Agency Information Collection Request; 60-Day Public Comment Request, 45804-45805 [2011-19323]
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srobinson on DSK4SPTVN1PROD with NOTICES
45804
Federal Register / Vol. 76, No. 147 / Monday, August 1, 2011 / Notices
divestitures to Watson is not acceptable,
the parties must unwind the sale and
divest the Products within six months of
the date the Order becomes final to
another Commission-approved acquirer.
If the parties fail to divest within six
months, the Commission may appoint a
trustee to divest the Product assets.
The proposed remedy contains
several provisions to ensure that the
divestitures are successful. The Order
requires Perrigo and Paddock to provide
transitional services to enable Watson to
obtain all of the necessary approvals
from the FDA. These transitional
services include technology transfer
assistance to manufacture the Products
in substantially the same manner and
quality employed or achieved by Perrigo
and Paddock. In addition, the parties
must supply Watson with the Products
pursuant to a supply agreement while
they transfer the manufacturing
technology to a third-party
manufacturer of Watson’s choice.
The Consent Agreement also
preserves competition in the market for
testosterone gel by prohibiting the
parties from: (1) receiving any payments
that accrue after the initial term of the
backup supply agreement aside from
those for manufacturing the product;
and (2) entering into any
anticompetitive pay-for-delay
arrangements with Abbott regarding the
testosterone gel product.
The Commission has appointed F.
William Rahe of Quantic Regulatory
Services, LLC (‘‘Quantic’’) as the Interim
Monitor to oversee the asset transfer and
to ensure Perrigo and Paddock’s
compliance with the provisions of the
proposed Consent Agreement. Mr. Rahe
is a senior consultant at Quantic and has
several years of experience in the
pharmaceutical industry. He is a highlyqualified expert on FDA regulatory
matters and currently advises Quantic
clients on achieving satisfactory
regulatory compliance and interfacing
with the FDA. In order to ensure that
the Commission remains informed
about the status of the proposed
divestitures and the transfers of assets,
the proposed Consent Agreement
requires the parties to file reports with
the Commission periodically until the
divestitures and transfers are
accomplished.
The purpose of this analysis is to
facilitate public comment on the
proposed Consent Agreement, and it is
not intended to constitute an official
interpretation of the proposed Order or
to modify its terms in any way.
VerDate Mar<15>2010
17:45 Jul 29, 2011
Jkt 223001
By direction of the Commission.
Richard C. Donohue,
Acting Secretary.
[FR Doc. 2011–19422 Filed 7–29–11; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–New; 60-day
Notice]
Agency Information Collection
Request; 60-Day Public Comment
Request
Office of the Secretary, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act (PRA) of
1995, the Office of the Secretary (OS),
Department of Health and Human
Services, is publishing the following
summary of a proposed information
collection request for public comment.
Interested persons are invited to send
comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, e-mail your request,
including your address, phone number,
OMB number, and OS document
identifier, to Sherette.funncoleman@
hhs.gov, or call the Reports Clearance
Office on (202) 690–6162. Written
comments and recommendations for the
proposed information collections must
be directed to the OS Paperwork
Clearance Officer at the above e-mail
address within 60 days.
Proposed Project: Descriptive
information of solutions provided to the
Federal government in response to
Challenge and Competition solicitations
posted on Challenge.gov.— OMB No.
0990-New-Immediate Office of the
Secretary.
Abstract: This request is to seek
generic clearance for the collection of
routine information requested of
responders to solicitations the Federal
government makes during the issuance
of challenges and competitions posted
AGENCY:
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
on the General Service Administration
(GSA)’s Challenge.gov Web site. Since
passage of the America COMPETES Act
of 2011, challenge competitions are
increasingly being used by Federal
agencies to solve complex problems and
obtain innovative solutions. In this role,
the Federal government places a
description of a problem and parameters
of the solution on the Challenge.gov
Web site. The solutions are evaluated by
the submitting agency and typically
prizes (monetary and non-monetary) are
awarded to the winning entries.
This clearance applies to challenges
posted on Challenge.gov which uses a
common platform for the solicitation of
challenges from the public. Each agency
designs the criteria for its solicitations
based on the goals of the challenge and
the specific needs of the agency. There
is no standard submission format for
solution providers to follow.
