Federal Register / Vol. 62, No. 35 / Friday, February 21, 1997 / Notices 8025

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a guidance entitled

‘‘Deciding When to Submit a 510(k) for

a Change to an Existing Device.’’ This

guidance is intended to provide

direction to manufacturers of devices

who intend to modify their devices and

are in the process of deciding whether

the modification requires a new

premarket notification submission

(510(k)).

DATES: Written comments on this

guidance may be submitted at any time.

ADDRESSES: Submit written requests for

single copies of ‘‘Deciding When to

Submit a 510(k) for a Change to an

Existing Device’’ to the Division of

Small Manufacturers Assistance, Center

for Devices and Radiological Health

(HFZ–220), Food and Drug

Administration, 1350 Piccard Dr.,

Rockville, MD 20850, 301–443–6597

(outside MD 1–800–638–2041). Send

two self-addressed adhesive labels to

assist that office in processing your

requests, or fax your request to 301–

443–8818. Copies of a facsimile of the

guidance, are available from the

Division of Small Manufacturers

Assistance (DSMA) Facts on Demand,

Center for Devices and Radiological

Health (CDRH), 1–800–899–0381.

Copies of the guidance may also be

obtained from the World Wide Web at

http://www.fda.gov/cdrh administered

by DSMA and are available to anyone

with a video terminal or personal

computer (1–800–252–1366). Submit

written comments on this guidance to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857. Two copies of any

comments are to be submitted, except

that individuals may submit one copy.

Requests and comments should be

identified with the docket number

found in brackets in the heading of this

document. A copy of the guidance and

received comments are available for

public examination in the Dockets

Management Branch (address above)

between 9 a.m. and 4 p.m., Monday

through Friday.

FOR FURTHER INFORMATION CONTACT:

Heather S. Rosecrans, Center for Devices

and Radiological Health (HFZ–404),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–1190.

SUPPLEMENTARY INFORMATION: On April

8, 1994, FDA circulated for comment

the first draft guidance entitled

‘‘Deciding When to Submit a 510(k) for

a Change to an Existing Device.’’ The

draft guidance was intended to provide

direction to manufacturers on deciding

when to submit a new 510(k) for

changes to an existing device. The April

8, 1994, draft guidance was the subject

of a May 12, 1994, FDA teleconference

and the subject of discussion at several

trade and industry association meetings.

FDA received over 60 comments

regarding the April 8, 1994, draft

guidance. Based on the comments

received, FDA developed an August 1,

1995, second draft guidance entitled

‘‘Deciding When to Submit a 510(k) for

a Change to an Existing Device.’’ FDA

received 11 comments regarding the

October 16, 1996, draft guidance. The

comments supported the October 16,

1996, draft guidance and suggested that

FDA make the following changes: (1)

Include the recent publication of the

Quality Systems Regulation; (2) add

more references for definition and as a

referral to other guidance documents;

(3) give more examples and explanation

of materials, particularly with labeling

changes and changes in material for in

vitro devices; (4) update Appendix A on

suggested material terminology to reflect

latest industry comment on the

biomaterials compendium; and (5)

correct the logic flow in the materials

change chart.

Guidances have generally been issued

under § 10.90(b) (21 CFR 10.90(b)),

which provides for the use of guidances

to state procedures or standards of

general applicability that are not legal

requirements, but that are acceptable to

FDA. The agency is now in the process

of revising § 10.90(b). Therefore, the

guidance is not being issued under the

authority of current § 10.90(b), and it

does not create or confer any rights,

privileges, or benefits for or on any

person, nor does it operate to bind FDA

or device manufacturers in any way.

Interested persons may, at any time,

submit to the Dockets Management

Branch (address above) written

comments on the guidance. Two copies

of any comments are to be submitted,

except that individuals may submit one

copy. Comments are to be identified

with the docket number found in

brackets in the heading of this

document. The guidance and received

comments are available for public

examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

Received comments will be

considered to determine if further

revision of the guidance is warranted.

