Federal Register / Vol. 60, No. 239 / Wednesday, December 13, 1995 / Notices 64067

DATES: The workshop will be held on

January 26, 1996, from 9 a.m. to 4:30

p.m. Participants and other persons who

want to be heard must be present by 9

a.m. Submit written notices of

participation on or before January 15,

1996.

ADDRESSES: The workshop will be held

at the Parklawn Bldg., conference room

D, 5600 Fishers Lane, Rockville, MD.

Written comments, identified with the

docket number found in brackets in the

heading of this document, regarding

reviewer guidance for CADx devices

may be submitted to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Mary P. Anderson, Center for Devices

and Radiological Health (HFZ–142),

12720 Twinbrook Pkwy., Rockville, MD

20852, 301–443–5020 ext. 40, FAX 301–

443–9101.

Contact Mary Anderson (address

above) for a registration form for the

workshop. There is no registration fee

but advance registration is required.

Interested persons are encouraged to

register early because space is limited.

Persons with disabilities who require

special assistance to attend or

participate in the workshop can be

accommodated if advance notification is

provided. If you have a disability that

affects your attendance at, or

participation in, this meeting, please

contact Mary Anderson (address and

telephone number above), in writing

and identify your needs. The

availability of appropriate

accommodations cannot be assured

unless prior written notification is

provided.

SUPPLEMENTARY INFORMATION:

I. Background

FDA anticipates receiving increasing

numbers of premarket submissions for

CADx medical devices. Some of these

devices are accessories that analyze data

produced by diagnostic medical

devices, such as digital radiography

systems, and highlight possible findings

which assist the device user in

interpreting such data. An example of

such a device is an automated Pap

smear reader. In order to develop

reviewer guidance for appropriate

device description and assessment

methodologies in premarket

submissions for these devices, FDA has

established a computer-aided diagnostic

device working group. This working

group is in the process of evaluating the

agency’s approach to review of

premarket submissions for these

medical devices.

II. Purpose and Tentative Agenda of the

Workshop

The purpose of the public workshop

is to obtain suggestions that will help

FDA develop reviewer guidance for

device description and assessment

methodologies in premarket

submissions for CADx medical devices.

Presiding over the workshop will be:

David G. Brown, Chief Scientist, and

Mary P. Anderson, Chief of the Medical

Imaging and Computer Applications

Branch, Division of Electronics and

Computer Systems, Office of Science

and Technology, Center for Devices and

Radiological Health, FDA. They will be

assisted by other FDA officials.

FDA will open the workshop with a

summary of the present status of FDA

review of these devices. This

presentation will provide information

on the impetus, objectives, and scope of

the FDA’s activities in this area.

Following FDA’s presentation, a specific

period of time will be provided for

participants to make presentations.

Interested persons who wish to

participate in the public workshop may,

on or before January 15, 1996, submit a

written notice of participation to the

Dockets Management Branch (address

above) identified with the docket

number found in brackets in the

heading of this document, including

name, address, telephone number,

business affiliation, a brief summary of

the presentation, and an estimate of the

amount of the time required for

comments.

FDA requests that individuals or

groups having similar interests

consolidate their comments and present

them through a single representative.

FDA may require joint presentations by

persons with common interests. A

schedule of the allotted times will be

available at the workshop. Each

participant will be notified before the

workshop of the approximate time of

their presentation. The schedule will be

placed on file in the Dockets

Management Branch under the docket

number found in brackets in the

heading of this document. The

workshop will also include an

opportunity for interested persons who

did not submit a notice of participation

to make brief statements or comments,

if time permits. The workshop will then

proceed to a panel discussion of specific

issues to be considered in developing

FDA’s approach to the review of

premarket submissions for CADx

medical devices. The workshop is

informal, and the rules of evidence will

not apply. No participant may interrupt

the presentation of another participant.

Dated: November 28, 1995.

D. B. Burlington,

Director, Center for Devices and Radiological

Health.

[FR Doc. 95–30333 Filed 12–12–95; 8:45 am]

BILLING CODE 4160–01–F

Health Care Financing Administration

Public Information Collection

Requirements Submitted for Public

Comment and Recommendations

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, 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.

1. Type of Information Collection

Request: Reinstatement, with change, of

a previously approved collection for

which approval has expired.

Title of Information Collection: Request

for Medicare Payment-Ambulance.

Form No.: HCFA–1491.

Use: This form is completed on an

‘‘occasional’’ basis by beneficiaries and/

or ambulance services. It is also

submitted to a Medicare carrier to

request payment for ambulance services.

Frequency: On occasion.

Affected Public: Individuals or

households, business or other for-profit,

not-for-profit institutions.

Number of Respondents: 8,513,300.

Total Annual Hours Requested:

1,418,883.

