33926 Federal Register / Vol. 61, No. 127 / Monday, July 1, 1996 / Notices

submitted only once and amended as

necessary. Our experience is that a State

will amend a Plan once every 4 years;

approximately 12 per year.

Respondents: State governments.

ANNUAL BURDEN ESTIMATES

Instrument Number of

respondents

Number of

responses

per respondent

Average

burden

hours per

response

Total burden hours

Case plan ......................................................................................................................... 51 1 15 180

Estimated Total Annual Burden

Hours: 180.

Additional Information: Copies of the

proposed collection may be obtained by

writing to The Administration for

Children and Families, Office of

Information Services, Division of

Information Resource Management

Services, 370 L’Enfant Promenade, S.W.,

Washington, D.C. 20447, Attn: ACF

Reports Clearance Officer.

OMB Comment: OMB is required to

make a decision concerning the

collection of information between 30

and 60 days after publication of this

document in the Federal Register.

Therefore, a comment is best assured of

having its full effect if OMB receives it

within 30 days of publication. Written

comments and recommendations for the

proposed information collection should

be sent directly to the following: Office

of Management and Budget, Paperwork

Reduction Project, 725 17th Street,

N.W., Washington, D.C. 20503, Attn:

Ms. Wendy Taylor.

Dated: June 12, 1996.

Larry Guerrero,

Director, Office of Information Services.

[FR Doc. 96–16620 Filed 6–28–96; 8:45 am]

BILLING CODE 4184–01–M

Food and Drug Administration

[Docket No. 96M–0193]

Kaneka America Corp.; Premarket

Approval of Liposorber LA–15 System

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application by Kaneka

America Corp., New York, NY, for

premarket approval, under the Federal

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

of the Liposorber LA–15 System. After

reviewing the recommendation of the

Gastroenterology and Urology Devices

Panel, FDA’s Center for Devices and

Radiological Health (CDRH) notified the

applicant, by letter of February 21, 1996,

of the approval of the application.

DATES: Petitions for administrative

review by July 31, 1996.

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:

Linda L. Dart, Center for Devices and

Radiological Health (HFZ–470), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–1220.

SUPPLEMENTARY INFORMATION: On

October 3, 1991, Kaneka America Corp.,

New York, NY 10022, submitted to

CDRH an application for premarket

approval of the Liposorber LA–15

System. The device is a low density

lipoprotein (LDL) apheresis system,

indicated for use in performing low

density lipoprotein cholesterol (LDL–C)

apheresis to acutely remove LDL–C from

the plasma of the following high risk

patient populations for whom diet has

been ineffective and maximum drug

therapy has either been ineffective or

not tolerated: Group A—functional

hypercholesterolemic homozygotes with

LDL–C > 500 milligrams/deciliter (mg/

dL); Group B—functional

hypercholesterolemic heterozygotes

with LDL–C ≥ 300 mg/dL; and Group

C—functional hypercholesterolemic

heterozygotes with LDL–C ≥ 200 mg/dL

and documented coronary heart disease

(CHD).

The LDL–C levels for the indicated

patient populations are baseline LDL–C

levels obtained after the patient has had,

at a minimum, a 6-month trial of an

American Heart Association Step II diet

(or equivalent) and maximum tolerated

combination drug therapy designed to

reduce LDL–C. Maximum tolerated

combination drug therapy is an

adequate trial of drugs from at least two

separate classes of hypolipidemic agents

such as, bile acid sequesterants, HMG–

CoA reductase inhibitors, fibric acid

derivatives, niacin/nicotinic acid, etc.

Documented CHD includes

documentation of coronary artery

disease by coronary angiography or a

history of myocardial infarction,

coronary artery bypass surgery,

percutaneous transluminal coronary

angioplasty (PTCA) or alternative

revascularization procedure (e.g.,

atherectomy or stent), or progressive

angina documented by exercise or

nonexercise stress test. Baseline lipid

levels are to be determined after

stabilization on diet and drug therapy

by making two measurements during a

2- to 4-week period. (Note: the two

values should be within 10 percent of

each other, indicating a stable

condition.)

Although clinical benefit of LDL–C

lowering has been documented in

several diet, drug and/or surgical

intervention trials, clinical studies using

the Liposorber LA–15 System were not

designed to address and did not

establish the long-term clinical benefit

of acutely lowering LDL–C.

