Federal Register / Vol. 61, No. 127 / Monday, July 1, 1996 / Notices 33925

The total annual burden is 78.00.

Send comments to Desk officer, CDC;

Human Resources and Housing Branch,

New Executive Office Building, Room

10235; Washington, DC 20503.

Dated: June 25, 1996.

Wilma G. Johnson,

Acting Associate Director for Policy Planning

and Evaluation, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 96–16648 Filed 6–28–96; 8:45 am]

BILLING CODE 4163–18–P

National Center for Environmental

Health; Meeting

The National Center for

Environmental Health (NCEH), of the

Centers for Disease Control and

Prevention (CDC) will convene the

following meeting cosponsored by the

American Association for Clinical

Chemistry and the American Heart

Association.

Name: Frontiers in Lipid and Lipoprotein

Research: Basic Science, Analytical, Clinical,

and Public Health Applications.

Times and Dates: 8 a.m.–5 p.m., October 4,

1996; 8 a.m.–5 p.m., October 5, 1996; 8 a.m.–

12 noon, October 6, 1996.

Place: Renaissance Hotel—Dallas, 2222

Stemmons Freeway, Dallas, Texas 75207,

telephone 214/631–2222.

Status: Open to the public, limited only by

the space available. The meeting room

accommodates approximately 500 people.

Purpose: The purpose of this meeting is to

provide a forum for presentation of recent

advances in lipid and lipoprotein research by

recognized experts in the areas of clinical

practice, biochemistry, analytical

measurement, and public health.

Matters To Be Discussed: Agenda includes:

significant advances in lipid and lipoprotein

research and new observations that are of

critical importance to clinical practice and

public health; an integrated review of

relevant advances in basic science,

measurement technology, epidemiological

and clinical research, and public health

practice to clearly define the state of the art

for understanding and preventing morbidity

and mortality due to heart disease.

Contact Persons For More Information:

Mary M. Kimberly, Ph.D., Research Chemist,

Special Activities Branch, Division of

Environmental Health Laboratory Sciences,

M/S F25, NCEH, CDC, 4770 Buford Highway,

NE., Chamblee, Georgia 30341–3724,

telephone 770/488–4683, or Paula M. Steiner,

Medical Research Laboratories, 2 Tesseneer

Drive, Highland Heights, Kentucky 41076,

telephone 606/781–8877 extension 252, fax

606/781–9310.

Dated: June 24, 1996.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 96–16649 Filed 6–28–96; 8:45 am]

BILLING CODE 4163–18–M

Administration for Children and

Families

Proposed Information Collection

Activity; Comment Request

Proposed Projects

Title 45 CFR 303.7—Provision of

Services in Interstate Child Support

Enforcement Cases; Standard Forms.

OMB No.: 0970–0085.

Description: Regulations at 45 CFR

303.7 require a State child support

enforcement agency to transmit child

support case information on standard

interstate forms when referring a case to

another State for processing. The forms

promote uniformity and

standardization.

States will have the choice of using

one of two sets of forms—one set

accommodates the Uniform Reciprocal

Enforcement of Support Act (URESA)

and the other set accommodates the

Uniform Interstate Family Support Act

(UIFSA). The URESA forms are the

existing forms currently used by States.

The UIFSA forms were recently

developed by a workgroup of child

support practitioners; these forms have

been pilot-tested in several

jurisdictions. UIFSA has now been

adopted by over 30 States. OCSE

contemplates that UIFSA forms will

eventually be used for all cases.

Respondents: State Governments.

ANNUAL BURDEN ESTIMATES

Instrument Number of

respondents

Number of

responses

per respondent

Average

burden

hours per

response

Total burden hours

Standard forms ................................................................................................................. 54 3000 .2666667 43,200

Estimated Total Annual Hours:

43,200.

In compliance with the requirements

of Section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Administration for Children and

Families is soliciting public comment

on the specific aspects of the

information collection described above.

Copies of the proposed collection of

information can be obtained and

comments may be forwarded 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. All requests should be

identified by the title of the information

collection.

The Department specifically requests

comments on: (a) whether the proposed

collection of information is necessary

for the proper performance of the

functions of the agency, including

whether the information shall have

practical utility; (b) the accuracy of the

agency’s estimate of the burden of the

proposed collection of information; (c)

ways to enhance the quality, utility, and

clarity of the information to be

collected; and (d) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques

or other forms of information

technology. Consideration will be given

to comments and suggestions submitted

within 60 days of this publication.

Dated: June 25, 1996.

Larry Guerrero,

Director, Office of Information Services.

[FR Doc. 96–16694 Filed 6–28–96; 8:45 am]

BILLING CODE 4184–01–M

Submission for OMB Review;

Comment Request

Title: State Plan for Foster Care and

Adoption Assistance—Title IV–E.

OMB No.: 0980–0141.

Description: A State Plan for foster

care and adoption assistance is required

by section 471 of the Social Security Act

from any State wishing to claim Federal

Financial Participation for foster care

and adoption assistance. States may use

a preprinted format or may develop

their own format which meets the

requirements of the law. The Plan is
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