animal drugs. CVM is

publishing standards for the prompt

review of supplemental applications

and referencing an existing guidance

that describes how supplemental

applications may qualify for priority

review. CVM is also designating an

Federal Register / Vol. 65, No. 26 / Tuesday, February 8, 2000 / Notices 6215

individual within the Center who is

responsible for encouraging the prompt

review of supplemental applications

and for working with sponsors to

facilitate the development and

submission of data to support

supplemental applications. Further,

CVM is describing its efforts to

collaborate with other organizations and

persons to identify published and

unpublished studies that may support

supplemental applications and to

encourage sponsors to submit

supplemental applications based on

such studies. In addition, CVM is

announcing the availability of a draft

guidance entitled ‘‘Guidance for

Industry: Development of Supplemental

Applications for Approved New Animal

Drugs.’’ This draft guidance explains

how drug sponsors can use data

submitted in support of an original

application to support supplemental

applications.

DATES: Written comments should be

submitted by May 8, 2000. Written

comments on the existing guidance

entitled ‘‘CVM’s Program Policy and

Procedures Guide 1240.3135,’’ which

describes how supplemental

applications qualify for priority review,

may be submitted at any time.

ADDRESSES: Submit written requests for

single copies of ‘‘Guidance for Industry:

Development of Supplemental

Applications for Approved New Animal

Drugs’’ or ‘‘CVM’s Program Policy and

Procedures Guide 1240.3135’’ to the

Communications Staff (HFV–12), Center

for Veterinary Medicine, Food and Drug

Administration, 7500 Standish Place,

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that

office in processing your request. Copies

of the draft guidance and the existing

guidance may be obtained on the

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

Submit written comments on the draft

guidance, ‘‘Guidance for Industry:

Development of Supplemental

Applications for Approved New Animal

Drugs’’ to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. Submit

written comments on CVM’s ‘‘Program

Policy and Procedures Guide

1240.3135’’ to the Policy and

Regulations Team (HFV–6), Center for

Veterinary Medicine, Food and Drug

Administration, 7500 Standish Place,

Rockville, MD 20855.

FOR FURTHER INFORMATION CONTACT:

Marilyn N. Martinez, Office of New

Animal Drug Evaluation (HFV–130),

Center for Veterinary Medicine, Food

and Drug Administration, 7500 Standish

Place, Rockville, MD 20855, 301–827–

7577.

SUPPLEMENTARY INFORMATION:

I. Background

Section 403 of the FDAMA (Pub. L.

105–115) instructs FDA to provide

certain information regarding approval

of supplemental applications for

approved products. Among other things,

section 403 requires that FDA do the

following: (1) Section 403(a) requires

that the agency publish standards for

the prompt review of supplemental

applications; (2) section 403(b)(1)

requires that FDA provide guidance to

‘‘clarify circumstances in which

published matter may be the basis for

the approval of a supplemental

application’’; (3) section 403(b)(2)

requires that FDA provide guidance that

specifies ‘‘data requirements that will

avoid duplication of previously

submitted data by recognizing the

availability of data previously submitted

in support of an original application.’’

(4) section 403(b)(3) requires that FDA

provide guidance that defines

supplemental applications that are

eligible for priority review; (5) section

403(c) requires that FDA designate an

individual within each Center to be

responsible for encouraging the prompt

review of supplemental applications

and working with sponsors to facilitate

development and submission of data to

support supplemental applications; and

(6) section 403(d) requires the

implementation of programs and

policies to foster collaboration between

FDA and other organizations and

persons to identify published and

unpublished studies that might support

supplemental applications and to

encourage sponsors to submit

supplemental applications based on

such studies.

This document and the guidance

documents discussed in it fulfill the

requirements of section 403(a), (b)(2),

(b)(3), and (c). This document also

discusses FDA’s continuing efforts at

collaboration as required by section

403(d). Section 403(b)(1) will be

addressed in a future Federal Register

notice.

II. Section 403(a): Standards

Section 403(a) of FDAMA requires

that FDA publish ‘‘standards for the

prompt review of supplemental

applications submitted for approved

articles * * *.’’ The legislative history

of this section indicates that these

performance standards should cover

supplements submitted for changes in

product use.

Section 512(c)(1) of the Food, Drug,

and Cosmetic Act (the act) (21 U.S.C.

360b(c)(1))sets a 180-day time frame for

review of new animal drug applications

(NADA’s). This time frame applies to all

applications, including supplements to

approved applications.

The agency intends to use the

performance goals set forth in the fiscal

year (FY) 2001 performance plan to

fulfill the requirement of the FDAMA

that it establish standards for the

prompt review of efficacy supplements.

In FY 2000, the agency’s goal is to

review and act on 65 percent of NADA’s

and abbreviated new animal drug

applications (ANADA’s), including

supplemental applications, within 180

days of receipt. For FY 2001, the goal is

70 percent.

To facilitate prompt reviews, CVM

encourages sponsors of supplemental

applications to work closely with CVM

personnel through presubmission

conferences or other means to aid CVM

in assuring that supplemental

applications are reviewed promptly.

