25214 Federal Register / Vol. 63, No. 88 /Thursday, May 7, 1998 / Notices

attorney to reiterate the agency’s

initiative to remove from its pending

petition inventory those petitions that

are no longer being pursued by the

petitioner. In that letter, the agency

stated that if Dairy Crest Foods, Ltd.,

wished to pursue the petition, the

agency would continue to work on it.

However, if Dairy Crest Food, Ltd., did

not wish to pursue the petition, the

agency requested that Dairy Crest Food,

Ltd., withdraw the petition without

prejudice to a future filing. FDA asked

that the petitioner inform the agency of

its decision within 30 days of the date

of the letter; the agency added that

failure to respond within that time

would be considered approval to

withdraw the petition. As of this date,

Dairy Crest Food, Ltd., has not

responded to FDA in any way.

Therefore, the agency is announcing

that it considers this petition to be

withdrawn by the firm, without

prejudice to a future filing (21 CFR

171.7).

Dated: April 27, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–12055 Filed 5–6–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Ophthalmic Devices Panel of the

Medical Devices 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: Ophthalmic

Devices Panel of the Medical Devices

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 June 5, 1998, 9 a.m. to 5 p.m.

Location: Corporate Bldg., conference

room 020B, 9200 Corporate Blvd.,

Rockville, MD.

Contact Person: Sara M. Thornton,

Center for Devices and Radiological

Health (HFZ–460), Food and Drug

Administration, 9200 Corporate Blvd.,

Rockville, MD 20850, 301–594–2053, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12396, or the World Wide Web (WWW)

at http://www.fda.gov. Please call the

Information Line for up-to-date

information on this meeting.

Agenda: The committee will discuss,

make recommendations, and vote on a

premarket approval application (PMA)

for an excimer laser for the correction of

myopia using laser in-situ

keratomileusis. FDA staff will present to

the committee the clinical requirements

section of the proposed International

Standards Organization standard for

ophthalmic viscosurgical devices.

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 May 29, 1998. Oral

presentations from the public will be

scheduled between approximately 9:30

a.m. and 10 a.m., and between

approximately 1 p.m. and 1:30 p.m. An

additional 30-minute time period will

be given for public comment at the end

of the panel discussion on the PMA.

Time allotted for each presentation may

be limited. Those desiring to make

formal oral presentations should notify

the contact person before May 29, 1998,

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: April 30, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98–12170 Filed 5–6–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–2567–A]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Health Care Financing

Administration, HHS.

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 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.

Type of Information Collection

Request: Extension of a currently

approved collection; Title of

Information Collection: Statement of

Deficiencies and Plan of Correction and

Supporting Regulations in 42 CFR

486.301–.325; Form No.: HCFA–2567–A

(OMB# 0938–0391); Use: This

Paperwork package provides

information regarding deficiencies for

Organ Procurement Organizations

(OPO) as well as deficiencies noted

during periodic facility and laboratory

certification surveys. This information

is used to make decisions concerning

OPO redesignation, certification/

recertification of health care facilities

participating in the Medicare/Medicaid

Programs, and laboratories regulated by

the Clinical Laboratory Improvement

Amendments; Frequency: Biennially

and Annually; Affected Public: Business

or other for-profit, not-for-profit

institutions, Federal Government, and

State, local or tribal government;

Number of Respondents: 49,200; Total

Annual Responses: 98,400; Total

Annual Hours: 196,800.

To obtain copies of the supporting

statement and any related forms for the

proposed paperwork collections

referenced above, access HCFA’s Web

Site address at http://www.hcfa.gov/

regs/prdact95.htm, or E-mail your

request, including your address, phone

number, OMB number, and HCFA

document identifier, 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 Information Services,

Information Technology Investment

Management Group, Division of HCFA

Enterprise Standards, Attention: Louis

Blank, Room C2–26–17, 7500 Security
Federal Register / Vol. 63, No. 88 /Thursday, May 7, 1998 / Notices 25215

Boulevard, Baltimore, Maryland 21244–

1850.

