Proposed Information Collection Activity; Comment Request, 67745-67746 [2011-28273]
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emcdonald on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 76, No. 212 / Wednesday, November 2, 2011 / Notices
The RFA requires agencies to analyze
options for regulatory relief of small
businesses. For purposes of the RFA,
small entities include small businesses,
nonprofit organizations, and small
governmental jurisdictions. Most
hospitals and most other providers and
suppliers are small entities, either by
nonprofit status or by having revenues
of $7.0 million to $34.5 million in any
1 year. Individuals and States are not
included in the definition of a small
entity. As we stated in the RIA for the
February 2, 2011 final rule with
comment period (76 FR 5952) and the
regulatory impact statement of the
March 23, 2011 notice (76 FR 16423),
we do not believe that the application
fee will have a significant impact on
small entities.
In addition, section 1102(b) of the Act
requires us to prepare a regulatory
impact analysis if a rule may have a
significant impact on the operations of
a substantial number of small rural
hospitals. This analysis must conform to
the provisions of section 604 of the
RFA. For purposes of section 1102(b) of
the Act, we define a small rural hospital
as a hospital that is located outside of
a Metropolitan Statistical Area for
Medicare payment regulations and has
fewer than 100 beds. We are not
preparing an analysis for section 1102(b)
of the Act because we have determined
that this notice would not have a
significant impact on the operations of
a substantial number of small rural
hospitals.
Section 202 of the Unfunded
Mandates Reform Act of 1995 (UMRA)
also requires that agencies assess
anticipated costs and benefits before
issuing any rule whose mandates
require spending in any 1 year of $100
million in 1995 dollars, updated
annually for inflation. In 2011, that
threshold is approximately $136
million. This notice does not mandate
such expenditures by States and local
governments.
Executive Order 13132 establishes
certain requirements that an agency
must meet when it promulgates a
proposed rule that imposes substantial
direct requirement costs on State and
local governments, preempts State law,
or otherwise has Federalism
implications. Since this notice does not
impose substantial direct costs on State
or local governments, the requirements
of Executive Order 13132 are not
applicable.
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The costs associated with this notice
involve the increase in the application
fee that certain providers and suppliers
must pay in CY 2012. In the RIA for the
February 2, 2011 final rule with
comment period (76 FR 5955 through
5958), we estimated the total amount of
application fees for CYs 2011 through
2015. For 2012, and based on a $515
application fee, we projected in Tables
11 and 12 (76 FR 5955 and 5956) a total
cost in fees of $71,803,875 for Medicare
institutional providers (or 139,425
providers × $515). In the February 2,
2011 final rule with comment period (76
FR 5957 and 5958), we estimated the
total cost in CY 2012 for Medicaid
providers to be $12,944,010 (or 25,134
providers × $515), as indicated in Tables
13 and 14.
We are retaining the figure of 25,134
Medicaid providers for purposes of this
notice. However, we are changing the
Medicare provider estimate based on
our plan to revalidate all Medicare
providers and suppliers– even if the
revalidation is considered ‘‘off-cycle’’
per 42 CFR 424.515(e).
1. Medicare
For purposes of this notice only, we
estimate that approximately 840,000
Medicare providers and suppliers will
be subject to revalidation in CY 2012. Of
this total, we believe that roughly 80
percent will be exempt from the
application fee requirement because the
provider or supplier: (1) Is of a type (for
example, a physician) that is exempt
from the requirement, or (2) qualifies for
a hardship exception under 42 CFR
424.514(c). This leaves 168,000
revalidating providers and suppliers
that will have to pay the fee.
In the February 2, 2011 final rule with
comment period (76 FR 5955), we
estimated that 31,200 newly-enrolling
institutional providers would be subject
to the application fee in CY 2012. We
stand by this projection for purposes of
this notice. Using a figure of 199,200
providers and suppliers (168,000 +
31,200), we estimate an increase in the
cost of the Medicare application fee
requirement in CY 2012 of $1,593,600
(or 199,200 × $8.00).
2. Medicaid and CHIP
In the February 2, 2011 final rule with
comment period (76 FR 5957 and 5958),
we estimated that 25,134 (8,438 newly
enrolling + 16,696 re-enrolling)
Medicaid and CHIP providers would be
subject to an application fee in CY 2012.
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67745
This results in an increase in the cost of
the Medicaid and CHIP application fee
requirement in CY 2012 of $201,072 (or
25,134 × $8.00).
3. Total
Based on the foregoing, we estimate
the total increase in the cost of the
application fee requirement for
Medicare, Medicaid, and CHIP
providers and suppliers in CY 2012 to
be $1,794,672.
In accordance with the provisions of
Executive Order 12866, this notice was
not reviewed by the Office of
Management and Budget.
(Catalog of Federal Domestic Assistance
Program No. 93.778, Medical Assistance
Program; No. 93.773 Medicare—Hospital
Insurance Program; and No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: September 30, 2011.
Donald M. Berwick,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2011–28424 Filed 11–1–11; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Title: Descriptive Study of Tribal
Temporary Assistance for Needy
Families (TANF) Programs.
OMB No.: New Collection.
Description: The Administration for
Children and Families (ACF) is
proposing an information collection
activity as part of the Descriptive Study
of Tribal TANF Programs. The proposed
information collection consists of semistructured interviews and focus groups
with key Tribal TANF respondents on
questions of Tribal TANF
administration, policies, service
delivery, and program context. Through
this information collection, ACF seeks
to gain an in-depth, systematic
understanding of program
implementation, operations, outputs
and outcomes in selected sites, and
identify promising practices and other
areas for further study.
