Guidance for Industry: What You Need To Know About Administrative Detention of Foods; Small Entity Compliance Guide; Availability, 15017-15018 [2013-05470]
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15017
Federal Register / Vol. 78, No. 46 / Friday, March 8, 2013 / Notices
Description: This information
collection is authorized under Section
411(a)(3) of the Social Security Act. This
request is for renewal of approval to use
the Administration for Children and
Families’ (ACF) 196 form for periodic
financial reporting under the Temporary
Assistance for Needy Families (TANF)
program. States participating in the
TANF program are required by statute to
report financial data on a quarterly
basis. This form meets the legal
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects:
Title: TANF Quarterly Financial
Report, ACF–196.
OMB No.: 0970–0247.
standard and provides essential data on
the use of Federal funds. Failure to
collect the data would seriously
compromise ACF’s ability to monitor
program expenditures, estimate funding
needs, and to prepare budget
submissions required by Congress.
Financial reporting under the TANF
program is governed by 45 CFR part
265.
Respondents: TANF Agencies.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
ACF–196 ..........................................................................................................
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Instrument
51
4
10
2,040
Estimated Total Annual Burden
Hours: 2,040.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer.
Email address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2013–05378 Filed 3–7–13; 8:45 am]
BILLING CODE 4184–01–P
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18:44 Mar 07, 2013
Jkt 229001
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.
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
PO 00000
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Fmt 4703
Sfmt 4703
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 https://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
E:\FR\FM\08MRN1.SGM
08MRN1
mstockstill on DSK4VPTVN1PROD with NOTICES
15018
Federal Register / Vol. 78, No. 46 / Friday, March 8, 2013 / Notices
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
VerDate Mar<15>2010
18:44 Mar 07, 2013
Jkt 229001
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.
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
§§ 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 https://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 https://
www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the guidance at either https://
www.fda.gov/RegulatoryInformation/
Guidances/default.htm or https://
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]
BILLING CODE 4160–01–P
II. Paperwork Reduction Act of 1995
This guidance refers to collections of
information found in FDA regulations.
These collections of information are
PO 00000
Frm 00060
Fmt 4703
Sfmt 9990
E:\FR\FM\08MRN1.SGM
08MRN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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 https://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 https://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the guidance at
either https://www.fda.gov/RegulatoryInformation/Guidances/default.htm
or https://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]
BILLING CODE 4160-01-P
