Agency Information Collection Activities: Application for Family Unity Benefits, Form I-817; Revision of a Currently Approved Collection, 17765-17766 [2015-07506]
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Federal Register / Vol. 80, No. 63 / Thursday, April 2, 2015 / Notices
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
Submit electronic comments on the
guidance to https://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.
FOR FURTHER INFORMATION CONTACT:
Brutrinia D. Cain, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993, 301–796–4633, Brutrinia.Cain@
fda.hhs.gov.
[FR Doc. 2015–07541 Filed 4–1–15; 8:45 am]
SUPPLEMENTARY INFORMATION:
BILLING CODE CODE 4163–18–P
I. Background
Elimination of Tuberculosis,
Department of Health and Human
Services, 1600 Clifton Road NE.,
Mailstop E–10, Atlanta, Georgia 30333,
telephone 404/639–8000 or fax 404/
639–8600.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–0045]
Abuse-Deterrent Opioids—Evaluation
and Labeling; Guidance for Industry;
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 ‘‘Abuse-Deterrent Opioids—
Evaluation and Labeling’’. This
guidance explains FDA’s current
thinking about the studies that should
be conducted to demonstrate that a
given formulation has abuse-deterrent
properties. This guidance also makes
recommendations about how those
studies should be performed and
evaluated, and discusses how to
describe those studies and their
implications in product labeling. It is
intended to assist sponsors who wish to
develop opioid drug products with
potentially abuse-deterrent properties
and is not intended to apply to products
that are not opioids or opioid products
that do not have the potential for abuse.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
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SUMMARY:
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FDA is announcing the availability of
a guidance for industry entitled ‘‘AbuseDeterrent Opioids—Evaluation and
Labeling.’’ Prescription opioid products
are an important component of modern
pain management. However, abuse and
misuse of these products have created a
serious and growing public health
problem. One potentially important step
towards the goal of creating safer opioid
analgesics has been the development of
opioids that are formulated with some
properties intended to deter abuse. FDA
considers development of these
products a high public health priority.
The guidance is intended to provide
industry with a framework for
evaluating and labeling abuse-deterrent
opioid products. The guidance
discusses how the potentially abusedeterrent properties of an opioid
analgesic formulated to deter abuse
should be studied, specifically
addressing in vitro studies,
pharmacokinetic studies, clinical abuse
potential studies, and postmarket
studies. The guidance also describes the
types of information that may be
suitable for inclusion in labeling.
Providing a clear framework for the
evaluation and labeling of the abusedeterrent properties of opioid analgesics
intended to deter abuse should help to
incentivize the development of safer,
less abusable opioid analgesics, and
should also facilitate the dissemination
of fair and accurate information
regarding such products.
In the Federal Register of January 14,
2013 (78 FR 2676), FDA announced the
availability of a draft version of this
guidance and provided interested
parties an opportunity to submit
comments. The Agency has carefully
reviewed and considered the comments
it received in developing this final
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17765
version of the guidance. The Agency has
made revisions to the guidance as it
deemed appropriate.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on the evaluation and
labeling of abuse-deterrent opioids. It
does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
II. Comments
Interested persons may submit either
electronic comments regarding this
document to https://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 https://
www.regulations.gov.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://www.
regulations.gov.
Dated: March 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–07562 Filed 4–1–15; 8:45 am]
BILLING CODE CODE 4164–01–P
DEPARTMENT OF HOMELAND
SECURITY
U.S. Citizenship and Immigration
Services
[OMB Control Number 1615–0005]
Agency Information Collection
Activities: Application for Family Unity
Benefits, Form I–817; Revision of a
Currently Approved Collection
U.S. Citizenship and
Immigration Services (USCIS),
Department of Homeland Security
(DHS).
ACTION: 60-Day notice.
AGENCY:
DHS, USCIS invites the
general public and other Federal
agencies to comment upon this
proposed revision of a currently
SUMMARY:
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02APN1
tkelley on DSK3SPTVN1PROD with NOTICES
17766
Federal Register / Vol. 80, No. 63 / Thursday, April 2, 2015 / Notices
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 June
1, 2015.
