Agency Information Collection Activities: Application for Foreign-Trade Zone Admission and/or Status Designation, and Application for Foreign-Trade Zone Activity Permit, 47345-47346 [2018-20306]

Download as PDF Federal Register / Vol. 83, No. 182 / Wednesday, September 19, 2018 / Notices Dated: September 14, 2018. Martique Jones, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2018–20372 Filed 9–18–18; 8:45 am] U.S. Customs and Border Protection [1651–0029] DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency Information Collection Activities: Application for ForeignTrade Zone Admission and/or Status Designation, and Application for Foreign-Trade Zone Activity Permit Food and Drug Administration AGENCY: BILLING CODE 4120–01–P U.S. Customs and Border Protection (CBP), Department of Homeland Security. ACTION: 30-Day notice and request for comments; extension of an existing collection of information. [Docket No. FDA–2018–D–3152] Postapproval Changes to Drug Substances; Draft Guidance for Industry; Availability; Correction AGENCY: Notice; correction. The Food and Drug Administration is correcting a notice entitled ‘‘Postapproval Changes to Drug Substances; Draft Guidance for Industry; Availability’’ that appeared in the Federal Register of September 11, 2018. The document announced a draft guidance that provides recommendations to holders of approved new drug applications, abbreviated new drug applications, new animal drug applications, abbreviated new animal drug applications, and holders of drug master files and veterinary master files who may want to make a change to the drug substance manufacturing process during the drug product application postapproval period. The document was published with the incorrect docket number. This document corrects that error. FOR FURTHER INFORMATION CONTACT: Lisa Granger, Office of Policy and Planning, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3330, Silver Spring, MD 20993–0002, 301–796–9115. SUPPLEMENTARY INFORMATION: In the Federal Register of Tuesday, September 11, 2018 (83 FR 45944), in FR Doc. 2018–19666, on page 45944, the following correction is made: On page 45944, in the first column, in the header of the document, and also in the third column under Instructions, ‘‘Docket No. FDA–2018–D–3151’’ is corrected to read ‘‘Docket No. FDA– 2018–D–3152’’. SUMMARY: Dated: September 12, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–20317 Filed 9–18–18; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 17:09 Sep 18, 2018 Jkt 244001 The Department of Homeland Security, U.S. Customs and Border Protection will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). The information collection is published in the Federal Register to obtain comments from the public and affected agencies. Comments are encouraged and will be accepted no later than October 19, 2018 to be assured of consideration. ADDRESSES: Interested persons are invited to submit written comments on this proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should be addressed to the OMB Desk Officer for Customs and Border Protection, Department of Homeland Security, and sent via electronic mail to dhsdeskofficer@ omb.eop.gov. SUMMARY: Food and Drug Administration, HHS ACTION: amozie on DSK3GDR082PROD with NOTICES1 DEPARTMENT OF HOMELAND SECURITY FOR FURTHER INFORMATION CONTACT: Requests for additional PRA information should be directed to Seth Renkema, Chief, Economic Impact Analysis Branch, U.S. Customs and Border Protection, Office of Trade, Regulations and Rulings, 90 K Street NE, 10th Floor, Washington, DC 20229–1177, Telephone number (202) 325–0056 or via email CBP_PRA@cbp.dhs.gov. Please note that the contact information provided here is solely for questions regarding this notice. Individuals seeking information about other CBP programs should contact the CBP National Customer Service Center at 877–227–5511, (TTY) 1–800–877–8339, or CBP website at https://www.cbp .gov/. SUPPLEMENTARY INFORMATION: CBP invites the general public and other Federal agencies to comment on the proposed and/or continuing information collections pursuant to the Paperwork PO 00000 Frm 00018 Fmt 4703 Sfmt 4703 47345 Reduction Act of 1995 (44 U.S.C. 3501 et seq.). This proposed information collection was previously published in the Federal Register (Volume 83 FR Page 23286) on May 18, 2018, allowing for a 60-day comment period. This notice allows for an additional 30 days for public comments. This process is conducted in accordance with 5 CFR 1320.8. Written comments and suggestions from the public and affected agencies should address one or more of the following four points: (1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) suggestions to enhance the quality, utility, and clarity of the information to be collected; and (4) suggestions to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. The comments that are submitted will be summarized and included in the request for approval. All comments will become a matter of public record. Overview of This Information Collection Title: Application for Foreign-Trade Zone Admission and/or Status Designation, and Application for Foreign-Trade Zone Activity Permit. OMB Number: 1651–0029. Form Numbers: 214, 214A, 214B, 214C, and 216. Type of Review: Extension (without change). Action: CBP proposes to extend the expiration date of this information collection with no change to the burden hours or to CBP Forms 214, 214A, 214B, 214C, and 216. Affected Public: Businesses. Abstract: Foreign trade zones (FTZs) are geographical enclaves located within the geographical limits of the United States but for tariff purposes are considered to be outside