Requirements To Submit Prior Notice of Imported Food; Technical Amendments, 15627-15630 [2017-06201]
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Federal Register / Vol. 82, No. 60 / Thursday, March 30, 2017 / Rules and Regulations
already been accredited to test for
conformity to other mandatory juvenile
product standards, and the only costs to
them would be the cost of adding the
infant bath tubs standard to their scope
of accreditation. For these reasons, the
Commission certifies that the NOR
amending 16 CFR part 1112 to include
the infant bath tubs standard will not
have a significant impact on a
substantial number of small entities.
§ 1234.2
tubs.
Requirements for infant bath
Consumer protection, Imports,
Incorporation by reference, Infants and
children, Labeling, Law enforcement,
bath tub, and Toys.
Each infant bath tub must comply
with all applicable provisions of ASTM
F2670–17, Standard Consumer Safety
Specification for Infant Bath Tubs,
approved on January 1, 2017. The
Director of the Federal Register
approves this incorporation by reference
in accordance with 5 U.S.C. 552(a) and
1 CFR part 51. You may obtain a copy
from ASTM International, 100 Bar
Harbor Drive, P.O. Box 0700, West
Conshohocken, PA 19428; https://
www.astm.org/. You may inspect a copy
at the Office of the Secretary, U.S.
Consumer Product Safety Commission,
Room 820, 4330 East West Highway,
Bethesda, MD 20814, telephone 301–
504–7923, or at the National Archives
and Records Administration (NARA).
For information on the availability of
this material at NARA, call 202–741–
6030, or go to: https://www.archives.gov/
federal_register/code_of_
federalregulations/ibr_locations.html.
For the reasons discussed in the
preamble, the Commission amends Title
16 of the Code of Federal Regulations as
follows:
Dated: March 27, 2017.
Todd A. Stevenson,
Secretary, Consumer Product Safety
Commission.
PART 1112—REQUIREMENTS
PERTAINING TO THIRD PARTY
CONFORMITY ASSESSMENT BODIES
[FR Doc. 2017–06270 Filed 3–29–17; 8:45 am]
■
1. The authority citation for part 1112
continues to read as follows:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Authority: 15 U.S.C. 2063; Pub. L. 110–
314, section 3, 122 Stat. 3016, 3017 (2008).
Food and Drug Administration
2. Amend § 1112.15 by adding
paragraph (b)(41) to read as follows:
21 CFR Part 1
§ 1112.15 When can a third party
conformity assessment body apply for
CPSC acceptance for a particular CPSC rule
and/or test method?
Requirements To Submit Prior Notice
of Imported Food; Technical
Amendments
*
AGENCY:
List of Subjects
16 CFR Part 1112
Administrative practice and
procedure, Audit, Consumer protection,
Incorporation by reference, Reporting
and recordkeeping requirements, Thirdparty conformity assessment body.
16 CFR Part 1234
■
[Docket No. FDA–2017–N–0011]
*
*
*
*
(b) * * *
(41) 16 CFR part 1234, Safety
Standard for Infant Bath Tubs.
*
*
*
*
*
■
Final rule; technical
amendments.
ACTION:
jstallworth on DSK7TPTVN1PROD with RULES
Scope.
Requirements for infant bath tubs.
Authority: The Consumer Product Safety
Improvement Act of 2008, Pub. L. 110–314,
104, 122 Stat. 3016 (August 14, 2008); Pub.
L. 112–28, 125 Stat. 273 (August 12, 2011).
Scope.
This part establishes a consumer
product safety standard for infant bath
tubs.
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The Food and Drug
Administration (FDA or we) is
amending the prior notice of imported
food regulations to reflect a change in
the electronic data interchange system
and its expanded capabilities, to correct
inaccurate number designations in
section headings, and to reflect a change
in an office’s name. This action is
ministerial or editorial in nature.
DATES: This rule is effective March 30,
2017.
FOR FURTHER INFORMATION CONTACT:
Jennifer Thomas, Center for Food Safety
and Applied Nutrition, Food and Drug
Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–2094.
SUMMARY:
PART 1234—SAFETY STANDARD FOR
INFANT BATH TUBS
§ 1234.1
Food and Drug Administration,
HHS.
3. Add part 1234 to read as follows:
Sec.
1234.1
1234.2
BILLING CODE 6355–01–P
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15627
SUPPLEMENTARY INFORMATION:
I. Background
Section 801(m) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 381(m)) requires that FDA
establish regulations requiring that
those persons importing articles of food
or offering articles of food for import
into the United States submit certain
information about imported foods before
the products’ arrival in the United
States. We have established the
regulations at title 21, Code of Federal
Regulations (CFR) part 1, subpart I (21
CFR 1.276 to 1.285). Section 801(m) of
the FD&C Act also provides that an
article of food imported or offered for
import is subject to refusal of admission
into the United States if adequate prior
notice has not been provided to FDA.
Our regulations in 21 CFR part 1,
subpart I, include information on when
to submit prior notice, how to submit
prior notice, and what information is
required in a prior notice.
