Requirements To Submit Prior Notice of Imported Food; Technical Amendments, 15627-15630 [2017-06201]

Download as PDF 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; http:// 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: http://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. VerDate Sep<11>2014 14:26 Mar 29, 2017 Jkt 241001 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 PO 00000 Frm 00019 Fmt 4700 Sfmt 4700 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 E:\FR\FM\30MRR1.SGM 30MRR1 jstallworth on DSK7TPTVN1PROD with RULES 15628 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, VerDate Sep<11>2014 14:26 Mar 29, 2017 Jkt 241001 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 PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 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. E:\FR\FM\30MRR1.SGM 30MRR1 Federal Register / Vol. 82, No. 60 / Thursday, March 30, 2017 / Rules and Regulations 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, VerDate Sep<11>2014 14:26 Mar 29, 2017 Jkt 241001 (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 PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 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.* * * * * * * * E:\FR\FM\30MRR1.SGM 30MRR1 15630 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). VerDate Sep<11>2014 14:26 Mar 29, 2017 Jkt 241001 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 http://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: PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 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.

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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