[Federal Register Volume 78, Number 46 (Friday, March 8, 2013)]
[Notices]
[Pages 15017-15018]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-05470]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0643]
Guidance for Industry: What You Need To Know About Administrative
Detention of Foods; Small Entity Compliance Guide; 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; Small Entity Compliance
Guide'' (SECG) which updates an earlier guidance of similar title.
Previously, this guidance restated the legal requirements of FDA's
administrative detention regulation. This document also at one time
served as FDA's guidance for administrative detention. In October 2011,
FDA revised an earlier version of this guidance document to be
consistent with the changes made by an interim final rule (IFR) issued
in the Federal Register of May 5, 2011, and to serve as guidance for
industry on administrative detention. FDA has since issued a final rule
adopting the IFR as final without changes which was published in the
Federal Register of February 5, 2013. Accordingly, FDA is further
revising the existing guidance document to provide guidance intended to
help any entity comply with the requirements in FDA's administrative
detention regulation, including the amendments to these requirements
made by the final rule. This notice also clarifies that this document
continues to serve as FDA's guidance for administrative detention.
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 request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance.
Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments on the guidance to the
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
The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) 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 Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.
334(h)(1)(A)) 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
[[Page 15018]]
published an IFR in the Federal Register amending its regulations in 21
CFR part 1, subpart K (76 FR 25538), that pertain to the criteria for
ordering administrative detention. This IFR became effective on July 3,
2011. On February 5, 2013, FDA issued a final rule which adopted the
IFR as final without changes. FDA is announcing the availability of an
update to an existing guidance document that will also serve as FDA's
SECG.
In October 2011, FDA updated an existing guidance which had
restated the legal requirements of FDA's administrative detention
regulation at 21 CFR part 1, subpart K, implementing section 304(h) of
the FD&C Act, as added by the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002. This document had also served as
FDA's guidance for 21 CFR part 1, subpart K in accordance with the
Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA).
The title of the October 2011 guidance was ``What You Need to Know
About Administrative Detention of Foods,'' (76 FR 66073, October 25,
2011). The guidance was 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, as amended by section 207 of FSMA. It
provided 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 identified references that
contain more information regarding FDA's authority to order
administrative detention.
FDA received one general comment about FDA decisionmaking to the
docket associated with the October 2011 version (Docket Number FDA-
2011-D-0643). The comment stated that it would like to ensure that FDA
makes sound decisions based on testing from qualified laboratories. As
such, the comment continued, FDA and private laboratories must be
accredited and must follow good laboratory practices in their testing
programs. In addition, the comment stated that testing should be
conducted using validated testing methods that have been accredited and
approved. Sound science is the cornerstone of FDA regulatory programs
and actions and, to that extent, FDA agrees with the comment; however,
in the context of administrative detention, FDA is not limited, as
implied by the comment, to relying on analytical test results to
determine whether FDA has a reason to believe a food is adulterated or
misbranded. All evidence available to the Agency may be considered when
making such a determination.
Since then, in the Federal Register of February 5, 2013 (78 FR
7994), FDA issued a final rule adopting the IFR as final without
changes. The final rule adopts without change the interim final rule's
amendments to certain regulations in 21 CFR part 1, subpart K to be
consistent with amendments to the criteria for ordering administrative
detention of human or animal food made by FSMA. The final rule, which
adopts the interim final rule as final, is effective upon publication
in the Federal Register.
The Regulatory Flexibility Act (5 U.S.C. 601-612) requires Agencies
to determine whether a final rule will have a significant impact on
small entities when an Agency issues a final rule ``after being
required * * * to publish a general notice of proposed rulemaking.''
Although FDA is not required to perform a regulatory flexibility
analysis because, in accordance with 5 U.S.C. 553(b)(3)(B) and 21 CFR
10.40(e)(1), the Agency found for good cause that use of prior notice
and comment procedures were contrary to the public interest; FDA has
nonetheless examined the economic implications of the final rule in
accordance with the Regulatory Flexibility Act and determined that the
final rule will not have a significant economic impact on a substantial
number of small entities (78 FR 7994). Similarly because FDA is not
required to perform a final regulatory flexibility analysis under 5
U.S.C. 605(b) for the final rule, FDA is not required to issue a
guidance to comply with section 212 of SBREFA (Pub. L.104-121);
nevertheless, FDA has updated this guidance to state in plain language
the requirements of 21 CFR part 1, subpart K.
FDA is issuing this guidance consistent with FDA's good guidance
practices regulation (21 CFR 10.115(c)(2)). This guidance represents
the Agency's current thinking on administrative detention of 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 alternative 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. 3518(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 either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of 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, and will be posted to the docket at http://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/RegulatoryInformation/Guidances/default.htm
or http://www.regulations.gov. Always access an FDA guidance document
by using FDA's Web site listed previously to find the most current
version of the guidance.
Dated: March 5, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-05470 Filed 3-7-13; 8:45 am]
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