Agency Information Collection Activities; Proposed Collection; Comment Request; Extension of a Currently Approved Information Collection; Funding Opportunity Announcement and Grant Application Instructions Template for ACL Discretionary Grant Programs, 54897-54898 [2013-21654]
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Federal Register / Vol. 78, No. 173 / Friday, September 6, 2013 / Notices
Title of Information Collection:
Conditions for Payment of Power
Mobility Devices, including Power
Wheelchairs and Power-Operated
Vehicles; Use: We are renewing our
request for approval for the collection
requirements associated with the final
rule, CMS–3017–F (71 FR 17021), which
published on April 5, 2006, and became
effective on June 5, 2006. The regulation
CMS–3017–F finalized provisions set
forth in the interim final regulation (70
FR 50940) which published on August
26, 2005. This final rule conforms our
regulations to section 302(a)(2)(E)(iv) of
the Medicare Prescription Drug,
Improvement, and Modernization Act of
2003. This rule defines the term power
mobility devices (PMDs) as power
wheelchairs and power operated
vehicles (POVs or scooters). It sets forth
revised conditions for Medicare
payment of PMDs and defines who may
prescribe PMDs. This rule also requires
a face-to-face examination of the
beneficiary by the physician or treating
practitioner, a written prescription, and
receipt of pertinent parts of the medical
record by the supplier within 45 days
after the face-to-face examination that
the durable medical equipment (DME)
suppliers maintain in their records and
make available to us and our agents
upon request. Finally, this rule
discusses our policy on documentation
that we and our agents may request to
support a Medicare claim for payment.
Form Number: CMS–10116 (OCN:
0938–0971); Frequency: Yearly; Affected
Public: Private sector—business or other
for-profits; Number of Respondents:
90,521; Number of Responses: 173,810;
Total Annual Hours: 34,762. (For policy
questions regarding this collection
contact Susan Miller at 410–786–2118.)
Dated: September 3, 2013.
Martique Jones,
Deputy Director, Regulations Development
Group, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2013–21720 Filed 9–5–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Extension of a
Currently Approved Information
Collection; Funding Opportunity
Announcement and Grant Application
Instructions Template for ACL
Discretionary Grant Programs
Administration for Community
Living, HHS.
ACTION: Notice.
AGENCY:
The Administration for
Community Living (ACL) is announcing
an opportunity for public comment on
the proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
Information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the information collection requirements
relating to the standard Funding
Opportunity Announcement and Grant
Application Instructions template for
ACL Discretionary Grant Programs.
DATES: Submit written or electronic
comments on the collection of
information by November 5, 2013.
ADDRESSES: Submit electronic
comments on the collection of
information to: lori.stalbaum@
acl.hhs.gov.
Submit written comments on the
collection of information to Lori
Stalbaum, Administration for
Community Living, Washington, DC
20201 or by fax to (202) 357–3466.
FOR FURTHER INFORMATION CONTACT: Lori
Stalbaum at (202) 357–3452 or
lori.stalbaum@acl.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency request
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
SUMMARY:
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54897
including each proposed extension, or
update, of an existing collection of
information, before submitting the
collection to OMB for approval. To
comply with this requirement, ACL is
publishing notice of the proposed
collection of information set forth in
this document. With respect to the
following collection of information,
ACL invites comments on: (1) Whether
the proposed collection of information
is necessary for the proper performance
of ACL’s functions, including whether
the information will have practical
utility; (2) the accuracy of ACL’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques
when appropriate, and other forms of
information technology.
