18150 Federal Register / Vol. 61, No. 80 / Wednesday, April 24, 1996 / Notices

dismissed on March 3, 1995. During a

June 1, 1995, telephone conversation

with FDA staff at the Center for

Biologics Evaluation and Research

(CBER), one of the owners of the firm

stated that the firm ceased operations in

December 1994. FDA explained that it

could move to revoke the license if the

firm remained inoperative. FDA

requested a written response within 30

days regarding whether the owners

intended to reopen the establishment.

As of July 24, 1995, none of the owners

had contacted FDA regarding the firm’s

intentions. In addition, messages left by

FDA staff on one owner’s telephone

answering machine were not answered.

An FDA investigator, from the Nashville

District Office, was permitted to visit

the unoccupied facility by the property

owner on August 3, 1995. The

investigator documented that the office

space and two walk-in freezers were

empty and that there was no electrical

or water service at the facility. The U.S.

Postal Service supplied FDA with the

firm’s forwarding address, and FDA sent

a certified letter, dated September 8,

1995, to the firm’s responsible head.

The certified letter stated that, under 21

CFR 601.5(b), a license may be revoked

if the Commissioner finds that after

reasonable efforts authorized FDA

employees have been unable to gain

access to an establishment for the

purposes of conducting an inspection,

or that the manufacturing of a product

has been discontinued to an extent that

a meaningful inspection cannot be

made. The letter also stated that

following repeated attempts to conduct

an inspection, FDA had determined that

a meaningful inspection could not be

made. The letter provided the firm’s

responsible head notice of FDA’s intent

to revoke U.S. License No. 1131 and

announced FDA’s intent to offer an

opportunity for a hearing. The

responsible head responded by

telephone on September 12, 1995, and

said that she was no longer employed by

Personal Blood Storage of Memphis, Inc.

She also sent a copy of a March 3, 1995,

letter to CBER in which she had stated

that she was no longer the Technical

Director or responsible head for

Personal Blood Storage of Memphis, Inc.

A copy of FDA’s letter of intent to

revoke U.S. License No. 1131 was also

sent to one owner’s address in Texas

and was returned by the U.S. Postal

Service as unclaimed.

Because FDA made reasonable efforts

to notify the firm of the proposed

revocation and no response was

received from the firm, FDA is

proceeding pursuant to 21 CFR 12.21(b)

and publishing this notice of an

opportunity for a hearing on a proposal

to revoke the licenses of the above

establishment.

FDA has placed copies of the

documents relevant to the proposed

license revocation on file with the

Dockets Management Branch (address

above) under the docket number found

in brackets in the heading of this notice.

These documents include the following:

(1) Record of teleconference dated June

1, 1995; (2) letter to FDA from

responsible head dated March 3, 1995;

(3) Summary of Findings dated August

3, 1995, (Endorsement-Form FDA 481);

(4) FDA certified letter to responsible

head dated September 8, 1995; (5) copy

of information returned from the U.S.

Postal Service showing that the copy of

FDA certified letter of September 8,

1995, sent to one owner’s Texas address,

was unclaimed; and (6) record of

teleconference dated September 12,

1995. These documents are available for

public examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

Personal Blood Storage of Memphis,

Inc., may submit a written request for a

hearing to the Dockets Management

Branch by May 24, 1996, and any data

and information justifying a hearing

must be submitted by June 24, 1996.

Other interested persons may submit

comments on the proposed revocation

by June 24, 1996. The failure of the

licensee to file a timely written request

for a hearing constitutes an election by

the licensee not to avail itself of the

opportunity for a hearing concerning the

proposed license revocation.

FDA procedures and requirements

governing a notice of opportunity for a

hearing, notice of appearance and

request for a hearing, grant or denial of

a hearing, and submission of data and

information to justify a hearing on a

proposed revocation of a license are

contained in 21 CFR parts 12 and 601.

A request for a hearing may not rest

upon mere allegations or denials but

must set forth a genuine and substantial

issue of fact that requires a hearing. If

it conclusively appears from the face of

the data, information, and factual

analyses submitted in support of the

request for a hearing that there is no

genuine and substantial issue of fact for

resolution at a hearing, or if a request for

a hearing is not made within the

requested time, or in the required format

or with the required analyses, the

Commissioner of Food and Drugs will

deny the hearing request, making

available the findings and conclusions

that justify the denial.

Two copies of any submissions are to

be provided to FDA, except that

individuals may submit one copy.

Submissions are to be identified with

the docket number found in brackets in

the heading of this document. The

public availability of information in

submissions is governed by 21 CFR

10.20(j)(2)(i). Publicly available

submissions may be seen in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

This notice is issued under section

351 the Public Health Service Act (42

U.S.C. 262) and sections 201, 501, 502,

505, and 701 of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 321, 351,

352, 355, and 371), and under authority

delegated to the Commissioner of Food

and Drugs (21 CFR 5.10) and

redelegated to the Director of CBER (21

CFR 5.67).

Dated: April 12, 1996.

Kathryn C. Zoon,

Director, Center for Biologics Evaluation and

Research.

[FR Doc. 96–10025 Filed 4–23–96; 8:45 am]

BILLING CODE 4160–01–F

Food and Drug Administration

Grassroots Regulatory Partnership

Meeting; Southeast Region, Atlanta

District Office; Turkey/Broiler Industry

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of public meeting.

SUMMARY: The Food and Drug

Administration (FDA) (Office of

External Affairs, Office of Regulatory

Affairs, Office of the Southeast Region,

and Center for Veterinary Medicine) is

announcing a free public meeting.

FDA’s Atlanta District Office (Southeast

Region) and the Center for Veterinary

Medicine will meet with interested

persons in the Southeast Region to

address specific issues related to the

turkey/broiler industry. The agency is

holding this meeting to promote the

President’s initiative for a partnership

approach with front-line regulators and

the people affected by the work of the

agency, and to create local partnerships.

DATES: The public meeting will be held

on Tuesday, May 14, 1996, from 8 a.m.

to 5 p.m.

ADDRESSES: The public meeting will be

held at the Sheraton Inn—Raleigh at

Crabtree Valley, 4501 Creedmoor Rd.,

Raleigh, NC 27812. Attendees requiring

overnight accommodations may contact

the hotel at 919–787–7111.

FOR FURTHER INFORMATION CONTACT:

JoAnn M. Pittman, FDA Atlanta District,

60 Eighth St. NE., Atlanta, GA 30309,

404–347–7355, or FAX 404–347–1912.
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