Agency Information Collection Activities: Form I-817, Extension of a Currently Approved Information Collection; Comment Request, 69274-69275 [2011-28954]
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69274
Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0453]
Draft Guidance for Industry and Food
and Drug Administration Staff; 510(k)
Device Modifications: Deciding When
To Submit a 510(k) for a Change to an
Existing Device; Availability;
Reopening of Comment Period
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; reopening of comment
period.
The Food and Drug
Administration (FDA) is reopening until
November 28, 2011, the comment
period for the notice entitled ‘‘Draft
Guidance for Industry and Food and
Drug Administration Staff; 510(k)
Device Modifications: Deciding When to
Submit a 510(k) for a Change to an
Existing Device; Availability,’’ that
appeared in the Federal Register of July
27, 2011 (76 FR 44935). In that
document, FDA announced the
availability of a draft guidance for
industry and FDA staff and requested
comments. The Agency is taking this
action to allow interested persons
additional time to submit comments.
DATES: Submit either electronic or
written comments by November 28,
2011.
SUMMARY:
Submit electronic
comments on the draft guidance to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:
Michael J. Ryan, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 1615,
Silver Spring, MD 20993–0002, (301)
796–6283; or
Stephen Ripley, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, Suite 200N, Rockville,
MD 20852, (301) 827–6210.
ADDRESSES:
mstockstill on DSK4VPTVN1PROD with NOTICES
I. Background
In the Federal Register of July 27,
2011 (76 FR 44935), FDA published a
notice with a 90-day comment period to
request comments on the draft guidance
for industry and FDA staff entitled
‘‘510(k) Device Modifications: Deciding
When to Submit a 510(k) for a Change
to an Existing Device.’’ Comments on
the draft guidance will assist FDA in the
VerDate Mar<15>2010
17:43 Nov 07, 2011
Jkt 223001
development of a final guidance for
industry and FDA staff.
FDA is reopening the comment period
for the notice until November 28, 2011.
The Agency believes that this will allow
adequate time for interested persons to
submit comments without significantly
delaying action by the Agency.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed 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.
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by using
the Internet. A search capability for all
Center for Devices and Radiological
Health (CDRH) guidance documents is
available at https://www.fda.gov/Medical
Devices/DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov or from
the Center for Biologics Evaluation and
Research at https://www.fda.gov/
BiologicsBloodVaccines/Guidance
ComplianceRegulatoryInformation/
default.htm. To receive ‘‘510(k) Device
Modifications: Deciding When to
Submit a 510(k) for a Change to an
Existing Device’’ from CDRH, you may
either send an email request to
dsmica@fda.hhs.gov to receive an
electronic copy of the document or send
a fax request to (301) 847–8149 to
receive a hard copy. Please use the
document number 1793 to identify the
guidance you are requesting.
Dated: November 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–28875 Filed 11–7–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HOMELAND
SECURITY
Citizenship and Immigration Services
Agency Information Collection
Activities: Form I–817, Extension of a
Currently Approved Information
Collection; Comment Request
30-Day Notice of Information
Collection Under Review: Form I–817,
ACTION:
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
Application for Family Unity Benefits;
OMB Control No. 1615–0005.
The Department of Homeland
Security, U.S. Citizenship and
Immigration Services (USCIS) will be
submitting the following information
collection request to the Office of
Management and Budget (OMB) for
review and clearance in accordance
with the Paperwork Reduction Act of
1995. An information collection notice
was previously published in the Federal
Register on August 12, 2011, at 76 FR
50237, allowing for a 60-day public
comment period. USCIS did not receive
any comments on the extension of this
information collection.
The purpose of this notice is to allow
an additional 30 days for public
comments. Comments are encouraged
and will be accepted until December 8,
2011. This process is conducted in
accordance with 5 CFR 1320.10.
Written comments and/or suggestions
regarding the item(s) contained in this
notice, especially regarding the
estimated public burden and associated
response time, should be directed to the
Department of Homeland Security
(DHS), and to the Office of Management
and Budget (OMB) USCIS Desk Officer.
Comments may be submitted to: USCIS,
Chief, Regulatory Products Division,
Office of the Executive Secretariat, 20
Massachusetts Avenue NW.,
Washington, DC 20529–2020.
