[Federal Register Volume 64, Number 152 (Monday, August 9, 1999)]
[Proposed Rules]
[Page 43114]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-20363]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 207, 607, and 807

[Docket No. 98N-1215]


Foreign Establishment Registration and Listing; 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 for 60 
days the comment period for the proposed rule that appeared in the 
Federal Register of May 14, 1999 (64 FR 26330). The proposed rule would 
require foreign establishments whose products are imported or offered 
for import into the United States to register with FDA and to identify 
a U.S. agent. The proposal would also describe some of the agent's 
responsibilities. FDA is taking this action in response to a request 
from the Canadian Embassy.

DATES: Written comments by October 8, 1999.
ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Philip L. Chao, Office of Policy, 
Planning, and Legislation (HF-23), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-3380.

SUPPLEMENTARY INFORMATION: In the Federal Register of May 14, 1999 (64 
FR 26330), FDA published a proposed rule that would require foreign 
establishments whose products are imported or offered for import into 
the United States to register with FDA. The proposal would also require 
foreign establishments to identify a U.S. agent and would describe some 
of the agent's responsibilities. FDA issued the proposed rule in order 
to implement section 417 of the Food and Drug Administration 
Modernization Act of 1997. Interested persons were given until July 28, 
1999, to comment on the proposed rule.
    On July 23, 1999, the Government of Canada requested an extension 
of the comment period, stating that the proposed requirement could 
present significant cost and compliance burdens to small and medium-
sized Canadian establishments. The Canadian Government requested the 
extension so that it could: (1) Ensure that affected Canadian 
establishments are aware of the proposal and (2) prepare informed 
comments. The requested extension was 60 days.
    The agency considered the Canadian Government's request and because 
the request was submitted too late to permit an extension of the 
comment period the agency is reopening the comment period until October 
8, 1999.
    Interested persons may submit to the Dockets Management Branch 
(address above) written comments on the proposed rule. 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. A copy of the proposed rule 
and received comments may be seen in the office above between 9 a.m. 
and 4 p.m., Monday through Friday.

    Dated: August 1, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-20363 Filed 8-6-99; 8:45 am]
BILLING CODE 4160-01-F