Federal Register / Vol. 62, No. 57 / Tuesday, March 25, 1997 / Notices 14155

fluoride excimer laser and is indicated

for PRK treatments: (1) For the

reduction or elimination of mild to

moderate myopia (nearsightedness) of

between -1.0 to -6.0 diopters spherical

equivalent at the corneal plane, in

patients with less than or equal to 1.0

diopters of astigmatism; (2) in patients

with documented evidence of a change

in manifest refraction of less than or

equal to 0.50 diopters (in both cylinder

and sphere components) per year for at

least 1 year prior to the date of

preoperative examination; and (3) in

patients who are 18 years of age or

older.

On October 20, 1995, the Ophthalmic

Devices Panel of the Medical Devices

Advisory Committee, an FDA advisory

committee, reviewed and recommended

conditional approval of the application.

On March 27, 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 (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 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 April 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: February 20, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–7478 Filed 3–24–97; 8:45 am]

BILLING CODE 4160–01–F

Health Care Financing Administration

[Document Identifier: HCFA–R–183]

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 currently

approved collection; Title of

Information Collection: Voluntary

Customer Surveys to Implement

Executive Order 12862 within HCFA;

Form No.: HCFA–R–183; Use: These

voluntary customer surveys will be used

to implement E.O. 12862 to ascertain

customer satisfaction with HCFA

programs in terms of service quality.

Surveys will involve individuals that

are in direct or indirect beneficiaries of

HCFA service and/or assistance, not

partners. Frequency: Annually; Affected

Public: Individuals or households;

Number of Respondents: 1; Total

Annual Responses: 1; Total Annual

Hours: 1.

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 Burke,

Room C2–26–17, 7500 Security

Boulevard, Baltimore, Maryland 21244–

1850.

Dated: March 18, 1997.

Edwin J. Glatzel,

Director, Management Analysis and Planning

Staff, Office of Financial and Human

Resources.

[FR Doc. 97–7402 Filed 3–24–97; 8:45 am]

BILLING CODE 4120–03–P

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, 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 this 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.