We anticipate that approximately 100
challenges would be issued each year by
HHS, with an average of 15 submissions
to each challenge solicitation. It is
expected that other federal agencies will
issue a similar number of challenges.
There is no set schedule for the issuance
of challenges; they are developed and
issued on an ‘‘as needs’’ basis in
response to issues the federal agency
wishes to solve. The respondents to the
challenges, who are participating
voluntarily, are unlikely to reply to
more than one or several of the
challenges.
Although in recent memoranda the
GSA and Office of Management and
Budget (OMB) described circumstances
whereby OMB approval of a PRA
request is not needed, program officials
at HHS have identified several sets of
information that will typically need to
be requested of solution providers to
enable the solutions to be adequately
evaluated by the federal agency issuing
the challenge. These requests for
additional information have been
suggested to require a PRA review as
they represent structured data requests.
There are three types of additional
data that will be routinely requested by
the federal agencies. These include the
following:
Title of the submission. Due to the nature
of the submission and evaluation processes,
it is important that a title be requested and
submitted for each submission in order to
ensure the solution is correctly identified
with its provider.
Identification of data resources. In many
cases, the solution to a problem will require
the solution provider to use data resources.
Often, the nature of the data sets will be
derived from Federal data resources, such as
data.gov. Evaluations of solutions will often
depend on the understanding of the selection
of the data resource(s) used in the solution.
E:\FR\FM\01AUN1.SGM
01AUN1
45805
Federal Register / Vol. 76, No. 147 / Monday, August 1, 2011 / Notices
Description of methodology. For effective
judging and evaluation, a description of the
development methods for the solution to the
challenge will be requested. For instance, a
prize may be awarded to the solution of a
challenge to develop an algorithm that
enables reliable prediction of a certain event.
A responder could submit the correct
algorithm, but without the methodology, the
evaluation process could not be adequately
performed.
ESTIMATED ANNUALIZED BURDEN TABLE
Forms
Challenge
Challenge
Challenge
Challenge
Template
Template
Template
Template
A
A
A
A
No. of
respondents
Type of respondent
......................
......................
......................
......................
No. of responses per
respondent
Average burden (in hours)
per response
Total burden
hours
500
500
500
30
1
1
1
1
10/60
10/60
10/60
10/60
83.3
83.3
83.3
5
Challenge Template A ......................
Individuals or Households ................
Organizations ...................................
Businesses .......................................
State, territory, tribal or local governments.
Federal government .........................
30
1
10/60
5
Total ...........................................
...........................................................
1,560
Mary Forbes,
Paperwork Reduction Act Clearance Officer,
Office of the Secretary.
[FR Doc. 2011–19323 Filed 7–29–11; 8:45 am]
BILLING CODE 4150–03–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Calculation of Annual Federal Medical
Assistance Percentages for Indian
Tribes for Use in the Title IV–E Foster
Care, Adoption Assistance, and
Kinship Guardianship Assistance
Programs
Office of the Secretary, DHHS.
Notice.
AGENCY:
ACTION:
This notice finalizes the
methodology that will be used to
calculate reimbursement rates
applicable to fiscal years 2010 and
beyond for assistance payments under
the tribal Foster Care, Adoption
Assistance and Guardianship Assistance
Programs authorized by title IV–E of the
Social Security Act. A Notice with
Comment Period on this topic was
previously published on October 8,
2010.
DATES: Effective Date. The methodology
described in this Notice is effective
upon publication.
srobinson on DSK4SPTVN1PROD with NOTICES
SUMMARY:
A. Background
The Fostering Connections to Success
and Increasing Adoptions Act of 2008
(‘‘Fostering Connections Act, ’’ Pub. L.
