80 FR 35365 - Agency Information Collection Activities: Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 80, Issue 118 (June 19, 2015)
Centers for Medicare & Medicaid Services
Federal Register Volume 80, Issue 118 (June 19, 2015)
| Page Range | 35365-35366 | |
| FR Document | 2015-15126 |
[Federal Register Volume 80, Number 118 (Friday, June 19, 2015)] [Notices] [Pages 35365-35366] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-15126] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-643] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Centers for Medicare & Medicaid Services, HHS. 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: The necessity and utility of the proposed information collection for the proper performance of the agency's functions; the accuracy of the estimated burden; ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden. DATES: Comments must be received by August 18, 2015. 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. [[Page 35366]] 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 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-643 Hospice Survey and Deficiencies Report Form and Supporting Regulations 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 without change of a currently approved collection; Title of Information Collection: Hospice Survey and Deficiencies Report Form and Supporting Regulations; Use: We use the information collected as the basis for certification decisions for hospices that wish to obtain or retain participation in the Medicare and Medicaid programs. The information is used by CMS regional offices, which have the delegated authority to certify Medicare facilities for participation, and by State Medicaid agencies, which have comparable authority under Medicaid. The information on the Hospice Survey and Deficiencies Report Form is coded for entry into the OSCAR system. The data is analyzed by the CMS regional offices and by the CMS central office components for program evaluation and monitoring purposes. The information is also available to the public upon request. Form Number: CMS-643 (OMB control number: 0938-0379); Frequency: Yearly; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 3,976; Total Annual Responses: 1,325; Total Annual Hours: 1,325. (For policy questions regarding this collection contact Annette Snyder at 410-786-0807.) Dated: June 16, 2015. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2015-15126 Filed 6-18-15; 8:45 am] BILLING CODE 4120-01-P
![Federal Register / Vol. 80, No. 118 / Friday, June 19, 2015 / Notices 35365
Oncology Care Model (OCM) beginning participate in the testing of OCM must DEPARTMENT OF HEALTH AND
in 2016. The new deadline for receipt of submit non-binding letters of intent HUMAN SERVICES
online applications from payers and (LOIs) by March 19, 2015 and April 23,
practices is 5:00 p.m. Eastern Daylight 2015, respectively; and that all Centers for Medicare & Medicaid
Time (EDT) on June 30, 2015. Only applications from payers and practices Services
those payers and practices that must be received by 5:00 p.m. EDT on
[Document Identifier: CMS–643]
submitted timely, complete Letters of June 18, 2015. We subsequently
Intent (LOIs) are eligible to apply to extended the deadlines for the Agency Information Collection
participate in OCM, and only the submission of LOIs to April 9, 2015 Activities: Proposed Collection;
submission of web-based applications (payers) and May 7, 2015 (practices), as Comment Request
will be accepted. announced on the Innovation Center
DATES: Application Submission Web site at (http://innovation.cms.gov/ AGENCY: Centers for Medicare &
Deadline: Applications for payers and initiatives/Oncology-Care/), in updates Medicaid Services, HHS.
practices must be received by 5:00 p.m. to the RFA and related informational ACTION: Notice.
Eastern Daylight Time (EDT) on June 30, materials, and in emails to stakeholders.
2015. Application materials and SUMMARY: The Centers for Medicare &
II. Provisions of the Notice Medicaid Services (CMS) is announcing
instructions are available at http://
innovation.cms.gov/initiatives/ Since the publication of the February an opportunity for the public to
Oncology-Care/. 17, 2015 notice, several stakeholders comment on CMS’ intention to collect
have requested additional time to information from the public. Under the
FOR FURTHER INFORMATION CONTACT:
prepare their applications and form Paperwork Reduction Act of 1995 (the
OncologyCareModel@cms.hhs.gov for
partnerships in order to participate in PRA), federal agencies are required to
questions regarding the application
the OCM beginning in 2016. Therefore, publish notice in the Federal Register
process of OCM.
the Innovation Center is extending the concerning each proposed collection of
SUPPLEMENTARY INFORMATION: information (including each proposed
deadline for receipt of payer and
I. Background practice applications from June 18, 2015 extension or reinstatement of an existing
at 5:00 p.m. Eastern Daylight Time collection of information) and to allow
The Oncology Care Model (OCM)
(EDT) to June 30, 2015 at 5:00 p.m. EDT. 60 days for public comment on the
aims to improve health outcomes for
Only those payers and practices that proposed action. Interested persons are
people with cancer, improve the quality
submitted timely, complete LOIs are invited to send comments regarding our
of cancer care, and reduce spending for
eligible to apply to participate in OCM, burden estimates or any other aspect of
cancer treatment. We expect that
and only the submission of web-based this collection of information, including
physician practices selected for
applications will be accepted. The any of the following subjects: The
participation in the model will be able
extended application deadline has necessity and utility of the proposed
to transform care delivery for their
already been announced on the information collection for the proper
patients undergoing chemotherapy,
Innovation Center Web site at (http:// performance of the agency’s functions;
leading to improved quality of care for
innovation.cms.gov/initiatives/ the accuracy of the estimated burden;
beneficiaries at a decreased cost to
Oncology-Care/), in updates to the RFA ways to enhance the quality, utility, and
payers. Through this care
and related informational materials, and clarity of the information to be
transformation, practices participating
in emails to stakeholders. collected; and the use of automated
in OCM can reduce Medicare
collection techniques or other forms of
expenditures while improving cancer In the DATES section of this notice, we information technology to minimize the
care for Medicare Fee-for-Service are including the new submission information collection burden.
