[Federal Register Volume 60, Number 226 (Friday, November 24, 1995)]
[Proposed Rules]
[Page 58025]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-28520]



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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