15528 Federal Register / Vol. 62, No. 62 / Tuesday, April 1, 1997 / Notices

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. 97–8169 Filed 3–31–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 97M–0122]

Xillix Technologies Corp.; Premarket

Approval of Xillix LIFE-Lung

Fluoresence Endoscopy System

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application submitted

by Hogan and Hartson, Washington, DC,

U.S. representative for Xillix

Technologies Corp., Richmond, B.C.,

Canada, for premarket approval, under

the Federal Food, Drug, and Cosmetic

Act (the act), of Xillix LIFE-Lung

Fluoresence Endoscopy System. After

reviewing the recommendation of the

Ear, Nose, and Throat Devices Panel,

FDA’s Center for Devices and

Radiological Health (CDRH) notified the

applicant, by letter of September 19,

1996, of the approval of the application.

DATES: Petitions for administrative

review by May 1, 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:

Kirby J. Cooper, Center for Devices and

Radiological Health (HFZ–470), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–2080.

SUPPLEMENTARY INFORMATION: On

December 21, 1995, Hogan and Hartson,

Washington, DC, U.S. representative for

Xillix Technologies Corp., Richmond,

B.C. Canada, submitted to CDRH an

application for premarket approval of

Xillix LIFE-Lung Fluorescence

Endoscopy System. The device is a

fluorescence endoscopy system and is

indicated for use as an adjunct to white

light bronchoscopy, using an Olympus

BF-20D bronchoscope, to enhance the

physician’s ability to identify and locate

bronchial tissue, suspicious for

moderate/severe dysplasia or worse, for

biopsy and histologic evaluation in the

following patient populations:

1. Patients with known or previously

diagnosed lung cancer; and

2. Patients with suspected lung cancer

including: (a) Patients with Stage I

completely resected lung cancer, with

no evidence of metastatic disease, who

are at risk for secondary disease; and (b)

patients suspected of having lung cancer

because of clinical symptoms such as

positive sputum cytology, hemoptysis,

unresolved pneumonia, persistent

cough, or positive x-ray.

On June 11, 1996, the Ear, Nose, and

Throat Devices Panel of the Medical

Devices Advisory Committee, an FDA

advisory committee, reviewed and

recommended approval of the

application. On September 19, 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 May 1, 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. 97–8170 Filed 3–31–97; 8:45 am]

BILLING CODE 4160–01–F

Health Resources and Services

Administration

Agency Information Collection

Activities: Proposed Collection:

Comment Request

In compliance with the requirement

for opportunity for public comment on

proposed data collection projects

(section 3506(c)(2)(A) of Title 35, United

States Code, as amended by the

Paperwork Reduction Act of 1995,

Public Law 104–13), the Health

Resources and Services Administration

(HRSA) will publish periodic

summaries of proposed projects being

developed for submission to OMB under

the Paperwork Reduction Act of 1995.

To request more information on the

proposed project or to obtain a copy of

the data collection plans, call the HRSA

Reports Clearance Officer on (301) 443–

1129.

Comments are invited on: (a) Whether

the proposed collection of information

is necessary for the proper performance

of the functions of the agency, including

whether the information shall have

practical utility; (b) the accuracy of the

agency’s estimate of the burden of the

proposed collection of information; (c)

ways to enhance the quality, utility, and

clarity of the information to be

collected; and (d) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques

or other forms of information

technology.
Federal Register / Vol. 62, No. 62 / Tuesday, April 1, 1997 / Notices 15529

Proposed Project: Program Data Report

Form for the Ryan White

Comprehensive AIDS Resources

Emergency (CARE) Act of 1990, Title III

HIV Early Intervention Services Program

(OMB No. 0915–0158)—Revision and

Extension—Title III of the Ryan White

Comprehensive AIDS Resources

Emergency (CARE) Act of 1990, as

amended by the CARE Act Amendments

of 1996, provides categorical funding to

increase the capacity and capability of

organizations that provide primary

health care to provide HIV-related early

intervention services to medically

underserved persons who have, or are at

high risk for, HIV infection. These

services are provided as part of a

continuum of HIV prevention and

health care services.

This clearance request is for extension

of OMB approval of the Title III Program

Data Report form, which is submitted

annually by Title III grant recipients.

The bulk of the information being

collected describes the epidemiologic

and demographic data on the

populations receiving early intervention

services from grant recipients, and

provides the basis for the annual report

to the Secretary, which is legislatively

mandated. It is also used to monitor the

delivery of services, guide federal

policy, and assist in program

development and evaluation. Only

minor revisions to the form are

proposed, including deletion of some

sections found to lack utility, revision of

some data elements and instructions for

clarity, and addition of data elements to

improve the usefulness of the data.