110–351), authorizes Indian tribes, tribal
organizations and tribal consortia to
receive funding directly for Foster Care,
Adoption Assistance, and Kinship
Guardianship Assistance Programs
under title IV–E of the Social Security
Act (42 U.S.C. 679c). Such direct
funding was authorized to begin in
fiscal year (FY) 2010 for Indian tribes,
tribal organizations or tribal consortia
VerDate Mar<15>2010
17:45 Jul 29, 2011
Jkt 223001
with approved title IV–E plans, or
eligible Indian tribes may submit plans
to operate such programs at any time in
the future. Indian tribes not operating
their own programs may receive title
IV–E funds through cooperative
agreements or contracts with the States
within which they are located. The
methodology described in this notice is
also applicable in calculating
reimbursement rates under such
agreements beginning in FY 2010.
The Federal share of assistance
payments for the Title IV–E Foster Care,
Adoption Assistance and Kinship
Guardianship Assistance Programs is
calculated using the Federal Medical
Assistance Percentage (FMAP), a match
rate calculated annually for each State
by the Department of Health and Human
Services (HHS) according to a formula
specified in statute (section 1905(b) of
the Social Security Act, 42 U.S.C.
1396d(b)). The FMAP formula involves
comparing the State’s average per capita
income over a three year period with the
average per capita income of the U.S. as
a whole for the same three year period,
and results in FMAP rates that vary
between statutory minimum and
maximum levels of 50 and 83 percent.
The formula produces higher Federal
matching rates for jurisdictions with
lower per capita incomes relative to the
U.S. as a whole.
Indian tribes previously have not been
authorized to directly administer
Federal programs that use FMAPs and
therefore tribal FMAPs have not
previously been calculated. However,
the Fostering Connections Act requires
HHS to establish FMAP rates for Indian
tribes, tribal organizations, or tribal
consortia (Pub. L. 110–351, section
301(d); 42 U.S.C. 679c(d)). The Act
further specifies that each Tribe’s
annual FMAP shall be based on the per
capita income of the service population
of the Indian tribe, tribal organization,
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
255.9
or tribal consortium. However, no tribal
FMAP shall be lower than the FMAP of
any State in which the Indian tribe,
tribal organization, or tribal consortium
is located.
The FMAP rates calculated using the
methodology described here will be
used for Indian tribes’ title IV–E Foster
Care, Adoption Assistance, and Kinship
Guardianship Assistance programs
whether they are administered directly
by the Indian tribe or through an
agreement or contract with a title IV–E
State agency per sections 474(a)(1) and
(2) of the Social Security Act, 42 U.S.C.
674(a)(1) and (2). Thus, a State may also
claim reimbursement for title IV–E
allowable assistance payments made on
behalf of tribal children served through
agreements or contracts with Indian
tribes at the higher of the FMAP rate
applicable to the State or the FMAP rate
for the involved Indian tribe.
B. Outreach Regarding the October 8,
2010, Federal Register Notice and
Comments Received
On October 8, 2010, HHS published a
Federal Register Notice requesting
comments on its proposed methodology
for calculating FMAP for Indian tribes.
A 60-day comment period was
provided. HHS mailed copies of the
Notice to tribal chairman of all federally
recognized Indian tribes and posted the
Notice to several electronic listserves
operated by the Department’s
Administration for Children and
Families that are most relevant to tribal
child welfare programs. Each of the
letters and postings provided dates and
call-in instructions for four conference
calls that were to be held to describe the
content of the Notice and answer any
questions Tribes may have had about it.
These calls were held on November 3,
4, 9 and 10, 2010.
A single set of written comments was
received on the content of the Federal
E:\FR\FM\01AUN1.SGM
01AUN1
Agencies
[Federal Register Volume 76, Number 147 (Monday, August 1, 2011)]
[Notices]
[Pages 45804-45805]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19323]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-New; 60-day Notice]
Agency Information Collection Request; 60-Day Public Comment
Request
AGENCY: Office of the Secretary, HHS.
In compliance with the requirement of section 3506(c)(2)(A) of the
Paperwork Reduction Act (PRA) of 1995, the Office of the Secretary
(OS), Department of Health and Human Services, is publishing the
following summary of a proposed information collection request for
public comment. Interested persons are invited to send comments
regarding this burden estimate or any other aspect of this collection
of information, including any of the following subjects: (1) The
necessity and utility of the proposed information collection for the
proper performance of the agency's functions; (2) the accuracy of the
estimated burden; (3) ways to enhance the quality, utility, and clarity
of the information to be collected; and (4) the use of automated
collection techniques or other forms of information technology to
minimize the information collection burden.
