Agency Information Collection Activities; Proposed Collection; Comment Request; Annual Reporting Requirements for the Older American Act Title VI Grant Program, 20226-20227 [2015-08654]
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Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Notices
Synopsis: The amendment changes
the name of NYKCool AB to Cool
Carriers AB and makes related
conforming changes.
Agreement No.: 012326.
Title: CSCL/HSD Slot Charter
Agreement
Parties: China Shipping Container
Lines Co., Ltd. and China Shipping
Container Lines (Hong Kong) Co., Ltd.
(acting as a single party); and Hamburg
Sud.
Filing Party: Patricia M. O’Neill;
Blank & Rome LLP; 600 New Hampshire
Ave., NW., Washington, DC 20037.
Synopsis: The agreement authorizes
Hamburg Sud to charter slots on
services operated by CSCL in the trade
between China and Korea, on the one
hand, and the U.S. West Coast on the
other hand.
Agreement No.: 012327.
Title: ‘‘K’’ Line/WHL/WHS/PIL Space
Charter and Sailing Agreement
Parties: Kawasaki Kisen Kaisha, Ltd.;
Wan Hai Lines (Singapore) PTE Ltd.;
Wan Hai Lines Ltd.; Pacific
International Lines (PTE) Ltd.
Filing Party: Eric. C. Jeffrey, Esq.;
Nixon Peabody LLP; 401 9th Street NW,
Suite 900; Washington, DC 20004.
Synopsis: The agreement authorizes
the parties to operate a joint service in
the trade between the U.S. West Coast
on the one hand, and China (including
Hong Kong) and Japan on the other
hand.
By Order of the Federal Maritime
Commission.
Dated: April 10, 2015.
Rachel E. Dickon,
Assistant Secretary.
BILLING CODE 6731–AA–P
FEDERAL RESERVE SYSTEM
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Change in Bank Control Notices;
Acquisitions of Shares of a Bank or
Bank Holding Company
The notificants listed below have
applied under the Change in Bank
Control Act (12 U.S.C. 1817(j)) and
§ 225.41 of the Board’s Regulation Y (12
CFR 225.41) to acquire shares of a bank
or bank holding company. The factors
that are considered in acting on the
notices are set forth in paragraph 7 of
the Act (12 U.S.C. 1817(j)(7)).
The notices are available for
immediate inspection at the Federal
Reserve Bank indicated. The notices
also will be available for inspection at
the offices of the Board of Governors.
Interested persons may express their
views in writing to the Reserve Bank
17:29 Apr 14, 2015
Jkt 235001
Board of Governors of the Federal Reserve
System, April 9, 2015.
Michael J. Lewandowski,
Assistant Secretary of the Board.
[FR Doc. 2015–08623 Filed 4–14–15; 8:45 am]
BILLING CODE 6210–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Annual Reporting
Requirements for the Older American
Act Title VI Grant Program
Administration for Community
Living, HHS.
ACTION: Notice.
AGENCY:
The Administration on Aging
Office (AoA), within the Administration
for Community Living (ACL) is
announcing an opportunity for public
comment on the proposed extension of
an existing collection of information by
the agency. Under the Paperwork
Reduction Act of 1995 (the PRA),
Federal agencies are required to publish
notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the information collection requirements
relating to Performance Reports for Title
VI grants.
DATES: Submit written or electronic
comments on the collection of
information by June 15, 2015.
ADDRESSES: Submit electronic
comments on the collection of
information to: Cynthia.Lacounte@
acl.hhs.gov. Submit written comments
on the collection of information to
Cynthia Lacounte, ACL/Administration
SUMMARY:
[FR Doc. 2015–08644 Filed 4–14–15; 8:45 am]
VerDate Sep<11>2014
indicated for that notice or to the offices
of the Board of Governors. Comments
must be received not later than April 30,
2015.
A. Federal Reserve Bank of
Minneapolis (Jacquelyn K. Brunmeier,
Assistant Vice President) 90 Hennepin
Avenue, Minneapolis, Minnesota
55480–0291:
1. Christian David Heitzman,
Minneapolis, Minnesota, to retain 25
percent or more of the shares of First
BancShares, Inc., of Cold Spring, Cold
Spring, Minnesota, and thereby
indirectly retain control of Granite
Community Bank, Cold Spring,
Minnesota.
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on Aging, Washington, DC 20201 or by
fax at (202–357–3560).
FOR FURTHER INFORMATION CONTACT:
Margaret Graves at (202) 357–3502 or
Margaret.Graves@acl.hhs.gov.
Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency request
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, ACL/AoA is publishing
notice of the proposed collection of
information set forth in this document.
With respect to the following collection
of information, ACL/AoA invites
comments on: (1) Whether the proposed
collection of information is necessary
for the proper performance of ACL/
AoA’s functions, including whether the
information will have practical utility;
(2) the accuracy of ACL/AoA’s estimate
of the burden of the proposed collection
of information, including the validity of
the methodology and assumptions used;
(3) ways to enhance the quality, utility,
and clarity of the information to be
collected; and (4) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
when appropriate, and other forms of
information technology. ACL/AoA
estimates the burden of this collection
of information as follows: Annual
submission of the Program Performance
Reports are due 90 days after the end of
the budget period and final project
period.
Respondents: Federally Recognized
Tribes, Tribal and Native Hawaiian
Organizations receiving grants under
Title VI, Part A, Grants for Native
Americans; Title VI, Part B, Native
Hawaiian Program and Title VI, Part C,
Native American Caregiver Support
Program.
Estimated Number of Responses: 266.
Total Estimated Burden Hours: 731.5.
