Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Notices 49693

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:

Theodore R. Stevens, Center for Devices

and Radiological Health (HFZ–410),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–2036.

SUPPLEMENTARY INFORMATION: On

December 24, 1996, Avanta

Orthopaedics Corp., San Diego, CA

92121, submitted to CDRH an

application for premarket approval of

the Braun-Cutter Trapezo-metacarpal

Prosthesis. The device is a finger joint

metal/polymer cemented prosthesis and

is indicated for total joint replacement

in skeletally mature patients with pain

or instability of the trapezo-metacarpal

joint due to trauma, inflammatory or

degenerative disease or revision of

previous procedures, as an alternative to

arthrodesis or reconstructive surgery.

On June 9, 1997, the Orthopedics and

Rehabilitation Devices Panel of the

Medical Devices Advisory Committee,

an FDA advisory committee, reviewed

and recommended approval of the

application. On June 19, 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 Federal Food,

Drug, and Cosmetic Act (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 October 23, 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: August 26, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–25127 Filed 9–22–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97M–0392]

Mallinckrodt, Inc.; Premarket Approval

of Albunex

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the supplemental

application by Mallinckrodt, Inc., St.

Louis, MO, for premarket approval,

under the Federal Food, Drug, and

Cosmetic Act (the act), of Albunex .

After reviewing the recommendation of

the Radiological Devices Panel, FDA’s

Center for Devices and Radiological

Health (CDRH) notified the applicant,

by letter of June 17, 1997, of the

approval of the supplemental

application.

DATES: Petitions for administrative

review by October 23, 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:

Robert A. Phillips, Center for Devices

and Radiological Health (HFZ–470),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–1212.

SUPPLEMENTARY INFORMATION: On

September 3, 1995, Mallinckrodt, Inc.,

St. Louis, MO 63134, submitted to

CDRH a supplemental application for

premarket approval of Albunex . The

device is an ultrasound contrast agent

and is indicated for use with

transvaginal ultrasound to assess

fallopian tube patency.

On February 24, 1997, the

Radiological Devices Panel of the

Medical Devices Advisory Committee,

an FDA advisory committee, reviewed

and recommended approval of the

supplemental application. On June 17,

1997, CDRH approved the supplemental

application by a letter to the applicant

from the Deputy Director of Clinical and

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
49694 Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Notices

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 October 23, 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: August 26, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–25180 Filed 9–22–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D–0318]

Revised Precautionary Measures to

Reduce the Possible Transmission of

Creutzfeldt-Jakob Disease (CJD) by

Blood and Blood Products; Guidance

Document; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a guidance document

entitled ‘‘Revised Precautionary

Measures to Reduce the Possible

Transmission of Creutzfeldt-Jakob

Disease (CJD) by Blood and Blood

Products,’’ dated December 11, 1996.

The guidance document is intended to

provide recommendations to the blood

industry and may include information

useful to other interested persons.

DATES: Written comments may be

submitted at any time.

ADDRESSES: Submit written requests for

single copies of ‘‘Revised Precautionary

Measures to Reduce the Possible

Transmission of Creutzfeldt-Jakob

Disease (CJD) by Blood and Blood

Products’’ to the Office of

Communication, Training, and

Manufacturers Assistance (HFM–40),

Center for Biologics Evaluation and

Research (CBER), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448. Send one

self-addressed adhesive label to assist

that office in processing your requests.

The guidance document may also be

obtained by mail by calling the CBER

Voice Information System at 1–800–

835–4709 or 301–827–1800, or by fax by

calling the FAX Information System at

1–888–CBER–FAX or 301–827–3844.

Submit written comments on the

guidance document to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Joseph Wilczek, Center for Biologics

Evaluation and Research (HFM–350),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–827–3514.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a

guidance document entitled ‘‘Revised

Precautionary Measures to Reduce the

Possible Transmission of CreutzfeldtJakob Disease (CJD) by Blood and Blood

Products,’’ dated December 11, 1996,

and sent to all registered blood and

plasma establishments and all

establishments engaged in

manufacturing plasma derivatives.

The guidance document updates and

supersedes the FDA guidance

documents of August 8, 1995, entitled

‘‘Disposition of Products Derived from

Donors Diagnosed with, or at Known

High Risk for, Creutzfeldt-Jakob

Disease’’ and ‘‘Precautionary Measures

to Further Reduce the Possible Risk of

Transmission of Creutzfeldt-Jakob

Disease by Blood and Blood Products,’’

and the November 25, 1987, guidance

document entitled ‘‘Deferral of Donors

Who Have Received Human PituitaryDerived Growth Hormone.’’

The guidance document presents

recommendations for donor deferral,

product disposition, recipient

notification, and labeling. The

recommendations were developed after

considering donor and product risk

factors and the impact such

recommendations could have on the

availability of blood and blood

products. Topics addressed in the

guidance document include: (1)

Recommended questions that will help

identify donors at an increased risk for

CJD; (2) recommended actions to take

when a donor is identified to be at an

increased risk for developing CJD; (3)

recommended actions to take when a

donor is subsequently diagnosed with

CJD; (4) recommendations for recipient

notification and counseling; (5)

recommendations for disposition of

implicated products; and (6)

recommendations for the labeling of

implicated products intended for

research or further manufacture into

non-injectable products. The guidance

document also includes FDA’s

recommendations regarding ‘‘lookback’’

notification of persons possibly exposed

to CJD contaminated blood or blood

products.

As with other guidance documents,

FDA does not intend this document to

be all-inclusive and cautions that not all

information may be applicable to all

situations. It is intended to provide

recommendations and does not set forth

requirements. In response to public

comment, development of suitable

alternatives or other new information,

FDA may revise the guidance document

at anytime to improve its usefulness.

Any revisions to this guidance

document will be announced in the

Federal Register. The recommendations

in the guidance document represent the

agency’s current thinking on

precautionary measures to use to reduce

the possible transmission of CJD by

blood and blood products. It does not

create or confer any rights for or on any

person and does not operate to bind

FDA or the public. An alternative

approach may be used if such approach

satisfies the requirements of the

applicable statute, regulations, or both.

Interested persons may submit to the

Dockets Management Branch (address

above) written comments on the

guidance document. Two copies of any

comments are to be submitted, except

that individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. Any

comments previously submitted to the

Division of Blood Applications (HFM–

370), CBER, FDA, do not have to be

resubmitted. Comments previously

submitted will be filed with the Dockets

Management Branch (address above)

under the docket number in the heading

of this document. The guidance

document and received comments may

be seen in the office above between 9

a.m. and 4 p.m., Monday through

Friday. Received comments will be

considered in determining whether

further revision is warranted.

Persons with access to the Internet

may obtain the guidance document