80 FR 15796 - Agency Information Collection Activities: Submission for OMB Review; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 80, Issue 57 (March 25, 2015)
Centers for Medicare & Medicaid Services
Federal Register Volume 80, Issue 57 (March 25, 2015)
| Page Range | 15796-15797 | |
| FR Document | 2015-06884 |
[Federal Register Volume 80, Number 57 (Wednesday, March 25, 2015)] [Notices] [Pages 15796-15797] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-06884] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifiers: CMS-10241, CMS-10249, and CMS-10545] 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 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 April 24, 2015. 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: Revision of a currently approved collection; Title of Information Collection: Survey of Retail Prices: Payment and Utilization Rates, and Performance Rankings; Use: This study is divided into two parts. Part I focuses on the retail community pharmacy consumer prices. It also includes reporting by the states of payment and utilization rates for the 50 most widely prescribed drugs, and comparing state drug payment rates with the national retail survey prices. Part II focuses on the retail community pharmacy ingredient costs. This segment surveys the average acquisition costs of all covered outpatient drugs purchased by retail community pharmacies. The prices will be updated on at least a monthly basis. Subsequent to the publication of the 60-day Federal Register notice (79 FR 75816), the burden has been reduced by removing requirements for Part I pending funding decisions. There are no changes to Part II. Form Number: CMS-10241 (OMB control number 0938-1041); Frequency: Yearly and Occasionally; Affected Public: Private sector (Business or other for- profits); Number of Respondents: 30,000; Total Annual Responses: 30,000; Total Annual Hours: 15,000. (For policy questions regarding this collection contact: Lisa Ferrandi at 410-786-5445). 2. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Administrative Requirements for Section 6071 of the Deficit Reduction Act; Use: State Operational Protocols should provide enough information such that: The CMS Project Officer and other federal officials may use it to understand the operation of the demonstration, prepare for potential site visits without needing additional information, or both; the State Project Director can use it as the manual for program implementation; and external stakeholders may use it to understand the operation of the demonstration. The financial information collection is used in our financial statements and shared with the auditors who validate CMS' financial position. The Money Follows the Person Rebalancing Demonstration (MFP) Finders File, MFP Program Participation Data file, and MFP Services File are used by the national evaluation contractor to assess program outcomes while we use the information to monitor program implementation. The MFP Quality of Life data is used by the national evaluation contractor to assess [[Page 15797]] program outcomes. The evaluation is used to determine how participants' quality of life changes after transitioning to the community. The semi- annual progress report is used by the national evaluation contractor and CMS to monitor program implementation at the grantee level. Form Number: CMS-10249 (OMB control number: 0938-1053); Frequency: Yearly, quarterly, and semi-annually; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 45; Total Annual Responses: 28,590; Total Annual Hours: 14,225. (For policy questions regarding this collection contact Michael Smith at 410-786-2267.) 3. Type of Information Collection Request: New collection (Request for a new OMB control number); Title of Information Collection: Outcome and Assessment Information Set (OASIS) OASIS-C1/ICD-10; Use: Home health agencies (HHAs) are required to collect the outcome and assessment information data set (OASIS) to participate in the Medicare program. We are requesting a new OMB control number for the proposed revised OASIS item set, referred to hereafter as OASIS-C1/ICD-10. The current version of the OASIS-C1/ICD-9 data set was approved by OMB on October 7, 2014 (0938-0760), and will be in use until the implementation of the ICD-10 coding system which is currently scheduled for October 1, 2015. Subsequent to the 60-day Federal Register notice (80 FR 1419), there was a minor typographical correction made to the data set. Form Number: CMS-10545 (OMB control number: 0938-NEW); Frequency: Occasionally; Affected Public: Private Sector (Business or other for-profit and Not-for-profit institutions); Number of Respondents: 12,014; Total Annual Responses: 17,268,890; Total Annual Hours: 15,320,253. (For policy questions regarding this collection contact Cheryl Wiseman at 410-786-1175). Dated: March 17, 2015. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2015-06884 Filed 3-20-15; 5:15 pm] BILLING CODE 4120-01-P
![15796 Federal Register / Vol. 80, No. 57 / Wednesday, March 25, 2015 / Notices
SUPPLEMENTARY INFORMATION: information, including any of the the following proposed collection(s) of
Authority: 42 CFR 83.9–83.12. following subjects: (1) The necessity and information for public comment:
utility of the proposed information 1. Type of Information Collection
Pursuant to 42 CFR 83.12, the initial collection for the proper performance of Request: Revision of a currently
proposed definition for the class being the agency’s functions; (2) the accuracy approved collection; Title of
evaluated, subject to revision as of the estimated burden; (3) ways to Information Collection: Survey of Retail
warranted by the evaluation, is as enhance the quality, utility, and clarity Prices: Payment and Utilization Rates,
follows: of the information to be collected; and and Performance Rankings; Use: This
Facility: Hanford site. (4) the use of automated collection study is divided into two parts. Part I
Location: Richland, Washington. techniques or other forms of information focuses on the retail community
Job Titles and/or Job Duties: All pharmacy consumer prices. It also
technology to minimize the information
employees of Department of Energy includes reporting by the states of
collection burden.
