Agency Information Collection Activities: Proposed Collection; Comment Request, 70117-70118 [2016-24415]
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Federal Register / Vol. 81, No. 196 / Tuesday, October 11, 2016 / Notices
System of Records Notice (SORN)
published at 78 Federal Register (FR)
63211 (Oct. 23, 2013).
The OPM System of Records for this
matching program is titled ‘‘General
Personnel Records’’ (OPM/GOVT–1),
published at 77 Federal Register, 73694
(December 11, 2012). OPM will submit
to CMS a monthly Status File that is a
full refresh of all Federal employee
health care insurance information. OPM
also will submit to CMS, on an annual
basis, a Premium Spread Index File that
provides information identifying the
lowest self-only premium for an OPM
FEHB plan available to a Federal
employee in each State as well as
national OPM FEHB plans.
Inclusive Dates of the Match
The CMP will become effective no
sooner than 40 days after the report of
the matching program is sent to 0MB, 30
days after a copy of the matching
agreement is transmitted to Congress, or
30 days after publication in the Federal
Register, whichever is later. The
matching program will continue for 18
months from the effective date and may
be extended for an additional 12 months
thereafter, if certain conditions are met.
[FR Doc. 2016–24387 Filed 10–7–16; 8:45 am]
BILLING CODE 4120–03–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–R–138 and
10088]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, Department of
Health and Human 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
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
20:12 Oct 07, 2016
Jkt 241001
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.
Comments must be received by
December 12, 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 llRoom 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.
DATES:
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–R–138 Medicare Geographic
Classification Review Board
Procedures and Criteria
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
70117
CMS–10088 Notification of FIs and
CMS of co-located Medicare providers
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: Medicare
Geographic Classification Review Board
Procedures and Criteria; Use: During the
first few years of IPPS, hospitals were
paid strictly based on their physical
geographic location concerning the
wage index (Metropolitan Statistical
Areas (MSAs)) and the standardized
amount (rural, other urban, or large
urban). However, a growing number of
hospitals became concerned that their
payment rates were not providing
accurate compensation. The hospitals
argued that they were not competing
with the hospitals in their own
geographic area, but instead that they
were competing with hospitals in
neighboring geographic areas. At that
point, Congress enacted Section
1886(d)(10) of the Act which enabled
hospitals to apply to be considered part
of neighboring geographic areas for
payment purposes based on certain
criteria. The application and decision
process is administered by the MGCRB
which is not a part of CMS so that CMS
could not be accused of any untoward
action. However, CMS needs to remain
apprised of any potential payment
changes. Hospitals are required to
provide CMS with copy of any
applications that they made to the
MGCRB. CMS also developed the
guidelines for the MGCRB that were the
interim final issue of the Federal
Register, and must ensure that the
MGCRB properly applied the
guidelines. This check and balance
process also contributes to limiting the
E:\FR\FM\11OCN1.SGM
11OCN1
70118
Federal Register / Vol. 81, No. 196 / Tuesday, October 11, 2016 / Notices
number of hospitals that ultimately
need to appeal their MGCRB decisions
to the CMS Administrator. Form
Number: CMS–R–138 (OMB control
number: 0938–0573); Frequency:
Occasionally; Affected Public:
Businesses or other for-profits and Notfor-profit institutions; Number of
Respondents: 300; Total Annual
Responses: 300; Total Annual Hours:
300. (For policy questions regarding this
collection contact Noel Manlove at 410–
786–5161.)
2. Type of Information Collection
Request: Reinstatement of a previously
approved collection; Title of
Information Collection: Notification of
FIs and CMS of co-located Medicare
providers; Use: Many long-term care
hospitals (LTCHs) are co-located with
other Medicare providers (acute care
hospitals, IRFs, SNFs, psychiatric
facilities), which leads to potential
gaming of the Medicare system based on
patient shifting. In regulations at 42 CFR
412.22(e)(3) and (h)(6) and 412.532(i),
CMS is requiring LTCHs to notify
Medicare Administrative Contractors
(MACs) and CMS of co-located
providers in order to establish policies
to limit payment abuse that will be
based on FIs tracking patient movement
among these co-located providers. Form
Number: CMS–10088 (OMB control
number: 0938–0897); Frequency:
Annually; Affected Public: Businesses
or other for-profits and Not-for-profit
institutions; Number of Respondents:
25; Total Annual Responses: 25; Total
Annual Hours: 6. (For policy questions
regarding this collection contact Emily
Lipkin at 410–786–3633.)
Dated: October 4, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2016–24415 Filed 10–7–16; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
asabaliauskas on DSK3SPTVN1PROD with NOTICES
[Docket No. FDA–2015–D–3990]
Sunscreen Innovation Act: Section
586C(c) Advisory Committee Process;
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a
guidance for industry entitled
SUMMARY:
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20:12 Oct 07, 2016
Jkt 241001
‘‘Sunscreen Innovation Act: Section
586C(c) Advisory Committee Process.’’