Dated: April 28, 1998.

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. 98–12092 Filed 5–6–98; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–116, HCFA–R–

148, and HCFA–R–231]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Health Care Financing

Administration, HHS.

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 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.

1. Type of Information Collection

Request: Revision of a currently

approved collection; Title of

Information Collection: Clinical

Laboratory Improvement Amendments

(CLIA) Application Form and

Supporting Regulations in 42 CFR

493.1–.2001; Form No.: HCFA–116

(OMB# 0938–0581); Use: These

certification requirements have been

established for any entity that performs

testing on human beings for diagnostic

or treatment purposes. If a laboratory

conducts relatively simple tests that are

categorized as waived or provider

performed microscopy test procedures

(PPMP), it must obtain a certificate of

waiver or certificate of PPMP. If the

laboratory conducts any tests outside of

these two categories, it must apply for

a certificate of compliance or certificate

of accreditation and initially obtain a

registration certificate. These certificates

ensure that laboratories are in

compliance with CLIA.; Frequency:

Biennially; Affected Public: Business or

other for profit, not for profit

institutions, Federal Government, and

State, local or tribal government;

Number of Respondents: 16,000; Total

Annual Responses: 16,000; Total

Annual Hours: 20,000.

2. Type of Information Collection

Request: Extension of a currently

approved collection; Title of

Information Collection: Limitation on

Provider-Related Donations and Health

Care-Related Taxes; Limitations on

Payments to Disproportionate Share

Hospitals; Medicaid and Supporting

Regulations in 42 CFR 433.68, 433.74,

447.74 and 447.272; Form No.: HCFA–

R–148 (OMB# 0938–0618); Use: These

information collection requirements

specify limitations on the amount of

Federal financial participation available

for medical assistance expenditures in a

fiscal year. States receive donated funds

from providers and revenues are

generated by health care related taxes.

These donations and revenues are used

to fund medical assistance programs.;

Frequency: Quarterly; Affected Public:

State, Local, or Tribal Government;

Number of Respondents: 51; Total

Annual Responses: 51; Total Annual

Hours: 3,892.

3. Type of Information Request:

Revision of a currently approved

collection; Title of Information

Collection: Medicare+Choice (M+C)

Providers Sponsored Organization

(PSO) Waiver Request Form and

Supporting Regulations in 42 CFR

422.374; Form Number: HCFA–R–231;

Use: The PSO waiver request form is for

use by PSO’s that do not have a State

risk-bearing entity license and that wish

to enter into a M+C contract with HCFA

to provide prepaid health care services

to eligible Medicare beneficiaries. HCFA

will use the information requested on

this form to determine whether the

applicant is eligible for a waiver of the

state licensure requirement for M+C

organizations as allowed under section

1855(a)(2) of the Social Security Act.;

Frequency: One-time.; Affected Public:

Business or other for-profit, not-forprofit institutions, and Federal

Government.; Annual Number of

Respondents: 30.; Total Annual

Responses: 30.; Total Annual Hours

Requested: 300.

To obtain copies of the supporting

statement and any related forms for the

proposed paperwork collections

referenced above, access HCFA’s Web

Site address at http://www.hcfa.gov/

regs/prdact95.htm, or E-mail your

request, including your address, phone

number, OMB number, and HCFA

document identifier, 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 Information Services,

Information Technology Investment

Management Group, Division of HCFA

Enterprise Standards, Attention: Louis

Blank, Room C2–26–17, 7500 Security

Boulevard, Baltimore, Maryland 21244–

1850.

Dated: April 24, 1998.

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. 98–12094 Filed 5–6–98; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–R–235]

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: New Collection; Title of

Information Collection: Data Use

Agreement Information Collection

Requirements, model agreement, and

Supporting regulations; Form No.: