Federal Register / Vol. 60, No. 73 / Monday, April 17, 1995 / Notices 19265

ADDRESSES: Relevant information on

this application may be directed to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

rm. 1–23, 12420 Parklawn Dr.,

Rockville, MD 20857, and to the contact

person identified below. Any future

inquiries concerning the export of

human biological products under the

Drug Export Amendments Act of 1986

should also be directed to the contact

person.

FOR FURTHER INFORMATION CONTACT:

Cathy Conn, Center for Biologics

Evaluation and Research (HFM–610),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–594–1070.

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 human biological products

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 Organon Teknika Corp., 100

Akzo Ave., Durham, NC 27712, has filed

an application requesting approval for

the export of the human biological

product Vironostika HTLV–I/II

Microelisa System to The Netherlands.

The Vironostika HTLV–I/II Microelisa

System is an in vitro diagnostic test kit

for the detection of antibodies to Human

T–Lymphotropic Virus Type I (HTLV–I)

and/or Human T–Lymphotropic Virus

Type II (HTLV–II) in human serum or

plasma. The application was received

and filed in the Center for Biologics

Evaluation and Research on March 2,

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 onthe

application to do so by April 27, 1995,

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 Biologics

Evaluation and Research (21 CFR 5.44).

Dated: March 22, 1995.

James C. Simmons,

Acting Director, Office of Compliance, Center

for Biologics Evaluation and Research.

[FR Doc. 95–9413 Filed 4–14–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 93N–0122]

Hema Systems, Ltd.; Revocation of

U.S. License No. 1052

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

revocation of the establishment license

(U.S. License No. 1052) and product

licenses (the licenses) issued to Hema

Systems, Ltd., for the manufacture of

Whole Blood, Plasma, Fresh Frozen

Plasma, Red Blood Cells, Red Blood

Cells Frozen, Red Blood Cells

Deglycerolized, Red Blood Cells

Leukocytes Removed, Red Blood Cells

Frozen Rejuvenated, and Red Blood

Cells Rejuvenated Deglycerolized. Hema

Systems, Ltd., did not respond to a

notice of opportunity for a hearing on a

proposal to revoke its licenses.

DATES: The revocation of the

establishment license (U.S. License No.

1052) and product licenses is effective

April 17, 1995.

FOR FURTHER INFORMATION CONTACT:

Stephen M. Ripley, Center for Biologics

Evaluation and Research (HFM–635),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–594–3074.

SUPPLEMENTARY INFORMATION: FDA is

revoking the establishment license (U.S.

License No. 1052) and product licenses

issued to Hema Systems, Ltd., formerly

located at 310 East 44th St., New York,

NY 10017, for the manufacture of Whole

Blood, Plasma, Fresh Frozen Plasma,

Red Blood Cells, Red Blood Cells

Frozen, Red Blood Cells Deglycerolized,

Red Blood Cells Leukocytes Removed,

Red Blood Cells Frozen Rejuvenated,

and Red Blood Cells Rejuvenated

Deglycerolized.

An attempted onsite inspection by

FDA on August 26, 1992, revealed that

the facility was no longer in operation

at the location listed on the license. The

U.S. Post Office reported no forwarding

address for the firm. Based on the

inability of authorized FDA employees

to conduct a meaningful inspection of

the facility, FDA initiated proceedings

for the revocation of the licenses under

21 CFR 601.5(b)(1) and (b)(2). FDA

issued a certified letter dated November

3, 1992, to the firm stating FDA’s intent

to revoke the licenses and its intent to

offer an opportunity for a hearing on the

proposed revocation. The letter was

returned to FDA as undeliverable.

Pursuant to 21 CFR 12.21(b), FDA

published in the Federal Register of

May 14, 1993 (58 FR 28589), a notice of

opportunity for a hearing on a proposal

to revoke the licenses of Hema Systems

Ltd. In the notice, FDA explained that

the proposed license revocation was

based on the inability of authorized

FDA employees to conduct a

meaningful inspection of the facility

because it was no longer in operation

and noted that documentation in

support of the license 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. The notice provided the firm 30

days to submit a written request for a

hearing and 60 days to submit any data

and information justifying a hearing.

The notice provided other interested

persons with 60 days to submit written

comments on the proposed revocation.

The firm did not respond within the 30-

day time period with a written request

for a hearing. The 30-day time period,

prescribed in the notice of opportunity

for a hearing and in the regulations, may

not be extended. One comment was

submitted from the State of New York

Department of Health which indicated

that the facility was closed according to

their records.

Accordingly, under 21 CFR 12.38,

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), the

establishment license (U.S. License No.

1052) and the product licenses issued to

Hema Systems, Ltd., are revoked,

effective April 17, 1995.

This notice is issued and published

under 21 CFR 601.8.
19266 Federal Register / Vol. 60, No. 73 / Monday, April 17, 1995 / Notices

Dated: April 10, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–9412 Filed 4–14–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 93N–0109]

Houston Apheresis, Inc.; Revocation of

U.S. License No. 990

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

revocation of the establishment license

(U.S. License No. 990) and product

licenses (the licenses) issued to Houston

Apheresis, Inc., for the manufacture of

Whole Blood, Red Blood Cells, Plasma,

and Fresh Frozen Plasma. Houston

Apheresis, Inc., did not respond to a

notice of opportunity for a hearing on a

proposal to revoke its licenses.

DATES: The revocation of the

establishment license (U.S. License No.

