Federal Register / Vol. 60, No. 75 / Wednesday, April 19, 1995 / Notices 19595

Note: In the certification process, some

certificants used software developed by other

firms and may not be holding themselves out

to file tariffs for the public, generally.

Joseph T. Farrell,

Acting Secretary.

[FR Doc. 95–9548 Filed 4–18–95; 8:45 am]

BILLING CODE 67301–01–M

FEDERAL RESERVE SYSTEM

Community Capital Corporation, et al.;

Formations of; Acquisitions by; and

Mergers of Bank Holding Companies

The companies listed in this notice

have applied for the Board’s approval

under section 3 of the Bank Holding

Company Act (12 U.S.C. 1842) and §

225.14 of the Board’s Regulation Y (12

CFR 225.14) to become a bank holding

company or to acquire a bank or bank

holding company. The factors that are

considered in acting on the applications

are set forth in section 3(c) of the Act

(12 U.S.C. 1842(c)).

Each application is available for

immediate inspection at the Federal

Reserve Bank indicated. Once the

application has been accepted for

processing, it will also be available for

inspection at the offices of the Board of

Governors. Interested persons may

express their views in writing to the

Reserve Bank or to the offices of the

Board of Governors. Any comment on

an application that requests a hearing

must include a statement of why a

written presentation would not suffice

in lieu of a hearing, identifying

specifically any questions of fact that

are in dispute and summarizing the

evidence that would be presented at a

hearing.

Unless otherwise noted, comments

regarding each of these applications

must be received not later than May 12,

1995.

A. Federal Reserve Bank of

Richmond (Lloyd W. Bostian, Jr., Senior

Vice President) 701 East Byrd Street,

Richmond, Virginia 23261:

1. Community Capital Corporation,

Greenwood, South Carolina; to acquire

100 percent of the voting shares of

Clemson Bank & Trust, Clemson, South

Carolina (in organization).

B. Federal Reserve Bank of Dallas

(Genie D. Short, Vice President) 2200

North Pearl Street, Dallas, Texas 75201-

2272:

1. First Grayson Bancshares, Inc.,

Employee Stock Ownership Plan,

Whitesboro, Texas; to become bank

holding company by acquiring 15.82

percent of the voting shares of First

Grayson Bancshares, Inc., Whitesboro,

Texas, and thereby indirectly acquire

Security Bank of Whitesboro,

Whitesboro, Texas.

2. Metroplex North Bancshares, Inc.,

Employee Stock Ownership Plan,

Whitesboro, Texas; to become a bank

holding company by acquiring 17.87

percent of the voting shares of

Metroplex North Bancshares, Inc.,

Whitesboro, Texas, and thereby

indirectly acquire The First Bank of

Celeste, Celeste, Texas.

Board of Governors of the Federal Reserve

System, April 13, 1995.

Jennifer J. Johnson,

Deputy Secretary of the Board.

[FR Doc. 95-9634 Filed 4–18–95; 8:45 am]

BILLING CODE 6210-01-F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Clinical Laboratory Improvement

Advisory Committee: Meeting

In accordance with section 10(a)(2) of

the Federal Advisory Committee Act

(Pub. L. 92–463), the Centers for Disease

Control and Prevention (CDC)

announces the following committee

meeting.

Name: Clinical Laboratory Improvement

Advisory Committee.

Times and Dates: 8:30 a.m.–4:30 p.m., May

10, 1995; 8 a.m.–3:30 p.m., May 11, 1995.

Place: CDC, Auditorium A, Building 2,

1600 Clifton Road, NE., Atlanta, Georgia

30333.

Status: Open to the public, limited only by

the space available.

Purpose: This committee is charged with

providing scientific and technical advice and

guidance to the Secretary of Health and

Human Services, the Assistant Secretary for

Health, and the Director, CDC, regarding the

need for, and the nature of, revisions to the

standards under which clinical laboratories

are regulated; the impact of proposed

revisions to the standards; and the

modification of the standards to

accommodate technological advances.

