Agency Information Collection Activities: Proposed Collection; Comment Request, 10686-10687 [2015-04115]
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10686
Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Notices
security of United States citizens living
abroad and that involves EV–D68.
III. Declaration of the Secretary of
Health and Human Services
Also on February 6, 2015, on the basis
of my determination of a significant
potential for a public health emergency
that has a significant potential to affect
national security or the health and
security of United States citizens living
abroad and that involves EV–D68, I
declared that circumstances exist
justifying the authorization of
emergency use of new in vitro
diagnostics for detection of EV–D68
pursuant to section 564 of the FD&C
Act, subject to the terms of any
authorization issued under that section.
Notice of the EUAs issued by the FDA
Commissioner pursuant to this
determination and declaration will be
provided promptly in the Federal
Register as required under section 564
of the FD&C Act.
Dated: February 6, 2015.
Sylvia M. Burwell,
Secretary.
[FR Doc. 2015–04121 Filed 2–26–15; 8:45 am]
BILLING CODE 4150–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Secretary’s Advisory
Committee on Human Research
Protections
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
Pursuant to Section 10(a) of
the Federal Advisory Committee Act,
U.S.C. Appendix 2, notice is hereby
given that the Secretary’s Advisory
Committee on Human Research
Protections (SACHRP) will hold a
meeting that will be open to the public.
Information about SACHRP and the full
meeting agenda will be posted on the
SACHRP Web site at: https://
www.dhhs.gov/ohrp/sachrp/mtgings/
index.html.
SUMMARY:
The meeting will be held on
Tuesday, March 24, 2015, from 8:30
a.m. until 5:00 p.m. and Wednesday,
March 25, 2015, from 8:30 a.m. until
4:30 p.m.
ADDRESSES: Fishers Lane Conference
Center, Terrace Level, 5635 Fishers
Lane, Rockville, Maryland 20852.
FOR FUTHER INFORMATION CONTACT: Jerry
Menikoff, M.D., J.D., Director, Office for
Human Research Protections (OHRP), or
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DATES:
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Julia Gorey, J.D., Executive Director,
SACHRP; U.S. Department of Health
and Human Services, 1101 Wootton
Parkway, Suite 200, Rockville,
Maryland 20852; 240–453–8141; fax:
240–453–6909; email address:
SACHRP@hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
authority of 42 U.S.C. 217a, Section 222
of the Public Health Service Act, as
amended, SACHRP was established to
provide expert advice and
recommendations to the Secretary of
Health and Human Services, through
the Assistant Secretary for Health, on
issues and topics pertaining to or
associated with the protection of human
research subjects.
The meeting will open to the public
at 8:30 a.m., on Tuesday, March 24.
Following opening remarks from Dr.
Jerry Menikoff, Executive Secretary of
SACHRP and OHRP Director, and Dr.
Jeffrey Botkin, SACHRP Chair, Dr.
Botkin and invited speakers will discuss
issues surrounding the use of newborn
dried bloodspots in research. The
Subpart A Subcommittee (SAS) report
will follow; SAS will discuss draft
recommendations on the research uses
of newborn dried bloodspots and the
Newborn Screening Saves Lives
Reauthorization Act of 2014. SAS was
established by SACHRP in October 2006
and is charged with developing
recommendations for consideration by
SACHRP regarding the application of
subpart A of 45 CFR part 46 in the
current research environment.
In the afternoon of March 24, the
Subcommittee on Harmonization (SOH)
will present their report; SOH was
established by SACHRP at its July 2009
meeting and charged with identifying
and prioritizing areas in which
regulations and/or guidelines for human
subjects research adopted by various
agencies or offices within HHS would
benefit from harmonization,
consistency, clarity, simplification and/
or coordination. SOH will present
recommendations on the research use of
‘‘big data’’ and the intersection of the
HHS and FDA regulations.
On March 25, the SOH will discuss
the return of individual research results
with special considerations regarding
HIPAA and CLIA; this will be followed
by presentation of SOH
recommendations on the FDA draft
guidance ‘‘General Clinical
Pharmacology Considerations for
Pediatric Studies for Drugs and
Biologics.’’ The meeting will adjourn at
4:30 p.m. March 25, 2015. Time for
public comment sessions will be
allotted both days.
Public attendance at the meeting is
limited to space available. Individuals
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who plan to attend and need special
assistance, such as sign language
interpretation or other reasonable
accommodations, should notify one of
the designated SACHRP points of
contact at the address/phone number
listed above at least one week prior to
the meeting. Pre-registration is required
for participation in the on-site public
comment session; individuals may preregister the day of the meeting.
Individuals who would like to submit
written statements should email or fax
their comments to SACHRP at
SACHRP@hhs.gov at least five business
days prior to the meeting.
Dated: February 23, 2015.
Jerry Menikoff,
Executive Secretary, Secretary’s Advisory
Committee on Human Research Protections,
Director, Office for Human Research
Protections.
