30 day FRN

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:

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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Substances; Draft Guidance for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Substances; Draft Guidance for Industry;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The document announced a draft
guidance that provides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]
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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:

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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 [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

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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-

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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: http://
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.

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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]
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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.

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Brock Long,
Administrator, Federal Emergency
Management Agency.
[FR Doc. 2018–20320 Filed 9–18–18; 8:45 am]
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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:

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