II. Description of the Technical
Amendments
We are making technical amendments
in our prior notice regulations in part 1,
subpart I (§§ 1.276 to 1.285), to:
• Reflect the change in an electronic
data interchange system and its
expanded capabilities;
• correct paragraph number
designations in certain introductory text
paragraphs; and
• revise the name of an FDA office
receiving certain information.
The technical amendments are
ministerial or editorial in nature and are
not intended to modify any substantive
requirements.
A. Revising an Electronic Data
Interchange System and Recognizing Its
Expanded Capabilities
Our current regulations, at §§ 1.279,
1.280, 1.281, and 1.282, refer to the
‘‘Automated Broker Interface/
Automated Commercial System (ABI/
ACS)’’ or ‘‘Automated Broker Interface
of the Automated Commercial System
(ABI/ACS).’’ We are amending these
regulations to reflect the change of the
electronic data interchange system from
‘‘Automated Broker Interface/
Automated Commercial System (ABI/
ACS)’’ or ‘‘Automated Broker Interface
of the Automated Commercial System
(ABI/ACS)’’ to ‘‘Automated Broker
Interface/Automated Commercial
Environment/International Trade Data
System (ABI/ACE/ITDS).’’ In the
Federal Register of May 16, 2016 (81 FR
30320), the Department of Homeland
Security’s U.S. Customs and Border
Protection (CBP) issued a notice
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Federal Register / Vol. 82, No. 60 / Thursday, March 30, 2017 / Rules and Regulations
announcing that the Automated
Commercial Environment (ACE) will be
the sole electronic data interchange
(EDI) system authorized by the
Commissioner of CBP for processing
electronic entries and entry summaries
associated with the entry types specified
in the notice, for merchandise that is
subject to our import requirements. The
notice also announced that the
Automated Commercial System (ACS)
will no longer be a CBP-authorized EDI
system for purposes of processing these
electronic filings. Therefore, we are
revising our regulations at §§ 1.279,
1.280, 1.281, and 1.282 by replacing all
references to the ‘‘Automated Broker
Interface/Automated Commercial
System (ABI/ACS)’’ and ‘‘Automated
Broker Interface of the Automated
Commercial System (ABI/ACS)’’ with
‘‘Automated Broker Interface/
Automated Commercial Environment/
International Trade Data System (ABI/
ACE/ITDS)’’ to accurately identify the
current EDI system. We note, however,
that there is no change in the FDA Prior
Notice System Interface (FDA PNSI).
Additionally, current § 1.280 states
that, for purposes of submitting prior
notice, prior notice for articles that have
been refused under section 801(m)(1) of
the FD&C Act and our regulations must
be submitted through the FDA PNSI
until such time as we and CBP issue a
determination that ACS or its successor
system can accommodate such
transactions. In addition, current § 1.281
describes what information must be
provided in the prior notice and states
that, until such time as we and CBP
issue a determination that ACS can
accommodate such transactions, the
tracking number may not be submitted
in lieu of other certain information if the
prior notice is submitted via ABI/ACS.
Furthermore, if an article of food is
arriving by express consignment
operator or carrier, our current
regulations state that the tracking
number can only be submitted in certain
circumstances when neither the
submitter nor transmitter is the express
consignment operator or carrier, and the
prior notice is submitted via the FDA
PNSI. We are revising the regulations to
remove these limitations because the
new ACE EDI system can accommodate
such transactions. These faster,
streamlined, and automated processes
allow traders to submit tracking
numbers much more easily. Therefore,
we are removing the limitation that the
tracking number may not be submitted
in lieu of certain other information
throughout the prior notice regulations.
Furthermore, with the tracking
number, we can learn the information
we need to make entry determinations,
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such as port, date and time of arrival,
airway bill, bill of lading, and vessel
name and voyage or flight number.
Removing the condition that the
transmitter or submitter cannot be the
operator or carrier gives submitters more
options for providing the information
we require. Accordingly, the technical
amendment provides greater flexibility
to industry while also allowing us to
screen imported food articles
adequately.
These changes are deregulatory in
nature because they lessen the burden
imposed on traders without impairing
our ability to ensure the safety of
imported food. The expanded
capabilities of the new ACE EDI system
allow for additional flexibility in
submitting certain information. Because
of technical limitations of the former
system, in certain cases the prior notice
information could be submitted only via
FDA PNSI because ACS could not
accommodate such transactions. For
example, ACS could not accept the
tracking number in lieu of other certain
information such as port, date and time
of arrival, airway bill, bill of lading,
vessel name, and voyage or flight
number.
The new ACE EDI system can
accommodate these transactions, which
results in additional flexibility to
industry. Some filers no longer have to
use two systems to file prior notice
information for the same food import
line. In addition, FDA staff will be able
to more efficiently process import entry
submissions and more quickly make the
initial import entry determination for
food imports, in furtherance of our goal
to ensure the safety of imported food.
B. Correcting Number Designations in
Headings and Changing an FDA Office’s
Title
The FDA Food Safety Modernization
Act (FSMA) (Pub. L. 111–353) was
signed into law on January 4, 2011.
