[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