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Notices
Dated: April 9, 2015.
Kathy Greenlee,
Administrator and Assistant Secretary for
Aging.
[FR Doc. 2015–08654 Filed 4–14–15; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–E–0688]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; AUBAGIO—Patent No.
5,679,709
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
AUBAGIO and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of an
application to the Director of the U.S.
Patent and Trademark Office (USPTO),
Department of Commerce, for the
extension of a patent which claims that
human drug product.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
petitions (two copies are required) and
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
Submit petitions electronically to https://
www.regulations.gov at Docket No.
FDA–2013–S–0610.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of
Management, Food and Drug
Administration, 10001 New Hampshire
Ave., Hillandale Campus Rm. 3180,
Silver Spring, MD 20993, 301–796–
7900.
SUMMARY:
The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
and the Generic Animal Drug and Patent
Term Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
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SUPPLEMENTARY INFORMATION:
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17:29 Apr 14, 2015
Jkt 235001
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of USPTO may award (for
example, half the testing phase must be
subtracted as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a human drug product will include all
of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the
human drug product AUBAGIO
(teriflunomide). AUBAGIO is indicated
for treatment of patients with relapsing
forms of multiple sclerosis. Subsequent
to this approval, the USPTO received a
patent term restoration application for
AUBAGIO (U.S. Patent No. 5,679,709)
from sanofi-aventis Deutschland GMBH,
and the USPTO requested FDA’s
assistance in determining this patent’s
eligibility for patent term restoration. In
a letter dated January 31, 2014, FDA
advised the USPTO that this human
drug product had undergone a
regulatory review period and that the
approval of AUBAGIO represented the
first permitted commercial marketing or
use of the product. Thereafter, the
USPTO requested that FDA determine
the product’s regulatory review period.
FDA has determined that the
applicable regulatory review period for
AUBAGIO is 2,940 days. Of this time,
2,542 days occurred during the testing
phase of the regulatory review period,
while 398 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 355(i)) became effective: August
27, 2004. FDA has verified the
applicant’s claim that the date the
investigational new drug application
became effective was on August 27,
2004.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: August 12,
2011. FDA has verified the applicant’s
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20227
claim that the new drug application
(NDA) for AUBAGIO (NDA 202992) was
submitted on August 12, 2011.
3. The date the application was
approved: September 12, 2012. FDA has
verified the applicant’s claim that NDA
202992 was approved on September 12,
2012.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 5 years of patent
term extension.
Anyone with knowledge that any of
the dates as published are incorrect may
submit to the Division of Dockets
Management (see ADDRESSES) either
electronic or written comments and ask
for a redetermination by June 15, 2015.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
October 13, 2015. To meet its burden,
the petition must contain sufficient facts
to merit an FDA investigation. (See H.
Rept. 857, part 1, 98th Cong., 2d sess.,
pp. 41–42, 1984.) Petitions should be in
the format specified in 21 CFR 10.30.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
comments and written or electronic
petitions. 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. If you submit a written
petition, two copies are required. A
petition submitted electronically must
be submitted to https://
www.regulations.gov, Docket No. FDA–
2013–S–0610.
Comments and petitions that have not
been made publicly available on https://
www.regulations.gov may be viewed in
the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: April 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–08615 Filed 4–14–15; 8:45 am]
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]]>Agencies
[Federal Register Volume 80, Number 72 (Wednesday, April 15, 2015)]
[Notices]
[Pages 20226-20227]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-08654]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Community Living
Agency Information Collection Activities; Proposed Collection;
Comment Request; Annual Reporting Requirements for the Older American
Act Title VI Grant Program
AGENCY: Administration for Community Living, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Administration on Aging Office (AoA), within the
Administration for Community Living (ACL) is announcing an opportunity
for public comment on the proposed extension of an existing collection
of information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
requirements relating to Performance Reports for Title VI grants.
DATES: Submit written or electronic comments on the collection of
information by June 15, 2015.
ADDRESSES: Submit electronic comments on the collection of information
to: Cynthia.Lacounte@acl.hhs.gov. Submit written comments on the
collection of information to Cynthia Lacounte, ACL/Administration on
Aging, Washington, DC 20201 or by fax at (202-357-3560).
FOR FURTHER INFORMATION CONTACT: Margaret Graves at (202) 357-3502 or
Margaret.Graves@acl.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency request or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, ACL/AoA is publishing notice of the proposed
collection of information set forth in this document. With respect to
the following collection of information, ACL/AoA invites comments on:
(1) Whether the proposed collection of information is necessary for the
proper performance of ACL/AoA's functions, including whether the
information will have practical utility; (2) the accuracy of ACL/AoA's
estimate of the burden of the proposed collection of information,
including the validity of the methodology and assumptions used; (3)
ways to enhance the quality, utility, and clarity of the information to
be collected; and (4) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques when appropriate, and other forms of information
technology. ACL/AoA estimates the burden of this collection of
information as follows: Annual submission of the Program Performance
Reports are due 90 days after the end of the budget period and final
project period.
Respondents: Federally Recognized Tribes, Tribal and Native
Hawaiian Organizations receiving grants under Title VI, Part A, Grants
for Native Americans; Title VI, Part B, Native Hawaiian Program and
Title VI, Part C, Native American Caregiver Support Program.
Estimated Number of Responses: 266.
Total Estimated Burden Hours: 731.5.
[[Page 20227]]
Dated: April 9, 2015.
Kathy Greenlee,
Administrator and Assistant Secretary for Aging.
[FR Doc. 2015-08654 Filed 4-14-15; 8:45 am]
BILLING CODE 4154-01-P
