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