[Federal Register Volume 62, Number 184 (Tuesday, September 23, 1997)]
[Notices]
[Pages 49693-49694]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-25180]


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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.

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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

[[Page 49694]]

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]
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