Federal Register / Vol. 62, No. 43 / Wednesday, March 5, 1997 / Notices 10059

assets in the hands of Schering-Plough

are sufficient to replace the lost

competition that would result from the

acquisition.

Public comments regarding all aspects

of the proposed divestiture to ScheringPlough will be considered with other

comments on the proposed Order.

Under the proposed Order, if

Schering-Plough ceases to sell contract

manufactured canine lyme, canine

corona virus combination and feline

leukemia combination vaccines prior to

obtaining USDA certification, abandons

its efforts to obtain USDA approval, or

fails to obtain timely USDA approval, or

in the event AHP fails to divest the

assets absolutely and in good faith, the

Commission may terminate the

divestiture agreement and appoint a

trustee to divest Solvay’s canine lyme

vaccine, canine corona virus

combination vaccines, and feline

leukemia combination vaccines, as well

as Solvay’s Charles City Facility and

equine vaccines. The crown jewel

provision also includes, at AHP’s

discretion, a supply contract for a term

not to exceed (3) three years from the

date of the divestiture, which requires

the new acquirer to supply AHP (i) any

swine or poultry vaccines for sale

worldwide, (ii) any canine lyme

vaccine, canine corona virus

combination vaccines and feline

leukemia combination vaccines for sale

by AHP outside the United States and

Canada and (iii) single antigen rabies

vaccine and feline leukemia

combination vaccine with rabies for sale

worldwide being produced at the

Charles City Facility at the time of

divestiture, priced at each vaccine’s

average total cost. This crown jewel

provision will ensure that a trustee can

divest a package of assets that is

sufficiently attractive to potential

buyers.

Under the provisions of the proposed

Order, AHP is also required to provide

the Commission with a report of

compliance with the divestiture

provisions of the Order within sixty (60)

days following the date this Order

becomes final, and every ninety (90)

days thereafter until AHP has fully

complied with the divestiture

provisions of the proposed Order.

The purpose of this analysis is to

facilitate public comment on the

proposed Order, and it is not intended

to constitute an official interpretation of

the agreement and proposed Order or to

modify in any way their terms.

Donald S. Clark,

Secretary.

Concurring Statement of Commissioner

Mary L. Azcuenaga in American Home

Products Corp., File No. 971–0009

I concur in the decision to accept the

consent agreement for public comment

and write separately to invite comment

on whether and when the Commission

should require the firm divesting assets

to give up patent rights beyond those

acquired in the transaction at issue.

Paragraph IID of the proposed order

requires American Home Products

(AHP) not only to license the

intellectual property that is acquired

from Solvay S.A., but also to agree not

to sue the acquiring firm for

infringement of vaccine patents that

AHP owned before the acquisition. The

firm purchasing the divested assets will

obtain Solvay’s intellectual property

free and clear of any claim that the

Solvay vaccines infringe AHP’s patents.

Should the Commission resolve the

patent dispute regarding whether

Solvay’s vaccines infringed AHP’s

patents, and if so, how should such a

dispute be resolved?

[FR Doc. 97–5343 Filed 3–4–97; 8:45 am]

BILLING CODE 6750–01–M

[File No. 942–3341]

Schering-Plough Healthcare Products,

Inc.; Analysis To Aid Public Comment

AGENCY: Federal Trade Commission.

ACTION: Proposed consent agreement.

SUMMARY: In settlement of alleged

violations of federal law prohibiting

unfair or deceptive acts or practices and

unfair methods of competition, this

consent agreement, accepted subject to

final Commission approval, would

prohibit, among other things, the

marketer of Coppertone Kids sunscreens

for children from making deceptive

claims about the effectiveness of

sunscreens marketed for use on

children. The agreement will also

require that the company produce and

distribute 150,000 consumer education

brochures to alert parents to the

importance of sunscreen protection for

children and the need to reapply

sunscreens after toweling or sustained

vigorous activity. The complaint

accompanying the consent agreement

alleges that Schering’s ads for

Coppertone Kids 6-Hour Waterproof

Sunblock make unsubstantiated claims

that one application of Coppertone Kids

provides six hours of protection from

the sun for children engaged in

sustained vigorous activity in and out of

the water.

DATES: Comments must be received on

or before May 5, 1997.

ADDRESSES: Comments should be

directed to: FTC/Office of the Secretary,

Room 159, 6th St. and Pa. Ave., N.W.,

Washington, D.C. 20580.