Section 304 of FSMA amended section
801(m)(1) of the FD&C Act to require
that a person submitting prior notice of
imported food, in addition to other
information already required, report
‘‘any country to which the article has
been refused entry.’’ On May 5, 2011,
we issued an interim final rule (2011
IFR) (76 FR 25542) implementing
section 304 of FSMA. Specifically, the
2011 IFR amended § 1.281 by adding a
new requirement to paragraphs (a), (b),
and (c) that any person submitting prior
notice of imported food report the name
of any country to which the article has
been refused entry. However, the 2011
IFR neglected to make corresponding
edits to change the paragraph number
designations in the introductory text for
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paragraphs (a), (b), and (c) in § 1.281 to
reflect the additional data element as
added by the 2011 IFR and affirmed in
a final rule published on May 30, 2013
(78 FR 32359). The technical
amendment corrects those designations.
Furthermore, current § 1.285(i)(2)
refers to the ‘‘FDA Prior Notice Center.’’
The office is now named the ‘‘FDA
Division of Food Defense Targeting,’’ so
we are amending § 1.285(i)(2)
accordingly.
III. The Administrative Procedure Act
Publication of this document
constitutes final action of these changes
under the Administrative Procedure Act
(APA) (5 U.S.C. 553). Under 5 U.S.C.
553(b)(3)(B) of the APA, an Agency may,
for good cause, find (and incorporate the
finding and a brief statement of reasons
in the rules issued) that notice and
public comment procedure on a rule is
impracticable, unnecessary, or contrary
to the public interest. We have
determined that notice and public
comment are unnecessary because these
amendments only make technical or
non-substantive, ministerial changes to
reflect the change in an electronic data
interchange system and its expanded
capabilities, correct number
designations in headings as a result of
the FSMA amendments to prior notice,
and amend the name of an FDA office.
For these reasons we have determined
that publishing a notice of proposed
rulemaking and providing opportunity
for public comment is unnecessary.
In addition, we find good cause for
these amendments to become effective
on the date of publication of this action.
The APA allows an effective date less
than 30 days after publication as
‘‘provided by the agency for good cause
found and published with the rule’’ (5
U.S.C. 553(d)(3)). A delayed effective
date is unnecessary in this case because
the amendments do not impose any new
regulatory requirements on affected
parties. As a result, affected parties do
not need time to prepare before the rule
takes effect. Therefore, we find good
cause for this correction to become
effective on the date of publication of
this action.
IV. Paperwork Reduction Act of 1995
This final rule refers to previously
approved 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). The collections of information in
21 CFR part 1, subpart I, have been
approved under OMB control number
0910–0520.
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List of Subjects in 21 CFR Part 1
Cosmetics, Drugs, Exports, Food
labeling, Imports, Labeling, Reporting
and recordkeeping requirements.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 1 is
amended as follows:
PART 1—GENERAL ENFORCEMENT
REGULATIONS
1. The authority citation for part 1
continues to read as follows:
■
Authority: 15 U.S.C. 1333, 1453, 1454,
1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C.
321, 331, 332, 333, 334, 335a, 342, 343, 350c,
350d, 350e, 350j, 350k, 352, 355, 360b,
360ccc, 360ccc–1, 360ccc–2, 362, 371, 373,
374, 379j–31, 381, 382, 384a, 384b, 384d,
387, 387a, 387c, 393; 42 U.S.C. 216, 241, 243,
262, 264, 271; Pub. L. 107–188, 116 Stat. 594,
668–69; Pub. L. 111–353, 124 Stat. 3885,
3889.
2. Amend § 1.279 by revising
paragraph (b)(1) to read as follows:
■
§ 1.279 When must prior notice be
submitted to FDA?
*
*
*
*
*
(b) * * *
(1) If prior notice is submitted via the
Automated Broker Interface/Automated
Commercial Environment/International
Trade Data System (ABI/ACE/ITDS),
you may not submit prior notice more
than 30-calendar days before the
anticipated date of arrival.
*
*
*
*
*
■ 3. Amend § 1.280 by revising
paragraphs (a)(1) and (2) and (b) to read
as follows:
jstallworth on DSK7TPTVN1PROD with RULES
§ 1.280
How must you submit prior notice?
(a) * * *
(1) The U.S. Customs and Border
Protection (CBP) Automated Broker
Interface/Automated Commercial
Environment/International Trade Data
System (ABI/ACE/ITDS); or
(2) The FDA PNSI at https://
www.access.fda.gov/. You must submit
prior notice through the FDA Prior
Notice System Interface (FDA PNSI) for
articles of food imported or offered for
import by international mail, and other
transaction types that cannot be made
through ABI/ACE/ITDS.
(b) If a customhouse broker’s or selffiler’s system is not working or if the
ABI/ACE/ITDS interface is not working,
prior notice must be submitted through
the FDA PNSI.
