61130 Federal Register / Vol. 62, No. 220 / Friday, November 14, 1997 / Notices

of each person engaged in the

manufacturing, processing, packing, or

holding of a drug product to have the

necessary education, training, and

experience to perform their assigned

functions § 211.25(a) (21 CFR 211.25(a));

(2) failure to thoroughly investigate any

unexplained discrepancy in drug

product production and control records

or the failure of a batch to meet any of

its specifications (21 CFR 211.192); (3)

failure to establish separate or defined

areas or other control systems for

manufacturing and processing

operations to prevent contamination or

mixups (§ 211.42(c) (21 CFR 211.42(c))

and 21 CFR 600.11(a)); (4) failure to

establish and follow appropriate written

procedures designed to prevent

microbiological contamination of drug

products purporting to be sterile and to

assure that such procedures include

validation of any sterilization processes

(21 CFR 211.113(b)); (5) failure to report

adverse experience information (21 CFR

600.80(c)); (6) failure to establish

laboratory controls that include

scientifically sound and appropriate

specifications, standards, sampling

plans, and test procedures designed to

assure that components, drug product

containers, closures, in-process

materials, labeling, and drug products

conform to appropriate standards of

identity, strength, quality, and purity

(21 CFR 211.160(b)); (7) failure to

provide adequate space for the orderly

placement of equipment and materials

to prevent mixups between different

components, drug product containers,

closures, labeling, in-process materials,

or drug products, and to prevent

contamination (§ 211.42(b)); (8) failures

to establish and/or follow written

procedures for production and process

controls designed to assure that the drug

products have the identity, strength,

quality, and purity they purport or are

represented to possess and to assure that

such procedures, including any

changes, are drafted, reviewed, and

approved by the appropriate

organizational units and reviewed and

approved by quality control (21 CFR

211.100); (9) failure to maintain

buildings used in the manufacture,

processing, packing, or holding of a

drug product in a good state of repair

(21 CFR 211.58); and (10) failure to

demonstrate that adequate ventilation is

provided (21 CFR 211.46(a)).

Based on the results of FDA’s

inspection and investigation, FDA

determined that the firm’s Coccidioidin,

USP (BioCox) was adulterated within

the meaning of section 501(b) of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 351(b)) and in

violation of section 351(a) of the Public

Health Service Act (the PHS Act) (42

U.S.C. 262(a)). These products were also

misbranded within the meaning of

section 502(a) of the act (21 U.S.C.

352(a)).

FDA concluded that the nature of the

deficiencies noted at Iatric Corp. were

the direct consequence of a disregard for

the applicable regulations and standards

in the license application. 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 adequately trained

and supervised and have a thorough

understanding of the procedures that

they perform, as required by § 211.25.

FDA determined that these deficiencies

constitute a danger to the public health

that warranted suspension under

§ 601.5(b) (21 CFR 601.5(b)) and 21 CFR

601.6(a).

In a letter to the firm dated April 25,

1997, FDA suspended the establishment

license (U.S. License No. 0416) and

product license for Coccidioidin, USP

(BioCox). In a letter dated May 13, 1997,

Iatric Corp. requested voluntary

revocation of its product license for the

manufacture of Coccidioidin, USP

(BioCox).

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, 12420

Parklawn Dr., rm. 1–23, 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 § 601.5(a), section

351 of the PHS Act, 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 product license issued to

Iatric Corp. for the manufacture of

Coccidioidin, USP (BioCox) was

revoked, effective June 25, 1997.

This notice is issued and published

under 21 CFR 601.8 and the

redelegation at 21 CFR 5.67(c).

Dated: October 31, 1997.

Mark Elengold,

Acting Deputy Director, Center for Biologics

Evaluation and Research.

[FR Doc. 97–30028 Filed 11–13–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97M–0453]

HealthTronics, Inc.; Premarket

Approval of LithotronTM Lithotripsy

System

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application submitted

by HealthTronics, Inc., Marietta, GA, for

premarket approval, under the Federal

Food, Drug, and Cosmetic Act (the act),

of the LithoTronTM Lithotripsy System.

FDA’s Center for Devices and

Radiological Health (CDRH) notified the

applicant, by letter of July 21, 1997, of

the approval of the application.

DATES: Petitions for administrative

review by December 15, 1997.

ADDRESSES: Written requests for copies

of the summary of safety and

effectiveness data and petitions for

administrative review, to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Russell P. Pagano, Center for Devices

and Radiological Health (HFZ–470),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–2194.

SUPPLEMENTARY INFORMATION: On May

16, 1997, HealthTronic, Inc., Marietta,

GA 30060, submitted to CDRH an

application for premarket approval of

the LithoTronTM Lithotripsy System.

The device is an extracorporeal

shockwave lithotripter and is indicated

for use in patients with renal and upper

ureteral calculi between 4 and 20

millimeters in size.

In accordance with the provisions of

section 515(c)(2) of the the act (21

U.S.C. 360e(c)(2)) as amended by the

Safe Medical Devices Act of 1990, this

premarket approval was not referred to

the Gastroenterology and Urology

Devices Panel of the Medical Devices

Advisory Committee, an FDA advisory

committee, for review and

recommendation because the

information in the PMA substantially

duplicates information previously

reviewed by this panel.

On July 21, 1997, CDRH approved the

application by a letter to the applicant

from the Deputy Director of Clinical and
Federal Register / Vol. 62, No. 220 / Friday, November 14, 1997 / Notices 61131

Review Policy of the Office of Device

Evaluation, CDRH.

