Agency Information Collection Activities: Submission for OMB Review; Comment Request; Protection and Advocacy for Assistive Technology (PAAT) Program Performance Report, 52295-52296 [2015-21409]
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Federal Register / Vol. 80, No. 167 / Friday, August 28, 2015 / Notices
the outpatient setting, as well as other
forms of relevant expertise. For
supervision deliberations, the Panel
shall have members that represent the
interests of CAHs, who advise CMS only
regarding the level of supervision for
hospital outpatient therapeutic services.
It is not necessary for a nominee to
possess expertise in all of the areas
listed, but each must have a minimum
of 5 years experience and currently have
full-time employment in his or her area
of expertise. Generally, members of the
Panel serve overlapping terms up to 4
years, based on the needs of the Panel
and contingent upon the rechartering of
the Panel. A member may serve after the
expiration of his or her term until a
successor has been sworn in.
Any interested person or organization
may nominate one or more qualified
individuals. Self-nominations will also
be accepted. Each nomination must
include the following:
• Letter of Nomination stating the
reasons why the nominee should be
considered.
• Curriculum vitae or resume of the
nominee that includes an email address
where the nominee can be contacted.
• Written and signed statement from
the nominee that the nominee is willing
to serve on the Panel under the
conditions described in this notice and
further specified in the Charter.
• The hospital or hospital system
name and address, or CAH name and
address, as well as all Medicare hospital
and or Medicare CAH billing numbers
of the facility where the nominee is
employee.
III. Copies of the Charter
To obtain a copy of the Panel’s
Charter, we refer readers to our Web site
at https://www.cms.gov/Regulations-andGuidance/Guidance/FACA/Advisory
PanelonAmbulatoryPayment
ClassificationGroups.html.
IV. Collection of Information
Requirements
This document does not impose
information collection requirements,
that is, reporting, recordkeeping or
third-party disclosure requirements.
Consequently, there is no need for
review by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.).
Dated: August 17, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2015–21419 Filed 8–27–15; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Purchase, Construction and
Major Renovation of Head Start
Facilities.
OMB No.: 0970–0193.
52295
Description: The Office of Head Start
within the Administration for Children
and Families, United States Department
of Health and Human Services, is
proposing to renew authority to collect
information on funding for the
purchase, construction or renovation of
facilities. All information is collected
electronically through the Head Start
Enterprise System (HSES). The
information required is in conformance
with Section 644 (f) and (g) of the Act.
Federal funding officials use the
information to determine that the
proposed purchase has resulted in
savings when compared to the costs that
would be incurred to acquire the use of
an alternative facility, or that the lack of
alternative facilities will prevent, or
would have prevented, the operation of
the program. The rule further describes
the assurances which are necessary to
protect the Federal interest in real
property and the conditions under
which federal interest may be
subordinated and protected when
grantees make use of debt instruments
when purchasing facilities. The
information is used by funding officials
to determine if grantee’s arrangements
adequately conform to other applicable
statutes which apply to the expenditure
of public funds for the purchase of real
property.
Respondents: Head Start and Early
Head Start program grant recipients.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average burden
hours per
response
Total burden
hours
Administrative Requirements ...................................................
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Instrument
225
1
41
9225
Estimated Total Annual Burden
Hours: 9225.
Cost per respondent is $40 estimated
at 2 hours x $20.00 per hour.
Additional Information: Copies of the
proposed collection may be obtained 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. All requests should be
identified by the title of the information
collection. Email address:
infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
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14:19 Aug 27, 2015
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document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Fax: 202–395–7285,
Email: OIRA_SUBMISSION@
OMB.EOP.GOV, Attn: Desk Officer for
the Administration for Children and
Families.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Robert Sargis,
Reports Clearance Officer.
ACTION:
[FR Doc. 2015–21304 Filed 8–27–15; 8:45 am]
BILLING CODE 4184–01–P
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Administration for Community Living
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request; Protection
and Advocacy for Assistive
Technology (PAAT) Program
Performance Report
Administration for Community
Living, HHS.
AGENCY:
Notice.
The Administration on
Intellectual and Developmental
Disabilities (AIDD), Administration for
SUMMARY:
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52296
Federal Register / Vol. 80, No. 167 / Friday, August 28, 2015 / Notices
Community Living (ACL) is announcing
an opportunity to comment on the
proposed collection of 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 30 days for
public comment in response to the
notice. This notice collects comments
on the information collection
requirements relating to an existing
collection: Protection and Advocacy for
Assistive Technology (PAAT) Program
Performance Report (0985–0046).
Submit written comments on the
collection of information by September
28, 2015.
DATES:
Submit written comments
on the collection of information by
email to by fax 202–395–5806 or by
email to OIRA_submission@
omb.eop.gov, Attn: OMB Desk Officer
for ACL.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Clare Barnett, Administration for
Community Living, Administration on
Intellectual and Developmental
Disabilities, Office of Program Support,
One Massachusetts Avenue NW., Room
4204, Washington, DC 20201, 202–357–
3426.
