81 FR 70117 - Agency Information Collection Activities: Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 81, Issue 196 (October 11, 2016)
Centers for Medicare & Medicaid Services
Federal Register Volume 81, Issue 196 (October 11, 2016)
| Page Range | 70117-70118 | |
| FR Document | 2016-24415 |
[Federal Register Volume 81, Number 196 (Tuesday, October 11, 2016)] [Notices] [Pages 70117-70118] From the Federal Register Online [www.thefederalregister.org] [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 http://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 http://www.cms.hhs.gov/PaperworkReductionActof1995. 2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to [email protected]. 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
![Federal Register / Vol. 81, No. 196 / Tuesday, October 11, 2016 / Notices 70117
System of Records Notice (SORN) any of the following subjects: (1) The CMS–10088 Notification of FIs and
published at 78 Federal Register (FR) necessity and utility of the proposed CMS of co-located Medicare providers
63211 (Oct. 23, 2013). information collection for the proper Under the PRA (44 U.S.C. 3501–
The OPM System of Records for this performance of the agency’s functions; 3520), federal agencies must obtain
matching program is titled ‘‘General (2) the accuracy of the estimated approval from the Office of Management
Personnel Records’’ (OPM/GOVT–1), burden; (3) ways to enhance the quality, and Budget (OMB) for each collection of
published at 77 Federal Register, 73694 utility, and clarity of the information to information they conduct or sponsor.
(December 11, 2012). OPM will submit be collected; and (4) the use of The term ‘‘collection of information’’ is
to CMS a monthly Status File that is a automated collection techniques or defined in 44 U.S.C. 3502(3) and 5 CFR
full refresh of all Federal employee other forms of information technology to 1320.3(c) and includes agency requests
health care insurance information. OPM minimize the information collection or requirements that members of the
also will submit to CMS, on an annual burden. public submit reports, keep records, or
basis, a Premium Spread Index File that provide information to a third party.
DATES: Comments must be received by
provides information identifying the Section 3506(c)(2)(A) of the PRA
December 12, 2016.
lowest self-only premium for an OPM requires federal agencies to publish a
FEHB plan available to a Federal ADDRESSES: When commenting, please
reference the document identifier or 60-day notice in the Federal Register
employee in each State as well as concerning each proposed collection of
national OPM FEHB plans. OMB control number. To be assured
consideration, comments and information, including each proposed
Inclusive Dates of the Match recommendations must be submitted in extension or reinstatement of an existing
any one of the following ways: collection of information, before
The CMP will become effective no
1. Electronically. You may send your submitting the collection to OMB for
sooner than 40 days after the report of
comments electronically to http:// approval. To comply with this
the matching program is sent to 0MB, 30
www.regulations.gov. Follow the requirement, CMS is publishing this
days after a copy of the matching
instructions for ‘‘Comment or notice.
agreement is transmitted to Congress, or
30 days after publication in the Federal Submission’’ or ‘‘More Search Options’’ Information Collection
Register, whichever is later. The to find the information collection
document(s) that are accepting 1. Type of Information Collection
matching program will continue for 18 Request: Extension of a currently
months from the effective date and may comments.
2. By regular mail. You may mail approved collection; Title of
be extended for an additional 12 months Information Collection: Medicare
thereafter, if certain conditions are met. written comments to the following
address: CMS, Office of Strategic Geographic Classification Review Board
[FR Doc. 2016–24387 Filed 10–7–16; 8:45 am] Procedures and Criteria; Use: During the
Operations and Regulatory Affairs,
BILLING CODE 4120–03–P
Division of Regulations Development, first few years of IPPS, hospitals were
Attention: Document Identifier/OMB paid strictly based on their physical
Control Number llRoom C4–26–05, geographic location concerning the
DEPARTMENT OF HEALTH AND wage index (Metropolitan Statistical
HUMAN SERVICES 7500 Security Boulevard, Baltimore,
Maryland 21244–1850. Areas (MSAs)) and the standardized
To obtain copies of a supporting amount (rural, other urban, or large
Centers for Medicare & Medicaid
statement and any related forms for the urban). However, a growing number of
Services
proposed collection(s) summarized in hospitals became concerned that their
[Document Identifier: CMS–R–138 and this notice, you may make your request payment rates were not providing
10088] accurate compensation. The hospitals
using one of following:
1. Access CMS’ Web site address at argued that they were not competing
Agency Information Collection with the hospitals in their own
Activities: Proposed Collection; http://www.cms.hhs.gov/
PaperworkReductionActof1995. geographic area, but instead that they
Comment Request were competing with hospitals in
2. Email your request, including your
AGENCY: Centers for Medicare & address, phone number, OMB number, neighboring geographic areas. At that
Medicaid Services, Department of and CMS document identifier, to point, Congress enacted Section
Health and Human Services. Paperwork@cms.hhs.gov. 1886(d)(10) of the Act which enabled
ACTION: Notice. 3. Call the Reports Clearance Office at hospitals to apply to be considered part
(410) 786–1326. of neighboring geographic areas for
SUMMARY: The Centers for Medicare & payment purposes based on certain
FOR FURTHER INFORMATION CONTACT:
Medicaid Services (CMS) is announcing criteria. The application and decision
Reports Clearance Office at (410) 786–
an opportunity for the public to process is administered by the MGCRB
1326.