the United States. Imported merchandise may be brought into FTZs for storage, manipulation, manufacture or other processing and subsequent removal for exportation, consumption in the United States, or destruction. A company bringing goods into an FTZ has a choice of zone status (privileged/nonprivileged foreign, domestic, or zone- E:\FR\FM\19SEN1.SGM 19SEN1 47346 Federal Register / Vol. 83, No. 182 / Wednesday, September 19, 2018 / Notices restricted), which affects the way such goods are treated by Customs and Border Protection (CBP) and treated for tariff purposes upon entry into the customs territory of the U.S. CBP Forms 214, 214A, 214B, and 214C, which make up the Application for Foreign-Trade Zone Admission and/ or Status Designation, are used by companies that bring merchandise into an FTZ to register the admission of such merchandise into FTZs and to apply for the appropriate zone status. CBP Form 216, Foreign-Trade Zone Activity Permit, is used by companies to request approval to manipulate, manufacture, exhibit, or destroy merchandise in an FTZ. These FTZ forms are authorized by 19 U.S.C. 81 and provided for by 19 CFR 146.22, 146.32, 146.39, 146.40, 146.41, 146.44, 146.52, 146.53, and 146.66. These forms are accessible at: https:// www.cbp.gov/newsroom/publications/ forms. Form 214, Application for ForeignTrade Zone Admission and/or Status Designation Estimated Number of Respondents: 6,749. Estimated Number of Annual Responses per Respondent: 25. Estimated Total Annual Responses: 168,725. Estimated Time per Response: 15 minutes. Estimated Total Annual Burden Hours: 42,181. Form 216, Application for ForeignTrade Zone Activity Permit Estimated Number of Respondents: 2,500. Estimated Number of Annual Responses per Respondent: 10. Estimated Total Annual Responses: 25,000. Estimated Time per Response: 10 minutes. Estimated Total Annual Burden Hours: 4,167. amozie on DSK3GDR082PROD with NOTICES1 Dated: September 13, 2018. Seth D. Renkema, Branch Chief, Economic Impact Analysis Branch, U.S. Customs and Border Protection. [FR Doc. 2018–20306 Filed 9–18–18; 8:45 am] BILLING CODE 9111–14–P VerDate Sep<11>2014 17:09 Sep 18, 2018 Jkt 244001 DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency Further, you are authorized to make changes to this declaration for the approved assistance to the extent allowable under the Stafford Act. Federal Emergency Management Agency, DHS. ACTION: Notice. The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Timothy B. Manner, of FEMA is appointed to act as the Federal Coordinating Officer for this major disaster. The following areas have been designated as adversely affected by this major disaster: This is a notice of the Presidential declaration of a major disaster for the Confederated Tribes of the Colville Reservation (FEMA–4384– DR), dated August 17, 2018, and related determinations. DATES: The declaration was issued August 17, 2018. FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, (202) 646–2833. SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter dated August 17, 2018, the President issued a major disaster declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ‘‘Stafford Act’’), as follows: The Confederated Tribes of the Colville Reservation for Public Assistance. The Confederated Tribes of the Colville Reservation are eligible to apply for assistance under the Hazard Mitigation Grant Program. The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance— Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant. [Internal Agency Docket No. FEMA–4384– DR; Docket ID FEMA–2018–0001] Confederated Tribes of the Colville Reservation; Major Disaster and Related Determinations AGENCY: SUMMARY: I have determined that the damage to the lands associated with the Confederated Tribes of the Colville Reservation resulting from flooding during the period of May 5 to May 28, 2018, is of sufficient severity and magnitude to warrant a major disaster declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ‘‘Stafford Act’’). Therefore, I declare that such a major disaster exists for the Confederated Tribes of the Colville Reservation. In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal disaster assistance and administrative expenses. You are authorized to provide Public Assistance and Hazard Mitigation for the Confederated Tribes of the Colville Reservation. Consistent with the requirement that Federal assistance be supplemental, any Federal funds provided under the Stafford Act for Hazard Mitigation will be limited to 75 percent of the total eligible costs. Federal funds provided under the Stafford Act for Public Assistance also will be limited to 75 percent of the total eligible costs, with the exception of projects that meet the eligibility criteria for a higher Federal cost-sharing percentage under the Public Assistance Alternative Procedures Pilot Program for Debris Removal implemented pursuant to Section 428 of the Stafford Act. PO 00000 Frm 00019 Fmt 4703 Sfmt 4703 Brock Long, Administrator, Federal Emergency Management Agency. [FR Doc. 2018–20320 Filed 9–18–18; 8:45 am] BILLING CODE 9111–11–P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Internal Agency Docket No. FEMA–4385– DR; Docket ID FEMA–2018–0001] Connecticut; Major Disaster and Related Determinations Federal Emergency Management Agency, DHS. ACTION: Notice. AGENCY: This is a notice of the Presidential declaration of a major disaster for the State of Connecticut (FEMA–4385–DR), dated August 20, 2018, and related determinations. DATES: The declaration was issued August 20, 2018. FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and SUMMARY: E:\FR\FM\19SEN1.SGM 19SEN1

