Document ID: FDA-2008-D-0510-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry: Submission of Laboratory Packages by Accredited Laboratories
Posted Date: 2009-01-16T05:00Z

[Federal Register: January 16, 2009 (Volume 74, Number 11)]
[Notices]               
[Page 3056-3057]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16ja09-102]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0510]

 
Draft Guidance for Industry: Submission of Laboratory Packages by 
Accredited Laboratories; 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 draft document entitled ``Guidance for Industry: 
Submission of Laboratory Packages by Accredited Laboratories.'' The 
draft guidance document provides information and recommendations about 
accreditation standards for laboratories and the quality and type of 
data that accredited laboratories produce to support testing results 
submitted to FDA about the admissibility of detained articles offered 
for import. We are taking this action under a recommendation made by 
the President's Interagency Working Group on Import Safety (Working 
Group).

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by April 16, 2009.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Executive Operations (HFC-2), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-
addressed adhesive label to assist that office in processing your 
requests.
    Submit written comments on the draft guidance to the Division of 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://www.regulations.gov. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Donna Porter, Division of Field 
Science (HFA-141), Office of Regulatory Affairs, Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7605.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft document entitled 
``Guidance for Industry: Submission of Laboratory Packages by 
Accredited Laboratories.'' The draft guidance is about accreditation 
standards for laboratories and about the quality and type of data that 
accredited laboratories should produce in support of testing results 
submitted to FDA pertaining to the admissibility of detained articles 
offered for import of all product types (i.e., biological products, 
drugs, devices, and food) that we regulate. FDA is taking this action 
under a recommendation made by the President's Interagency Working 
Group on Import Safety (Working Group). The Working Group was to 
conduct a comprehensive review of the U.S. import system and identify 
ways to further increase the safety of imports entering the country, 
and it presented its initial findings to the President on September 10, 
2007, in a report entitled ``Protecting American Consumers Every Step 
of the Way: A Strategic Framework for Continual Improvement in Import 
Safety.''
    On November 6, 2007, the Working Group presented to the President 
its Import Safety Action Plan (Action Plan), which contains short- and 
long-term recommendations for continuing to improve the safety of 
imports entering the United States. The Action Plan recommended that 
FDA issue guidance that ``would set standards for the sampling and 
testing of imported products, including the use of accredited 
laboratories submitting data to FDA to assist in evaluating whether an 
appearance of a violation may be resolved.''
    The issuance of the draft guidance is, therefore, consistent with 
the Action Plan and also consistent with FDA's good guidance practices 
regulation (21 CFR 10.115). The draft guidance, when finalized, will 
represent FDA's current thinking on this topic. It does not create or 
confer any rights for or on any person and does not operate to bind FDA 
or the public. An alternative approach may be used if such approach 
satisfies the requirements of the applicable statutes and regulations.

II. Comments

    The draft guidance is being distributed for comment purposes only 
and is not intended for implementation at this time. Interested persons 
may submit to the Division of Dockets Management (see ADDRESSES) 
written or electronic comments regarding the draft guidance. 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. A copy of the draft guidance and received 
comments are available for public examination 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://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/ora or http://www.regulations.gov.

[[Page 3057]]

    Dated: January 9, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-837 Filed 1-15-09; 8:45 am]

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