Federal Register / Vol. 62, No. 229 / Friday, November 28, 1997 / Notices 63349

Application No. Drug Applicant

ANDA 87–107 ........................................ Heparin Sodium Injection USP, 10,000 units/mL

(syringe).

SoloPak Laboratories

ANDA 87–109 ........................................ Nitroglycerin Extended-Release Capsules, 9 mg .. KV Pharmaceutical Co.

ANDA 87–310 ........................................ Hydroxyzine Hydrochloride Injection USP, 50 mg/

mL.

SoloPak Laboratories

ANDA 87–344 ........................................ Isosorbide Dinitrate Extended-release Capsules,

40 mg.

Inwood Laboratories, Inc., 909 Third Ave., New

York, NY 10022–4731.

ANDA 87–363 ........................................ Heparin Sodium Injection USP, 10,000 units/0.5

mL (syringe).

SoloPak Laboratories

ANDA 87–395 ........................................ Heparin Sodium Injection USP, 5,000 units/0.5

mL (syringe).

Do.

ANDA 87–551 ........................................ Cyanocobalamin Injection USP, 1,000

micrograms/mL (syringe).

Do.

ANDA 87–596 ........................................ Hydroxyzine Hydrochloride Injection USP, 50 mg/

mL and 100 mg/mL.

Do.

ANDA 87–903 ........................................ Heparin Lock Flush Solution USP, 10 units/mL

(syringe).

Do.

ANDA 87–905 ........................................ Heparin Lock Flush Solution USP, 100 units/mL

(syringe).

Do.

ANDA 88–120 ........................................ Hydroxyzine Hydrochloride Tablets USP, 10 mg .. Purepac Pharmaceutical Co.

ANDA 88–121 ........................................ Hydroxyzine Hydrochloride Tablets USP, 25 mg .. Do.

ANDA 88–122 ........................................ Hydroxyzine Hydrochloride Tablets USP, 50 mg .. Do.

ANDA 88–139 ........................................ Chlorthalidone Tablets USP, 25 mg ...................... Do.

ANDA 88–177 ........................................ Hydralazine Hydrochloride Tablets, 25 mg ............ Do.

ANDA 88–520 ........................................ Phenytoin Sodium Injection USP, 50 mg/mL (syringe).SoloPak Laboratories

ANDA 88–532 ........................................ Procainamide Hydrochloride Injection USP, 500

mg/mL (syringe).

Do.

ANDA 89–094 ........................................ Trimethobenzamide Hydrochloride Injection USP,

100 mg/mL (syringe).

Do.

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

December 29, 1997.

Dated: November 17, 1997.

Janet Woodcock,

Director, Center for Drug Evaluation and

Research.

[FR Doc. 97–31214 Filed 11–26–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0451]

Microbial Safety of Produce;

Grassroots and International Meetings

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing six

grassroots meetings and one

international meeting to discuss

generally the President’s recently

announced initiative to ensure the

safety of imported and domestic fruits

and vegetables and other foods, and

specifically the microbial safety of

produce. The meetings are intended to

give an overview of, and obtain input on

the general draft guide entitled ‘‘Guide

to Minimizing Microbial Food Safety

Hazards for Fresh Fruit and Vegetables.’’

DATES AND TIME: For the domestic

meetings see Table 1 in the

‘‘SUPPLEMENTARY INFORMATION’’

section of this document. For the

international meeting see Table 2.

Submit written comments by December

19, 1997. All the meetings will be held

from 9 a.m. to 4 p.m.

ADDRESSES: For the domestic meetings

see Table 1 in the ‘‘SUPPLEMENTARY

INFORMATION’’ section of this

document. For the international meeting

see Table 2. Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857. Copies

of the ‘‘Guide to Minimizing Microbial

Food Safety Hazards for Fresh Fruit and

Vegetables’’ may be obtained from Joan

E. Duy, Center for Food Safety and

Applied Nutrition (HFS–335), Food and

Drug Administration, 200 C St. SW., rm.

3812, Washington, DC 20204, 202–260–

8920, FAX 202–205–4422, e-mail

jduy@bangate.fda.gov.

FOR FURTHER INFORMATION CONTACT: For

general information on this document:

Camille E. Brewer, Center for Food

Safety and Applied Nutrition (HFS–

165), Food and Drug Administration,

200 C St. SW., rm. 3169, Washington,

DC, 202–260–8920, FAX 202–205–4422,

e-mail ceb@cfsan.fda.gov. Send

registration information (including

name, title, firm name, mailing address,

telephone number and fax number if

appropriate) to the contact person listed

for the city in which you will attend.

