Administration on Intellectual and Developmental Disabilities, President's Committee for People With Intellectual Disabilities, 38448-38449 [2015-16488]
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38448
Federal Register / Vol. 80, No. 128 / Monday, July 6, 2015 / Notices
1. Home Bancorp, Inc., Lafayette,
Louisiana; to acquire Louisiana
Bancorp, Inc., Metairie, Louisiana, and
indirectly acquire Bank of New Orleans,
Metairie, Louisiana, a federal savings
association, and thereby engage in
operating a savings association,
pursuant to section 225.28(b)(4)(ii).
Board of Governors of the Federal Reserve
System, June 30, 2015.
Michael J. Lewandowski,
Associate Secretary of the Board.
[FR Doc. 2015–16466 Filed 7–2–15; 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; Extension of
Certification of Maintenance of Effort
on Help America Vote Act, Public Law
107–252, Title II, Subtitle D, Section
291, Payments for Protection and
Advocacy Systems (P&A Voting
Access Narrative Annual Report)
Administration on Intellectual
and Developmental Disabilities,
Administration for Community Living,
HHS.
ACTION: Notice.
AGENCY:
The Administration for
Community Living (ACL) is announcing
that the proposed collection of
information listed below has been
submitted to the Office of Management
and Budget (OMB) for review and
clearance. 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 public
comment in response to the notice. This
notice solicits comments on the
information collection requirements
relating to the Help America Vote Act
(HAVA), Public Law 107–252, Title II,
Subtitle D, Section 291, Payments for
Protection and Advocacy Systems (P&A
Voting Access Narrative Annual
Report).
DATES: Submit written comments on the
collection of information by August 5,
2015.
ADDRESSES: Submit written comments
on the collection of information by fax
202.395.5806 or by email to OIRA_
submission@omb.eop.gov, Attn: OMB
Desk Officer for ACL.
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SUMMARY:
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FOR FURTHER INFORMATION CONTACT:
Melvenia Wright, Program Specialist,
Administration for Community Living,
Washington, DC 20001. Telephone:
(202) 357–3486; email melvenia.wright@
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 is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following collection
of information, ACL invites comments
on: (1) Whether the proposed collection
of information is necessary for the
proper performance of ACL’s functions,
including whether the information will
have practical utility; (2) the accuracy of
ACL’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. The Protection
and Advocacy Voting Access Annual
Narrative Report from the Protection
and Advocacy Systems is required by
federal statute and regulation, the Help
America Vote Act (HAVA), Public Law
107–252, Title II, Subtitle D, Section
291, Payments for Protection and
Advocacy to Assure Access for
Individuals with Disabilities (42 U.S.C.
15461). The report is provided in
writing to the Administration for
Community Living, Administration on
Intellectual and Developmental
Disabilities (AIDD). Each eligible
Protection and Advocacy System (P&As)
must prepare and submit an annual
report at the end of every fiscal year by
the 31st of December. The report
addresses the activities conducted with
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the funds provided during the year. The
information collected from the annual
report will be aggregated into an annual
profile of how the P&As have utilized
the funds and review the P&As activities
carried out for each of the seven
mandated area. These areas include full
participation in the electoral process;
education, training and assistance;
advocacy and education around HAVA
implementation efforts; training and
education of election officials, poll
workers and election volunteers
regarding the rights of voters with
disabilities and best practices;
assistance in filing complaints;
assistance to State and other
governmental entities regarding the
physical accessibility of polling places;
and obtaining training and technical
assistance on voting issues. The PAVA
annual narrative report will also provide
an overview of the goals and
accomplishments for each P&A as well
as permit the Administration on
Intellectual and Developmental
Disabilities (AIDD) to track voting
progress to monitor grant activities and
create the bi-annual report to Congress.
ACL estimates the burden of this
collection of information as follows: 55
Protection and Advocacy Systems (P&A)
respond annually which should be an
average burden of 20 hours per State per
year or a total of 1,100 hours for all
states annually.
Dated: June 29, 2015.
Kathy Greenlee,
Administrator and Assistant Secretary for
Aging.
[FR Doc. 2015–16492 Filed 7–2–15; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
Administration on Intellectual and
Developmental Disabilities, President’s
Committee for People With Intellectual
Disabilities
Administration for Community
Living, HHS.
ACTION: Notice.
AGENCY:
Monday, August 3, 2015 from
9:00 a.m. to 4:30 p.m.; and Tuesday,
August 4, 2015 from 9:30 a.m. to 4:00
p.m. These meetings will be open to the
general public.
