81 FR 30309 - Agency Information Collection Activities: Submission for OMB Review; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 81, Issue 94 (May 16, 2016)
Centers for Medicare & Medicaid Services
Federal Register Volume 81, Issue 94 (May 16, 2016)
| Page Range | 30309-30310 | |
| FR Document | 2016-11500 |
[Federal Register Volume 81, Number 94 (Monday, May 16, 2016)] [Notices] [Pages 30309-30310] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-11500] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10409] 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 a 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 June 15, 2016: 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: [email protected]. 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: 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: Extension of a currently approved collection; Title of Information Collection: Long Term Care Hospital (LCTH) Continuity Assessment Record and Evaluation (CARE) Data Set; Use: Section 3004 of the Affordable Care Act authorized the establishment of quality reporting program for long term care hospitals (LTCHs). Beginning in FY 2014, LTCHs that fail to submit quality measure data may be subject to a 2 percentage point reduction in their annual update to the standard Federal rate for discharges occurring during a rate year. The LTCH CARE Data Set was developed specifically for use in LTCHs for data collection of NQF #0678 Pressure Ulcer measures beginning [[Page 30310]] October 1, 2012, with the understanding that the data set would expand in future rulemaking years with the adoption of additional quality measures. Relevant data elements contained in other well-known and clinically established data sets, including but not limited to the Minimum Data Set 3.0 (MDS 3.0) and CARE, were incorporated into the LTCH CARE Data Set V1.01, V2.00 and V2.01. LTCH CARE Data Set V3.00 will be implemented April 1, 2016. Form Number: CMS-10409 (OMB control number: 0938-1163); Frequency: Occasionally; Affected Public: Private Sector: Business or other for-profit and not-for-profit institutions; Number of Respondents: 424; Total Annual Responses: 405,344; Total Annual Hours: 328,346. (For policy questions regarding this collection contact Staci Payne at 410-786-2838.) Dated: May 11, 2016. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2016-11500 Filed 5-13-16; 8:45 am] BILLING CODE 4120-01-P
![Federal Register / Vol. 81, No. 94 / Monday, May 16, 2016 / Notices 30309
person requesting the Protected Health 0938–1214); Frequency: Annually; the OMB desk officer via one of the
Information (PHI) and the person’s Affected Public: Private sector following transmissions: OMB, Office of
authority to have access to Medicare (Businesses or other for-profits); Information and Regulatory Affairs,
eligibility information. Furthermore, Number of Respondents: 575; Total Attention: CMS Desk Officer, Fax
CMS requires that trading partners who Annual Responses: 575; Total Annual Number: (202) 395–5806 OR, Email:
wish to conduct eligibility transactions Hours: 13,200. (For policy questions OIRA_submission@omb.eop.gov.
on a real-time basis with CMS provide regarding this collection contact Pat To obtain copies of a supporting
certain assurances as a condition of Meisol at 410–786–1917.) statement and any related forms for the
receiving access to the Medicare Dated: May 11, 2016. proposed collection(s) summarized in
eligibility information for the purpose of this notice, you may make your request
William N. Parham, III,
conducting real-time 270/271 inquiry/ using one of following:
response transactions. Form Number: Director, Paperwork Reduction Staff, Office 1. Access CMS’ Web site address at
of Strategic Operations and Regulatory
CMS–10157 (OMB control number: Affairs.
http://www.cms.hhs.gov/
0938–0960); Frequency: Quarterly; PaperworkReductionActof1995.
[FR Doc. 2016–11499 Filed 5–13–16; 8:45 am]
Affected Public: Private sector (Business 2. Email your request, including your
BILLING CODE 4120–01–P
or other For-profits and Not-For-Profits); address, phone number, OMB number,
Number of Respondents: 2,000; Total and CMS document identifier, to
Annual Responses: 2,000; Total Annual Paperwork@cms.hhs.gov.
DEPARTMENT OF HEALTH AND 3. Call the Reports Clearance Office at
Hours: 250. (For policy questions
HUMAN SERVICES (410) 786–1326.
regarding this collection contact
Rupinder Singh at 410–786–7484). Centers for Medicare & Medicaid FOR FURTHER INFORMATION CONTACT:
3. Type of Information Collection Services Reports Clearance Office at (410) 786–
Request: Extension of a currently 1326.
approved collection; Title of [Document Identifier: CMS–10409]
Information Collection: Issuer Reporting SUPPLEMENTARY INFORMATION: Under the
Requirements for Selecting a Cost- Agency Information Collection Paperwork Reduction Act of 1995 (PRA)
Sharing Reductions Reconciliation Activities: Submission for OMB (44 U.S.C. 3501–3520), federal agencies
Methodology; Use: Sections 1402 and Review; Comment Request must obtain approval from the Office of
1412 of the Affordable Care Act provide Management and Budget (OMB) for each
ACTION: Notice. collection of information they conduct
for reductions in cost sharing on
essential health benefits for low- and or sponsor. The term ‘‘collection of
SUMMARY: The Centers for Medicare & information’’ is defined in 44 U.S.C.
