[Federal Register Volume 64, Number 80 (Tuesday, April 27, 1999)]
[Notices]
[Pages 22616-22617]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-10359]
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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INFORMATION section for electronic access to the draft guidance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
