Agency Information Collection Activities; Proposed Collection; Public Comment Request, 67412-67413 [2015-27860]
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Federal Register / Vol. 80, No. 211 / Monday, November 2, 2015 / Notices
FOR FURTHER INFORMATION CONTACT:
II. Significance of Guidance
Donald Witters, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave. Bldg. 62, Rm. 1130, Silver Spring,
MD 20993–0002, 301–796–2483.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on information that should be provided
to support claims of electromagnetic
compatibility of electrically powered
medical devices. It does not establish
any rights for any person and is not
binding on FDA or the public. You can
use an alternative approach if it satisfies
the requirements of the applicable
statute and regulations.
SUPPLEMENTARY INFORMATION:
asabaliauskas on DSK5VPTVN1PROD with NOTICES
I. Background
FDA is announcing the availability of
a draft guidance to provide FDA’s
current thinking on the types of
information that should be provided in
a premarket submission to support a
claim of electromagnetic compatibility
for an electrically powered medical
device. EMI is a hazard with associated
risk for electrically powered medical
devices. EMC assessment can help to
ensure that the risks associated with
performance degradation of electrically
powered medical devices due to EMI are
adequately mitigated.
The draft guidance includes
information consistent with
specifications described in FDArecognized consensus national or
international standards for EMC such as
in the International Electrotechnical
Commission (IEC) 60601–1–2: Edition 3:
2007–03, Medical Electrical
Equipment—Part 1–2: General
Requirements for Basic Safety and
Essential Performance—Collateral
Standard: Electromagnetic
Compatibility—Requirements and Tests;
IEC 60601–1–2: Edition 4.0: 2014–01,
Medical Electrical Equipment, Part 1–2:
General Requirements for Basic Safety
and Essential Performance—Collateral
Standard: Electromagnetic
Disturbances—Requirements and Tests;
Association for the Advancement of
Medical Instrumentation (AAMI)/
American National Standards Institute
(ANSI)/IEC 60601–1–2: 2007/(R) 2012
Medical Electrical Equipment—Part 1–
2: General Requirements for Basic Safety
and Essential Performance—Collateral
Standard: Electromagnetic
Compatibility—Requirements and Tests;
and AAMI/ANSI/IEC 60601–1–2: 2014,
Medical Electrical Equipment—Part 1–
2: General Requirements for Basic Safety
and Essential Performance—Collateral
Standard: Electromagnetic
Disturbances—Requirements and Tests
Standards that sponsors and
manufacturers of electrically powered
medical devices often reference. This
draft guidance is intended to help
ensure that clear and consistent
information is provided in premarket
submissions regarding medical device
EMC and to facilitate the review of
submissions with EMC claims.
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III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by
downloading an electronic copy from
the Internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Information to Support a Claim of
Electromagnetic Compatibility (EMC) of
Electrically-Powered Medical Devices’’
may send an email request to CDRHGuidance@fda.hhs.gov to receive an
electronic copy of the document. Please
use the document number 1400057 to
identify the guidance you are
requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 814 have
been approved under OMB control
number 0910–0231. The collections of
information in 21 CFR part 807, subpart
E have been approved under OMB
control number 0910–0120. The
collections of information in 21 CFR
part 812 have been approved under
OMB control number 0910–0078. The
collections of information in 21 CFR
part 814, subpart H have been approved
under OMB control number 0910–0332.
The collections of information in
sections 520(m) and 515A of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
360j and 21 U.S.C. 360e–1, respectively)
and 613(b) of Food and Drug
Administration Safety and Innovation
Act have been approved under OMB
control number 0910–0661.
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Dated: October 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–27818 Filed 10–30–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
[Document Identifier: HHS–OS–4040–New–
60D]
Agency Information Collection
Activities; Proposed Collection; Public
Comment Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
SUMMARY: In compliance with section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, announces plans
to submit a new Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, OS seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on the ICR must be
received on or before January 4, 2016.
ADDRESSES: Submit your comments to
Information.CollectionClearance@
hhs.gov or by calling (202) 690–6162.
FOR FURTHER INFORMATION CONTACT:
Information Collection Clearance staff,
Information.CollectionClearance@
hhs.gov or (202) 690–6162.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
document identifier HHS–OS–4040–
New–60D for reference.
Information Collection Request Title:
DATA Act Sec. 5. ‘‘Simplifying Federal
Award Reporting’’ Grants Pilot.
Abstract: Public Law 113–101, The
Digital Accountability and
Transparency Act of 2014 (DATA Act)
expands the Federal Funding
Accountability and Transparency Act of
2006 by increasing accountability and
transparency in Federal spending.