ADDRESSES: These meetings will be held
in the U.S. Department of Health and
Human Services/Hubert H. Humphrey
Building located at 200 Independence
Avenue SW., Conference Room 800,
Washington, DC 20201.
DATES:
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Federal Register / Vol. 80, No. 128 / Monday, July 6, 2015 / Notices
Individuals who would like to
participate via conference call may do
so by dialing toll-free 888–469–0957,
when prompted enter pass code:
8955387. Individuals whose full
participation in the meeting will require
special accommodations (e.g., sign
language interpreting services, assistive
listening devices, materials in
alternative format such as large print or
Braille) should notify Dr. MJ Karimi,
PCPID Team Lead, via email at
MJ.Karimie@acl.hhs.gov, or via
telephone at 202–357–3588, no later
than Monday, July 27, 2015. The PCPID
will attempt to accommodate requests
made after this date, but cannot
guarantee the ability to grant requests
received after the deadline. All meeting
sites are barrier free, consistent with the
Americans with Disabilities Act (ADA)
and the Federal Advisory Committee
Act (FACA).
Agenda: The Committee Members
will discuss, finalize and approve the
2015 PCPID Report to the President.
They will also begin exploring the
topics for the next PCPID Report to the
President.
FOR FURTHER INFORMATION CONTACT: For
further information, please contact Dr.
MJ Karimi, Team Lead, President’s
Committee for People with Intellectual
Disabilities, One Massachusetts Avenue
NW., Room 4206, Washington, DC
20201. Telephone: 202–357–3588. Fax:
202–205–8037. Email: MJ.Karimie@
acl.hhs.gov
The
PCPID acts in an advisory capacity to
the President and the Secretary of
Health and Human Services on a broad
range of topics relating to programs,
services and support for individuals
with intellectual disabilities. The PCPID
executive order stipulates that the
Committee shall: (1) Provide such
advice concerning intellectual
disabilities as the President or the
Secretary of Health and Human Services
may request; and (2) provide advice to
the President concerning the following
for people with intellectual disabilities:
(A) expansion of educational
opportunities; (B) promotion of
homeownership; (C) assurance of
workplace integration; (D) improvement
of transportation options; (E) expansion
of full access to community living; and
(F) increasing access to assistive and
universally designed technologies.
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SUPPLEMENTARY INFORMATION:
Dated: June 24, 2015.
Aaron Bishop,
Commissioner, Administration on Intellectual
and Developmental Disabilities (AIDD).
[FR Doc. 2015–16488 Filed 7–2–15; 8:45 am]
BILLING CODE 4154–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–D–2270]
The Drug Supply Chain Security Act
Implementation: Product Tracing
Requirements for Dispensers—
Compliance Policy; Guidance for
Industry, Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing the availability of a
guidance for industry entitled ‘‘DSCSA
Implementation: Product Tracing
Requirements for Dispensers—
Compliance Policy.’’ This guidance
announces FDA’s intention with regard
to enforcement of certain product
tracing requirements of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) added by the Drug Supply Chain
Security Act (DSCSA). FDA does not
intend to take action against dispensers
who, prior to November 1, 2015, accept
ownership of product without receiving
product tracing information, prior to or
at the time of a transaction or do not
capture and maintain the product
tracing information, as required by the
FD&C Act.
DATES: Effective July 1, 2015. For
information about enforcement dates,
please see the SUPPLEMENTARY
INFORMATION section.
ADDRESSES: All communications in
response to this notice should be
identified with Docket No. FDA–2015–
D–2270, and should be directed to the
office listed in the FOR FURTHER
INFORMATION CONTACT section.
FOR FURTHER INFORMATION CONTACT:
Office of Compliance, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002, 301–796–3130,
drugtrackandtrace@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
We are announcing the availability of
a guidance for industry entitled
‘‘DSCSA Implementation: Product
Tracing Requirements for Dispensers—
Compliance Policy.’’ We are issuing this
guidance consistent with our good
guidance practices regulation (21 CFR
10.115). We are implementing this
guidance without prior public comment
because we have determined that prior
public participation is not feasible or
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38449
appropriate (21 CFR 10.115(g)(2)). We
made this determination because this
guidance document provides
information pertaining to statutory
requirements that take effect on July 1,
2015, regarding the provisions to
provide and capture product tracing
information under section 582(d)(1) of
the FD&C Act (21 U.S.C 360eee–1(d)(1)).
It is important that FDA provide this
information before that date. Although
this guidance document is immediately
in effect, it remains subject to comment
in accordance with the Agency’s good
guidance practices (21 CFR
10.115(g)(3)).
