[Federal Register Volume 64, Number 48 (Friday, March 12, 1999)]
[Notices]
[Pages 12341-12342]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-6118]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-0254]


Draft Guidance for Industry on Product Name Placement, Size, and 
Prominence in Advertising and Promotional Labeling; 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availability of a draft guidance for industry entitled ``Product Name 
Placement, Size, and Prominence in Advertising and Promotional 
Labeling.'' This draft guidance modifies a previous guidance issued by 
the Division of Drug Marketing, Advertising, and Communications 
(DDMAC). It documents the applicability of the previous guidance to 
animal prescription drugs and biologic products.

DATES:  Written comments on the draft guidance may be submitted by May 
11, 1999.

ADDRESSES: Submit written requests for single copies of the draft 
guidance for industry entitled ``Product Name Placement, Size, and 
Prominence in Advertising and Promotional Labeling'' to: (1) The Drug 
Information Branch (HFD-210), Center for Drug Evaluation and Research, 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857; 
or (2) the Office of Communications, Training, and Manufacturers 
Assistance (HFM-40), Center for Biologics Evaluation and Research, Food 
and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448; 
or (3) the Communication Staff, Center for Veterinary Medicine, 7500 
Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive 
label to assist the office in processing your requests. Submit written 
comments on this draft guidance to the Dockets Management Branch (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. See the SUPPLEMENTARY INFORMATION section for 
information on electronic access to the draft guidance.
FOR FURTHER INFORMATION CONTACT: 
    For information on the content of the draft guidance: Melissa M. 
Moncavage, Center for Drug Evaluation and Research (HFD-40), Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-
2828, e-mail ``[email protected]''; or
    Toni M. Stifano, Center for Biologics Evaluation and Research (HFM-
602), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 
20852-1448, 301-827-3028, e-mail ``[email protected]''; or
    Mukund R. Parkhie, Center for Veterinary Medicine (HFV-216, Food 
and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-
594-6642, e-mail ``[email protected]''.

SUPPLEMENTARY INFORMATION: 

[[Page 12342]]

I. Background

     DDMAC is currently reissuing guidances pertaining to prescription 
drug advertising and promotional labeling. These guidances have been 
issued to the pharmaceutical industry at various times since 1970, 
usually as letters or guidance papers. In the Federal Register of March 
28, 1997 (62 FR 14912), FDA published a notice listing all previous 
guidances and indicating whether the agency believed they were obsolete 
or needed revision. Under section II.B.3 of that document, FDA listed a 
guidance, issued in April 1994, that needed revision. The guidance 
addressed placement, size, and prominence of the proprietary (brand) 
name and established (generic) name in advertising and labeling of 
prescription drug products.
    This draft revision of that guidance for industry is entitled 
``Product Name Placement, Size, and Prominence in Advertising and 
Promotional Labeling.'' It has been revised in the following ways: (1) 
It modifies the format of the guidance issued in April 1994; (2) it 
adds new sections to discuss the applicability of the guidance to 
audiovisual, broadcast, and computer-based advertisements, and 
promotional labeling; (3) it adds a new section to discuss the 
placement, size, and prominence of the proprietary (brand) name and 
established (generic) name for products with two or more active 
ingredients; and (4) it documents the applicability of this guidance to 
animal prescription drugs and biologic products.
    This draft guidance for industry represents the agency's current 
thinking on proprietary and established name placement, size, and 
prominence in advertising and promotional labeling. It does not create 
or confer any rights for or on any person and does not operate to bind 
FDA or the public. An alternative approach may be used if such approach 
satisfies the requirement of the applicable statute, regulations, or 
both.

II. Electronic Access

     Copies of this draft guidance are available on the Internet at 
``http://www.fda.gov/cder/guidance/index.htm'' or ``http://www.fda.gov/
cber/guidelines.html'' or ``http://www.fda.gov/cvm''.

III. Comments

    Interested persons may, on or before May 11, 1999, submit to the 
Dockets Management Branch (address above) written comments on the draft 
guidance. Two copies of any comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. The 
draft guidance and received comments are available for public 
examination in the office above between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: March 5, 1999.
 William K. Hubbard,
 Acting Deputy Commissioner for Policy.
[FR Doc. 99-6118 Filed 3-11-99; 8:45 am]
BILLING CODE 4160-01-F