comment on CMS’ intention to collect which is not a part of CMS so that CMS
information from the public. Under the SUPPLEMENTARY INFORMATION: could not be accused of any untoward
Paperwork Reduction Act of 1995 (the Contents action. However, CMS needs to remain
PRA), federal agencies are required to apprised of any potential payment
publish notice in the Federal Register This notice sets out a summary of the changes. Hospitals are required to
concerning each proposed collection of use and burden associated with the provide CMS with copy of any
asabaliauskas on DSK3SPTVN1PROD with NOTICES
information (including each proposed following information collections. More applications that they made to the
extension or reinstatement of an existing detailed information can be found in MGCRB. CMS also developed the
collection of information) and to allow each collection’s supporting statement guidelines for the MGCRB that were the
60 days for public comment on the and associated materials (see interim final issue of the Federal
proposed action. Interested persons are ADDRESSES). Register, and must ensure that the
invited to send comments regarding our CMS–R–138 Medicare Geographic MGCRB properly applied the
burden estimates or any other aspect of Classification Review Board guidelines. This check and balance
this collection of information, including Procedures and Criteria process also contributes to limiting the
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![70118 Federal Register / Vol. 81, No. 196 / Tuesday, October 11, 2016 / Notices
number of hospitals that ultimately ‘‘Sunscreen Innovation Act: Section • If you want to submit a comment
need to appeal their MGCRB decisions 586C(c) Advisory Committee Process.’’ with confidential information that you
to the CMS Administrator. Form This guidance explains the process by do not wish to be made available to the
Number: CMS–R–138 (OMB control which FDA intends to carry out the public, submit the comment as a
number: 0938–0573); Frequency: section of the Federal Food, Drug, and written/paper submission and in the
Occasionally; Affected Public: Cosmetic Act (the FD&C Act), as manner detailed (see ‘‘Written/Paper
Businesses or other for-profits and Not- amended by the Sunscreen Innovation Submissions’’ and ‘‘Instructions’’).
for-profit institutions; Number of Act (SIA), which governs the convening Written/Paper Submissions
Respondents: 300; Total Annual of advisory committees to provide
Responses: 300; Total Annual Hours: recommendations on requests submitted Submit written/paper submissions as
300. (For policy questions regarding this under the SIA regarding follows:
collection contact Noel Manlove at 410– nonprescription sunscreen active • Mail/Hand delivery/Courier (for
786–5161.) ingredients and the number of requests written/paper submissions): Division of
2. Type of Information Collection to be considered per meeting. The Dockets Management (HFA–305), Food
Request: Reinstatement of a previously recommendations in this guidance and Drug Administration, 5630 Fishers
approved collection; Title of apply to 586A requests submitted under Lane, Rm. 1061, Rockville, MD 20852.