Proposed Collection of Information
ACL plans to submit to the Office of
Management and Budget for approval
Funding Opportunity Announcement
and Grant Application Instructions
Template for ACL Discretionary Grants
Program. The Funding Opportunity
Announcement and Application
Instructions provide the requirements
and instructions for the submission of
an application for funding opportunities
of the Administration for Community
Living. The Administration for
Community Living (ACL) funds
discretionary grants under the
Developmental Disabilities Assistance
and Bill of Rights Act of 2000 (DD Act),
which is administered by the
Administration on Intellectual and
Developmental Disabilities (AIDD) as
well as the Older Americans Act, which
is administered by the Administration
on Aging (AoA). In addition, ACL is also
responsible for administering other
authorizing statutes relevant to older
Americans and individuals with
disabilities. Through its discretionary
grant programs, the Administration for
Community Living (ACL) supports
projects for the purpose of developing
and testing new knowledge and program
innovations with the potential for
maximizing the independence, wellbeing, and health of older adults, people
with disabilities across the lifespan, and
their families and caregivers. The
Funding Opportunity Announcement
(FOA) template may be found on the
ACL Web site at www.acl.gov/Funding_
Opportunities/Announcements/docs/
ACL_PA_Template_FINAL_8-12-13.doc.
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54898
Federal Register / Vol. 78, No. 173 / Friday, September 6, 2013 / Notices
ACL estimates the burden of this
collection of information as follows:
Frequency: Based on the budget
authorization for that Fiscal Year, ACL
publishes, on average, 15 to 20 FOAs
annually. Respondents: States, public
agencies, private nonprofit agencies,
institutions of higher education, and
organizations including tribal
organizations. Estimated Number of
Responses: 350 annually. Total
Estimated Burden Hours: 16,800.
Dated: August 29, 2013.
Kathy Greenlee,
Administrator and Assistant Secretary for
Aging.
[FR Doc. 2013–21654 Filed 9–5–13; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0523]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Applications for
Food and Drug Administration
Approval To Market a New Drug;
Postmarketing Reports; Reporting
Information About Authorized Generic
Drugs
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by October 7,
2013.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0646. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
ADDRESSES:
Applications for Food and Drug
Administration Approval To Market a
New Drug; Postmarketing Reports;
Reporting Information About
Authorized Generic Drugs—(OMB
Control Number 0910–0646)—Extension
In the Federal Register of July 28,
2009 (74 FR 37163), FDA published a
final rule that required, under
§ 314.81(b)(2)(ii)(b) (21 CFR
314.81(b)(2)(ii)(b)), the holder of a new
drug application (NDA) to notify the
Agency if an authorized generic drug is
marketed by clearly including this
information in annual reports in an
easily accessible place and by sending a
copy of the relevant portion of the
annual reports to a central contact point.
We took this action as part of our
implementation of the Food and Drug
Administration Amendments Act (Pub.
L. 110–85), which requires that FDA
publish a list of all authorized generic
drugs included in an annual report after
January 1, 1999, and that the Agency
update the list quarterly. We initially
published this list on June 27, 2008, on
the Internet and notified relevant
Federal Agencies that the list was
published, and we will continue to
update it.
Based on the number of annual
reports the Agency currently receives
under § 314.81(b)(2) containing
authorized generic drug information, we
estimate that we will receive
approximately 500 annual reports
containing the required information on
authorized generic drugs. Based on the
number of sponsors that currently
submit these annual reports, we
estimate that approximately 70 sponsors
will submit these 500 annual reports.
We estimate that each sponsor will need
approximately 30 minutes to include
the required information on authorized
generic drugs in each annual report.
We also estimate that we will receive
authorized generic drug information on
first marketed generics in approximately
20 annual reports from approximately
20 sponsors, and that each sponsor will
need approximately 1 hour to include
the required information in each annual
report.
We also estimate that we will receive
a copy of that portion of each annual
report containing the authorized generic
drug information for approximately 500
annual reports from approximately 70
sponsors, and that each sponsor will
need approximately 3 minutes to submit
a copy of that portion of each annual
report containing the authorized generic
drug information.
In the Federal Register of May 10,
2013 (78 FR 27404), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information is as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
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21 CFR 314.81(b)(2)(ii)(b)
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
Submission of authorized generic drug information
in each annual report.
