Agency Information Collection Activities: Proposed Collection; Comment Request, 59772-59773 [2014-23613]
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59772
Federal Register / Vol. 79, No. 192 / Friday, October 3, 2014 / Notices
Management and Budget, Attention:
Desk Officer for the Federal Trade
Commission, New Executive Office
Building, Docket Library, Room 10102,
725 17th Street NW., Washington, DC
20503. Comments sent to OMB by U.S.
postal mail, however, are subject to
delays due to heightened security
precautions. Thus, comments instead
should be sent by facsimile to (202)
395–5806.
David C. Shonka,
Principal Deputy General Counsel.
[FR Doc. 2014–23601 Filed 10–2–14; 8:45 am]
BILLING CODE 6750–01–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
Wednesday, October 29, 2014, from 8:30
a.m. until 5:00 p.m. and Thursday,
October 30, 2014, from 8:30 a.m. until
4:00 p.m.
ADDRESSES: Fishers Lane Conference
Center, Terrace Level, 5635 Fishers
Lane, Rockville, Maryland 20852.
FOR FURTHER INFORMATION CONTACT: Jerry
Menikoff, M.D., J.D., Director, Office for
Human Research Protections (OHRP), or
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 and the
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DATES:
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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., Wednesday, October 29.
Following opening remarks from Dr.
Jerry Menikoff, Executive Secretary of
SACHRP and OHRP Director, and Dr.
Jeffrey Botkin, SACHRP Chair, new
members will be introduced. The
Subpart A Subcommittee (SAS) will
then give their report on the new SAS
initiative examining informed consent.
SAS 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. SAS was
established by SACHRP in October
2006. Following this report, an OHRP
staff member will present and discuss
OHRP data addressing incidental
findings and corrective action plans.
On October 30, the Subcommittee on
Harmonization (SOH) will discuss their
work on the topic of the intersection of
the HHS and FDA regulations and ‘‘big
data’’; this will be followed by a
presentation of SOH work on the topic
of return of general results. SOH was
established by SACHRP at its July 2009
meeting. SOH is 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.
Public attendance at the meeting is
limited to space available. Individuals
who plan to attend and need special
assistance, such as sign language
interpretation or other reasonable
accommodations, should notify the
SACHRP 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: September 29, 2014.
Jerry Menikoff,
Executive Secretary, Secretary’s Advisory
Committee on Human Research Protections,
Director, Office for Human Research
Protections.
[FR Doc. 2014–23664 Filed 10–2–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10538]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services.
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
minimize the information collection
burden.
DATES: Comments must be received by
December 2, 2014:
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number (OCN). 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 lll, Room C4–26–
05, 7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
SUMMARY:
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Federal Register / Vol. 79, No. 192 / Friday, October 3, 2014 / Notices
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/Paperwork
ReductionActof1995.
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–10538 Prior Authorization Form
for Beneficiaries Enrolled in Hospice
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.
mstockstill on DSK4VPTVN1PROD with NOTICES
Information Collection
1. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: Prior
Authorization Form for Beneficiaries
Enrolled in Hospice; Use: The form
would be completed by the prescriber or
the beneficiary’s hospice, or if the
prescriber or hospice provides the
information verbally to the Part D
sponsor, the form would be completed
by the sponsor. Information provided on
the form would be used by the Part D
sponsor to establish coverage of the drug
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18:08 Oct 02, 2014
Jkt 235001
under Medicare Part D. Per statute,
drugs that are necessary for the
palliation and management of the
terminal illness and related conditions
are not eligible for payment under Part
D. The standard form provides a vehicle
for the hospice provider, prescriber or
sponsor to document that the drug
prescribed is ‘‘unrelated’’ to the
terminal illness and related conditions.
It also gives a hospice organization the
option to communicate a beneficiary’s
change in hospice status and care plan
to Part D sponsors. Form Number: CMS–
10538 (OMB control number 0938-New;
Frequency: Occasionally; Affected
Public: Private sector (business or other
for-profits); Number of Respondents:
424; Total Annual Responses: 376,487;
Total Annual Hours: 31,374. (For policy
questions regarding this collection
contact Shelly Winston at 410–786–
3694).
Dated: September 30, 2014.
Martique Jones,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2014–23613 Filed 10–2–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10237, CMS–
10357 and CMS–10499]
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
SUMMARY:
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59773
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 November 3, 2014.
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
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: Under the
Paperwork Reduction Act of 1995 (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 (44 U.S.C.
3506(c)(2)(A)) requires federal agencies
to publish a 30-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 that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Part C—
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Agencies
[Federal Register Volume 79, Number 192 (Friday, October 3, 2014)]
[Notices]
[Pages 59772-59773]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-23613]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10538]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid Services.
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 minimize the information collection burden.
DATES: Comments must be received by December 2, 2014:
ADDRESSES: When commenting, please reference the document identifier or
OMB control number (OCN). 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.
[[Page 59773]]
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-10538 Prior Authorization Form for Beneficiaries Enrolled in
Hospice
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: New collection (Request
for a new OMB control number); Title of Information Collection: Prior
Authorization Form for Beneficiaries Enrolled in Hospice; Use: The form
would be completed by the prescriber or the beneficiary's hospice, or
if the prescriber or hospice provides the information verbally to the
Part D sponsor, the form would be completed by the sponsor. Information
provided on the form would be used by the Part D sponsor to establish
coverage of the drug under Medicare Part D. Per statute, drugs that are
necessary for the palliation and management of the terminal illness and
related conditions are not eligible for payment under Part D. The
standard form provides a vehicle for the hospice provider, prescriber
or sponsor to document that the drug prescribed is ``unrelated'' to the
terminal illness and related conditions. It also gives a hospice
organization the option to communicate a beneficiary's change in
hospice status and care plan to Part D sponsors. Form Number: CMS-10538
(OMB control number 0938-New; Frequency: Occasionally; Affected Public:
Private sector (business or other for-profits); Number of Respondents:
424; Total Annual Responses: 376,487; Total Annual Hours: 31,374. (For
policy questions regarding this collection contact Shelly Winston at
410-786-3694).
Dated: September 30, 2014.
Martique Jones,
Director, Regulations Development Group, Office of Strategic Operations
and Regulatory Affairs.
[FR Doc. 2014-23613 Filed 10-2-14; 8:45 am]
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