[Federal Register Volume 69, Number 39 (Friday, February 27, 2004)]
[Rules and Regulations]
[Page 9340]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-4310]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0478]


Draft Guidance on Marketed Unapproved Drugs; Compliance Policy 
Guide; Availability; Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening until 
April 27, 2004, the comment period on the draft guidance for industry 
entitled ``Marketing Unapproved Drugs; Compliance Policy Guide.'' The 
agency announced the availability of this draft guidance in the Federal 
Register of October 23, 2003 (68 FR 60702). The initial comment period 
closed December 22, 2003. The agency is taking this action to provide 
interested persons additional time to review the draft guidance and 
submit comments.

DATES: Submit written or electronic comments on the draft guidance by 
April 27, 2004. General comments on agency guidance documents are 
welcome at anytime.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research (CDER), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive 
label to assist the office in processing your requests. Submit written 
comments on the draft guidance to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. See the Supplementary Information section for 
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Sakineh H. Walther, Center for Drug 
Evaluation and Research (HFD-318), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-8964.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of October 23, 2003 (68 FR 60702), FDA 
published the draft guidance for industry entitled ``Marketing 
Unapproved Drugs; Compliance Policy Guide.'' This draft guidance 
describes how FDA intends to exercise its enforcement discretion with 
regard to drugs marketed in the United States that do not have required 
FDA approval for marketing. This document will, when finalized, 
supersede section 440.100 entitled ``Marketed New Drugs Without 
Approved NDAs or ANDAs'' (CPG 7132c.02) of the Compliance Policy Guide. 
It applies to any new drug required to have FDA approval for marketing, 
including new drugs covered by the over-the-counter review. The initial 
comment period closed on December 22, 2003, but to provide interested 
persons additional time to review the draft guidance and submit 
comments, the agency is reopening the comment period for an additional 
60 days, until April 27, 2004.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the draft guidance. 
Two copies of any mailed comments are to be submitted, except that 
individuals may submit one paper 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 Division of Dockets Management between 9 a.m. 
and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain copies of this draft 
guidance for industry at either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: February 20, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-4310 Filed 2-26-04; 8:45 am]
BILLING CODE 4160-01-S