contractors and subcontractors payment and utilization rates for the 50
DATES: Comments on the collection(s) of
(excluding employees of the following most widely prescribed drugs, and
Hanford prime contractors during the information must be received by the
OMB desk officer by April 24, 2015. comparing state drug payment rates
specified periods: Battelle Memorial with the national retail survey prices.
Institute, January 1, 1984 through ADDRESSES: When commenting on the
proposed information collections, Part II focuses on the retail community
December 31, 1990; Rockwell Hanford pharmacy ingredient costs. This
Operations, January 1, 1984 through please reference the document identifier
or OMB control number. To be assured segment surveys the average acquisition
June 28, 1987; Boeing Computer costs of all covered outpatient drugs
Services Richland, January 1, 1984 consideration, comments and
recommendations must be received by purchased by retail community
through June 28, 1987; UNC Nuclear pharmacies. The prices will be updated
Industries, January 1, 1984 through June the OMB desk officer via one of the
following transmissions: OMB, Office of on at least a monthly basis. Subsequent
28, 1987; Westinghouse Hanford to the publication of the 60-day Federal
Company, January 1, 1984 through Information and Regulatory Affairs,
Attention: CMS Desk Officer, Fax Register notice (79 FR 75816), the
December 31, 1990; and Hanford burden has been reduced by removing
Environmental Health Foundation, Number: (202) 395–5806 OR, Email:
OIRA_submission@omb.eop.gov. requirements for Part I pending funding
January 1, 1984 through December 31, decisions. There are no changes to Part
1990. To obtain copies of a supporting
statement and any related forms for the II. Form Number: CMS–10241 (OMB
Period of Employment: January 1, control number 0938–1041); Frequency:
1984 through December 31, 1990. proposed collection(s) summarized in
this notice, you may make your request Yearly and Occasionally; Affected
John Howard using one of following: Public: Private sector (Business or other
Director, National Institute for Occupational 1. Access CMS’ Web site address at for-profits); Number of Respondents:
Safety and Health. http://www.cms.hhs.gov/Paperwork 30,000; Total Annual Responses:
[FR Doc. 2015–06784 Filed 3–24–15; 8:45 am] ReductionActof1995. 30,000; Total Annual Hours: 15,000.
2. Email your request, including your (For policy questions regarding this
BILLING CODE 4163–19–P
address, phone number, OMB number, collection contact: Lisa Ferrandi at 410–
and CMS document identifier, to 786–5445).
DEPARTMENT OF HEALTH AND Paperwork@cms.hhs.gov. 2. Type of Information Collection
HUMAN SERVICES 3. Call the Reports Clearance Office at Request: Extension of a currently
(410) 786–1326. approved collection; Title of
Centers for Medicare & Medicaid FOR FURTHER INFORMATION CONTACT:
Information Collection: Administrative
Services Reports Clearance Office at (410) 786– Requirements for Section 6071 of the
Deficit Reduction Act; Use: State
[Document Identifiers: CMS–10241, CMS– 1326.