SUPPLEMENTARY INFORMATION: On

October 2, 1997, the President

announced an initiative to ensure the

safety of imported and domestic

produce and other foods. This initiative

is geared to optimize the microbial

safety of domestic and imported fresh

fruits and vegetables. As part of this

initiative, the President directed the

Secretary of the Department of Health

and Human Services (DHHS), in

partnership with the Secretary of the

Department of Agriculture (USDA), and

in cooperation with the agricultural

community, to issue advice on good

agricultural practices and good

manufacturing practices for fresh fruits

and vegetables. FDA will coordinate the

effort for DHHS. As part of this effort,

FDA plans to publish for public
63350 Federal Register / Vol. 62, No. 229 / Friday, November 28, 1997 / Notices

comment a draft guide early in 1998,

and a final guide later in 1998.

On November 17, 1997, at a public

meeting in Washington, DC, FDA and

USDA provided details on a broad,

general draft approach on how to

minimize microbial contamination

through the control of water, manure,

worker sanitation and health, field and

facility sanitation, and transportation

and handling. A draft guide entitled

‘‘Guide to Minimizing Microbial Food

Safety Hazards for Fresh Fruit and

Vegetables,’’ will be available December

1, 1997, on FDA’s World Wide Web

Home Page (http//www.fda.gov).

The grassroots and the international

meetings will include an overview of

the President’s initiative and a review of

the general draft guide. The meetings

are intended to obtain input into the

draft guide. While all meetings are open

to any interested parties, the grassroots

meetings will focus specifically on

domestic produce, and the international

meeting will focus on imported

produce.

Transcripts of the grassroots and

international meetings 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,

approximated 15 working days after

each meeting at a cost of 10 cents per

page. The transcripts of the grassroots

and the international meetings will be

available for public examination at the

Dockets Management Branch (address

above) between 9 a.m. and 4 p.m.,

Monday through Friday.

TABLE 1.—DOMESTIC MEETINGS

Meeting Address Date FDA Contact Person

GRAND RAPIDS: Amway Grand Hotel, Pearl

and Monroe, Grand Rapids, MI..

December 1, 1997 Evelyn Denke, Food and Drug Administration,

Detroit District Office (HFR–MW245), 1500

E. Jefferson Ave., Detroit, MI 48207–3179,

313–226–6158.

GENEVA: New York State Agricultural Experiment Station, 630 West North St., Geneva,

NY..

December 3, 1997 Beverly Kent, Food and Drug Administration,

Buffalo District Office, 599 Delaware Ave.,

Buffalo, NY 14202, 716–551–4461 ext.

3131.

WEST PALM BEACH: Clayton Hutchinson Agricultural Center, 559 North Military Trail,

West Palm Beach, FL..

December 5, 1997 Lynn Isaacs, Food and Drug Administration,

Florida District Office, 7200 Lake Ellenor

Dr., suite 120, Orlando, FL 32809, 407–

648–6922 ext. 202.

SAN ANTONIO: Helotes 4–H Center, San Antonio, TX, 12132 Leslie Rd., Helotes, TX..December 8, 1997 Sylvia Yetts, Food and Drug Administration,

Dallas District Office (HFR–SW100), 3310

Live Oak St., Dallas, TX 75204, 214–655–

5315 ext. 344.

SALINAS: Salinas Community Center, 490

North Main St., Salinas, CA..

December 10, 1997 Mary Acton, Food and Drug Administration,

San Francisco District Office (HFR–

PA150), 1431 Harbor Bay Pkwy., Alameda,

CA 94502, 510–337–6765.

PORTLAND: Monarch Hotel, 12566 SE. 93d

Ave., Clackamas, OR..

December 12, 1997 Debra Tucker, Food and Drug Administration,

Portland District Office, 9780 SW. Nimus

Ave., Beaverton, OR 97008, 503–671–

9711 ext. 10.

TABLE 2.—INTERNATIONAL MEETING

Meeting Address Date FDA Contact Person

WASHINGTON, DC: Department of Health and

Human Services, Hubert Humphrey Bldg.,

200 and Independence, Washington, DC..

Monday, December 8, 1997 Marilyn Veek, Food and Drug Administration,

Office of International Affairs (HFG–1),

5600 Fishers Lane, Rockville, MD 20857,

301–827–0906

Dated: November 24, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–31366 Filed 11-25-97; 11:18 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food And Drug Administration

[Docket No. 97F–0468]

Ciba Specialty Chemicals Corp.; Filing

of Food Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Ciba Specialty Chemicals Corp., has

filed a petition proposing that the food

additive regulations be amended to

provide for the safe use of tris(2,4-ditert-butylphenyl)phosphite by removing

the restrictions on the temperature of

use in low density polyethylene films of

thickness greater than 0.051 millimeter

(mm) (0.002 inch (in)), provided that the

film does not contain a total of tris(2,4-

di-tert-butylphenyl)phosphite in excess

of 0.062 milligram (mg) per in2 of the

food-contact surface.

DATES: Written comments on

petitioner’s environmental assessment

by December 29, 1997.

ADDRESSES: Submit written comments

to the Dockets Management Branch