Agency Information Collection Activities: Submission for OMB Review; Comment Request, 15796-15797 [2015-06884]

Download as PDF 15796 Federal Register / Vol. 80, No. 57 / Wednesday, March 25, 2015 / Notices SUPPLEMENTARY INFORMATION: Authority: 42 CFR 83.9–83.12. Pursuant to 42 CFR 83.12, the initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Hanford site. Location: Richland, Washington. Job Titles and/or Job Duties: All employees of Department of Energy contractors and subcontractors (excluding employees of the following Hanford prime contractors during the specified periods: Battelle Memorial Institute, January 1, 1984 through December 31, 1990; Rockwell Hanford Operations, January 1, 1984 through June 28, 1987; Boeing Computer Services Richland, January 1, 1984 through June 28, 1987; UNC Nuclear Industries, January 1, 1984 through June 28, 1987; Westinghouse Hanford Company, January 1, 1984 through December 31, 1990; and Hanford Environmental Health Foundation, January 1, 1984 through December 31, 1990. Period of Employment: January 1, 1984 through December 31, 1990. John Howard Director, National Institute for Occupational Safety and Health. [FR Doc. 2015–06784 Filed 3–24–15; 8:45 am] BILLING CODE 4163–19–P 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. 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 rljohnson on DSK3VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 15:26 Mar 24, 2015 Jkt 235001 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: OIRA_submission@omb.eop.gov. 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 https://www.cms.hhs.gov/Paperwork ReductionActof1995. 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: 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 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 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 E:\FR\FM\25MRN1.SGM 25MRN1 Federal Register / Vol. 80, No. 57 / Wednesday, March 25, 2015 / Notices 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 60day 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] rljohnson on DSK3VPTVN1PROD with NOTICES BILLING CODE 4120–01–P VerDate Sep<11>2014 15:26 Mar 24, 2015 Jkt 235001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–0001] Ninth Annual Drug Information Association/Food and Drug Administration Statistics Forum— 2015; Public Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. The Food and Drug Administration (FDA), in cosponsorship with the Drug Information Association (DIA), is announcing a public conference entitled ‘‘Ninth Annual DIA/ FDA Statistics Forum—2015’’. The purpose of the conference is to discuss relevant statistical issues associated with the development and review of therapeutic drugs and biologics. A primary focus for this meeting will be to establish an ongoing dialogue regarding FDA’s ‘‘Critical Path’’ initiative— emphasizing the regulatory and statistical challenges associated with innovative approaches to the design and analysis of clinical trial data and measuring the progress being made in designing and implementing innovative solutions. DATES: The public conference will be held from April 20, 2015, to April 22, 2015, from 8:30 a.m. to 5 p.m. each day. ADDRESSES: The public conference will be held at the Marriott Bethesda North Hotel and Conference Center, 5701 Marinelli Rd., North Bethesda, MD 20852, 301–822–9200. FOR FURTHER INFORMATION CONTACT: Ellen Diegel, Drug Information Association, 800 Enterprise Rd., Horsham, PA 19044, 215–442–6100, Ellen.Diegel@diahome.org; or Stephen Wilson, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 3630, Silver Spring, MD 20993– 0002, 301–796–0579, Stephen.Wilson@ fda.hhs.gov. SUMMARY: 15797 The goals of the program are to: • Explore and implement innovative statistical solutions to issues associated with the regulatory review of therapeutic drugs and biologics. • Describe the application of statistical methodologies and thinking to the development of new therapeutic biologics and drugs. • Assess the impact of regulations and guidance on statistical practice. • Discuss ideas for improving the communication between industry statisticians and FDA reviewers. A description of the planned activities of the working groups can be found at https://www.diahome.org/en-US/ Meetings-and-Training/Find-Meetingsand-Training/MeetingDetails.aspx?ProductID= 3630578&EventType=Meeting. II. Registration and Accommodations A. Registration To register, please submit the registration form online at https:// www.diahome.org/en-US/Meetings-andTraining/Find-Meetings-and-Training/ Meeting-Details.aspx?ProductID= 3630578&EventType=Meeting. (FDA has verified this Web site address but is not responsible for changes to the Web site after this document publishes in the Federal Register.) Seats are limited, and conference space will be filled in the order in which registrations are received. On-site registration will be available to the extent that space is available on the day of the conference. The costs of registration for different categories of attendees are as follows: Category Industry Representatives ...... Charitable Nonprofit/Academic (Full time) ............... Government (Full time) ......... Tutorial Fees ......................... Cost $1,440 720 430 405 I. Background This annual FDA/DIA statistics forum will be a unique, open, international forum for statisticians and clinicians from industry, academia, contract research organizations, and Government Agencies. Meeting participants will learn, discuss, and collaborate on the current and emerging statistical methodologies and quantitative approaches used by sponsors to provide evidence for the approval of new therapies. All registrants will be required to pay the applicable fee, with the exception of a limited number of speakers/organizers who will have a complimentary registration. (Government and nonprofit attendees and exhibitors will need an invitation code to register at the discounted rate. An invitation code can be obtained by sending an email to Ellen.Diegel@diahome.org.) Registration fees cover the costs of facilities, materials, and food functions. B. Accommodations SUPPLEMENTARY INFORMATION: PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 Attendees are responsible for their own accommodations. Reservations may be made online via the conference hotel reservation page at https:// www.tphousing.com/ph2/ E:\FR\FM\25MRN1.SGM 25MRN1

Agencies

[Federal Register Volume 80, Number 57 (Wednesday, March 25, 2015)]
[Notices]
[Pages 15796-15797]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[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: 
OIRA_submission@omb.eop.gov.
    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 https://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: 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

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