On November 27, 2013, the DSCSA
(Title II of Pub. L. 113–54) was signed
into law. Section 202 of DSCSA adds
sections 581 and 582 to the FD&C Act,
which set forth new definitions and
requirements for the tracing of products
through the pharmaceutical distribution
supply chain. Starting in 2015, trading
partners (manufacturers, wholesale
distributors, dispensers, and
repackagers) are required under sections
582(b)(1), (c)(1), (d)(1), and (e)(1) of the
FD&C Act to exchange product tracing
information when engaging in
transactions involving certain
prescription drugs. For dispensers,
requirements for the tracing of products
through the pharmaceutical distribution
supply chain under section 582(d)(1) of
the FD&C Act go into effect on July 1,
2015.
Some dispensers have expressed
concern that electronic systems used to
exchange, capture, and maintain
product tracing information will not be
operational by this effective date.
Although the DSCSA allows product
tracing information to be exchanged
through paper in certain circumstances,
FDA understands that many dispensers
intend to utilize electronic systems to
capture and maintain product tracing
information. Thus, FDA recognizes that
some dispensers may need additional
time beyond July 1, 2015, to work with
trading partners to ensure that the
product tracing information required by
section 582 is captured and maintained
by dispensers. In light of these concerns,
FDA does not intend to take action
against dispensers who, prior to
November 1, 2015: (1) Accept
ownership of product without receiving
product tracing information, prior to or
at the time of a transaction, as required
by section 582(d)(1)(A)(i) of the FD&C
Act or (2) do not capture and maintain
the product tracing information, as
required by section 582(d)(1)(A)(iii) of
the FD&C Act. This compliance policy
does not extend to other requirements of
the FD&C Act applicable to dispensers
and other trading partners, including
E:\FR\FM\06JYN1.SGM
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Agencies
[Federal Register Volume 80, Number 128 (Monday, July 6, 2015)]
[Notices]
[Pages 38448-38449]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16488]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Community Living
Administration on Intellectual and Developmental Disabilities,
President's Committee for People With Intellectual Disabilities
AGENCY: Administration for Community Living, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
DATES: Monday, August 3, 2015 from 9:00 a.m. to 4:30 p.m.; and Tuesday,
August 4, 2015 from 9:30 a.m. to 4:00 p.m. These meetings will be open
to the general public.
ADDRESSES: These meetings will be held in the U.S. Department of Health
and Human Services/Hubert H. Humphrey Building located at 200
Independence Avenue SW., Conference Room 800, Washington, DC 20201.
[[Page 38449]]
Individuals who would like to participate via conference call may
do so by dialing toll-free 888-469-0957, when prompted enter pass code:
8955387. Individuals whose full participation in the meeting will
require special accommodations (e.g., sign language interpreting
services, assistive listening devices, materials in alternative format
such as large print or Braille) should notify Dr. MJ Karimi, PCPID Team
Lead, via email at MJ.Karimie@acl.hhs.gov, or via telephone at 202-357-
3588, no later than Monday, July 27, 2015. The PCPID will attempt to
accommodate requests made after this date, but cannot guarantee the
ability to grant requests received after the deadline. All meeting
sites are barrier free, consistent with the Americans with Disabilities
Act (ADA) and the Federal Advisory Committee Act (FACA).
Agenda: The Committee Members will discuss, finalize and approve
the 2015 PCPID Report to the President. They will also begin exploring
the topics for the next PCPID Report to the President.
FOR FURTHER INFORMATION CONTACT: For further information, please
contact Dr. MJ Karimi, Team Lead, President's Committee for People with
Intellectual Disabilities, One Massachusetts Avenue NW., Room 4206,
Washington, DC 20201. Telephone: 202-357-3588. Fax: 202-205-8037.
Email: MJ.Karimie@acl.hhs.gov
SUPPLEMENTARY INFORMATION: The PCPID acts in an advisory capacity to
the President and the Secretary of Health and Human Services on a broad
range of topics relating to programs, services and support for
individuals with intellectual disabilities. The PCPID executive order
stipulates that the Committee shall: (1) Provide such advice concerning
intellectual disabilities as the President or the Secretary of Health
and Human Services may request; and (2) provide advice to the President
concerning the following for people with intellectual disabilities: (A)
expansion of educational opportunities; (B) promotion of homeownership;
(C) assurance of workplace integration; (D) improvement of
transportation options; (E) expansion of full access to community
living; and (F) increasing access to assistive and universally designed
technologies.
Dated: June 24, 2015.
Aaron Bishop,
Commissioner, Administration on Intellectual and Developmental
Disabilities (AIDD).
[FR Doc. 2015-16488 Filed 7-2-15; 8:45 am]
BILLING CODE 4154-01-P