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. 

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 

http://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 

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 


rljohnson on DSK3VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 57 / Wednesday, March 25, 2015 / Notices 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 

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. 

SUMMARY: 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. 

SUPPLEMENTARY INFORMATION: 

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. 

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 

http://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 http://

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 Cost 

Industry Representatives ...... $1,440 

Charitable Nonprofit/Academic (Full time) ............... 720 

Government (Full time) ......... 430 

Tutorial Fees ......................... 405 

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 

Attendees are responsible for their 

own accommodations. Reservations may 

be made online via the conference hotel 

reservation page at https://

www.tphousing.com/ph2/


rljohnson on DSK3VPTVN1PROD with NOTICES