Submission of authorized generic drug information
on first marketed generics in an annual report.
Submission of a copy of that portion of each annual report containing authorized generic drug
information.
70
7
490
0.50 (30 minutes) ......
245
20
1
20
1 ................................
20
70
7
490
0.05 (3 minutes) ........
25
Total ..................................................................
........................
........................
........................
....................................
290
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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]]>Agencies
[Federal Register Volume 78, Number 173 (Friday, September 6, 2013)]
[Notices]
[Pages 54897-54898]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-21654]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Community Living
Agency Information Collection Activities; Proposed Collection;
Comment Request; Extension of a Currently Approved Information
Collection; Funding Opportunity Announcement and Grant Application
Instructions Template for ACL Discretionary Grant Programs
AGENCY: Administration for Community Living, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Administration for Community Living (ACL) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of Information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
requirements relating to the standard Funding Opportunity Announcement
and Grant Application Instructions template for ACL Discretionary Grant
Programs.
DATES: Submit written or electronic comments on the collection of
information by November 5, 2013.
ADDRESSES: Submit electronic comments on the collection of information
to: lori.stalbaum@acl.hhs.gov.
Submit written comments on the collection of information to Lori
Stalbaum, Administration for Community Living, Washington, DC 20201 or
by fax to (202) 357-3466.
FOR FURTHER INFORMATION CONTACT: Lori Stalbaum at (202) 357-3452 or
lori.stalbaum@acl.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency request or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension, or update, of an existing collection of
information, before submitting the collection to OMB for approval. To
comply with this requirement, ACL is publishing notice of the proposed
collection of information set forth in this document. With respect to
the following collection of information, ACL invites comments on: (1)
Whether the proposed collection of information is necessary for the
proper performance of ACL's functions, including whether the
information will have practical utility; (2) the accuracy of ACL's
estimate of the burden of the proposed collection of information,
including the validity of the methodology and assumptions used; (3)
ways to enhance the quality, utility, and clarity of the information to
be collected; and (4) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques when appropriate, and other forms of information
technology.
Proposed Collection of Information
ACL plans to submit to the Office of Management and Budget for
approval Funding Opportunity Announcement and Grant Application
Instructions Template for ACL Discretionary Grants Program. The Funding
Opportunity Announcement and Application Instructions provide the
requirements and instructions for the submission of an application for
funding opportunities of the Administration for Community Living. The
Administration for Community Living (ACL) funds discretionary grants
under the Developmental Disabilities Assistance and Bill of Rights Act
of 2000 (DD Act), which is administered by the Administration on
Intellectual and Developmental Disabilities (AIDD) as well as the Older
Americans Act, which is administered by the Administration on Aging
(AoA). In addition, ACL is also responsible for administering other
authorizing statutes relevant to older Americans and individuals with
disabilities. Through its discretionary grant programs, the
Administration for Community Living (ACL) supports projects for the
purpose of developing and testing new knowledge and program innovations
with the potential for maximizing the independence, well-being, and
health of older adults, people with disabilities across the lifespan,
and their families and caregivers. The Funding Opportunity Announcement
(FOA) template may be found on the ACL Web site at www.acl.gov/Funding_Opportunities/Announcements/docs/ACL_PA_Template_FINAL_8-12-13.doc.
[[Page 54898]]
ACL estimates the burden of this collection of information as follows:
Frequency: Based on the budget authorization for that Fiscal Year, ACL
publishes, on average, 15 to 20 FOAs annually. Respondents: States,
public agencies, private nonprofit agencies, institutions of higher
education, and organizations including tribal organizations. Estimated
Number of Responses: 350 annually. Total Estimated Burden Hours:
16,800.
Dated: August 29, 2013.
Kathy Greenlee,
Administrator and Assistant Secretary for Aging.
[FR Doc. 2013-21654 Filed 9-5-13; 8:45 am]
BILLING CODE 4154-01-P