III. Section 403(b)(2)(i): Specify Data

Requirements That Will Avoid

Duplication of Previously Submitted

Data by Recognizing the Availability of

Data Previously Submitted in Support

of an Original Application

CVM has developed and is

announcing the availability of a draft

guidance, ‘‘Guidance for Industry:

Development of Supplemental

Applications for Approved New Animal

Drugs’’ that represents the agency’s

current thinking. The Center designates

two categories of supplemental new

animal drug applications (NADA’s),

Category I and Category II. Ordinarily,

for Category I supplemental NADA’s,

FDA does not require a reevaluation of

any of the safety or effectiveness data in

the parent application. For Category II

supplemental NADA’s, FDA may

ordinarily require drug sponsors to

submit new data. Therefore, the Center

may be required to reevaluate certain

safety or effectiveness data in the

original application. The draft guidance

lists the types of supplemental NADA’s

that fall into each of the categories, and

it provides an overview of issues that

drug sponsors should consider with

respect to safety and effectiveness data

and data supporting the environmental

and manufacturing controls technical

sections when seeking the approval of

Category II supplemental NADA’s.

The draft guidance is organized by

type of Category II supplement. For each

type (e.g., a change in the amount of

drug administered per dose), the

document provides a table and

comments. The table lists each technical

section for which information would be

required for approval of the supplement

6216 Federal Register / Vol. 65, No. 26 / Tuesday, February 8, 2000 / Notices

and whether the information in a

previously approved application is

sufficient or new information would be

needed. Comments provide additional

information to assist the sponsor. In this

way, the draft guidance specifies data

requirements that will avoid duplication

of previously submitted data. It also

refers drug sponsors to related guidance

documents that will aid them in the

preparation of supplemental NADA’s.

This draft guidance does not create or

confer any rights for or on any person

and does not operate to bind FDA or the

public. An alternative approach may be

used if such approach satisfies the

requirement of the applicable statute,

regulations, or both.

IV. Section 403(b)(3): Define

Supplemental Applications That Are

Eligible for Priority Review

When CVM determines that a product

represents an important advance in

animal health, it may expedite the

review of original and supplemental

applications. The circumstances in

which CVM may make such a

determination are outlined in an

existing guidance entitled ‘‘CVM

Program Policy and Procedures Guide

1240.3135,’’ available at the address

above.

V. Section 403(c): Responsibilities of

Centers

FDA has designated the following

individual within CVM to be

responsible for encouraging prompt

review of supplemental applications for

approved articles and for working with

sponsors to facilitate the development

and submission of data to support the

approval of supplemental applications

in accordance with section 403(c) of

FDAMA:

Director, Office of New Animal Drug

Evaluation (ONADE), Center for

Veterinary Medicine, (HFV–100), Food

and Drug Administration, 7500 Standish

Place, Rockville MD 20855, 301–594–

1620.

VI. Section 403(d): Collaboration to

Identify Published and Unpublished

Studies

CVM currently collaborates with the

U.S. Department of Agriculture (USDA)

National Research Support Project #7

(NRSP–7) and others, including state

agencies, extension agents, universities,

the National Coordinator for

Aquaculture NADA’s, and other USDA

agencies, to encourage sponsors to make

supplemental applications for minor use

new animal drugs by encouraging

development of Public Master Files

(PMF’s). Minor use new animal drugs

are drugs used in minor animal species

or drugs used in any animal species for

the control of a disease that occurs

infrequently or occurs in limited

geographic areas. Minor species are

defined in 21 CFR 514.1(d). PMF’s

contain public data from unpublished

and published studies that can be used

in conjunction with data already

available in a major use product’s

original NADA to support a

supplemental NADA. The majority of

approved minor use drugs have been

approved as supplements to products

approved for use in major species.

In a notice entitled ‘‘Proposals to

Increase the Legal Availability of

Animal Drugs for Minor Species and

Minor Uses; Availability’’ published in

the Federal Register (63 FR 58056,

October 29, 1998), CVM proposed other

methods of collaboration to make data

available for minor use supplemental

applications.

In addition, CVM frequently

participates in discussions with animal

industry trade associations to help

clarify the new animal drug approval

process. These discussions encourage

university researchers and others to

identify or initiate studies that may be

used to support supplemental

applications.

VII. Comments

The draft guidance discussed in

section III of this 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.

Written comments may be submitted at

any time, however, comments should be

submitted by May 8, 2000, to ensure

adequate consideration in preparation of

the final document. 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. 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 the brackets in the

heading of this document. 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: January 24, 2000.

Margaret M. Dotzel,

Acting Associate Commissioner for Policy.

[FR Doc. 00–2767 Filed 2–7–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Heart, Lung, and Blood

Institute; Notice of Closed Meeting

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

meeting.

The meeting will be closed to the

public in accordance with the

provisions set forth in sections

552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,

as amended. The grant applications and

the discussions could disclose

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with the grant

applications, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: National Heart, Lung,

and Blood Institute Special Emphasis Panel.

Date: February 28, 2000.

Time: 1:30 pm to 6 pm.

Agenda: To review and evaluate grant

applications.

Place: Hyatt Regency Bethesda, One

Bethesda Metro Center, Bethesda, MD 20814.

Contact Person: Joyce A. Hunter, PHD,

NIH, NHLBI, DEA, Rockledge Center, II, 6701

Rockledge Drive, Suite 7192, Bethesda, MD

20892–7924, (301) 435–0287.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.233, National Center for

Sleep Disorders Research; 93.837, Heart and

Vascular Diseases Research; 93.838, Lung

Diseases Research; 93.839, Blood diseases

and Resources Research, National Institutes

of Health, HHS)

Dated: January 31, 2000.

LaVerne Y. Stringfield,

Director, Office of Federal Advisory

Committee Policy.

[FR Doc. 00–2757 Filed 2–7–00; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute on Aging; Notice of

Closed Meetings

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

meetings.

The meetings will be closed to the

public in accordance with the

provisions set forth in sections

552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,

as amended. The contract proposals and