Information Collection: Notification of • For written/paper comments
the FD&C Act and to pending requests
FIs and CMS of co-located Medicare submitted to the Division of Dockets
as defined by the SIA that seek a
providers; Use: Many long-term care Management, FDA will post your
determination from FDA on whether a
hospitals (LTCHs) are co-located with comment, as well as any attachments,
nonprescription sunscreen active
other Medicare providers (acute care except for information submitted,
ingredient, or a combination of
hospitals, IRFs, SNFs, psychiatric marked and identified, as confidential,
nonprescription sunscreen active
facilities), which leads to potential if submitted as detailed in
ingredients, is generally recognized as
gaming of the Medicare system based on ‘‘Instructions.’’
safe and effective (GRASE) for use under Instructions: All submissions received
patient shifting. In regulations at 42 CFR specified conditions and should be
412.22(e)(3) and (h)(6) and 412.532(i), must include the Docket No. FDA–
included in the over-the-counter (OTC) 2015–D–3990 for ‘‘Sunscreen
CMS is requiring LTCHs to notify sunscreen drug monograph. The SIA
Medicare Administrative Contractors Innovation Act: Section 586C(c)
describes specific circumstances under Advisory Committee Process.’’ Received
(MACs) and CMS of co-located which FDA is not required to convene
providers in order to establish policies comments will be placed in the docket
or submit requests to the and, except for those submitted as
to limit payment abuse that will be Nonprescription Drugs Advisory
based on FIs tracking patient movement ‘‘Confidential Submissions,’’ publicly
Committee (NDAC). We are issuing this viewable at http://www.regulations.gov
among these co-located providers. Form guidance pursuant to the SIA, which
Number: CMS–10088 (OMB control or at the Division of Dockets
directs FDA to issue guidance on four Management between 9 a.m. and 4 p.m.,
number: 0938–0897); Frequency: topics, including the topic discussed in
Annually; Affected Public: Businesses Monday through Friday.
this guidance. This guidance finalizes • Confidential Submissions—To
or other for-profits and Not-for-profit the draft guidance on the same topic submit a comment with confidential
institutions; Number of Respondents: issued on November 23, 2015. information that you do not wish to be
25; Total Annual Responses: 25; Total
DATES: Submit either electronic or made publicly available, submit your
Annual Hours: 6. (For policy questions
written comments on Agency guidances comments only as a written/paper
regarding this collection contact Emily
at any time. submission. You should submit two
Lipkin at 410–786–3633.)
ADDRESSES: You may submit comments copies total. One copy will include the
Dated: October 4, 2016. as follows: information you claim to be confidential
William N. Parham, III, with a heading or cover note that states
Director, Paperwork Reduction Staff, Office Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
of Strategic Operations and Regulatory Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
Affairs. following way: Agency will review this copy, including
[FR Doc. 2016–24415 Filed 10–7–16; 8:45 am] • Federal eRulemaking Portal: http:// the claimed confidential information, in
BILLING CODE 4120–01–P www.regulations.gov. Follow the its consideration of comments. The
instructions for submitting comments. second copy, which will have the
Comments submitted electronically, claimed confidential information
DEPARTMENT OF HEALTH AND including attachments, to http:// redacted/blacked out, will be available
HUMAN SERVICES www.regulations.gov will be posted to for public viewing and posted on http://
the docket unchanged. Because your www.regulations.gov. Submit both
Food and Drug Administration
comment will be made public, you are copies to the Division of Dockets
[Docket No. FDA–2015–D–3990] solely responsible for ensuring that your Management. If you do not wish your
comment does not include any name and contact information to be
Sunscreen Innovation Act: Section confidential information that you or a made publicly available, you can
586C(c) Advisory Committee Process; third party may not wish to be posted, provide this information on the cover
Guidance for Industry; Availability such as medical information, your or sheet and not in the body of your
asabaliauskas on DSK3SPTVN1PROD with NOTICES
AGENCY: Food and Drug Administration, anyone else’s Social Security number, or comments and you must identify this
HHS. confidential business information, such information as ‘‘confidential.’’ Any
ACTION: Notice of availability. as a manufacturing process. Please note information marked as ‘‘confidential’’
that if you include your name, contact will not be disclosed except in
SUMMARY: The Food and Drug information, or other information that accordance with 21 CFR 10.20 and other
Administration (FDA or Agency) is identifies you in the body of your applicable disclosure law. For more
announcing the availability of a comments, that information will be information about FDA’s posting of
guidance for industry entitled posted on http://www.regulations.gov. comments to public dockets, see 80 FR
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Document Created: 2018-02-13 16:33:37
Document Modified: 2018-02-13 16:33:37
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments must be received by December 12, 2016. | |
| Contact | Reports Clearance Office at (410) 786- 1326. | |
| FR Citation | 81 FR 70117 |
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