Agency Information Collection Activities: Submission for OMB Review; Comment Request; Developmental Disabilities Protection & Advocacy Program Statement of Goals and Priorities, 60123-60124 [2012-24236]
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wreier-aviles on DSK5TPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 191 / Tuesday, October 2, 2012 / Notices
all persons who receive a copy. Section
VII requires DesignerWare to submit
compliance reports to the Commission
within sixty (60) days, and periodically
thereafter as requested. It also requires
the company to notify the Commission
of changes in DesignerWare’s corporate
status.
Section VI of the proposed order with
the DesignerWare principals requires
respondents to distribute it to all current
and future principals, officers, directors,
and managers of any company that
either respondent controls that engages
in any covered RTO transaction as well
as to all current and future employees,
agents, and representatives having
responsibilities relating to the subject
matter of this order. It also requires the
respondents to secure a signed and
dated statement acknowledging receipt
of the order from all persons who
receive a copy. Section VII of the
proposed order with the DesignerWare
principals requires them to submit
compliance reports to the Commission
within sixty (60) days, and periodically
thereafter as requested. In addition, this
section requires them to notify the
Commission of changes in their
business or employment for three (3)
years.
Under Section VIII of the proposed
orders with both DesignerWare and its
principals, respondents must retain
documents relating to their compliance
with the order for a five (5) year period.
Finally, Section IX of both proposed
orders is a provision ‘‘sunsetting’’ the
orders after twenty (20) years, with
certain exceptions.
The proposed orders against the RTO
stores (which are identical to each
other) contain similar injunctive
provisions to those in the proposed
orders with DesignerWare and its
principals. Section I of each of the
proposed orders bans the RTO stores
from using monitoring technology in
connection with any covered RTO
transaction. Section II prohibits the
stores from using geophysical location
tracking technology to gather
information from any computer without
providing clear and prominent notice to
the computer’s renter and obtaining
affirmative express consent from the
computer’s renter at the time the
computer is rented. This section also
requires clear and prominent notice to
a computer user immediately prior to
each time such technology is activated.
The proposed RTO store orders also
suspend the notice requirement if (1)
there is a reasonable basis to believe that
the computer has been stolen and (2) a
police report has been filed. Section III
of each of the proposed orders prohibits
the deceptive collection of consumer
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information via fake software
registration notices.
Section IV bars the stores from
collecting or attempting to collect a
debt, money, or property pursuant to a
consumer rental contract by using any
information or data that was improperly
obtained from a computer by monitoring
technology. Section V requires that any
data collected through any monitoring
or tracking software without the
requisite notice and consent be
destroyed, and that any properly
collected data be encrypted when
transmitted. As fencing in, Section VI
bars misrepresentations about the
privacy or security of any personal
information gathered from or about
consumers.
Sections VII through X of the
proposed RTO store orders contain
reporting and compliance provisions.
Section VII requires distribution of the
order now and in the future to all
current and future principals, officers,
directors, and managers, and to persons
with responsibilities relating to the
subject matter of the order. It also
requires the RTO stores to secure signed
and dated statements acknowledging
receipt of the order from all persons
who receive a copy of the order. Section
VIII requires the RTO stores to submit
compliance reports to the Commission
within sixty (60) days, and periodically
thereafter as requested, and ensures
notification to the Commission of
changes in corporate status. Under
Section IX, the RTO stores must retain
documents relating to order compliance
for a five (5) year period. Finally,
Section X is a provision ‘‘sunsetting’’
the order after twenty (20) years, with
certain exceptions.
The purpose of this analysis is to
facilitate public comment on the
proposed orders. It is not intended to
constitute an official interpretation of
the proposed complaints or orders or to
modify the terms of the orders in any
way.
By direction of the Commission,
Commissioner Rosch abstaining.
Donald S. Clark,
Secretary.
[FR Doc. 2012–24177 Filed 10–1–12; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting Notice for the President’s
Advisory Council on Faith-Based and
Neighborhood Partnerships
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
PO 00000
Frm 00023
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60123
(Pub. L. 92–463), the President’s
Advisory Council on Faith-based and
Neighborhood Partnerships announces
the following three conference calls:
Name: President’s Advisory Council on
Faith-based and Neighborhood Partnerships
Council Conference Calls
Time and Date: Thursday, October 18th 4
p.m.–5:30 p.m. (EDT); Thursday, November
15th 4 p.m.–5:30 p.m. (EST); December 13th
4 p.m.–5:30 p.m. (EST)
Place: All meetings announced herein will
be held by conference call. The call-in line
is: 1–866–823–5144; Passcode: 1375705.
