64066 Federal Register / Vol. 60, No. 239 / Wednesday, December 13, 1995 / Notices

Improvements Act of 1994, Pub. L. 103–

296, was enacted, establishing SSA as

an independent agency. As a result, the

Secretary of Health and Human Services

has decided to delegate to the Chair of

the Departmental Appeals Board the

authority to review ALJ decisions

concerning claims for payment under

Medicare Part A and B as well as ALJ

decisions concerning entitlement to

Medicare coverage. The delegation will

be effective October 1, 1995. All

Medicare cases pending before SSA’s

Appeals Council on September 30,

1995, will thereafter be the

responsibility of the Departmental

Appeals Board (DAB). Request for ALJ

hearings on claims for payment under

Parts A and B and requests for ALJ

hearings on entitlement to Medicare

coverage will continue to be decided by

the ALJs in SSA’s Office of Hearings and

Appeals.

Until the procedures are modified, the

DAB will conduct its review of ALJ

decisions under the existing regulations

governing appeals of Part A and B

claims. Therefore, in conducting its

review, the DAB will use the procedures

provided in the following authorities, as

applicable: 20 CFR Part 404, Subparts J

and R, 42 CFR Part 405, Subparts G and

H, 42 CFR Part 473, Subpart B

(concerning review of decisions on Part

A and B determinations made by peer

review organizations) and regulations in

42 CFR part 417 governing review of

decisions concerning Part A and B

claims submitted by enrollees of health

maintenance organizations, competitive

health plans and health care

prepayment plans. For the cases covered

by this delegation, where ever the term

‘‘Appeals Council’’ is used, the term

‘‘Departmental Appeals Board’’ should

be inserted.

The DAB, in cooperation with the

Health Care Financing Administration,

will review current procedures for

appropriate changes and improvements.

Interested parties may send comments

and suggestions to the DAB at the

following address: Departmental

Appeals Board, Department of Health &

Human Services, 200 Independence

Avenue, S.W., Room 637D, Washington,

DC 20201, or at the following e-mail

address: gbm@ospahb.ssw.dhhs.gov.

On October 13, 1993, I delegated to

the Departmental Appeals Board my

authority to make final decisions on

review of, or to decline to review,

decisions of Administrative Law Judges

involving, inter alia, provider

participation and termination under

section 1866(b)(2) of the Social Security

Act and the other authorities

enumerated in that delegation. See 58

Fed. Reg. 58171 (October 29, 1993). The

delegation to the Departmental Appeals

Board dated October 13, 1993,

superseded all previous delegations of

authority to review decisions by

Administrative Law Judges on the

referenced authorities, except that the

delegation provided that the Social

Security Administration, Office of

Hearings and Appeals, Appeals Council

continued to have the authority to

review, or to decline to review,

decisions in cases pending before it.

There are still five of those cases

pending; they are assigned to the same

specialized personnel who are

transferring to DAB to process the other

Medicare appeals being delegated in

this notice. Thus, notice is hereby given

that any case pending before SSA’s

Appeals Council on September 30, 1995

that concerns the authorities referenced

in the October 13, 1993 delegation will

be transferred to the Departmental

Appeals Board effective October 1,

1995.

Delegation of Authority

Notice is hereby given that I have

delegated to the Chair of the

Departmental Appeals Board my

authority to make final decisions on

review of, or to decline to review,

decisions of Administrative Law Judges

of the Office of Hearings and Appeals of

the Social Security Administration

involving Title XVIII, Parts A and B of

the Social Security Act, as provided

below:

1. The authority to make final

decisions on review of, or to decline to

review, decisions of Administrative Law

Judges involving determinations made

under section 1869 of the Social

Security Act concerning whether an

individual is entitled to benefits under

Part A or Part B, and concerning claims

for benefits under Parts A or B.

2. The authority to make final

decisions on review of, or to decline to

review, decisions of Administrative Law

Judges involving determinations made

under section 1876(c)(5) of the Social

Security Act, which affect an

individual’s right to receive items and

services, without additional cost, from a

health maintenance organization.

3. The authority to make final

decisions on review of, or to decline to

review, decisions of Administrative law

Judges involving determinations made

under section 1155 of the Social

Security Act.

I have also delegated to the Chair of

the Departmental Appeals Board the

authority to make final decisions on

review of, or to decline to review,

decisions of Administrative Law Judges

of the Office of Hearings and Appeals of

the Social Security Administration

involving, inter alia, provider

participation and termination under

section 1866(b)(2) of the Social Security

Act and the other authorities

enumerated in that delegation for any

cases pending before SSA’s Appeals

Council on September 30, 1995 that

concern the authorities referenced in my

October 13, 1993 delegation. See 58 Fed.

Reg. 58171 (October 29, 1993).

These delegations include, but are not

limited to, the authority to administer

oaths and affirmations, to subpoena

witnesses and documents, to examine

witnesses, to exclude or receive and

give appropriate weight to materials and

testimony offered as evidence, and to

make findings of fact and conclusions of

law. These delegations, which

supersede all previous delegations of

authority to make final decisions on

review of, or to decline to review,

decisions by Administrative Law Judges

on the above-referenced authorities, are

effective October 1, 1995. Accordingly,

all cases decided pursuant to the abovereferenced authorities that are pending

with the Appeals Council of the Office

of Hearing and Appeals, Social Security

Administration on September 30, 1995,

will thereafter be the responsibility of

the Chair of the Departmental Appeals

Board.

Dated: October 24, 1995.

Donna E. Shalala,

Secretary.

[FR Doc. 95–30282 Filed 12–12–95; 8:45 am]

BILLING CODE 4120–03–M

Food and Drug Administration

[Docket No. 95N–0363]

Medical Devices; Review of ComputerAided Diagnostic Software Devices;

Notice of Public Workshop

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of public workshop.

SUMMARY: The Food and Drug

Administration (FDA) is announcing a

public workshop to discuss the

appropriate approach to the review of

premarket submissions for computeraided diagnostic (CADx) medical

devices. Because there is increasing

interest in and development of CADx

medical devices, the agency is holding

this workshop to obtain public

comments and suggestions that may

help FDA develop device description

and assessment methodologies for

reviewer guidance for premarket

submissions for these CADx medical

devices.
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