To request copies of the proposed

paperwork collections referenced above,

E-mail your request, including your

address, to Paperwork@hcfa.gov, or call

the Reports Clearance Office on (410)

786–1326. Written comments and

recommendations for the proposed

information collections should be sent
64068 Federal Register / Vol. 60, No. 239 / Wednesday, December 13, 1995 / Notices

within 30 days of this notice directly to

the OMB Desk 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: December 5, 1995.

Kathleen B. Larson,

Director, Management Planning and Analysis

Staff, Office of Financial and Human

Resources, Health Care Financing

Administration.

[FR Doc. 95–30393 Filed 12–12–95; 8:45 am]

BILLING CODE 4120–03–P

Public Information Collection

Requirements Submitted for Public

Comment and Recommendations

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, has submitted to the

Office of Management and Budget

(OMB) the following proposals for the

collection of information. 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 Request: Revision of a

currently approved collection.

Title of Information Collection: Annual

Report on Home and Community-Based

Waivers.

Form No.: HCFA–372, HCFA–372(S).

Use: States with an approved waiver

under section 1915 of the Social

Security Act are required to submit the

HCFA–372 or HCFA–372(S) annually in

order for HCFA to: (1) verify that State

assurances regarding waiver cost

neutrality are met, and (2) determine the

waiver’s impact on the type, amount,

and cost of services provided under the

State plan and health and welfare of

recipients.

Frequency: Annually.

Affected Public: State, local, or tribal

government.

Number of Respondents: 49.

Total Annual Hours: 18,000.

To request copies of the proposed

paperwork collection referenced above,

E-mail your request, including your

address, to Paperwork@hcfa.gov, or call

the Reports Clearance Office on (410)

786–1326. Written comments and

recommendations for the proposed

information collections should be sent

within 30 days of this notice directly to

the OMB Desk 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: December 4, 1995.

Kathleen B. Larson,

Director, Management Planning and Analysis

Staff, Office of Financial and Human

Resources, Health Care Financing

Administration.

[FR Doc. 95–30290 Filed 12–12–95; 8:45 am]

BILLING CODE 4120–03–P

Health Resources and Services

Administration

Request for Nominations to the

National Advisory Committee on Rural

Health; Extension of Closing Date

AGENCY: Health Resources and Services

Administration, HHS.

ACTION: Extension of Closing Date.

SUMMARY: The Health Resources and

Services Administration is requesting

nominations to fill five vacancies on the

Secretary’s National Advisory

Committee on Rural Health. The closing

date is extended to February 2, 1996. All

other aspects of the November 7, 1995

Federal Register Notice (60 FR 62254)

remain the same.

ADDRESSES: Nominations and curricula

vitae of nominees should be sent to

Dena S. Puskin, SC.D., Executive

Secretary to the National Advisory

Committee on Rural Health, Room 9–05,

5600 Fishers Lane, Rockville, MD

20857.

Dated: December 7, 1995.

Ciro V. Sumaya,

Administrator.

[FR Doc. 95–30338 Filed 12–12–95; 8:45 am]

BILLING CODE 4160–15–P

Funding Notice for Grant Programs

Funded Under Title VIII of the Public

Health Service Act for Fiscal Year

1996; Notice of Extension of

Application Due Date

This notice extends the application

due date for fiscal year (FY) 1996 grant

program for Nursing Education

Opportunities for Individuals from

Disadvantaged Backgrounds (section

827). The application due date is

extended to January 12, 1996. All

applications must be received in the

Parklawn Building by close of business

on January 12, 1996. This change is

necessary because of difficulties

experienced with electronically

accessing the program materials and

unexpected delays in mailing. All other

aspects of the October 20, 1995 Federal

Register Notice (60 FR 54243) remain

the same.

Dated: December 7, 1995.

Ciro V. Sumaya,

Administrator.

[FR Doc. 95–30337 Filed 12–12–95; 8:45 am]

BILLING CODE 4160–15–M

Public Health Service

National Institutes of Health; Proposed

Data Collection Available for Public

Comment

In compliance with the requirement

of Section 3506(c)(2)(A) of the

Paperwork Reduction Action of 1995 for

opportunity for public comment on

proposed data collection projects, the

National Institutes of Health (NIH).

National Cancer Institute (NCI) will

publish periodic summaries of proposed

projects. To request more information

on the proposed project, call Ruth A.

Kleinerman, M.P.H., Epidemiologist, at

(301) 496–6600.

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. Send comments to Ruth A.

Kleinerman, M.P.H., National Cancer

Institute. EPN 408, 6130 Executive

Boulevard, Rockville, MD 20892–7364.

Written comments should be received

by [Federal Register insert the date 60

days following the date of publication].

Proposed Project: Cancer Risk in Xray Technologists: Second Survey for

Incidence—renewal—A cohort study

will be conducted to quantify the risk of

radiation-induced cancer among

135,000 registered x-ray technologists.

X-ray technologists will be asked to

respond to a mail questionnaire which

collects information about incident