Section 5 of the DATA Act (‘‘Sec. 5.
Simplifying Federal Award Reporting’’)
tasks the Director of the Office of
Management and Budget (OMB) to
establish a pilot program (Sec. 5 (b)).
OMB has designated the Department
of Health and Human Services (HHS) as
the executing agent of the pilot program.
Within HHS, the DATA Act Program
Management Office (PMO) (DAP) has
been established under the Office of the
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Federal Register / Vol. 80, No. 211 / Monday, November 2, 2015 / Notices
Assistant Secretary for Financial
Resources (ASFR) in order to implement
this pilot program. ASFR/DAP, in
coordination with Grants.gov, is
requesting a generic clearance for the
purpose of conducting tests under the
pilot program to obtain qualitative and
quantitative data and gain an
understanding of the burden imposed
on Federal recipients.
The DAP has designed several test
models to evaluate recipient burden and
assess quality of data. The goal of these
test models is to determine whether new
technology, data standards, processes,
and forms aid in reducing recipient
burden and increase the accuracy and
quality of the data submitted. Under this
clearance, a variety of methods (surveys,
focus groups, etc.) could be used to
collect data, with the exact nature of the
questions currently undetermined. DAP
expects these questions to include, but
not be limited to, topics pertaining to
the Standard Form (SF) 424, the
Consolidated Federal Financial Reports,
and the expanded Single Audit form
(SF–SAC). If this data is not collected,
67413
the requirements of the DATA Act
Section 5 pilot will not be met. The
types of collections that this generic
clearance covers include, but are not
limited to:
• Surveys,
• Focus Groups,
• Other qualitative methods such as
interviews, small discussion groups,
and case studies.
Likely Respondents: Recipients of
Federal contracts, grants, and subawards.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Estimated annual reporting burden
Annual
frequency per
response
Number of
respondents
Type of collection
Hours per
response
Total hours
Surveys, Focus Groups, and other qualitative methods .................................
300
1
56.25
16,875
Total ..........................................................................................................
300
........................
........................
16,875
OS specifically requests comments on
(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.
Darius Taylor,
Information Collection Clearance Officer.
[FR Doc. 2015–27860 Filed 10–30–15; 8:45 am]
BILLING CODE 4150–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Notice To Propose the Redesignation
of the Service Delivery Area for the
Wampanoag Tribe of Gay Head
(Aquinnah)
Indian Health Service, HHS.
Notice; extension of the
comment period.
AGENCY:
asabaliauskas on DSK5VPTVN1PROD with NOTICES
ACTION:
SUMMARY: This document extends the
comment period for the notice to
propose Redesignation of the Service
Delivery Area for the Wampanoag Tribe
of Gay Head (Aquinnah), which was
published in the Federal Register on
October 5, 2015. The comment period
for the notice, which would have ended
on October 23, 2015, is extended by 30
days.
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The comment period for the
notice published in the Federal Register
on August 24, 2015 (80 FR 51281)
allowed for thirty days; the comment
period was subsequently extended in
the Federal Register (80 FR 60158) for
an additional 30 days to October 23,
2015. This notice extends the comment
period for an additional 30 days to
November 22, 2015.
ADDRESSES: Because of staff and
resource limitations, we cannot accept
comments by facsimile transmission.
You may submit comments in one of
three ways (please choose only one of
the ways listed):
1. By regular mail. You may mail
written comments to the following
address ONLY: Betty Gould, Regulations
Officer, Indian Health Service, 801
Thompson, Avenue, TMP STE 450,
Rockville, Maryland 20852.
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.
2. By express or overnight mail. You
may send written comments to the
above address.
3. By hand or courier. If you prefer,
you may deliver (by hand or courier)
your written comments before the close
of the comment period to the address
above. If you intend to deliver your
comments to the Rockville address,
please call telephone number (301) 443–
1116 in advance to schedule your
arrival with a staff member.
Comments will be made available for
public inspection at the Rockville
address from 8:30 a.m. to 5:00 p.m.,
Monday–Friday, approximately three
weeks after publication of this notice.
DATES:
PO 00000
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Carl
Harper, Director, Office of Resource
Access and Partnerships, Indian Health
Service, 801 Thompson Avenue,
Rockville, Maryland 20852. Telephone:
(301) 443–1553.
FOR FURTHER INFORMATION CONTACT:
The notice
that was published in the Federal
Register on August 24, 2015 advises the
public that the Indian Health Service
proposes to expand the geographic
boundaries of the Service Delivery Area
for the Wampanoag Tribe of Gay Head
(Aquinnah) of Massachusetts. The
Aquinnah service delivery area is
currently comprised of members of the
Tribe residing in Martha’s Vineyard,
Dukes County in the State of
Massachusetts.