Matters To Be Discussed: The agenda will

include an update from CDC on the

implementation of the Clinical Laboratory

Improvement Amendments, including the

current process for reviewing tests for waived

status, a discussion of the ongoing review of

the regulatory burden and benefits of

laboratory personnel requirements, and

quality control standards.

Agenda items are subject to change as

priorities dictate.

Contact Person for Additional Information:

John C. Ridderhof, Dr.P.H., Division of

Laboratory Systems, Public Health Practice

Program Office, CDC, 4770 Buford Highway,

NE., Mailstop G–25, Atlanta, Georgia 30341–

3724, telephone 404/488–7660.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 95–9618 Filed 4–18–95; 8:45 am]

BILLING CODE 4163–18–M

National Committee on Vital and Health

Statistics (NCVHS) Subcommittee on

Medical Classification Systems:

Meeting

Pursuant to Pub. L. 92–463, the

National Center for Health Statistics

(NCHS), Centers for Disease Control and

Prevention (CDC), announces the

following meeting.

Name: NCVHS Subcommittee on Medical

Classification Systems.

Time and Date: 9 a.m.–5 p.m., May 16,

1995.

Place: Room 703A, Hubert H. Humphrey

Building, 200 Independence Avenue, SW,

Washington, D.C. 20201.

Status: Open.

Purpose: The subcommittee will discuss:

the procedure classification systems for

managed care; replacement for the

International Classification of Diseases-9-

Clinical Modification, Volume III, revision of

Physicians’ Current Procedural Terminology

4; and discuss the subcommittee’s work plan.

Contact Person for More Information:

Substantive program information as well as

summaries of the meeting and a roster of

committee members may be obtained from

Gail F. Fisher, Ph.D., Executive Secretary,

NCVHS, NCHS, CDC, Room 1100,

Presidential Building, 6525 Belcrest Road,

Hyattsville, Maryland 20782, telephone 301/

436–7050.

Dated: April 13, 1995.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 95–9619 Filed 4–18–95; 8:45 am]

BILLING CODE 4163–18–M

Food and Drug Administration

[Docket No. 94N–0299]

Plasmalab Donor Centers, Inc.;

Revocation of U.S. License No. 1072–

001

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. 1072–001) and the

product license issued to Plasmalab

Donor Centers, Inc., doing business as

Douglas Plasmalab, for the manufacture
19596 Federal Register / Vol. 60, No. 75 / Wednesday, April 19, 1995 / Notices

of Source Plasma. This revocation

notice affects only the Douglas

Plasmalab, Douglas, AZ, facility and has

no bearing on other establishment and

product licenses issued to Plasmalab

Donor Centers, Inc. In a letter to FDA

dated March 28, 1994, the firm

requested that the establishment and

product licenses issued to its Douglas

Plasmalab, Douglas, AZ, facility be

revoked and thereby waived its

opportunity for a hearing on the matter.

DATES: The revocation of the

establishment license (U.S. License No.

1072–001) and product license became

effective June 8, 1994.

FOR FURTHER INFORMATION CONTACT:

Timothy W. Beth, 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 has

revoked the establishment license (U.S.

License No. 1072–001) and the product

license for the manufacture of Source

Plasma issued to Plasmalab Donor

Centers, Inc., doing business as Douglas

Plasmalab at 11 J Ave., Douglas, AZ

85607.

FDA inspected Douglas Plasmalab at

11 J Ave., Douglas, AZ, from February

10, 1994, through March 9, 1994,

following the report by the

establishment of an error from the

reinfusion of the wrong red blood cells

to a donor undergoing plasmapheresis.

The inspection revealed serious

deviations from Federal regulations.

FDA has determined that these

deviations constitute a danger to health.