Comments may also be submitted to
DHS via facsimile to (202) 272–0997 or
via email at rfs.regs@dhs.gov, and to the
OMB USCIS Desk Officer via facsimile
at (202) 395–5806 or via email at
oira_submission@omb.eop.gov. When
submitting comments by email please
make sure to add OMB Control Number
1615–0005 in the subject box. 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
agencies 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
E:\FR\FM\08NON1.SGM
08NON1
Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Notices
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:
Extension of a currently approved
information collection.
(2) Title of the Form/Collection:
Application for Family Unity Benefits.
(3) Agency form number, if any, and
the applicable component of the
Department of Homeland Security
sponsoring the collection: Form I–817;
U.S. Citizenship and Immigration
Services (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: 1,750 responses at 2 hours per
response.
(6) An estimate of the total public
burden (in hours) associated with the
collection: 3,500 annual burden hours.
If you need a copy of the information
collection instrument, please visit the
Web site at: https://www.regulations.gov.
We may also be contacted at: USCIS,
Regulatory Products Division, 20
Massachusetts Avenue NW.,
Washington, DC 20529–2020;
Telephone (202) 272–8377.
Dated: November 3, 2011.
Sunday Aigbe,
Chief, Regulatory Products Division, Office
of the Executive Secretariat, U.S. Citizenship
and Immigration Services, Department of
Homeland Security.
[FR Doc. 2011–28954 Filed 11–7–11; 8:45 am]
BILLING CODE 9111–97–P
DEPARTMENT OF HOMELAND
SECURITY
mstockstill on DSK4VPTVN1PROD with NOTICES
U.S. Citizenship and Immigration
Services
Agency Information Collection
Activities: Form N–400, Extension of a
Currently Approved Information
Collection; Comment Request
30-Day Notice of Information
Collection Under Review: Form N–400,
Application for Naturalization; OMB
Control No. 1615–0052.
ACTION:
The Department of Homeland
Security, U.S. Citizenship and
VerDate Mar<15>2010
17:43 Nov 07, 2011
Jkt 223001
Immigration Services (USCIS) will be
submitting the following information
collection request to the Office of
Management and Budget (OMB) for
review and clearance in accordance
with the Paperwork Reduction Act of
1995. An information collection notice
was previously published in the Federal
Register on August 12, 2011, at 76 FR
50236, allowing for a 60-day public
comment period. USCIS did not receive
any comments on the 60-day notice.
The purpose of this notice is to allow
an additional 30 days for public
comments. Comments are encouraged
and will be accepted until December 8,
2011. This process is conducted in
accordance with 5 CFR 1320.10.
Written comments and/or suggestions
regarding the item(s) contained in this
notice, especially regarding the
estimated public burden and associated
response time, should be directed to the
Department of Homeland Security
(DHS), and to the Office of Management
and Budget (OMB), USCIS Desk Officer.
Comments may be submitted to: USCIS,
Chief, Regulatory Products Division, 20
Massachusetts Avenue, Washington, DC
20529–2020. Comments may also be
submitted to DHS via facsimile to (202)
272–0997 or via email at
uscisfrcomment@dhs.gov and to the
OMB USCIS Desk Officer via facsimile
at (202) 395–5806 or via email at
oira_submission@omb.eop.gov.
When submitting comments by email
please make sure to add OMB Control
Number 1615–0052 in the subject box.
Written comments and suggestions from
the public and affected agencies should
address one or more of the following
four points:
(1) Evaluate whether the 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
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:
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
69275
(1) Type of Information Collection:
Extension of an existing information
collection.
(2) Title of the Form/Collection:
Application for Naturalization.
(3) Agency form number, if any, and
the applicable component of the
Department of Homeland Security
sponsoring the collection: Form N–400.
U.S. Citizenship and Immigration
Services.
(4) Affected public who will be asked
or required to respond, as well as a brief
abstract: Primary: Individuals or
households. USCIS uses the information
on this form to determine an applicant’s
eligibility for naturalization.
(5) An estimate of the total number of
respondents and the amount of time
estimated for an average respondent to
respond: 693,890 responses at 6 hours
and 8 minutes (6.13 hours) per
response.
(6) An estimate of the total public
burden (in hours) associated with the
collection: 4,253,545 annual burden
hours.
