Federal Register / Vol. 61, No. 80 / Wednesday, April 24, 1996 / Notices 18151

SUPPLEMENTARY INFORMATION: In the

Federal Register of April 20, 1995 (60

FR 19753), FDA announced that a series

of Grassroots Regulatory Partnership

meetings would be held. Those persons

interested in attending this meeting

should FAX their comments and

registration by Tuesday, April 22, 1996,

including name, firm/organization

name, address, and telephone number to

404–347–1912. There is no registration

fee for this meeting, but advance

registration is required. Space is limited

and all interested parties are encouraged

to register early. The goal of this

meeting is to ‘‘listen’’ to concerns and

ideas, and to identify next-steps for the

agency.

Dated: April 15, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–10023 Filed 4–23–96; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 84F–0314]

Coconut Products Corp.; Withdrawal

of Food Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

withdrawal, without prejudice to a

future filing, of a food additive petition

(FAP 4A3824) proposing that the food

additives regulations be amended to

provide for the safe use of polysorbate

60 as an emulsifier to be used in the

preparation of coconut milk drink.

FOR FURTHER INFORMATION CONTACT:

Andrew D. Laumbach, Center for Food

Safety and Applied Nutrition (HFS–

217), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–418–3071.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

October 9, 1984 (49 FR 39615), FDA

announced that a food additive petition

(FAP 4A3824) had been filed by the

Coconut Products Corp., 779 Kii St.,

Honolulu, HI 96825, proposing that

§ 172.836 Polysorbate 60 (21 CFR

172.836) be amended to provide for the

safe use of polysorbate 60 as an

emulsifier in the preparation of coconut

milk drink. Coconut Products Corp. has

now withdrawn the petition without

prejudice to a future filing (21 CFR

171.7).

Dated: April 4, 1996.

George H. Pauli,

Acting Director, Office of Premarket

Approval, Center for Food Safety and Applied

Nutrition.

[FR Doc. 96–10024 Filed 4–23–96; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 96N–0125]

Drug Export; Benadryl Injection SteriVials (Diphenhydramine

Hydrochloride Injection, USP) 50

Milligram Per Milliliter (mg/mL), 1-mL

Vials

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Parke-Davis Pharmaceutical

Research has filed an application

requesting approval for the export of the

human drug Benadryl Injection SteriVials 50 mg/mL, 1-mL Vials

(diphenhydramine hydrochloride)

Injection, USP, to Canada.

ADDRESSES: Relevant information on

this application may be directed to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857, and to the contact

person identified below. Any future

inquiries concerning the export of

human drugs under the Drug Export

Amendments Act of 1986 should also be

directed to the contact person.

FOR FURTHER INFORMATION CONTACT:

James E. Hamilton, Center for Drug

Evaluation and Research (HFD–310),

Food and Drug Administration, 7520

Standish Pl., Rockville, MD 20855, 301–

594–3150.

SUPPLEMENTARY INFORMATION: The drug

export provisions in section 802 of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 382) provide that

FDA may approve applications for the

export of drugs that are not currently

approved in the United States. Section

802(b)(3)(B) of the act sets forth the

requirements that must be met in an

application for approval. Section

802(b)(3)(C) of the act requires that the

agency review the application within 30

days of its filing to determine whether

the requirements of section 802(b)(3)(B)

have been satisfied. Section 802(b)(3)(A)

of the act requires that the agency

publish a notice in the Federal Register

within 10 days of the filing of an

application for export to facilitate public

participation in its review of the

application. To meet this requirement,

the agency is providing notice that

Parke-Davis Pharmaceutical Research,

2800 Plymouth Rd., Ann Arbor, MI

48105, has filed an application

requesting approval for the export of the

human drug Benadryl Injection SteriVials 50 mg/mL, 1-mL Vials

(diphenhydramine hydrochloride)

Injection, USP, to Canada. The firm has

FDA approval to market this product in

1-mL ampoules and a 1-mL syringe.

This product is indicated to be used as

an antiallergic, antipruritic, antiemetic,

and antispasmodic. The application was

received and filed in the Center for Drug

Evaluation and Research on November

15, 1995, which shall be considered the

filing date for purposes of the act.

Interested persons may submit

relevant information on the application

to the Dockets Management Branch

(address above) in two copies (except

that individuals may submit single

copies) and identified with the docket

number found in brackets in the

heading of this document. These

submissions may be seen in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

The agency encourages any person

who submits relevant information on

the application to do so by May 6, 1996,

and to provide an additional copy of the

submission directly to the contact

person identified above, to facilitate

consideration of the information during

the 30-day review period.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(sec. 802 (21 U.S.C. 382)) and under

authority delegated to the Commissioner

of Food and Drugs (21 CFR 5.10) and

redelegated to the Center for Drug

Evaluation and Research (21 CFR 5.44).

Dated: April 5, 1996.

Betty L. Jones,

Deputy Director, Office of Compliance, Center

for Drug Evaluation and Research.

[FR Doc. 96–10020 Filed 4–23–96; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 90N–0330]

The Kasdenol Corp., et al.; Withdrawal

of Approval of Three New Drug

Applications

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is withdrawing

three new drug applications (NDA’s)

held by The Kasdenol Corp.; Lever

Brothers Co., Inc.; and United

Pharmaceutical Inc. The basis for the

withdrawals is that the holders of the

applications have repeatedly failed to