*
*
*
*
*
■ 4. Amend § 1.281 by revising
paragraphs (a) introductory text,
(a)(11)(iv), (a)(17)(i) and (iii), (b)
introductory text, (c) introductory text,
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(c)(11)(iii), and (c)(17)(i) and (iii) to read
as follows:
§ 1.281 What information must be in a
prior notice?
(a) General. For each article of food
that is imported or offered for import
into the United States, except by
international mail, you must submit the
information for the article that is
required in paragraphs (a)(1) through
(18) of this section:
*
*
*
*
*
(11) * * *
(iv) Notwithstanding paragraphs
(a)(11) introductory text and (a)(11)(i)
through (iii) of this section, if the article
of food is arriving by express
consignment operator or carrier, the
express consignment operator or carrier
tracking number may be submitted in
lieu of the information required in
paragraphs (a)(11) introductory text and
(a)(11)(i) through (iii) of this section.
*
*
*
*
*
(17) * * *
(i) The Airway Bill number(s) or Bill
of Lading number(s), as applicable. This
information is not required for an article
of food when carried by or otherwise
accompanying an individual when
entering the United States. If the article
of food is arriving by express
consignment operator or carrier, the
express consignment operator or carrier
tracking number may by submitted in
lieu of the Airway Bill number(s) or Bill
of Lading number(s), as applicable;
*
*
*
*
*
(iii) For food arriving by air carrier,
the flight number. If the article of food
is arriving by express consignment
operator or carrier, the express
consignment operator or carrier tracking
number may be submitted in lieu of the
flight number;
*
*
*
*
*
(b) Articles arriving by international
mail. For each article of food that is
imported or offered for import into the
United States by international mail, you
must submit the information for the
article that is required in paragraphs
(b)(1) through (12) of this section:
*
*
*
*
*
(c) Refused articles. If the article of
food has been refused under section
801(m)(1) of the act and under this
subpart, you must submit the
information for the article that is
required in paragraphs (c)(1) through
(19) of this section. However, if the
refusal is based on § 1.283(a)(1)(iii)
(Untimely Prior Notice), you do not
have to resubmit any information
previously submitted unless it has
changed or the article has been exported
and the original prior notice was
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15629
submitted through ABI/ACE/ITDS. If the
refusal is based on § 1.283(a)(1)(ii), you
should cancel the previous submission
per § 1.282(b) and (c).
*
*
*
*
*
(11) * * *
(iii) Notwithstanding paragraphs
(c)(11) introductory text and (c)(11)(i)
and (ii) of this section, if the article of
food arrived by express consignment
operator or carrier, the express
consignment operator or carrier tracking
number may be submitted in lieu of the
information required in paragraphs
(c)(11) introductory text and (c)(11)(i)
and (ii) of this section.
*
*
*
*
*
(17) * * *
(i) The Airway Bill number(s) or Bill
of Lading number(s), as applicable;
however, this information is not
required for an article of food when
carried by or otherwise accompanying
an individual when entering the United
States. If the article of food arrived by
express consignment operator or carrier,
the express consignment operator or
carrier tracking number may be
submitted in lieu of the Airway Bill
number(s) or Bill of Lading number(s),
as applicable;
*
*
*
*
*
(iii) For food that arrived by air
carrier, the flight number. If the article
of food arrived by express consignment
operator or carrier, the express
consignment operator or carrier tracking
number may be submitted in lieu of the
flight number;
*
*
*
*
*
■ 5. Amend § 1.282 by revising
paragraph (c) to read as follows:
§ 1.282 What must you do if information
changes after you have received
confirmation of a prior notice from FDA?
*
*
*
*
*
(c) If you submitted the prior notice
via ABI/ACE/ITDS, you should cancel
the prior notice via ACE by requesting
that CBP cancel the entry.
■ 6. Amend § 1.285 by revising the first
sentence in paragraph (i)(2) to read as
follows:
§ 1.285 What happens to food that is
imported or offered for import from
unregistered facilities that are required to
register under subpart H of this part?
*
*
*
*
*
(i) * * *
(2) The FDA Division of Food Defense
Targeting must be notified of the
applicable registration number in
writing.* * *
*
*
*
*
*
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Federal Register / Vol. 82, No. 60 / Thursday, March 30, 2017 / Rules and Regulations
Dated: March 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
Commodity Futures Trading
Commission, qfccontact@cftc.gov
Federal Deposit Insurance Corporation,
Part148QFC@fdic.gov
Securities and Exchange Commission,
QFCContact@sec.gov
[FR Doc. 2017–06201 Filed 3–29–17; 8:45 am]
BILLING CODE 4164–01–P
Authority: 12 U.S.C. 5390(c)(8)(H).
Dated: March 27, 2017.
Monique Y.S. Rollins,
Acting Assistant Secretary for Financial
Markets.
DEPARTMENT OF THE TREASURY
31 CFR Part 148
[FR Doc. 2017–06288 Filed 3–29–17; 8:45 am]
Qualified Financial Contracts
Recordkeeping Related to Orderly
Liquidation Authority
BILLING CODE P
Department of the Treasury.
Notification.
