25496 Federal Register / Vol. 61, No. 99 / Tuesday, May 21, 1996 / Notices

Rockville, MD 20852–1448, 301–594–

3074.

SUPPLEMENTARY INFORMATION: FDA has

revoked the establishment license (U.S.

License No. 832–003) and the product

license for the manufacture of Source

Plasma issued to Worldwide

Biologicals, Inc., 508–A Owen Dr.,

Fayetteville, NC 28304.

By letter dated June 15, 1992, issued

pursuant to 21 CFR 601.5(b), FDA

notified the firm of FDA’s intent to

revoke U.S. License No. 832–003 and

announced its intent to offer an

opportunity for a hearing. In a facsimile

dated June 24, 1992, the firm notified

FDA of its intent to request a hearing on

the proposed license revocation.

In the Federal Register of March 22,

1993 (58 FR 15351), FDA issued a notice

of opportunity for a hearing, pursuant to

21 CFR 12.21(b), on the proposal to

revoke the establishment license (U.S.

License No. 832–003) and product

license issued to Worldwide Biologicals,

Inc., for the manufacture of Source

Plasma. As described in the notice of

opportunity for a hearing, the grounds

for the proposed license revocation

included the following: (1) The results

of FDA inspections of the firm

conducted from June 24 through July 2,

1991; January 17 through January 27,

1992; and May 5 and 6, 1992; as well

as from the inspection of Worldwide

Biologicals, Inc., 1085 Ohio Pike,

Cincinnati, OH, the site of the testing

laboratory approved to perform all

required testing for the Fayetteville

facility, from July 18 through August 26,

1991; (2) a determination by FDA that

the deviations documented during the

inspections of the firm demonstrated

significant noncompliance with the

applicable regulations and standards in

the firm’s license; and (3) a

determination by FDA that there was no

assurance that the firm would properly

implement a corrective action plan that

it had proposed. FDA’s determination

was based on the firm’s failure to

adequately implement previously

promised corrections. Documentation in

support of the proposed revocation had

been placed on file for public

examination with the Dockets

Management Branch (HFA–305), Food

and Drug Administration, rm. 1–23,

12420 Parklawn Dr., Rockville, MD

20857.

Following publication of the notice of

opportunity for a hearing on March 22,

1993, FDA’s Dockets Management

Branch received two letters, dated April

12, 1993, and May 20, 1993, from the

firm’s responsible head. In the letter of

April 12, 1993, Worldwide Biologicals,

Inc., requested a hearing on the

proposed license revocation. In the

letter of May 20, 1993, Worldwide

Biologicals, Inc., submitted its request

for a hearing and set forth information

and factual analyses to support its

request.

While the request for a hearing was

pending, representatives of the U.S.

Department of Justice, on behalf of FDA,

charged the responsible head of

Worldwide Biologicals, Inc., with

criminal violations of Federal laws

governing the manufacturing, labeling,

and shipping of human blood plasma.

On April 6, 1994, the responsible head

entered into a plea agreement with the

United States Attorney for the Southern

District of Ohio and the Office of

Consumer Litigation, United States

Department of Justice. In a superseding

plea agreement filed on April 29, 1994,

with the clerk of the United States

District Court, Southern District of Ohio,

Western Division, the responsible head

of the firm agreed to surrender U.S.

License No. 832 immediately upon

sentencing. Sentencing took place on

September 23, 1994. FDA notified

Worldwide Biologicals, Inc., by letter of

September 29, 1994, that the licenses

had been revoked.

Based on the voluntary surrender of

U.S. License No. 832, Worldwide

Biologicals Inc.’s request for a hearing

on the issue of license revocation

became moot. Although the revocation

proceedings that FDA initiated only

pertained to the firm’s Fayetteville, NC

location (U.S. License No. 832–003), the

surrender of U.S. License No. 832 affects

all Worldwide Biologicals, Inc.,

locations under that license.

Accordingly, under 21 CFR 601.5,

section 351 of the Public Health Service

Act (42 U.S.C. 262), and under 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. 832–003) and the

product license for the manufacture of

Source Plasma issued to Worldwide

Biologicals, Inc., were revoked, effective

September 29, 1994.

This notice is issued and published

under 21 CFR 601.8 and the

redelegation at 21 CFR 5.67.

