Federal Register / Vol. 62, No. 193 / Monday, October 6, 1997 / Notices 52135

for nonimpact-resistant lenses. Because

most prescription orders are now filled

by impact-resistant plastic lenses, and

only one or two orders for nonimpactresistant lenses are estimated to be

completed annually, this de minimus

burden is not included in the chart.

Dated: September 29, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–26451 Filed 10–3–97 ; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0384]

Knickerbocker Biologicals, Inc.;

Opportunity for Hearing on a Proposal

to Revoke U.S. License No. 458–001

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

opportunity for a hearing on a proposal

to revoke the establishment license (U.S.

License No. 458–001) and product

licenses issued to Knickerbocker

Biologicals, Inc., for the manufacture of

Whole Blood, Red Blood Cells, Plasma,

and Source Leukocytes. The proposed

revocation is based on the inability of

authorized FDA employees to conduct

an inspection of this facility, which is

no longer in operation.

DATES: The firm may submit written

requests for a hearing to the Dockets

Management Branch by November 5,

1997, and any data and information

justifying a hearing by December 5,

1997. Other interested persons may

submit written comments on the

proposed revocation by December 5,

1997.

ADDRESSES: Submit written requests for

a hearing, any data and information

justifying a hearing, and any written

comments on the proposed revocation

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Astrid L. Szeto, Center for Biologics

Evaluation and Research (HFM–17),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–827–6210.

SUPPLEMENTARY INFORMATION: FDA is

initiating proceedings to revoke the

establishment license (U.S. License

458–001) and product licenses issued to

Knickerbocker Biologicals, Inc., doing

business as Knickerbocker Blood Bank,

272 Willis Ave., Bronx, NY 10454, for

the manufacture of Whole Blood, Red

Blood Cells, Plasma, and Source

Leukocytes. Proceedings to revoke the

licenses are being initiated because an

attempted inspection of the facility by

FDA revealed that the firm was no

longer in operation.

In a certified, return-receipt letter

dated November 14, 1996, FDA notified

the Responsible Head of the firm that its

attempt to conduct an inspection at

Knickerbocker Biologicals, Inc., at 272

Willis Ave., Bronx, NY 10454, was

unsuccessful because the facility was

apparently no longer in operation, and

requested that the firm notify FDA in

writing of the firm’s status. This letter

was returned to the agency marked

‘‘undeliverable; address unknown.’’

On December 3, 1996, FDA visited

three other known addresses of

Knickerbocker Biologicals, Inc., New

York, NY, and attempted to conduct an

inspection. These attempts were also

unsuccessful. Upon consultation, the

U.S. Postal Service reported no

information regarding a forwarding

address or change of address for any of

the last known locations.

In a certified, return-receipt letter sent

to Knickerbocker Biologicals, Inc., dated

January 24, 1997, and returned as

undeliverable, FDA indicated that the

attempts to conduct an inspection at the

facility were unsuccessful. The letter

also advised the Responsible Head that,

under 21 CFR 601.5(b)(1) and (b)(2),

when FDA finds that authorized

employees have been unable to gain

access to an establishment for the

purpose of carrying out an inspection or

the manufacturing of products or of a

product has been discontinued to an

extent that a meaningful inspection

cannot be made, proceedings for license

revocation may be instituted. In the

same letter, FDA indicated that a

meaningful inspection could not be

made at the establishment and issued

the firm notice of FDA’s intent to revoke

U.S. License No. 458–001 and

announced its intent to offer an

opportunity for a hearing.

Because FDA has made reasonable

efforts to notify the firm of the proposed

revocation and no response was

received from the firm, FDA is

proceeding under 21 CFR 12.21(b) and

publishing this notice of 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

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) FDA letters to the Responsible Head

dated November 14, 1996, and January

24, 1997; and (2) memorandum

regarding the investigation and

inspection dated December 9, 1996.

These documents are available for

public examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

Knickerbocker Biologicals, Inc., may

submit a written request for a hearing to

the Dockets Management Branch by

November 5, 1997, and any data and

information justifying a hearing must be

submitted by December 5, 1997. Other

interested persons may submit

comments on the proposed license

revocation to the Dockets Management

Branch by December 5, 1997. 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’s 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 to

justify a hearing on 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

required time with the required format

or required analyses, the Commissioner

of Food and Drugs will deny the hearing

request, making 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. Such

submissions, except for data and

information prohibited from public

disclosure under 21 CFR 10.20(j)(2)(i),

21 U.S.C. 331(j), or 18 U.S.C. 1905, may

be seen in the Dockets Management

Branch (address above) between 9 a.m.

and 4 p.m., Monday through Friday.

