[Federal Register Volume 59, Number 148 (Wednesday, August 3, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-18845]
[[Page Unknown]]
[Federal Register: August 3, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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--
[email protected]'' 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