FOR FURTHER INFORMATION CONTACT:

Joel Winston, Federal Trade

Commission, S–4002, 6th St. and Pa.

Ave., N.W., Washington, D.C. 20580.

(202) 326–3153; Toby Milgrom Levin,

Federal Trade Commission, S–4002, 6th

St. and Pa. Ave., N.W., Washington,

D.C. 20580. (202) 326–3156.

SUPPLEMENTARY INFORMATION: Pursuant

to Section 6(f) of the Federal Trade

Commission Act, 38 Stat. 721, 15 U.S.C.

46, and Section 2.34 of the

Commission’s Rules of Practice (16 CFR

2.34), notice is hereby given that the

above-captioned consent agreement

containing a consent order to cease and

desist, having been filed with and

accepted, subject to final approval, by

the Commission, has been placed on the

public record for a period of sixty (60)

days. The following Analysis to Aid

Public Comment describes the terms of

the consent agreement, and the

allegations in the accompanying

complaint. An electronic copy of the

full text of the consent agreement

package can be obtained from the

Commission Actions section of the FTC

Home Page (for February 18, 1997), on

the World Wide Web, at ‘‘http://

www.ftc.gov/os/actions/htm.’’ A paper

copy can be obtained from the FTC

Public Reference Room, Room H–130,

Sixth Street and Pennsylvania Avenue,

N.W., Washington, D.C. 20580, either in

person or by calling (202) 326–3627.

Public comment is invited. Such

comments or views will be considered

by the Commission and will be available

for inspection and copying at its

principal office in accordance with

Section 4.9(b)(6)(ii) of the Commission’s

Rules of Practice (16 CFR 4.9(b)(6)(ii)).

Analysis of Proposed Consent Order to

Aid Public Comment

The Federal Trade Commission has

accepted an agreement to a proposed

consent order from Schering-Plough

Healthcare Products, Inc. (‘‘ScheringPlough Healthcare’’). Schering-Plough

Healthcare, a wholly-owned subsidiary

of the Schering-Plough Corporation, is a

manufacturer and distributor of health

care products, including sunscreens.

The proposed consent order has been

placed on the public record for sixty

(60) days for receipt of comments by

interested persons. Comments received
10060 Federal Register / Vol. 62, No. 43 / Wednesday, March 5, 1997 / Notices

1FTC v. Colgate-Palmolive Co., 380 U.S. 374,

394–95 (1965); FTC v. National Lead Co., 352 U.S.

419, 428 (1957).

2FTC v. Ruberoid Co., 343 U.S. 470, 473 (1952).

3The product label already contains the

statement, ‘‘Reapply after toweling.’’

4 It would be even more difficult to justify Part

IV of the order as corrective advertising, because it

is unlikely that the implied claim challenged in the

complaint would linger in the minds of consumers

long after it ceased being made. See WarnerLambert Co. v. FTC, 562 F.2d 749, 762 (D.C. Cir.

1977), cert. denied, 435 U.S. 950 (1978).

during this period will become part of

the public record. After sixty (60) days,

the Commission will again review the

agreement and the comments received

and will decide whether it should

withdraw from the agreement or make

final the agreement’s proposed order.

This matter involves alleged

deceptive representations made in

advertising for Coppertone Kids, a

sunscreen product promoted for use on

children. According to the FTC

complaint, Schering-Plough Healthcare

represented, without adequate

substantiation, that a single application

of Coppertone Kids provides six hours

of protection from the sun, at the

advertised SPF level, for children

engaged in sustained vigorous activity

in and out of the water. The complaint

also alleges that Schering-Plough

Healthcare falsely represented that it

had conducted tests demonstrating that

the product provides such protection.

According to the complaint, among

other things, the company’s tests did not

evaluate a single application of the

product under the advertised conditions

of use (sustained vigorous activity).

The consent order contains provisions

designed to remedy the violations

charged and to prevent Schering-Plough

Healthcare from engaging in similar acts

and practices in the future.

Part I of the proposed order prohibits

Schering-Plough Healthcare from

representing: (a) the length of time that

Coppertone Kids or any other children’s

sun protection product will provide

protection from the sun for persons

engaged in sustained vigorous activity

in and out of the water; or (b) the

efficacy of any children’s sun protection

product in providing protection against

any harmful effect of sun exposure or

ultraviolet radiation, unless the

company has scientific substantiation

for the representation.

