81 FR 90360 - Agency Information Collection Activities: Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 81, Issue 240 (December 14, 2016)
Centers for Medicare & Medicaid Services
Federal Register Volume 81, Issue 240 (December 14, 2016)
| Page Range | 90360-90361 | |
| FR Document | 2016-30024 |
[Federal Register Volume 81, Number 240 (Wednesday, December 14, 2016)] [Notices] [Pages 90360-90361] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-30024] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier CMS-10266 and CMS-R-71] 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: (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 February 13, 2017. 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-10266 Conditions of Participation: Requirements for Approval and Reapproval of Transplant Centers to Perform Organ Transplants CMS-R-71 Quality Improvement Organization (QIO) Assumption of Responsibilities 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 of a previously approved collection; Title of Information Collection: Conditions of Participation: Requirements for Approval and Reapproval of Transplant Centers to Perform Organ Transplants; Use: The Conditions of Participation and accompanying requirements specified in the regulations are used by our surveyors as a basis for determining whether a transplant center qualifies for approval or re-approval under Medicare. We, along with the healthcare industry, believe that the availability to the facility of the type of records and general content of records is standard medical practice and is necessary in order to ensure the well-being and safety of patients and professional treatment accountability. Form Number: CMS-10266 (OMB Control Number: 0938-1069); Frequency: Yearly; Affected Public: Business or other for-profits and Not-for-profit institutions; Number of Respondents: 226; Total Annual Responses: 528; Total Annual Hours: 2,523. (For policy questions regarding this collection contact Diane Corning at 410-786-8486.) 2. Type of Information Collection Request: Extension of a previously approved collection; Title of Information Collection: Quality Improvement Organization (QIO) Assumption of Responsibilities and Supporting Regulations; Use: The Peer [[Page 90361]] Review Improvement Act of 1982 amended Title XI of the Social Security Act to create the Utilization and Quality Control Peer Review Organization (PRO) program which replaces the Professional Standards Review Organization (PSRO) program and streamlines peer review activities. The term PRO has been renamed Quality Improvement Organization (QIO). This information collection describes the review functions to be performed by the QIO. It outlines relationships among QIOs, providers, practitioners, beneficiaries, intermediaries, and carriers. Form Number: CMS-R-71 (OMB Control Number: 0938-0445); Frequency: Yearly; Affected Public: Private sector--Business or other for-profit and Not-for-profit institutions; Number of Respondents: 6,939; Total Annual Responses: 44,015; Total Annual Hours: 100,065. (For policy questions regarding this collection contact Tennille Coombs at 410-786-3472.) Dated: December 9, 2016. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2016-30024 Filed 12-13-16; 8:45 am] BILLING CODE 4120-01-P
![90360 Federal Register / Vol. 81, No. 240 / Wednesday, December 14, 2016 / Notices
Commission by courier or overnight burden estimates or any other aspect of Approval and Reapproval of
service. this collection of information, including Transplant Centers to Perform Organ
Comments on the disclosure any of the following subjects: (1) The Transplants
requirements subject to review under necessity and utility of the proposed CMS–R–71 Quality Improvement
the PRA should additionally be information collection for the proper Organization (QIO) Assumption of
submitted to OMB. If sent by U.S. mail, performance of the agency’s functions; Responsibilities and Supporting
they should be addressed to Office of (2) the accuracy of the estimated Regulations
Information and Regulatory Affairs, burden; (3) ways to enhance the quality, Under the PRA (44 U.S.C. 3501–
Office of Management and Budget, utility, and clarity of the information to 3520), federal agencies must obtain
Attention: Desk Officer for the Federal be collected; and (4) the use of approval from the Office of Management
Trade Commission, New Executive automated collection techniques or and Budget (OMB) for each collection of
Office Building, Docket Library, Room other forms of information technology to
information they conduct or sponsor.
10102, 725 17th Street NW., minimize the information collection
The term ‘‘collection of information’’ is
Washington, DC 20503. Comments sent burden.
defined in 44 U.S.C. 3502(3) and 5 CFR
to OMB by U.S. postal mail, however, DATES: Comments must be received by 1320.3(c) and includes agency requests
are subject to delays due to heightened February 13, 2017. or requirements that members of the
security precautions. Thus, comments ADDRESSES: When commenting, please public submit reports, keep records, or
instead should be sent by facsimile to reference the document identifier or provide information to a third party.
(202) 395–5806. OMB control number. To be assured Section 3506(c)(2)(A) of the PRA
The FTC Act and other laws that the consideration, comments and requires federal agencies to publish a
Commission administers permit the recommendations must be submitted in 60-day notice in the Federal Register
collection of public comments to any one of the following ways: concerning each proposed collection of
consider and use in this proceeding as 1. Electronically. You may send your information, including each proposed
appropriate. The Commission will comments electronically to http:// extension or reinstatement of an existing
consider all timely and responsive www.regulations.gov. Follow the collection of information, before
public comments that it receives on or instructions for ‘‘Comment or submitting the collection to OMB for
before January 13, 2017. For information Submission’’ or ‘‘More Search Options’’ approval. To comply with this
on the Commission’s privacy policy, to find the information collection requirement, CMS is publishing this
including routine uses permitted by the document(s) that are accepting notice.
