Proposed Information Collection Activity; Comment Request, 9943-9944 [2012-3895]
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9943
Federal Register / Vol. 77, No. 34 / Tuesday, February 21, 2012 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Emergency Contingency Fund
for Temporary Assistance for Needy
Families (TANF) Programs OFA–100.
OMB No.: 0970–0366.
Description
On February 17, 2009, the President
signed the American Recovery and
Reinvestment Act of 2009 (Recovery
Act), which establishes the Emergency
Contingency Fund for State TANF
Programs (Emergency Fund) as section
403(c) of the Social Security Act (the
Act). This legislation provides up to $5
billion to help States, Territories, and
Tribes in fiscal year (FY) 2009 and FY
2010 that have an increase in assistance
caseloads and basic assistance
expenditures, or in expenditures related
to short-term benefits or subsidized
employment. The Recovery Act made
additional changes to TANF extending
supplemental grants through FY 2010,
expanding flexibility in the use of TANF
funds carried over from one fiscal year
to the next, and adding a hold-harmless
provision to the caseload reduction
credit for States and Territories serving
more TANF families.
The Emergency Fund is intended to
build upon and renew the principles of
work and responsibility that underlie
successful welfare reform initiatives.
The Emergency Fund provides
resources to States, Territories, and
Tribes to support work and families
during this difficult economic period.
On July 20, 2009 we issued a Program
Instruction accompanied by the
Emergency Fund Request Form (OFA–
100), and instructions for jurisdictions
to complete the OFA–100 to apply for
emergency funds.
Failure to collect this data would
compromise ACF’s ability to monitor
caseload and expenditure data that must
increase in order for jurisdictions to
receive awards under the Emergency
Fund.
Documentation maintenance on
financial reporting for the Emergency
Fund is governed by 45 CFR 92.20 and
45 CFR 92.42.
ACF is planning to extend the
information collection with the
adjustment to the Estimated Annual
Burden shown in the table below. Based
on our projections for a lower Estimated
Annual Burden, we have revised the
Number of Responses per Respondent to
1 from its previous number of 5.
Because the Number of Responses per
Respondent has been revised, the
Estimated Total Burden Hours is now
2,232, down from its previous number
of 11,160.
Respondents
State, Territory, and Tribal agencies
administering the Temporary Assistance
for Needy Families (TANF) Program that
are applying for the Emergency Fund.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
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TANF Emergency Fund Request Form, OFA–100 .........................................
Estimated Total Annual Burden
Hours: 2,232.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer.
Email address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
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17:29 Feb 17, 2012
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Number of
responses per
respondent
93
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2012–3873 Filed 2–17–12; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
1
Frm 00056
Fmt 4703
Sfmt 4703
24
Total burden
hours
2,232
OMB No.: 0970–0247.
Description: This information
collection is authorized under Section
411(a)(3) of the Social Security Act. This
request is for renewal of approval to use
the Administration for Children and
Families’ (ACF) 196 form for periodic
financial reporting under the Temporary
Assistance for Needy Families (TANF)
program. Approval of this information
collection expires on April 30, 2012.
States participating in the TANF
program are required by statute to report
financial data on a quarterly basis. This
form meets the legal standard and
provides essential data on the use of
Federal funds. Failure to collect the data
would seriously compromise ACF’s
ability to monitor program
expenditures, estimate funding needs,
and to prepare budget submissions
required by Congress. Financial
reporting under the TANF program is
governed by 45 CFR part 265.
Respondents: TANF Agencies.
Proposed Projects
Title: TANF Quarterly Financial
Report, ACF–196.
PO 00000
Average
burden hours
per response
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9944
Federal Register / Vol. 77, No. 34 / Tuesday, February 21, 2012 / Notices
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
ACF–196T ........................................................................................................
ACF–196 ..........................................................................................................
Estimated Total Annual Burden
Hours: 2,040.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer.
