55410 Federal Register / Vol. 62, No. 206 / Friday, October 24, 1997 / Notices

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Grassroots Regulatory Partnership

Workshop

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

The Food and Drug Administration

(FDA) (Office of Regulatory Affairs,

Nashville District Office and New

Orleans District Office), in conjunction

with the Health Industry Manufacturers

Association (HIMA) is announcing the

following workshop: Grassroots

Regulatory Partnership Workshop. The

topic to be discussed is FDA regulatory

requirements for the medical device

industry. The purpose of the workshop

is to promote open dialogue between

FDA and the medical device industry on

quality system regulations and medical

device reporting requirements.

Date and Time: The workshop will be

held on Tuesday, December 16, 1997,

from 8:30 a.m. to 5 p.m, and on

Wednesday, December 17, 1997, from 8

a.m. to 3 p.m.

Location: The meeting will be held at

the Holiday Inn Select–Vanderbilt, 2613

West End Ave., Nashville, TN 37203, 1–

800–633–4427.

Contact: Rebecca K. Keenan, Food

and Drug Administration (HFR–SE–

350), Nashville District Office, 297 Plus

Park Blvd., Nashville, TN 37217, 615–

781–5380, ext. 145, FAX 615–781–5391.

Registration: Fax registration

information (including name, title, firm

name, address, telephone, and fax

number) to the contact person by

November 20, 1997. There is no

registration fee for this workshop. Space

is limited, therefore interested parties

are encouraged to register early.

If you need special accommodations

due to a disability, please contact

Rebecca K. Keenan at least 7 days in

advance.

SUPPLEMENTARY INFORMATION: In 1995

President Clinton directed the heads of

all Federal regulatory agencies to carry

out a four step regulatory reinvention

initiative. The basic idea of the

President’s initiative was to replace

adversarial approaches with a

partnership approach based on clear

goals and cooperation. The President

specifically directed top management

from regulatory agencies to hold

‘‘grassroots’’ workshops with regulated

industry, and this workshop is designed

to meet that requirement.

Priority will be given to those

businesses located in the Nashville and

New Orleans Districts, which include

the States of: Alabama, Louisiana,

Mississippi, and Tennessee. Companies

located outside of these States may

register to attend the workshop and will

be accepted if space is available.

Dated: October 17, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–28170 Filed 10–23–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–1513]

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

AGENCY: Health Care Financing

Administration.

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, is publishing the

following summary of proposed

collections for public comment.

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.

Type of Information Collection

Request: Reinstatement, with change, of

a previously approved collection for

which approval has expired; Title of

Information Collection: Medicare/

Medicaid Disclosure of Ownership and

Control Interest Statement and

Supporting Regulations in 42 CFR

420.200–.206, 455.100–.106; Form No.:

HCFA–1513 (OMB# 0938–0086); Use:

The Medicare/Medicaid Disclosure of

Ownership and Control Interest

Statement must be used by State

agencies and HCFA regional offices to

determine whether providers meet the

eligibility requirements for Titles 18 and

19 (Medicare and Medicaid) and for

grants under Titles V and XX. Review of

ownership and control is particularly

necessary to prohibit ownership and

control for individuals excluded under

Federal fraud statutes; Frequency: Other

(every 1 to 3 years); Affected Public:

Business or other for-profit, and Not-forprofit institutions; Number of

Respondents: 92,000; Total Annual

Responses: 92,000; Total Annual Hours:

46,000.

To obtain copies of the supporting

statement and any related forms for the

proposed paperwork collections

referenced above, E-mail your request,

including your address, phone number,

OMB number, and HCFA document

identifier, 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 OMB desk officer: OMB Human

Resources and Housing Branch,

Attention: Allison Eydt, New Executive

Office Building, Room 10235,

Washington, D.C. 20503.

Dated: October 17, 1997.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA Office

of Information Services, Information

Technology Investment Management Group,

Division of HCFA Enterprise Standards.

[FR Doc. 97–28208 Filed 10–23–97; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Office of Inspector General

Criteria for Implementing Permissive

Exclusion Authority Under Section

1128(b)(7) of the Social Security Act

AGENCY: Office of Inspector General

(OIG), HHS.

ACTION: Notice.

SUMMARY: This notice sets forth a

proposed policy statement, in the form

of non-binding guidelines, to be used by

the OIG in assessing whether to impose

a permissive exclusion in accordance

with section 1128(b)(7) of the Social

Security Act. These guidelines identify

specific factors with regard to whether

an individual’s or entity’s continued

participation in the Medicare and other

Federal and State health care programs

will pose a risk to the programs or

program beneficiaries, and explain how

these factors would be used by the OIG

to assess a permissive exclusion

decision.

COMMENT PERIOD: Parties interested in

commenting on these guidelines may

submit their written comments to the