Space is limited so please RSVP to
partnerships@hhs.gov to participate.
Status: Open to the public, limited only by
lines available.
Purpose: The Council brings together
leaders and experts in fields related to the
work of faith-based and neighborhood
organizations in order to: Identify best
practices and successful modes of delivering
social services; evaluate the need for
improvements in the implementation and
coordination of public policies relating to
faith-based and other neighborhood
organizations; and make recommendations
for changes in policies, programs, and
practices.
Contact Person for Additional Information:
Please contact Ben O’Dell for any additional
information about the President’s Advisory
Council meeting at partnerships@hhs.gov.
Agenda: Please visit https://
www.whitehouse.gov/partnerships for further
updates on the Agenda for the meeting.
Public Comment: There will be an
opportunity for public comment at the
conclusion of the meeting. Comments and
questions can be asked over the conference
call line, or sent in advance to
partnerships@hhs.gov.
Dated: September 26, 2012.
Ben O’Dell,
Designated Federal Officer and Associate
Director, HHS Center for Faith-Based and
Neighborhood Partnerships.
[FR Doc. 2012–24218 Filed 10–1–12; 8:45 am]
BILLING CODE 4154–07–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request;
Developmental Disabilities Protection
& Advocacy Program Statement of
Goals and Priorities
Administration for Community
Living, HHS.
ACTION: Notice.
AGENCY:
The Administration
Intellectual and Developmental
Disabilities (AIDD), Administration for
Community Living (ACL) is announcing
that the proposed collection of
SUMMARY:
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60124
Federal Register / Vol. 77, No. 191 / Tuesday, October 2, 2012 / Notices
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. This notice
originally had a submission deadline of
September 19, 2012. We are
republishing the notice to due to
incorrect contact information for OMB.
Comments already successfully
submitted will be given consideration
and in the event an individual or
organization resubmits comments, there
most recent submission will be
considered.
DATES: Submit written comments on the
collection of information by November
1, 2012.
ADDRESSES: Submit written comments
on the collection of information to
OIRA_submission@omb.eop.gov or by
fax to 202.395.5806. Attn: OMB Desk
Officer for ACL, Office of Information
and Regulatory Affairs, OMB.
FOR FURTHER INFORMATION CONTACT:
Brianne Burger, 202.618.5525.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, ACL
has submitted the following proposed
collection of information to OMB for
review and clearance. Federal statute
and regulation require each State
Protection and Advocacy (P&A) System
to prepare and solicit public comment
on a Statement of Goals and Priorities
(SGP) for the P&A for Developmental
Disabilities (PADD) program for each
coming fiscal year. While the P&A is
mandated to protect and advocate under
a range of different federally authorized
disabilities programs, only the PADD
program requires an SGP. Following the
required public input for the coming
fiscal year, the P&As submit the final
version of this SGP to the
Administration on Intellectual and
Developmental Disabilities (AIDD).
AIDD will aggregate the information in
the SGPs into a national profile of
programmatic emphasis for P&A
Systems in the coming year. This
aggregation will provide AIDD with a
tool for monitoring of the public input
requirement. Furthermore, it will
provide an overview of program
direction, and permit AIDD to track
accomplishments against goals/targets,
permitting the formulation of technical
assistance and compliance with the
Government Performance and Results
Act of 1993. ACL estimates the burden
of this collection of information as
follows:
ANNUAL BURDEN ESTIMATES
Instrument
Number of respondents
Number of responses per
respondent
Average burden hours per
response
Total burden hours
P&A SGP
57
1
44
2,508
amendments or prior approval
supplements to these applications, will
be required to undergo an initial
completeness assessment in accordance
with FDA criteria. This guidance is
intended to clarify the criteria FDA will
use in the initial completeness
assessment.
Dated: September 27, 2012.
Kathy Greenlee,
Administrator & Assistant Secretary for
Aging.