Agencies

[Federal Register Volume 83, Number 182 (Wednesday, September 19, 2018)]
[Notices]
[Pages 47345-47346]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20306]


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DEPARTMENT OF HOMELAND SECURITY

U.S. Customs and Border Protection

[1651-0029]


Agency Information Collection Activities: Application for 
Foreign-Trade Zone Admission and/or Status Designation, and Application 
for Foreign-Trade Zone Activity Permit

AGENCY: U.S. Customs and Border Protection (CBP), Department of 
Homeland Security.

ACTION: 30-Day notice and request for comments; extension of an 
existing collection of information.

-----------------------------------------------------------------------

SUMMARY: The Department of Homeland Security, U.S. Customs and Border 
Protection will be submitting the following information collection 
request to the Office of Management and Budget (OMB) for review and 
approval in accordance with the Paperwork Reduction Act of 1995 (PRA). 
The information collection is published in the Federal Register to 
obtain comments from the public and affected agencies. Comments are 
encouraged and will be accepted no later than October 19, 2018 to be 
assured of consideration.

ADDRESSES: Interested persons are invited to submit written comments on 
this proposed information collection to the Office of Information and 
Regulatory Affairs, Office of Management and Budget. Comments should be 
addressed to the OMB Desk Officer for Customs and Border Protection, 
Department of Homeland Security, and sent via electronic mail to 
[email protected].

FOR FURTHER INFORMATION CONTACT: Requests for additional PRA 
information should be directed to Seth Renkema, Chief, Economic Impact 
Analysis Branch, U.S. Customs and Border Protection, Office of Trade, 
Regulations and Rulings, 90 K Street NE, 10th Floor, Washington, DC 
20229-1177, Telephone number (202) 325-0056 or via email 
[email protected]. Please note that the contact information provided 
here is solely for questions regarding this notice. Individuals seeking 
information about other CBP programs should contact the CBP National 
Customer Service Center at 877-227-5511, (TTY) 1-800-877-8339, or CBP 
website at https://www.cbp.gov/.

