Agency Information Collection Activities: Submission for OMB Review; Comment Request, 48321-48322 [2015-19837]
Download as PDF
mstockstill on DSK4VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 155 / Wednesday, August 12, 2015 / Notices
largely extends the transparency
reporting provisions set forth in section
1311(e)(3) to non-grandfathered group
health plans (including large group and
self-insured health plans) and health
insurance issuers offering group and
individual health insurance coverage
(non-QHP issuers), the Departments
intend to propose other transparency
reporting requirements at a later time,
through a separate rulemaking
conducted by the Departments, for nonQHP issuers and non-grandfathered
group health plans. Those proposed
reporting requirements may differ from
those prescribed in the HHS proposal
under section 1311(e)(3), and will take
into account differences in markets,
reporting requirements already in
existence for non-QHPs (including
group health plans), and other relevant
factors. The Departments also intend to
streamline reporting under multiple
reporting provisions and reduce
unnecessary duplication. The
Departments intend to implement any
transparency reporting requirements
applicable to non-QHP issuers and nongrandfathered group health plans only
after notice and comment, and after
giving those issuers and plans sufficient
time, following the publication of final
rules, to come into compliance with
those requirements. Form Number:
CMS–10572 (OMB control number:
0938–New); Frequency: Annually;
Affected Public: Private Sector (Business
or other For-profit and Not-for-profit
institutions); Number of Respondents:
475; Total Annual Responses: 475; Total
Annual Hours: 16,150. (For policy
questions regarding this collection
contact Valisha Price at 301–492–4343).
3. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: Home Health
Face-to-Face Encounter Clinical
Templates; Use: The Centers for
Medicare & Medicare Services (CMS) is
requesting the Office of Management
and Budget (OMB) approval of the
collection of data required to support
the eligibility of Medicare home health
services. Home health services are
covered under the Hospital Insurance
(Part A) and Supplemental Medical
Insurance (Part B) benefits of the
Medicare program. It consists of parttime, medically necessary skilled care
(nursing, physical therapy, occupational
therapy, and speech-language therapy)
that is ordered by a physician. The CMS
has developed a list of clinical elements
within a suggested electronic clinical
template that would allow electronic
health record vendors to create prompts
to assist physicians when documenting
VerDate Sep<11>2014
18:16 Aug 11, 2015
Jkt 235001
the HH face-to-face encounter for
Medicare purposes. Once completed by
the physician, the resulting progress
note or clinic note would be part of the
medical record. The primary users of
these new clinical templates will be
physicians and/or allowed nonphysician practitioners (NPPs). The
templates will help users to capture the
necessary information needed to
complete the face-to-face encounter
documentation. This will help
physicians and/or allowed NPPs comply
with Medicare policy requirements,
thereby reducing the possibility of a
home health claim not being paid
because of failure to meet Medicare
requirements. Form Number: CMS–
10564 (OMB control number: 0938–
New); Frequency: Occasionally;
Affected Public: Private Sector (Business
or other For-profit and Not-for-profit
institutions); Number of Respondents:
2,926,420; Total Annual Responses:
2,926,420; Total Annual Hours:
1,220,317. (For policy questions
regarding this collection contact Kristal
Vines at 410–786–0119).
Dated: August 7, 2015.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2015–19818 Filed 8–11–15; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–2540–10]
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
SUMMARY:
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
48321
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 September 11,
2015.
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/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.
ADDRESSES:
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
SUPPLEMENTARY INFORMATION:
E:\FR\FM\12AUN1.SGM
12AUN1
48322
Federal Register / Vol. 80, No. 155 / Wednesday, August 12, 2015 / Notices
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: Skilled Nursing
Facility and Skilled Nursing Facility
Health Care Complex Cost Report Form;
Use: Providers of services participating
in the Medicare program are required
under sections 1815(a), 1833(e) and
1861(v)(1)(A) of the Social Security Act
(42 U.S.C. 1395g) to submit annual
information to achieve settlement of
costs for health care services rendered to
Medicare beneficiaries. In addition,
regulations at 42 CFR 413.20 and 413.24
require adequate cost data and cost
reports from providers on an annual
basis. The Form CMS–2540–10 cost
report is needed to determine a
provider’s reasonable cost incurred in
furnishing medical services to Medicare
beneficiaries and reimbursement due to
or from a provider. The revisions made
to the SNF cost report are in accordance
with the statutory requirement for
hospice payment reform in § 3132 of the
Patient Protection and Affordable Care
Act (ACA). Form Number: CMS–2540–
10 (OMB control number 0938–0463);
Frequency: Annually; Affected Public:
Private sector (Business or other forprofits and Not-for-profit institutions);
Number of Respondents: 14,398; Total
Annual Responses: 14,398; Total
Annual Hours: 2,908,396. (For policy
questions regarding this collection
contact Amelia Citerone at 410–786–
8008).
