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
Federal Register / Vol. 60, No. 73 / Monday, April 17, 1995 / Notices 19267

ascites production; and current good

manufacturing practice requirements in

the production of clinical material,

including recordkeeping, processing

changes, and environmental monitoring.

Dated: April 12, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–9411 Filed 4–14–95; 8:45 am]

BILLING CODE 4160–01–F

National Institutes of Health

National Institute of Environmental

Health Sciences; Meeting of National

Advisory Environmental Health

Sciences Council

Pursuant to Pub. L. 92–463, notice is

hereby given of the meeting of the

National Advisory Environmental

Health Sciences Council, May 22–23,

1995, in Building 31C, Conference

Room 10, National Institutes of Health,

Bethesda, Maryland 20892.

This meeting will be open to the

public on May 22 from 9 a.m. to

approximately 3:30 p.m. for the report

of the Director, NIEHS, and for

discussion of the NIEHS budget,

program policies and issues, recent

legislation, and other items of interest.

Attendance by the public will be limited

to space available.

In accordance with the provisions set

forth in secs. 552b(c)(4) and 552b(c)(6),

Title 5, U.S.C. and sec. 10(d) of Pub. L.

92–463, the meeting will be closed to

the public on May 22 from

approximately 3:30 p.m. to recess and

from 9 a.m. to adjournment on May 23,

for the review, discussion and

evaluation of individual grant

applications.

These applications and the

discussions could reveal confidential

trade secrets or commercial property

such as patentable material, and

personal information concerning

individuals associated with the

applications, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Kim Whitcher, Council Secretary,

NIEHS, P.O. Box 12233, Research

Triangle Park, N.C. 27709 (919–541–

7723), will provide summaries of the

meeting and rosters of council members.

Individuals who plan to attend and

need special assistance, such as sign

language interpretation or other

reasonable accommodations, should

contact Ms. Whitcher in advance of the

meeting.

Dr. Anne Sassaman, Director &

Executive Secretary, Division of

Extramural Research and Training,

NIEHS, P.O. Box 12233, Research

Triangle Park, North Carolina 27709,

(919) 541–7723, will furnish substantive

program information.

(Catalog of Federal Domestic Assistance

Program Nos. 93.113, Biological Response to

Environmental Agents; 93.114, Applied

Toxicological Research and Testing; 93.115,

Biometry and Risk Estimation; 93.894,

Resource and Manpower Development,

National Institutes of Health)

Dated: April 11, 1995.

Susan K. Feldman,

Committee Management Officer, NIH.

[FR Doc. 95–9310 Filed 4–14–95; 8:45 am]

BILLING CODE 4140–01–M

National Heart, Lung, and Blood

Institute; Closed Meetings

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following Heart,

Lung, and Blood Special Emphasis

Panel (SEP) meetings:

Name of SEP: Multidisciplinary Course on

the Genetics of Heart, Lung, and Blood

Disease (Conference Call).

Date: April 24, 1995.

Time: 12:00 p.m.

Place: Rockledge Building (RKL2), Rm.

7220, Rockville, Maryland.

Contact Person: C. James Scheirer, Ph.D.,

6701 Rockledge Drive, Room 7220, Bethesda,

Maryland 20892–7924, (301) 435–0266.

Purpose/Agenda: To review and evaluate

contract proposals.

Name of SEP: Molecular Genetics of

Hypertension—SCOR.

Date: April 30–May 1, 1995.

Time: 7:00 p.m.

Place: Holiday Inn Crowne Plaza,

Rockville, Maryland.

Contact Person: Anthony M. Coelho, Jr.,

Ph.D., 6701 Rockledge Drive, Room 7182,

Bethesda, Maryland 20892–7924, (301) 435–

0277.

Purpose/Agenda: To review and evaluate

grant applications.

Name of SEP: Programs of Excellence in

Molecular Biology.

Date: May 17, 1995.

Time: 8:30 a.m.

Place: Holiday Inn, Bethesda, Maryland.

Contact Person: Lynn M. Amende, Ph.D.,

6701 Rockledge Building, Room 7192,

Bethesda, Maryland 20892–7924, (301) 435–

0287.

Purpose/Agenda: To review and evaluate

grant applications.

These meetings will be closed in

accordance with the provisions set forth in

secs. 552b(c)(4) and 552b(c)(6), Title 5, U.S.C.

Applications and/or proposals and the

discussions could reveal confidential trade

secrets or commercial property such as

patentable material and personal information

concerning individuals associated with the

applications and/or proposals, the disclosure

of which would constitute a clearly

unwarranted invasion of personal privacy.

This notice is being published less than

fifteen days prior to the meeting due to the

urgent need to meet timing limitations

imposed by the grant review cycle.

(Catalog of Federal Domestic Assistance

Programs Nos. 93.837, Heart and Vascular

Diseases Research; 93.838, Lung Diseases

Research; and 93.839, Blood Diseases and

Resources Research, National Institutes of

Health)

Dated: April 11, 1995.

Susan K. Feldman,

Committee Management Officer, NIH.

[FR Doc. 95–9308 Filed 4–14–95; 8:45 am]

BILLING CODE 4140–01–M

National Heart, Lung, and Blood

Institute; Meeting of Board of Scientific

Counselors

Pursuant to Pub. L. 92–463, notice is

hereby given of the meeting of the Board

of Scientific Counselors, National Heart,

Lung, and Blood Institute on June 1–2,

1995, National Institutes of Health, 9000

Rockville Pike, Building 10, Room

7C101, Bethesda, Maryland 20892.

This meeting will be open to the

public from 8:30 to 9:00 a.m. on June 1

and from 8:30 to 9:00 a.m. on June 2 for

discussion of the general trends in

research relating to cardiovascular,

pulmonary and certain hematologic

diseases. Attendance by the public will

be limited to space available.

In accordance with the provisions set

forth in sec. 552b(c)(6), Title 5, U.S.C.

and sec. 10(d) of Pub. L. 92–463, the

meeting will be closed to the public

from 9:00 a.m. to adjournment on June

1 and from 9:00 a.m. to adjournment on

June 2, 1995 for the review, discussion,

and evaluation of individual programs

and projects conducted by the National

Institutes of Health, including

consideration of personnel

qualifications and performance, the

competence of individual investigators,

and similar items, the disclosure of

which would constitute a clearly

unwarranted invasion of personal

privacy.

Ms. Terry Long, Chief,

Communications and Public

Information Branch, National Heart,

Lung, and Blood Institute, Building 31,

Room 4A21, National Institutes of

Health, Bethesda, Maryland 20892,

phone (301) 496–4236, will provide a

summary of the meeting and a roster of

the Board members.

Individuals who plan to attend and

need special assistance, such as sign

language interpretation or other

reasonable accommodations, should

contact the Executive Secretary in

advance of the meeting.

Substantive program information may

be obtained from Dr. Edward D. Korn,