Privacy Act, see http://www.ftc.gov/ftc/ comments.
privacy.htm. 2. By regular mail. You may mail Information Collection
David C. Shonka, written comments to the following 1. Type of Information Collection
Acting General Counsel. address: CMS, Office of Strategic Request: Extension of a previously
Operations and Regulatory Affairs, approved collection; Title of
[FR Doc. 2016–29946 Filed 12–13–16; 8:45 am]
Division of Regulations Development, Information Collection: Conditions of
BILLING CODE 6750–01–P
Attention: Document Identifier/OMB Participation: Requirements for
Control Number ll, Room C4–26–05, Approval and Reapproval of Transplant
7500 Security Boulevard, Baltimore, Centers to Perform Organ Transplants;
DEPARTMENT OF HEALTH AND Maryland 21244–1850. Use: The Conditions of Participation
HUMAN SERVICES To obtain copies of a supporting and accompanying requirements
statement and any related forms for the specified in the regulations are used by
Centers for Medicare & Medicaid
proposed collection(s) summarized in our surveyors as a basis for determining
Services
this notice, you may make your request whether a transplant center qualifies for
[Document Identifier CMS–10266 and CMS– using one of following: approval or re-approval under Medicare.
R–71] 1. Access CMS’ Web site address at We, along with the healthcare industry,
http://www.cms.hhs.gov/Paperwork believe that the availability to the
Agency Information Collection ReductionActof1995. facility of the type of records and
Activities: Proposed Collection; 2. Email your request, including your general content of records is standard
Comment Request address, phone number, OMB number, medical practice and is necessary in
AGENCY: Centers for Medicare & and CMS document identifier, to order to ensure the well-being and
Medicaid Services, HHS. Paperwork@cms.hhs.gov. safety of patients and professional
3. Call the Reports Clearance Office at treatment accountability. Form Number:
ACTION: Notice. (410) 786–1326. CMS–10266 (OMB Control Number:
SUMMARY: The Centers for Medicare & FOR FURTHER INFORMATION CONTACT: 0938–1069); Frequency: Yearly; Affected
Medicaid Services (CMS) is announcing Reports Clearance Office at (410) 786– Public: Business or other for-profits and
an opportunity for the public to 1326. Not-for-profit institutions; Number of
comment on CMS’ intention to collect SUPPLEMENTARY INFORMATION: Respondents: 226; Total Annual
information from the public. Under the Responses: 528; Total Annual Hours:
Paperwork Reduction Act of 1995 (the Contents
2,523. (For policy questions regarding
PRA), federal agencies are required to This notice sets out a summary of the this collection contact Diane Corning at
publish notice in the Federal Register use and burden associated with the 410–786–8486.)
sradovich on DSK3GMQ082PROD with NOTICES
concerning each proposed collection of following information collections. More 2. Type of Information Collection
information (including each proposed detailed information can be found in Request: Extension of a previously
extension or reinstatement of an existing each collection’s supporting statement approved collection; Title of
collection of information) and to allow and associated materials (see Information Collection: Quality
60 days for public comment on the ADDRESSES). Improvement Organization (QIO)
proposed action. Interested persons are CMS–10266 Conditions of Assumption of Responsibilities and
invited to send comments regarding our Participation: Requirements for Supporting Regulations; Use: The Peer
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![Federal Register / Vol. 81, No. 240 / Wednesday, December 14, 2016 / Notices 90361
Review Improvement Act of 1982 be received by March 27, 2017 (see comment, as well as any attachments,
amended Title XI of the Social Security SUPPLEMENTARY INFORMATION for except for information submitted,
Act to create the Utilization and Quality instructions). Public comments will be marked and identified, as confidential,
Control Peer Review Organization (PRO) accepted through June 6, 2017. See the if submitted as detailed in
program which replaces the Professional ADDRESSES section for information about ‘‘Instructions.’’
Standards Review Organization (PSRO) submitting comments to the public Instructions: All submissions received
program and streamlines peer review docket. must include the Docket No. FDA–
activities. The term PRO has been ADDRESSES: The public meeting will be 2016–N–4198 for ‘‘Public Meeting on
renamed Quality Improvement held at the FDA White Oak Campus, Patient-Focused Drug Development for
Organization (QIO). This information 10903 New Hampshire Ave., Bldg. 31 Sarcopenia; Request for Comments.’’
collection describes the review Conference Center, the Great Room, Received comments will be placed in
functions to be performed by the QIO. (Rm. 1503), Silver Spring, MD 20993– the docket and, except for those
It outlines relationships among QIOs, 0002. Entrance for the public meeting submitted as ‘‘Confidential
providers, practitioners, beneficiaries, participants (non-FDA employees) is Submissions,’’ publicly viewable at
intermediaries, and carriers. Form through Building 1 where routine https://www.regulations.gov or at the
Number: CMS–R–71 (OMB Control security check procedures will be Division of Dockets Management
Number: 0938–0445); Frequency: performed. For more information on between 9 a.m. and 4 p.m., Monday
Yearly; Affected Public: Private sector— parking and security procedures, please through Friday.