AGENCY:
ACTION:
DEPARTMENT OF HOMELAND
SECURITY
On October 31, 2016, the
Secretary of the Treasury, as
Chairperson of the Financial Stability
Oversight Council, published a final
rule in consultation with the Federal
Deposit Insurance Corporation (the
‘‘FDIC’’) to implement the qualified
financial contract recordkeeping
requirements of the Dodd-Frank Wall
Street Reform and Consumer Protection
Act. This notification provides the
means by which records entities and
top-tier financial companies may submit
the required point of contact
information.
SUMMARY:
DATES:
March 30, 2017.
jstallworth on DSK7TPTVN1PROD with RULES
FOR FURTHER INFORMATION CONTACT:
Brian Smith, Director, Office of Capital
Markets (202) 622–0157; Peter
Nickoloff, Financial Economist, Office
of Capital Markets, (202) 622–1692;
Steven D. Laughton, Assistant General
Counsel (Banking & Finance), (202)
622–8413; or Stephen T. Milligan,
Attorney-Advisor, (202) 622–4051.
SUPPLEMENTARY INFORMATION: Section
148.3(a)(2) of the rule (see 81 FR 75624
(Oct. 31, 2016)) requires each records
entity and top-tier financial company to
provide a point of contact who is
responsible for recordkeeping under the
rule by written notice to its primary
financial regulatory agency or agencies
and the FDIC.1 Each records entity and
top-tier financial company is also
required to provide written notice to its
primary financial regulatory agency or
agencies and the FDIC within 30 days of
any change in its point of contact.
Records entities and top-tier financial
companies may provide such point of
contact information to each of the
following primary financial regulatory
agencies by email at the addresses listed
below:
Board of Governors of the Federal
Reserve System, QFC-Record@frb.gov
1 31
CFR 148.3(a)(2).
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Coast Guard
33 CFR Part 117
[Docket No. USCG–2017–0251
Drawbridge Operation Regulation;
Barnegat Bay, Seaside Heights, NJ
Coast Guard, DHS.
Notice of deviation from
drawbridge regulation.
AGENCY:
ACTION:
The Coast Guard has issued a
temporary deviation from the operating
schedule that governs the S37 Bridge
across the Barnegat Bay, mile 14.1, New
Jersey Intracoastal Waterway, at Seaside
Heights, NJ. This deviation is necessary
to perform bridge maintenance and
repairs. This deviation allows the bridge
to remain in the closed-to-navigation
position.
SUMMARY:
This deviation is effective from
8 p.m. on March 31, 2017, to 8 p.m. on
April 21, 2017.
ADDRESSES: The docket for this
deviation, [USCG–2017–0251] is
available at https://www.regulations.gov.
Type the docket number in the
‘‘SEARCH’’ box and click ‘‘SEARCH’’.
Click on Open Docket Folder on the line
associated with this deviation.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this temporary
deviation, call or email Mr. Hal R. Pitts,
Bridge Administration Branch Fifth
District, Coast Guard, telephone 757–
398–6222, email Hal.R.Pitts@uscg.mil.
SUPPLEMENTARY INFORMATION: The New
Jersey Department of Transportation,
that owns and operates the S37 Bridge,
has requested a temporary deviation
from the current operating regulations to
continue performing a maintenance and
repair project on the bridge that
commenced at 8 a.m. on December 1,
2016, and was scheduled to cease at 8
p.m. on March 31, 2017. The bridge is
a bascule draw bridge and has a vertical
DATES:
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clearance in the closed position of 30
feet above mean high water.
The current operating schedule as set
out in 33 CFR 117.733(c) allows the
bridge to remain in the closed-tonavigation position from 8 a.m. on
December 1, 2016, until 8 p.m. on
March 31, 2017. Under this temporary
deviation, the bridge will continue to
remain in the closed-to-navigation
position from 8 p.m. on March 31, 2017,
to 8 p.m. on April 21, 2017.
The Barnegat Bay on the New Jersey
Intracoastal Waterway is used by a
variety of vessels including small
government and public vessels, small
commercial vessels, and recreational
vessels. The Coast Guard has carefully
considered the nature and volume of
vessel traffic on the waterway in
publishing this temporary deviation.
Vessels able to safely pass through the
bridge in the closed position may do so
at any time. The bridge will not be able
to open for emergencies and there is no
immediate alternate route for vessels to
pass. The Coast Guard will also inform
the users of the waterways through our
Local and Broadcast Notices to Mariners
of the change in operating schedule for
the bridge so that vessel operators can
arrange their transit to minimize any
impact caused by the temporary
deviation.
In accordance with 33 CFR 117.35(e),
the drawbridge must return to its regular
operating schedule immediately at the
end of the effective period of this
temporary deviation. This deviation
from the operating regulations is
authorized under 33 CFR 117.35.
Dated: March 24, 2017.
Hal R. Pitts,
Bridge Program Manager, Fifth Coast Guard
District.