beneficiaries. Beneficiaries can deadline. For additional information on
experience improved health outcomes DATES: Comments must be received by
the OCM and how to apply, we refer
when health care providers work in a readers to click on the RFA and related August 18, 2015.
coordinated and person-centered informational materials located on the ADDRESSES: When commenting, please
manner. We are interested in partnering Innovation Center Web site at http:// reference the document identifier or
with payers and practitioners who are innovation.cms.gov/initiatives/ OMB control number. To be assured
working to redesign care to deliver these Oncology-Care/. consideration, comments and
aims. recommendations must be submitted in
The Request for Applications (RFA) III. Collection of Information any one of the following ways:
requests applications to test the model, Requirements 1. Electronically. You may send your
which is centered around a This document does not impose comments electronically to http://
chemotherapy episode of care. For more information collection requirements, www.regulations.gov. Follow the
details, see the RFA and related that is, reporting, recordkeeping or instructions for ‘‘Comment or
informational materials available on the third-party disclosure requirement. Submission’’ or ‘‘More Search Options’’
Center for Medicare and Medicaid Consequently, there is no need for to find the information collection
Innovation (Innovation Center) Web site review by the Office of Management and document(s) that are accepting
at http://innovation.cms.gov/initiatives/ Budget under the authority of the comments.
Oncology-Care/. 2. By regular mail. You may mail
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Paperwork Reduction Act of 1995 (44
On February 17, 2015, we published U.S.C. Chapter 35). written comments to the following
a notice in the Federal Register address: CMS, Office of Strategic
announcing the RFA for payers and Dated: June 12, 2015. Operations and Regulatory Affairs,
practices to apply to participate in the Andrew M. Slavitt, Division of Regulations Development,
testing of OCM for a 5-year performance Acting Administrator, Centers for Medicare Attention: Document Identifier/OMB
period beginning in 2016 (80 FR 8323). & Medicaid Services. Control Number llll Room C4–26–
In that notice, we stated that payers and [FR Doc. 2015–15129 Filed 6–18–15; 8:45 am] 05, 7500 Security Boulevard, Baltimore,
practices interested in applying to BILLING CODE 4120–01–P Maryland 21244–1850.
VerDate Sep<11>2014 19:33 Jun 18, 2015 Jkt 235001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 E:\FR\FM\19JNN1.SGM 19JNN1](https://thefederalregister.org/doc/80_FR_35483/page/1.svg)
![35366 Federal Register / Vol. 80, No. 118 / Friday, June 19, 2015 / Notices
To obtain copies of a supporting facilities for participation, and by State 0002. Send one self-addressed adhesive
statement and any related forms for the Medicaid agencies, which have label to assist that office in processing
proposed collection(s) summarized in comparable authority under Medicaid. your requests. See the SUPPLEMENTARY
this notice, you may make your request The information on the Hospice Survey INFORMATION section for electronic
using one of following: and Deficiencies Report Form is coded access to the guidance document.
1. Access CMS’ Web site address at for entry into the OSCAR system. The Submit electronic comments on the
http://www.cms.hhs.gov/ data is analyzed by the CMS regional guidance to http://www.regulations.gov.
PaperworkReductionActof1995. offices and by the CMS central office Submit written comments to the
2. Email your request, including your components for program evaluation and Division of Dockets Management (HFA–
address, phone number, OMB number, monitoring purposes. The information is 305), Food and Drug Administration,
and CMS document identifier, to also available to the public upon 5630 Fishers Lane, Rm. 1061, Rockville,
Paperwork@cms.hhs.gov. request. Form Number: CMS–643 (OMB MD 20852.