This guidance explains the process by
which FDA intends to carry out the
section of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act), as
amended by the Sunscreen Innovation
Act (SIA), which governs the convening
of advisory committees to provide
recommendations on requests submitted
under the SIA regarding
nonprescription sunscreen active
ingredients and the number of requests
to be considered per meeting. The
recommendations in this guidance
apply to 586A requests submitted under
the FD&C Act and to pending requests
as defined by the SIA that seek a
determination from FDA on whether a
nonprescription sunscreen active
ingredient, or a combination of
nonprescription sunscreen active
ingredients, is generally recognized as
safe and effective (GRASE) for use under
specified conditions and should be
included in the over-the-counter (OTC)
sunscreen drug monograph. The SIA
describes specific circumstances under
which FDA is not required to convene
or submit requests to the
Nonprescription Drugs Advisory
Committee (NDAC). We are issuing this
guidance pursuant to the SIA, which
directs FDA to issue guidance on four
topics, including the topic discussed in
this guidance. This guidance finalizes
the draft guidance on the same topic
issued on November 23, 2015.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: You may submit comments
as follows:
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
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.
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
• 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–3990 for ‘‘Sunscreen
Innovation Act: Section 586C(c)
Advisory Committee Process.’’ 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
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
E:\FR\FM\11OCN1.SGM
11OCN1
Agencies
[Federal Register Volume 81, Number 196 (Tuesday, October 11, 2016)]
[Notices]
[Pages 70117-70118]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-24415]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-R-138 and 10088]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid Services, Department of Health
and Human 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 12, 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 each collection's supporting statement and associated
materials (see ADDRESSES).
CMS-R-138 Medicare Geographic Classification Review Board Procedures
and Criteria
CMS-10088 Notification of FIs and CMS of co-located Medicare providers
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: Medicare
Geographic Classification Review Board Procedures and Criteria; Use:
During the first few years of IPPS, hospitals were paid strictly based
on their physical geographic location concerning the wage index
(Metropolitan Statistical Areas (MSAs)) and the standardized amount
(rural, other urban, or large urban). However, a growing number of
hospitals became concerned that their payment rates were not providing
accurate compensation. The hospitals argued that they were not
competing with the hospitals in their own geographic area, but instead
that they were competing with hospitals in neighboring geographic
areas. At that point, Congress enacted Section 1886(d)(10) of the Act
which enabled hospitals to apply to be considered part of neighboring
geographic areas for payment purposes based on certain criteria. The
application and decision process is administered by the MGCRB which is
not a part of CMS so that CMS could not be accused of any untoward
action. However, CMS needs to remain apprised of any potential payment
changes. Hospitals are required to provide CMS with copy of any
applications that they made to the MGCRB. CMS also developed the
guidelines for the MGCRB that were the interim final issue of the
Federal Register, and must ensure that the MGCRB properly applied the
guidelines. This check and balance process also contributes to limiting
the
[[Page 70118]]
number of hospitals that ultimately need to appeal their MGCRB
decisions to the CMS Administrator. Form Number: CMS-R-138 (OMB control
number: 0938-0573); Frequency: Occasionally; Affected Public:
Businesses or other for-profits and Not-for-profit institutions; Number
of Respondents: 300; Total Annual Responses: 300; Total Annual Hours:
300. (For policy questions regarding this collection contact Noel
Manlove at 410-786-5161.)
2. Type of Information Collection Request: Reinstatement of a
previously approved collection; Title of Information Collection:
Notification of FIs and CMS of co-located Medicare providers; Use: Many
long-term care hospitals (LTCHs) are co-located with other Medicare
providers (acute care hospitals, IRFs, SNFs, psychiatric facilities),
which leads to potential gaming of the Medicare system based on patient
shifting. In regulations at 42 CFR 412.22(e)(3) and (h)(6) and
412.532(i), CMS is requiring LTCHs to notify Medicare Administrative
Contractors (MACs) and CMS of co-located providers in order to
establish policies to limit payment abuse that will be based on FIs
tracking patient movement among these co-located providers. Form
Number: CMS-10088 (OMB control number: 0938-0897); Frequency: Annually;
Affected Public: Businesses or other for-profits and Not-for-profit
institutions; Number of Respondents: 25; Total Annual Responses: 25;
Total Annual Hours: 6. (For policy questions regarding this collection
contact Emily Lipkin at 410-786-3633.)
Dated: October 4, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2016-24415 Filed 10-7-16; 8:45 am]
BILLING CODE 4120-01-P