SUPPLEMENTARY INFORMATION: CBP invites the general public and other 
Federal agencies to comment on the proposed and/or continuing 
information collections pursuant to the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501 et seq.). This proposed information collection was 
previously published in the Federal Register (Volume 83 FR Page 23286) 
on May 18, 2018, allowing for a 60-day comment period. This notice 
allows for an additional 30 days for public comments. This process is 
conducted in accordance with 5 CFR 1320.8. Written comments and 
suggestions from the public and affected agencies should address one or 
more of the following four points: (1) Whether the proposed collection 
of information is necessary for the proper performance of the functions 
of the agency, including whether the information will have practical 
utility; (2) the accuracy of the agency's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) suggestions to enhance the 
quality, utility, and clarity of the information to be collected; and 
(4) suggestions to minimize the burden of the collection of information 
on those who are to respond, including through the use of appropriate 
automated, electronic, mechanical, or other technological collection 
techniques or other forms of information technology, e.g., permitting 
electronic submission of responses. The comments that are submitted 
will be summarized and included in the request for approval. All 
comments will become a matter of public record.

Overview of This Information Collection

    Title: Application for Foreign-Trade Zone Admission and/or Status 
Designation, and Application for Foreign-Trade Zone Activity Permit.
    OMB Number: 1651-0029.
    Form Numbers: 214, 214A, 214B, 214C, and 216.
    Type of Review: Extension (without change).
    Action: CBP proposes to extend the expiration date of this 
information collection with no change to the burden hours or to CBP 
Forms 214, 214A, 214B, 214C, and 216.
    Affected Public: Businesses.
    Abstract: Foreign trade zones (FTZs) are geographical enclaves 
located within the geographical limits of the United States but for 
tariff purposes are considered to be outside the United States. 
Imported merchandise may be brought into FTZs for storage, 
manipulation, manufacture or other processing and subsequent removal 
for exportation, consumption in the United States, or destruction. A 
company bringing goods into an FTZ has a choice of zone status 
(privileged/non-privileged foreign, domestic, or zone-

[[Page 47346]]

restricted), which affects the way such goods are treated by Customs 
and Border Protection (CBP) and treated for tariff purposes upon entry 
into the customs territory of the U.S.
    CBP Forms 214, 214A, 214B, and 214C, which make up the Application 
for Foreign-Trade Zone Admission and/or Status Designation, are used by 
companies that bring merchandise into an FTZ to register the admission 
of such merchandise into FTZs and to apply for the appropriate zone 
status. CBP Form 216, Foreign-Trade Zone Activity Permit, is used by 
companies to request approval to manipulate, manufacture, exhibit, or 
destroy merchandise in an FTZ.
    These FTZ forms are authorized by 19 U.S.C. 81 and provided for by 
19 CFR 146.22, 146.32, 146.39, 146.40, 146.41, 146.44, 146.52, 146.53, 
and 146.66. These forms are accessible at: https://www.cbp.gov/newsroom/publications/forms.
    Form 214, Application for Foreign-Trade Zone Admission and/or 
Status Designation
    Estimated Number of Respondents: 6,749.
    Estimated Number of Annual Responses per Respondent: 25.
    Estimated Total Annual Responses: 168,725.
    Estimated Time per Response: 15 minutes.
    Estimated Total Annual Burden Hours: 42,181.
    Form 216, Application for Foreign-Trade Zone Activity Permit
    Estimated Number of Respondents: 2,500.
    Estimated Number of Annual Responses per Respondent: 10.
    Estimated Total Annual Responses: 25,000.
    Estimated Time per Response: 10 minutes.
    Estimated Total Annual Burden Hours: 4,167.

    Dated: September 13, 2018.
Seth D. Renkema,
Branch Chief, Economic Impact Analysis Branch, U.S. Customs and Border 
Protection.
[FR Doc. 2018-20306 Filed 9-18-18; 8:45 am]
 BILLING CODE 9111-14-P
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