moderate-income enrollees in silver Medicaid Services (CMS) is announcing
level qualified health plans (QHP) on 3502(3) and 5 CFR 1320.3(c) and
an opportunity for the public to includes agency requests or
individual market Exchanges. It also comment on CMS’ intention to collect
provides for reductions in cost sharing requirements that members of the public
information from the public. Under the submit reports, keep records, or provide
for Indians enrolled in QHPs at any Paperwork Reduction Act of 1995
metal level. These cost-sharing information to a third party. Section
(PRA), federal agencies are required to 3506(c)(2)(A) of the PRA (44 U.S.C.
reductions will help eligible individuals publish a notice in the Federal Register
and families afford the out-of-pocket 3506(c)(2)(A)) requires federal agencies
concerning each proposed collection of to publish a 30-day notice in the
spending associated with health care information, including each proposed
services provided through Exchange- Federal Register concerning each
extension or reinstatement of an existing proposed collection of information,
based QHP coverage. collection of information, and to allow
The law directs QHP issuers to notify including each proposed extension or
a second opportunity for public reinstatement of an existing collection
the Secretary of the Department of comment on the notice. Interested
Health and Human Services (HHS) of of information, before submitting the
persons are invited to send comments collection to OMB for approval. To
cost-sharing reductions made under the regarding the burden estimate or any
statute for qualified individuals, and comply with this requirement, CMS is
other aspect of this collection of publishing this notice that summarizes
directs the Secretary to make periodic information, including any of the
and timely payments to the QHP issuer the following proposed collection(s) of
following subjects: (1) The necessity and information for public comment:
equal to the value of those reductions.
utility of the proposed information 1. Type of Information Collection
Further, the law permits advance
collection for the proper performance of Request: Extension of a currently
payment of the cost-sharing reduction
the agency’s functions; (2) the accuracy approved collection; Title of
amounts to QHP issuers based upon
of the estimated burden; (3) ways to Information Collection: Long Term Care
amounts specified by the Secretary.
Under established HHS regulations, enhance the quality, utility, and clarity Hospital (LCTH) Continuity Assessment
QHP issuers will receive advance of the information to be collected; and Record and Evaluation (CARE) Data Set;
payments of the cost-sharing reductions (4) the use of automated collection Use: Section 3004 of the Affordable Care
throughout the year. Each issuer will techniques or other forms of information Act authorized the establishment of
then be subject to one of two technology to minimize the information quality reporting program for long term
reconciliation processes after the year to collection burden. care hospitals (LTCHs). Beginning in FY
ensure that HHS reimbursed each issuer DATES: Comments on the collection(s) of 2014, LTCHs that fail to submit quality
asabaliauskas on DSK3SPTVN1PROD with NOTICES
the correct advance cost-sharing information must be received by the measure data may be subject to a 2
amount. This information collection OMB desk officer by June 15, 2016: percentage point reduction in their
request establishes the data collection ADDRESSES: When commenting on the annual update to the standard Federal
requirements for a QHP issuer to report proposed information collections, rate for discharges occurring during a
to HHS which reconciliation reporting please reference the document identifier rate year. The LTCH CARE Data Set was
option the issuer will be subject to for or OMB control number. To be assured developed specifically for use in LTCHs
a given benefit year. Form Number: consideration, comments and for data collection of NQF #0678
CMS–10469 (OMB control number: recommendations must be received by Pressure Ulcer measures beginning
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![30310 Federal Register / Vol. 81, No. 94 / Monday, May 16, 2016 / Notices
October 1, 2012, with the understanding nonclinical biomarker qualification that 2011–D–0872 for ‘‘Considerations for
that the data set would expand in future justify the proposed context of use, Use of Histopathology and Its
rulemaking years with the adoption of where scientifically rigorous evaluation Associated Methodologies to Support
additional quality measures. Relevant of biomarker performance in relation to Biomarker Qualification; Guidance for
data elements contained in other well- histopathologic changes is essential. Industry; Availability.’’ Received
known and clinically established data The principles outlined in this guidance comments will be placed in the docket
sets, including but not limited to the are also applicable to exploratory and, except for those submitted as
Minimum Data Set 3.0 (MDS 3.0) and nonclinical biomarker studies. This ‘‘Confidential Submissions,’’ publicly
CARE, were incorporated into the LTCH guidance finalizes the draft guidance viewable at http://www.regulations.gov
CARE Data Set V1.01, V2.00 and V2.01. ‘‘Use of Histology in Biomarker or at the Division of Dockets
LTCH CARE Data Set V3.00 will be Qualification Studies,’’ issued in Management between 9 a.m. and 4 p.m.,
implemented April 1, 2016. Form December 2011. Monday through Friday.