Respondents: Tribal TANF
administrators, staff and participants,
and staff of related programs.
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67746
Federal Register / Vol. 76, No. 212 / Wednesday, November 2, 2011 / Notices
ANNUAL BURDEN ESTIMATES
Annual
number of
respondents
Instrument
Discussion
Discussion
Discussion
Discussion
Guide
Guide
Guide
Guide
for
for
for
for
Number of
responses per
respondent
Average
burden hours
per response
Total annual
burden hours
Use with Tribal TANF administrators ............................
Use with Tribal TANF staff ............................................
Focus Groups with Tribal TANF clients ........................
Use with staff of related programs ................................
13
12
20
20
1
1
1
1
2
1
2
1
26
12
40
20
All Instruments ..........................................................................................
65
........................
........................
98
Estimated Total Annual Burden
Hours: 98.
In compliance with the requirements
of Section 3506(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: OPRE Reports Clearance
Officer. Email address:
OPREinfocollection@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 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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: October 26, 2011.
Steven M. Hanmer,
Reports Clearance, Officer.
[Docket No. FDA–1999–D–2955]
emcdonald on DSK5VPTVN1PROD with NOTICES
[FR Doc. 2011–28273 Filed 11–1–11; 8:45 am]
BILLING CODE 4184–09–M
Administration for Children and
Families
President’s Committee for People With
Intellectual Disabilities Meeting, Via
Conference Call, Cancellation
President’s Committee for
People with Intellectual Disabilities
(PCPID).
ACTION: Notice of PCPID Conference Call
Cancellation.
AGENCY:
The conference call was
scheduled for October 28, 2011, 1 p.m.
to 2:30 p.m.
FOR FURTHER INFORMATION CONTACT:
Laverdia Taylor Roach, Senior Advisor,
President’s Committee for People with
Intellectual Disabilities, The Aerospace
Center, Second Floor West, 370 L’Enfant
Promenade SW., Washington, DC 20447.
Telephone: (202) 619–0634. Fax: (202)
205–9519. Email: LRoach@acf.hhs.gov.
Further meetings will be announced
through a separate Federal Register
notice.
DATES:
Dated: October 26, 2011.
Jamie Kendall,
Deputy Commissioner, Administration on
Developmental Disabilities.
[FR Doc. 2011–28292 Filed 11–1–11; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Revised Guidance for Industry on
Impurities: Residual Solvents in New
Veterinary Medicinal Products, Active
Substances and Excipients (Revision),
VICH GL18(R); Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
SUMMARY:
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availability of a revised guidance for
industry (#100) entitled ‘‘Impurities:
Residual Solvents in New Veterinary
Medicinal Products, Active Substances
and Excipients (Revision)’’ VICH
GL18(R). This revised guidance has
been developed for veterinary use by the
International Cooperation on
Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products (VICH).
The guidance is intended to recommend
acceptable amounts of residual solvents
in new animal drugs (referred to as
pharmaceuticals or veterinary medicinal
products in this guidance) for the safety
of the target animal as well as for the
safety of human consumers of products
derived from treated food producing
animals. It is intended to assist in
developing new animal drug
applications (referred to as marketing
applications in this guidance) submitted
to the European Union, Japan, and the
United States.
Submit either electronic or
written comments on Agency guidances
at any time.
DATES:
Submit written requests for
single copies of the guidance to the
Communications Staff (HFV–12), Center
for Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
Submit electronic comments on the
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.
ADDRESSES:
Mai
Huynh, Center for Veterinary Medicine
(HFV–142), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, (240) 276–8273,
mai.huynh@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 76, Number 212 (Wednesday, November 2, 2011)]
[Notices]
[Pages 67745-67746]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-28273]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Title: Descriptive Study of Tribal Temporary Assistance for Needy
Families (TANF) Programs.
OMB No.: New Collection.
Description: The Administration for Children and Families (ACF) is
proposing an information collection activity as part of the Descriptive
Study of Tribal TANF Programs. The proposed information collection
consists of semi-structured interviews and focus groups with key Tribal
TANF respondents on questions of Tribal TANF administration, policies,
service delivery, and program context. Through this information
collection, ACF seeks to gain an in-depth, systematic understanding of
program implementation, operations, outputs and outcomes in selected
sites, and identify promising practices and other areas for further
study.
Respondents: Tribal TANF administrators, staff and participants,
and staff of related programs.
[[Page 67746]]
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Annual number Number of Average
Instrument of responses per burden hours Total annual
respondents respondent per response burden hours
----------------------------------------------------------------------------------------------------------------
Discussion Guide for Use with Tribal TANF 13 1 2 26
administrators.................................
Discussion Guide for Use with Tribal TANF staff. 12 1 1 12
Discussion Guide for Focus Groups with Tribal 20 1 2 40
TANF clients...................................
Discussion Guide for Use with staff of related 20 1 1 20
programs.......................................
---------------------------------------------------------------
All Instruments............................. 65 .............. .............. 98
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 98.
In compliance with the requirements of Section 3506(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: OPRE Reports Clearance Officer. Email
address: OPREinfocollection@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 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.
Dated: October 26, 2011.
Steven M. Hanmer,
Reports Clearance, Officer.
[FR Doc. 2011-28273 Filed 11-1-11; 8:45 am]
BILLING CODE 4184-09-M