If you need a copy of the information
collection instrument, please visit the
Web site at:
https://www.regulations.gov/
We may also be contacted at: USCIS,
Regulatory Products Division, 20
Massachusetts Avenue, NW.,
Washington, DC 20529–2020, telephone
number (202) 272–8377.
Dated: November 3, 2011.
Sunday Aigbe,
Chief, Regulatory Products Division, Office
of the Executive Secretariat, U.S. Citizenship
and Immigration Services, Department of
Homeland Security.
[FR Doc. 2011–28946 Filed 11–7–11; 8:45 am]
BILLING CODE 9111–97–P
DEPARTMENT OF HOMELAND
SECURITY
U.S. Citizenship and Immigration
Services
Agency Information Collection
Activities: Form I–192, Extension of a
Currently Approved Information
Collection; Comment Request
30-Day Notice of Information
Collection Under Review: Form I–192,
Application for Advance Permission to
Enter as Nonimmigrant (Pursuant to
212(d)(3) of the Immigration and
Nationality Act); OMB Control No.
1615–0017.
ACTION:
The Department of Homeland
Security, U.S. Citizenship and
Immigration Services (USCIS) will be
submitting the following information
E:\FR\FM\08NON1.SGM
08NON1
Agencies
[Federal Register Volume 76, Number 216 (Tuesday, November 8, 2011)]
[Notices]
[Pages 69274-69275]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-28954]
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DEPARTMENT OF HOMELAND SECURITY
Citizenship and Immigration Services
Agency Information Collection Activities: Form I-817, Extension
of a Currently Approved Information Collection; Comment Request
ACTION: 30-Day Notice of Information Collection Under Review: Form I-
817, Application for Family Unity Benefits; OMB Control No. 1615-0005.
-----------------------------------------------------------------------
The Department of Homeland Security, U.S. Citizenship and
Immigration Services (USCIS) will be submitting the following
information collection request to the Office of Management and Budget
(OMB) for review and clearance in accordance with the Paperwork
Reduction Act of 1995. An information collection notice was previously
published in the Federal Register on August 12, 2011, at 76 FR 50237,
allowing for a 60-day public comment period. USCIS did not receive any
comments on the extension of this information collection.
The purpose of this notice is to allow an additional 30 days for
public comments. Comments are encouraged and will be accepted until
December 8, 2011. This process is conducted in accordance with 5 CFR
1320.10.
Written comments and/or suggestions regarding the item(s) contained
in this notice, especially regarding the estimated public burden and
associated response time, should be directed to the Department of
Homeland Security (DHS), and to the Office of Management and Budget
(OMB) USCIS Desk Officer. Comments may be submitted to: USCIS, Chief,
Regulatory Products Division, Office of the Executive Secretariat, 20
Massachusetts Avenue NW., Washington, DC 20529-2020. Comments may also
be submitted to DHS via facsimile to (202) 272-0997 or via email at
rfs.regs@dhs.gov, and to the OMB USCIS Desk Officer via facsimile at
(202) 395-5806 or via email at oira_submission@omb.eop.gov. When
submitting comments by email please make sure to add OMB Control Number
1615-0005 in the subject box. 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 agencies 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
[[Page 69275]]
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: Extension of a currently
approved information collection.
(2) Title of the Form/Collection: Application for Family Unity
Benefits.
(3) Agency form number, if any, and the applicable component of the
Department of Homeland Security sponsoring the collection: Form I-817;
U.S. Citizenship and Immigration Services (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: 1,750 responses
at 2 hours per response.
(6) An estimate of the total public burden (in hours) associated
with the collection: 3,500 annual burden hours.
If you need a copy of the information collection instrument, please
visit the Web site at: https://www.regulations.gov.
We may also be contacted at: USCIS, Regulatory Products Division,
20 Massachusetts Avenue NW., Washington, DC 20529-2020; Telephone (202)
272-8377.
Dated: November 3, 2011.
Sunday Aigbe,
Chief, Regulatory Products Division, Office of the Executive
Secretariat, U.S. Citizenship and Immigration Services, Department of
Homeland Security.
[FR Doc. 2011-28954 Filed 11-7-11; 8:45 am]
BILLING CODE 9111-97-P