Number: CMS–10409 (OMB control DATES: Submit either electronic or
• Confidential Submissions—To
number: 0938–1163); Frequency: written comments on Agency guidances submit a comment with confidential
Occasionally; Affected Public: Private at any time. information that you do not wish to be
Sector: Business or other for-profit and made publicly available, submit your
ADDRESSES: You may submit comments comments only as a written/paper
not-for-profit institutions; Number of
Respondents: 424; Total Annual as follows: submission. You should submit two
Responses: 405,344; Total Annual Electronic Submissions copies total. One copy will include the
Hours: 328,346. (For policy questions information you claim to be confidential
Submit electronic comments in the with a heading or cover note that states
regarding this collection contact Staci
following way: ‘‘THIS DOCUMENT CONTAINS
Payne at 410–786–2838.)
• Federal eRulemaking Portal: http:// CONFIDENTIAL INFORMATION.’’ The
Dated: May 11, 2016. www.regulations.gov. Follow the Agency will review this copy, including
William N. Parham, III, instructions for submitting comments. the claimed confidential information, in
Director, Paperwork Reduction Staff, Office Comments submitted electronically, its consideration of comments. The
of Strategic Operations and Regulatory including attachments, to http://
Affairs. second copy, which will have the
www.regulations.gov will be posted to claimed confidential information
[FR Doc. 2016–11500 Filed 5–13–16; 8:45 am] the docket unchanged. Because your redacted/blacked out, will be available
BILLING CODE 4120–01–P comment will be made public, you are for public viewing and posted on http://
solely responsible for ensuring that your www.regulations.gov. Submit both
comment does not include any copies to the Division of Dockets
DEPARTMENT OF HEALTH AND confidential information that you or a
HUMAN SERVICES Management. If you do not wish your
third party may not wish to be posted, name and contact information to be
such as medical information, your or made publicly available, you can
Food and Drug Administration
anyone else’s Social Security number, or provide this information on the cover
[Docket No. FDA–2011–D–0872] confidential business information, such sheet and not in the body of your
as a manufacturing process. Please note comments and you must identify this
Considerations for Use of that if you include your name, contact
Histopathology and Its Associated information as ‘‘confidential.’’ Any
information, or other information that information marked as ‘‘confidential’’
Methodologies To Support Biomarker identifies you in the body of your
Qualification; Guidance for Industry; will not be disclosed except in
comments, that information will be accordance with 21 CFR 10.20 and other
Availability posted on http://www.regulations.gov. applicable disclosure law. For more
AGENCY: Food and Drug Administration, • If you want to submit a comment information about FDA’s posting of
HHS. with confidential information that you comments to public dockets, see 80 FR
ACTION: Notice of availability. do not wish to be made available to the 56469, September 18, 2015, or access
public, submit the comment as a the information at: http://www.fda.gov/
SUMMARY: The Food and Drug written/paper submission and in the regulatoryinformation/dockets/
Administration (FDA) is announcing the manner detailed (see ‘‘Written/Paper default.htm.
availability of a guidance for industry Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to
entitled ‘‘Considerations for Use of read background documents or the
Histopathology and Its Associated Written/Paper Submissions
electronic and written/paper comments
Methodologies to Support Biomarker Submit written/paper submissions as received, go to http://
Qualification.’’ This guidance is follows: www.regulations.gov and insert the
intended to assist submitters of a • Mail/Hand delivery/Courier (for docket number, found in brackets in the
biomarker for qualification that conduct written/paper submissions): Division of heading of this document, into the
nonclinical biomarker qualification Dockets Management (HFA–305), Food ‘‘Search’’ box and follow the prompts
studies in which histopathology is used and Drug Administration, 5630 Fishers and/or go to the Division of Dockets
as a reference or truth standard. This Lane, Rm. 1061, Rockville, MD 20852. Management, 5630 Fishers Lane, Rm.
guidance discusses the processes that • For written/paper comments 1061, Rockville, MD 20852.
we recommend be considered when submitted to the Division of Dockets Submit written requests for single
asabaliauskas on DSK3SPTVN1PROD with NOTICES
generating histopathology data to be Management, FDA will post your copies of this guidance to the Division
included in biomarker studies and comment, as well as any attachments, of Drug Information, Center for Drug
outlines the scientific standards except for information submitted, Evaluation and Research, Food and
recommended for histopathology used marked and identified, as confidential, Drug Administration, 10001 New
in nonclinical biomarker if submitted as detailed in Hampshire Ave., Hillandale Building,
characterization and qualification. The ‘‘Instructions.’’ 4th Floor, Silver Spring, MD 20993–
recommendations in this guidance are Instructions: All submissions received 0002. Send one self-addressed adhesive
intended for confirmatory studies in must include the Docket No. FDA– label to assist that office in processing
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Document Created: 2016-05-14 01:17:38
Document Modified: 2016-05-14 01:17:38
| 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 on the collection(s) of information must be received by the OMB desk officer by June 15, 2016: | |
| Contact | Reports Clearance Office at (410) 786- 1326. | |
| FR Citation | 81 FR 30309 |
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