Prescription Drug Product Labeling; Medication Guide Requirements; Extension of Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 201, 208, 314, and 601

[Docket No. 93N-0371]

RIN 0910-AA37

Prescription Drug Product Labeling; Medication Guide

Requirements; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending to

December 22, 1995, the comment period for the proposed rule for

Prescription Drug Product Labeling; Medication Guide Requirements,

which appeared in the Federal Register of August 24, 1995 (60 FR

44182). FDA is taking this action in response to several requests for

an extension of the comment period.

DATES: Written comments by December 22, 1995.

ADDRESSES: Submit written comments to the Dockets Management Branch

(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Louis A. Morris, Center for Drug

Evaluation and Research (HFD-240), Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857, 301-594-6818.

SUPPLEMENTARY INFORMATION: In the Federal Register of August 24, 1995

(60 FR 44182), FDA published a proposed rule for Prescription Drug

Product Labeling; Medication Guide Requirements. Interested persons

were given until November 22, 1995, to submit comments on the proposal.

In response to the proposal, FDA received several requests for an

extension of the comment period for an additional 90 days. Requestors

specified that this extension would allow sufficient time to adequately

review and analyze the proposal by various organization members, in

order to formulate and submit comments. After careful consideration,

FDA is granting a 30-day extension. Accordingly, the comment period is

extended to December 22, 1995.

Interested persons may, on or before December 22, 1995, submit to

the Dockets Management Branch (address above) written comments

regarding the proposal. 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. Received comments may be seen in the office above

between 9 a.m. and 4 p.m., Monday through Friday.

Dated: November 13, 1995.

William K. Hubbard,

Acting Deputy Commissioner for Policy.

[FR Doc. 95-28520 Filed 11-22-95; 8:45 am]

BILLING CODE 4160-01-F