Business or other for-profit and Not-for- refer to http://www.fda.gov/AboutFDA/ • Confidential Submissions—To
profit institutions; Number of WorkingatFDA/BuildingsandFacilities/ submit a comment with confidential
Respondents: 6,939; Total Annual WhiteOakCampusInformation/ information that you do not wish to be
Responses: 44,015; Total Annual Hours: ucm241740.htm. made publicly available, submit your
100,065. (For policy questions regarding You may submit comments as comments only as a written/paper
this collection contact Tennille Coombs follows: submission. You should submit two
at 410–786–3472.) copies total. One copy will include the
Dated: December 9, 2016.
Electronic Submissions information you claim to be confidential
William N. Parham, III, Submit electronic comments in the with a heading or cover note that states
Director, Paperwork Reduction Staff, Office following way: ‘‘THIS DOCUMENT CONTAINS
of Strategic Operations and Regulatory • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
Affairs. https://www.regulations.gov. Follow the Agency will review this copy, including
[FR Doc. 2016–30024 Filed 12–13–16; 8:45 am] instructions for submitting comments. the claimed confidential information, in
BILLING CODE 4120–01–P Comments submitted electronically, its consideration of comments. The
including attachments, to https:// second copy, which will have the
www.regulations.gov will be posted to claimed confidential information
DEPARTMENT OF HEALTH AND the docket unchanged. Because your redacted/blacked out, will be available
HUMAN SERVICES comment will be made public, you are for public viewing and posted on
solely responsible for ensuring that your https://www.regulations.gov. Submit
Food and Drug Administration comment does not include any both copies to the Division of Dockets
confidential information that you or a Management. If you do not wish your
[Docket No. FDA–N–2016–4198]
third party may not wish to be posted, name and contact information to be
Public Meeting on Patient-Focused such as medical information, your or made publicly available, you can
Drug Development for Sarcopenia; anyone else’s Social Security number, or provide this information on the cover
Request for Comments confidential business information, such sheet and not in the body of your
as a manufacturing process. Please note comments and you must identify this
AGENCY: Food and Drug Administration, that if you include your name, contact information as ‘‘confidential.’’ Any
HHS. information, or other information that information marked as ‘‘confidential’’
ACTION: Notice of public meeting; identifies you in the body of your will not be disclosed except in
request for comments. comments, that information will be accordance with 21 CFR 10.20 and other
posted on https://www.regulations.gov. applicable disclosure law. For more
SUMMARY: The Food and Drug • If you want to submit a comment information about FDA’s posting of
Administration (FDA or Agency) is with confidential information that you comments to public dockets, see 80 FR
announcing a public meeting and an do not wish to be made available to the 56469, September 18, 2015, or access
opportunity for public comment on public, submit the comment as a the information at: http://www.fda.gov/
‘‘Patient-Focused Drug Development for written/paper submission and in the regulatoryinformation/dockets/
Sarcopenia.’’ Patient-Focused Drug manner detailed (see ‘‘Written/Paper default.htm.
Development is part of FDA’s Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to
performance commitments made as part read background documents or the
of the fifth authorization of the Written/Paper Submissions electronic and written/paper comments
Prescription Drug User Fee Act (PDUFA Submit written/paper submissions as received, go to https://
V). The public meeting is intended to follows: www.regulations.gov and insert the
allow FDA to obtain patient • Mail/Hand delivery/Courier (for docket number, found in brackets in the
sradovich on DSK3GMQ082PROD with NOTICES
perspectives on the impact of written/paper submissions): Division of heading of this document, into the
sarcopenia on daily life as well as Dockets Management (HFA–305), Food ‘‘Search’’ box and follow the prompts
patient views on treatment approaches and Drug Administration, 5630 Fishers and/or go to the Division of Dockets
for sarcopenia. Lane, Rm. 1061, Rockville, MD 20852. Management, 5630 Fishers Lane, Rm.
DATES: The public meeting will be held • For written/paper comments 1061, Rockville, MD 20852.
on April 6, 2017, from 1 p.m. to 5 p.m. submitted to the Division of Dockets FDA will post the agenda
Registration to attend the meeting must Management, FDA will post your approximately 5 days before the meeting
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Document Created: 2016-12-14 00:48:36
Document Modified: 2016-12-14 00:48:36
| 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 February 13, 2017. | |
| Contact | Reports Clearance Office at (410) 786- 1326. | |
| FR Citation | 81 FR 90360 |
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