Federal Register / Vol. 62, No. 220 / Friday, November 14, 1997 / Notices 61131

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

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 15, 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 17, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–30029 Filed 11–13–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97M–0458]

NeuroControl, Corp.; Premarket

Approval of Freehand 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 NeuroControl, Corp., Cleveland, OH,

for premarket approval, under the

Federal Food, Drug, and Cosmetic Act

(the act), of the Freehand System . After

reviewing the recommendation of the

Neurological Devices Panel, FDA’s

Center for Devices and Radiological

Health (CDRH) notified the applicant,

by letter of August 15, 1997, of the

approval of the application.

DATES: Petitions for administrative

review by December 15, 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:

Levering G. Keely, Center for Devices

and Radiological Health (HFZ–450),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–443–8517.

SUPPLEMENTARY INFORMATION: On June

17, 1996, NeuroControl Corp.,

Cleveland, OH 44106, submitted to

CDRH an application for premarket

approval of the Freehand System . The

system includes: Implantable receiverstimulator Model 202–1, implantable

epimysial electrode set Model 203–1,

surgical electrode positioning kit Model

207–1, patient external system Model

204–1, and programming system Model

209–1. The system is an upper extremity

neuroprosthesis and is intended to

improve a patient’s ability to grasp,

hold, and release objects. The system is

indicated for use in patients who: (1)

Are tetraplegic due to C5 or C6 spinal

cord injury (ASIA Classification), (2)

have adequate functional range of

motion of the upper extremity, (3) have

intact lower motor neuron innervation

of the forearm and hand musculature,

and (4) are skeletally mature.

On September 25, 1996, the

Neurological Devices Panel of the

Medical Devices Advisory Committee,

an FDA advisory committee, reviewed

and recommended approval of the

application. On August 15, 1997, 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 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 15, 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.
61132 Federal Register / Vol. 62, No. 220 / Friday, November 14, 1997 / Notices

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. 97–30030 Filed 11–13–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Psychopharmacologic Drugs Advisory

Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). The meeting will be open to the

public.

Name of Committee:

Psychopharmacologic Drugs Advisory

Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on FDA

regulatory issues.

Date and Time: The meeting will be

held on December 4, 1997, 8:30 a.m to

5 p.m.

Location: Holiday Inn, Versailles

Ballrooms I and II, 8120 Wisconsin

Ave., Bethesda, MD.

Contact Person: Rhonda W. Stover, or

Robinette Taylor, Center for Drug

Evaluation and Research (HFD–21),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–443–5455, or FDA Advisory

Committee Information Line, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area), code 12544.

Please call the Information Line for upto-date information on this meeting.

Agenda: On December 4, 1997, the

committee will hear presentations from

the Institute of Medicine on the

marketed product Halcion (triazolam,

Pharmacia and Upjohn Co.).

Procedure: Interested persons may

present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by December 1, 1997. Oral

presentations from the public will be

scheduled between approximately 8:30

a.m. and 9:30 a.m. Time allotted for

each presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before December 1, 1997, and

submit a brief statement of the general

nature of the evidence or arguments

they wish to present, the names and

addresses of proposed participants, and

an indication of the approximate time

requested to make their presentation.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: November 10, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–30034 Filed 11–13–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

Periodically, the Health Resources

and Services Administration (HRSA)

publishes abstracts of information

collection requests under review by the

Office of Management and Budget, in

compliance with the Paperwork

Reduction Act of 1995 (44 U.S.C.

Chapter 35). To request a copy of the

clearance requests submitted to OMB for

review, call the HRSA Reports

Clearance Office on (301) 443–1129.

The following request has been

submitted to the Office of Management

and Budget for review under the

Paperwork Reduction Act of 1995:

Proposed Project: The Health

Education Assistance Loan (HEAL)

Program: Application Form—0915–

0038—Extension, No Change. The

Health Education Assistance Loan

(HEAL) program provides federallyinsured loans to students in schools of

allopathic medicine, osteopathic

medicine, dentistry, veterinary

medicine, optometry, podiatric

medicine, pharmacy, public health,

allied health, or chiropractic, and

graduate students in health

administration or clinical psychology.

Eligible lenders, such as banks, savings

and loan associations, credit unions,

pension funds, State agencies, HEAL

schools, and insurance companies,

make HEAL loans which are insured by

the Federal Government against loss due

to borrowers’ death, disability,

bankruptcy, and default. The basic

purpose of the program is to assure the

availability of funds for loans to eligible

students who need to borrow money to

pay for their educational costs.

The HEAL program is being phased

out and no new loans will be made after

September 30, 1998, unless

reauthorization is enacted. We are,

however, requesting a 3-year extension

of the OMB approval of the HEAL

Application Form HRSA–700 because

lenders will continue to use this form

for consolidation loans through fiscal

year (FY) 2000. Students use the

application to apply for HEAL loans

(through FY 1998) and consolidation of

loans, schools use the application to

determine a student’s eligibility and

maximum approval amount of each loan

(through FY 1998 only), and lenders use

the application to determine student

eligibility and the amount of the

installment or disbursement to be given

to the borrower, and to process

consolidation loans.

The estimate of burden for the

application form for FY 1998 is as

follows:

Type of respondent Number of

respondents

Responses

per

respondent

Total

number of

responses

Burden per

response

(minutes)

Total

burden

hours

Applicants ................................................................................................. 8,230 1 8,230 25 3,429

Schools ..................................................................................................... 190 41 7,730 32 4,123

Lenders ..................................................................................................... 11 748 8,230 35 4,801

Total ............................................................................................... 8,431 .................... 24,190 .................... 12,353

The estimate of burden for the application form for FY 1999 and 2000 (for consolidation loans only) is as follows: