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                               Federal Register
                               Vol. 59, No. 148
                          Wednesday, August 3, 1994

 Food and Drug Administration

 [Docket No. 93D─0120]

 Revised Procedural Guidance Document of the Advertising and Promotional
Labeling Staff, Center for Biologics Evaluation and Research; Availability

Agency: Food and Drug Administration, HHS.

Action: Notice.

SUMMARY: The Food and Drug Administration (FDA) is announcing the availability
of a revised guidance document prepared by the ~~Advertising and Promotional
Labeling Staff (APLS) within the Office of Establishment Licensing and Product
Surveillance (OELPS), Center for Biologics Evaluation and Research (CBER).
This document revises the original procedural guide. FDA revised the guide to
address comments received and also to address the submission of promotional
materials for products reviewed under the regulations for accelerated
approval.

ADDRESSES: Correspondence concerning advertising and promotion of biologic
products from manufacturers or distributors of biologic products should be
directed to the Advertising and Promotional Labeling Staff (HFM─202), Center
for Biologics Evaluation and Research, Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852─1448. Persons with access to INTERNET may
request this document from "CBER [e-mail]." or by calling the CBER
FAX Information System at 301─594─1939 from a FAX machine with a touch tone
phone attached or built in. Submit written requests for single copies of the
APLS Procedural Guidance to the Congressional and Consumer Affairs Branch
(HFM─12), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD
20852─1448. Send two self-addressed adhesive labels to assist that office in
processing your requests. Submit written comments on the guidance to the
Dockets Management Branch (HFA─305), Food and Drug Administration, rm. 1─23,
12420 Parklawn Dr., Rockville, MD 20857. Requests and comments should be
identified with the docket number found in brackets in the heading of this
document. A copy of the APLS Procedural Guidance and received comments are
available for public examination in the Dockets Management Branch between 9
a.m. and 4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Toni Stifano, Center for Biologics Evaluation
and Research (HFM─202), Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852─1448, 301─594─2084.

SUPPLEMENTARY INFORMATION: FDA is making available a revised APLS Procedural
Guidance document. This document supersedes the APLS Procedural Guide that was
announced in the Federal Register of August 9, 1993 (58 FR 42340). FDA revised
the guide to address received comments and also to address requirements for
the submission of promotional materials for products reviewed under the
regulations for accelerated approval (21 CFR part 601 subpart E).

 The APLS Procedural Guidance document details the approach that manufacturers
and distributors should follow in submitting advertising and promotional
material for review by CBER, and APLS' approach in the review and evaluation
of this material. The APLS Procedural Guidance document also provides guidance
on CBER's current interpretation of the regulation requiring the reporting of
important proposed changes in the labeling, specifically promotional labeling,
of biological products for which a license is in effect or for which an
application for license is pending (21 CFR 601.12).

 In general, the changes to the original procedural guide respond to requests
for additional clarification and guidance in several areas involving biologic
advertising and promotion. The term "significant amendment" has been changed
throughout the document to "any supplement requiring a labeling change." A
brief description of the types of supplements that would require a labeling
change has also been added. The guide also contains information on advertising
and promotional materials for products reviewed under the accelerated approval
regulations (21 CFR part 601, subpart E). The revised procedural guide also
addresses the submission for pre-review of "Coming Soon" advertising as part
of the introductory campaign. FDA also clarifies when Part I versus Part II of
the FDA form 2567 is used.

 As with other procedural guidance documents, FDA does not intend this revised
document to be all-inclusive. Alternative approaches may be warranted in
specific situations, and certain aspects may not be applicable to all
situations. If a manufacturer believes that a procedure described in this
guidance document is inapplicable to a particular product and other procedures
are appropriate for CBER's consideration, the manufacturer may wish to discuss
the matter further with the agency to prevent expenditure of money and effort
on activities that later may be determined to be unacceptable by FDA. CBER
will continue to review advertising and promotional materials on a
case-by-case basis.

This document does not bind FDA and does not create or confer any rights,
privileges, or benefits on or for any person, but is intended merely for
guidance.

 Interested persons may submit to the Dockets Management Branch (address
above) written comments on this guide. Two copies of any comments are to be
submitted, except that individuals may submit one copy. Comments and
information should be identified with the docket number found in brackets in
the heading of this document. The APLS Procedural Guidance and received
comments are available for public examination in the Dockets Management Branch
between 9 a.m. and 4 p.m., Monday through Friday.

FDA will consider any comments received in determining whether additional
revisions to the guide are warranted. FDA will announce the availability of
any revised guidance statement in the Federal Register.

Dated: July 28, 1994.

 William K. Hubbard,

 Acting Deputy Commissioner for Policy.

[FR Doc. 94─18845 Filed 8─2─94; 8:45 am]

BILLING CODE 4160─01─F