12834 Federal Register / Vol. 62, No. 52 / Tuesday, March 18, 1997 / Notices

are never advised, either in the review

process or thereafter, which of the

clinical holds were randomly chosen

and which were submitted by sponsors.

The committee will evaluate the

selected clinical holds for scientific

content and consistency with FDA

regulations and CBER policy.

The meetings of the oversight

committee are closed to the public

because committee discussions deal

with confidential commercial

information. Summaries of the

committee deliberations, excluding

confidential commercial information,

may be requested in writing from the

Freedom of Information Office (HFI–35),

Food and Drug Administration, 5600

Fishers Lane, rm. 12A–16, Rockville,

MD 20857, approximately 15 working

days after the meeting, at a cost of 10

cents per page. If the status of a clinical

hold changes following the committee’s

review, the appropriate division will

notify the sponsor.

FDA invites biological product

companies to submit to the FDA Chief

Mediator and Ombudsman the name

and IND number of any investigational

biological product trial that was placed

on clinical hold during the past 12

months that they want the committee to

review at its May 13, 1997, meeting.

Submissions should be made by April 4,

1997, to Amanda Bryce Norton, FDA

Chief Mediator and Ombudsman

(address above).

Dated: March 5, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–6779 Filed 3–17–97; 8:45 am]

BILLING CODE 4160–01–F

Health Care Financing Administration,

HHS

Submitted for Collection of Public

Comment: Submission for OMB

Review (HCFA–R–4)

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: Extension of a

currently approved collection; Title of

Information Collection: Information

Collection Requirements contained in

42 CFR 447.253; Form No.: HCFA–R–4;

Use: The Medicaid Management

Information System (MMIS) is a Stateoperated, Federally mandated computer

system used for automated Medicaid

claims processing and information

retrieval for program management. Data

elements represent the Federally

imposed recordkeeping requirements of

MMIS; Frequency: Annually; Affected

Public: Business or other for profit;

State, local, or tribal government;

Number of Respondents: 50; Total

Annual Responses: 50; Total Annual

Hours: 2,298,250.

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 HCFA Paperwork Clearance 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: March 5, 1997.

Edwin J. Glatzel,

Director, Management Analysis and Planning

Staff, Office of Financial and Human

Resources, Health Care Financing

Administration.

[FR Doc. 97–6789 Filed 3–17–97; 8:45 am]

BILLING CODE 4120–03–P

[Document Identifier: HCFA-R–201]

Correction Notice: Agency Information

Collection Activities: Submission for

Emergency OMB Review; Comment

Request

AGENCY: Health Care Financing

Administration, HHS.

In compliance with the Paperwork

Reduction Act of 1995 (44 U.S.C. 3501

et seq.), 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 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: New collection; Title of

Information Collection: Managed Care

Organization, Incentive Arrangement

Disclosure Form and Supporting

Regulations 42 CFR 417.479, 417.500,

434.44, 434.67, 434.70, 1003.100,

1003.101, 1003.103, 1003.106; Form

No.: HCFA–R–201; Use: Final rule

OMC–10, published in the Federal

Register on 12/31/96, disclosed to the

public that the information collection

requirements referenced in OMC–10-F,

would be submitted to OMB for

emergency review upon publication of

the rule. However, Section V of final

rule OMC–10 neglected to denote that

the forms used to capture the

information collection requirements

referenced in OMC–10 would also be

submitted to OMB as part of the

emergency review. These forms which

will be used to demonstrate and monitor

compliance with statute governing

physician incentives under Medicare

and Medicaid managed care

organizations, were created in an

extensive cooperative effort with the

American Association of Health Plans,

State Medicaid Agency representatives,

and the Medicaid Managed Care

Technical Advisory group. Therefore,

we are correcting this oversight and are

requesting comment on the forms and

supporting regulations. These forms are

available for inspection on the HCFA

website, on the Internet, at http://

www.hcfa.gov; Frequency: Annually;

Affected Public: Business or other for

profit, not for profit institutions, state,

local or tribal government, and federal

government; Number of Respondents:

450; Total Annual Responses: 450; Total

Annual Hours: 45,000.

To obtain copies of the supporting

statement and any related forms, E-mail

your request, including your address

and phone number, to

Paperwork@hcfa.gov, or call the Reports

Clearance Office on (410) 786–1326.

Written comments and

recommendations for the proposed

information collection should be sent

within 5 days of this notice directly to