This notice is issued under section

351 of the Public Health Service Act (42

U.S.C. 262) and sections 201, 501, 502,
52136 Federal Register / Vol. 62, No. 193 / Monday, October 6, 1997 / Notices

505, and 701 of the Federal Food, Drug,

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

352, 355, and 371), and under the

authority delegated to Commissioner of

Food and Drugs (21 CFR 5.10) and

redelegated to the Director of the Center

for Biologics Evaluation and Research

(21 CFR 5.67).

Dated: September 17, 1997.

Kathryn C. Zoon,

Director, Center for Biologics Evaluation and

Research.

[FR Doc. 97–26454 Filed 10–3–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97C–0415]

Zauder Bros., Inc.; Filing of Color

Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Zauder Bros., Inc., has filed a

petition proposing that the color

additive regulations be amended to

provide for the safe use of zinc sulfide

as a color additive in externally applied

cosmetics.

FOR FURTHER INFORMATION CONTACT:

Aydin O ̈ rstan, Center for Food Safety

and Applied Nutrition (HFS–215), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3076.

SUPPLEMENTARY INFORMATION: Under the

Federal Food, Drug, and Cosmetic Act

(sec. 721(d)(1) (21 U.S.C. 379e(d)(1))),

notice is given that a color additive

petition (CAP 7C0251) has been filed by

Zauder Bros., Inc., c/o Schiff & Co., 1129

Bloomfield Ave., West Caldwell, NJ

07006. The petition proposes to amend

the color additive regulations to provide

for the safe use of zinc sulfide as a color

additive in externally applied

cosmetics.

The agency has determined under 21

CFR 25.32(r) that this action is of a type

that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

Dated: September 11, 1997.

Alan M. Rulis,

Director, Office of Premarket Approval,

Center for Food Safety and Applied Nutrition.

[FR Doc. 97–26354 Filed 10–3–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 95F–0040]

Chemie Research and Manufacturing

Co., Inc.; 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

filed by Chemie Research and

Manufacturing Co., Inc., proposing that

the food additive regulations be

amended to provide for the safe use of

a glycerin extract of dried grapefruit

seeds and pulp as an antimicrobial

agent in the processing of fresh or frozen

poultry, fish, and shellfish.

FOR FURTHER INFORMATION CONTACT:

Valerie M. Davis, Center for Food Safety

and Applied Nutrition (HFS–206), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3181.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

March 16, 1995 (60 FR 14286), FDA

announced that a food additive petition

(FAP 2A4336) had been filed by Chemie

Research and Manufacturing Co., Inc.,

160 Concord Dr., P.O. Box 181279,

Casselberry, FL 32718–1279. The

petition proposed that the food additive

regulations be amended to provide for

the safe use of a glycerin extract of dried

grapefruit seeds and pulp as an

antimicrobial agent in the processing of

fresh or frozen poultry, fish, and

shellfish.

By letter dated May 10, 1995, the

agency notified the petitioner that

consideration of the petitioned use for

the glycerin extract of dried grapefruit

seed and pulp would require the

submission and evaluation of specific

additional data. By letter of June 1,

1995, the petitioner provided a partial

response to the agency’s request for

information and stated an intent to

provide a complete response within 180

days. However, no further information

was submitted within the 180-day time

period.

By letter of July 24, 1996, FDA again

requested that the necessary data be

submitted within 30 days and stated

that a failure to respond would be

considered to be an agreement by the

petitioner to withdraw the petition.

Because FDA has received no response

from the petitioner, and the required

information has not been submitted, the

petition is now withdrawn without

prejudice to a future filing (21 CFR

171.7(b)). Future consideration of the

use of a glycerin extract of dried

grapefruit seeds and pulp as an

antimicrobial agent in the processing of

fresh or frozen poultry, fish, and

shellfish will require submission of a

new food additive petition.

Dated: September 22, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–26413 Filed 10–3–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97F–0412]

Mitsui Petrochemical Industries, Ltd.;

Filing of Food Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Mitsui Petrochemical Industries,

Ltd., has filed a petition proposing that

the food additive regulations be

amended to provide for the safe use of

ethylene/propylene copolymers that

contain up to 20 mole-percent of

polymer units derived from propylene,

with the remainder of the polymer

consisting of ethylene, and having a

minimum viscosity-average molecular

weight of 95,000 and a minimum

Mooney viscosity of 13 at up to 30

percent of other regulated polymer

blends.

DATES: Written comments on the

petitioner’s environmental assessment

by November 5, 1997.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Hortense S. Macon, Center for Food

Safety and Applied Nutrition (HFS–

215), Food and Drug Administration,