[FR Doc. 2017–06266 Filed 3–29–17; 8:45 am]
BILLING CODE 9110–04–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[Docket Number USCG–2017–0023]
RIN 1625–AA–08
Safety Zone; Charleston Race Week,
Charleston Harbor, Charleston, SC
Coast Guard, DHS.
Temporary final rule.
AGENCY:
ACTION:
The Coast Guard is
establishing a safety zone on the waters
of the Charleston Harbor in Charleston,
SC during the Charleston Race Week
SUMMARY:
E:\FR\FM\30MRR1.SGM
30MRR1
Agencies
[Federal Register Volume 82, Number 60 (Thursday, March 30, 2017)]
[Rules and Regulations]
[Pages 15627-15630]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-06201]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1
[Docket No. FDA-2017-N-0011]
Requirements To Submit Prior Notice of Imported Food; Technical
Amendments
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is amending the
prior notice of imported food regulations to reflect a change in the
electronic data interchange system and its expanded capabilities, to
correct inaccurate number designations in section headings, and to
reflect a change in an office's name. This action is ministerial or
editorial in nature.
DATES: This rule is effective March 30, 2017.
FOR FURTHER INFORMATION CONTACT: Jennifer Thomas, Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740, 240-402-2094.
SUPPLEMENTARY INFORMATION:
I. Background
Section 801(m) of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 381(m)) requires that FDA establish regulations
requiring that those persons importing articles of food or offering
articles of food for import into the United States submit certain
information about imported foods before the products' arrival in the
United States. We have established the regulations at title 21, Code of
Federal Regulations (CFR) part 1, subpart I (21 CFR 1.276 to 1.285).
Section 801(m) of the FD&C Act also provides that an article of food
imported or offered for import is subject to refusal of admission into
the United States if adequate prior notice has not been provided to
FDA. Our regulations in 21 CFR part 1, subpart I, include information
on when to submit prior notice, how to submit prior notice, and what
information is required in a prior notice.
II. Description of the Technical Amendments
We are making technical amendments in our prior notice regulations
in part 1, subpart I (Sec. Sec. 1.276 to 1.285), to:
Reflect the change in an electronic data interchange
system and its expanded capabilities;
correct paragraph number designations in certain
introductory text paragraphs; and
revise the name of an FDA office receiving certain
information.
The technical amendments are ministerial or editorial in nature and
are not intended to modify any substantive requirements.
A. Revising an Electronic Data Interchange System and Recognizing Its
Expanded Capabilities
Our current regulations, at Sec. Sec. 1.279, 1.280, 1.281, and
1.282, refer to the ``Automated Broker Interface/Automated Commercial
System (ABI/ACS)'' or ``Automated Broker Interface of the Automated
Commercial System (ABI/ACS).'' We are amending these regulations to
reflect the change of the electronic data interchange system from
``Automated Broker Interface/Automated Commercial System (ABI/ACS)'' or
``Automated Broker Interface of the Automated Commercial System (ABI/
ACS)'' to ``Automated Broker Interface/Automated Commercial
Environment/International Trade Data System (ABI/ACE/ITDS).'' In the
Federal Register of May 16, 2016 (81 FR 30320), the Department of
Homeland Security's U.S. Customs and Border Protection (CBP) issued a
notice
[[Page 15628]]
announcing that the Automated Commercial Environment (ACE) will be the
sole electronic data interchange (EDI) system authorized by the
Commissioner of CBP for processing electronic entries and entry
summaries associated with the entry types specified in the notice, for
merchandise that is subject to our import requirements. The notice also
announced that the Automated Commercial System (ACS) will no longer be
a CBP-authorized EDI system for purposes of processing these electronic
filings. Therefore, we are revising our regulations at Sec. Sec.
1.279, 1.280, 1.281, and 1.282 by replacing all references to the
``Automated Broker Interface/Automated Commercial System (ABI/ACS)''
and ``Automated Broker Interface of the Automated Commercial System
(ABI/ACS)'' with ``Automated Broker Interface/Automated Commercial
Environment/International Trade Data System (ABI/ACE/ITDS)'' to
accurately identify the current EDI system. We note, however, that
there is no change in the FDA Prior Notice System Interface (FDA PNSI).
Additionally, current Sec. 1.280 states that, for purposes of
submitting prior notice, prior notice for articles that have been
refused under section 801(m)(1) of the FD&C Act and our regulations
must be submitted through the FDA PNSI until such time as we and CBP
issue a determination that ACS or its successor system can accommodate
such transactions. In addition, current Sec. 1.281 describes what
information must be provided in the prior notice and states that, until
such time as we and CBP issue a determination that ACS can accommodate
such transactions, the tracking number may not be submitted in lieu of
other certain information if the prior notice is submitted via ABI/ACS.
Furthermore, if an article of food is arriving by express consignment
operator or carrier, our current regulations state that the tracking
number can only be submitted in certain circumstances when neither the
submitter nor transmitter is the express consignment operator or
carrier, and the prior notice is submitted via the FDA PNSI. We are
revising the regulations to remove these limitations because the new
ACE EDI system can accommodate such transactions. These faster,
streamlined, and automated processes allow traders to submit tracking
numbers much more easily. Therefore, we are removing the limitation
that the tracking number may not be submitted in lieu of certain other
information throughout the prior notice regulations.