ADDRESSES: All submissions received
must include the OMB Control Number
1615–0005 in the subject box, the
agency name and Docket ID USCIS–
2009–0021. To avoid duplicate
submissions, please use only one of the
following methods to submit comments:
(1) Online. Submit comments via the
Federal eRulemaking Portal Web site at
www.regulations.gov under e-Docket ID
number USCIS–2009–0021;
(2) Email. Submit comments to
USCISFRComment@uscis.dhs.gov;
(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.
FOR FURTHER INFORMATION CONTACT:
USCIS, Office of Policy and Strategy,
Regulatory Coordination Division, Laura
Dawkins, Chief, 20 Massachusetts
Avenue NW., Washington, DC 20529–
2140, telephone number 202–272–8377
(comments are not accepted via
telephone message). Please note contact
information provided here is solely for
questions regarding this notice. It is not
for individual case status inquiries.
Applicants seeking information about
the status of their individual cases can
check Case Status Online, available at
the USCIS Web site at https://
www.uscis.gov, or call the USCIS
National Customer Service Center at
800–375–5283 (TTY 800–767–1833).
SUPPLEMENTARY INFORMATION:
Comments: You may access the
information collection instrument with
instructions, or additional information
by visiting the Federal eRulemaking
Portal site at: https://
www.regulations.gov and enter USCIS–
2009–0021 in the search box. Regardless
of the method used for submitting
comments or material, all submissions
will be posted, without change, to the
Federal eRulemaking Portal at https://
www.regulations.gov, and will include
any personal information you provide.
Therefore, submitting this information
makes it public. You may wish to
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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
https://www.regulations.gov.
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.
Overview of This Information
Collection
(1) Type of Information Collection:
Revision of a Currently Approved
Collection.
(2) Title of the Form/Collection:
Application for Family Unity Benefits.
(3) Agency form number, if any, and
the applicable component of the DHS
sponsoring the collection: I–817; USCIS.
(4) Affected public who will be asked
or required to respond, as well as a brief
abstract: Primary: Individuals or
households: The information collected
will be used to determine whether the
applicant meets the eligibility
requirements for benefits under 8 CFR
236.14 and 245a.33.
(5) An estimate of the total number of
respondents and the amount of time
estimated for an average respondent to
respond: The estimated total number of
respondents for the information
collection I–817 is approximately 2,557
and the estimated hour burden per
response is 2 hours per response; and
the estimated number of respondents
providing biometrics is 2,557 and the
estimated hour burden per response is
1.17 hours.
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(6) An estimate of the total public
burden (in hours) associated with the
collection: The total estimated annual
hour burden associated with this
collection is 8,106 hours.
Dated: March 27, 2015.
Laura Dawkins,
Chief, Regulatory Coordination Division,
Office of Policy and Strategy, U.S. Citizenship
and Immigration Services, Department of
Homeland Security.
[FR Doc. 2015–07506 Filed 4–1–15; 8:45 am]
BILLING CODE 9111–97–P
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
[Docket No. FR–5843–N–04]
Implementation of the Privacy Act of
1974, as Amended; New System of
Records, the Housing Search Process
for Racial and Ethnic Minorities
Evaluation Data Files
Office of the Chief Information
Officer, HUD.
ACTION: New system of records.
AGENCY:
The Department’s Office of
Policy Development and Research
(PD&R) is proposing to create a new
system of records, the ‘‘Housing Search
Process for Racial and Ethnic Minorities
Evaluation Data Files.’’ The
Department’s Office of PD&R is
responsible for maintaining current
information on housing needs, market
conditions and existing programs, as
well as conducting research on priority
housing and community development
issues.
