Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Notices 49691

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

Paper records are kept in file folders,

card files, and cabinets; microfilm

records on reels and in cabinets;

microfiches in cabinets; magnetic tapes

and cards in cabinets and storage

libraries; and computer records within a

computer and attached equipment.

RETRIEVAL:

Records are filed by name or social

security number at each location.

SAFEGUARDS:

Records are stored in locked

containers or secured rooms when not

in use by an authorized person.

Electronic records are protected by a

password system.

DISPOSAL:

The Finance Division disposes of the

records by shredding or burning, as

scheduled in the handbook GSA

Records Maintenance and Disposition

System (OAD P 1820.2A).

SYSTEM MANAGER AND ADDRESS:

Director, Finance Division, General

Services Administration (6BC), 1500

East Bannister Road, Kansas City, MO

64131.

NOTIFICATION PROCEDURE:

An individual inquiry should be

addressed to the system manager.

RECORD ACCESS PROCEDURES:

An individual request should be

addressed to the system manager.

Furnish full name, social security

number, address, telephone number,

and approximate dates and places of

employment. For the identification

required, see 41 CFR part 105–64,

published in the Federal Register.

CONTESTING RECORD PROCEDURE:

GSA rules for contesting the content

of a record and appealing an initial

decision are in 41 CFR part 105–64,

RECORD SOURCE CATEGORIES:

The sources are individuals

themselves, other employees,

supervisors, officials of other agencies,

State governments, record systems GSA/

HRO–37, OPM/GOVT–1, EEOC/GOVT–

1, and private firms.

Dated: July 8, 1997.

John H. Davenjay,

Director, Administrative Policy and

Information Management Division.

[FR Doc. 97–24881 Filed 9–22–97; 8:45 am]

BILLING CODE 6820–34–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[30DAY–24–97]

Agency Forms Undergoing Paperwork

Reduction Act Review

The Centers for Disease Control and

Prevention (CDC) publishes a list of

information collection requests under

review by the Office of Management and

Budget (OMB) in compliance with the

Paperwork Reduction Act (44 U.S.C.

Chapter 35). To request a copy of these

requests, call the CDC Reports Clearance

Office on (404) 639–7090. Send written

comments to CDC, Desk Officer; Human

Resources and Housing Branch, New

Executive Office Building, Room 10235;

Washington, DC 20503. Written

comments should be received within 30

days of this notice.

Proposed Projects

1. Airways Disease in Miners—(0920–

0349)—Reinstatement—A relationship

between coal mining exposure and lung

function loss has been demonstrated.

Both smoking and coal mine dust

exposure are associated with clinically

important respiratory dysfunction. Their

separate contributions to obstructive

airway disease in coal miners appear to

be additive. However, much of the

apparent variation in the health risks of

coal mine dust exposure remains

unexplained. Miners exposed to similar

levels of coal mine dust demonstrate

large variations in lung function loss.

Intrinsic susceptibility to the dust or

some environmental factor not yet

identified must be sought to explain

why some individuals suffer severe lung

damage and others experience stable or

age related changes in lung function in

response to inhalation of respirable

dust.

The spectrum of respiratory disease in

coal miners is certainly broad.

Pneumoconiosis is widely accepted as

specific to mine dust exposure. It has

been observed that emphysema is more

common and severe in coal miners than

non-miners. Symptoms of chronic

bronchitis are common in miners and

the risk of their development has been

related to exposure to the mine

environment. Over 50% of non-smoking

coal miners with identifiable airflow

obstruction may have asthma. Questions

that remain include: What are the

predictable factors which relate

variations in airflow obstruction in

miners to measured respirable coal mine

dust exposure? What are the specific

processes responsible for lung function

losses in miners?

The goals of this investigation are to:

(1) Improve our understanding of the

processes and mechanisms involved in

the development of pulmonary diseases

and accelerated lung function losses in

underground coal miners and other dust

exposed workers, and to further define

the consequences of inhalation of coal

mine and other dusts; and (2) Identify

potential risk factors in the development

of excessive respiratory function loss as

a basis for interventions to reduce

morbidity and mortality associated with

respirable dust in the work place.

