61824 Federal Register / Vol. 62, No. 223 / Wednesday, November 19, 1997 / Notices

that Ciba Specialty Chemicals Corp. has

filed a petition proposing that the food

additive regulations be amended to

provide for the safe use of

benzenesulfonic acid, 4-chloro–5-

methyl–2-[[4,5-dihydro–3-methyl–5-

oxo–1–(3-sulfophenyl)–1H-pyrazo–4-

yl]azo], ammonium salt (C.I. Pigment

Yellow 191:1) as a colorant in polymers

intended for use in contact with food.

DATES: Written comments on

petitioner’s environmental assessment

by December 19, 1997.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Vir

D. Anand, Center for Food Safety and

Applied Nutrition (HFS–216), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3081.

SUPPLEMENTARY INFORMATION: Under the

Federal Food, Drug, and Cosmetic Act

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

notice is given that a food additive

petition (FAP 8B4566) has been filed by

Ciba Specialty Chemicals Corp., 335

Water St., Newport, DE 19804. The

petition proposes to amend the food

additive regulations in § 178.3297

Colorants for polymers (21 CFR

178.3297) to provide for the safe use of

benzenesulfonic acid, 4-chloro–5-

methyl–2-[[4,5-dihydro–3-methyl–5-

oxo–1–(3-sulfophenyl)–1H-pyrazo–4-

yl]azo], ammonium salt (C.I. Pigment

Yellow 191:1) as a colorant in polymers

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. 97-30406 Filed 11–18–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97M–0460]

Ventritex, Inc.; Premarket Approval of

the TVL Lead System

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application submitted

by Ventritex, Inc., Sunnyvale, CA, for

premarket approval, under the Federal

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

of the TVL Lead System. FDA’s Center

for Devices and Radiological Health

(CDRH) notified the applicant, by letter

of May 10, 1996, of the approval of the

application.

DATES: Petitions for administrative

review by December 19, 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:

Doris J. Terry, Center for Devices and

Radiological Health (HFZ–450), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–443–8609.

SUPPLEMENTARY INFORMATION: On June

30, 1995, Ventritex, Inc., Sunnyvale, CA

94086–6527, submitted to CDRH an

application for premarket approval of

the TVL Lead System. The TVL Lead

System is indicated for use with

commercially available pulse generators

with which it has been tested. The

TVL Lead System is a transvenous

defibrillation lead system and is

indicated for use in patients with a

history of hemodynamically

compromising ventricular

tachyarrhythmias. These patients may

have experienced a cardiac arrest not

associated with an acute myocardial

infarction or have ventricular

tacharrhythmias. In addition, the TVL

Lead System can be used in patients

whose primary therapy for

hemodynamically significant, sustained

ventricular tachycardia is

antitachycardia pacing; the

defibrillation capabilities of the

connected pulse generator provide

therapy backup in the event that the

arrhythmia accelerates.

In accordance with the provisions of

section 515(c)(2) of the Federal Food,

Drug, and Cosmetic Act (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 Circulatory

System Devices Advisory 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 May 10,

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 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 19, 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).
Federal Register / Vol. 62, No. 223 / Wednesday, November 19, 1997 / Notices 61825

Dated: October 16, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–30333 Filed 11–18–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

Document Identifier: HCFA–R–94

Agency Information Collection

Activities: Submission for OMB

Review; 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, has submitted to the

Office of Management and Budget

(OMB) the following proposal for the

collection of information. 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: Extension of a currently

approved collection; Title of

Information Collection: Medicaid

Sterilization Regulations 45 CFR 96.73,

42 CFR 441 subpart F and Consent

Form; Form No.: HCFA–R–94 OMB

0938–0481; Use: All Medicaid-eligible

individuals seeking sterilization are

required to sign the federally mandated

consent form, acknowledging that they

understand the benefits and risks of

sterilization, and have received oral

information concerning the sterilization

operation from the provider. Frequency:

Other (each time sterilization is sought);

Affected Public: Individuals or

Households; Number of Respondents:

112,526; Total Annual Responses:

112,526; Total Annual Hours: 140,658.

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 30 days of this notice directly to

the OMB Desk Officer designated at the

following address: OMB Human

Resources and Housing Branch,

Attention: Allison Eydt, New Executive

Office Building, Room 10235,

Washington, D.C. 20503.

Dated: October 6, 1997.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA,

Office of Information Services,Information

Technology Investment Management

Group,Division of HCFA Enterprise

Standards.

[FR Doc. 97–30368 Filed 11–18–97; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–R–200]

Agency Information Collection

Activities: Submission for OMB

Review; 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, has submitted to the

Office of Management and Budget

(OMB) the following proposal for the

collection of information. 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 Request: Revision

of a currently approved collection; Title

of Information Collection: HEDIS 3.0

(Health Plan Data and Information Set),

including the Health of Seniors and

Consumer Assessment of Health Plans

Study (CAHPS) surveys and supporting

regulations 42 CFR 417.470, and 42 CFR

417.126; Form Number: HCFA–R–200

(OMB #0938–0701); Use: HEDIS and

CAHPS will be used for 3 purposes: (1)

To provide summary comparative data

to the Medicare beneficiary to assist

them in choosing among health plans;

(2) to provide information to health

plans for internal quality improvement

activity; and (3) to provide HCFA, as

purchaser, information useful for

monitoring quality of and access to care

provided by the plans; Frequency:

Annually; Affected Public: Individuals

or Households, non-profit and for profit

HMOs which contract with HCFA to

provide managed health care to

Medicare beneficiaries; Number of

Respondents: 293,834; Total Annual

Responses: 293,834; Total Annual

Hours Requested: 181,520.

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 30 days of this notice directly to

the OMB Desk Officer designated at the

following address: OMB Human

Resources and Housing Branch,

Attention: Allison Eydt, New Executive

Office Building, Room 10235,

Washington, D.C. 20503.

Dated: October 21, 1997.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA,

Office of Information Services, Information

Technology Investment Management Group,

Division of HCFA Enterprise Standards.

[FR Doc. 97–30369 Filed 11–18–97; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Drug Accountability Record;

Submission of OMB Review; Comment

Request

SUMMARY: Under the provisions of

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

Reduction Act of 1995, the National

Cancer Institute, the National Institutes

of Health (NIH) has submitted to the

Office of Management and Budget

(OMB) a request to review and approve

the information collection listed below.

This proposed information collection

was previously published in the Federal

Register on July 10, 1997, page 37069

and allowed 60-days for public

comment. No public comments were

received. The purpose of this notice is

to allow an additional 30-days for

public comment. The National Institutes