Dated: May 2, 1996.

Kathryn C. Zoon,

Director, Center for Biologics Evaluation and

Research.

[FR Doc. 96–12688 Filed 5–20–96; 8:45 am]

BILLING CODE 4160–01–F

Grassroots Regulatory Partnership

Meeting; Pacific Region San Francisco

District Office; Medicated Feed

Industry

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of a public meeting.

SUMMARY: The Food and Drug

Administration (FDA) (Office of

External Affairs, Office of Regulatory

Affairs, Office of the Pacific Region, and

the Center for Veterinary Medicine) is

announcing a free public meeting as a

followup to a meeting held in April

1995. FDA’s San Francisco District

Office (Pacific Region) and the Center

for Veterinary Medicine will meet with

interested persons in the Pacific Region

to address specific issues related to the

medicated feed industry to help the

industry comply with FDA regulations.

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 this agency.

DATES: The public meeting will be held

on Friday, May 31, 1996, from 8 a.m. to

4:30 p.m.

ADDRESSES: The public meeting will be

held at the Red Lion Inn, 1401 Arden

Way, Sacramento, CA 95815. Attendees

requiring overnight accommodations

may contact the hotel at 916–922–8041.

FOR FURTHER INFORMATION CONTACT:

Regarding the Sacramento area: Karen

L. Robles or Susan R. Nelson, Food and

Drug Administration, 650 Capitol Mall,

rm. 6002, Sacramento, CA 95814, 916–

498–6403 or 916–498–6400 or FAX

916–498–6401.

Regarding the Fresno area: Robert J.

Anderson, Food and Drug

Administration, 2202 Monterey St.,

suite 104E, Fresno, CA 93721, 209–487–

5321 or FAX 209–487–5305.

SUPPLEMENTARY INFORMATION: In the

Federal Register of April 20, 1995 (60

FR 19753), FDA announced that a series

of Grassroots Regulatory Partnerships

meetings would be held. This document

announces a free public meeting as a

followup to the meetings held in April

1995. Those persons interested in

attending this public meeting should

FAX their comments and registration

including name, firm/organization,

address, telephone and FAX numbers to

the appropriate contact person listed

above, by Friday, May 24, 1996.

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 goals of this meeting

are to listen to concerns and ideas, and

to identify next steps for the agency.
Federal Register / Vol. 61, No. 99 / Tuesday, May 21, 1996 / Notices 25497

Dated: May 15, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–12650 Filed 5–20–96; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95P–0285]

Determination That Glyburide Tablets

4.5 Milligrams Was Not Withdrawn

From Sale for Reasons of Safety or

Effectiveness

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

that glyburide (Glynase PresTab)

tablets 4.5 milligrams (mg) was not

withdrawn from sale for reasons of

safety or effectiveness. This

determination will allow sponsors to

submit abbreviated new drug

applications (ANDA’s) for glyburide

tablets 4.5 mg.

FOR FURTHER INFORMATION CONTACT:

Wayne H. Mitchell, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–594–

1049.

SUPPLEMENTARY INFORMATION: In 1984,

Congress passed into law the Drug Price

Competition and Patent Term

Restoration Act of 1984 (Pub. L. 98–417)

(the 1984 amendments), which

authorized the approval of duplicate

versions of drug products approved

under an ANDA procedure. ANDA

sponsors must, with certain exceptions,

show that the drug for which they are

seeking approval contains the same

active ingredient in the same strength

and dosage form as the listed drug,

which is a version of the drug that was

previously approved under a new drug

application (NDA). Sponsors of ANDA’s

do not have to repeat the extensive

clinical testing otherwise necessary to

gain approval of an NDA. The only

clinical data required in an ANDA are

data to show that the drug that is the

subject of the ANDA is bioequivalent to

the listed drug.

The 1984 amendments included what

is now section 505(j)(6) of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 355(j)(6)), which requires

FDA to publish a list of all approved

drugs. FDA publishes this list as part of

the ‘‘Approved Drug Products with

Therapeutic Equivalence Evaluations,’’

which is generally known as the

‘‘Orange Book.’’ Under FDA regulations,

drugs are withdrawn from the list if the

agency withdraws or suspends approval

of the drug’s NDA or ANDA for reasons

of safety or effectiveness, or if FDA

determines that the listed drug was

withdrawn from sale for reasons of

safety or effectiveness (§ 314.162 (21

CFR 314.162)). Another FDA regulation

also provides that the agency must make

a determination as to whether a listed

drug was withdrawn from sale for

reasons of safety or effectiveness before

an ANDA that refers to that listed drug

may be approved (§ 314.161(a)(1) (21

CFR 314.161(a)(1))). FDA may not

approve an ANDA that does not refer to

a listed drug.

