16862 Federal Register / Vol. 62, No. 67 / Tuesday, April 8, 1997 / Notices

Certification Regarding Environmental

Tobacco Smoke

Public Law 103–227, Part C—

Environmental Tobacco Smoke, also known

as the Pro-Children Act of 1994 (Act),

requires that smoking not be permitted in any

portion of any indoor routinely owned or

leased or contracted for by an entity and used

routinely or regularly for provision of health,

day care, education, or library services to

children under the age of 18, if the services

are funded by Federal programs either

directly or through State or local

governments, by Federal grant, contract, loan,

or loan guarantee. The law does not apply to

children’s services provided in private

residences, facilities funded solely by

Medicare or Medicaid funds, and portions of

facilities used for inpatient drug or alcohol

treatment. Failure to comply with the

provisions of the law may result in the

imposition of a civil monetary penalty of up

to $1,000 per day and/or the imposition of an

administrative compliance order on the

responsible entity.

By signing and submitting this application

the applicant/grantee certifies that it will

comply with the requirements of the Act. The

applicant/grantee further agrees that it will

require the language of this certification be

included in any subawards which contain

provisions for the children’s services and that

all subgrantees shall certify accordingly.

[FR Doc. 97–8840 Filed 4–7–97; 8:45 am]

BILLING CODE 4184–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Grassroots Consumer Participation:

Public Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of a public meeting.

SUMMARY: The Food and Drug

Administration (FDA) is announcing a

grassroots consumer exchange meeting

between the general public and FDA

officials. The meeting will be chaired by

FDA’s Cincinnati District Director and is

intended to encourage dialogue between

consumers and FDA officials, to solicit

consumers’ concerns about the drug

review process, drug clinical trials

(including inclusion of women in

clinical trials), and to discuss how FDA

can improve consumer services.

DATES: The public meeting will be held

on Tuesday, April 29, 1997, 9 a.m. to 12

m.

ADDRESSES: The public meeting will be

held at the Cincinnati Bell Long

Distance Bldg., 36 East 7th St., rm. 1703,

Cincinnati, OH.

FOR FURTHER INFORMATION CONTACT:

Marilyn R. Zipkes, Food and Drug

Administration, 1141 Central Pkwy.,

Cincinnati, OH 45212, 513–684–3501,

ext. 110.

SUPPLEMENTARY INFORMATION: The

purpose of the meeting is to encourage

dialogue between consumers and FDA

officials, to identify consumers’ current

and future health concerns, and to

enhance relations between consumers

and FDA. There is no registration fee for

this meeting. Interested persons are

encouraged to register early because

space is limited. To register contact the

contact person listed above.

Dated: March 31, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–8908 Filed 4–7–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97M–0126]

CIBA Vision Corp.; Premarket

Approval of Unizyme Enzymatic

Cleaner

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application by CIBA

Vision Corp., Duluth, GA, for premarket

approval, under the Federal Food, Drug,

and Cosmetic Act (the act), of Unizyme

Enzymatic Cleaner. FDA’s Center for

Devices and Radiological Health (CDRH)

notified the applicant, by letter of

January 31, 1997, of the approval of the

application.

DATES: Petitions for administrative

review by May 8, 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:

James F. Saviola, Center for Devices and

Radiological Health (HFZ–460), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–1744.

SUPPLEMENTARY INFORMATION: On August

15, 1996, CIBA Vision Corp., Duluth,

GA, 30155–1518, submitted to CDRH an

application for premarket approval of

Unizyme Enzymatic Cleaner. The device

is a periodic cleaner and is indicated for

use with (hydrogen peroxide), lens care

systems in the weekly cleaning of soft

(hydrophilic) contact lenses (including

daily wear, extended wear, tinted

lenses, and lenses prescribed for

scheduled replacement).

In accordance with the provisions of

section 515(c)(2) of the act (21 U.S.C.

360e(c)(2)) as amended by the Safe

Medical Devices Act of 1990, this

premarket approval application (PMA)

was not referred to the Ophthalmic

Devices Panel of the Medical Devices

Advisory Committee, an FDA advisory

committee, for review and

recommendation because the

information in the PMA substantially

duplicates information previously

reviewed by this panel. On January 31,

1997, 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 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.
Federal Register / Vol. 62, No. 67 / Tuesday, April 8, 1997 / Notices 16863

Petitioners may, at any time on or

before May 8, 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: March 4, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–8853 Filed 4–7–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–643]

Agency Information Collection

Activities: Submission for OMB

Review; 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 proposal 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 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: Reinstatement, without change,

of previously approved collection for

which approval has expired; Title of

Information Collection: Hospice Survey

and Deficiencies Report Form and

Supporting Regulations 42 CFR Sections

488,488.26(c), 442.30(a)(4), 442, Subpart

B, C, D, E and F; Form No.: HCFA–643;

