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

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