Novopharm Ltd., submitted a citizen

petition, dated August 21, 1995 (Docket

No. 95P–0285/CP1), under 21 CFR

10.25(a) and 10.30 requesting that the

agency determine whether glyburide

tablets 4.5 mg was withdrawn from sale

for reasons of safety or effectiveness

and, if the agency determines that the

drug was not withdrawn from sale for

reasons of safety or effectiveness, to

keep the drug in the ‘‘Approved Drug

Products with Therapeutic Equivalence

Evaluations.’’ Glyburide tablets 4.5 mg,

along with the 1.5-mg, 3-mg, and 6-mg

strengths, is the subject of approved

NDA 20–051 held by the Upjohn Co.

(Upjohn). Upjohn obtained approval to

market the 4.5-mg strength of glyburide

tablets on September 24, 1993. Upjohn

has never marketed the 4.5-mg strength

of glyburide tablets. FDA has

determined, for purposes of §§ 314.161

and 314.162(c), that never marketing an

approved drug product is equivalent to

withdrawing the drug for sale.

FDA has reviewed its records and,

under §§ 314.161 and 314.162(c), has

determined that glyburide tablets 4.5 mg

was not withdrawn from sale for reasons

of safety or effectiveness and will

continue to list glyburide tablets 4.5 mg

in the ‘‘Discontinued Drug Product List’’

contained in the ‘‘Approved Drug

Products with Therapeutic Equivalence

Evaluations.’’ The ‘‘Discontinued Drug

Product List’’ lists, among other items,

drug products that have been

discontinued from marketing for reasons

other than safety or effectiveness.

ANDA’s that refer to glyburide tablets

4.5 mg may be submitted to the agency.

The agency notes that there is a patent

listed in the Orange Book for Glynase

PresTab tablets that will not expire

until April 10, 2007. This patent will

prevent FDA from approving ANDA’s

that refer to Glynase PresTab tablets

with an effective date before April 10,

2007, if the patent is valid and the

manufacture, use, or sale of the drug

product for which approval is being

sought would infringe the patent.

Novopharm Ltd., states in its petition

that it does not intend to make a generic

drug that refers to Glynase PresTab

tablets available for sale until the

expiration of the patent. Between now

and the time an ANDA for glyburide

tablets 4.5 mg is submitted, approved, or

the approval goes into effect, FDA may

obtain new information on the safety

and effectiveness of glyburide tablets

that will prevent the agency from

receiving or approving the ANDA.

Dated: May 15, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–12759 Filed 5–20–96; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95P–0128]

Determination That Hydrocortisone

Acetate Topical Ointment 2.5% Was

Not Withdrawn From Sale for Reasons

of Safety or Effectiveness

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

that hydrocortisone (Cortef) acetate

topical ointment 2.5% was not

withdrawn from sale for reasons of

safety or effectiveness. This

determination will allow sponsors to

submit abbreviated new drug

applications (ANDA’s) for

hydrocortisone acetate topical ointment

2.5%.

FOR FURTHER INFORMATION CONTACT:

Wayne H. Mitchell, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–594–

1049.

SUPPLEMENTARY INFORMATION: In 1984,

Congress passed into law the Drug Price

Competition and Patent Term

Restoration Act of 1984 (Pub. L. 98–417)

(the 1984 amendments), which

authorized the approval of duplicate

versions of drug products approved

under an ANDA procedure. ANDA

sponsors must, with certain exceptions,

show that the drug for which they are

seeking approval contains the same

active ingredient in the same strength

and dosage form as the listed drug,

which is a version of the drug that was

previously approved under a new drug

application (NDA). Sponsors of ANDA’s

do not have to repeat the extensive

clinical testing otherwise necessary to

gain approval of an NDA. The only

clinical data required in an ANDA are

data to show that the drug that is the