[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]
-----------------------------------------------------------------------
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Draft Guidance for Industry on Product Name Placement, Size, and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.
-----------------------------------------------------------------------
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availability of a draft guidance for industry entitled ``Product Name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 This draft guidance modifies a previous guidance issued by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DATES: Written comments on the draft guidance may be submitted by May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ADDRESSES: Submit written requests for single copies of the draft
guidance for industry entitled ``Product Name Placement, Size, and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comments on this draft guidance to the Dockets Management Branch (HFA-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information on electronic access to the draft guidance.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For information on the content of the draft guidance: Melissa M.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 moncavage@cder.fda.gov''; 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 mparkhie@bangate.fda.gov''.
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
