62776 Federal Register / Vol. 62, No. 227 / Tuesday, November 25, 1997 / Notices

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0445]

Intermountain Health Care, Inc.;

Revocation of U.S. License No. 0729

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. 0729) and the product

licenses issued to Intermountain Health

Care, Inc., for the manufacture of Whole

Blood, Red Blood Cells,

Cryoprecipitated AHF, Plasma, and

Platelets. The firm voluntarily

surrendered its licenses as part of a

Consent Decree of Permanent

Injunction.

DATES: The revocation of the

establishment license (U.S. License No.

0729) and the product licenses became

effective October 8, 1997.

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 has

revoked the establishment license (U.S.

License No. 0729) and product licenses

issued to Intermountain Health Care,

Inc., Eighth Ave. and C St., Salt Lake

City, UT 84143, for the manufacture of

Whole Blood, Red Blood Cells,

Cryoprecipitated AHF, Plasma, and

Platelets. The revocation affects all

locations under the license which

included: Salt Lake City, Ogden, Provo,

Logan, and St. George, UT.

FDA inspected Intermountain Health

Care, Inc., facilities located in Ogden,

UT, December 3 through December 18,

1996; Provo, UT, February 13, 1997,

through March 14, 1997; and Salt Lake

City, UT, March 17, 1997, through April

18, 1997. These inspections revealed

numerous serious deviations from

applicable Federal regulations and the

standards established in the firm’s

license. Based on the serious nature of

the deficiencies identified, FDA

determined that a danger to health

existed. The deficiencies noted

included, but were not limited to, the

following: (1) Failure to operate

equipment in a manner for which it was

designed (21 CFR 606.60(a)); and (2)

failure to perform and document a

thorough investigation, including

conclusions and followup, of: (a) Any

unexplained discrepancy or the failure

of any lot or unit to meet any of its

specifications; (b) any reports of

complaints of adverse reactions

regarding each unit of blood or blood

product arising as a result of either

blood collection or transfusion (21 CFR

606.100(c) and 606.170(a)); (c) failure to

adequately determine donor suitability

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

adequately prepare the skin of the donor

at the site of phlebotomy by a method

that provides maximum assurance of a

sterile container of blood (21 CFR

640.4(f)); (e) failure to assure that

personnel responsible for the collection,

processing, compatibility testing,

storage, or distribution of blood or blood

products have adequate training and

experience (§ 606.20(b) (21 CFR

606.20(b))); and (f) failure to maintain

complete, accurate, and concurrent

records (21 CFR 606.160).

FDA determined that these

deficiencies constituted a danger to the

public health that warranted suspension

under 21 CFR 601.6(a). These

deficiencies also demonstrated

management’s failure to exercise control

over the establishment in all matters

relating to compliance and to ensure

that personnel are adequate in number,

adequately trained and supervised, and

have a thorough understanding of the

procedures that they perform, as

required by 21 CFR 600.10(a) and (b)

and § 606.20(a) and (b).

In a letter to the firm dated April 28,

1997, FDA suspended the establishment

license (U.S. License No. 0729) and

product licenses for the manufacture of

Whole Blood, Red Blood Cells,

Cryoprecipitated AHF, Plasma, and

Platelets. As required by a Consent

Decree of Permanent Injunction signed

by the court on July 9, 1997,

Intermountain Health Care, Inc., waived

its opportunity for a hearing, and in a

letter to FDA dated July 11, 1997,

surrendered its licenses.

FDA has placed copies of the letters

previously discussed 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, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857. These letters 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(a),

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. 0729) and the product

licenses for the manufacture of the

aforementioned products issued to

Intermountain Health Care, Inc., were

revoked, effective October 8, 1997.

This notice is issued and published

under 21 CFR 601.8 and the

redelegation under 21 CFR 5.67(c).

Dated: November 12, 1997.

Kathryn C. Zoon,

Director, Center for Biologics Evaluation and

Research.

[FR Doc. 97–30915 Filed 11–24–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Biological Response Modifiers

Advisory Committee; Notice of

Subcommittee Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). At least one portion of the

meeting will be closed to the public.

Name of Committee: Subcommittee

meeting of the Biological Response

Modifiers Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on FDA

regulatory issues.

Date and Time: The meeting will be

held on December 17, 1997, 9 a.m. to 6

p.m.

Location: DoubleTree Hotel, Plaza

Ballrooms I and II, 1750 Rockville Pike,

Rockville, MD.

Contact Person: Gail M. Dapolito or

Rosanna L. Harvey, Center for Biologics

Evaluation and Research (HFM–21),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852,

301–827–0314, or FDA Advisory

Committee Information Line, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area), code 12388.

Please call the Information Line for upto-date information on this meeting.

