60-Day notice

Federal Register / Vol. 79, No. 136 / Wednesday, July 16, 2014 / Notices
I. Background

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–0917]

Small Entity Compliance Guide:
Requirements for the Submission of
Data Needed To Calculate User Fees
for Domestic Manufacturers and
Importers of Tobacco Products;
Availability
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice.

The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Requirements for the
Submission of Data Needed to Calculate
User Fees for Domestic Manufacturers
and Importers of Tobacco Products—
Small Entity Compliance Guide’’ for a
final rule published in the Federal
Register of July 10, 2014. This small
entity compliance guide (SECG) is
intended to set forth in plain language
the requirements of the regulation and
to help small businesses understand and
comply with the regulation.
DATES: Submit either electronic or
written comments on the SECG at any
time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Center for Tobacco Products, Food and
Drug Administration, Document Control
Center, ATTN: Office of Small Business
Assistance, Bldg. 71, Rm. G335, 10903
New Hampshire Ave., Silver Spring, MD
20993–0002. Send one self-addressed
adhesive label to assist that office in
processing your request or include a fax
number to which the guidance
document may be sent. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance.
Submit electronic comments on the
guidance to http://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852. Identify comments with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Nancy Boocker or Annette Marthaler,
Center for Tobacco Products, Food and
Drug Administration, Document Control
Center, Bldg. 71, Rm. G335, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002, 1–877–287–1373,
[email protected].
SUPPLEMENTARY INFORMATION:

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SUMMARY:

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In the Federal Register of July 10,
2014 (79 FR 39302), FDA issued a final
rule to add 21 CFR part 1150 to require
domestic manufacturers and importers
of tobacco products to submit to FDA
information needed to calculate the
amount of user fees assessed under the
Federal Food, Drug, and Cosmetic Act.
In compliance with section 212 of the
Small Business Regulatory Enforcement
Fairness Act (Pub. L. 104–121), FDA is
making available this SECG stating in
plain language the legal requirements of
the July 10, 2014, final rule, set forth in
21 CFR part 1150.
FDA is issuing this SECG as level 2
guidance consistent with FDA’s good
guidance practices regulation (21 CFR
10.115(c)(2)). The SECG represents the
Agency’s current thinking on this topic.
It does not create or confer any rights for
or on any person and does not operate
to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit either
electronic comments regarding this
document to http://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at http://
www.regulations.gov.
III. Electronic Access
Persons with access to the Internet
may obtain an electronic version of the
guidance at either http://
www.regulations.gov or http://
www.fda.gov/TobaccoProducts/
GuidanceComplianceRegulatory
Information/default.htm.
Dated: July 10, 2014.
Peter Lurie,
Associate Commissioner for Policy and
Planning.
[FR Doc. 2014–16590 Filed 7–15–14; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
U.S. Citizenship and Immigration
Services
[OMB Control Number 1615–0018]

Agency Information Collection
Activities: Application for Permission
To Reapply for Admission Into the
United States After Deportation or
Removal, Form I–212; Revision of a
Currently Approved Collection
ACTION:

*

60-Day notice.

*

*
*
*
The Department of Homeland
Security (DHS), U.S. Citizenship and
Immigration Services (USCIS) invites
the general public and other Federal
agencies to comment upon this
proposed revision of a currently
approved collection of information. In
accordance with the Paperwork
Reduction Act (PRA) of 1995, the
information collection notice is
published in the Federal Register to
obtain comments regarding the nature of
the information collection, the
categories of respondents, the estimated
burden (i.e., the time, effort, and
resources used by the respondents to
respond), the estimated cost to the
respondent, and the actual information
collection instruments.
DATES: Comments are encouraged and
will be accepted for 60 days until
September 15, 2014.
ADDRESSES: All submissions received
must include the OMB Control Number
1615–0018 in the subject box, the
agency name and Docket ID USCIS–
2008–0068. To avoid duplicate
submissions, please use only one of the
following methods to submit comments:
(1) Online. You may access the
Federal Register Notice and submit
comments via the Federal eRulemaking
Portal Web site by visiting
www.regulations.gov. In the search box
either copy and paste, or type in, the eDocket ID number USCIS–2008–0068.
Click on the link titled Open Docket
Folder for the appropriate Notice and
supporting documents, and click the
Comment Now tab to submit a
comment;
(2) Email. Submit comments to
[email protected];
(3) Mail. Submit written comments to
DHS, USCIS, Office of Policy and
Strategy, Chief, Regulatory Coordination
Division, 20 Massachusetts Avenue
NW., Washington, DC 20529–2140.
SUPPLEMENTARY INFORMATION:
Comments: Regardless of the method
used for submitting comments or
SUMMARY:

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Federal Register / Vol. 79, No. 136 / Wednesday, July 16, 2014 / Notices

material, all submissions will be posted,
without change, to the Federal
eRulemaking Portal at http://
www.regulations.gov, and will include
any personal information you provide.
Therefore, submitting this information
makes it public. You may wish to
consider limiting the amount of
personal information that you provide
in any voluntary submission you make
to DHS. DHS may withhold information
provided in comments from public
viewing that it determines may impact
the privacy of an individual or is
offensive. For additional information,
please read the Privacy Act notice that
is available via the link in the footer of
http://www.regulations.gov.
Note: The address listed in this notice
should only be used to submit comments
concerning this information collection.
Please do not submit requests for individual
case status inquiries to this address. If you
are seeking information about the status of
your individual case, please check ‘‘My Case
Status’’ online at: https://egov.uscis.gov/cris/
Dashboard.do, or call the USCIS National
Customer Service Center at 1–800–375–5283.

