[Federal Register: January 13, 2009 (Volume 74, Number 8)]
[Notices]               
[Page 1692-1693]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13ja09-58]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0675]

 
Draft Guidance for Industry on Good Importer Practices; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing on behalf 
of several members of the Interagency Working Group on Import Safety 
(agencies) the availability of a draft guidance for industry entitled 
``Good Importer Practices.'' This draft guidance document provides 
general recommendations to importers on possible practices and 
procedures they may follow to increase the likelihood the products they 
import are in

[[Page 1693]]

compliance with applicable U.S. safety and security requirements. The 
recommendations provided here are intended to promote and facilitate an 
assessment by importers of a product's life cycle so the importer may 
make sound decisions about how best to address the product's potential 
to cause harm and to facilitate compliance with U.S. requirements.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the agencies consider your comments on 
this draft guidance before they begin work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by April 13, 2009.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Food and Drug Administration, Office of Policy and 
Planning, 10903 New Hampshire Ave., White Oak Building 1, 4th 
Floor,Silver Spring, MD 20993. Send one self-addressed adhesive label 
to assist the office in processing your request.Submit written comments 
on the draft guidance to the Division of Dockets Management (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov. All 
comments should be identified with the docket number found in brackets 
in the heading of this document. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Jeffrey Shuren, Food and Drug 
Administration, 10903 New Hampshire Avenue, White Oak Building 1, 
Silver Spring, MD 20993, 301-796-4840.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing on behalf of the agencies\1\ the availability of 
a draft guidance for industry entitled ``Good Importer Practices.'' 
This draft guidance is issued in response to recommendations contained 
in the Action Plan for Import Safety: A Roadmap for Continual 
Improvement (Action Plan) issued on November 6, 2007, by the 
Interagency Working Group on Import Safety (Working Group) established 
by Executive Order 13439 (see http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.importsafety.gov/report/actionplan.pdf). The Action Plan recommends that the Federal Government 
work with the importing community and other members of the public to 
develop Good Importer Practices and issue guidance. The Action Plan 
specifies that the focus of these practices should be to ensure that 
imported products meet U.S. standards, as well as to promote effective 
supply-chain management. The Action Plan recommended that these 
practices be risk-based and provide concrete guidance to the importing 
community for evaluating imported products. This evaluation would be 
based on due diligence and preventive control principles.
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    \1\ The agencies who developed this draft guidance are the U.S. 
Consumer Product Safety Commission, the Department of Agriculture, 
the Department of Commerce, the Department of Health and Human 
Services (FDA), the Department of Homeland Security, the Department 
of Transportation, and the Environmental Protection Agency, as well 
as with input from the Office of the U.S. Trade Representative.
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    This guidance is intended for use by the importer that initiates or 
causes the entry or attempted entry of foreign-sourced products into 
the United States or the reimportation of U.S.-made products (American 
goods returned) for commercial purposes to help ensure that such 
products are safe and comply with applicable U.S. requirements.\2\ At 
any point during the product's life cycle, hazards can be introduced 
that may place consumers at risk unless appropriate preventive controls 
are implemented. In general, the recommendations advise the importer to 
know the foreign firms with whom they do business and through which the 
products they purchase pass, understand the products they import and 
their vulnerabilities, understand the hazards that may be introduced 
during the product life cycle, and ensure that these hazards have been 
properly controlled and monitored. Importers should consider 
instituting practices to identify and minimize risk. Importers should 
put into place controls for known vulnerabilities, such as to 
microbiological contamination or product defects, and monitor for other 
risks, such as counterfeiting or intentional contamination.
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    \2\ While this guidance document sets out principles and 
recommendations for helping to ensure the safety and security of 
imported products, the principles and the non-customs related 
recommendations are also applicable to helping ensure the safety and 
security of products that are domestically produced.
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    These Good Importer Practices are broadly organized by four guiding 
principles. These four guiding principles are as follows:
     Establishing a product safety management program
     Knowing the product and applicable U.S. requirements
     Verifying product and firm compliance with U.S. 
requirements throughout the supply chain and product life cycle
     Taking corrective and preventive action when the imported 
product or firm is not compliant with U.S. Requirements
The guidance suggests actions the importer can take to accomplish each 
of these objectives.
    This draft guidance is being issued consistent with the Office of 
Management and Budget's Final Bulletin for Agency Good Guidance 
Practices (No. 07-02 (M-07-07)). The draft guidance, when finalized, 
will represent the agencies' current thinking on Good Importer 
Practices. It does not create or confer any rights for or on any person 
and does not operate to bind the agencies or the public. An alternative 
approach may be used if such approach satisfies the requirements of the 
applicable U.S. statutes and regulations.

II. Comments

    FDA is coordinating the receipt of submitted comments on behalf of 
the agencies. Interested persons may submit to FDA's Division of 
Dockets Management (see ADDRESSES) written or electronic comments 
regarding this document. Submit a single copy of electronic comments or 
two paper copies of any mailed comments, except that individuals may 
submit one paper 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 Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/guidance/goodimportpractice.html or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov.

    Dated: January 8, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-453 Filed 1-12-09; 8:45 am]

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