The order defines a ‘‘children’s sun

protection product’’ as any sun

protection product that uses the word

‘‘babies,’’ ‘‘children,’’ ‘‘kids,’’ or other

similar words in the name or promotion

of the product, or that is advertised or

promoted for use primarily on children

under the age of twelve.

Part II of the proposed order prohibits

Schering-Plough Healthcare from

misrepresenting the existence, contents,

validity, or conclusions of any test or

study concerning any sun protection

product.

Part III of the order allows ScheringPlough Healthcare to make any

representation for a sun protection

product that is specifically permitted in

labeling for that product under any

tentative final or final Food and Drug

Administration standard or under any

new drug application approved by the

Food and Drug Administration.

Part IV of the proposed order requires

Schering-Plough Healthcare to produce

and disseminate a consumer brochure

addressing the importance of sunscreen

usage to children and the health benefits

associated with it, and promoting the

proper use and application of

sunscreens on children. The brochure,

which is subject to FTC approval, will

be disseminated by Schering-Plough

Healthcare to organizations with direct

access to parents or organizations with

access to parents or others who work

with or care for children under the age

of 12.

Parts V, VII, IX, and X of the proposed

order require Schering-Plough

Healthcare to keep copies of all

materials relied upon in making any

representations covered by Parts I and II

of the order; to provide copies of the

order to certain of the company’s

personnel; to notify the Commission of

any change in corporate structure; and

to file compliance reports with the

Commission. Part VI permits respondent

to use existing labeling for 100 days

after the date of service of the order. Part

VIII provides that the order will

terminate after twenty (20) years under

certain circumstances.

The purpose of this analysis is to

facilitate public comment on the

proposed order, and it is not intended

to constitute an official interpretation of

the agreement and proposed order or to

modify in any way their terms.

Donald S. Clark,

Secretary.

Separate Statement of Commissioner

Mary L. Azcuenaga Concurring in Part

and Dissenting in Part in ScheringPlough Healthcare, File No. 942 3341

Today, the Commission accepts for

public comment a proposed consent

agreement resolving allegations about

certain claims in the advertising of

Coppertone Kids 6-Hour Waterproof

Sunblock. I concur except with respect

to Part IV of the proposed order, which

requires the respondent to develop and

disseminate a consumer education

brochure addressing the dangers of

unprotected exposure to the sun.

Consumer education brochures are an

integral part of the Commission’s

consumer protection program, but they

are not necessarily defensible adjuncts

to Commission orders.

A fencing-in provision will be

sustained by the courts as long as it is

‘‘reasonably related’’ to the violation

found.1 Fencing-in relief properly may

include requirements beyond simply

prohibiting the challenged conduct that

are designed to ‘‘close all roads to the

prohibited goal, so that [the

Commission’s] order may not be bypassed with impunity.’’ 2 The allegedly

deceptive claim is that the respondent’s

sunblock for children would remain

effective for six hours even if the

children engaged in ‘‘sustained vigorous

activities in and out of the water,’’ such

as playing in sand, taking off and

putting on clothes and toweling off after

swimming. Complaint ¶5. The proposed

order expressly enjoins the respondents

from making the challenged claim,

either directly or indirectly, for the

product at issue as well as for ‘‘any

other children’s sun protection

product.’’ Order ¶I.

In addition, the proposed order

requires the respondent to develop and

distribute 150,000 copies of a color

brochure concerning the importance of

sunscreen usage by children. The order

requires that the brochure contain six

messages or themes only one of which

addresses the issue in this case, the

need to reapply so-called water-proof or

water-resistant sunblock after vigorous

activity or after toweling off. Order

¶ IV–E.

The brochure requirement, even the

message that relates most closely to the

challenged claim, is not focused on

preventing the respondent from making

the challenged claim or otherwise from

avoiding compliance with the order.

The brochure would help educate

consumers regarding an important

health issue, and, presumably, make

them less likely to be misled by the kind

of implied claims challenged in this

action.3 There is no reason to think that

it would enhance the deterrent effect of

the order on Schering.

Presumably, the brochure requirement

will not be unduly burdensome or

costly for Schering because it will

promote the use of its product, and the

brochure is undoubtedly commendable

as a public health initiative.

