20998 Federal Register / Vol. 60, No. 82 / Friday, April 28, 1995 / Notices

FDA conducted an inspection and

concurrent investigation of BSI from

March 23 through April 14, 1993. The

inspection and concurrent inspection

revealed serious deviations from the

standards established in the applicable

Federal regulations and approved

license.

The concurrent investigation revealed

significant deficiencies that occurred

routinely in quality control

recordkeeping, as well as in personnel

training and supervision. BSI

employees, with the knowledge of

management, falsified blood storage

temperature records whenever the

temperature was outside the range

specified in written procedures. BSI

employees also routinely discarded

donor registration forms of temporarily

deferred donors because the staff would

receive negative performance

evaluations if a high number of donors

were deferred.

During the inspection, FDA observed

deviations that included, but were not

limited to, the following: (1) Failure to

determine donor suitability, in that BSI

accepted donations from individuals

who reported disqualifying information

(21 CFR 640.3(b)); (2) failure to

adequately prepare the donor’s

phlebotomy site by a method that gives

maximum assurance of sterility, in that

the site was sometimes repalpated after

the arm scrub was performed, and the

arm scrubs were performed for less than

the 30 seconds required by BSI’s

standard operating procedures (21 CFR

640.4(f)); and (3) failure to assure that

the personnel responsible for the

collection of blood on mobile drives

were adequate in number, in that it was

observed that donors were rushed

through medical history questions, were

not provided with adequate privacy

during medical history interviews, and

were only allowed 1 to 2 minutes of

recovery time following blood donation

(21 CFR 606.20(b)).

The inspection observations and the

concurrent investigation showed that

BSI knowingly falsified blood storage

records. Consequently, FDA determined

that BSI willfully failed to comply with

the standards established in the

approved license and in the applicable

regulations. In accordance with that

determination, FDA initiated

proceedings under 21 CFR 601.5(b) for

license revocation without providing

BSI with an opportunity to achieve or

demonstrate compliance.

In a letter to BSI dated June 1, 1993,

FDA delineated the observations listed

above and announced its intent to offer

an opportunity for a hearing on FDA’s

proposal to revoke U.S. License 0183–

020 issued to BSI. In a letter to FDA

dated June 28, 1993, BSI requested

voluntary revocation of its license and

waived its opportunity for a hearing

under 21 CFR 601.5(a). In a letter dated

July 23, 1993, FDA acknowledged

voluntary revocation of the

establishment license (U.S. License No.

0183–020) and the aforementioned

product licenses of BSI at the

Texarkana, TX, location.

FDA has placed copies of documents

relevant to the license revocation on file

under the docket number found in

brackets in the heading of this notice

with the Dockets Management Branch

(HFA–305), Food and Drug

Administration, rm. 1–23, 12420

Parklawn Dr., Rockville, MD 20857.

These documents are available for

public examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

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. 0183–020) and

product licenses for Whole Blood (ACD,

CPD, CPDA–1), Red Blood Cells, Red

Blood Cells Leukocytes Removed,

Plasma, Fresh Frozen Plasma,

Cryoprecipitated AHF, Platelets,

Platelets Pheresis, and Source

Leukocytes issued to BSI at the

Texarcana, TX, location were revoked,

effective July 23, 1993.

This notice is issued and published

under 21 CFR 601.8 and the

redelegation at (21 CFR 5.67).

Dated: April 8, 1995.

Kathryn C. Zoon,

Director, Center for Biologics Evaluation and

Research.

[FR Doc. 95–10541 Filed 4–27–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 88G–0388]

Fuji Oil Co., Ltd.; Filing of Petition for

Affirmation of GRAS Status;

Amendment

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

filing notice for a petition (GRASP

8G0348) filed by Fuji Oil Co., Ltd.,

proposing to affirm that cocoa butter

substitutes from safflower oil and

sunflower oil are generally recognized

as safe (GRAS) for use as direct human

food ingredients. This amendment is

intended to clarify that the sunflower

and safflower oils used in the

manufacture of the petitioned cocoa

butter substitute are the high-oleic

rather than the typical high-linoleic

varieties.

DATES: Comments by July 12, 1995.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, rm. 1–23, 12420

Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Nega Beru, Center for Food Safety and

Applied Nutrition (HFS–206), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3097.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

January 26, 1989 (54 FR 3853), FDA

announced that Fuji Oil Co., Ltd., 6–1,

Hachiman-cho, Minami-ku, Osaka 542

Japan, had filed a petition (GRASP

8G0348) proposing to affirm that cocoa

butter substitutes from safflower oil and

sunflower oil are GRAS for use as direct

human food ingredients. The agency

recognizes that the terms ‘‘safflower oil’’

and ‘‘sunflower oil’’ normally refer to

the traditional high-linoleic varieties.

However, the agency has determined

that the proposed starting materials for

the manufacture of the petitioned cocoa

butter substitutes are the high-oleic

rather than the typical high-linoleic

safflower or sunflower oils. Therefore,

the agency is amending the filing notice

to make this distinction clear.

Interested persons may, on or before

July 12, 1995, submit to the Dockets

Management Branch (address above)

written comments with respect to the

above mentioned change only. Two

copies of any comments are to be

submitted, except that individuals may

submit one copy. Comment are to be

identified with the docket number

found in brackets in the heading of this

document. A copy of the petition and

received comments may be seen in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

Dated: April 19, 1995.

Alan M. Rulis,

Acting Director, Office of Premarket

Approval, Center for Food Safety and Applied

Nutrition.

[FR Doc. 95–10540 Filed 4–27–95; 8:45 am]

BILLING CODE 4160–01–F