Dated: February 4, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–4303 Filed 2–20–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 97M–0054]

Schneider (USA), Inc.; Premarket

Approval of WALLSTENT Iliac

Endoprosthesis

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application by

Schneider (USA), Inc., Minneapolis,

MN, for premarket approval, under the

Federal Food, Drug, and Cosmetic Act

(the act), of the WALLSTENT Iliac

Endoprosthesis. After reviewing the

recommendation of the Circulatory

System Devices Panel, FDA’s Center for

Devices and Radiological Health (CDRH)

notified the applicant, by letter of May

28, 1996, of the approval of the

application. In addition, the

WALLSTENT Iliac Endoprosthesis

requires tracking under the act as

amended by the Safe Medical Devices

Act of 1990.

DATES: Petitions for administrative

review by March 24, 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: Judy

J. Danielson, Center for Devices and

Radiological Health (HFZ–450), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–443–8243.

SUPPLEMENTARY INFORMATION: On June 9,

1994, Schneider (USA), Inc.,

Minneapolis, MN 55432, submitted to

CDRH an application for premarket

approval of the WALLSTENT Iliac

Endoprosthesis. The device is a

peripheral stent and is indicated for use

following suboptimal percutaneous

transluminal angioplasty (PTA) of

common and/or external iliac artery

stenotic lesions, which are less than or

equal to 10 centimeters in length. A

suboptimal PTA is defined as a

technically successful dilation, judged

by the physician to be suboptimal due

to the presence of unfavorable lesion

morphology such as: An inadequate

angiographic and/or hemodynamic

result as defined by a 30 percent or

greater residual stenosis after PTA,

lesion recoil, or intimal flaps; flow

limiting dissections post PTA longer

than the initial lesion length; or a 5

mmHg or greater mean transtenotic

pressure gradient post PTA.
8026 Federal Register / Vol. 62, No. 35 / Friday, February 21, 1997 / Notices

On March 4, 1996, the Circulatory

System Devices Panel of the Medical

Devices Advisory Committee, an FDA

advisory committee, reviewed and

recommended approval of the

application. On May 28, 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.

Under section 519(e) of the act (21

U.S.C. 360i(e)) as amended by the Safe

Medical Devices Act of 1990,

manufacturers of certain types of

devices are required to adopt a method

of tracking that follows the devices

through the distribution chain and then

identifies and follows the patients who

receive them. FDA has identified the

above device as a new generic type of

device requiring tracking. FDA is

providing a 30-day period for interested

persons to submit to the Dockets

Management Branch (address above)

written comments regarding the

agency’s position that this new generic

type of device requires tracking.

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

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 March 24, 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: January 16, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–4228 Filed 2–20–97; 8:45 am]

BILLING CODE 4160–01–F

Health Care Financing Administration

[HCFA–462 A/B]

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: Extension of a currently

approved collection; Title of

Information Collection: Clinical

Laboratory Improvement Amendments

(CLIA) Adverse Action Extract; Form

No.: HCFA–462A/B; Use: This form is

used by HCFA surveyors (State Health

Department surveyors and other HCFA

agents) to record which types of adverse

actions are imposed against laboratories.

The form will also serve to track dates

of the impostion of adverse actions,

dates on which a laboratory corrects

deficiences, and all appeals activity.

Frequency: Biennially; Affected Public:

Not-for-profit institutions, Federal

Government, State, Local or Tribal Govt;

Number of Respondents: 2,500; Total

Annual Responses: 2,500; Total Annual

Hours: 5,625

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, access

HCFA’s WEB SITE ADDRESS at http://

www.hcfa.gov/regs/prdact95.htm, 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 Financial and Human

Resources, Management Analysis and

Planning Staff, Attention: John Rudolph,

Room C2–25–05, 7500 Security

Boulevard, Baltimore, Maryland 21244–

1850.

Dated: February 13, 1997.

Edwin J. Glatzel,

Director, Management Analysis and Planning

Staff, Office of Financial and Human

Resources.

[FR Doc. 97–4338 Filed 2–20–97; 8:45 am]

BILLING CODE 4120–03–P

[HCFA–841–853]

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

AGENCY: Health Care Financing

Administration, HHS.

In compliance with the Paperwork

Reduction Act of 1995 (44 U.S.C. 3501

et seq.), the Health Care Financing

Administration (HCFA), Department of

Health and Human Services, has

submitted to the Office of Management

and Budget (OMB) the following

proposals 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