Draft Guidance for Industry on Placing the Therapeutic Equivalence Code on Prescription Drug Labels and Labeling; Availability; Reopening of Comment Period

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Draft Guidance for Industry on Placing the Therapeutic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June 21, 1999, the comment period for the draft guidance for industry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ADDRESSES: Copies of the draft guidance for industry are available on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written requests for single copies of the draft guidance to the Drug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 Submit written comments on the draft guidance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 The draft guidance is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