The estimate of burden for the form is

as follows:

Form name No. of

respondents

Responses

per

respondent

Hours per

response

Total

burden

hours

Program Data Report Form .............................................................................................. 170 1 500 85,000

Send comments to Patricia Royston,

HRSA Reports Clearance Officer, Room

14–36, Parklawn Building, 5600 Fishers

Lane, Rockville, MD 20857. Written

comments should be received within 60

days of this notice.

Dated: March 26, 1997.

J. Henry Montes,

Director, Office of Policy and Information

Coordination.

[FR Doc. 97–8168 Filed 3–31–97; 8:45 am]

BILLING CODE 4160–15–P

The Ryan White Comprehensive AIDS

Resources Emergency Act of 1990, as

Amended by the Ryan White CARE Act

Amendments of 1996

AGENCY: Health Resources and Services

Administration, HHS.

ACTION: Notice of a Pre-Application

Technical Assistance Workshop for

Ryan White Title III HIV Planning

Grants.

SUMMARY: The Health Resources and

Services Administration (HRSA) will

hold a pre-application technical

assistance workshop for competing

applicants for Ryan White Title III HIV

Planning Grants, of Part C of Title XXVI

of the Public Health Service (PHS) Act.

A Ryan White Title III HIV Planning

Grant will assist health care service

entities to qualify for grant support

under the Ryan White Title III Early

Intervention Services Program.

Eligible applicants for the Ryan White

Title III HIV Planning Grants are public

or nonprofit private entities. Grant

recipients of the Ryan White Title III

Early Intervention Services Program are

not eligible to receive Ryan White Title

III HIV Planning Grants.

It should be noted that eligible

applicants for the Ryan White Title III

Early Intervention Services Program are

public or private, nonprofit entities that

are: Current primary care service

providers to populations at risk for HIV

disease; community health centers

under section 330 of the PHS Act;

migrant health centers under section

330(g) of the PHS Act; health care for

the homeless grantees under section

330(h) of the PHS Act; family planning

grantees under section 1001 of the PHS

Act, other than states; comprehensive

hemophilia diagnostic and treatment

centers; or federally qualified health

centers under section 1905(1)(2)(B) of

the Social Security Act.

PURPOSE: The purpose of the preapplication technical assistance

workshop is to provide information

about the Ryan White Title III HIV

Planning Grant program, and to review

application procedures. Information

will also be provided about the Ryan

White Title III Early Intervention

Services Program. Participants will have

the opportunity to review the program

guidance and to receive technical

assistance pertaining to all aspects of

writing a Ryan White Title III HIV

Planning Grant application.

FOR FURTHER INFORMATION AND TO

REGISTER: Anyone interested in

attending this workshop must contact

Ms. Karin Martinsen, Professional and

Scientific Associates, Inc., 8180

Greensboro Drive, Suite 1050, McLean

VA 22102–3823 (phone: 703–442–9824).

Costs of attending the workshop are the

sole responsibility of the attendee.

There is a nominal registration fee of

$50 to cover the cost of materials, lunch

and refreshments.

For general information, contact the

HIV Primary Care Programs Branch,

Division of Programs for Special

Populations, Bureau of Primary Health

Care, 4350 East West Highway,

Bethesda, MD 20814 (telephone: 301–

594–4444).

Date, Time, and Location

Wednesday, April 9, 1997 (the due

date for the Ryan White Title III HIV

Planning Grant is May 1, 1997). 10:00

a.m.–5:00 p.m., St. Louis Airport

Marriot, St. Louis, Missouri, (314) 423–

9700.

The OMB Catalog of Federal Domestic

Assistance number for this program is

93.918.

Dated: March 26, 1997.

Claude Earl Fox,

Acting Administrator.

[FR Doc. 97–8167 Filed 3–31–97; 8:45 am]

BILLING CODE 4160–15–P

National Institutes of Health

National Institute of Child Health and

Human Development: Opportunity for

a Cooperative Research and

Development Agreement (CRADA) for

the Development of a Microbial Screen

for Anti-Virals Targeting PKR or

Inhibitors of PKR

AGENCY: National Institutes of Health,

Public Health Service, DHHS.

ACTION: Notice.

SUMMARY: The National Institutes of

Health is seeking one or more CRADA

partners for further development and

evaluation of a microbial screen in yeast

to identify anti-viral agents that target

regulators of and/or the PKR kinase. The

National Institute of Child Health and

Human Development has established a

system in yeast to identify and