18846 Federal Register / Vol. 60, No. 71 / Thursday, April 13, 1995 / Notices

premarket approval, under the Federal

Food, Drug, and Cosmetic Act (the act),

of the BOSTON Advance Comfort

Formula Conditioning Solution. FDA’s

Center for Devices and Radiological

Health (CDRH) notified the applicant,

by letter of March 1, 1995, of the

approval of the application.

DATES: Petitions for administrative

review by May 15, 1995.

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, rm. 1–23,

12420 Parklawn Dr., Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

David M. Whipple, Center for Devices

and Radiological Health (HFZ–460),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–1744.

SUPPLEMENTARY INFORMATION: On

December 29, 1992, Polymer

Technology Division of Wilmington

Partners L. P., Wilmington, MA 01887,

submitted to CDRH an application for

premarket approval of the BOSTON

Advance Comfort Formula

Conditioning Solution. The device is a

disinfecting and soaking solution and is

indicated for disinfecting and soaking

fluoro silicone acrylate and silicone

acrylate rigid gas permeable contact

lenses.

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 March 1,

1995, 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 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 § 10.33(b) (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 May 15, 1995, 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 24, 1995.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 95–9181 Filed 4–12–95; 8:45 am]

BILLING CODE 4160–01–F

Public Health Service

Statement of Organization, Functions,

and Delegations of Authority; Office of

the Assistant Secretary for Health

Part H, Public Health Service (PHS),

Chapter HA (Office of the Assistant

Secretary for Health), of the Statement

of Organization, Functions, and

Delegations of Authority for the

Department of Health and Human

Services (DHHS) (42 FR 61318,

December 2, 1977, as amended most

recently at 60 FR 8410, February 14,

1995) is amended to reflect a title

change for the Office of Management,

Office of the Assistant Secretary for

Health.

Office of the Assistant Secretary for

Health

Under Chapter HA, Office of the

Assistant Secretary for Health, Section

HA–10, Organization, change item.11.

Office of Management (HAU) to 11.

Office of Management and Budget

(HAU).

Under Section HA–20, Functions,

following the title and statement for

Office of Emergency Preparedness

(HAP), change the title for Office of

Management (HAU) to Office of

Management and Budget (HAU).

Under Chapter HA, Section HA–30,

Delegations of Authority, add the

following:

Delegations of authority made to and

by the Director, Office of Management

will continue in the successor position

Deputy Assistant Secretary for Health

(Management and Budget) pending

further redelegation.

Delegations of authority made to and

by the Deputy Assistant Secretary for

Health Management Operations will

continue in the successor position

Deputy Assistant Secretary for Health

(Management and Budget) pending

further redelegation.

Dated: March 28, 1995.

Philip R. Lee,

Assistant Secretary for Health.

[FR Doc. 95–9040 Filed 4–12–95; 8:45 am]

BILLING CODE 4160–17–M

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

Office of Administration

[Docket No. R–95–1700; FR–3517–N–03]

Notice of Submission of Proposed

Information Collection to OMB

AGENCY: Office of Administration, HUD.

ACTION: Notice.

SUMMARY: The proposed information

collection requirement described below

has been submitted to the Office of

Management and Budget (OMB) for

review, as required by the Paperwork

Reduction Act. The Department is

soliciting public comments on the

subject proposal.

ADDRESSES: Interested persons are

invited to submit comments regarding

this proposal. Comments must be