Nevertheless, under the circumstances,

it is an overly broad order requirement

as measured against the current

standard for ordering relief.4 There is a
Federal Register / Vol. 62, No. 43 / Wednesday, March 5, 1997 / Notices 10061

1The proposed complaint challenges as false the

claim that Schering has conducted tests

demonstrating that a single application of

Coppertone Kids provides six hours of protection

from the sun for children engaged in sustained

vigorous activity in and out of the water. The

proposed order broadly prohibits false

establishment claims for any sun protection

product.

2Like the brochure, the dissemination plan is

subject to the approval of the Associate Director in

charge of DAP.

3The consumer education remedy here stands in

contrast to a fencing-in provision contained in a

consent order issued by the Commission last year.

See Blenheim Expositions, Inc., Docket No. C–3633

(Jan. 18, 1996) (requiring a franchise show promoter

to undertake a limited distribution of an FTC

consumer education brochure to customers

attending its franchise shows). The respondent in

Blenheim allegedly made unsubstantiated claims

regarding the earnings and success of franchise

owners and false claims regarding a poll of

franchise owners. The brochure specifically

identified FTC requirements with which franchisors

must comply, including consumers’ right to receive

an earnings claims document, and it provided

instructions on how to evaluate earnings claims. It

thus contained information likely to assist the

respondent’s customers to detect and protect

themselves from possible future misrepresentations

of earnings like those alleged in the complaint.

Although the brochure also addressed other issues

related to the purchase of a franchise, all of the

advice in the brochure at least arguably would help

prospective franchisees avoid becoming victims of

future violations by the respondent.

value to the Commission in maintaining

the integrity of the standard for

imposing a fencing-in remedy.

I respectfully dissent from Part IV of

the order.

Separate Statement of Commissioner

Roscoe B. Starek, III Concurring in Part

and Dissenting in Part in ScheringPlough Healthcare, File No. 9423341

I have voted to accept for public

comment the consent agreement with

Schering-Plough Healthcare Products,

Inc. (‘‘Schering’’), because I have reason

to believe that the challenged

advertisements are deceptive and I find

that the proposed order, for the most

part, provides appropriate relief. I do

not, however, support the requirement

that Schering produce and distribute a

consumer education brochure that

includes numerous specified ‘‘messages

or themes.’’ As set forth in the proposed

order, this consumer education remedy

is overbroad and in any event is

unlikely to assist in the prevention of

the violations alleged in the complaint.

Although I am an advocate of a strong

Commission consumer education

program, and we can be proud of the

valuable work done by the Bureau of

Consumer Protection’s Office of

Consumer and Business Education, this

remedy is a well-meaning but not

legally justifiable effort to fund a general

consumer education campaign.

The Commission enjoys extensive

authority to fashion fencing-in relief for

deceptive practices so long as the

remedy has a reasonable relation to the

violations alleged in the complaint. See,

e.g., FTC versus Colgate-Palmolive Co.,

380 U.S. 374, 394–95 (1965); FTC versus

National Lead Co., 352 U.S. 419, 428–

29 (1957). With such authority,

however, comes the responsibility to

exercise it judiciously. In my view, the

consumer education remedy mandated

by this proposed order bears no

reasonable relationship to the violations

alleged in the complaint.

The proposed complaint alleges that

Schering lacked a reasonable basis for

the claim that a single application of

Coppertone Kids provides six hours of

protection from the sun for children

engaged in sustained vigorous activity

in and out of the water.1 The order

addresses this allegation by requiring

scientific substantiation for claims about

the efficacy of any children’s sun

protection product in providing

protection against any harmful effect of

sun exposure or ultraviolet radiation, or

about the length of time that any such

product will provide sun protection for

individuals engaged in sustained

vigorous activity in and out of the water.

In addition, however, the order would

require Schering to design, produce and

print a brochure—subject to the

approval of the Associate Director of the

Division of Advertising Practices

(‘‘DAP’’) in the Commission’s Bureau of

Consumer Protection—about the

importance of sunscreen usage by

children. The order mandates that the

brochure include all of the following

‘‘messages or themes’’:

(A) The importance of sunscreens in

preventing skin damage, including skin

cancer, sunburn, and premature skin

aging;

(B) Regular use of a high SPF

sunscreen during childhood can

significantly reduce the risk of certain

types of skin cancers later in life;

(C) A single bad sunburn during

childhood can significantly increase a

child’s risk of developing skin cancer

later in life;

(D) The importance of proper

application of sunscreens;

(E) The need to reapply sunscreens

after toweling or sustained vigorous

activity; and

(F) The need to use sunscreens during

outdoor activities—not only in

connection with water activities.

