Proposed Information Collection Activity; Comment Request, 93-94 [2015-32969]
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Federal Register / Vol. 81, No. 1 / Monday, January 4, 2016 / Notices
tkelley on DSK3SPTVN1PROD with NOTICES
invited to send comments regarding our
burden estimates or any other aspect of
this collection of information, including
any of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
DATES: Comments must be received by
March 4, 2016.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address:
CMS, Office of Strategic Operations and
Regulatory Affairs, Division of
Regulations Development, Attention:
Document Identifier/OMB Control
Number ______, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ Web site address at
https://www.cms.hhs.gov/
PaperworkReductionActof1995.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
Reports Clearance Office at (410) 786–
1326.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
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16:43 Dec 31, 2015
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each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–359/360 Comprehensive
Outpatient Rehabilitation Facility
(CORF) Eligibility and Survey Forms
and Supporting Regulations
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.
The term ‘‘collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
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
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
1. Type of Information Collection
Request: Extension of a currently
approved information collection; Title
of Information Collection:
Comprehensive Outpatient
Rehabilitation Facility (CORF)
Eligibility and Survey Forms and
Supporting Regulations; Use: The form
CMS–359 is used as the application for
health care providers seeking to
participate in the Medicare program as
a Comprehensive Outpatient
Rehabilitation Facility (CORF). This
form initiates the process for facilities to
become certified as a CORF and it
provides the CMS Regional Office State
Survey Agency staff identifying
information regarding the applicant that
is stored in the Automated Survey
Processing Environment (ASPEN)
system.
The form CMS–360 is a survey tool
used by the State Survey Agencies to
record information in order to
determine a provider’s compliance with
the CORF Conditions of Participation
(CoPs) and to report this information to
the Federal government. The form
includes basic information on the CoP
requirements, check boxes to indicate
the level of compliance, and a section
for recording notes. We have the
responsibility and authority for
certification decisions which are based
on provider compliance with the CoPs
and this form supports this process.
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93
Form Number: CMS–359/360 (OMB
Control Number: 0938–0267);
Frequency: Occasionally; Affected
Public: Private Sector (Business or other
for-profits); Number of Respondents: 50;
Number of Responses: 50; Total Annual
Hours: 123.
(For questions regarding this collection
contact James Cowher (410) 786–1948.)
Dated: December 28, 2015.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2015–32965 Filed 12–31–15; 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
Administration for Children
and Families; HHS.
AGENCY:
ACTION:
Notice.
Proposed Projects
Title: ACF Performance Progress
Reports—Program Indicators.
OMB No.: 0970–0406.
Description: The Office of Grants
Management (OGM), in the
Administration for Children and
Families (ACF) is proposing the
continued collection of program
performance data for ACF’s
discretionary grantees. The form
developed by OGM was created from
the basic template of the OMB-approved
reporting format of the Program
Performance Report. OGM uses this data
to ensure grantees are proceeding in a
satisfactory manner in meeting the
approved goals and objectives of the
project, and if funding should be
continued for another budget period.
The requirement for grantees to report
on performance is OMB grants policy.
Specific citations are contained in 45
CFR part 75 Uniform Administrative
Requirements, Cost Principles, and
Audit Requirements for HHS Awards.
Respondents: All ACF Discretionary
Grantees. State governments, Native
American Tribal governments, Native
American Tribal Organizations, Local
Governments, and Nonprofits with or
without 501(c)(3) status with the IRS.
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94
Federal Register / Vol. 81, No. 1 / Monday, January 4, 2016 / Notices
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
ACF–OGM–SF–PPR–B ...........................................................
6000
1
1
6000
Estimated Total Annual Burden
Hours: 6000.
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. 2015–32969 Filed 12–31–15; 8:45 am]
tkelley on DSK3SPTVN1PROD with NOTICES
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–D–4048]
Unique Device Identification:
Convenience Kits; Draft Guidance for
Industry and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘Unique Device Identification:
Convenience Kits; Draft Guidance for
Industry and Food and Drug
Administration Staff.’’ This proposed
guidance document is intended to
outline the Agency’s current thinking
that for purposes of Unique Device
Identification (UDI) labeling and data
submission requirements, the term
‘‘convenience kit’’ applies solely to two
or more different medical devices
packaged together for the convenience
of the user, where they are intended to
remain packaged together and not
replaced, substituted, repackaged,
sterilized, or otherwise processed or
modified before the devices are used by
an end user. This draft guidance is not
final nor is it in effect at this time. When
finalized, this guidance document will
constitute a change in policy.
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 of this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by April 4, 2016.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
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16:43 Dec 31, 2015
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comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2015–D–4048 for ‘‘Unique Device
Identification: Convenience Kits; Draft
Guidance for Industry and Food and
Drug Administration Staff.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
E:\FR\FM\04JAN1.SGM
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Agencies
[Federal Register Volume 81, Number 1 (Monday, January 4, 2016)]
[Notices]
[Pages 93-94]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32969]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
AGENCY: Administration for Children and Families; HHS.
ACTION: Notice.
-----------------------------------------------------------------------
Proposed Projects
Title: ACF Performance Progress Reports--Program Indicators.
OMB No.: 0970-0406.
Description: The Office of Grants Management (OGM), in the
Administration for Children and Families (ACF) is proposing the
continued collection of program performance data for ACF's
discretionary grantees. The form developed by OGM was created from the
basic template of the OMB-approved reporting format of the Program
Performance Report. OGM uses this data to ensure grantees are
proceeding in a satisfactory manner in meeting the approved goals and
objectives of the project, and if funding should be continued for
another budget period.
The requirement for grantees to report on performance is OMB grants
policy. Specific citations are contained in 45 CFR part 75 Uniform
Administrative Requirements, Cost Principles, and Audit Requirements
for HHS Awards.
Respondents: All ACF Discretionary Grantees. State governments,
Native American Tribal governments, Native American Tribal
Organizations, Local Governments, and Nonprofits with or without
501(c)(3) status with the IRS.
[[Page 94]]
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
ACF-OGM-SF-PPR-B................ 6000 1 1 6000
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 6000.
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. 2015-32969 Filed 12-31-15; 8:45 am]
BILLING CODE 4184-01-P