[FR Doc. 2015–04120 Filed 2–26–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–1696 and CMS–
10417]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. 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 or reinstatement of an existing
collection of information) and to allow
60 days for public comment on the
proposed action. Interested persons are
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
SUMMARY:
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Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Notices
minimize the information collection
burden.
DATES: Comments must be received by
April 28, 2015.
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:
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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
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–1696 Appointment of
Representative
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.
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10687
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.
Dated: February 24, 2015.
William N. Parham, III
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
Information Collection
Centers for Medicare & Medicaid
Services
1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Appointment of
Representative; Use: The Appointment
of Representative form is completed by
beneficiaries, providers and suppliers,
and any party seeking to appoint a
representative to assist them with their
initial determinations and filing
appeals. This extension request
proposes non-substantive changes to the
form. Form Number: CMS–1696 (OMB
control number 0938–0950); Frequency:
Once; Affected Public: Individuals and
households and the Private sector
(Business or other for-profits); Number
of Respondents: 4,073,960; Total
Annual Responses: 407,396; Total
Annual Hours: 101,849. (For policy
questions regarding this collection
contact Katherine Hosna at 410–786–
4993).
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Medicare Feefor-Service Prepayment Medical
Review; Use: The information required
under this collection is requested by
Medicare contractors to determine
proper payment or if there is a suspicion
of fraud. Medicare contractors request
the information from providers or
suppliers submitting claims for payment
from the Medicare program when data
analysis indicates aberrant billing
patterns or other information which
may present a vulnerability to the
Medicare program. Form Number:
CMS–10417 (OMB control number:
0938–0969); Frequency: Occasionally;
Affected Public: Private Sector (Business
or other for-profit and Not-for-profit
institutions); Number of Respondents:
3,211,800; Total Annual Responses:
3,211,800; Total Annual Hours:
1,597,950. (For policy questions
regarding this collection contact Debbie
Skinner at 410–786–7480.)
[Document Identifier CMS–10341 and CMS–
10522]
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[FR Doc. 2015–04115 Filed 2–26–15; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
ACTION:
Notice.
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995
(PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, and to allow
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate 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 on the collection(s) of
information must be received by the
OMB desk officer by March 30, 2015.
ADDRESSES: When commenting on the
proposed information collections,
please reference the document identifier
or OMB control number. To be assured
consideration, comments and
recommendations must be received by
the OMB desk officer via one of the
following transmissions: OMB, Office of
Information and Regulatory Affairs,
Attention: CMS Desk Officer, Fax
Number: (202) 395–5806 or Email:
OIRA_submission@omb.eop.gov.
To obtain copies of a supporting
statement and any related forms for the
SUMMARY:
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]]>Agencies
[Federal Register Volume 80, Number 39 (Friday, February 27, 2015)]
[Notices]
[Pages 10686-10687]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-04115]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-1696 and CMS-10417]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid Services, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is
announcing an opportunity for the public to comment on CMS' intention
to collect information from the public. 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 or reinstatement of an
existing collection of information) and to allow 60 days for public
comment on the proposed action. Interested persons are 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
[[Page 10687]]
minimize the information collection burden.
DATES: Comments must be received by April 28, 2015.
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 each collection's supporting statement and associated
materials (see ADDRESSES).
CMS-1696 Appointment of Representative
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.
Information Collection
1. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Appointment of
Representative; Use: The Appointment of Representative form is
completed by beneficiaries, providers and suppliers, and any party
seeking to appoint a representative to assist them with their initial
determinations and filing appeals. This extension request proposes non-
substantive changes to the form. Form Number: CMS-1696 (OMB control
number 0938-0950); Frequency: Once; Affected Public: Individuals and
households and the Private sector (Business or other for-profits);
Number of Respondents: 4,073,960; Total Annual Responses: 407,396;
Total Annual Hours: 101,849. (For policy questions regarding this
collection contact Katherine Hosna at 410-786-4993).
2. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Medicare Fee-for-
Service Prepayment Medical Review; Use: The information required under
this collection is requested by Medicare contractors to determine
proper payment or if there is a suspicion of fraud. Medicare
contractors request the information from providers or suppliers
submitting claims for payment from the Medicare program when data
analysis indicates aberrant billing patterns or other information which
may present a vulnerability to the Medicare program. Form Number: CMS-
10417 (OMB control number: 0938-0969); Frequency: Occasionally;
Affected Public: Private Sector (Business or other for-profit and Not-
for-profit institutions); Number of Respondents: 3,211,800; Total
Annual Responses: 3,211,800; Total Annual Hours: 1,597,950. (For policy
questions regarding this collection contact Debbie Skinner at 410-786-
7480.)
Dated: February 24, 2015.
William N. Parham, III
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2015-04115 Filed 2-26-15; 8:45 am]
BILLING CODE 4120-01-P