Order ¶ IV. The respondent must

disseminate 150,000 copies of this

brochure to parents or to organizations

with access to parents or others who

work with or care for children under age

twelve.2

Of the six required messages, only

statement (E) seems likely to assist in

the prevention of future deception like

or related to that alleged in the

complaint. Yet by including this key

reapplication information in an

extensive list of other facts about

sunscreen, the order makes it less likely

that consumers will see the

reapplication information. In my view,

it is highly unlikely that a parent who

receives and reviews whatever brochure

is approved will recall the one piece of

information related to the complaint

allegation when the parent makes a

sunscreen purchase. Because the scope

of the information to be included in the

brochure is so broad, the consumer

education remedy is not reasonably

related to the violations alleged in the

proposed complaint.3

It is also troubling that if the

Commission issues this order, it

essentially will be ordering the

respondent to advertise that persons

should buy and use more of the

respondent’s products. Schering already

has every incentive to communicate the

required messages to consumers. In fact,

the consumer education remedy is

advertising (‘‘use more sunscreen’’) that

the company might wish to do in any

event since the conduct provisions of

the order may prevent it from

continuing to distinguish its children’s

sun protection product from others by

claiming that it requires fewer

applications. The deterrence value of

this remedy is minimal at best.

Finally, if this relief were sought in

litigation, rather than obtained through

a consent agreement, it would not

withstand scrutiny under the First

Amendment. For purposes of First

Amendment analysis, there is no

difference between compelled speech

and restrictions on speech. Riley v.

National Fed’n of the Blind, 487 U.S.

781, 796–97 (1988). A valid restriction

on commercial speech must be no more

extensive than necessary to serve the

substantial governmental interest

directly advanced by the restriction.

Rubin v. Coors Brewing Co., 115 S. Ct.

1585, 1591 (1995) (discussing Central

Hudson Gas & Elec. Corp. v. Public

Serv. Comm’n of N.Y., 447 U.S. 557, 566

(1980)). Thus, disclosures compelled by

the FTC can be no broader than

necessary to prevent future deception or

to correct the effects of past deception.

See, e.g., National Comm’n on Egg

Nutrition v. FTC, 570 F.2d 157, 164 (7th

Cir. 1977), cert. denied, 439 U.S. 821

(1978). Additionally, the government

bears the burden of showing that a

speech restriction will advance its
10062 Federal Register / Vol. 62, No. 43 / Wednesday, March 5, 1997 / Notices

interest ‘‘to a material degree.’’ 44

Liquormart, Inc. v. Rhode Island, 116 S.

Ct. 1495, 1509 (1996) (plurality opinion

of Justice Stevens) (citing Edenfield v.

Fane, 507 U.S. 761, 771 (1993)). A

commercial speech restriction that

‘‘provides only ineffective or remote

support for the government’s purpose’’

does not pass this test. 44 Liquormart,

116 S. Ct. at 1509 (citing Central

Hudson, 447 U.S. at 564).

The dubious efficacy of the proposed

consumer education remedy makes it

unlikely that it will directly advance the

asserted governmental interest in

preventing future deception by the

respondent. In addition, I doubt that a

credible argument can be made that the

information that the order specifically

requires be included in the brochure is

no more extensive than necessary to

prevent future violations by Schering.

Certainly Schering has waived any First

Amendment objections to this relief by

entering into the consent agreement.

Nonetheless, when a remedy implicates

First Amendment rights, the

Commission should be particularly

reluctant to obtain through negotiations

relief that it lacks at least a colorable

chance to obtain in litigation.

In my view, it would be better to have

no consumer information remedy in the

consent order if the only alternative is

an overbroad remedy of doubtful

efficacy that raises First Amendment

concerns.

[FR Doc. 97–5344 Filed 3–4–97; 8:45 am]

BILLING CODE 6750–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Citizens Advisory Committee on Public

Health Service (PHS) Activities and

Research at Department of Energy

(DOE) Sites: Idaho National

Engineering Laboratory Health Effects

Subcommittee

In accordance with section 10(a)(2) of

the Federal Advisory Committee Act

(Pub. L. 92–463), the Centers for Disease

Control and Prevention (CDC)

announces the following meeting.

Name: Citizens Advisory Committee on

PHS Activities and Research at DOE Sites:

Idaho National Engineering Laboratory

Health Effects Subcommittee (INEL).

