Federal Register / Vol. 62, No. 240 / Monday, December 15, 1997 / Notices 65707

available from the Commission’s Public Reference

Branch, H–130, 600 Pennsylvania Avenue, N.W.,

Washington, D.C. 20580.

1Copies of the Complaint and the Decision and

Order are available from the Commission’s Public

Reference Branch, H–130, 600 Pennsylvania

Avenue, NW., Washington, DC 20580.

1Copies of the Complaint and the Decision and

Order are available from the Commission’s Public

Reference Branch, H–130, 600 Pennsylvania

Avenue, NW., Washington, DC 20580.

FOR FURTHER INFORMATION CONTACT:

Howard Morse or William Baer, FTC/H–

394, Washington, D.C. 20580. (202) 326–

2949 or 326–2932.

SUPPLEMENTARY INFORMATION: On Friday,

January 3, 1997, there was published in

the Federal Register, 62 FR 409, a

proposed consent agreement with

analysis In the Matter of Ciba-Geigy

Limited, et al., for the purpose of

soliciting public comment. Interested

parties were given sixty (60) days in

which to submit comments, suggestions

or objections regarding the proposed

form of the order.

No comments having been received,

the Commission has ordered the

issuance of the complaint in the form

contemplated by the agreement, made

its jurisdictional findings and entered

an order to divest, as set forth in the

proposed consent agreement,

indisposition of this proceeding.

(Sec. 6, 38 Stat. 721; 15 U.S.C. 46. Interpret

or apply sec. 5, 38 Stat. 719, as amended; sec.

7, 38 Stat. 731, as amended; 15 .S.C. 45, 18)

Benjamin I. Berman,

Acting Secretary.

[FR Doc. 97–32635 Filed 12–12–97; 8:45 am]

BILLING CODE 6750–01–M

FEDERAL TRADE COMMISSION

[Dkt. C–3727]

Jeanette L. Douglas Co.; Prohibited

Trade Practices, and Affirmative

Corrective Actions

AGENCY: Federal Trade Commission.

ACTION: Consent Order.

SUMMARY: In settlement of alleged

violations of federal law prohibiting

unfair or deceptive acts or practices and

unfair methods of competition, this

consent order prohibits, among other

things, Jeanette L. Douglas, an officer of

Computer Business Services, Inc.

(‘‘CBSI’’), from misrepresenting the

earnings or success rate of CBSI

investors; the existence of a market for

CBSI’s products or services; the amount

of time it takes investors to recoup their

investments; and from making any

representation regarding the

performance, benefits, efficacy or

success rate of any product or service

unless she possesses reliable evidence

to substantiate the claims. The consent

order also prohibits the use of

misleading testimonials or

endorsements and requires certain

disclosures to investors.

DATES: Complaint and Order issued

March 24, 1997.1

FOR FURTHER INFORMATION CONTACT:

C. Steven Baker or Catherine Fuller,

Federal Trade Commission, Chicago

Regional Office, 55 East Monroe St.,

Suite 1860, Chicago, IL 60603. (312)

353–8156 or (312) 353–5576.

SUPPLEMENTARY INFORMATION: On Friday,

January 17, 1997, there was published

in the Federal Register, 62 FR 2671, a

proposed consent agreement with

analysis In the Matter of Jeanette L.

Douglas Co., for the purpose of

soliciting public comment. Interested

parties were given sixty (60) days in

which to submit comments, suggestions

or objections regarding the proposed

form of the order.

No comments having been received,

the Commission has ordered the

issuance of the complaint in the form

contemplated by the agreement, made

its jurisdictional findings and entered

an order to cease and desist, as set forth

in the proposed consent agreement, in

disposition of this proceeding.

(Sec. 6, 38 Stat. 721; 15 U.S.C. 46. Interprets

or applies sec. 5, 38 Stat. 719, as amended;

15 U.S.C. 45)

Benjamin I. Berman,

Acting Secretary.

[FR Doc. 97–32637 Filed 12–12–97; 8:45 am]

BILLING CODE 6750–01–M

FEDERAL TRADE COMMISSION

[Dkt. C–3728]

Phillips Petroleum Company;

Prohibited Trade Practices, and

Affirmative Corrective Actions

AGENCY: Federal Trade Commission.

ACTION: Consent order.

