[Federal Register: February 27, 2004 (Volume 69, Number 39)]
[Page 9340]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27fe04-65]
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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Draft Guidance on Marketed Unapproved Drugs; Compliance Policy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April 27, 2004, the comment period on the draft guidance for industry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agency announced the availability of this draft guidance in the Federal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interested persons additional time to review the draft guidance and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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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comments on the draft guidance to the Division of Dockets Management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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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electronic access to the draft guidance document.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published the draft guidance for industry entitled ``Marketing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 This draft guidance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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm.
ault.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