On April 21, 1995, the

Gastroenterology and Urology Devices

Panel of the Medical Devices Advisory

Committee, an FDA advisory panel,

reviewed and recommended approval of

the application. On February 21, 1996,

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 part 12 (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
Federal Register / Vol. 61, No. 127 / Monday, July 1, 1996 / Notices 33927

committee of experts. A petition is to be

in the form of a petition for

reconsideration under § 10.33(b) (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 July 31, 1996, 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: April 9, 1996.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 96–16663 Filed 6–28–96; 8:45 am]

BILLING CODE 4160–01–F

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: This notice announces a

forthcoming meeting of a public

advisory committee of the Food and

Drug Administration (FDA). This notice

also summarizes the procedures for the

meeting and methods by which

interested persons may participate in

open public hearings before FDA’s

advisory committees.

FDA has established an Advisory

Committee Information Hotline (the

hotline) using a voice-mail telephone

system. The hotline provides the public

with access to the most current

information on FDA advisory committee

meetings. The advisory committee

hotline, which will disseminate current

information and information updates,

can be accessed by dialing 1–800–741–

8138 or 301–443–0572. Each advisory

committee is assigned a 5-digit number.

This 5-digit number will appear in each

individual notice of meeting. The

hotline will enable the public to obtain

information about a particular advisory

committee by using the committee’s 5-

digit number. Information in the hotline

is preliminary and may change before a

meeting is actually held. The hotline

will be updated when such changes are

made.

MEETING: The following advisory

committee meeting is announced:

Advisory Committee for Reproductive

Health Drugs

Date, time, and place. July 19, 1996,

9 a.m., FDA Technical Center, 16071

Industrial Dr., Gaithersburg, MD.

Attendees should allow time to proceed

through security procedures. Admission

to the facility by public participants will

be available on a first come, first serve

basis, and will be limited to

approximately 200, the number of seats

available to the public in the conference

room. There will be an overflow room

with both audio and video link to the

meeting. The overflow room is located

at the Hilton Hotel, 620 Perry Pkwy.,

Gaithersburg, MD.

Type of meeting and contact person.

Open committee discussion, 9 a.m. to

1:30 p.m.; open public hearing, 1:30

p.m. to 3:30 p.m., unless public

participation does not last that long;

open committee discussion, 3:30 p.m. to

5 p.m.; Philip A. Corfman, Center for

Drug Evaluation and Research (HFD–

580), Food and Drug Administration,

5600 Fishers Lane, rm. 14B–04,

Rockville, MD 20857, 301–443–3510,

FAX 301–443–9282, or e-mail

july19@cder.fda.gov. Information

concerning the meeting is available from

FDA Advisory Committee Information

Hotline, 1–800–741–8138 (301–443–

0572 in the Washington, DC area),

Advisory Committee for Reproductive

Health Drugs, code 12537. Please call

the hotline for information concerning

any possible changes.

General function of the committee.

The committee reviews and evaluates

data on the safety and effectiveness of

marketed and investigational human

drugs for use in the practice of

obstetrics, gynecology, and related

specialties.

Agenda—Open public hearing.

Interested persons may present data,

information, or views, orally or in

writing, on issues pending before the

committee. Those desiring to make

formal presentations should notify the

contact person in writing by mail, email, or fax no later than 5 p.m., EDT

on July 12, 1996, with a brief statement

of the general nature of the evidence or

arguments they wish to present, the

names, telephone numbers, and

addresses of proposed participants, and

an indication of the approximate time

required to make their comments. The

time for presentations will be allotted

equitably, and will depend on how

many individuals give advance notice

within the time indicated of their

intention to speak. In the interest of

time, the agency may require persons

with common interests to make joint

presentations.

Open committee discussion. The

committee will discuss the new drug

application for mifepristone for the

interruption of early pregnancy.

FDA public advisory committee

meetings may have as many as four

separable portions: (1) An open public

hearing, (2) an open committee

discussion, (3) a closed presentation of

data, and (4) a closed committee

deliberation. Every advisory committee

meeting shall have an open public

hearing portion. Whether or not it also

includes any of the other three portions

will depend upon the specific meeting

involved. There are no closed portions

for the meetings announced in this

notice. The dates and times reserved for

the open portions of each committee

meeting are listed above.

The open public hearing portion of

each meeting shall be at least 1 hour

long unless public participation does

not last that long. It is emphasized,

however, that the 1 hour time limit for

an open public hearing represents a

minimum rather than a maximum time

for public participation, and an open

public hearing may last for whatever

longer period the committee

chairperson determines will facilitate

the committee’s work.

Public hearings are subject to FDA’s

guideline (subpart C of 21 CFR part 10)

concerning the policy and procedures

for electronic media coverage of FDA’s

public administrative proceedings,

including hearings before public

advisory committees under 21 CFR part

14. Under 21 CFR 10.205,

representatives of the electronic media

may be permitted, subject to certain

limitations, to videotape, film, or

otherwise record FDA’s public

administrative proceedings, including

presentations by participants.

Meetings of advisory committees shall

be conducted, insofar as is practical, in

accordance with the agenda published