Dated: August 7, 2015.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2015–19837 Filed 8–11–15; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
mstockstill on DSK4VPTVN1PROD with NOTICES
[Docket No. FDA–2009–D–0268]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Labeling of Certain
Beers Subject to the Labeling
Jurisdiction of the Food and Drug
Administration
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing an opportunity for public
SUMMARY:
VerDate Sep<11>2014
18:16 Aug 11, 2015
Jkt 235001
comment on our proposed collection of
certain 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 60 days for public comment.
This notice solicits comments on the
information collection provisions of the
recommended labeling of certain beers
subject to our labeling jurisdiction.
DATES: Submit either electronic or
written comments on the collection of
information by October 13, 2015.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: 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.
‘‘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 provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, we are publishing notice of
the proposed collection of information
set forth in this document.
With respect to the following
collection of information, we invite
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of our functions, including whether the
information will have practical utility;
(2) the accuracy of our estimate of the
burden of the proposed collection of
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
information, including the validity of
the methodology and assumptions used;
(3) ways to enhance the quality, utility,
and clarity of the information to be
collected; and (4) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques,
when appropriate, and other forms of
information technology.
Labeling of Certain Beers Subject to the
Labeling Jurisdiction of the Food and
Drug Administration—(OMB Control
Number 0910–0728)—Extension
The definition of ‘‘food’’ under
section 201(f) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) See 21
U.S.C. 321(f), includes ‘‘articles used for
food or drink’’ and thus includes
alcoholic beverages. As such, alcoholic
beverages are subject to the FD&C Act’s
adulteration and misbranding
provisions, and implementing
regulations, related to food. For
example, manufacturers of alcoholic
beverages are responsible for adhering
to the registration of food facilities
requirements in 21 CFR part 1 and to
the good manufacturing practice
regulations in 21 CFR part 110. There
are also certain requirements for
nutrition labeling on menus, menu
boards, and other written materials for
alcohol beverages served in restaurants
or similar retail food establishments in
21 CFR part 101 (79 FR 71156,
December 1, 2014). However, as
reflected in a 1987 Memorandum of
Understanding between FDA and the
Alcohol and Tobacco Tax and Trade
Bureau (TTB), TTB is responsible for the
promulgation and enforcement of
regulations with respect to the labeling
of distilled spirits, certain wines, and
malt beverages pursuant to the Federal
Alcohol Administration Act (FAA Act).
In TTB Ruling 2008–3, dated July 7,
2008, TTB clarified that certain beers,
which are not made from both malted
barley and hops but are instead made
from substitutes for malted barley (such
as sorghum, rice, or wheat) or are made
without hops, do not meet the definition
of a ‘‘malt beverage’’ under the FAA
Act. Accordingly, TTB stated in its
ruling that such products (other than
sake, which is classified as a wine under
the FAA Act), are not subject to the
labeling, advertising, or other provisions
of the TTB regulations promulgated
under the FAA Act.
In cases where an alcoholic beverage
is not covered by the labeling provisions
of the FAA Act, the product is subject
to ingredient and other labeling
requirements under the FD&C Act and
the implementing regulations that we
administer. In addition, as provided for
E:\FR\FM\12AUN1.SGM
12AUN1
Agencies
[Federal Register Volume 80, Number 155 (Wednesday, August 12, 2015)]
[Notices]
[Pages 48321-48322]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-19837]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-2540-10]
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
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 (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 September 11, 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 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
[[Page 48322]]
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: Skilled Nursing
Facility and Skilled Nursing Facility Health Care Complex Cost Report
Form; Use: Providers of services participating in the Medicare program
are required under sections 1815(a), 1833(e) and 1861(v)(1)(A) of the
Social Security Act (42 U.S.C. 1395g) to submit annual information to
achieve settlement of costs for health care services rendered to
Medicare beneficiaries. In addition, regulations at 42 CFR 413.20 and
413.24 require adequate cost data and cost reports from providers on an
annual basis. The Form CMS-2540-10 cost report is needed to determine a
provider's reasonable cost incurred in furnishing medical services to
Medicare beneficiaries and reimbursement due to or from a provider. The
revisions made to the SNF cost report are in accordance with the
statutory requirement for hospice payment reform in Sec. 3132 of the
Patient Protection and Affordable Care Act (ACA). Form Number: CMS-
2540-10 (OMB control number 0938-0463); Frequency: Annually; Affected
Public: Private sector (Business or other for-profits and Not-for-
profit institutions); Number of Respondents: 14,398; Total Annual
Responses: 14,398; Total Annual Hours: 2,908,396. (For policy questions
regarding this collection contact Amelia Citerone at 410-786-8008).
Dated: August 7, 2015.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2015-19837 Filed 8-11-15; 8:45 am]
BILLING CODE 4120-01-P