Operational Protocols should provide
10249, and CMS–10545] SUPPLEMENTARY INFORMATION: Under the enough information such that: The CMS
Paperwork Reduction Act of 1995 (PRA) Project Officer and other federal officials
Agency Information Collection (44 U.S.C. 3501–3520), federal agencies
Activities: Submission for OMB may use it to understand the operation
must obtain approval from the Office of of the demonstration, prepare for
Review; Comment Request Management and Budget (OMB) for each potential site visits without needing
ACTION: Notice. collection of information they conduct additional information, or both; the
or sponsor. The term ‘‘collection of State Project Director can use it as the
SUMMARY: The Centers for Medicare & information’’ is defined in 44 U.S.C. manual for program implementation;
Medicaid Services (CMS) is announcing 3502(3) and 5 CFR 1320.3(c) and and external stakeholders may use it to
an opportunity for the public to includes agency requests or understand the operation of the
comment on CMS’ intention to collect requirements that members of the public demonstration. The financial
information from the public. Under the submit reports, keep records, or provide information collection is used in our
Paperwork Reduction Act of 1995 information to a third party. Section financial statements and shared with the
(PRA), federal agencies are required to 3506(c)(2)(A) of the PRA (44 U.S.C. auditors who validate CMS’ financial
publish notice in the Federal Register 3506(c)(2)(A)) requires federal agencies position. The Money Follows the Person
concerning each proposed collection of to publish a 30-day notice in the Rebalancing Demonstration (MFP)
information, including each proposed Federal Register concerning each Finders File, MFP Program Participation
rljohnson on DSK3VPTVN1PROD with NOTICES
extension or reinstatement of an existing proposed collection of information, Data file, and MFP Services File are
collection of information, and to allow including each proposed extension or used by the national evaluation
a second opportunity for public reinstatement of an existing collection contractor to assess program outcomes
comment on the notice. Interested of information, before submitting the while we use the information to monitor
persons are invited to send comments collection to OMB for approval. To program implementation. The MFP
regarding the burden estimate or any comply with this requirement, CMS is Quality of Life data is used by the
other aspect of this collection of publishing this notice that summarizes national evaluation contractor to assess
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![Federal Register / Vol. 80, No. 57 / Wednesday, March 25, 2015 / Notices 15797
program outcomes. The evaluation is DEPARTMENT OF HEALTH AND The goals of the program are to:
used to determine how participants’ HUMAN SERVICES • Explore and implement innovative
quality of life changes after transitioning statistical solutions to issues associated
to the community. The semi-annual Food and Drug Administration with the regulatory review of
progress report is used by the national [Docket No. FDA–2015–N–0001] therapeutic drugs and biologics.
evaluation contractor and CMS to • Describe the application of
monitor program implementation at the Ninth Annual Drug Information statistical methodologies and thinking
grantee level. Form Number: CMS– Association/Food and Drug to the development of new therapeutic
10249 (OMB control number: 0938– Administration Statistics Forum— biologics and drugs.
2015; Public Conference • Assess the impact of regulations
1053); Frequency: Yearly, quarterly, and
and guidance on statistical practice.
semi-annually; Affected Public: State, AGENCY: Food and Drug Administration, • Discuss ideas for improving the
Local, or Tribal Governments; Number HHS. communication between industry
of Respondents: 45; Total Annual ACTION: Notice of public conference. statisticians and FDA reviewers.
Responses: 28,590; Total Annual Hours: A description of the planned activities
14,225. (For policy questions regarding SUMMARY: The Food and Drug of the working groups can be found at
this collection contact Michael Smith at Administration (FDA), in cosponsorship http://www.diahome.org/en-US/
410–786–2267.) with the Drug Information Association Meetings-and-Training/Find-Meetings-
3. Type of Information Collection (DIA), is announcing a public and-Training/Meeting-
conference entitled ‘‘Ninth Annual DIA/ Details.aspx?ProductID=
Request: New collection (Request for a
FDA Statistics Forum—2015’’. The 3630578&EventType=Meeting.
