[Federal Register Volume 59, Number 135 (Friday, July 15, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-17288]


[[Page Unknown]]

[Federal Register: July 15, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 203 and 205

[Docket No. 92N-0297]
RIN 0905-AC81

 

Prescription Drug Marketing Act of 1987; Prescription Drug 
Amendments of 1992; Policies, Requirements, and Administrative 
Procedures; Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening to August 
15, 1994 the comment period for the proposed rule to establish agency 
policies and requirements, and to provide administrative procedures, 
information, and guidance for sections of the Prescription Drug 
Marketing Act of 1987 (PDMA) and the Prescription Drug Amendments of 
1992 (PDA), which was published in the Federal Register of Monday, 
March 14, 1994. This action is in response to requests for an extension 
of the comment period.

DATES: Written comments by August 15, 1994.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: May-Lis A. Manley, Center for Drug 
Evaluation and Research (HFD-362), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1046.

SUPPLEMENTARY INFORMATION: In the Federal Register of March 14, 1994 
(59 FR 11842), FDA issued a proposed rule to implement sections of PDMA 
and PDA. The proposed rule focuses primarily on reimportation, sales 
restrictions, and drug samples. These provisions are intended to 
benefit consumers by providing safeguards to ensure that prescription 
drug products are safe and effective and to avoid an unacceptable risk 
that counterfeit, adulterated, misbranded, subpotent, or expired drugs 
are being sold to consumers. The proposal gave interested persons an 
opportunity to submit written comments by May 30, 1994.
    In response to the proposal, Alza Corp. requested a 1-month 
extension of the comment period; Piper & Marbury requested a 90- to 
120-day extension; and Wolf, Block, Schorr and Solis-Cohen on behalf of 
Diagnostek, Inc., requested a 10-day extension. These organizations 
requested additional time to respond to the proposal because of its 
length and because of complex issues and questions that need careful 
analysis and evaluation.
    FDA has carefully considered these requests and has determined that 
reopening the comment period to August 15, 1994 for the preparation and 
submission of meaningful comments on this proposed rule, is in the 
public interest. A longer comment period is not warranted because the 
proposal provided an extended comment period and because FDA previously 
made available many of the procedures contained in the proposal in a 
series of letters containing interim guidance. Accordingly, the comment 
period for submissions by any interested person is reopened to August 
15, 1994.
    Interested persons may, on or before August 15, 1994, submit to the 
Dockets Management Branch (address above) written comments regarding 
this 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: July 11, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-17288 Filed 7-14-94; 8:45 am]
BILLING CODE 4160-01-F