Email address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2012–3895 Filed 2–17–12; 8:45 am]
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BILLING CODE 4184–01–P
VerDate Mar<15>2010
17:29 Feb 17, 2012
Jkt 226001
Food and Drug Administration
[Docket No. FDA–2009–P–0170]
Determination That REQUIP XL
(Ropinerole Hydrochloride) ExtendedRelease Tablets, 3 Milligrams, Were
Not Withdrawn From Sale for Reasons
of Safety or Effectiveness
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
that REQUIP XL (ropinerole
hydrochloride) extended-release tablets,
3 milligrams (mg), were not withdrawn
from sale for reasons of safety or
effectiveness. This determination will
allow FDA to approve abbreviated new
drug applications (ANDAs) for
ropinerole hydrochloride extendedrelease tablets, 3 mg, if all other legal
and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Jay
Sitlani, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 6370, Silver Spring,
MD 20993–0002, 301–796–3601.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA). The only clinical data required
in an ANDA are data to show that the
drug that is the subject of the ANDA is
bioequivalent to the listed drug.
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
SUMMARY:
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
Average burden hours per
response
4
4
2
8
51
51
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Number of
responses per
respondent
Total burden
hours
408
1,632
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (§ 314.162 (21
CFR 314.162)).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
REQUIP XL (ropinerole
hydrochloride) extended-release tablets,
3 mg, are the subject of NDA 22–008,
held by GlaxoSmithKline, and initially
approved on June 13, 2008. REQUIP XL
is indicated for the treatment of
treatment of signs and symptoms of
idiopathic Parkinson’s disease.
REQUIP XL (ropinerole
hydrochloride) extended-release tablets,
3 mg, are currently listed in the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
GlaxoSmithKline has never marketed
REQUIP XL (ropinerole hydrochloride)
extended-release tablets, 3 mg. In
previous instances (see, e.g., 72 FR
9763, 61 FR 25497), the Agency has
determined that, for purposes of
§§ 314.161 and 314.162, never
marketing an approved drug product is
equivalent to withdrawing the drug
from sale.
Lachman Consultant Services, Inc.
submitted a citizen petition dated April
1, 2009 (Docket No. FDA–2009–P–
0170), under 21 CFR 10.30, requesting
that the Agency determine whether
REQUIP XL (ropinerole hydrochloride)
extended-release tablets, 3 mg, were
withdrawn from sale for reasons of
safety or effectiveness.
E:\FR\FM\21FEN1.SGM
21FEN1
]]>Agencies
[Federal Register Volume 77, Number 34 (Tuesday, February 21, 2012)]
[Notices]
[Pages 9943-9944]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-3895]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Proposed Projects
Title: TANF Quarterly Financial Report, ACF-196.
OMB No.: 0970-0247.
Description: This information collection is authorized under
Section 411(a)(3) of the Social Security Act. This request is for
renewal of approval to use the Administration for Children and
Families' (ACF) 196 form for periodic financial reporting under the
Temporary Assistance for Needy Families (TANF) program. Approval of
this information collection expires on April 30, 2012. States
participating in the TANF program are required by statute to report
financial data on a quarterly basis. This form meets the legal standard
and provides essential data on the use of Federal funds. Failure to
collect the data would seriously compromise ACF's ability to monitor
program expenditures, estimate funding needs, and to prepare budget
submissions required by Congress. Financial reporting under the TANF
program is governed by 45 CFR part 265.
Respondents: TANF Agencies.
[[Page 9944]]
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
ACF-196T........................................ 51 4 2 408
ACF-196......................................... 51 4 8 1,632
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 2,040.
In compliance with the requirements of Section 506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Administration for Children and
Families is soliciting public comment on the specific aspects of the
information collection described above. Copies of the proposed
collection of information can be obtained and comments may be forwarded
by writing to the Administration for Children and Families, Office of
Planning, Research and Evaluation, 370 L'Enfant Promenade SW.,
Washington, DC 20447, Attn: ACF Reports Clearance Officer. Email
address: infocollection@acf.hhs.gov. All requests should be identified
by the title of the information collection.
The Department specifically requests comments on: (a) Whether the
proposed collection of information is necessary for the proper
performance of the functions of the agency, including whether the
information shall have practical utility; (b) the accuracy of the
agency's estimate of the burden of the proposed collection of
information; (c) the quality, utility, and clarity of the information
to be collected; and (d) ways to minimize the burden information to be
collected; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2012-3895 Filed 2-17-12; 8:45 am]
BILLING CODE 4184-01-P
