[Federal Register: April 27, 1999 (Volume 64, Number 80)]
[Notices]               
[Page 22616-22617]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27ap99-61]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-0972]

 
Policy on the Disposition of Publications That Constitute 
Labeling; Draft Revised Compliance Policy Guide; 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 revised Compliance Policy Guide (CPG 7153.13) 
entitled ``Regulatory Policy on the Disposition of Publications that 
Constitute Labeling.'' We are revising the current CPG to provide 
clarification and further guidance to our field employees about when 
publications may constitute labeling for regulated products and to 
stress our policy with regard to the disposition of these materials 
when they cause a product to be in violation of the Federal Food, Drug, 
and Cosmetic Act.

Dates: You may submit written comments on the draft revised CPG by July 
26, 1999.

Addresses: You may submit written requests for single copies of the 
draft revised CPG to the Division of Compliance Policy (HFC-230), 
Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-0420. Please send two self-addressed 
adhesive labels to assist us in processing your requests, or you may 
fax your request to 301-827-0482. Please see the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance 
document. Submit written comments on the draft revised CPG to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 
Fishers Lane rm., 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: JoAnne C. Marrone, Division of 
Compliance Policy (HFC-230), Office of Enforcement, Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1242.

SUPPLEMENTARY INFORMATION:

 I. Background

     FDA has had a longstanding policy related to the seizure of books 
that constitute labeling for a product. We articulated this policy in a 
Compliance Policy Guide (CPG 7153.13) in December 1982, which we 
revised on August 31, 1989. In recent years, questions have arisen 
concerning when published materials may constitute labeling for 
regulated products, as well as our position and policy on the 
disposition of these materials. We intend this draft revised CPG to 
clarify these issues and to improve guidance to our field employees.
     This draft Level 1 guidance document is being issued consistent 
with FDA's Good Guidance Practices (62 FR 8961, February 27, 1997). It 
represents the agency's current thinking on the disposition of 
publications that constitute labeling for a product that renders a 
product violative. 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 
requirements of the applicable statute, regulations, or both.

 II. Request for Comments

     You may submit to the Dockets Management Branch (address above) 
written comments on the draft revised CPG entitled ``Regulatory Policy 
on the Disposition of Publications that Constitute Labeling.'' You must 
submit two copies of any comments, except that you may submit one copy 
if you are an individual. You must identify your comments with the 
docket number found in brackets in the heading of this document. The 
agency will review all comments, but in issuing a final CPG, need not 
specifically address every comment. We will make changes to the CPG in 
response to comments, as appropriate. You may see a copy of the draft 
revised CPG and comments received in the office above between 9 a.m. 
and 4 p.m., Monday through Friday.

 III. Electronic Access

     You also may download copies of the draft revised CPG to a 
personal computer with access
 to the World Wide Web (WWW). The Office of Regulatory Affairs' (ORA) 
home page entitled ``compliance references'' includes this draft 
revised CPG, and you may access it at ``http//www.fda.gov/ora/
compliance__ref/default.htm''.


[[Page 22617]]


    Dated: April 20, 1999.
Dennis E. Baker,
Associate Commissioner for Regulatory Affairs.
[FR Doc. 99-10359 Filed 4-26-99; 8:45 am]
BILLING CODE 4160-01-F