SUMMARY: In settlement of alleged

violations of federal law prohibiting

unfair or deceptive acts or practices and

unfair methods of competition, this

consent order requires, among other

things, the Oklahoma-based corporation

to divest approximately 160 miles of

pipeline belonging to ANR Pipeline

Company and Phillips in the Anadarko

Basin area, and to maintain the assets in

their current condition and to provide

customers under the contract with ANR

with gathering services at existing terms

and conditions pending divestiture. The

consent order also requires Phillips, for

ten years, to notify the Commission

before acquiring during any 18-month

period more than five miles of gas

gathering pipelines in the specified

areas of the Oklahoma counties.

DATES: Complaint and Order issued

March 28, 1997.1

FOR FURTHER INFORMATION CONTACT:

George Cary, FTC/H–374, Washington,

DC 20580. (202) 326–3741.

SUPPLEMENTARY INFORMATION: On Friday,

January 10, 1997, there was published

in the Federal Register, 62 FR 1459, a

proposed consent agreement with

analysis In the Matter of Phillips

Petroleum Company, for the purpose of

soliciting public comment. Interested

parties were given sixty (60) days in

which to submit comments, suggestions

or objections regarding the proposed

form of the order.

No comments have been received, the

Commission has ordered the issuance of

the complaint in the form contemplated

by the agreement, made its

jurisdictional findings and entered an

order to divest, as set forth in the

proposed consent agreement, in

disposition of this proceeding.

(Sec. 6, 38 Stat. 721; 15 U.S.C. 46. Interpret

or apply sec. 5, 38 Stat. 719, as amended; sec.

7, 38 Stat. 731, as amended; 15 U.S.C. 45, 18)

Benjamin I. Berman,

Acting Secretary.

[FR Doc. 97–32638 Filed 12–12–97; 8:45 am]

BILLING CODE 6750–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Agency for Toxic Substances and

Disease Registry; Senior Executive

Service; Performance Review Board

Members

AGENCY: Centers for Disease Control and

Prevention (CDC), and Agency for Toxic

Substances and Disease Registry

(ATSDR), Department of Health and

Human Services.

ACTION: Notice.

SUMMARY: Title 5, U.S. Code, Section

4314(c)(4) of the Civil Service Reform

Act of 1978, Pub. L. 95–454, requires

that appointment of Performance

Review Board members be published in

the Federal Register.

FOR FURTHER INFORMATION CONTACT:

Connie Clayton, Human Resources

Management Office, Office of Program

Support, Centers for Disease Control

and Prevention, 4770 Buford Highway,
65708 Federal Register / Vol. 62, No. 240 / Monday, December 15, 1997 / Notices

Mailstop K–07, Atlanta, Georgia 30341–

3724, telephone 770–488–1874.

SUPPLEMENTARY INFORMATION: The

following persons will serve on the

Performance Review Board which

oversees the evaluation of performance

appraisals of Senior Executive Service

members of the Department of Health

and Human Services in the Centers for

Disease Control and Prevention, and the

Agency for Toxic Substances and

Disease Registry:

Claire V. Broome, M.D., Chairperson

Helene D. Gayle, M.D., M.P.H.

James M. Hughes, M.D.

Arthur C. Jackson

Richard J. Jackson, M.D., M.P.H.

Wanda K. Jones, Dr.P.H.

James S. Marks, M.D., M.P.H.

Peter J. McCumiskey

Linda Rosenstock, M.D., M.P.H.

Dated: December 8, 1997.

Claire Broome,

Deputy Director, Centers for Disease Control

and Prevention (CDC) and Deputy

Administrator, Agency for Toxic Substances

and Disease Registry (ATSDR).

[FR Doc. 97–32589 Filed 12–12–97; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

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 the

1998 meetings 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.

For each meeting, 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 next meetings will be held

on February 10, 1998; May 12, 1998;

August 11, 1998; and November 10,

1998. Biological product companies

may submit review requests for the

February meeting by January 12, 1998;

for the May meeting by March 31, 1998;

for the August meeting by June 30, 1998;

and for the November meeting by

September 29, 1998.

ADDRESSES: Submit clinical hold review

requests to Amanda Bryce Norton, FDA

Chief Mediator and Ombudsman, Office

of the Commissioner (HF–7), 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. 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 an

oversight committee to review clinical

holds (see 61 FR 1031 at 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 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 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 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.

For each meeting, FDA invites

biological product companies to submit

to the FDA Chief Mediator and