Federal Register / Vol. 61, No. 101 / Thursday, May 23, 1996 / Notices 25883

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 in

August 1996. Biological product

companies may submit review requests

for the August meeting by June 28, 1996.

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–4), 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. FDA regulations in § 312.42

describe 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 (61 FR 1033, January 11, 1996).

CBER held its first clinical hold review

committee meeting on May 17, 1995. It

will meet quarterly or semiannually.

The committee last met in May 1996.

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,

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 review 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 August 1996 meeting.

Submissions should be made by June 1,

1996, to Amanda B. Pedersen, FDA

Chief Mediator and Ombudsman

(address above).

Dated: May 17, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–13042 Filed 5–22–96; 8:45 am]

BILLING CODE 4160–01–F

Health Care Financing Administration

[HCFA 301]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

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: Certification of

Medicaid Eligibility Quality Control

(MEQC) Payment Error Rates; Form No.:

HCFA–301; Use: This certification is the

new form by which States will report

their MEQC payment error rate findings.

This form represents aggregate data

which were formerly collected through

the Integrated Review Schedule;

Frequency: Semi-annually; Affected

Public: State, local, or tribal

government; Number of Respondents:
25884 Federal Register / Vol. 61, No. 101 / Thursday, May 23, 1996 / Notices

51; Total Annual Responses: 102; Total

Annual Hours: 22,515.

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 60 days of this notice directly to

the HCFA Paperwork Clearance Officer

designated at the following address:

HCFA, Office of Financial and Human

Resources, Management Planning and

Analysis Staff, Attention: Linda

Mansfield, Room C2–26–17, 7500

Security Boulevard, Baltimore,

Maryland 21244–1850.

Dated: May 16, 1996.

Kathleen B. Larson,

Director, Management Planning and Analysis

Staff, Office of Financial and Human

Resources, Health Care Financing

Administration.

[FR Doc. 96–12961 Filed 5–22–96; 8:45 am]

BILLING CODE 4120–03–M

National Institutes of Health

Submission for OMB Review;

Comment Request; ‘‘Screen for

Alcohol Problems in the Elderly’’ Study

SUMMARY: Under the provisions of

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

Reduction Act of 1995, the National

Institute on Alcohol Abuse and

Alcoholism (NIAAA), National

Institutes of Health (NIH) has submitted

to the Office of Management and Budget

(OMB) a request to review and approve

the information collection listed below.

This proposed information collection

was previously in the Federal Register

on February 27, 1996, and allowed 60

days for public comment. There were

seven (7) requests for additional

information about this data collection

activity, but no public comments were

received. The purpose of this notice is

to allow an additional 30 days for public

comment.

The NIH may not conduct or sponsor,

and the respondent is not required to

respond to, an information collection

that has been extended, revised, or

implemented on or after September 28,

1997, unless it displays a currently valid

OMB control number.

PROPOSED COLLECTION: Title: Screening

for Alcohol Problems in the Elderly.

Type of Information Collection request:

NEW. Need and Use of Information

Collection: The information proposed

for collection will be used by the

NIAAA to develop an alcohol problem

screening instrument suitable for use

with the population age 65 and over and

that can be administered in health care

settings. The prevalence of alcohol

problems among older persons is not

well established. The instruments used

for assessment are often not sensitive to

alcohol abuse and dependence in this

population, and many alcohol-related

problems go undetected.

Frequency of Response: On occasion.

Affected Public: Individuals and small

businesses. Type of Respondents: The

elderly (65 and older) and physicians.

Estimated Number of Respondents: 636.

Estimated Number of Responses per

Respondent: 1. Average Burden Hours

per Response: .281. And Estimated

Total Annual Burden Hours Requested:

89.2. There are no Capital Costs to

report. There are no Operating or

Maintenance Costs to report.

The annual burden estimates are as

follows:

Type and number of respondents

Responses

per respondent

Total responses Hours Total hours

Patients/500 .................................................................................................................... 1 500 .3340 167

Physicians/136 ................................................................................................................ 1 136 .0835 11.4

Total Number of Respondents: 636 (318 per year).

Total Number of Responses: 636 (318 per year).

Total Hours: 178.4 (89.2 per year).

REQUEST FOR COMMENTS: Comments are

invited on: (a) whether the proposed

collection is necessary, including

whether the information has practical

use; (b) ways to enhance the clarity,

quality, and use of the information to be

collected; (c) the accuracy of the agency

estimate of burden of the proposed

collection; and (d) ways to minimize the

collection burden of the respondents.

Send written comments to Dr. Gayle

Boyd, Prevention Research Branch,

Division of Clinical and Prevention

Research (CPR), NIAAA, NIH, Willco

Building 6000, Room 505, 6000

Executive Boulevard, Bethesda,

Maryland 20892–7003.

DIRECT COMMENTS TO OMB: Written

comments and/or suggestions regarding

the item(s) contained in this notice,

especially regarding the estimated

public burden and associated response

time should be directed to the Office of

Management and Budget, Office of

Regulatory Affairs, New Executive

Office Building, Room 10235,

Washington, D.C. 20503, Attention:

Desk Officer for NIH.

FOR FURTHER INFORMATION CONTACT: To

request more information on the

proposed project or to obtain a copy of

the data collection plans, contact Dr.

Gayle Boyd, Prevention Research

Branch, Division of Clinical and

Prevention Research (CPR), NIAAA,

NIH, 6000 Willco Building, Room 505,

6000 Executive Boulevard, Bethesda,

Maryland 20892–7003, or call non-tollfree number (301) 443–8766.

COMMENTS DUE DATE: Comments

regarding this information collection are

best assured of having their full effect if

received on or before June 24, 1996.

Dated: May 10, 1996.

Martin K. Trusty,

Executive Officer, NIAAA.

[FR Doc. 96–12932 Filed 5–22–96; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

Information Collection for Renewal

AGENCY: Fish and Wildlife Service,

Interior.

ACTION: Notice.

SUMMARY: This notice announces that

the Fish and Wildlife Services (Service)

is planning to submit the collection of

information requirement described

below to the Office of Management and

Budget (OMB) for continuing approval

under the provisions of the Paperwork

Reduction Act. Copies of the

information collection requirement and

related forms and explanatory material

may be obtained by contacting the

Service’s clearance officer at the phone

number listed below. The Service is

soliciting comments and suggestions on

the requirement as described below.

DATES: Comments must be submitted on

or before July 22, 1996.