Federal
statute requires the Protection and
Advocacy (P&A) System in each State to
annually prepare and submit to the
Secretary a report that includes
documentation of the progress made.
AIDD reviews the program performance
report (PPR) for compliance and for
program outcomes. AIDD will aggregate
the information in the PPRs into a
national profile of programmatic
activities and accomplishments, and
permit AIDD to track accomplishments
against goals and formulate areas of
technical assistance and compliance
with Federal requirements.
ACL estimates the burden of this
collection of information as follows:
SUPPLEMENTARY INFORMATION:
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
PADD SGP ......................................................................................................
57
1
16
912
Estimated Total Annual Burden
Hours: 912.
Dated: August 25, 2015.
Kathy Greenlee,
Administrator & Assistant Secretary for
Aging.
[FR Doc. 2015–21409 Filed 8–27–15; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–1543]
Nonproprietary Naming of Biological
Products; Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, we, or the
Agency) is announcing the availability
of a draft guidance for industry entitled
‘‘Nonproprietary Naming of Biological
Products.’’ The draft guidance describes
our current thinking on the need for
biological products licensed under the
Public Health Service Act (PHS Act) to
bear a nonproprietary name that
includes an FDA-designated suffix. Our
current thinking is that shared
nonproprietary names are not
appropriate for all biological products.
There is a need to clearly identify
biological products to improve
pharmacovigilance, and, for the
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SUMMARY:
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purposes of safe use, to clearly
differentiate among biological products
that have not been determined to be
interchangeable. Accordingly, for
biological products, we intend to
designate a nonproprietary name that
includes a suffix composed of four
lowercase letters. Each suffix will be
incorporated in the nonproprietary
name of the product. This naming
convention is applicable to biological
products previously licensed and newly
licensed under the PHS Act. The
nonproprietary name designated for
originator biological products, related
biological products, and biosimilars will
include a unique suffix. However, FDA
is considering whether the
nonproprietary name for an
interchangeable product should include
a unique suffix, or should share the
same suffix as its reference product.
FDA invites comment on the draft
guidance and solicits comments on
ways to improve active
pharmacovigilance systems for the
purposes of monitoring the safety of
biological products.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance, including
responses to the questions in this notice,
by October 27, 2015. Submit either
electronic or written comments on the
collection of information by October 27,
2015.
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Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002; or to the Office of
Communication, Outreach and
Development, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft 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:
FOR FURTHER INFORMATION CONTACT:
Sandra Benton, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6340,
Silver Spring, MD 20993–0002, 301–
796–1042; or Stephen Ripley, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911.
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 80, Number 167 (Friday, August 28, 2015)]
[Notices]
[Pages 52295-52296]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21409]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Community Living
Agency Information Collection Activities: Submission for OMB
Review; Comment Request; Protection and Advocacy for Assistive
Technology (PAAT) Program Performance Report
AGENCY: Administration for Community Living, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Administration on Intellectual and Developmental
Disabilities (AIDD), Administration for
[[Page 52296]]
Community Living (ACL) is announcing an opportunity to comment on the
proposed collection of 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 30 days for public
comment in response to the notice. This notice collects comments on the
information collection requirements relating to an existing collection:
Protection and Advocacy for Assistive Technology (PAAT) Program
Performance Report (0985-0046).
DATES: Submit written comments on the collection of information by
September 28, 2015.
ADDRESSES: Submit written comments on the collection of information by
email to by fax 202-395-5806 or by email to
OIRA_submission@omb.eop.gov, Attn: OMB Desk Officer for ACL.
FOR FURTHER INFORMATION CONTACT: Clare Barnett, Administration for
Community Living, Administration on Intellectual and Developmental
Disabilities, Office of Program Support, One Massachusetts Avenue NW.,
Room 4204, Washington, DC 20201, 202-357-3426.
SUPPLEMENTARY INFORMATION: Federal statute requires the Protection and
Advocacy (P&A) System in each State to annually prepare and submit to
the Secretary a report that includes documentation of the progress
made. AIDD reviews the program performance report (PPR) for compliance
and for program outcomes. AIDD will aggregate the information in the
PPRs into a national profile of programmatic activities and
accomplishments, and permit AIDD to track accomplishments against goals
and formulate areas of technical assistance and compliance with Federal
requirements.
ACL estimates the burden of this collection of information as
follows:
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
PADD SGP.................................... 57 1 16 912
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 912.
Dated: August 25, 2015.
Kathy Greenlee,
Administrator & Assistant Secretary for Aging.
[FR Doc. 2015-21409 Filed 8-27-15; 8:45 am]
BILLING CODE 4154-01-P
