Federal Register / Vol. 62, No. 224 / Thursday, November 20, 1997 / Notices 62063

(sec. 409(b)(5) (21 U.S.C. 348(b)(5))),

notice is given that a food additive

petition (FAP 8B4567) has been filed by

General Electric Co., One Lexan Lane,

Mt. Vernon, IN 47620–9364. The

petition proposes to amend the food

additive regulations in § 178.2010

Antioxidants and/or stabilizers for

polymers (21 CFR 178.2010) to provide

for the expanded safe use of

phosphorous acid, cyclic butylethyl

propanediol, 2,4,6-tri-tert-butylphenyl

ester, which may contain up to 1

percent by weight of

triisopropanolamine, as an antioxidant

and/or stabilizer in high density

polyethylene and high density olefin

copolymers intended for use in contact

with food.

The agency has determined under 21

CFR 25.32(i) that this action is of the

type that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

Dated: November 3, 1997.

Alan M. Rulis,

Director, Office of Premarket Approval,

Center for Food Safety and Applied Nutrition.

[FR Doc. 97–30484 Filed 11–19–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97M–0457]

Urologix, Inc.; Premarket Approval of

the T3 Targeted Transurethral

Thermoablation System: Model 4000

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application by Urologix,

Inc., Minneapolis, MN, for premarket

approval, under the Federal Food, Drug,

and Cosmetic Act (the act), of the T3

Targeted Transurethral Thermoablation

System: Model 4000. FDA’s Center for

Devices and Radiological Health (CDRH)

notified the applicant, by letter of

August 22, 1997, of the approval of the

application.

DATES: Petitions for administrative

review by December 22, 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:

Nicole L. Wolanski, Center for Devices

and Radiological Health (HFZ–472),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–2194.

SUPPLEMENTARY INFORMATION: On

February 24, 1997, Urologix, Inc.,

Minneapolis, MN 55447, submitted to

CDRH an application for premarket

approval of the T3 Targeted

Transurethral Thermoablation System:

Model 4000. The device is a

transurethral microwave thermal

therapy system and is indicated to

relieve symptoms associated with

benign prostatic hyperplasia (BPH) and

is indicated for men with prostatic

lengths of 30 to 50 millimeters.

In accordance with the provisions of

section 515(c)(2) of the act (21 U.S.C.

360e(c)(2)) as amended by the Safe

Medical Devices Act of 1990, this

premarket approval application (PMA)

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 August 22, 1997, CDRH approved

the application by a letter to the

applicant from the Deputy Director,

Clinical and Review Policy, 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 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 22, 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 16, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–30482 Filed 11–19–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–R–219]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

In compliance with the requirement

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

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding the burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) the

necessity and utility of the proposed

information collection for the proper
62064 Federal Register / Vol. 62, No. 224 / Thursday, November 20, 1997 / Notices

performance of the agency’s functions;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

Type of Information Collection

Request: New Collection; Title of

Information Collection: End Stage Renal

Disease (ESRD) Managed Care

Demonstration Evaluation; Form No.:

HCFA–R–219; Use: This demonstration

is congressionally mandated under the

Social Health Maintenance Organization

(SHMO) requirements. This evaluation

will demonstrate the effectiveness of

integrating acute and chronic care

patients with ESRD through expanded

community care case management

services, using innovative approaches to

financing methodologies and benefit

design. Frequency: Other 0,12, and 30

months; Affected Public: Business or

other for-profit, Individuals or

Households; Number of Respondents:

5,365; Total Annual Responses: 5,365;

Total Annual Hours: 4,431.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, or to

obtain the supporting statement and any

related forms, E-mail your request,

including your address and phone

number, to Paperwork@hcfa.gov, or call

the Reports Clearance Office on (410)

786–1326. Written comments and

recommendations for the proposed

information collections must be mailed

within 60 days of this notice directly to

the HCFA Paperwork Clearance Officer

designated at the following address:

HCFA, Office of Information Services,

nformation Technology Investment

Management Group, Division of HCFA

Enterprise Standards, Attention: John

Rudolph, Room C2–26–17, 7500

Security Boulevard, Baltimore,

Maryland 21244–1850.

Dated: November 12, 1997.

John P. Burke III,

HCFA Reports Clearance Officer, Division of

HCFA Enterprise Standards, Health Care

Financing Administration.

[FR Doc. 97–30471 Filed 11–19–97; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–64]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

In compliance with the requirement

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

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding the burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) the

necessity and utility of the proposed

information collection for the proper

performance of the agency’s functions;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

Type of Information Collection

Request: Reinstatement, without change,

of a previously approved collection for

which approval has expired; Title of

Information Collection: Quarterly

Medicaid Statement of Expenditures for

the Medical Assistance Program; Form

No.: HCFA–64; Use: This form is used

by State Medicaid agencies to report

their actual program benefit costs and

administrative expenses to the Health

Care Financing Administration (HCFA).

HCFA uses this information to compute

the Federal financial participation (FFP)

for the State’s Medicaid Program costs.

Frequency: Quarterly; Affected Public:

State, Local or Tribal Government;

Number of Respondents: 56; Total

Annual Responses: 224; Total Annual

Hours: 11,984.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, or to

obtain the supporting statement and any

related forms, E-mail your request,

including your address and phone

number, to Paperwork@hcfa.gov, or call

the Reports Clearance Office on (410)

786–1326. Written comments and

recommendations for the proposed

information collections must be mailed

within 60 days of this notice directly to

the HCFA Paperwork Clearance Officer

designated at the following address:

HCFA, Office of Information Services,

Information Technology Investment

Management Group, Division of HCFA

Enterprise Standards, Attention: John

Rudolph, Room C2–26–17, 7500

Security Boulevard, Baltimore,

Maryland 21244–1850.

Dated: November 14, 1997.

John P. Burke III,

HCFA Reports Clearance Officer, Division of

HCFA Enterprise Standards, Health Care

Financing Administration.

[FR Doc. 97–30530 Filed 11–19–97; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–316]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

In compliance with the requirement

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

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding the burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) the

necessity and utility of the proposed

information collection for the proper

performance of the agency’s functions;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

Type of Information Collection

Request: Reinstatement without change

of a previously approved collection for

which approval has expired; Title of

Information Collection: Medicaid,

Integrated Quality Control Review

Worksheet and Supporting Regulations

42 CFR 431.800, 42 CFR 431.865; Form

No.: HCFA–316 OMB # 0938–0094; Use:

States use the Integrated Quality Control

Review Worksheet to collect quality

control (QC) data captured during the

course of all Federally required State QC

reviews of Food Stamp (FS) and

Medicaid programs. The integrated

worksheet is designed to be flexible for

use in fully integrated, partially

integrated, or separate QC program

reviews. The primary objective of the

QC system is to measure, identify, and