The principal purpose of the
evaluation of the Housing Search
Process for Racial and Ethnic Minorities
is to: Help guide the Department’s
research toward a more comprehensive
understanding of the rental housing
search processes for individual
households; Make informed decisions
on the development of more effective
enforcement strategies to combat
discriminatory practices; Identify ways
to expand housing opportunities for
racial and ethnic minorities. Further,
HUD’s Office of Housing Counseling for
rental housing assistance, and the Office
of Housing Choice Vouchers, among
others will leverage the outcome study
results for policy development and best
practices aimed to ‘‘build inclusive and
sustainable communities free from
discrimination’’, and to identify and
correct barriers that racial and ethnic
minorities may experiences in the rental
housing market. Finally, this study will
allow the Department to leverage its
own regular data collection efforts, like
SUMMARY:
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Agencies
[Federal Register Volume 80, Number 63 (Thursday, April 2, 2015)]
[Notices]
[Pages 17765-17766]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-07506]
=======================================================================
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DEPARTMENT OF HOMELAND SECURITY
U.S. Citizenship and Immigration Services
[OMB Control Number 1615-0005]
Agency Information Collection Activities: Application for Family
Unity Benefits, Form I-817; Revision of a Currently Approved Collection
AGENCY: U.S. Citizenship and Immigration Services (USCIS), Department
of Homeland Security (DHS).
ACTION: 60-Day notice.
-----------------------------------------------------------------------
SUMMARY: DHS, USCIS invites the general public and other Federal
agencies to comment upon this proposed revision of a currently
[[Page 17766]]
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
June 1, 2015.
ADDRESSES: All submissions received must include the OMB Control Number
1615-0005 in the subject box, the agency name and Docket ID USCIS-2009-
0021. To avoid duplicate submissions, please use only one of the
following methods to submit comments:
(1) Online. Submit comments via the Federal eRulemaking Portal Web
site at www.regulations.gov under e-Docket ID number USCIS-2009-0021;
(2) Email. Submit comments to USCISFRComment@uscis.dhs.gov;
(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.
FOR FURTHER INFORMATION CONTACT: USCIS, Office of Policy and Strategy,
Regulatory Coordination Division, Laura Dawkins, Chief, 20
Massachusetts Avenue NW., Washington, DC 20529-2140, telephone number
202-272-8377 (comments are not accepted via telephone message). Please
note contact information provided here is solely for questions
regarding this notice. It is not for individual case status inquiries.
Applicants seeking information about the status of their individual
cases can check Case Status Online, available at the USCIS Web site at
https://www.uscis.gov, or call the USCIS National Customer Service
Center at 800-375-5283 (TTY 800-767-1833).
SUPPLEMENTARY INFORMATION:
Comments: You may access the information collection instrument with
instructions, or additional information by visiting the Federal
eRulemaking Portal site at: https://www.regulations.gov and enter USCIS-
2009-0021 in the search box. Regardless of the method used for
submitting comments or material, all submissions will be posted,
without change, to the Federal eRulemaking Portal at https://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 https://www.regulations.gov.
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.
Overview of This Information Collection
(1) Type of Information Collection: Revision of a Currently
Approved Collection.
(2) Title of the Form/Collection: Application for Family Unity
Benefits.
(3) Agency form number, if any, and the applicable component of the
DHS sponsoring the collection: I-817; USCIS.
(4) Affected public who will be asked or required to respond, as
well as a brief abstract: Primary: Individuals or households: The
information collected will be used to determine whether the applicant
meets the eligibility requirements for benefits under 8 CFR 236.14 and
245a.33.
(5) An estimate of the total number of respondents and the amount
of time estimated for an average respondent to respond: The estimated
total number of respondents for the information collection I-817 is
approximately 2,557 and the estimated hour burden per response is 2
hours per response; and the estimated number of respondents providing
biometrics is 2,557 and the estimated hour burden per response is 1.17
hours.
(6) An estimate of the total public burden (in hours) associated
with the collection: The total estimated annual hour burden associated
with this collection is 8,106 hours.
Dated: March 27, 2015.
Laura Dawkins,
Chief, Regulatory Coordination Division, Office of Policy and Strategy,
U.S. Citizenship and Immigration Services, Department of Homeland
Security.
[FR Doc. 2015-07506 Filed 4-1-15; 8:45 am]
BILLING CODE 9111-97-P