[Federal Register Volume 76, Number 206 (Tuesday, October 25, 2011)]
[Notices]
[Pages 66073-66074]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-27529]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0643]


Guidance for Industry on What You Need to Know About 
Administrative Detention of Foods; 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 guidance for industry entitled ``What You Need to 
Know About Administrative Detention of Foods.'' This guidance provides 
information pertaining to FDA's authority to order the administrative 
detention of food for human or animal consumption under the Federal 
Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food 
Safety and Modernization Act (FSMA).

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Outreach and Information Center (HFS-009), Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740. Send one self-addressed adhesive label 
to assist that office in processing your requests. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the guidance 
document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the

[[Page 66074]]

Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: William A. Correll, Jr., Office of 
Compliance (HFS-607), Center for Food Safety and Applied Nutrition, 
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740, 240-402-1611.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``What You Need to Know About Administrative Detention of 
Foods,'' which replaces the guidance of the same title issued in 
November 2004. The guidance is intended to provide individuals in the 
human and animal food industries with an understanding of FDA's 
authority to order the administrative detention of human or animal food 
under section 304(h) of the FD&C Act (21 U.S.C. 334(h)), as amended by 
section 207 of FSMA. It provides practical information, including who 
can approve an administrative detention order, what food may be subject 
to administrative detention, who receives a copy of an administrative 
detention order, and the process for appealing an administrative 
detention order. Additionally, the guidance identifies references that 
contain more information regarding FDA's authority to order 
administrative detention.
    This guidance is being issued consistent with FDA's good guidance 
practices (GGPs) regulation Sec.  10.115 (21 CFR 10.115) as a level 1 
guidance. The Agency will accept comments, but it is implementing this 
document immediately, in accordance with Sec.  10.115(g)(2) because the 
Agency has determined that prior public participation is not feasible 
or appropriate. The Agency made this determination because much of this 
guidance remains the same as the guidance issued in November 2004. In 
addition, this guidance simply reflects the statutory changes made by 
section 207 of FSMA to section 304(h)(1)(A) of the FD&C Act (21 U.S.C. 
334(h)(1)(A)) and seeks to remove any confusion that might arise due to 
the existence of a guidance document that is inconsistent with the FD&C 
Act and its implementing regulations. Although this guidance document 
is immediately in effect, it remains subject to comment in accordance 
with the Agency's GGPs regulation.
    FSMA was signed into law on January 4, 2011. Section 207 of FSMA 
amended the criteria for ordering administrative detention in section 
304(h)(1)(A) of the FD&C Act to provide FDA the authority to order 
administrative detention if there is reason to believe that an article 
of food is adulterated or misbranded. On May 5, 2011, in accordance 
with FSMA, FDA published an interim final rule in the Federal Register 
amending its regulations in part 1, subpart K (21 CFR part 1, subpart 
K), (76 FR 25538), that pertain to the criteria for ordering 
administrative detention. This interim final rule became effective on 
July 3, 2011.
    The guidance represents the Agency's current thinking on its 
authority to order the administrative detention of human or animal 
foods. It does not create or confer any rights for or on any person and 
does not operate to bind FDA or the public. An alternate approach may 
be used if such approach satisfies the requirements of the applicable 
statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance refers to collections of information found in FDA 
regulations. These collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501-3520). We conclude that the collections of 
information in Sec. Sec.  1.381(d) and 1.402 are exempt from OMB review 
under 44 U.S.C. 18(c)(1)(B)(ii) and 5 CFR 1320.4(a)(2) as collections 
of information obtained during the conduct of a civil action to which 
the United States or any official or agency thereof is a party, or 
during the conduct of an administrative action, investigation, or audit 
involving an agency against specific individuals or entities. The 
regulations in 5 CFR 1320(c) provide that the exception in 5 CFR 
1320.4(a)(2) applies during the entire course of the investigation, 
audit, or action, but only after a case file or equivalent is opened 
with respect to a particular party. Such a case file would be opened as 
part of the decision to detain an article of food.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments 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.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either  http://www.fda.gov/RegulatoryInformation/Guidances/default.htm 
or http://www.regulations.gov. Always access an FDA guidance document 
by using the FDA's Web site listed previously to find the most current 
version of the guidance.

    Dated: October 20, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-27529 Filed 10-24-11; 8:45 am]
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