Furthermore, with the tracking number, we can learn the information
we need to make entry determinations, such as port, date and time of
arrival, airway bill, bill of lading, and vessel name and voyage or
flight number. Removing the condition that the transmitter or submitter
cannot be the operator or carrier gives submitters more options for
providing the information we require. Accordingly, the technical
amendment provides greater flexibility to industry while also allowing
us to screen imported food articles adequately.
These changes are deregulatory in nature because they lessen the
burden imposed on traders without impairing our ability to ensure the
safety of imported food. The expanded capabilities of the new ACE EDI
system allow for additional flexibility in submitting certain
information. Because of technical limitations of the former system, in
certain cases the prior notice information could be submitted only via
FDA PNSI because ACS could not accommodate such transactions. For
example, ACS could not accept the tracking number in lieu of other
certain information such as port, date and time of arrival, airway
bill, bill of lading, vessel name, and voyage or flight number.
The new ACE EDI system can accommodate these transactions, which
results in additional flexibility to industry. Some filers no longer
have to use two systems to file prior notice information for the same
food import line. In addition, FDA staff will be able to more
efficiently process import entry submissions and more quickly make the
initial import entry determination for food imports, in furtherance of
our goal to ensure the safety of imported food.
B. Correcting Number Designations in Headings and Changing an FDA
Office's Title
The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) was
signed into law on January 4, 2011. Section 304 of FSMA amended section
801(m)(1) of the FD&C Act to require that a person submitting prior
notice of imported food, in addition to other information already
required, report ``any country to which the article has been refused
entry.'' On May 5, 2011, we issued an interim final rule (2011 IFR) (76
FR 25542) implementing section 304 of FSMA. Specifically, the 2011 IFR
amended Sec. 1.281 by adding a new requirement to paragraphs (a), (b),
and (c) that any person submitting prior notice of imported food report
the name of any country to which the article has been refused entry.
However, the 2011 IFR neglected to make corresponding edits to change
the paragraph number designations in the introductory text for
paragraphs (a), (b), and (c) in Sec. 1.281 to reflect the additional
data element as added by the 2011 IFR and affirmed in a final rule
published on May 30, 2013 (78 FR 32359). The technical amendment
corrects those designations.
Furthermore, current Sec. 1.285(i)(2) refers to the ``FDA Prior
Notice Center.'' The office is now named the ``FDA Division of Food
Defense Targeting,'' so we are amending Sec. 1.285(i)(2) accordingly.
III. The Administrative Procedure Act
Publication of this document constitutes final action of these
changes under the Administrative Procedure Act (APA) (5 U.S.C. 553).
Under 5 U.S.C. 553(b)(3)(B) of the APA, an Agency may, for good cause,
find (and incorporate the finding and a brief statement of reasons in
the rules issued) that notice and public comment procedure on a rule is
impracticable, unnecessary, or contrary to the public interest. We have
determined that notice and public comment are unnecessary because these
amendments only make technical or non-substantive, ministerial changes
to reflect the change in an electronic data interchange system and its
expanded capabilities, correct number designations in headings as a
result of the FSMA amendments to prior notice, and amend the name of an
FDA office. For these reasons we have determined that publishing a
notice of proposed rulemaking and providing opportunity for public
comment is unnecessary.
In addition, we find good cause for these amendments to become
effective on the date of publication of this action. The APA allows an
effective date less than 30 days after publication as ``provided by the
agency for good cause found and published with the rule'' (5 U.S.C.
553(d)(3)). A delayed effective date is unnecessary in this case
because the amendments do not impose any new regulatory requirements on
affected parties. As a result, affected parties do not need time to
prepare before the rule takes effect. Therefore, we find good cause for
this correction to become effective on the date of publication of this
action.
IV. Paperwork Reduction Act of 1995
This final rule refers to previously approved 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). The
collections of information in 21 CFR part 1, subpart I, have been
approved under OMB control number 0910-0520.
[[Page 15629]]
List of Subjects in 21 CFR Part 1
Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling,
Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
1 is amended as follows:
PART 1--GENERAL ENFORCEMENT REGULATIONS
0
1. The authority citation for part 1 continues to read as follows:
Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C.
1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342, 343, 350c,
350d, 350e, 350j, 350k, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2,
362, 371, 373, 374, 379j-31, 381, 382, 384a, 384b, 384d, 387, 387a,
387c, 393; 42 U.S.C. 216, 241, 243, 262, 264, 271; Pub. L. 107-188,
116 Stat. 594, 668-69; Pub. L. 111-353, 124 Stat. 3885, 3889.
0
2. Amend Sec. 1.279 by revising paragraph (b)(1) to read as follows:
Sec. 1.279 When must prior notice be submitted to FDA?