A summary of the safety and

effectiveness data on which CDRH

based its approval is on file in the

Dockets Management Branch (address

above) and is available from that office

upon written request. Requests should

be identified with the name of the

device and the docket number found in

brackets in the heading of this

document.

Opportunity for Administrative Review

Section 515(d)(3) of the act (21 U.S.C.

360e(d)(3)) authorizes any interested

person to petition, under section 515(g)

of the act, for administrative review of

CDRH’s decision to approve this

application. A petitioner may request

either a formal hearing under 21 CFR

part 12 of FDA’s administrative

practices and procedures regulations or

a review of the application and CDRH’s

action by an independent advisory

committee of experts. A petition is to be

in the form of a petition for

reconsideration under 21 CFR 10.33(b).

A petitioner shall identify the form of

review requested (hearing or

independent advisory committee) and

shall submit with the petition

supporting data and information

showing that there is a genuine and

substantial issue of material fact for

resolution through administrative

review. After reviewing the petition,

FDA will decide whether to grant or

deny the petition and will publish a

notice of its decision in the Federal

Register. If FDA grants the petition, the

notice will state the issue to be

reviewed, the form of the review to be

used, the persons who may participate

in the review, the time and place where

the review will occur, and other details.

Petitioners may, at any time on or

before December 15, 1997, file with the

Dockets Management Branch (address

above) two copies of each petition and

supporting data and information,

identified with the name of the device

and the docket number found in

brackets in the heading of this

document. Received petitions may be

seen in the office above between 9 a.m.

and 4 p.m., Monday through Friday.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(secs. 515(d), 520(h), (21 U.S.C. 360e(d),

360j(h))) and under authority delegated

to the Commissioner of Food and Drugs

(21 CFR 5.10) and redelegated to the

Director, Center for Devices and

Radiological Health (21 CFR 5.53).

Dated: October 17, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–30029 Filed 11–13–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97M–0458]

NeuroControl, Corp.; Premarket

Approval of Freehand System

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application submitted

by NeuroControl, Corp., Cleveland, OH,

for premarket approval, under the

Federal Food, Drug, and Cosmetic Act

(the act), of the Freehand System . After

reviewing the recommendation of the

Neurological Devices Panel, FDA’s

Center for Devices and Radiological

Health (CDRH) notified the applicant,

by letter of August 15, 1997, of the

approval of the application.

DATES: Petitions for administrative

review by December 15, 1997.

ADDRESSES: Written requests for copies

of the summary of safety and

effectiveness data and petitions for

administrative review to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Levering G. Keely, Center for Devices

and Radiological Health (HFZ–450),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–443–8517.

SUPPLEMENTARY INFORMATION: On June

17, 1996, NeuroControl Corp.,

Cleveland, OH 44106, submitted to

CDRH an application for premarket

approval of the Freehand System . The

system includes: Implantable receiverstimulator Model 202–1, implantable

epimysial electrode set Model 203–1,

surgical electrode positioning kit Model

207–1, patient external system Model

204–1, and programming system Model

209–1. The system is an upper extremity

neuroprosthesis and is intended to

improve a patient’s ability to grasp,

hold, and release objects. The system is

indicated for use in patients who: (1)

Are tetraplegic due to C5 or C6 spinal

cord injury (ASIA Classification), (2)

have adequate functional range of

motion of the upper extremity, (3) have

intact lower motor neuron innervation

of the forearm and hand musculature,

and (4) are skeletally mature.

On September 25, 1996, the

Neurological Devices Panel of the

Medical Devices Advisory Committee,

an FDA advisory committee, reviewed

and recommended approval of the

application. On August 15, 1997, CDRH

approved the application by a letter to

the applicant from the Director of the

Office of Device Evaluation, CDRH.

A summary of the safety and

effectiveness data on which CDRH

based its approval is on file in the

Dockets Management Branch (address

above) and is available from that office

upon written request. Requests should

be identified with the name of the

device and the docket number found in

brackets in the heading of this

document.

Opportunity for Administrative Review

Section 515(d)(3) of the act (21 U.S.C.

360e(d)(3)) authorizes any interested

person to petition, under section 515(g)

of the act, for administrative review of

CDRH’s decision to approve this

application. A petitioner may request

either a formal hearing under 21 CFR

part 12 of FDA’s administrative

practices and procedures regulations or

a review of the application and CDRH’s

action by an independent advisory

committee of experts. A petition is to be

in the form of a petition for

reconsideration under 21 CFR 10.33(b).

A petitioner shall identify the form of

review requested (hearing or

independent advisory committee) and

shall submit with the petition

supporting data and information

showing that there is a genuine and

substantial issue of material fact for

resolution through administrative

review. After reviewing the petition,

FDA will decide whether to grant or

deny the petition and will publish a

notice of its decision in the Federal

Register. If FDA grants the petition, the

notice will state the issue to be

reviewed, the form of the review to be

used, the persons who may participate

in the review, the time and place where

the review will occur, and other details.

Petitioners may, at any time on or

before December 15, 1997, file with the

Dockets Management Branch (address

above) two copies of each petition and

supporting data and information,

identified with the name of the device

and the docket number found in

brackets in the heading of this

document. Received petitions may be

seen in the office above between 9 a.m.

and 4 p.m., Monday through Friday.