To obtain copies of the supporting statement and any related forms
for the proposed paperwork collections referenced above, e-mail your
request, including your address, phone number, OMB number, and OS
document identifier, to Sherette.funncoleman@hhs.gov, or call the
Reports Clearance Office on (202) 690-6162. Written comments and
recommendations for the proposed information collections must be
directed to the OS Paperwork Clearance Officer at the above e-mail
address within 60 days.
Proposed Project: Descriptive information of solutions provided to
the Federal government in response to Challenge and Competition
solicitations posted on Challenge.gov.-- OMB No. 0990-New-Immediate
Office of the Secretary.
Abstract: This request is to seek generic clearance for the
collection of routine information requested of responders to
solicitations the Federal government makes during the issuance of
challenges and competitions posted on the General Service
Administration (GSA)'s Challenge.gov Web site. Since passage of the
America COMPETES Act of 2011, challenge competitions are increasingly
being used by Federal agencies to solve complex problems and obtain
innovative solutions. In this role, the Federal government places a
description of a problem and parameters of the solution on the
Challenge.gov Web site. The solutions are evaluated by the submitting
agency and typically prizes (monetary and non-monetary) are awarded to
the winning entries.
This clearance applies to challenges posted on Challenge.gov which
uses a common platform for the solicitation of challenges from the
public. Each agency designs the criteria for its solicitations based on
the goals of the challenge and the specific needs of the agency. There
is no standard submission format for solution providers to follow.
We anticipate that approximately 100 challenges would be issued
each year by HHS, with an average of 15 submissions to each challenge
solicitation. It is expected that other federal agencies will issue a
similar number of challenges. There is no set schedule for the issuance
of challenges; they are developed and issued on an ``as needs'' basis
in response to issues the federal agency wishes to solve. The
respondents to the challenges, who are participating voluntarily, are
unlikely to reply to more than one or several of the challenges.
Although in recent memoranda the GSA and Office of Management and
Budget (OMB) described circumstances whereby OMB approval of a PRA
request is not needed, program officials at HHS have identified several
sets of information that will typically need to be requested of
solution providers to enable the solutions to be adequately evaluated
by the federal agency issuing the challenge. These requests for
additional information have been suggested to require a PRA review as
they represent structured data requests.
There are three types of additional data that will be routinely
requested by the federal agencies. These include the following:
Title of the submission. Due to the nature of the submission and
evaluation processes, it is important that a title be requested and
submitted for each submission in order to ensure the solution is
correctly identified with its provider.
Identification of data resources. In many cases, the solution to
a problem will require the solution provider to use data resources.
Often, the nature of the data sets will be derived from Federal data
resources, such as data.gov. Evaluations of solutions will often
depend on the understanding of the selection of the data resource(s)
used in the solution.
[[Page 45805]]
Description of methodology. For effective judging and
evaluation, a description of the development methods for the
solution to the challenge will be requested. For instance, a prize
may be awarded to the solution of a challenge to develop an
algorithm that enables reliable prediction of a certain event. A
responder could submit the correct algorithm, but without the
methodology, the evaluation process could not be adequately
performed.
Estimated Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
No. of Average burden
Forms Type of No. of responses per (in hours) per Total burden
respondent respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Challenge Template A.......... Individuals or 500 1 10/60 83.3
Households.
Challenge Template A.......... Organizations... 500 1 10/60 83.3
Challenge Template A.......... Businesses...... 500 1 10/60 83.3
Challenge Template A.......... State, 30 1 10/60 5
territory,
tribal or local
governments.
Challenge Template A.......... Federal 30 1 10/60 5
government.
---------------------------------------------------------------
Total..................... ................ 1,560 .............. .............. 255.9
----------------------------------------------------------------------------------------------------------------
Mary Forbes,
Paperwork Reduction Act Clearance Officer, Office of the Secretary.
[FR Doc. 2011-19323 Filed 7-29-11; 8:45 am]
BILLING CODE 4150-03-P