Times and Dates: 8:30 a.m.–5 p.m., March

20, 1997. 8:30 a.m.–5 p.m., March 21, 1997.

Place: Red Lion Inn-Riverside, 2900

Chinden Boulevard, Boise, Idaho 83714,

telephone 208/343–1871, FAX 208/344–

1079.

Status: Open to the public, limited only by

the space available. The meeting room

accommodates approximately 50 people.

Purpose: The Subcommittee is charged

with providing advice and recommendations

to the Director, CDC, and the Administrator,

Agency for Toxic Substances and Disease

Registry (ATSDR), regarding community,

American Indian Tribes, and labor concerns

pertaining to CDC’s and ATSDR’s public

health activities and research at this DOE

site. Activities shall focus on providing a

forum for community, American Indian

Tribal, and labor interaction and serve as a

vehicle for community concern to be

expressed as advice and recommendations to

CDC and ATSDR.

Matters to be Discussed: Agenda items

include presentations from the National

Center for Environmental Health (NCEH)

regarding current activities, the National

Institute for Occupational Safety and Health,

and ATSDR will provide updates on the

progress of current studies, and working

group discussions. Additional presentations

will include prioritization and screening of

chemicals for INEL dose reconstruction,

discussions of screening methodology, and

future dose reconstruction activities.

Agenda items are subject to change as

priorities dictate.

Contact Persons for More Information:

Arthur J. Robinson, Jr., or Nadine Dickerson,

Radiation Studies Branch, Division of

Environmental Hazards and Health Effects,

NCEH, CDC, 4770 Buford Highway, NE, M/

S F–35, Atlanta, Georgia 30341–3724,

telephone 770/488–7040, FAX 770/488–

7044.

John C. Burckhardt,

Acting Director, Management Analysis and

Services Office, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 97–5400 Filed 3–4–97; 8:45 am]

BILLING CODE 4163–18–P

Food and Drug Administration

[Docket No. 95N–0329]

Preclearance of Promotional Labeling;

Clarification

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the Center for Biologics Evaluation

and Research (CBER) is clarifying its

policy regarding the preapproval of

promotional labeling for biological

products. In the November 1995 report

issued by the President and Vice

President, ‘‘Reinventing the Regulation

of Drugs Made from Biotechnology,’’

FDA made a commitment to harmonize

immediately CBER’s requirements for

the preapproval of promotional labeling

with those of the Center for Drug

Evaluation and Research (CDER) under

which a company may submit such

information to the agency at the time the

company disseminates it. This notice is

issued to clarify that FDA has fulfilled

the commitment to allow industry to

submit promotional labeling to CBER at

the time of initial dissemination.

Sponsors need not wait for approval

from CBER before using promotional

labeling.

FOR FURTHER INFORMATION CONTACT: Toni

M. Stifano, Center for Biologics

Evaluation and Research (HFM–202),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–827–3028.

SUPPLEMENTARY INFORMATION: Under

CBER’s previous policy, as announced

in the Federal Register of August 9,

1993 (58 FR 42340) and revised in the

Federal Register of August 3, 1994 (59

FR 39570), preapproval by CBER was

required for promotional labeling prior

to introduction of a new biologic, for

120 days following approval of a new

biologic, and for 120 days following

approval of a new use for a currently

licensed biologic. In the November 1995

report issued by the President and Vice

President, ‘‘Reinventing the Regulation

of Drugs Made from Biotechnology,’’

FDA made a commitment that, effective

immediately, CBER would no longer

require preapproval of promotional

labeling. This approach, it was noted, is

consistent with that of CDER. FDA has

fulfilled its commitment.

In a proposed rule on changes to an

approved application, published in the

Federal Register of January 29, 1996 (61

FR 2739), FDA took a further step

toward harmonizing the two Centers’

promotional requirements. Among other

things, the proposed rule would amend

21 CFR 601.12 to make CBER

requirements for advertisements, as well

as promotional labeling, consistent with

those of CDER as set forth in 21 CFR

314.81(b)(3)(i).

The scope of this notice does not

extend to promotional materials for

products reviewed under the regulations

for accelerated approval (21 CFR part

601, subpart E), which should be

submitted to the agency for

consideration as required in 21 CFR

601.45.

Dated: February 28, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–5311 Filed 3–4–97; 8:45 am]

BILLING CODE 4160–01–F