[Federal Register Volume 66, Number 14 (Monday, January 22, 2001)]
[Notices]
[Page 6627]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-1700]



[[Page 6627]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0002]


Regulatory Procedures Manual; Chapter 9: Import Operations/
Action, Subchapter: Secured Storage; 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 ``Secured Storage.'' This subchapter has 
been provided to FDA's field offices to provide operational procedures 
for identifying those importers who should be referred to the U.S. 
Customs Service (U.S. Customs) so that U.S. Customs can require those 
importers to place their imported foods into secured storage under the 
control of U.S. Customs pending a decision by FDA of their 
admissibility. The subchapter is located in Chapter 9 of FDA's 
Regulatory Procedures Manual.

DATES: Submit written comments at any time.

ADDRESSES: Submit written requests for single copies of the subchapter 
entitled ``Secured Storage'' 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.
    Submit written comments on the subchapter to the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20857. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the subchapter.

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 the 
Department of Health and Human Services (DHHS) and the Secretary of the 
Treasury to develop new operational procedures to protect the public 
health. The initiative is geared to optimize the statutory authorities 
and resources available to the FDA, DHHS, and the U.S. Customs, 
Department of the 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 prevent distribution of imported unsafe food 
by requiring importers with a history of illegal distribution, 
misrepresentation, or substitution to hold future shipments in secure 
storage facilities until specifically released by FDA. The subchapter 
now being made available 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 the FDA's policy for Level 2 guidance documents as set out 
in the agency's good guidance practices, 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 new 
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 the brackets in the heading of this document. A 
copy of the subchapter and any 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 a copy of this 
subchapter at http://www.fda.gov/ora.

    Dated: January 12, 2001.
Dennis E. Baker,
Associate Commissioner for Regulatory Affairs.
[FR Doc. 01-1700 Filed 1-17-01; 11:07 am]
BILLING CODE 4160-01-F