Federal Register / Vol. 62, No. 234 / Friday, December 5, 1997 / Notices 64387

Application No. Drug

ANDA 88–932 ............................................................ Reserpine and Hydroflumethiazide Tablets, 0.125 mg/50 mg

Therefore, under section 505(e) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 355(e)) and under authority

delegated to the Director, Center for

Drug Evaluation and Research (21 CFR

5.82), approval of the applications listed

in the table in this document, and all

amendments and supplements thereto,

is hereby withdrawn, effective January

5, 1998.

Dated: November 17, 1997.

Janet Woodcock,

Director, Center for Drug Evaluation and

Research.

[FR Doc. 97–31879 Filed 12–4–97; 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

regulatory issues.

Date and Time: The meeting will be

held on December 18, 1997, 8:30 a.m. to

5:05 p.m., and December 19, 1997, 8

a.m. to 4:35 p.m.

Location: Holiday Inn, Versailles

Ballrooms I, II, and III, 8120 Wisconsin

Ave., Bethesda, MD.

Contact Person: Jannette O’NeillGonzalez, or Robinette Taylor, Center

for Drug Evaluation and Research (HFD–

21), Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857, 301–443–5455, 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 18, 1997, the

committee will discuss: (1) New drug

application (NDA) supplement 16–295/

S–029, Droxia (hydroxyurea capsules,

USP), for the treatment of sickle cell

anemia in adult patients to prevent

painful crises and to reduce the need for

blood transfusions; and (2) NDA 20–

798, Depocyt (cytarabine lipid-particle

injection), for the intrathecal treatment

of neoplastic meningitis of patients with

solid tumors, lymphoma, or leukemia.

On December 19, 1997, the committee

will discuss: (1) Biologics licensing

application (BLA) supplement 97–0501,

Proleukin/Aldesleukin (recombinant

human interlukin-2), for the treatment

of adult patients with metastatic

melanoma; and (2) NDA 20–806,

Neomark (broxuridine for injection),

for use as a cell proliferation marker to

determine the labeling index in breast

cancer.

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 10, 1997. Oral

presentations from the public will be

scheduled between approximately 8:35

a.m. and 9:05 a.m. on December 18,

1997, and between approximately 8:05

a.m. and 8:35 a.m. on December 19,

1997. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before December 10, 1997, 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

December 18, 1997, Oncologic Drugs

Advisory Committee meeting. Because

the agency believes there is some

urgency to bring these issues to public

discussion and qualified members of the

Oncologic Drugs Advisory Committee

were available at this time, the

Commissioner 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: November 26, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–31808 Filed 12–4–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0442]

Memoranda of Understanding Between

the Food and Drug Administration and

the United States Department of

Agriculture

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) and the United

States Department of Agriculture

(USDA) have revised three memoranda

of understanding (MOU’s) with regard

to control of aflatoxin in peanuts, inshell Brazil nuts, and in-shell pistachio

nuts. The purpose of the MOU’s is to set

forth the responsibility for aflatoxin

testing of domestic and imported raw

peanuts, imported in-shell Brazil nuts,

and imported in-shell pistachio nuts.

DATES: The MOU’s became effective

October 1, 1997.

FOR FURTHER INFORMATION CONTACT:

Henry Kim, Center for Food Safety and

Applied Nutrition (HFS–306), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–260–0631.

SUPPLEMENTARY INFORMATION: In

accordance with 21 CFR 20.108(c),

which states that all written agreements

and MOU’s signed by FDA and other

departments, agencies, and

organizations shall be published in the

Federal Register, the agency is

publishing three revised MOU’s

between FDA and USDA that set forth

the responsibility for aflatoxin testing of

domestic and imported raw peanuts,

imported in-shell Brazil nuts, and

imported in-shell pistachio nuts.

Dated: November 24, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

The text of the three MOU’s follows:

Agreement No.