60-day notice

Federal Register / Vol. 79, No. 215 / Thursday, November 6, 2014 / Notices
SUPPLEMENTARY INFORMATION:

I. Background
In the Federal Register of June 11,
2010 (75 FR 33311), FDA announced the
availability of a guidance for industry,
‘‘Bioequivalence Recommendations for
Specific Products,’’ which explained the
process that would be used to make
product-specific BE recommendations
available to the public on FDA’s Web
site at http://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm. As described in that
guidance, FDA adopted this process as
a means to develop and disseminate
product-specific BE recommendations
and provide a meaningful opportunity
for the public to consider and comment
on those recommendations. This notice
announces the availability of draft BE
recommendations for CONCERTA
(methylphenidate HCl) extended-release
tablets. This draft guidance revises and
replaces the draft guidance for industry
entitled ‘‘Draft and Revised Draft
Guidances for Industry Describing
Product-Specific Bioequivalence
Recommendations; Availability,’’ issued
on September 14, 2012 (77 FR 56851),
which provided recommendations to
establish BE to CONCERTA
(methylphenidate hydrochloride) (NDA
021121).
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on the design of BE studies to support
ANDAs for CONCERTA
(methylphenidate HCl) extended-release
tablets. 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.

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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.

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III. Electronic Access
Persons with access to the Internet
may obtain the document at either
http://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or http://
www.regulations.gov.
Dated: October 31, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–26306 Filed 11–5–14; 8:45 am]
BILLING CODE 4164–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director, Program on
Biosecurity and Biosafety Policy;
Notice of Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the meeting of the
National Science Advisory Board for
Biosecurity (NSABB).
Name of Committee: National Science
Advisory Board for Biosecurity.
Date: November 25, 2014.
Time: 11:00 a.m.–1:00 p.m. Eastern.
The teleconference line will be open at
10:30 a.m. to allow for check-in with the
operator. (Times are approximate and
subject to change.)
Agenda: Discussion regarding: (1)
Finalization of draft NSABB statement
regarding gain-of-function research; and
(2) other business of the Board. Time
will be allotted on the agenda for oral
public comment, with presentations
limited to three minutes per speaker.
Place: National Institutes of Health,
6705 Rockledge Drive, Suite 750,
Bethesda, Maryland. (Telephone
Conference call only; No in-person
meeting.)
Call-in Information: Toll-Free
Number: 1–888–469–1981. Participant
Passcode: NSABB. The line will be open
30 minutes in advance of the meeting to
allow time for operator-assisted checkin.
Contact Person: Carolyn Mosby,
NSABB Program Assistant, NIH Program
on Biosecurity and Biosafety Policy,
6705 Rockledge Drive, Suite 750,
Bethesda, Maryland 20892, (301) 435–
5504, carolyn.mosby@nih.gov.
Under authority 42 U.S.C. 217a,
Section 222 of the Public Health Service
Act, as amended, the Department of
Health and Human Services established
the NSABB to provide advice regarding
federal oversight of dual use research,
defined as biological research that
generates information and technologies

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that could be misused to pose a
biological threat to public health and/or
national security.
Please Note: The teleconference
meeting agenda, draft statement, and
other information about the NSABB will
be available at http://osp.od.nih.gov/
office-biotechnology-activities/
biosecurity/nsabb. Please check this
Web site for updates.
The meeting will be open to the
public through a teleconference call
phone number. Members of the public
who participate in the teleconference
will be able to listen to the meeting but
will not be heard apart from during the
public comment session. If you
experience any technical problems with
the conference call, please send an
email to carolyn.mosby@nih.gov.
Public Comments: The teleconference
will include opportunity for public
comment. In addition, any interested
person may file written comments with
the committee via email to nsabb@
od.nih.gov with ‘‘NSABB Public
Comment’’ as the subject line or by
regular mail to 6705 Rockledge Drive,
Suite 750, Bethesda, MD 20892,
Attention: Carolyn Mosby. Comments
should include the name, address,
telephone number and, when
applicable, the business or professional
affiliation of the commenter. Written
comments received by 5:00 p.m.
(Eastern) on Sunday November 23,
2014, will be provided to NSABB
members prior to the teleconference.
Accommodations Statement:
Individuals who participate by using
this teleconference call service and who
need special assistance such as
captioning or other reasonable
accommodations should submit a
request to the Contact Person listed on
this notice as soon as possible.
Dated: November 3, 2014.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–26422 Filed 11–5–14; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HOMELAND
SECURITY
U.S. Citizenship and Immigration
Services
[OMB Control Number 1615–0025]

Agency Information Collection
Activities: Waiver of Rights, Privileges,
Exemptions and Immunities, Forms I–
508 and I–508F; Revision of a Currently
Approved Collection.
ACTION:

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65980

Federal Register / Vol. 79, No. 215 / Thursday, November 6, 2014 / Notices

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 or
new 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
January 5, 2015.
ADDRESSES: All submissions received
must include the OMB Control Number
1615–0025 in the subject box, the
agency name and Docket ID USCIS–
2008–0015. 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–2008–0015.
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
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.
SUPPLEMENTARY INFORMATION:
SUMMARY:

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Comments
Regardless of the method used for
submitting comments or 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

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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.
Overview of This Information
Collection
(1) Type of Information Collection:
Revision of a Currently Approved
Collection.
(2) Title of the Form/Collection:
Waiver of Rights, Privileges, Exemptions
and Immunities.
(3) Agency form number, if any, and
the applicable component of the DHS
sponsoring the collection: Form I–508
and Form I–508F. 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. This form is used by the
USCIS to determine eligibility of an
applicant to retain the status of an alien
lawfully admitted to the United States
for permanent residence.
(5) An estimate of the total number of
respondents and the amount of time
estimated for an average respondent to
respond:
• Form I–508: 1,728 responses at .33
hours (20 minutes) per response, and

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• Form I–508F: 200 responses at .33
hours (20 minutes) per response.
(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 636.24 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: November 3, 2014.
Laura Dawkins,
Chief, Regulatory Coordination Division,
Office of Policy and Strategy, U.S. Citizenship
and Immigration Services, Department of
Homeland Security.
[FR Doc. 2014–26423 Filed 11–5–14; 8:45 am]
BILLING CODE 9111–97–P

DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
[FWS–HQ–IA–2014–N232;
FXIA16710900000–156–FF09A30000]

Endangered Species; Marine
Mammals; Receipt of Applications for
Permit
Fish and Wildlife Service,
Interior.
ACTION: Notice of receipt of applications
for permit.
AGENCY:

We, the U.S. Fish and
Wildlife Service, invite the public to
comment on the following applications
to conduct certain activities with
endangered species, marine mammals,
or both. With some exceptions, the
Endangered Species Act (ESA) and
Marine Mammal Protection Act
(MMPA) prohibit activities with listed
species unless Federal authorization is
acquired that allows such activities.
DATES: We must receive comments or
requests for documents on or before
December 8, 2014. We must receive
requests for marine mammal permit
public hearings, in writing, at the
address shown in the ADDRESSES section
by December 8, 2014.
ADDRESSES: Brenda Tapia, U.S. Fish and
Wildlife Service, Division of
Management Authority, Branch of
Permits, MS: IA, 5275 Leesburg Pike,
Falls Church, VA 22041; fax (703) 358–
2281; or email DMAFR@fws.gov.
SUMMARY:

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