Written comments and suggestions
from the public and affected agencies
should address one or more of the
following four points:
(1) Evaluate 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) Evaluate 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) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) 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.

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Overview of This Information
Collection
(1) Type of Information Collection:
Revision of a Currently Approved
Collection.
(2) Title of the Form/Collection:
Application for Permission to Reapply
for Admission into the United States
after Deportation or Removal.
(3) Agency form number, if any, and
the applicable component of the DHS
sponsoring the collection: I–212; USCIS.

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(4) Affected public who will be asked
or required to respond, as well as a brief
abstract: Primary: Individuals or
households. The information provided
on Form I–212 is used by USCIS to
adjudicate applications filed by aliens
requesting consent to reapply for
admission to the United States after
deportation, removal or departure, as
provided under section 212 of the
Immigration and Nationality Act.
(5) An estimate of the total number of
respondents and the amount of time
estimated for an average respondent to
respond: 5,160 responses at 2 hours per
response; 100 responses (biometrics) at
1.17 hours.
(6) An estimate of the total public
burden (in hours) associated with the
collection: 10,437 annual burden hours.
If you need a copy of the information
collection instrument with instructions,
or additional information, please visit
the Federal eRulemaking Portal site at:
http://www.regulations.gov. We may
also be contacted at: USCIS, Office of
Policy and Strategy, Regulatory
Coordination Division, 20
Massachusetts Avenue NW.,
Washington, DC 20529–2140,
Telephone number 202–272–8377.
Dated: July 10, 2014.
Laura Dawkins,
Chief, Regulatory Coordination Division,
Office of Policy and Strategy, U.S. Citizenship
and Immigration Services, Department of
Homeland Security.
[FR Doc. 2014–16663 Filed 7–15–14; 8:45 am]
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DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
[Docket No. FR–5802–N–01]

Mortgagee Review Board:
Administrative Actions
Office of the Assistant
Secretary for Housing–Federal Housing
Commissioner, Department of Housing
and Urban Development (‘‘HUD’’).
ACTION: Notice.
AGENCY:

In compliance with Section
202(c)(5) of the National Housing Act,
this notice advises of the cause and
description of administrative actions
taken by HUD’s Mortgagee Review
Board against HUD-approved
mortgagees.
FOR FURTHER INFORMATION CONTACT:
Nancy A. Murray, Secretary to the
Mortgagee Review Board, 451 Seventh
Street SW., Room B–133/3150,
Washington, DC 20410–8000; telephone
(202) 708–2224 (this is not a toll-free
number). Persons with hearing or
SUMMARY:

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speech impairments may access this
number through TTY by calling the tollfree Federal Information Service at (800)
877–8339.
SUPPLEMENTARY INFORMATION: Section
202(c)(5) of the National Housing Act
(12 U.S.C. 1708(c)(5)) requires that HUD
‘‘publish a description of and the cause
for administrative action against a HUDapproved mortgagee’’ by the
Department’s Mortgagee Review Board
(‘‘Board’’). In compliance with the
requirements of Section 202(c)(5), this
notice advises of actions that have been
taken by the Board in its meetings from
October 1, 2012, to September 19, 2013.
I. Civil Money Penalties, Withdrawals
of FHA Approval, Suspensions,
Probations, Reprimands, and
Administrative Payments
1. Amera Mortgage Corporation,
Milford, MI, [Docket No. 12–1648–MR]
Action: On April 23, 2013, the Board
entered into a Settlement Agreement
with Amera Mortgage Corporation
(‘‘Amera’’) that required Amera to pay a
civil money penalty in the amount of
$348,300 and indemnify the Department
for the life of the loan on twenty-one
(21) HUD/FHA insured loans, without
admitting fault or liability.
Cause: The Board took this action
based on the following violations of
HUD/FHA requirements alleged by
HUD: Amera violated underwriting
requirements in connection with sixtynine (69) loans when it did not check
the eligibility of all of the participants
in the transaction, failed to implement
quality control of branch origination
activities, failed to include the name
and Nationwide Mortgage Licensing
System (NMLS) identification number
of the mortgage loan officer in HUD
systems and loan documentation, used
the incorrect NMLS identification
numbers in loan documentation, falsely
represented branch information to HUD,
submitted or caused the submission of
false loan underwriting approval forms
in connection with six (6) loan files
involving a debarred individual,
employed a debarred individual, and
made two (2) false certifications to HUD
on Amera’s annual recertification
submissions in connection with
Amera’s annual renewal of eligibility
documentation for its fiscal years
ending in 2011 and 2012.
2. American Southwest Mortgage
Corporation, Oklahoma City, OK
[Docket No. 13–1544–MR]
Action: On November 14, 2013, the
Board entered into a Settlement
Agreement with American Southwest
Mortgage Corporation (‘‘ASMC’’) that

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