[Federal Register Volume 66, Number 14 (Monday, January 22, 2001)]
[Notices]
[Page 6626]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-1699]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0001]


Regulatory Procedures Manual; Chapter 9: Import Operations/
Action, Subchapter: Communication Concerning Assessment of Civil 
Monetary Penalties by U.S. Customs Service in Cases Involving Imported 
Food; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a new subchapter of the Regulatory Procedures Manual. 
The new subchapter is entitled ``Communication Concerning Assessment of 
Civil Monetary Penalties by U.S. Customs Service in Cases Involving 
Imported Food.'' This subchapter has been provided to FDA's field 
offices to provide procedures for communication with the U.S. Customs 
Service (U.S. Customs) regarding assessment of civil monetary penalties 
involving imported foods. The subchapter is located in FDA's Regulatory 
Procedures Manual.

DATES: Submit written comments at any time.

ADDRESSES: Submit written requests for single copies of the subchapter 
entitled ``Communication Concerning Assessment of Civil Monetary 
Penalties by U.S. Customs Service in Cases Involving Imported Food'' to 
Joseph L. McCallion, Division of Import Operations and Policy (HFC-
170), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857. Send one self-addressed adhesive label to assist that office in 
processing your request. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the subchapter.
    Submit written comments on the subchapter to the Dockets Management 
Branch (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Joseph L. McCallion, Division of 
Import Operations and Policy (HFC-170), Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857, 301-443-6553.

SUPPLEMENTARY INFORMATION:

I. Background

    On July 3, 1999, the President announced an initiative to ensure 
the safety of imported food by directing the Secretary of Health and 
Human Services (DHHS) and the Secretary of Treasury to develop new 
operational procedures to protect the public health. The initiative is 
geared to optimize the statutory authorities and resources available to 
FDA, DHHS and U.S. Customs, Department of Treasury to protect consumers 
from unsafe imported foods. The President directed the agencies to 
target unscrupulous importers who violate the import laws and work to 
subvert the system by introducing unsafe foods into U.S. markets. Six 
specific objectives were emphasized in the directive.
    On December 11, 1999, the President announced the plan developed by 
FDA and U.S. Customs in response to the directive of July 3, 1999. One 
element of the plan was to enhance enforcement by having U.S. Customs 
assess civil monetary penalties in cooperation with FDA. The subchapter 
now being announced is setting out the procedures for accomplishing 
this objective.
    The subchapter does not create or confer any rights, privileges, or 
benefits for, or on, any person and does not operate to bind FDA, U.S. 
Customs, or the public. The subchapter is being distributed in 
accordance with FDA's policy for Level 2 guidance documents as set out 
in the agency's good guidance practices regulation, published in the 
Federal Register of September 19, 2000 (65 FR 56468).

II. Comments

    Interested persons may, at any time, submit written comments to the 
Dockets Management Branch (address above) regarding this subchapter. 
Two copies of any comments are to be submitted, except individuals may 
submit one copy. Comments should be identified with the docket number 
found in brackets in the heading of this document. A copy of the 
document and received comments are available for public examination in 
the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

III. Electronic Access

    Persons with access to the Internet may obtain copies of the 
subchapter at http://www.fda.gov/ora.

    Dated: January 12, 2001.
Dennis E. Baker,
Associate Commissioner for Regulatory Affairs.
[FR Doc. 01-1699 Filed 1-17-01; 11:07 am]
BILLING CODE 4160-01-F