[FR Doc. 2012–24236 Filed 10–1–12; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–1010]
Draft Guidance for Industry on Initial
Completeness Assessments for Type II
Active Pharmaceutical Ingredient Drug
Master Files Under the Generic Drug
User Fee Amendments of 2012
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Initial
Completeness Assessments for Type II
API DMFs Under GDUFA.’’ Under the
Generic Drug User Fee Amendments of
2012 (GDUFA), holders of certain drug
master files, namely, Type II active
pharmaceutical ingredient (API) drug
master files (DMFs) that are referenced
in generic drug applications, or in
wreier-aviles on DSK5TPTVN1PROD with NOTICES
SUMMARY:
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FOR FURTHER INFORMATION CONTACT:
DATES:
Estimated Total Annual Burden
Hours: 2,508.
Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by December 3,
2012.
I. Background
Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist the office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
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.
Section 744B(a)(2)(D)(ii) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379j–42(a)(2)(D)(ii)) (FD&C
Act), which was added by GDUFA, Title
III, Food and Drug Administration
Safety and Innovation Act (Pub. L. 112–
144), states that, on or after October 1,
2012, a Type II API DMF will be
deemed available for reference in an
abbreviated new drug application
(ANDA), ANDA amendment, or ANDA
prior approval supplement (PAS), if the
required fee has been paid and if the
DMF has not failed an initial
completeness assessment ‘‘in
accordance with criteria to be published
by’’ FDA. Any Type II API DMF
intended for reference in a generic drug
submission for which the fee is paid
will undergo an initial completeness
assessment. Section 744B(a)(2)(D)(iii) of
the FD&C Act requires FDA to make
publicly available on its Web site a list
of DMF numbers that correspond to
DMFs that have successfully undergone
an initial completeness assessment in
accordance with criteria to be published
by FDA and are available for reference.
ADDRESSES:
PO 00000
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Jaewon Hong, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002, 1–866–405–5367 or 301–
796–6707.
SUPPLEMENTARY INFORMATION:
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Agencies
[Federal Register Volume 77, Number 191 (Tuesday, October 2, 2012)]
[Notices]
[Pages 60123-60124]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-24236]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Community Living
Agency Information Collection Activities: Submission for OMB
Review; Comment Request; Developmental Disabilities Protection &
Advocacy Program Statement of Goals and Priorities
AGENCY: Administration for Community Living, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Administration Intellectual and Developmental Disabilities
(AIDD), Administration for Community Living (ACL) is announcing that
the proposed collection of
[[Page 60124]]
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. This notice originally had a submission deadline of
September 19, 2012. We are republishing the notice to due to incorrect
contact information for OMB. Comments already successfully submitted
will be given consideration and in the event an individual or
organization resubmits comments, there most recent submission will be
considered.
DATES: Submit written comments on the collection of information by
November 1, 2012.
ADDRESSES: Submit written comments on the collection of information to
OIRA_submission@omb.eop.gov or by fax to 202.395.5806. Attn: OMB Desk
Officer for ACL, Office of Information and Regulatory Affairs, OMB.
FOR FURTHER INFORMATION CONTACT: Brianne Burger, 202.618.5525.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, ACL has
submitted the following proposed collection of information to OMB for
review and clearance. Federal statute and regulation require each State
Protection and Advocacy (P&A) System to prepare and solicit public
comment on a Statement of Goals and Priorities (SGP) for the P&A for
Developmental Disabilities (PADD) program for each coming fiscal year.
While the P&A is mandated to protect and advocate under a range of
different federally authorized disabilities programs, only the PADD
program requires an SGP. Following the required public input for the
coming fiscal year, the P&As submit the final version of this SGP to
the Administration on Intellectual and Developmental Disabilities
(AIDD). AIDD will aggregate the information in the SGPs into a national
profile of programmatic emphasis for P&A Systems in the coming year.
This aggregation will provide AIDD with a tool for monitoring of the
public input requirement. Furthermore, it will provide an overview of
program direction, and permit AIDD to track accomplishments against
goals/targets, permitting the formulation of technical assistance and
compliance with the Government Performance and Results Act of 1993. ACL
estimates the burden of this collection of information as follows:
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of responses Average burden hours
Instrument Number of respondents per respondent per response Total burden hours
----------------------------------------------------------------------------------------------------------------
P&A SGP 57 1 44 2,508
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 2,508.
Dated: September 27, 2012.
Kathy Greenlee,
Administrator & Assistant Secretary for Aging.
[FR Doc. 2012-24236 Filed 10-1-12; 8:45 am]
BILLING CODE 4154-01-P