990) and product licenses is effective

April 17, 1995.

FOR FURTHER INFORMATION CONTACT:

Stephen M. Ripley, Center for Biologics

Evaluation and Research (HFM–635),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–594–3074.

SUPPLEMENTARY INFORMATION: FDA is

revoking the establishment license (U.S.

License No. 990) and product licenses

issued to Houston Apheresis, Inc.,

formerly located at 9265 Kirby Dr.,

Houston, TX 77054, for the manufacture

of Whole Blood, Red Blood Cells,

Plasma, and Fresh Frozen Plasma.

An attempted onsite inspection by

FDA on March 26, 1991, revealed that

the facility was no longer in operation

at the location listed on the license. A

forwarding address, obtained from the

post office for the facility, was the home

address of the Responsible Head. An

FDA investigator left messages for the

Responsible Head requesting that the

agency be contacted; however, the

messages were not returned. Based on

the inability of authorized FDA

employees to conduct an inspection of

the facility after reasonable efforts, FDA

initiated proceedings for the revocation

of the licenses under 21 CFR 601.5(b).

FDA issued a certified letter, dated

October 26, 1992, to the Responsible

Head of the firm, providing notice of

FDA’s intent to revoke the licenses and

its intent to offer an opportunity for a

hearing on the proposed revocations.

Pursuant to 21 CFR 12.21(b), FDA

published in the Federal Register of

May 18, 1993 (58 FR 28982), a notice of

opportunity for a hearing on a proposal

to revoke the licenses of Houston

Apheresis, Inc. In the notice, FDA

explained that the proposed license

revocation was based on the inability of

authorized FDA employees to conduct

an inspection of the facility, which was

no longer in operation, and noted that

documentation in support of the license

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. The notice provided the firm

with 30 days to submit a written request

for a hearing and 60 days to submit any

data and information justifying a

hearing. The notice provided other

interested persons with 60 days to

submit written comments on the

proposed revocation. The firm did not

respond within the 30-day time period

with a written request for a hearing. The

30-day time period, prescribed in the

notice of opportunity for a hearing and

in the regulations, may not be extended.

No other interested persons submitted

written comments on the proposed

revocation within the 60-day time

period.

Accordingly, under 21 CFR 12.38,

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), the

establishment license (U.S. License No.

990) and the product licenses issued to

Houston Apheresis, Inc., for the

manufacture of Whole Blood, Red Blood

Cells, Plasma, and Fresh Frozen Plasma,

are revoked, effective April 17, 1995.

This notice is issued and published

under 21 CFR 601.8 and 12.38.

Dated: April 10, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–9410 Filed 4–14–95; 8:45 am]

BILLING CODE 4160–01–F

Regulatory Concerns in

Biopharmaceutical Manufacturing;

Notice of Public Workshops

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of public workshop.

SUMMARY: The Food and Drug

Administration (FDA) (Office of

Regulatory Affairs, Office of the Pacific

Region, Office of the Southwest Region,

Center for Biologics Evaluation and

Research, Center for Drug Evaluation

and Research, and Office of External

Affairs) is announcing a series of three

free public workshops to assist small

companies that are developing and

producing biopharmaceutical and

biologic therapeutic products for

clinical trials and product marketing

approval. The workshops will address

regulatory policy, licensing

requirements, cooperative

manufacturing arrangements, multiproduct facilities, clinical trial design,

and manufacturing requirements for

clinical material.

DATES: The public workshops are

scheduled as follows:

1. Monday, May 22, 1995, 8:30 a.m. to

5 p.m., Houston, TX.

2. Wednesday, May 24, 1995, 8:30 a.m.

to 5 p.m., San Diego, CA.

3. Friday, May 26, 1995, 8:30 a.m. to 5

p.m., San Francisco, CA.

ADDRESSES: The public workshops will

be held at the following locations:

1. Houston—Rice University, Sewall

Hall, rm. 301, Houston, TX.

2. San Diego—Pan Pacific Hotel, 400

West Broadway, San Diego, CA.

3. San Francisco—Holiday Inn Golden

Gateway, 1500 West Van Ness Ave., San

Francisco, CA.

FOR FURTHER INFORMATION CONTACT:

Regarding registration for the Houston

TX, public workshop: Marie T. Falcone,

Small Business Representative

Southwest Region, Food and Drug

Administration, 7920 Elmbrook Dr.,

suite 102, Dallas, TX 75247, 214–655–

8100, ext. 128 or FAX 214–655–8130.

Regarding registration for the San Diego

and San Francisco workshops: Mark S.

Roh, Small Business Representative

Pacific Region, Food and Drug

Administration, Federal Office Bldg., 50

United Nations Plaza, San Francisco,

CA 94102, 415–556–2263 or FAX 415–

556–2822.

SUPPLEMENTARY INFORMATION: The

public workshops are free of charge,

however registration is required. Due to

space limitations, early registration is

recommended. To register please submit

your name(s), affiliation, address, phone

and fax numbers and any specific

questions you want addressed at the

workshop, to the contact person listed

above.

The workshops are to further assist

small companies that are developing

and producing biopharmaceutical and

biologic therapeutic products in better

understanding current regulatory policy;

licensing requirements for products and

establishments and cooperative

manufacturing arrangements;

multiproduct facilities design and

operation; clinical trial design and

monitoring; points to consider during

processing, cell culture, fermentation,

harvest, recovery, purification and