The data collected in this study will

be used to provide a basis for improving

the understanding of pulmonary disease

processes in dust exposed workers, and

as a basis for intervention strategies to

reduce morbidity in the coal mining and

possibly other industries. The total

annual burden hours are 130 (259/2).

Respondents Number of

respondents

Number of

responses/respondent

Avg. burden/

response (in

hrs.)

Physicians ........................................................................................................................................ 40 1 0.17

Volunteers ........................................................................................................................................ 36 1 7.0
49692 Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Notices

Dated: September 17, 1997.

Wilma G. Johnson,

Acting Associate Director for Policy Planning

And Evaluation, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 97–25170 Filed 9–22–97; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97M–0396]

Advanced BionicsTM Corp.; Premarket

Approval of CLARION MultiStrategyTM Cochlear Implant

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application by

Advanced BionicsTM Corp., Sylmar, CA,

for premarket approval, under the

Federal Food, Drug, and Cosmetic Act

(the act), of the CLARION MultiStrategyTM Cochlear Implant. After

reviewing the recommendation of the

Ear, Nose, and Throat Devices Panel,

FDA’s Center for Devices and

Radiological Health (CDRH) notified the

applicant, by letter of June 26, 1997, of

the approval of the application.

DATES: Petitions for administrative

review by October 23, 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: I.

Sidney Jaffee, Center for Devices and

Radiological Health (HFZ–470), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–2080.

SUPPLEMENTARY INFORMATION: On

December 29, 1996, Advanced

BionicsTM Corp., Sylmar, CA 91342,

submitted to CDRH an application for

premarket approval of the CLARION

Multi-StrategyTM Cochlear Implant. The

device is a cochlear implant and is

intended to restore a level of auditory

sensation to individuals with profound

sensorineural deafness via electrical

stimulation of the auditory nerve. The

CLARION Multi-StrategyTM Cochlear

Implant is indicated for the following:

Children:

• Two through 17 years of age. If xrays demonstrate evidence of

ossification, children as young as 18

months may be implanted;

• Profound, bilateral sensorineural

deafness (≥90 dB);

• Undergone or be willing to

undergo a hearing aid trial with

appropriately fitted hearing aids; and

• Lack of benefit from appropriately

fitted hearing aids. In younger children,

lack of benefit with hearing aids is

defined as a failure to attain basic

auditory milestones such as a child’s

inconsistent response to his/her name in

quiet or to environmental sounds

(Meaningful Auditory Integration Scale).

In older children, lack of aided benefit

is defined as scoring 0 percent on openset word recognition (Phonetically

Balanced Kindergarten Test—Word List)

administered with monitored live-voice

(70 dB SPL). Both younger and older

children should demonstrate only

minimal ability on age appropriate

open-set sentence measures and a

plateau in auditory development.

On May 21, 1997, the Ear, Nose, and

Throat Devices Panel of the Medical

Devices Advisory Committee, an FDA

advisory committee, reviewed and

recommended approval of the

application. On June 26, 1997, CDRH

approved the application by a letter to

the applicant from the Deputy Director

of Clinical and Policy Review 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 October 23, 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: August 26, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–25163 Filed 9–22–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97M–0393]

Avanta Orthopaedics Corp.; Premarket

Approval of Braun-Cutter Trapezometacarpal prosthesis

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application by Avanta

Orthopaedics Corp., San Diego, CA, for

premarket approval, under the Federal

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

of the Braun-Cutter Trapezo-metacarpal

Prosthesis. After reviewing the

recommendation of the Orthopedics and

Rehabilitation Devices Panel, FDA’s

Center for Devices and Radiological

Health (CDRH) notified the applicant,

by letter of June 19, 1997, of the

approval of the application.

DATES: Petitions for administrative

review by October 23, 1997.