new OMB control number); Title of
purpose of the conference is to discuss
Information Collection: Outcome and relevant statistical issues associated II. Registration and Accommodations
Assessment Information Set (OASIS) with the development and review of
OASIS–C1/ICD–10; Use: Home health A. Registration
therapeutic drugs and biologics. A
agencies (HHAs) are required to collect primary focus for this meeting will be to To register, please submit the
the outcome and assessment establish an ongoing dialogue regarding registration form online at http://
information data set (OASIS) to FDA’s ‘‘Critical Path’’ initiative— www.diahome.org/en-US/Meetings-and-
participate in the Medicare program. We emphasizing the regulatory and Training/Find-Meetings-and-Training/
are requesting a new OMB control statistical challenges associated with Meeting-Details.aspx?ProductID=
number for the proposed revised OASIS innovative approaches to the design and 3630578&EventType=Meeting. (FDA has
item set, referred to hereafter as OASIS– analysis of clinical trial data and verified this Web site address but is not
C1/ICD–10. The current version of the measuring the progress being made in responsible for changes to the Web site
OASIS–C1/ICD–9 data set was approved designing and implementing innovative after this document publishes in the
by OMB on October 7, 2014 (0938– solutions. Federal Register.) Seats are limited, and
conference space will be filled in the
0760), and will be in use until the DATES: The public conference will be
order in which registrations are
implementation of the ICD–10 coding held from April 20, 2015, to April 22,
received. On-site registration will be
system which is currently scheduled for 2015, from 8:30 a.m. to 5 p.m. each day.
available to the extent that space is
October 1, 2015. Subsequent to the 60- ADDRESSES: The public conference will available on the day of the conference.
day Federal Register notice (80 FR be held at the Marriott Bethesda North The costs of registration for different
1419), there was a minor typographical Hotel and Conference Center, 5701 categories of attendees are as follows:
correction made to the data set. Form Marinelli Rd., North Bethesda, MD
Number: CMS–10545 (OMB control 20852, 301–822–9200. Category Cost
number: 0938–NEW); Frequency: FOR FURTHER INFORMATION CONTACT:
Occasionally; Affected Public: Private Ellen Diegel, Drug Information Industry Representatives ...... $1,440
Sector (Business or other for-profit and Association, 800 Enterprise Rd., Charitable Nonprofit/Aca-
Horsham, PA 19044, 215–442–6100, demic (Full time) ............... 720
Not-for-profit institutions); Number of Government (Full time) ......... 430
Respondents: 12,014; Total Annual Ellen.Diegel@diahome.org; or Stephen Tutorial Fees ......................... 405
Responses: 17,268,890; Total Annual Wilson, Food and Drug Administration,
Hours: 15,320,253. (For policy questions 10903 New Hampshire Ave., Bldg. 21, All registrants will be required to pay
regarding this collection contact Cheryl Rm. 3630, Silver Spring, MD 20993– the applicable fee, with the exception of
Wiseman at 410–786–1175). 0002, 301–796–0579, Stephen.Wilson@ a limited number of speakers/organizers
fda.hhs.gov. who will have a complimentary
Dated: March 17, 2015.
SUPPLEMENTARY INFORMATION: registration. (Government and nonprofit
William N. Parham, III,
attendees and exhibitors will need an
Director, Paperwork Reduction Staff, Office I. Background
invitation code to register at the
of Strategic Operations and Regulatory This annual FDA/DIA statistics forum discounted rate. An invitation code can
Affairs. will be a unique, open, international be obtained by sending an email to
[FR Doc. 2015–06884 Filed 3–20–15; 5:15 pm] forum for statisticians and clinicians Ellen.Diegel@diahome.org.) Registration
BILLING CODE 4120–01–P from industry, academia, contract fees cover the costs of facilities,
research organizations, and Government materials, and food functions.
rljohnson on DSK3VPTVN1PROD with NOTICES
Agencies. Meeting participants will
learn, discuss, and collaborate on the B. Accommodations
current and emerging statistical Attendees are responsible for their
methodologies and quantitative own accommodations. Reservations may
approaches used by sponsors to provide be made online via the conference hotel
evidence for the approval of new reservation page at https://
therapies. www.tphousing.com/ph2/
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Document Created: 2018-02-21 09:49:00
Document Modified: 2018-02-21 09:49:00
| 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 April 24, 2015. | |
| Contact | Reports Clearance Office at (410) 786- 1326. | |
| FR Citation | 80 FR 15796 |
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