3. Call the Reports Clearance Office at control number: 0938–0379); Frequency: FOR FURTHER INFORMATION CONTACT:
(410) 786–1326. Yearly; Affected Public: State, Local, or Debra Catterson, Center for Drug
FOR FURTHER INFORMATION CONTACT: Tribal Governments; Number of Evaluation and Research, Food and
Reports Clearance Office at (410) 786– Respondents: 3,976; Total Annual Drug Administration, 10903 New
1326. Responses: 1,325; Total Annual Hours: Hampshire Ave., Silver Spring, MD
1,325. (For policy questions regarding 20993–0002, 240–402–3861; or Vilayat
SUPPLEMENTARY INFORMATION:
this collection contact Annette Snyder Sayeed, Center for Drug Evaluation and
Contents at 410–786–0807.) Research, Food and Drug
This notice sets out a summary of the Dated: June 16, 2015. Administration, 10903 New Hampshire
use and burden associated with the William N. Parham, III, Ave., Silver Spring, MD 20993–0002,
following information collections. More Director, Paperwork Reduction Staff, Office 240–402–9077.
detailed information can be found in of Strategic Operations and Regulatory SUPPLEMENTARY INFORMATION:
each collection’s supporting statement Affairs.
I. Background
and associated materials (see [FR Doc. 2015–15126 Filed 6–18–15; 8:45 am]
ADDRESSES). BILLING CODE 4120–01–P FDA is announcing the availability of
a guidance for industry entitled ‘‘Size,
CMS–643 Hospice Survey and Shape, and Other Physical Attributes of
Deficiencies Report Form and DEPARTMENT OF HEALTH AND Generic Tablets and Capsules.’’ FDA is
Supporting Regulations HUMAN SERVICES concerned that the differences in size,
Under the PRA (44 U.S.C. 3501– shape, and other physical characteristics
3520), federal agencies must obtain Food and Drug Administration between a generic drug and the
approval from the Office of Management [Docket No. FDA–2013–N–1434] originator drug may affect patient
and Budget (OMB) for each collection of compliance and acceptability of
information they conduct or sponsor. Size, Shape, and Other Physical medication regimens or could lead to
The term ‘‘collection of information’’ is Attributes of Generic Tablets and medication errors. For example, studies
defined in 44 U.S.C. 3502(3) and 5 CFR Capsules; Guidance for Industry; show that tablet size and shape can
1320.3(c) and includes agency requests Availability affect ease of swallowing; generic tablets
or requirements that members of the that are significantly larger than their
public submit reports, keep records, or AGENCY: Food and Drug Administration, corresponding reference drug product
provide information to a third party. HHS. may be more difficult to swallow,
Section 3506(c)(2)(A) of the PRA ACTION: Notice. leading to potential adverse events as
requires federal agencies to publish a well as noncompliance with treatment
SUMMARY: The Food and Drug regimens. FDA is recommending that
60-day notice in the Federal Register
Administration (FDA) is announcing the generic manufacturers consider the size,
concerning each proposed collection of
availability of a guidance for industry shape, and other physical characteristics
information, including each proposed
entitled ‘‘Size, Shape, and Other of the originator drug when developing
extension or reinstatement of an existing
Physical Attributes of Generic Tablets a generic version.
collection of information, before
and Capsules.’’ This guidance discusses In the Federal Register of December
submitting the collection to OMB for
FDA recommendations for the size, 10, 2013 (78 FR 74154), this guidance
approval. To comply with this
shape, and other physical attributes of was published as a draft guidance. We
requirement, CMS is publishing this
generic tablets and capsules intended to have carefully reviewed and considered
notice.
be swallowed intact. FDA is concerned the comments that were received on the
Information Collection that differences in these physical draft guidance and have made editorial
1. Type of Information Collection characteristics between generic drugs changes primarily for clarification.
Request: Extension without change of a and the originator drug could affect This guidance is being issued
currently approved collection; Title of patient outcomes. consistent with FDA’s good guidance
Information Collection: Hospice Survey DATES: Submit either electronic or practices regulation (21 CFR 10.115).
and Deficiencies Report Form and written comments on Agency guidances The guidance represents the Agency’s
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Supporting Regulations; Use: We use at any time. current thinking on the size, shape, and
the information collected as the basis for ADDRESSES: Submit written requests for other physical attributes of generic
certification decisions for hospices that single copies of this guidance to the tablets and capsules. It does not
wish to obtain or retain participation in Division of Drug Information, Center for establish any rights for any person and
the Medicare and Medicaid programs. Drug Evaluation and Research, Food is not binding on FDA or the public.
The information is used by CMS and Drug Administration, 10001 New You can use an alternative approach if
regional offices, which have the Hampshire Ave., Hillandale Building, it satisfies the requirements of the
delegated authority to certify Medicare 4th Floor, Silver Spring, MD 20993– applicable statutes and regulations.
VerDate Sep<11>2014 19:33 Jun 18, 2015 Jkt 235001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 E:\FR\FM\19JNN1.SGM 19JNN1](https://thefederalregister.org/doc/80_FR_35483/page/2.svg)
Document Created: 2018-02-22 11:10:04
Document Modified: 2018-02-22 11:10:04
| 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 August 18, 2015. | |
| Contact | Reports Clearance Office at (410) 786- 1326. | |
| FR Citation | 80 FR 35365 |
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR