Proposed Information Collection Activity; Comment Request, 70165-70166 [2012-28340]
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Federal Register / Vol. 77, No. 226 / Friday, November 23, 2012 / Notices
services and technology applications for
fiscal year (FY) 2014. In addition, they
will help us to evaluate our policy on
the IPPS new technology add-on
payment process before the publication
of the FY 2014 IPPS proposed rule.
II. Town Hall Meeting and Conference
Calling/Live Streaming Information
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A. Format of the Town Hall Meeting
As noted in section I. of this notice,
we are required to provide for a meeting
at which organizations representing
hospitals, physicians, manufacturers
and any other interested party may
present comments, recommendations,
and data to the clinical staff of CMS
concerning whether the service or
technology represents a substantial
clinical improvement. This meeting will
allow for a discussion of the substantial
clinical improvement criteria on each of
the FY 2014 new medical services and
technology add-on payment
applications. Information regarding the
applications can be found on our Web
site at https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
AcuteInpatientPPS/newtech.html.
The majority of the meeting will be
reserved for presentations of comments,
recommendations, and data from
registered presenters. The time for each
presenter’s comments will be
approximately 10 to 15 minutes and
will be based on the number of
registered presenters. Presenters will be
scheduled to speak in the order in
which they register and grouped by new
technology applicant. Therefore,
individuals who would like to present
must register and submit their agenda
item(s) via email to
newtech@cms.hhs.gov by the date
specified in the DATES section of this
notice.
In addition, written comments will
also be accepted and presented at the
meeting if they are received via email to
newtech@cms.hhs.gov by the date
specified in the DATES section of this
notice. Written comments may also be
submitted after the meeting for our
consideration. If the comments are to be
considered before the publication of the
proposed rule, the comments must be
received via email to
newtech@cms.hhs.gov by the date
specified in the DATES section of this
notice.
B. Conference Call, Live Streaming, and
Webinar Information
For participants who cannot attend
the Town Hall Meeting in person, an
open toll-free phone line, (877) 267–
1577, has been made available. The
conference code is ‘‘7702.’’
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Also, there will be an option to view
and participate in the Town Hall
Meeting via live streaming technology
and/or a webinar. Information on the
option to participate via live streaming
technology and/or a webinar will be
provided through an upcoming listserv
notice and posted on the New
Technology Web site at https://www.cms.
gov/Medicare/Medicare-Fee-for-ServicePayment/AcuteInpatientPPS/
newtech.html. Continue to check the
Web site for updates.
Disclaimer: Because this is the first
year that we are providing an option for
live streaming technology and/or a
webinar, we cannot guarantee the
reliability of these technologies.
III. Registration Instructions
The Division of Acute Care in CMS is
coordinating the meeting registration for
the Town Hall Meeting on substantial
clinical improvement. While there is no
registration fee, individuals planning to
attend the Town Hall Meeting in person
must register to attend.
Registration may be completed online at the following web address:
https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
AcuteInpatientPPS/newtech.html.
Select the link at the bottom of the page
‘‘Register to Attend the New Technology
Town Hall Meeting’’. After completing
the registration, on-line registrants
should print the confirmation page(s)
and bring it with them to the meeting(s).
If you are unable to register on-line,
you may register by sending an email to
newtech@cms.hhs.gov. Please include
your name, address, telephone number,
email address and fax number. If seating
capacity has been reached, you will be
notified that the meeting has reached
capacity.
IV. Security, Building, and Parking
Guidelines
Because these meetings will be
located on Federal property, for security
reasons, any persons wishing to attend
these meetings must register by the date
specified in the DATES section of this
notice. Please allow sufficient time to go
through the security checkpoints. It is
suggested that you arrive at 7500
Security Boulevard no later than 8:30
a.m. e.s.t. if you are attending the Town
Hall Meeting so that you will be able to
arrive promptly for the meeting.
Security measures include the
following:
• Presentation of government-issued
photographic identification to the
Federal Protective Service or Guard
Service personnel.
• Interior and exterior inspection of
vehicles (this includes engine and trunk
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70165
inspection) at the entrance to the
grounds. Parking permits and
instructions will be issued after the
vehicle inspection.
• Passing through a metal detector
and inspection of items brought into the
building. We note that all items brought
to CMS, whether personal or for the
purpose of demonstration or to support
a demonstration, are subject to
inspection. We cannot assume
responsibility for coordinating the
receipt, transfer, transport, storage, setup, safety, or timely arrival of any
personal belongings or items used for
demonstration or to support a
demonstration.
Note: Individuals who are not registered in
advance will not be permitted to enter the
building and will be unable to attend the
meeting in person. The public may not enter
the building earlier than 45 minutes prior to
the convening of the meeting(s).
All visitors must be escorted in areas
other than the lower and first floor
levels in the Central Building. Seating
capacity is limited to the first 250
registrants.
Authority: Section 503 of Public Law 108–
173.
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: November 14, 2012.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2012–28478 Filed 11–21–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Form CB–496: Title IV–E
Programs Quarterly Financial Report.
OMB No.: 0970–0205.
Description: This is a financial report
submitted following the end of each
fiscal quarter by each State or Tribe with
an approved title IV–E plan
administering any of three title IV–E
entitlement grant programs—Foster
Care, Adoption Assistance or
Guardianship Assistance.
The purpose of this form is to enable
each State or Tribe to meet its statutory
and regulatory requirement to report
program expenditures made in the
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Federal Register / Vol. 77, No. 226 / Friday, November 23, 2012 / Notices
preceding fiscal quarter and to estimate
program expenditures to be made in the
upcoming fiscal quarter. This form also
allows States and Tribes to report the
actual and estimated average monthly
number of children assisted in each of
the three IV–E entitlement grant
programs in the preceding and
upcoming fiscal quarters, respectively.
The Administration for Children and
Families provides Federal funding at the
rate of 50 percent for nearly all
allowable and legitimate administrative
costs of these programs and at other
funding rates for other specific
categories of costs as detailed in Federal
statute and regulations. The information
collected in this report is used by this
agency to calculate quarterly Federal
grant awards and to enable oversight of
the financial management of the
programs.
Respondents: States (including Puerto
Rico and the District of Columbia) and
Tribes* with approved title IV–E plans.
(*An estimated 10 Tribes will have
approved title IV–E plans within the
next 3-year period.)
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
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Form CB–496: Title IV–E Programs Quarterly Financial Report ....................
Estimated Total Annual Burden
Hours: 4,960.
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 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. 2012–28340 Filed 11–21–12; 8:45 am]
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62
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–1090]
Provisions of the Food and Drug
Administration Safety and Innovation
Act Related to Medical Gases;
Establishment of a Public Docket
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is establishing a
public docket for information pertaining
to FDA’s implementation of the
provisions of the Food and Drug
Administration Safety and Innovation
Act (FDASIA) related to medical gases.
This action is intended to ensure that
information submitted to FDA on the
implementation of the medical gas
provisions of FDASIA is available to all
interested persons in a timely fashion.
DATES: Submit electronic or written
comments by November 25, 2013.
ADDRESSES: Submit electronic
comments 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. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Patrick Raulerson, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6368,
Silver Spring, MD 20993–0002, 301–
796–3522,
patrick.raulerson@fda.hhs.gov; or
Germaine Connolly, Center for
Veterinary Medicine, Food and Drug
SUMMARY:
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Number of
responses per
respondent
4
Average
burden hours
per response
20
Total burden
hours
4,960
Administration, 7500 Standish Pl.,
MPN2, Rockville, MD 20855, 240–276–
8331, germaine.connolly@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On July 9, 2012, President Obama
signed into law FDASIA (Pub. L. 112–
144, 126 Stat. 993). Title XI, Subtitle B,
section 1111 of FDASIA added new
sections 575, 576, and 577 to the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) regarding medical gases.
Among other things, these new sections
define the terms ‘‘designated medical
gas’’ and ‘‘medical gas’’ and establish
the process for the certification of a
medical gas as a designated medical gas.
(See sections 575(1) and (2) of the FD&C
Act.) The sections describe the process
for filing a request for certification and
describe the information that should be
included in the request for certification.
(See section 576(a) of the FD&C Act.)
Under section 576(a)(3) of the FD&C
Act, if a certification is granted for a
designated medical gas, the designated
medical gas will be deemed to have in
effect an approved new human drug
application under section 505 (21 U.S.C.
355) or an approved new animal drug
application under section 512 (21 U.S.C.
360b) of the FD&C Act for certain
specified indications and subject to all
applicable postapproval requirements.
Under section 576(a)(1) of the FD&C
Act, requests for certification may be
submitted to FDA beginning 180 days
after the enactment of FDASIA, or
January 5, 2013.
FDA is establishing a public docket
for information pertaining to FDA’s
implementation of these new medical
gas provisions. This action is intended
to ensure that information submitted to
FDA on the implementation of the
medical gas provisions of FDASIA is
available to all interested persons in a
timely fashion. The Compressed Gas
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Agencies
[Federal Register Volume 77, Number 226 (Friday, November 23, 2012)]
[Notices]
[Pages 70165-70166]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-28340]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Proposed Projects
Title: Form CB-496: Title IV-E Programs Quarterly Financial Report.
OMB No.: 0970-0205.
Description: This is a financial report submitted following the end
of each fiscal quarter by each State or Tribe with an approved title
IV-E plan administering any of three title IV-E entitlement grant
programs--Foster Care, Adoption Assistance or Guardianship Assistance.
The purpose of this form is to enable each State or Tribe to meet
its statutory and regulatory requirement to report program expenditures
made in the
[[Page 70166]]
preceding fiscal quarter and to estimate program expenditures to be
made in the upcoming fiscal quarter. This form also allows States and
Tribes to report the actual and estimated average monthly number of
children assisted in each of the three IV-E entitlement grant programs
in the preceding and upcoming fiscal quarters, respectively.
The Administration for Children and Families provides Federal
funding at the rate of 50 percent for nearly all allowable and
legitimate administrative costs of these programs and at other funding
rates for other specific categories of costs as detailed in Federal
statute and regulations. The information collected in this report is
used by this agency to calculate quarterly Federal grant awards and to
enable oversight of the financial management of the programs.
Respondents: States (including Puerto Rico and the District of
Columbia) and Tribes* with approved title IV-E plans. (*An estimated 10
Tribes will have approved title IV-E plans within the next 3-year
period.)
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average
Instrument Number of responses per burden hours Total burden
respondents respondent per response hours
----------------------------------------------------------------------------------------------------------------
Form CB-496: Title IV-E Programs Quarterly 62 4 20 4,960
Financial Report...............................
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 4,960.
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 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. 2012-28340 Filed 11-21-12; 8:45 am]
BILLING CODE 4184-01-P