Federal Register / Vol. 63, No. 88 /Thursday, May 7, 1998 / Notices 25213

components of articles intended for use

in contact with food.

The potential environmental impact

of this action is being reviewed. To

encourage public participation

consistent with regulations promulgated

under the National Environmental

Policy Act (40 CFR 1501.4(b)), the

agency is placing the environmental

assessment submitted with the petition

that is the subject of this notice on

public display at the Dockets

Management Branch (address above) for

public review and comment. Interested

persons may, on or before June 8, 1998,

submit to the Dockets Management

Branch (address above) written

comments. 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. Received

comments may be seen in the office

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

Monday through Friday. FDA will also

place on public display any

amendments to, or comments on, the

petitioner’s environmental assessment

without further announcement in the

Federal Register. If, based on its review,

the agency finds that an environmental

impact statement is not required and

this petition results in a regulation, the

notice of availability of the agency’s

finding of no significant impact and the

evidence supporting that finding will be

published with the regulation in the

Federal Register in accordance with 21

CFR 25.40(c).

Dated: April 24, 1998.

Laura M. Tarantino,

Acting Director, Office of Premarket

Approval, Center for Food Safety and Applied

Nutrition.

[FR Doc. 98–12169 Filed 5–6–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98F–0288]

Mitsui Chemicals, Inc.; Filing of Food

Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Mitsui Chemicals, Inc., has filed a

petition proposing that the food additive

regulations be amended to expand the

safe use of propylene/butene-1

copolymers containing greater than 15

but not more than 35 weight percent of

polymer units derived from butene-1 for

use in contact with food.

DATES: Written comments on the

petitioner’s environmental assessment

by June 8, 1998.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Julius Smith, Center for Food Safety and

Applied Nutrition (HFS–215), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3091.

SUPPLEMENTARY INFORMATION: Under the

Federal Food, Drug, and Cosmetic Act

(sec. 409(b)(5) (21 U.S.C. 348(b)(5))),

notice is given that a food additive

petition (FAP 8B4590) has been filed by

Mitsui Chemicals, Inc., c/o Keller &

Heckman, 1001 G St. NW., suite 500

West, Washington, DC 20001. The

petition proposes to amend the food

additive regulations in § 177.1520 Olefin

polymers (21 CFR 177.1520) to expand

the safe use of propylene/butene-1

copolymers containing greater than 15

but not more than 35 weight percent of

polymer units derived from butene-1 for

use in contact with food.

The potential environmental impact

of this action is being reviewed. To

encourage public participation

consistent with regulations promulgated

under the National Environmental

Policy Act (40 CFR 1501.4(b)), the

agency is placing the environmental

assessment submitted with the petition

that is the subject of this notice on

public display at the Dockets

Management Branch (address above) for

public review and comment. Interested

persons may, on or before June 8, 1998,

submit to the Dockets Management

Branch (address above) written

comments. 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. Received

comments may be seen in the office

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

Monday through Friday. FDA will also

place on public display any

amendments to, or comments on, the

petitioner’s environmental assessment

without further announcement in the

Federal Register. If, based on its review,

the agency finds that an environmental

impact statement is not required and

this petition results in a regulation, the

notice of availability of the agency’s

finding of no significant impact and the

evidence supporting that finding will be

published with the regulation in the

Federal Register in accordance with 21

CFR 25.40(c).

Dated: April 24, 1998.

Laura M. Tarantino,

Acting Director, Office of Premarket

Approval, Center for Food Safety and Applied

Nutrition.

[FR Doc. 98–12168 Filed 5–6–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 81G–0035]

Dairy Crest Food, Ltd.; Withdrawal of

GRAS Affirmation Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

withdrawal, without prejudice to a

future filing, of a petition (GRASP

1G0273) proposing that the use of

immobilized lactase composite is

generally recognized as safe (GRAS) for

use in the production of low-lactose

whey.

FOR FURTHER INFORMATION CONTACT:

Valerie M. Davis, Center for Food Safety

and Applied Nutrition (HFS–206), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3181.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

March 3, 1981 (46 FR 14970), FDA

announced that a petition (GRASP

1G0273) had been filed by Corning

Glass Works, Corning, NY. The petition

proposed affirmation that the use of

immobilized lactase composite is GRAS

for producing low-lactose whey.

In a letter dated January 8, 1988, a law

firm, on behalf of Corning Glass Works,

informed the agency that sponsorship of

the petition was transferred to Dairy

Crest Food, Ltd., Dairy Crest House,

Portsmouth Rd., Surbiton, Surrey KT6

5QL, England.

On May 29, 1996, the agency

contacted the attorney of record for

Dairy Crest Foods, Ltd., and inquired

whether Dairy Crest Foods, Ltd., was

still pursuing the petition, given that the

last communication from the petitioner

was 5 years previously. This inquiry

was prompted by an agency initiative to

remove those petitions that are no

longer being pursued from FDA’s

petition inventory. No response was

received.

By letter of May 29, 1997, FDA again

contacted Dairy Crest Food, Ltd.’s,
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