These deficiencies included, but were

not limited to, the following: (1) Failure

to follow procedures designed to

prevent the infusion of one donor’s red

blood cells into another donor (21 CFR

640.65(b)(3)); (2) failure to follow

procedures designed to prevent

contamination of red blood cells for

reinfusion (21 CFR 640.64(e)); (3) failure

to limit the frequency of Source Plasma

donation to two times within a 7-day

period (21 CFR 640.65(b)(5)); (4) failure

to maintain accurate and concurrent

records to document the performance of

each significant step in the collection,

processing, and storage of each unit of

blood and blood components (21 CFR

606.160); and (5) failure to maintain

adequate and complete standard

operating procedures that are available

to personnel in the areas where the

procedures are performed for all steps in

the collection, processing, storage, and

distribution of Source Plasma (21 CFR

606.100(b)). The inspection indicated

serious noncompliance with the donor

protection standards which are intended

to assure a continuous and healthy

donor population, as well as with

standards designed to assure the

continued safety, purity, potency, and

quality of products manufactured.

In addition to the inspection, the

agency conducted a concurrent

investigation that involved interviews

with individuals knowledgeable of the

daily operations of Douglas Plasmalab.

This investigation revealed that

deviations routinely occurred in

important areas of the plasmapheresis

operation. These deviations included,

but were not limited to, the following:

Maintenance of inaccurate red blood

cell reinfusion records, forced and

unfiltered reinfusion of whole blood

into donors whose donation of blood

exceeded the legally allowable limit,

and reinfusion of red blood cells which

may have been contaminated through a

break in the closed sterile system of

collection.

FDA concluded that the serious

nature of the deficiencies noted during

the inspection and concurrent

investigation at Douglas Plasmalab was

a direct consequence of the

establishment’s disregard for the

applicable regulations and standards in

the license applications and constitutes

a danger to public health warranting

suspension pursuant to 21 CFR 601.6(a).

In a letter to the firm dated March 17,

1994, FDA suspended and confirmed

telephone notice of the suspension of

the establishment license (U.S. License

No. 1072–001) and the product license

for Source Plasma. In a letter to FDA

dated March 28, 1994, Plasmalab Donor

Centers, Inc., voluntarily requested that

its Douglas Plasmalab licenses be

revoked and thereby waived its

opportunity for a hearing. The agency

granted the request by letter to the firm

dated, June 8, 1994, which revoked the

establishment license (U.S. License No.

1072–001) and the product license for

the manufacture of Source Plasma.

FDA has placed copies of the letters

relevant to the license revocation on file

under the docket number found in

brackets in the heading of this

document 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. 1072–001) and the

product license for the manufacture of

Source Plasma issued to Plasmalab

Donor Centers, Inc., Douglas, AZ, were

revoked, effective June 8, 1994.

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. 95–9578 Filed 4–18–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 94N–0298]

Putnam County Blood Bank, Inc.;

Revocation of U.S. License No. 1121

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. 1121) and the product

licenses issued to Putnam County Blood

Bank, Inc., (PCBB) for the manufacture

of Whole Blood, Red Blood Cells,

Platelets, and Plasma. In a letter to FDA

dated April 29, 1994, the firm requested

that its establishment and product

licenses be revoked and thereby waived

its opportunity for a hearing on the

matter.

DATES: The revocation of the

establishment license (U.S. License No.

1121) and product licenses became

effective June 3, 1994.

FOR FURTHER INFORMATION CONTACT:

Timothy W. Beth, 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

conducted an inspection of PCBB, 2919

Kennedy St., Palatka, FL 32077, from

September 1, 1992, through October 6,

1992. The inspection revealed serious

deviations from Federal regulations.

FDA determined these deviations to

constitute a danger to public health.

These deficiencies included, but were

not limited to, the following: (1) Failure

to establish scientifically sound and

appropriate specifications, standards,

and test procedures to assure that blood

and blood components are safe, pure,

potent, and effective (21 CFR 606.140(a)

and 610.45(c)), and (2) failure to

institute systems capable of precluding

release of unsuitable blood and blood

components (21 CFR 640.3(b) and (c)

and 606.160(b)(1)(ii) and (e)).