Agenda: On December 17, 1997, the

Xenotransplantation Subcommittee will

discuss the following public health

issues concerning cross-species

transplantation: (1) Development of

appropriate assays for detection and

identification of infectious retroviruses,

(2) limitations of current screening and

diagnostic tools, (3) diagnostic testing

and clinical care of patients posttransplant, (4) impact of diagnostic

screening results on clinical trial
Federal Register / Vol. 62, No. 227 / Tuesday, November 25, 1997 / Notices 62777

development, and (5) delineation of the

key features of informed consent for

patients who have received a porcine

xenograft and who undergo screening

for porcine endogenous retrovirus. Procedure: On December 17, 1997,

from 9 a.m. to 11:30 a.m., and 12 m. to

6 p.m., the meeting is open to the

public. Interested persons may present

data, information, or views, orally or in

writing, on issues pending before the

committee. Written submissions may be

made to the contact person by December

10, 1997. Oral presentations from the

public will be scheduled between

approximately 9 a.m. and 10 a.m. Time

allotted for each presentation may be

limited. Those desiring to make formal

oral presentations should notify the

contact person before December 10,

1997, and submit a brief statement of

the general nature of the evidence or

arguments they wish to present, the

names and addresses of proposed

participants, and an indication of the

approximate time requested to make

their presentation.

Closed Committee Deliberations: On

December 17, 1997, from 11:30 a.m. to

12 m., the meeting will be closed to

permit discussion and review of trade

secret and/or confidential information

(5 U.S.C. 552b(c)(4)). The meeting will

be closed to discuss current

investigational new drug application

submissions under FDA review.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: November 17, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–30910 Filed 11–24–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Orthopaedic and Rehabilitation

Devices Panel of the Medical Devices

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). At least one portion of the

meeting will be closed to the public.

Name of Committee: Orthopaedic and

Rehabilitation Devices Panel of the

Medical Devices Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on FDA

regulatory issues.

Date and Time: The meeting will be

held on December 11, 1997, 9 a.m. to 8

p.m., and December 12, 1997, 8 a.m. to

2 p.m.

Location: Holiday Inn, Versailles

Ballrooms III and IV, 8120 Wisconsin

Ave., Bethesda, MD.

Contact Person: Jodi H. Nashman,

Center for Devices and Radiological

Health (HFZ–410), Food and Drug

Administration, 9200 Corporate Blvd.,

Rockville, MD 20850, 301–594–2036, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12521. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: On December 11, 1997, the

committee will discuss, make

recommendations, and vote on one

premarket approval application (PMA)

for a spinal intervertebral fusion device.

Additionally, there will be a general

discussion of the minimum acceptable

length of patient followup for marketing

approval of spinal implant devices. On

December 12, 1997, the committee will

discuss, make recommendations, and

vote on a PMA for an anti-adhesion

barrier gel.

Procedure: On December 11, 1997,

from 9 a.m. to 8 p.m., and on December

12, 1997, from 9 a.m. to 2 p.m., the

meeting is open to the public. Interested

persons may present data, information,

or views, orally or in writing, on issues

pending before the committee. Written

submissions may be made to the contact

person by December 3, 1997. Oral

presentations from the public regarding

spinal intervertebral fusion systems and

devices will be scheduled between

approximately 9 a.m. and 10 a.m., on

December 11, 1997. Oral presentations

from the public regarding anti-adhesion

barrier gels will be scheduled between

9 a.m. and 10 a.m., on December 12,

1997. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before December 3, 1997, and

submit a brief statement of the general

nature of the evidence or arguments

they wish to present, the names and

addresses of proposed participants, and

an indication of the approximate time

requested to make their presentation.

Closed Committee Deliberations: On

December 12, 1997, from 8 a.m. to 9

a.m., the meeting will be closed to

permit discussion and review of trade

secret and/or confidential information

(5 U.S.C. 552b(c)(4)) regarding present

and future FDA issues.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: November 18, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–30914 Filed 11-24-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Circulatory System Devices Panel of

the Medical Devices Advisory

Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). At least one portion of the

meeting will be closed to the public.

Name of Committee: Circulatory

System Devices Panel of the Medical

Devices Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on FDA

regulatory issues.

Date and Time: The meeting will be

held on December 4, 1997, 8 a.m. to 5

p.m.

Location: Corporate Bldg., conference

room 020B, 9200 Corporate Blvd.,

Rockville, MD.

Contact Person: John E. Stuhlmuller,

Center for Devices and Radiological

Health (HFZ–450), Food and Drug

Administration, 9200 Corporate Blvd.,

Rockville, MD 20850, 301–443–8243,

ext. 157, or FDA Advisory Committee

Information Line, 1–800–741–8138

(301–443–0572 in the Washington, DC

area), code 12625. Please call the

Information Line for up-to-date

information on this meeting.

Procedure: On December 4, 1997,

from 8 a.m. to 9 a.m., the meeting is

open to the public. Interested persons

may present data, information, or views,

orally or in writing, on issues

appropriate for the committee. Written

submissions may be made to the contact

person by December 3, 1997. Oral

presentations from the public will be

scheduled between 8 a.m. and 9 a.m.

Time allotted for each presentation may

be limited. Those desiring to make

formal oral presentations should notify

the contact person before December 3,

1997, and submit a brief statement of

the general nature of the evidence or

arguments they wish to present, the

names and addresses of proposed

participants, and an indication of the

approximate time requested to make

their presentation.