Federal Register / Vol. 62, No. 52 / Tuesday, March 18, 1997 / Notices 12833

draft ‘‘Immunotoxicity Testing

Framework’’ to deal specifically with

testing for adverse effects of medical

devices or constituent materials on the

immune system. The draft guidance will

provide medical device manufacturers

with FDA’s current thinking on

immunotoxicity testing, and it will help

to ensure a consistent and scientifically

sound approach to the overall

evaluation of product safety.

The draft guidance also contains a

flow chart to determine if

immunotoxicity testing is

recommended, and three tables that lead

sequentially from potential

immunological effects, to potential

responses commonly associated with

those effects, to examples of testing that

might be considered as part of the

overall safety evaluation of finished

devices or constituent materials.

In the past, guidances generally have

been issued under § 10.90(b) (21 CFR

10.90(b)), which provides for the use of

guidances to state procedures or

standards of general applicability that

are not legal requirements, but that are

acceptable to FDA. This guidance

represents FDA’s current thinking on

the issue of immunotoxicity testing for

medical devices and constituent

materials. It does not create or confer

any rights for or on any person and does

not operate to bind FDA or the public.

An alternative approach may be used if

such approach satisfies the

requirements of the applicable statute,

regulations, or both.

II. Request for Comments

Interested persons may, on or before

June 16, 1997, submit to the Dockets

Management Branch (address above)

written comments regarding the draft

guidance. Two copies of any comments

are to be submitted, except that

individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. The draft

guidance and received comments may

be seen in the office above between 9

a.m. and 4 p.m., Monday through

Friday.

Received comments will be

considered in determining whether to

amend the current draft guidance

document.

Dated: March 6, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–6715 Filed 3–17–97; 8:45 am]

BILLING CODE 4160–01–F

Investigational Biological Product

Trials; Procedure to Monitor Clinical

Hold Process; Meeting of Oversight

Committee and Request for

Submissions

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing a

meeting of its clinical hold oversight

committee, which reviews the clinical

hold orders that the Center for Biologics

Evaluation and Research (CBER) has

placed on certain investigational

biological product trials. FDA is inviting

any interested biological product

company to use this confidential

mechanism to submit to the committee

for its review the name and number of

any investigational biological product

trial placed on clinical hold during the

past 12 months that the company wants

the committee to review.

DATES: The meeting will be held on May

13, 1997. Biological product companies

may submit review requests for the May

meeting by April 4, 1997.

ADDRESSES: Submit clinical hold review

requests to Amanda Bryce Norton, FDA

Chief Mediator and Ombudsman, Office

of the Commissioner (HF–7), Food and

Drug Administration, 5600 Fishers

Lane, rm. 14–105, Rockville, MD 20857,

301–827–3390.

FOR FURTHER INFORMATION CONTACT: Joy

A. Cavagnaro, Center for Biologics

Evaluation and Research (HFM–5), Food

and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–827–0379.

SUPPLEMENTARY INFORMATION: FDA

regulations in part 312 (21 CFR part

312) provide procedures that govern the

use of investigational new drugs and

biologics in human subjects. If FDA

determines that a proposed or ongoing

study may pose significant risks for

human subjects or is otherwise seriously

deficient, as discussed in the

investigational new drug regulations, it

may order a clinical hold on the study.

The clinical hold is one of FDA’s

primary mechanisms for protecting

subjects who are involved in

investigational new drug or biologic

trials. Section 312.42 describes the

grounds for ordering a clinical hold.

A clinical hold is an order that FDA

issues to a sponsor to delay a proposed

investigation or to suspend an ongoing

investigation. The clinical hold may be

ordered on one or more of the

investigations covered by an

investigational new drug application

(IND). When a proposed study is placed

on clinical hold, subjects may not be

given the investigational drug or

biologic as part of that study. When an

ongoing study is placed on clinical

hold, no new subjects may be recruited

to the study and placed on the

investigational drug or biologic, and

patients already in the study should

stop receiving therapy involving the

investigational drug or biologic unless

FDA specifically permits it.

When FDA concludes that there is a

deficiency in a proposed or ongoing

clinical trial that may be grounds for

ordering a clinical hold, ordinarily FDA

will attempt to resolve the matter

through informal discussions with the

sponsor. If that attempt is unsuccessful,

a clinical hold may be ordered by or on

behalf of the director of the division that

is responsible for the review of the IND.

FDA regulations in § 312.48 provide

dispute resolution mechanisms through

which sponsors may request

reconsideration of clinical hold orders.

The regulations encourage the sponsor

to attempt to resolve disputes directly

with the review staff responsible for the

review of the IND. If necessary, the

sponsor may request a meeting with the

review staff and management to discuss

the clinical hold.

CBER began a process to evaluate the

consistency and fairness of practices in

ordering clinical holds by instituting a

review committee to review clinical

holds (see 61 FR 1033, January 11,

1996). CBER held its first clinical hold

oversight committee meeting on May 17,

1995, and plans to conduct further

quality assurance oversight of the IND

process. The committee last met in

February 1997. The review procedure of

the committee is designed to afford an

opportunity for a sponsor who does not

wish to seek formal reconsideration of a

pending clinical hold to have that

clinical hold considered

‘‘anonymously.’’ The committee

consists of senior managers of CBER, a

senior official from the Center for Drug

Evaluation and Research, and the FDA

Chief Mediator and Ombudsman.

Clinical holds to be reviewed will be

chosen randomly. In addition, the

committee will review some of the

clinical holds proposed for review by

biological product sponsors. In general,

a biological product sponsor should

consider requesting review when it

disagrees with FDA’s scientific or

procedural basis for the decision.

Requests for committee review of a

clinical hold should be submitted to the

FDA Chief Mediator and Ombudsman,

who is responsible for selecting clinical

holds for review. The committee and

CBER staff, with the exception of the

FDA Chief Mediator and Ombudsman,
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