Use: The survey report form and

supporting regulations are needed to

ensure provider compliance with

Medicare and Medicaid conditions of

participation. In order to participate in

the Medicare program, a hospice must

meet certain Federal health and safety

conditions of participation. The survey

report form will be used by State

surveyors to record data about a

hospice’s compliance with Federal

health and safety conditions in order to

initiate the certification or

recertification process. Frequency:

Annually; Affected Public: State, Local

or Tribal Govt, Federal Govt; Number of

Respondents: 2,150; Total Annual

Responses: 2,150; Total Annual Hours:

5,375.

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 30 days of this notice directly to

the HCFA Paperwork Clearance Officer

designated at the following address:

OMB Human Resources and Housing

Branch, Attention: Allison Eydt, New

Executive Office Building, Room 10235,

Washington, D.C. 20503.

Dated: March 26, 1997.

Edwin J. Glatzel,

Director, Management Analysis and Planning

Staff, Office of Financial and Human

Resources, Health Care Financing

Administration.

[FR Doc. 97–8949 Filed 4–7–97; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National institute of Dental Research;

Notice of Closed Meetings

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

National Institute of Dental Research

Special Emphasis Panel (SEP) meetings:

Name of SEP: National Institute of Dental

Research Special Emphasis Panel-Review of

R03 application (97–32).

Date: April 3, 1997.

Time: 2:30 p.m.

Place: Natcher Building, Rm. 4AN–44F,

National Institutes of Health, Bethesda, MD

20892, (teleconference).

Contact Person: Dr. Philip Washko,

Scientific Review Administrator, 4500 Center

Drive, Natcher Building, Room 4AN–44F,

Bethesda, MD 20892, (301) 594–2372.

Purpose/Agenda: To evaluate and review

grant applications and/or contract proposals.

Name of SEP: National Institute of Dental

Research Special Emphasis Panel-Review of

R03 application (97–31).

Date: April 7, 1997.

Time: 10:00 a.m.

Place: Natcher Building, Rm. 4AN–44F,

National Institutes of Health, Bethesda, MD

20892, (teleconference).

Contact Person: Dr. Philip Washko,

Scientific Review Administrator, 4500 Center

Drive, Natcher Building, Room 4AN–44F,

Bethesda, MD 20892, (301) 594–2372.

Purpose/Agenda: To evaluate and review

grant applications and/or contract proposals.

Name of SEP: National Institute of Dental

Research Special Emphasis Panel-Review of

R44 application (97–27).

Date: April 8, 1997.

Time: 1:00 p.m.

Place: Natcher Building, Rm. 4AN–44F,

National Institutes of Health, Bethesda, MD

20892, (teleconference).

Contact Person: Dr. George Hausch, Chief,

Grants Review Section, 4500 Center Drive,

Natcher Building, Room 4AN–44F, Bethesda,

MD 20892, (301) 594–2372.

Purpose/Agenda: To evaluate and review

grant applications and/or contract proposals.

Name of SEP: National Institute of Dental

Research Special Emphasis Panel-Review of

R03 Applications (97–40).

Date: April 11, 1997.

Time: 2:00 p.m.

Place: Natcher Building, Rm. 4AN–44F,

National Institutes of Health, Bethesda, MD

20892, (teleconference).

Contact Person: Dr. George Hausch, Chief,

Grants Review Section, 4500 Center Drive,

Natcher Building, Room 4AN–44F, Bethesda,

MD 20892, (301) 594–2372.

Purpose/Agenda: To evaluate and review

grant applications and/or contract proposals.

Name of SEP: National Institute of Dental

Research Special Emphasis Panel-Review of

R03 application (97–36).

Date: April 15, 1997.

Time: 10:00 a.m.

Place: Natcher Building, Rm. 4AN–44F,

National Institutes of Health, Bethesda, MD

20892, (teleconference).

Contact Person: Dr. Philip Washko,

Scientific Review Administrator, 4500 Center

Drive, Natcher Building, Room 4AN–44F,

Bethesda, MD 20892, (301) 594–2372.

Purpose/Agenda: To evaluate and review

grant applications and/or contract proposals.

Name of SEP: National Institute of Dental

Research Special Emphasis Panel-Review of

R03 applications (97–35).

Date: April 24, 1997.

Time: 10:00 a.m.

Place: Natcher Building, Rm. 4AN–44F,

National Institutes of Health, Bethesda, MD

20892, (teleconference).

Contact Person: Dr. Philip Washko,

Scientific Review Administrator, 4500 Center