The Bureau of Indian Affairs
recognized the Wampanoag Tribe of Gay
Head on February 10, 1987. Martha’s
Vineyard, Dukes County was designated
as the Aquinnah service delivery area in
the Wampanoag Tribal Council of Gay
Head, Inc., Indian Claims Settlement
Act of 1987, Public Law 100–95.
This comment period is being
extended to allow all interested parties
the opportunity to comment on the
proposed rule. Therefore, we are
extending the comment period until
November 22, 2015.
SUPPLEMENTARY INFORMATION:
Dated: October 23, 2015.
Robert G. McSwain,
Principal Deputy Director, Indian Health
Service.
[FR Doc. 2015–27898 Filed 10–30–15; 8:45 am]
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]]>Agencies
[Federal Register Volume 80, Number 211 (Monday, November 2, 2015)]
[Notices]
[Pages 67412-67413]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27860]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
[Document Identifier: HHS-OS-4040-New-60D]
Agency Information Collection Activities; Proposed Collection;
Public Comment Request
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the Office of the Secretary (OS), Department of
Health and Human Services, announces plans to submit a new Information
Collection Request (ICR), described below, to the Office of Management
and Budget (OMB). Prior to submitting the ICR to OMB, OS seeks comments
from the public regarding the burden estimate, below, or any other
aspect of the ICR.
DATES: Comments on the ICR must be received on or before January 4,
2016.
ADDRESSES: Submit your comments to
Information.CollectionClearance@hhs.gov or by calling (202) 690-6162.
FOR FURTHER INFORMATION CONTACT: Information Collection Clearance
staff, Information.CollectionClearance@hhs.gov or (202) 690-6162.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the document identifier HHS-OS-4040-New-60D
for reference.
Information Collection Request Title: DATA Act Sec. 5.
``Simplifying Federal Award Reporting'' Grants Pilot.
Abstract: Public Law 113-101, The Digital Accountability and
Transparency Act of 2014 (DATA Act) expands the Federal Funding
Accountability and Transparency Act of 2006 by increasing
accountability and transparency in Federal spending. Section 5 of the
DATA Act (``Sec. 5. Simplifying Federal Award Reporting'') tasks the
Director of the Office of Management and Budget (OMB) to establish a
pilot program (Sec. 5 (b)).
OMB has designated the Department of Health and Human Services
(HHS) as the executing agent of the pilot program. Within HHS, the DATA
Act Program Management Office (PMO) (DAP) has been established under
the Office of the
[[Page 67413]]
Assistant Secretary for Financial Resources (ASFR) in order to
implement this pilot program. ASFR/DAP, in coordination with
Grants.gov, is requesting a generic clearance for the purpose of
conducting tests under the pilot program to obtain qualitative and
quantitative data and gain an understanding of the burden imposed on
Federal recipients.
The DAP has designed several test models to evaluate recipient
burden and assess quality of data. The goal of these test models is to
determine whether new technology, data standards, processes, and forms
aid in reducing recipient burden and increase the accuracy and quality
of the data submitted. Under this clearance, a variety of methods
(surveys, focus groups, etc.) could be used to collect data, with the
exact nature of the questions currently undetermined. DAP expects these
questions to include, but not be limited to, topics pertaining to the
Standard Form (SF) 424, the Consolidated Federal Financial Reports, and
the expanded Single Audit form (SF-SAC). If this data is not collected,
the requirements of the DATA Act Section 5 pilot will not be met. The
types of collections that this generic clearance covers include, but
are not limited to:
Surveys,
Focus Groups,
Other qualitative methods such as interviews, small
discussion groups, and case studies.
Likely Respondents: Recipients of Federal contracts, grants, and
sub-awards.
Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
Estimated annual reporting burden
-----------------------------------------------------------------------------------------------------------------
Annual
Type of collection Number of frequency per Hours per Total hours
respondents response response
----------------------------------------------------------------------------------------------------------------
Surveys, Focus Groups, and other qualitative 300 1 56.25 16,875
methods......................................
-----------------------------------------------------------------
Total..................................... 300 ............... ............... 16,875
----------------------------------------------------------------------------------------------------------------
OS specifically requests comments on (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.
Darius Taylor,
Information Collection Clearance Officer.
[FR Doc. 2015-27860 Filed 10-30-15; 8:45 am]
BILLING CODE 4150-37-P
