[Federal Register Volume 64, Number 77 (Thursday, April 22, 1999)]
[Notices]
[Page 19792]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-10010]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-1266]


Draft Guidance for Industry on Placing the Therapeutic 
Equivalence Code on Prescription Drug Labels and Labeling; 
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 
June 21, 1999, the comment period for the draft guidance for industry 
entitled ``Placing the Therapeutic Equivalence Code on Prescription 
Drug Labels and Labeling'' that appeared in the Federal Register of 
January 28, 1999 (64 FR 4434). FDA is taking this action in response to 
several requests for an extension and to allow interested parties 
additional time to submit comments.

DATES:  Written comments may be submitted by June 21, 1999. General 
comments on agency guidance documents are welcome at any time.

ADDRESSES:  Copies of the draft guidance for industry are available on 
the Internet at ``http://www.fda.gov/cder/guidance/index.htm''. Submit 
written requests for single copies of the draft guidance to the Drug 
Information Branch (HFD-210), Center for Drug Evaluation and Research, 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. 
Send one self-addressed adhesive label to assist that office in 
processing your requests. Submit written comments on the draft guidance 
to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Jerry Phillips, Center for Drug 
Evaluation and Research (HFD-730), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-3225.

SUPPLEMENTARY INFORMATION:  In the Federal Register of January 28, 
1999, FDA published a notice announcing the availability of a draft 
guidance for industry entitled ``Placing the Therapeutic Equivalence 
Code on Prescription Drug Labels and Labeling.'' The draft guidance is 
intended to clarify for prescription drug manufacturers, relabelers, 
and distributors FDA's position regarding placing the therapeutic 
equivalence code on approved FDA product labels and labeling. The 
January 28, 1999, notice invited interested persons to submit written 
comments on the draft guidance within 60 days.
    The agency has received several requests to extend the comment 
period on the draft guidance. The agency has decided to reopen the 
comment period on the draft guidance until June 21, 1999, to allow the 
public more time to review and comment on its contents.
    Interested persons may, on or before June 21, 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 may be seen in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: April 15, 1999.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 99-10010 Filed 4-21-99; 8:45 am]
BILLING CODE 4160-01-F