* * * * *
(b) * * *
(1) If prior notice is submitted via the Automated Broker
Interface/Automated Commercial Environment/International Trade Data
System (ABI/ACE/ITDS), you may not submit prior notice more than 30-
calendar days before the anticipated date of arrival.
* * * * *
0
3. Amend Sec. 1.280 by revising paragraphs (a)(1) and (2) and (b) to
read as follows:
Sec. 1.280 How must you submit prior notice?
(a) * * *
(1) The U.S. Customs and Border Protection (CBP) Automated Broker
Interface/Automated Commercial Environment/International Trade Data
System (ABI/ACE/ITDS); or
(2) The FDA PNSI at https://www.access.fda.gov/. You must submit
prior notice through the FDA Prior Notice System Interface (FDA PNSI)
for articles of food imported or offered for import by international
mail, and other transaction types that cannot be made through ABI/ACE/
ITDS.
(b) If a customhouse broker's or self-filer's system is not working
or if the ABI/ACE/ITDS interface is not working, prior notice must be
submitted through the FDA PNSI.
* * * * *
0
4. Amend Sec. 1.281 by revising paragraphs (a) introductory text,
(a)(11)(iv), (a)(17)(i) and (iii), (b) introductory text, (c)
introductory text, (c)(11)(iii), and (c)(17)(i) and (iii) to read as
follows:
Sec. 1.281 What information must be in a prior notice?
(a) General. For each article of food that is imported or offered
for import into the United States, except by international mail, you
must submit the information for the article that is required in
paragraphs (a)(1) through (18) of this section:
* * * * *
(11) * * *
(iv) Notwithstanding paragraphs (a)(11) introductory text and
(a)(11)(i) through (iii) of this section, if the article of food is
arriving by express consignment operator or carrier, the express
consignment operator or carrier tracking number may be submitted in
lieu of the information required in paragraphs (a)(11) introductory
text and (a)(11)(i) through (iii) of this section.
* * * * *
(17) * * *
(i) The Airway Bill number(s) or Bill of Lading number(s), as
applicable. This information is not required for an article of food
when carried by or otherwise accompanying an individual when entering
the United States. If the article of food is arriving by express
consignment operator or carrier, the express consignment operator or
carrier tracking number may by submitted in lieu of the Airway Bill
number(s) or Bill of Lading number(s), as applicable;
* * * * *
(iii) For food arriving by air carrier, the flight number. If the
article of food is arriving by express consignment operator or carrier,
the express consignment operator or carrier tracking number may be
submitted in lieu of the flight number;
* * * * *
(b) Articles arriving by international mail. For each article of
food that is imported or offered for import into the United States by
international mail, you must submit the information for the article
that is required in paragraphs (b)(1) through (12) of this section:
* * * * *
(c) Refused articles. If the article of food has been refused under
section 801(m)(1) of the act and under this subpart, you must submit
the information for the article that is required in paragraphs (c)(1)
through (19) of this section. However, if the refusal is based on Sec.
1.283(a)(1)(iii) (Untimely Prior Notice), you do not have to resubmit
any information previously submitted unless it has changed or the
article has been exported and the original prior notice was submitted
through ABI/ACE/ITDS. If the refusal is based on Sec. 1.283(a)(1)(ii),
you should cancel the previous submission per Sec. 1.282(b) and (c).
* * * * *
(11) * * *
(iii) Notwithstanding paragraphs (c)(11) introductory text and
(c)(11)(i) and (ii) of this section, if the article of food arrived by
express consignment operator or carrier, the express consignment
operator or carrier tracking number may be submitted in lieu of the
information required in paragraphs (c)(11) introductory text and
(c)(11)(i) and (ii) of this section.
* * * * *
(17) * * *
(i) The Airway Bill number(s) or Bill of Lading number(s), as
applicable; however, this information is not required for an article of
food when carried by or otherwise accompanying an individual when
entering the United States. If the article of food arrived by express
consignment operator or carrier, the express consignment operator or
carrier tracking number may be submitted in lieu of the Airway Bill
number(s) or Bill of Lading number(s), as applicable;
* * * * *
(iii) For food that arrived by air carrier, the flight number. If
the article of food arrived by express consignment operator or carrier,
the express consignment operator or carrier tracking number may be
submitted in lieu of the flight number;
* * * * *
0
5. Amend Sec. 1.282 by revising paragraph (c) to read as follows:
Sec. 1.282 What must you do if information changes after you have
received confirmation of a prior notice from FDA?
* * * * *
(c) If you submitted the prior notice via ABI/ACE/ITDS, you should
cancel the prior notice via ACE by requesting that CBP cancel the
entry.
0
6. Amend Sec. 1.285 by revising the first sentence in paragraph (i)(2)
to read as follows:
Sec. 1.285 What happens to food that is imported or offered for
import from unregistered facilities that are required to register under
subpart H of this part?
* * * * *
(i) * * *
(2) The FDA Division of Food Defense Targeting must be notified of
the applicable registration number in writing.* * *
* * * * *
[[Page 15630]]
Dated: March 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-06201 Filed 3-29-17; 8:45 am]
BILLING CODE 4164-01-P